Historical Catalyst Calendar

Biotech Stock Historical Catalysts listed from 2009.

What's included?

2009 ~ Most small/mid capFDA Approval and Complete Response Letters.

January 2015 ~ Most key small/mid cap Phase 3 data releases.

August 2016 ~ Most key small/mid cap Phase 2 and Phase 3 data releases.

January 2016 ~ Most key large cap releases (data and regulatory).

View the BioPharmCatalyst FDA Calendar for a list of upcoming key catalysts.

Note: Most bankrupt or acquired companies are not included.

Key catalysts are generally inputted at the end of each trading session.

showing 2363 records

Ticker	Drug	Stage	Catalyst
SPPI	ZEVALIN Non-Hodgkin’s lymphoma	CRL	07/05/2009 CRL received July 5, 2009.
ZGNX	Sumavel Migraine	Approved	07/16/2009 Approved July 16, 2009.
SPPI	ZEVALIN Non-Hodgkin’s lymphoma	Approved	09/04/2009 Approved September 4, 2009.
SPPI	FUSILEV Colorectal cancer	CRL	10/09/2009 CRL received October 9, 2009.
PRTK	Intermezzo Insomnia	CRL	11/02/2009 CRL issued November 2, 2009.
AIM	Ampligen CFS	CRL	12/01/2009 CRL issued December 1, 2009.
ACOR	Ampyra Improve walking in patients with multiple sclerosis	Approved	01/22/2010 Approved January 22, 2010.
ALKS	BYDUREON Type 2 diabetes	Approved	01/27/2010 Approved January 27, 2010.
ALKS	BYDUREON Type 2 diabetes	CRL	03/15/2010 CRL received March 15, 2010.
MNKD	AFREZZA Type 1/2 diabetes	CRL	03/15/2010 CRL issued March 15, 2010.
HRTX	APF530 - Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)	CRL	03/19/2010 CRL issued March 19, 2010.
CTIC	PIXUVRI - PIX306 Trial B-cell non-Hodgkin lymphoma	CRL	04/09/2010 CRL received April 9, 2010.
JAZZ	JZP-6 Fibromyalgia	CRL	10/11/2010 CRL received October 11, 2010.
VVUS	Qnexa Obesity	CRL	10/28/2010 October 28, 2010.
MNKD	AFREZZA Type 1/2 diabetes	CRL	01/19/2011 CRL received January 19, 2011.
ASRT	GRALISE Postherpetic neuralgia - shingles	Approved	01/28/2011 Approved January 28, 2011.
PLX	Taliglucerase alfa Gaucher disease	CRL	02/25/2011 CRL issued February 25, 2011.
SPPI	FUSILEV Colorectal cancer	Approved	04/29/2011 Approved April 29, 2011.
SGEN	ADCETRIS Hodgkin lymphoma and Anaplastic large cell lymphoma	Approved	08/19/2011 Approval announced August 19, 2011.
TAK	ADCETRIS Hodgkin lymphoma and Anaplastic large cell lymphoma	Approved	08/19/2011 Approval announced August 19, 2011.
PCRX	EXPAREL Postsurgical pain	Approved	10/31/2011 Approved October 31, 2011.
EYPT	Iluvien Diabetic macular edema	CRL	11/11/2011 CRL November 11, 2011.
ALIM	Iluvien Diabetic macular edema	CRL	11/11/2011 CRL November 2011.
INCY	Jakafi Myelofibrosis	Approved	11/16/2011 Approved November 16, 2011.
PRTK	Intermezzo Insomnia	Approved	11/23/2011 Approved November 23, 2011.
ATRS	Anturol Overactive bladder	Approved	12/08/2011 Approved December 8, 2011.
CRIS	Vismodegib Basal Cell Carcinoma	Approved	01/30/2012 Approved January 30, 2012.
CORT	Corlux - Korlym Cushing's Syndrome	Approved	02/17/2012 Approved February 17, 2012.
VVUS	Avanafil Erectile dysfunction	Approved	04/27/2012 Approved April 27, 2012.
PLX	Taliglucerase alfa Gaucher disease	Approved	05/01/2012 Approved May 1, 2012.
EBS	BioThrax Anthrax Vaccine	Approved	05/17/2012 Approved May 17, 2012.
RGEN	RG1068 Detection of pancreatic duct abnormalities	CRL	06/22/2012 CRL received June 22, 2012.
ARNA	Lorcaserin Obesity	Approved	06/27/2012 Approved June 27, 2012.
VVUS	Qnexa Obesity	Approved	07/17/2012 Approved July 17, 2012.
AMRN	Vascepa High Triglycerides With Mixed Dyslipidemia	Approved	07/26/2012 Approved July 26, 2012.
HALO	HYQVIA Subcutaneous treatment for patients with primary immunodeficiency (PI)	CRL	08/01/2012 CRL issued August 1, 2012.
NAVB	Lymphoseek Lymphatic-tissue tracing agent	CRL	09/10/2012 CRL issued September 10, 2012.
SUPN	Oxtellar Epilepsy	Approved	10/22/2012 Approved October 22, 2012.
EXEL	Cabozantinib Medullary thyroid cancer	Approved	11/29/2012 Approved November 29, 2012.
TAK	Cabozantinib Medullary thyroid cancer	Approved	11/29/2012 Approved November 29, 2012.
AIM	Ampligen CFS	CRL	02/04/2013 CRL February 4, 2013.
IMGN	Kadcyla 2nd-line HER2+ Metastatic Breast Cancer	Approved	02/22/2013 Approved February 22, 2013 - under priority review.
DVAX	HEPLISAV-B Hepatitis B	CRL	02/25/2013 CRL issued February 25, 2013.
NAVB	Lymphoseek Lymphatic-tissue tracing agent	Approved	03/13/2013 Approved March 13, 2013.
HRTX	APF530 - Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)	CRL	03/28/2013 CRL March, 28 2013.
TTNP	Probuphine Opioid dependence	CRL	04/30/2013 CRL issued April 30, 2013.
ENDP	AVEED (testosterone undecanoate) intramuscular injection Men diagnosed with hypogonadism	CRL	05/30/2013 CRL issued September 5, 2013.
ASRT	SEFELSA Hot flashes	CRL	05/31/2013 CRL issued May 31, 2013.
AVDL	Bloxiverz (neostigmine methylsulfate) Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery	Approved	06/03/2013 Approved June 3, 2013.
AVEO	Tivozanib Third line treatment of patients with renal cell cancer	CRL	06/10/2013 CRL issued June 10, 2013.
TBPH	VIBATIV (telavancin hydrochloride) for injection Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)	Approved	06/21/2013 Approved June 21, 2013.
SUPN	Trokendi Epilepsy	Approved	08/19/2013 Approved Aug 19, 2013.
ATRS	OTREXUP Rheumatoid arthritis (RA)	Approved	10/14/2013 Approved Oct 14, 2013.
ALIM	Iluvien Diabetic macular edema	CRL	10/17/2013 Second CRL October 17, 2013.
EYPT	Iluvien Diabetic macular edema	CRL	10/18/2013 Second CRL October 18, 2013.
ZGNX	Zohydro ER Moderate to severe pain	Approved	10/25/2013 Approved October 25, 2013.
ABBV	Ibrutinib Relapsed or refractory MCL mantle cell lymphoma	Approved	11/13/2013 Approved November 13, 2013.
AMAG	Feraheme Adults with iron deficiency anemia (IDA)	CRL	01/22/2014 CRL issued January 22, 2014.
VNDA	HETLIOZ (tasimelteon) Insomnia	Approved	01/31/2014 Approved January 31, 2014.
DRRX	Posidur Post-operative pain relief	CRL	02/12/2014 CRL issued February 12, 2014.
ABBV	Imbruvica Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy	Approved	02/12/2014 Approved February 12, 2014.
BMRN	Vimizim (GALNS) (MPS IVA) Morquio A Syndrome	Approved	02/14/2014 Approved February 14, 2014.
ENDP	AVEED (testosterone undecanoate) intramuscular injection Men diagnosed with hypogonadism	Approved	03/06/2014 Approved March 6, 2014.
NVS	Cangrelor Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)	CRL	04/30/2014 CRL April 30 2014.
OMER	Omidria Cataract surgery	Approved	06/02/2014 Approved June 2, 2014.
BDSI	BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL Opioid dependence	Approved	06/06/2014 Approved June 6, 2014.
NAVB	Lymphoseek Head and Neck Cancer	Approved	06/13/2014 Approved June 13, 2014.
MNKD	AFREZZA Type 1/2 diabetes	Approved	06/27/2014 Approved June 27, 2014.
AVDL	VAZCULEP (phenylephrine hydrochloride) Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia	Approved	06/30/2014 Approved June 30, 2014.
EGRX	EP-3101 (bendamustine RTD) Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphoma - cancer	Approved	07/02/2014 Tentative approval July 2 2014. Teva has also received orphan drug and related pediatric exclusivity expiring in September 2015 and May 2016 for the CLL and NHL indications, respectively.
SPPI	Belinostat Peripheral T-Cell Lymphoma cancer	Approved	07/07/2014 Approved July 7, 2014.
ABBV	Imbruvica Deletion 17p	Approved	07/19/2014 Approved July 19, 2014.
EGRX	Ryanodex Malignant hyperthermia - cancer	Approved	07/23/2014 Approved July 23, 2014 under priority review.
ACRX	Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery	CRL	07/25/2014 CRL issued July 25 2014.
NVS	Oritavancin ABSSSI	Approved	08/06/2014 Approved August 6, 2014 under priority review
AKBA	Auryxia Hyperphosphatemia	Approved	09/05/2014 Approved Sept 5, 2014.
HALO	HYQVIA Subcutaneous treatment for patients with primary immunodeficiency (PI)	Approved	09/12/2014 Approved September 12, 2014.
NKTR	MOVANTIK (Naloxegol) Opioid-induced constipation (OIC)	Approved	09/16/2014 Approved September 16, 2014.
EYPT	Iluvien Diabetic macular edema	Approved	09/26/2014 Approved Sept 26 2014.
ALIM	Iluvien Diabetic macular edema	Approved	09/26/2014 Approved September 26, 2014,
LNTH	Subcutaneous RELISTOR Chronic pain	Approved	09/29/2014 Approved September 29, 2014.
AEZS	Macimorelin Acetate - Macrilen Adult Growth Deficiency	CRL	11/06/2014 CRL issued November 6, 2014.
INCY	Jakafi (ruxolitinib) (RESPONSE) Polycythemia Vera	Approved	12/04/2014 Approved December 4, 2014.
ABBV	VIEKIRA PAK HCV - genotype 1	Approved	12/19/2014 Approved December 19, 2014.
ENTA	VIEKIRA PAK HCV - genotype 1	Approved	12/19/2014 Approved December 19, 2014.
BCRX	RAPIVAB (peramivir) INFLUENZA ACUTE	Approved	12/22/2014 Approved December 22, 2014.
ADMS	Namzaric Moderate to severe dementia of the Alzheimer's type.	Approved	12/24/2014 Approved December, 24 2014.
VRTX	KALYDECO Cystic fibrosis (CF) ages 6 and older who have the R117H mutation	Approved	12/29/2014 Approved December 29, 2014.
NBIX	Elagolix Endometriosis	Phase 3	01/08/2015 First Phase 3 trial met both co-primary endpoints - January 8, 2015.
ABBV	Elagolix Endometriosis	Phase 3	01/08/2015 First Phase 3 trial met both co-primary endpoints - January 8, 2015.
RMTI	Soluble Ferric Pyrophosphate Anemia	Approved	01/26/2015 Approved January 26, 2015.
ABBV	IMBRUVICA Waldenström’s Macroglobulinemia	Approved	01/29/2015 Approved January 29, 2015 - PCYC
ZGNX	Abuse deterrent formulations of Zohydro ER Moderate to severe pain	Approved	01/30/2015 Approved January 30, 2015.
PCRX	EXPAREL Post surgical pain	CRL	03/02/2015 CRL March 2, 2015.
VRTX	KALYDECO (ivacaftor) Children ages 2 to 5 with cystic fibrosis who have the G551D or one of the eight additional gating mutations	Approved	03/17/2015 Approved March 17, 2015.
NKTR	Etirinotecan pegol NKTR-102 (BEACON) Cancer - Metastatic Breast Cancer	Phase 3	03/17/2015 Phase 3 topline data mid March 17, 2015 did not reach primary endpoint.
ADMP	Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis.	CRL	03/25/2015 CRL issued March 27 2015.
EBS	Anthrax Immune Globulin Intravenous (Human) [AIGIV] Anthrax	PDUFA	03/25/2015 Approved March 25, 2015.
AMGN	Corlanor Chronic Heart Failure	Approved	04/15/2015 Approved April 15, 2015.
JNJ	Generic Copaxone Multiple sclerosis	Approved	04/16/2015 Approved April 16 2015.
MNK	RAPLIXA Hemostasis	Approved	04/30/2015 Approved April 30, 2015.
TBPH	BREO ELLIPTA Asthma	Approved	04/30/2015 Approved April 30, 2015.
NVS	IONSYS Acute postoperative pain	Approved	04/30/2015 Approved April 30, 2015.
VRTX	Lumacaftor and ivacaftor Cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation	Approved	07/02/2015 Approved July 2, 2015.
NYMX	NX-1207 Fexapotide BPH	Phase 3	07/27/2015 Phase 3 endpoints met in extension trial July 2015.
SGEN	ADCETRIS - AETHERA Post-transplant Hodgkin lymphoma (HL) cancer	Approved	08/17/2015 Approved August 17, 2015 under priority review.
TAK	ADCETRIS - AETHERA Post-transplant Hodgkin lymphoma (HL) cancer	Approved	08/17/2015 Approved August 17, 2015 under priority review.
MACK	ONIVYDE Cancer - second line pancreatic	Approved	10/22/2015 Approved October 22, 2015.
IMGN	Kadcyla GATSBY trial Cancer - metastatic HER2+ gastric cancer	Phase 3	10/22/2015 Phase 3 endpoint not met - October 22, 2015.
SPPI	EVOMELA (melphalan) for Injection Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma	CRL	10/23/2015 CRL issued October 23, 2015.
BDSI	BEMA Buprenorphine Pain	Approved	10/25/2015 Approved October 26, 2015.
ENDP	BEMA Buprenorphine Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate	Approved	10/26/2015 Approved October 26, 2015.
EXEL	Vemurafenib BRAF V600 Mutation-Positive Advanced Melanoma - Cancer	Approved	11/10/2015 Approved November 10, 2015.
NKTR	ADYNOVATE Hemophilia A	Approved	11/16/2015 Approved November 16, 2015.
EBS	BioThrax Anthrax Vaccine Adsorbed	Approved	11/24/2015 Approved November 24, 2015.
OTIC	OTIPRIO (ciprofloxacin otic suspension) Ear Tube Placement Surgery	Approved	12/11/2015 Approved December 11, 2015.
ADMS	GOCOVRI (ADS-5102) Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes	Phase 3	12/23/2015 Phase 3 data released December 23, 2015.
EGRX	Docetaxel Injection Breast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancer	Approved	12/24/2015 Approved December 24, 2015.
CHRS	CHS-0214 Rheumatoid arthritis	Phase 3	01/11/2016 Phase 3 data released January 2016. Endpoints met. However, commercialization not possible in US before 2029 due to patent issues
BMRN	Kyndrisa Duchenne Muscular Dystrophy (DMD)	CRL	01/14/2016 CRL issued January 14 2016.
NEOS	Adzenys XR-ODT Attention deficit hyperactivity disorder (ADHD)	Approved	01/27/2016 Approved January 27, 2016.
VRTX	KALYDECO (ivacaftor) Cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.	CRL	02/05/2016 CRL issued February 5, 2016.
NBIX	Elagolix Endometriosis	Phase 3	02/10/2016 First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints.
ABBV	Elagolix Endometriosis	Phase 3	02/10/2016 First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints.
RDHL	Talicia RHB-105 H. pylori	Phase 3	03/08/2016 Phase 3 final data released March 8, 2016.
GWPH	Epidiolex Dravet Syndrome and Lennox-Gastaut syndrome	Phase 3	03/14/2016 Top line Phase 3 data released March 14, 2016 met primary endpoint.
SPPI	EVOMELA (melphalan) for Injection Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma	Approved	03/15/2016 Approved March 15 2016.
EGRX	KANGIO (bivalirudin injection) Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)	CRL	03/18/2016 CRL March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product.
ALXN	Bevyxxa (betrixaban) Venous thromboembolism (VTE) Prevention	Phase 3	03/24/2016 Phase 3 data released March 24, 2016 did not meet primary endpoint.
OPK	RAYALDEE Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4	CRL	03/30/2016 CRL issued March 30, 2016.
CHMA	Mycapssa Acromegaly	CRL	04/15/2016 CRL April 15, 2016.
EXEL	CABOMETYX (cabozantinib) Metastatic renal cell cancer (RCC)	Approved	04/25/2016 Approved April 25, 2016.
ACAD	Pimavanserin Parkinson’s disease psychosis (PDP)	Approved	04/29/2016 Approved April 29, 2016.
AVDL	Akovaz Hypotension	Approved	05/02/2016 Approved May 2, 2016.
TTNP	Probuphine Opioid dependence	Approved	05/26/2016 CRL issued April 30, 2013. Approved May 26, 2016.
VNDA	Fanapt Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.	Approved	05/26/2016 Approved May 26, 2016.
AZN	Lokelma (ZS-9) Hyperkalaemia	CRL	05/26/2016 CRL issued May 26, 2016.
ICPT	Obeticholic acid (Ocaliva) Primary biliary cirrhosis (PBC) - POISE	Approved	05/27/2016 Approved May 27 2016.
ADMP	Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis.	CRL	06/06/2016 CRL issued March 27 2015. CRL issued again June 6, 2016.
OCUL	DEXTENZA Allergic conjunctivitis	Phase 3	06/06/2016 Phase 3 trial did not meet primary endpoint - June 6, 2016.
RVNC	DAXI (RT002) Lateral Canthal (Crow’s Feet) Lines	Phase 3	06/13/2016 Phase 3 endpoints not met June 13, 2016.
MRNS	Ganaxolone Focal onset seizures	Phase 3	06/13/2016 Phase 3 data did not meet endpoints - June 13, 2016
PRTK	Omadacycline Acute bacterial skin and skin structure infections (ABSSSI)	Phase 3	06/16/2016 Phase 3 top-line data met endpoints - June 16, 2016
OPK	RAYALDEE Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4	Approved	06/21/2016 Announced FDA Approval June 21, 2016.
NVS	Meropenem-vaborbactam Complicated urinary tract infections (cUTI)	Phase 3	06/27/2016 Phase 3 data met endpoints June 27, 2016.
CLVS	Rociletinib Mutant EGFR T790M-positive lung cancer	CRL	06/28/2016 CRL June 28, 2016. Phase 3 TIGER-3 also terminated.
GSK	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Phase 3	06/29/2016 Phase 3 data met endpoints - June 2016.
LPCN	TLANDO - LPCN 1021 Men with low testosterone (Low T)	CRL	06/29/2016 CRL issued June 29, 2016.
AMPE	Ampion Osteoarthritis of the Knee	Phase 3	06/30/2016 STRIDE study mid April 2015 did not meet endpoint. Second Phase 3 trial also did not meet primary endpoint - June 2016
RARE	MEPSEVII (vestronidase alfa) Mucopolysaccharidosis 7 (MPS 7)	Phase 3	07/14/2016 Phase 3 data released July 2016. Primary endpoint hit. Secondary missed.
LNTH	Oral RELISTOR Chronic pain	Approved	07/19/2016 Approved July 19 2016.
OCUL	DEXTENZA Ocular inflammation and pain following cataract surgery	CRL	07/25/2016 CRL July 25 2016 - due to manufacturing deficiencies.
ADMA	ASCENIV (RI-002) Primary Immune Deficiency Diseases	CRL	07/29/2016 CRL issued July 29 2016. Third-party manufacturing issues cited.
MCRB	SER-109 - ECOSPOR III Recurrent C. Difficile infection	Phase 2	07/29/2016 Phase 2 interim data did not meet primary endpoint.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Phase 3	08/01/2016 Phase 3 ENDEAR trial met primary endpoint August 1, 2016.
HRTX	APF530 - Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)	Approved	08/10/2016 CRL Mar 28 2013. Approved August 10, 2016.
VTVT	TTP399 - AGATA Type 2 Diabetes	Phase 2	08/10/2016 Phase 2 data released August 10, 2016. Primary endpoint met.
AUPH	Voclosporin - AURORA Lupus	Phase 2b	08/15/2016 Phase 2b data released August 2016. Primary endpoint met but with high number of deaths.
ACRX	DSUVIA (ARX-04) Moderate-to-severe acute pain following a surgical procedure	Phase 3	08/15/2016 Phase 3 data released August 15, 2016.
ALXN	Andexxa Factor Xa inhibitor reversal agent	CRL	08/17/2016 CRL August 17 2016.
ACRS	A-101 THWART-1 and THWART-2 Common warts (verruca vulgaris)	Phase 2	08/18/2016 Phase 2 data released August 2016.
EARS	AM-101 (Keyzilen) - TACTT2 Acute inner ear tinnitus	Phase 3	08/18/2016 Phase 3 trial did not meet primary endpoints.
KMDA	Inhaled formulation of AAT AATD - Alpha-1 Antitrypsin deficiency	Phase 2	08/30/2016 Top-line data released August 30, 2016. Primary endpoint met
RIGL	Tavalissetm (Fostamatinib) Immune Thrombocytopenic Purpura (ITP)	Phase 3	08/30/2016 Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
GSK	Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients	Approved	09/02/2016 Approved September 2, 2015.
OPK	Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV	Approved	09/02/2016 Approved September 2, 2015.
TNXP	TNX-102 SL (Tonmya) Fibromyalgia	Phase 3	09/06/2016 Phase 3 data released September 6, 2016. Primary endpoint not met. Program discontinued
KPTI	Selinexor Quadruple Refractory Multiple Myeloma	Phase 2	09/06/2016 Phase 2 positive top-line data released September 6, 2016
AERI	Roclatan Glaucoma	Phase 3	09/14/2016 Phase 3 Mercury 1 data released September 14, 2016. Primary endpoint met.
NVAX	RSV vaccine - Resolve trial Respiratory Syncytial Virus (RSV) in older adults	Phase 3	09/15/2016 Phase 3 released September 15, 2016 did not demonstrate efficacy.
SRPT	Eteplirsen - Exon 51 Duchenne muscular dystrophy	Approved	09/19/2016 Approved September 19, 2016.
ITCI	Lumateperone Schizophrenia	Phase 3	09/28/2016 Phase 3 trial failed - September 28, 2016.
GNCA	GEN-003 Genital herpes	Phase 2b	09/29/2016 Phase 2b virologic efficacy data released September 2016.
TENX	Levosimendan Septic shock	Phase 2b	10/05/2016 Phase 2b trial did not meet primary endpoint.
ALKS	ALKS 5461 Major depressive disorder	Phase 3	10/20/2016 Phase 3 data from first two trials did not meet their endpoints. FORWARD-5 data, the third of three trials did meet endpoints - October 2016.
PLXP	Locilex Mild infections of diabetic foot ulcers	Phase 3	10/25/2016 Phase 3 top-line data did not meet endpoints - October 25, 2016 - TICKER CHANGED FROM DPRX FOLLOWING MERGER
RIGL	Tavalissetm (Fostamatinib) Immune Thrombocytopenic Purpura (ITP)	Phase 3	10/30/2016 Phase 3 data from second trial did not meet the primary endpoint.
AMAG	Vyleesi (Bremelanotide) Female sexual dysfunction (FSD)	Phase 3	11/01/2016 Phase 3 data released November 1, 2016.
PTN	Vyleesi (Bremelanotide) Female sexual dysfunction (FSD)	Phase 3	11/01/2016 Phase 3 data released November 1, 2016.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Phase 3	11/07/2016 Phase 3 CHERISH data met primary endpoint - November 7, 2016.
DVAX	HEPLISAV-B Hepatitis B	CRL	11/14/2016 CRL November 14, 2016
ALNY	Inclisiran Hyperlipidemia	Phase 2	11/15/2016 Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
NVS	Inclisiran Hyperlipidemia	Phase 2	11/15/2016 Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
ACRS	ESKATA (hydrogen peroxide) Seborrheic keratosis (SK)	Phase 3	11/15/2016 Phase 3 trial met endpoints - November 15, 2016.
BSTC	QWO Edematous fibrosclerotic panniculopathy (“cellulite”)	Phase 2b	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints
ENDP	QWO Edematous fibrosclerotic panniculopathy (“cellulite”)	Phase 2b	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints
ACOR	Dalfampridine Post stroke deficits	Phase 3	11/21/2016 Phase 3 data released November 21, 2016 - failed to show efficacy, development to be discontinued.
BXRX	Intravenous (IV) meloxicam Acute pain following bunionectomy surgery	Phase 3	11/28/2016 Phase 3 data from second trial released November 28, 2016. Primary endpoint met.
CERC	CERC-301 Major depressive disorder (MDD)	Phase 2	11/29/2016 Phase 2 top-line data released November 29, 2016 failed to meet primary endpoint.
NOVN	SB206 Human papillomavirus (HPV)	Phase 2	11/29/2016 Phase 2 data released November 29, 2016. Primary endpoint met.
HTBX	HS-410 Bladder cancer	Phase 2	11/30/2016 Phase 2 trial did not meet primary endpoint - November 30, 2016.
HZNP	ACTIMMUNE Friedreich's Ataxia (FA)	Phase 3	12/08/2016 Phase 3 data released December 8, 2016 - primary endpoint not met
ISEE	Fovista Wet age-related macular degeneration (Wet-AMD)	Phase 3	12/12/2016 Phase 3 data released December 12, 2016 - primary endpoint not met.
VCEL	MACI Focal chondral cartilage defects in the knee.	Approved	12/13/2016 FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.
BDSI	Clonidine gel Painful diabetic neuropathy (PDN)	Phase 2b	12/13/2016 Phase 2b data released December 13, 2016 - primary endpoints not met.
VTVT	TTP273 - LOGRA Type 2 Diabetes	Phase 2	12/14/2016 Phase 2 primary endpoint met - December 14, 2016.
CLVS	Rucaparib ARIEL2 Cancer - ovarian second line	Approved	12/19/2016 Approved December 19, 2016. Original PDUFA date under priority review was February 23, 2017.
ACAD	Pimavanserin - Harmony Alzheimer’s disease psychosis	Phase 2	12/20/2016 Phase 2 top-line data released December 20, 2016. Primary endpoint met. Key secondary endpoint missed.
LXRX	Sotagliflozin Type 1 Diabetes	Phase 3	12/21/2016 Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
MACK	MM-302 HERMIONE Cancer - HER2-positive locally advanced or metastatic breast cancer	Phase 2	12/21/2016 Phase 2 trial discontinued December 21, 2016 due to poor efficacy.
NVS	Lutathera Inoperable progressive midgut NETs	CRL	12/21/2016 PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
IRWD	Linaclotide Irritable Bowel Syndrome with Constipation (IBS-C)	Phase 2b	12/22/2016 Phase 2b data released December 22, 2016.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Approved	12/23/2016 Approved December 23, 2016.
AMPH	Primatene Mist (epinephrine inhalation aerosol) Asthma	CRL	12/27/2016 CRL issued December 27, 2016.
OPK	hGH-CTP Adults - growth hormone deficiency	Phase 3	12/30/2016 Phase 3 data released December 30, 2016 - primary endpoint not met.
PLX	AIR DNase (PRX-110) Cystic Fibrosis	Phase 2	01/03/2017 Phase 2 interim data released January 3, 2017.
AGRX	Twirla Contraceptive patch	Phase 3	01/03/2017 CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data but intends to reflile NDA 1H 2017.
AEZS	Macimorelin Acetate - Macrilen Adult Growth Deficiency	Phase 3	01/04/2017 Phase 3 data released January 4, 2017 - trial failed.
HALO	HALO-301 Pancreatic cancer	Phase 2	01/05/2017 Primary endpoint met.
GNCA	GEN-003 Genital herpes	Phase 2b	01/05/2017 Phase 2b data released January 5, 2017.
OTIC	OTIPRIO Acute otitis externa	Phase 3	01/05/2017 Phase 3 trial met primary endpoint - January 5, 2017.
CHRS	CHS-1420 Psoriasis	Phase 3	01/10/2017 Phase 3 top-line data met endpoints August 2016. Full data due released January 10, 2016.
GSK	Rolapitant - intravenous (IV) Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients	CRL	01/11/2017 CRL issued January 11 2017.
FGEN	Pamrevlumab (LAPIS) Pancreatic cancer	Phase 2	01/17/2017 Phase 2 abstract released January 17, 2017.
NBIX	INGREZZA Tourette syndrome - adults	Phase 2	01/18/2017 Phase 2 data released January 18, 2017 did not meet primary endpoint.
ABBV	Oxymetazoline HCl cream 1.0% Facial Erythema (Redness) Associated with Rosacea	Approved	01/19/2017 Approved January 19, 2017.
ABBV	Imbruvica Marginal zone lymphoma	Approved	01/19/2017 sNDA filing under priority review approved January 19, 2017.
MRNS	Ganaxolone - Marigold CDKL5 Deficiency Disorder (CDD)	Phase 2	01/23/2017 Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
LGND	Ganaxolone - Marigold CDKL5 Deficiency Disorder (CDD)	Phase 2	01/23/2017 Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
IRWD	Linaclotide 72 mcg dose for use in the treatment of adults Chronic idiopathic constipation (CIC)	Approved	01/26/2017 sNDA approval announced January 26, 2017.
NOVN	SB204 Acne vulgaris	Phase 3	01/27/2017 Phase 3 top-line data released January 27, 2017. Met one of three co-primary endpoints in NI-AC301 trial. Met all endpoints in NI-AC302 trial.
NRBO	Gemcabene - COBALT-1 Homozygous Familial Hypercholesterolemia (HoFH)	Phase 2b	01/30/2017 Phase 2b interim data released January 30, 2017.
TENX	Levosimendan Reduce the incidence of low cardiac output syndrome during cardiac surgery	Phase 3	01/31/2017 Phase 3 top line data released January 31, 2017 - primary endpoints not met.
CATB	Edasalonexent (CAT-1004) Duchenne muscular dystrophy (DMD)	Phase 1/2	01/31/2017 Phase 1/2 top-line data released January 31 - primary endpoint not met.
GWPH	Sativex (Nabiximols) Spasticity due multiple sclerosis	Phase 2	02/07/2017 Phase 2 trial did not meet primary endpoint - noted February 7, 2017.
AMGN	Parsabiv Secondary hyperparathyroidism (SHPT)	Approved	02/07/2017 Approved February 7, 2017.
JNJ	XARELTO (rivaroxaban) Coronary Artery Disease or Peripheral Artery Disease	Phase 3	02/08/2017 Phase 3 trial stopped early due to positive efficacy - February 8, 2017.
ACOR	INBRIJA (CVT-301) OFF episodes of Parkinson’s disease (PD)	Phase 3	02/09/2017 Phase 3 data released February 9, 2017 - primary endpoint met.
TCON	TRC105 and Avastin Glioblastoma - cancer	Phase 2	02/09/2017 Phase 2 data released February 9, 2017 - primary endpoint not met.
ZSAN	M207 Migraine	Phase 3	02/13/2017 Phase 3 trial data due released February 13, 2017 - primary endpoints met.
SAGE	SAGE-217 - MOUNTAIN Major Depressive Disorder (MDD)	Phase 2	02/13/2017 Phase 2 top-line data from open-label trial released February 13, 2017
MRK	MK-8931 (017) - Verubecestat Mild-to-moderate Alzheimer's	Phase 3	02/14/2017 Phase 3 trial stopped due to lack of efficacy - February 14, 2017.
BHC	Brodalumab Psoriasis	Approved	02/15/2017 Approved February 15, 2017.
ARDX	Tenapanor Serum phosphorus - chronic kidney disease (CKD) on dialysis	Phase 3	02/15/2017 Phase 3 released February 15, 2017 - primary endpoint met.
AZN	Lynparza Breast cancer	Phase 3	02/17/2017 Phase 3 data released February 17, 2016 - primary endpoint met.
MRK	Lynparza Breast cancer	Phase 3	02/17/2017 Phase 3 data released February 17, 2016 - primary endpoint met.
TRVN	Oliceridine (TRV130) Moderate to severe acute pain	Phase 3	02/21/2017 Phase 3 APOLLO-1 and APOLLO-2 data released February 21, 2017 - primary endpoints met but commercial doubts raised.
CDTX	CD101 Topical - RADIANT Vulvovaginal candidiasis (VVC)	Phase 2	02/21/2017 Phase 2 data released February 21, 2017 - efficacy not evident, Development to be discontinued.
AMPH	Naloxone Intranasal Opioid overdose	CRL	02/21/2017 CRL announced February 21, 2017.
BMY	REVLIMID Multiple myeloma (MM) - autologous stem cell transplant (ASCT)	Approved	02/22/2017 Approved February 22, 2017.
CMRX	Brincidofovir - Advise trial Adenovirus Infection	Phase 3	02/22/2017 Phase 3 interim analysis released May 2016. Final data released February 22, 2017.
BCRX	Berotralstat BCX7353 Reduce or eliminate attacks in HAE patients	Phase 2	02/27/2017 Phase 2 interim data released February 27, 2017.
LJPC	GiaprezaTM (angiotensin II) Increase blood pressure in adults with septic or other distributive shock	Phase 3	02/27/2017 Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. NDA filing due 2H 2017.
AZN	Saxagliptin and dapagliflozin Type-2 diabetes	Approved	02/28/2017 Approval announced February 28, 2017.
AUPH	Voclosporin - AURORA Lupus	Phase 2b	03/01/2017 Phase 2b data released August 2016. Primary endpoint met but with high number of deaths. Further data released March 1, 2017 - no additional deaths and endpoints met.
MRK	Odactra (MK-8237) House dust mite allergies	Approved	03/01/2017 Approved March 1, 2017.
PTCT	Translarna Nonsense mutation cystic fibrosis	Phase 3	03/02/2017 Phase 3 data released March 2, 2017 - endpoints not met. Development to be discontinued.
KPTI	Selinexor SOPRA Cancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)	Phase 2	03/02/2017 Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.
IONS	Volanesorsen - APPROACH Familial chylomicronemia syndrome (FCS)	Phase 3	03/06/2017 Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
KURA	Tipifarnib - (AIM-HN/SEQ-HN) Head and neck squamous cell carcinomas (HNSCC)	Phase 2	03/06/2017 Phase 2 ongoing data released March 6, 2017 - further data due 2H 2017.
TGTX	TG-1101 and IMBRUVICA (GENUINE trial) Chronic Lymphocytic Leukemia (CLL) cancer	Phase 3	03/06/2017 Phase 3 trial met primary endpoint - March 6, 2017, meeting with FDA in 2H 2017.
ACOR	Ampyra Improve walking in patients with multiple sclerosis	-	03/09/2017 Decision on Inter Partes Review (IPR) released March 10, 2017 - patents upheld.
NVS	LEE011 HR+/HER2- advanced breast cancer	Approved	03/13/2017 Priority review granted November 1, 2016. Approval announced March 13, 2017.
MRK	KEYTRUDA Relapsed or Refractory Classical Hodgkin Lymphoma	Approved	03/14/2017 Approval announced March 14, 2017.
AZN	Lynparza - SOLO 2 Second-line ovarian cancer	Phase 3	03/14/2017 Data presented March 14, 2017 showed significant PFS benefit.
ENDP	OPANA ER Management of pain	-	03/14/2017 Advisory Committee Meeting March 14, 2017 voted 18 to eight that the benefits of reformulated OPANA ER no longer outweigh its risks.
CPRX	Firdapse MuSK-antibody positive myasthenia gravis (MuSK-MG)	Phase 2	03/15/2017 Phase 2 top-line data met endpoints - March 15, 2017. Pivotal trial planned.
AZN	Lokelma (ZS-9) Hyperkalaemia	CRL	03/17/2017 Second CRL issued March 17, 2017.
AMGN	Repatha Cardiovascular disease	Phase 3	03/17/2017 Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations.
LLY	Abemaciclib - MONARCH 1 and 2 Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer	Phase 3	03/20/2017 Phase 3 data released March 20, 2017 - PFS primary endpoint met.
BLRX	BL-8040 GENESIS Stem-cell mobilization for autologous transplantation	Phase 2	03/20/2017 Phase 2 trial initiated March 2016. Partial data released March 20, 2017.
JAZZ	JZP-110 Excessive sleepiness associated with obstructive sleep apnea	Phase 3	03/20/2017 Phase 3 data released March 20, 2017 - primary endpoints met.
NKTR	NKTR-181 Lower back pain	Phase 3	03/20/2017 Phase 3 data released March 20, 2017 - endpoints met.
NVS	RELAX-AHF-2 (RLX030) Acute heart failure	Phase 3	03/22/2017 Phase 3 data released March 22, 2017 - primary endpoints not met.
PFE	Avelumab Metastatic Merkel cell carcinoma	Approved	03/23/2017 Priority review announced November 29, 2016. Approval announced March 23, 2017.
XENE	XEN801 Acne	Phase 2	03/24/2017 Phase 2 data released March 24 2017 - endpoints not met.
GSK	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Approved	03/27/2017 PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
MNLO	FMX101 Acne	Phase 3	03/27/2017 Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
PRTK	Sarecycline Severe acne vulgaris	Phase 3	03/27/2017 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
VRTX	Tezacaftor / ivacaftor Cystic fibrosis - Two Copies of the F508del Mutation	Phase 3	03/28/2017 Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
QLGN	RP-G28 Lactose intolerance	Phase 2/3	03/28/2017 Phase 2/3 top-line data released March 28, 2017. Primary endpoint met. End of Phase 2 meeting with FDA planned.
REGN	Dupixent (dupilumab) Atopic dermatitis	Approved	03/28/2017 Approved under priority review - March 28, 2017.
SNY	Dupixent (dupilumab) Atopic dermatitis	Approved	03/28/2017 Approved under priority review - March 28, 2017.
LNTH	Azedra Pheochromocytoma	Phase 2b	03/30/2017 Pivotal Phase 2 trial resumed January 2015 following suspension of trial in 2010 due to lack of funding. Primary endpoint met - March 30, 2017. NDA filing due mid-2017.
CRBP	Lenabasum Cystic Fibrosis	Phase 2	03/30/2017 Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
AZN	Tagrisso Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)	Approved	03/31/2017 Approval announced March 31, 2017.
NVCR	Tumor Treating Fields (TTFields) - INNOVATE-3 Ovarian cancer	Phase 2	03/31/2017 Phase 2 data presented December 12, 2016. Further promising PFS data released March 31, 2017.
PFE	IBRANCE (palbociclib) HR+, HER2- Metastatic Breast Cancer	Approved	03/31/2017 sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
PRTK	Omadacycline Community-acquired bacterial pneumonia (CABP)	Phase 3	04/03/2017 Phase 3 data released April 3, 2017 - all endpoints met.
KPTI	Selinexor Diffuse Large B-Cell Lymphoma (DLBCL)	Phase 2b	04/04/2017 Phase 2b additional interim data released April 4, 2017 at AACR. Final top-line data due mid-2018.
NKTR	Cipro DPI Bronchiectasis	Phase 3	04/05/2017 Phase 3 second trial did not meet endpoint - April 5, 2017.
SUPN	Trokendi Migraine	Approved	04/05/2017 Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced April 6, 2017.
MRK	Januvia (Sitagliptin) Type 2 Diabetes	CRL	04/07/2017 CRL issued April 7 2017. sNDA for approved drug requested to include data on cardiovascular effects
GERN	Imetelstat Myelofibrosis	Phase 2/3	04/10/2017 Phase 2 clinical hold lifted Nov 2014. Phase 2 initiated September 2015. Internal review conducted September 2016. Low dose discontinued, high dose enrollment suspended. Further review conducted April 2017 - further development pending FDA feedback and longer term data.
MESO	Rexlemestrocel Heart failure	Phase 3	04/10/2017 Noted April 10, 2017 that interim analysis has been completed - trial to continue as planned.
NBIX	INGREZZA Tardive dyskinesia	Approved	04/11/2017 Approved April 11, 2017.
PLX	AIR DNase (PRX-110) Cystic Fibrosis	Phase 2	04/12/2017 Phase 2 interim data released January 3, 2017. Full data released April 12, 2017. Company noted data were positive but results showed efficacy down on January data.
NOVN	SB208 Fungal infections	Phase 2	04/12/2017 Phase 2 data released April 12, 2017. Primary endpoint met.
INCY	Baricitinib Rheumatoid arthritis	CRL	04/14/2017 Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017.
LLY	Baricitinib Rheumatoid arthritis	CRL	04/14/2017 Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017.
RARE	Crysvita (Burosumab) X-Linked Hypophosphatemia (XLH)	Phase 3	04/18/2017 Phase 3 data released April 18, 2017 - primary endpoint met, two of three secondary endpoints met (missed on pain).
ABBV	Veliparib Squamous non-small cell lung cancer (NSCLC) and triple negative breast cancer (TNBC)	Phase 3	04/19/2017 Phase 3 trial did not meet primary endpoints - April 19, 2017.
MRK	RENFLEXIS - SB2 (infliximab biosimilar) Biosimilar candidate of Remicade	Approved	04/21/2017 BLA acceptance announced May 23, 2016 by partner Samsung Bioepis. Approval annuonced April 21, 2017.
EIGR	Lonafarnib - D-LIVR Chronic hepatitis delta virus (HDV)	Phase 2	04/21/2017 Phase 2 end of trial data released April 21, 2017. Meeting with FDA scheduled for 4Q 2017.
LLY	Abemaciclib - MONARCH 3 HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)	Phase 3	04/24/2017 Phase 3 interim analysis April 24, 2017 met primary endpoint. Detailed data due 2H 2017 with regulatory filings due 3Q 2017.
JAZZ	Xyrem Pediatric narcolepsy patients with cataplexy	Phase 2/3	04/24/2017 Phase 2/3 positive data released April 24, 2017. sNDA filing due 4Q 2017.
XOMA	XOMA 213 Hyperprolactinemia	Phase 2	04/24/2017 Phase 2 proof-of-concept results released April 24, 2017.
AKTX	Nomacopan Paroxysmal nocturnal hemoglobinuria (PNH)	Phase 2	04/24/2017 Phase 2 interim data released April 24, 2017. Phase 3 program to commence 4Q 2017 with initial data due 1Q 2019.
REGN	Praluent (alirocumab) High low-density lipoprotein (LDL) cholesterol	Approved	04/25/2017 sBLA Approval announced April 25, 2017.
SNY	Praluent (alirocumab) High low-density lipoprotein (LDL) cholesterol	Approved	04/25/2017 sBLA Approval announced April 25, 2017.
JAZZ	Solriamfetol (JZP-110) Excessive sleepiness associated with narcolepsy	Phase 3	04/26/2017 Phase 3 data released April 26, 2017. NDA to be filed late 2017.
BMRN	Cerliponase alfa Batten Disease	Approved	04/27/2017 PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.
NVS	Rydapt (Midostaurin - PKC412) Acute myeloid leukemia (AML)	Approved	04/28/2017 Priority review granted November 14, 2016. Approval announced April 28, 2017.
RDUS	TYMLOS (Abaloparatide) Osteoporosis	Approved	04/28/2017 PDUFA date originally scheduled for March 30 2017 delayed by three months to June 30, 2017. Approval announced April 28, 2017.
TGTX	TG-1101 - ULTIMATE I Multiple Sclerosis	Phase 2	04/28/2017 Phase 2 preliminary results presented at American Academy of Neurology (AAN) annual meeting April 28, 2017.
AEZS	Zoptrex Endometrial cancer	Phase 3	05/01/2017 Phase 3 trial did not meet primary endpoint - May 1, 2017.
AZN	Urothelial carcinoma - Bladder cancer Bladder cancer	Approved	05/01/2017 BLA acceptance announced December 9, 2017. PDUFA under priority review. Approval announced May 1, 2017.
NTRP	Bryostatin Alzheimer's disease	Phase 3	05/01/2017 Phase 2 data released May 1, 2017 - primary endpoint not met.
AMAG	Feraheme Adults with iron deficiency anemia (IDA)	Phase 3	05/02/2017 Phase 3 trial completion announced May 2, 2017 - endpoints met. sNDA due mid-2017.
REGN	Dupixent (dupilumab) Eosinophilic esophagitis	Phase 2	05/04/2017 Phase 2 data released May 4, 2017.
SNY	Dupixent (dupilumab) Eosinophilic esophagitis	Phase 2	05/04/2017 Phase 2 data released May 4, 2017.
TXMD	Yuvvexy - TX-004HR Moderate-to-severe vaginal pain	CRL	05/08/2017 CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data.
LCTX	OpRegen Dry age-related macular degeneration (AMD)	Phase 2	05/09/2017 Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference.
PFE	Avelumab Urothelial Carcinoma	Approved	05/09/2017 Approval announced May 9, 2017.
MRK	Keytruda First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer	Approved	05/10/2017 Approved May 10, 2017.
GSK	Mepolizumab Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype	Phase 3	05/10/2017 Phase 3 METREX trial met primary endpoint. Phase 3 METREO failed to meet endpoint.
AZN	Tralokinumab (STRATOS1) Severe, uncontrolled asthma	Phase 3	05/10/2017 Phase 3 trial did not meet primary endpoint - May 10, 2017.
LLY	Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN Migraine prevention	Phase 3	05/12/2017 Phase 3 data released May 12, 2017 - primary endpoints hit in all trials. BLA filing due 2H 2017.
CAPR	CAP-1002 ALLSTAR Myocardial infarction (heart attack)	Phase 2	05/12/2017 Phase 2 data released May 12, 2017 - primary endpoint unlikely to be met.
AZN	Durvalumab (PACIFIC) Lung cancer	Phase 3	05/12/2017 Phase 3 interim analysis released May 12, 2017 - PFS primary endpoint already met. OS endpoint to be assessed.
ARDX	Tenapanor (T3MPO-1) Constipation-predominant irritable bowel syndrome (IBS-C)	Phase 3	05/12/2017 Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
IONS	Inotersen (IONIS-TTRRx) NEURO-TTR - familial amyloid polyneuropathy (FAP).	Phase 3	05/15/2017 Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns.
RVNC	DAXI (RT002) - ASPEN Cervical dystonia	Phase 2	05/18/2017 Phase 2 additional data released May 18, 2017 with oral presentation June 7, 2017 at International Congress of Parkinson's Disease and Movement Disorders.
MRK	KEYTRUDA First and Second line locally advanced or metastatic urothelial cancer - bladder cancer	Approved	05/18/2017 Approved May 18, 2017.
BMY	ZEPOSIA (Ozanimod) Relapsing Multiple Sclerosis	Phase 3	05/22/2017 Phase 3 data due released May 22, 2017 - primary endpoint met, disability endpoint not met.
AMGN	EVENITY (Romosozumab) Osteoporosis	Phase 3	05/22/2017 PDUFA date July 19, 2017. However, likely to be delayed due to safety data from ARCH trial released May 22, 2017.
SNY	Sarilumab Rheumatoid arthritis	Approved	05/22/2017 CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
REGN	Sarilumab Rheumatoid arthritis	Approved	05/22/2017 CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
LJPC	GiaprezaTM (angiotensin II) Increase blood pressure in adults with septic or other distributive shock	Phase 3	05/22/2017 Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. Data released May 22, 2017 confirmed primary endpoint was met but with lack of mortality improvement.
MRK	KEYTRUDA Microsatellite Instability-High Cancer	Approved	05/23/2017 PDUFA date March 8, 2017 extended to June 9, 2017 due to submission of extra data. Approved May 23, 2017.
NBIX	INGREZZA - T-Force GOLD Tourette syndrome - juvenile	Phase 2	05/23/2017 Phase 2 data released May 23 - primary endpoint not met.
AERI	Roclatan Glaucoma	Phase 3	05/24/2017 Phase 3 Mercury 1 data released September 14, 2016. Primary endpoint met. Mercury 2 trial data released may 24, 2017 - primary endpoint also hit with NDA filing due 1H 2018.
PBYI	Neratinib (NERLYNX) Extended adjuvant HER2-positive early stage breast cancer	-	05/24/2017 Announced acceptance of NDA Filing September 20, 2016. PDUFA estimate July 20, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
BCRX	Berotralstat BCX7353 Reduce or eliminate attacks in HAE patients	Phase 2	05/25/2017 Phase 2 interim data released February 27, 2017. Top-line data released May 25, 2017.
NVS	Zykadia First-line use in patients with ALK+ metastatic NSCLC	Approved	05/26/2017 Priority review granted February 22, 2017. Approval announced May 26, 2017.
MRK	ISENTRESS HIV-1	Approved	05/30/2017 Approval announced May 30, 2017.
GILD	Bictegravir/F/TAF HIV	Phase 3	05/30/2017 Phase 3 data released May 30 - primary endpoint met. NDA filing due 2Q 2017.
NVO	Nonacog beta pegol haemophilia B	Approved	05/31/2017 Approval announced May 31, 2017.
RETA	Omaveloxolone Friedreich’s ataxia (FA)	Phase 2	06/01/2017 Phase 2 initial data released June 1, 2017. Primary endpoint not met.
LLY	Larotrectinib (LOXO-101) Solid tumors that harbor a TRK fusion.	Phase 2	06/03/2017 Announced 76% ORR at ASCO - June 3, 2017. Primary analysis by the end of 2017 with NDA filing late 2017 or early 2018.
JNJ	ZYTIGA (abiraterone acetate) - LATITUDE metastatic hormone-naïve prostate cancer (mHNPC)	Phase 3	06/03/2017 Phase 3 data presented at ASCO June 3, 2017 - PFS 33 months.
TGTX	TG-1101 and IMBRUVICA (GENUINE trial) Chronic Lymphocytic Leukemia (CLL) cancer	Phase 3	06/03/2017 Phase 3 trial met primary endpoint - March 6, 2017. Data presented at ASCO 2017. Meeting with FDA in 2H 2017.
HALO	HALO-301 Pancreatic cancer	Phase 2	06/04/2017 Phase 2 data released January 5, 2017. Oral presentation of Phase 2 data at ASCO June 4, 2017 showed ORR of 45%.
AZN	Lynparza Breast cancer	Phase 3	06/04/2017 Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death).
MRK	Lynparza Breast cancer	Phase 3	06/04/2017 Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death).
FPRX	Cabiralizumab (FPA008) Pigmented Villonodular Synovitis (PVNS)	Phase 1/2	06/04/2017 Phase 1/2 initial data released at ASCO June 4, 2017.
PIRS	PRS-080 Anemia of chronic disease	Phase 1b	06/04/2017 Phase 1b data released at ERA-EDTA June 4, 2017.
BLUE	ide-cel bb2121 - KarMMa Relapsed/refractory multiple myeloma	Phase 1	06/05/2017 Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017 - ORR 89%.
BMY	ide-cel bb2121 - KarMMa Relapsed/refractory multiple myeloma	Phase 1	06/05/2017 Phase 1 interim data released November 30, 2016 - 78% ORR. Pivotal trial to be initiated 2017. Updated data at ASCO June 5, 2017 - ORR 89%.
GILD	Axicabtagene ciloleucel - (ZUMA-3) Adult patients with r/r ALL - cancer	Phase 1	06/05/2017 Phase 2 data due 2018. Phase 1 data released at ASCO June 5, 2017. Complete remission 73%.
GLYC	Uproleselan (GMI-1271) Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer	Phase 2	06/05/2017 Phase 2 enrollment completed - announced May 31, 2017. Data updates at ASCO June 5, 2017.
CRVS	CPI-444 Solid tumors - cancer	Phase 1b	06/05/2017 Phase 1/1b preliminary data released November 2016. Further update at ASCO June 5, 2017.
IOVA	LN-144 - lifileucel Refractory metastatic melanoma	Phase 2	06/05/2017 Phase 2 second cohort commenced enrollment - May 19, 2017. Initial data presented at ASCO June 5, 2017.
BMY	liso-cel (JCAR017) - TRANSCEND NHL-001 Relapsed or refractory (R/R) large B-cell lymphoma	Phase 1/2	06/05/2017 Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017 - ORR 86%.
CLSN	GEN-1 OVATION 2 Ovarian cancer	Phase 1b	06/05/2017 Phase 1b interim data released at ASCO 2017 - ORR 86%.
ALKS	Aristada Schizophrenia	Approved	06/06/2017 Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
NVS	Kymriah (CTL019 )- JULIET Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)	Phase 2	06/07/2017 Phase 2 pivotal primary analysis due International Conference on Malignant Lymphoma (ICML) on June 14, 2017. Abstract released June 7, 2017. ORR 45%.
LXRX	Sotagliflozin Type 1 Diabetes	Phase 3	06/09/2017 Phase 3 data released September 9, 2016 met primary endpoint. Secondary endpoint data due May 2017. Data from second trial released December 21, 2016 - primary endpoint met. Data from third trial also met primary endpoint - June 9, 2017.
JNJ	INVOKANA CANVAS Type 2 diabetes	Phase 3	06/12/2017 Cardiovascular Outcomes trial data released June 12, 2017 - 14% reduction in the risk of the composite primary endpoint of CV mortality.
XLRN	Dalantercept - DART Study Renal Cell Carcinoma (RCC) - cancer	Phase 2	06/12/2017 Phase 2 data released June 12, 2017 - primary endpoint not met.
CHRS	CHS-1701 Pegfilgrastim biosimilar	CRL	06/12/2017 CRL announced June 12, 2017.
EPZM	Tazemetostat Follicular lymphoma	Phase 2	06/14/2017 Phase 2 data released June 14, 2017 - DLBCL ORR 29%.
RDHL	BEKINDA Gastroenteritis	Phase 3	06/14/2017 Phase 3 top-line data released June 14, 2017 - primary endpoint met.
KURA	Tipifarnib Relapsed or refractory peripheral T-cell lymphoma	Phase 2	06/14/2017 Phase 2 data presented at ICML conference on June 14, 2017 - 3/18 partial responses.
ALDX	Reproxalap (ADX-102) Allergic conjunctivitis	Phase 2b	06/14/2017 Phase 2b data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned.
ADMP	Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis.	Approved	06/15/2017 CRL issued March 27 2015. CRL issued again June 6, 2016. Approval announced June 15, 2017 following third submission.
SELB	SEL-212 (COMPARE) - Head to head trial vs Krystexxa Tophaceous gout	Phase 2	06/15/2017 Phase 2 dosing commenced late October 2016. Initial data released at EULAR June 15, 2017.
ALXN	Cerdulatinib (PRT2070) Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer	Phase 2	06/15/2017 Phase 2 enrollment commenced May 2016. Interim data released June 15, 2017 - noted CLL/SLL 67% partial responese rate + two patient deaths.
JNJ	DARZALEX (Daratumumab) + pomalidomide and dexamethasone Relapsed or refractory multiple myeloma	Approved	06/16/2017 Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
GMAB	DARZALEX (Daratumumab) + pomalidomide and dexamethasone Relapsed or refractory multiple myeloma	Approved	06/16/2017 Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
CLVS	Rucaparib ARIEL3 Ovarian cancer patients with a BRCA-like mutation	Phase 3	06/19/2017 Phase 3 data released June 20 2017 - primary endpoint met. sNDA filing due 3Q or early 4Q 2017.
SGEN	Vadastuximab Talirine (CASCADE) Acute myeloid leukemia (AML) - cancer	Phase 3	06/19/2017 Phase 3 trial discontinued due to higher rate of deaths - June 19, 2017.
LPCN	TLANDO - LPCN 1021 Men with low testosterone (Low T)	-	06/19/2017 CRL issued June 2016. Flexibility trial data announced June 19, 2017 - primary endpoint met with NDA fiing due 3Q 2017.
NEOS	Cotempla XR-ODT Attention deficit hyperactivity disorder (ADHD)	Approved	06/19/2017 Approval announced June 19, 2017.
NVS	RTH258 (brolucizumab) Wet age-related macular degeneration (AMD)	Phase 3	06/20/2017 Phase 3 data released June 20, 2017 - primary and key secondary endpoints met.
CARA	IV CR845 Acute pain	Phase 3	06/21/2017 Interim conditional power analysis conducted June 21, 2017 - trial completion due 4Q 2017.
PFE	Epoetin alfa biosimilar	CRL	06/22/2017 CRL issued June 22, 2017.
NVS	Tafinlar (dabrafenib) and Mekinist (trametinib) Non-small cell lung cancer (NSCLC) with BRAF V600E mutation	Approved	06/22/2017 FDA Approval announced June 22, 2017.
HALO	Subcutaneous rituximab Various blood cancers	Approved	06/22/2017 Approval announced June 22, 2017.
XOMA	ACZ885 (canakinumab) CV risk reduction	Phase 3	06/22/2017 Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
NVS	ACZ885 (canakinumab) CV risk reduction	Phase 3	06/22/2017 Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
GBT	GBT440 HOPE-KIDS 1 Sickle cell disease - children age 6-17.	Phase 1/2	06/23/2017 Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (EHA) - June 23, 2017.
BLUE	LentiGlobin - HGB-210 Sickle Cell Disease (SCD)	Phase 1/2	06/23/2017 Phase 1/2 data presented at EHA June 23, 2017.
BLCM	BPX-501 Rivo-cel Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer	Phase 1/2	06/23/2017 Phase 1/2 update June 23, 2017.
BLUE	LentiGlobin - HGB-207 Northstar-2 non-β0/β0 transfusion-dependent thalassemia (TDT)	Phase 3	06/23/2017 Phase 3 early data released at EHA June 23, 2017.
ALXN	Bevyxxa (betrixaban) Venous thromboembolism (VTE) Prevention	Approved	06/23/2017 FDA Approval noted June 23, 2017.
AGIO	AG-348 (ACTIVATE-T) Pyruvate kinase deficiency	Phase 1/2	06/24/2017 Phase 2 updated data released at EHA June 24, 2017.
AMAG	Makena - auto injector Reduce the risk of preterm birth in women with a singleton pregnancy	Phase 2	06/26/2017 sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
ATRS	Makena - auto injector Reduce the risk of preterm birth in women with a singleton pregnancy	Phase 2	06/26/2017 sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
SGEN	ADCETRIS in combination with chemotherapy ECHELON-1 Frontline Hodgkin lymphoma	Phase 3	06/26/2017 Phase 3 data released June 26, 2017 - primary endpoint met.
TAK	ADCETRIS in combination with chemotherapy ECHELON-1 Frontline Hodgkin lymphoma	Phase 3	06/26/2017 Phase 3 data released June 26, 2017 - primary endpoint met.
XENE	TV-45070 Postherpetic neuralgia	Phase 2b	06/27/2017 Phase 2b data released June 27, 2017. Endpoints not met.
NRBO	Gemcabene - COBALT-1 Homozygous Familial Hypercholesterolemia (HoFH)	Phase 2b	06/28/2017 Phase 2b data released June 28, 2017 - primary endpoint met.
AMGN	Vectibix (Panitumumab) Wild-Type RAS Metastatic Colorectal Cancer	Approved	06/29/2017 sBLA approval announced June 29, 2017.
ALKS	ALKS 3831 - ENLIGHTEN-1 Schizophrenia	Phase 3	06/29/2017 Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
CARA	CR845 Osteoarthritis (OA)	Phase 2b	06/29/2017 Phase 2b data released June 29, 2017 - trial failed.
BMY	ORENCIA Psoriatic Arthritis (PsA)	Approved	07/06/2017 Approval announced July 6, 2017.
RCKT	Trabodenoson and latanoprost Glaucoma	Phase 2	07/07/2017 Phase 2 trial failed - noted July 7, 2017.
UTHR	Ralinepag ADVANCE OUTCOMES Pulmonary Arterial Hypertension	Phase 2	07/10/2017 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
IMRN	IMM-124E Nonalcoholic steatohepatitis (NASH)	Phase 2	07/10/2017 Phase 2 top-line data due 4Q 2017. Interim analysis July 10, 2017 showed no statistical difference with placebo.
PFE	Mylotarg (gemtuzumab ozogamicin) Acute myeloid leukemia (AML)	-	07/11/2017 Advisory Committee Meeting July 11, 2017 voted in favor 6-1 of a favorable risk:benefit profile.
AMGN	BLINCYTO Ph+ R/R ALL	Approved	07/11/2017 PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
KDMN	KD025 Chronic graft-versus-host disease (cGVHD)	Phase 2	07/11/2017 Phase 2 interim data presented July 11, 2017. ORR 71%.
BMRN	Valoctocogene roxaparvovec (BMN 270) - GENEr8-1 Hemophilia A	Phase 1/2	07/11/2017 Phase 1/2 updated data released July 11, 2017. 97% reduction in Annualized Bleed Rate (ABR).
OCUL	DEXTENZA Ocular inflammation and pain following cataract surgery	CRL	07/11/2017 CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017. Further CRL issued July 11, 2017 with FDA noting deficiencies in manufacturing processes and analytical testing.
SVRA	Aironite - INDIE Heart failure with preserved ejection fraction (HFpEF)	Phase 2	07/11/2017 Phase 2 interim data released July 11, 2017.
AMGN	KYPROLIS (ASPIRE) Relapsed Multiple Myeloma	Phase 3	07/12/2017 Phase 3 trial met primary endpoint. HR 79%.
LGND	KYPROLIS (ASPIRE) Relapsed Multiple Myeloma	Phase 3	07/12/2017 Phase 3 trial met primary endpoint. HR 79%.
NVS	Kymriah (CTL019) Relapsed/Refractory B-Cell Acute lymphoblastic leukemia	-	07/12/2017 Advisory Committee Meeting July 12, 2017 voted 10-0 recommending approval.
JNJ	Guselkumab Plaque psoriasis	Approved	07/13/2017 Approval announced July 13, 2017.
AMGN	EVENITY (Romosozumab) Osteoporosis	CRL	07/16/2017 CRL issued July 16, 2017.
CBAY	Seladelpar Primary biliary cholangitis (PBC)	Phase 2	07/17/2017 Phase 2 top-line data released late May 2016. Positive interim data from second trial data released July 17, 2017.
PBYI	Neratinib (NERLYNX) Extended adjuvant HER2-positive early stage breast cancer	Approved	07/17/2017 Approval announced July 17, 2017.
PRTK	Omadacycline - oral Acute bacterial skin and skin structure infections (ABSSSI)	Phase 3	07/17/2017 Phase 3 data released July 17, 2017 - all endpoints met.
GILD	Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Hepatitis C virus (HCV)	Approved	07/18/2017 Approval announced July 18, 2017.
TBPH	Revefenacin COPD	Phase 3	07/19/2017 12 month safety trial data released July 19, 2017 with NDA filing due 4Q 2017.
MYL	Revefenacin COPD	Phase 3	07/19/2017 12 month safety trial data released July 19, 2017 with NDA filing due 4Q 2017.
IRWD	IW-3718 Gastroesophageal reflux disease (GERD)	Phase 2b	07/20/2017 Phase 2b data released July 20, 2017. Primary endpoint met but data below expectations.
BVXV	M-001 Universal flu vaccine	Phase 2b	07/20/2017 Phase 2b data released July 20, 2017 - endpoints met.
GSK	Benlysta (belimumab) - subcutaneous Systemic lupus erythematosus (SLE)	Approved	07/21/2017 Approval announced July 21, 2017.
GNCA	GEN-003 Genital herpes	Phase 2b	07/24/2017 Phase 2b data released January 6, 2017. 12-month data released July 24, 2017. Phase 3 to commence 4Q 2017.
RETA	Bardoxolone methyl - CARDINAL Chronic Kidney Disease Caused by Alport Syndrome	Phase 2	07/24/2017 Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial released July 24, 2017.
MRK	KEYNOTE-040 KEYTRUDA Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)	Phase 3	07/24/2017 Phase 3 trial did not meet primary endpoint - July 24, 2017. Awarded accelerated approval in 2016.
LJPC	Eravacycline (TP-434) - IGNITE4 cIAI (complicated intra-abdominal infections)	Phase 3	07/25/2017 Phase 3 data released July 25, 2017 - primary endpoint met. NDA filing due 1Q 2018.
PCRX	EXPAREL Post surgical pain	Phase 3	07/25/2017 Phase 3 data released July 25, 2017. Upper extremity met primary endpoint, lower extremity trial missed endpoint.
EGRX	Ryanodex Exertional heat stroke (EHS)	CRL	07/26/2017 CRL issued July 26, 2017. Additional trial required.
AZN	Durvalumab +/- tremelimumab (MYSTIC) Lung cancer	Phase 3	07/27/2017 Phase 3 data released July 27, 2017 - primary endpoint not met.
DVAX	HEPLISAV-B Hepatitis B	-	07/28/2017 Advisory Committee Meeting July 28, 2017 voted 11 -1 in favor of recommending approval.
NVIV	Neuro-Spinal Scaffold: INSPIRE 2.0 Complete Thoracic AIS A Spinal Cord Injury	Phase 3	07/31/2017 Noted July 31, 2017 that enrollment has been temporarily halted as it discusses potential changes to patient enrollment criteria due to patient deaths - enrollment now due to be completed 1H 2018 with Humanitarian Device Exemption (HDE) application due 2H 2018.
RDHL	RHB-104 MAP Crohn’s disease	Phase 3	07/31/2017 Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Further analysis July 31, 2017 recommended trial continue as planned.
ICPT	Obeticholic acid (OCA) AESOP Primary Sclerosing Cholangitis (PSC)	Phase 2	07/31/2017 Phase 2 data released July 31, 2017 - primary endpoint met.
ICPT	Obeticholic acid (OCA) - CONTROL NASH patients taking statins	Phase 2	07/31/2017 Phase 2 primary endpoint met - July 31, 2017. One patient death noted but DSMB noted unlikely to be related to OCA (company unsure).
BMY	CM-142 – Opdivo (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)	Approved	08/01/2017 Approval announced August 1, 2017.
AGIO	IDHIFA (enasidenib) - AG-221 Advanced hematologic malignancies with an IDH2 mutation	Approved	08/01/2017 Approval announced August 1, 2017.
BMY	IDHIFA (enasidenib) - AG-221 Advanced hematologic malignancies with an IDH2 mutation	Approved	08/01/2017 Approval announced August 1, 2017.
ACRX	Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery	Phase 3	08/01/2017 Phase 2 data released August 1, 2017.
JNJ	Sirukumab Rheumatoid arthritis	-	08/02/2017 BLA filing announced September 23, 2016. PDUFA estimate September 23, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
ABBV	Imbruvica Second-line Chronic graft-versus-host disease (GVHD)	Approved	08/02/2017 Approval announced August 2, 2017.
TBPH	Velusetrag (TD-5108) Gastroparesis	Phase 2b	08/02/2017 Phase 2b data released August 2, 2017. Primary endpoint not met.
JNJ	Imbruvica Second-line Chronic graft-versus-host disease (GVHD)	Approved	08/02/2017 Approval announced August 2, 2017.
CRIS	Fimepinostat (CUDC-907) and venetoclax Diffuse-large B-cell lymphoma (DLBCL)	Phase 2	08/03/2017 Phase 2 initial data released August 3, 2017 - ORR 19%.
JAZZ	Vyxeos Acute myeloid leukemia	Approved	08/03/2017 Approval announced August 3, 2017.
PFE	Xeljanz Psoriatic arthritis	-	08/03/2017 PDUFA date December 2017. No exact date given. December 31, 2017 noted as last possible date using guidance of "December 31". Advisory Committee Meeting August 3, 2017 voted 10-1 in favor of recommending approval.
ENTA	Glecaprevir/Pibrentasvir (G/P) Hepatitis C virus (HCV)	Approved	08/03/2017 Approval announced August 3, 2017.
ABBV	Glecaprevir/Pibrentasvir (G/P) Hepatitis C virus (HCV)	Approved	08/03/2017 Approval announced August 3, 2017.
LLY	Lasmiditan Migraine	Phase 3	08/04/2017 Phase 3 data released August 4, 2017 - endpoints met. NDA filing due 2H 2018.
FGEN	Pamrevlumab (FG-3019) - ZEPHYRUS Idiopathic pulmonary fibrosis	Phase 2	08/07/2017 Phase 2 data released August 7, 2017 - primary endpoint met.
MYOK	Mavacamten (MYK-461) - EXPLORER-HCM Hypertrophic cardiomyopathy (HCM)	Phase 2	08/07/2017 Phase 2 data released August 7, 2017 - primary endpoint met.
BHC	Latanoprostene bunod Open angle glaucoma (OAG) or ocular hypertension (OHT)	CRL	08/07/2017 CRL issued August 7, 2017.
ZYNE	ZYN002 Adult Epilepsy Patients with Refractory Focal Seizures	Phase 2	08/07/2017 Phase 2 data released August 7, 2017 - endpoints not met.
ESPR	Bempedoic Acid/ Ezetimibe Hypercholesterolemia	Phase 2	08/08/2017 Phase 2 data released August 8, 2017. Primary endpoint met.
GLPG	ISABELA - GLPG1690 Idiopathic pulmonary fibrosis	Phase 2a	08/09/2017 Phase 2a top-line data released August 10, 2017. Disease progression halted. Further trials planned.
ABIO	Gencaro Chronic Heart Failure	Phase 2b	08/09/2017 Phase 2b interim analysis August 9, 2018 - trial to continue to completion. Data 1Q 2018.
TGTX	Umbralisib Follicular lymphoma (FL)	Phase 2b	08/10/2017 Phase 2b enrollment commenced June 2016. First interim analysis August 10, 2017 determined that enrollment in TGR-1202 arm will stop but continue in TG-1101 + TGR-1202 arm. TGR-1202 arm replaced by combo of TG-1101, TGR-1202, and bendamustine.
ISEE	Fovista Wet age-related macular degeneration (Wet-AMD)	Phase 3	08/14/2017 Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.
REGN	REGN2222 Respiratory syncytial virus (RSV)	Phase 3	08/14/2017 Phase 3 data released August 14, 2017 - primary endpoint not met.
CVM	Multikine Head and Neck cancer	Phase 3	08/14/2017 Initiated Dec 2010. Announced partial clinical hold September 27, 2016. Full clinical hold noted May 2017. Clinical hold released - August 14, 2017.
ZYNE	ZYN002 - STOP Osteoarthritis	Phase 2	08/14/2017 Phase 2 data released August 14, 2017 - primary endpoint not met. However, company still intends to initiate Phase 3 trial pending discussions with FDA.
BMY	CM-214 – Opdivo + Yervoy First-line Renal cell carcinoma (RCC)	Phase 3	08/15/2017 Phase 3 data released August 15, 2017 - one of two co-primary endpoints met.
AZN	Lynparza - SOLO 2 Second-line ovarian cancer	Approved	08/17/2017 Approval announced August 17, 2017.
PFE	Inotuzumab Ozogamicin Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults	Approved	08/17/2017 Approval announced August 17, 2017.
IRWD	DUZALLO (LESINURAD AND ALLOPURINOL) Hyperuricemia associated with gout	Approved	08/21/2017 Approval announced August 21, 2017.
RARE	Aceneuramic acid extended release (Ace-ER) GNE Myopathy	Phase 3	08/22/2017 Phase 3 data released August 22, 2017 - endpoints not met.
ADMS	GOCOVRI (ADS-5102) Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes	Approved	08/24/2017 Approval announced August 24, 2017.
NVO	Victoza (liraglutide) Type 2 diabetes	Approved	08/25/2017 Approval announced August 25, 2017.
KMDA	KamRAB Prophylaxis of rabies disease	Approved	08/25/2017 Approval announced August 25, 2017.
XOMA	ACZ885 (canakinumab) CV risk reduction	Phase 3	08/27/2017 Data presented August 27, 2017 showed a 77% reduction in lung cancer mortality.
NVS	ACZ885 (canakinumab) CV risk reduction	Phase 3	08/27/2017 Data presented August 27, 2017 showed a 77% reduction in lung cancer mortality.
AZN	Faslodex (fulvestrant) Monotherapy for expanded use in women with HR+, HER2- advanced breast cancer	Approved	08/28/2017 Expanded approval announced August 28, 2017.
NVS	Meropenem-vaborbactam Complicated urinary tract infections (cUTI)	Approved	08/29/2017 Approved August 29, 2017.
OTIC	OTO-104 AVERTS-1 Meniere's disease	Phase 3	08/30/2017 Phase 3 data released August 30 failed to meet primary and key secondary endpoints.
OTIC	OTIVIDEX Ménière's disease	Phase 3	08/30/2017 Phase 3 development suspended following failure of AVERTS-1 trial - August 30, 2017.
NVS	Kymriah (CTL019) Relapsed/Refractory B-Cell Acute lymphoblastic leukemia	Approved	08/30/2017 PDUFA date under priority review announced March 29, 2017. Approval announced early - August 30, 2017.
UTHR	Trevyent Pulmonary Arterial Hypertension (PAH)	-	08/31/2017 Refusal to file Letter (RTF) issued August 31, 2017 in response to NDA filing.
PFE	Mylotarg (gemtuzumab ozogamicin) Acute myeloid leukemia (AML)	Approved	09/01/2017 Approval announced September 1, 2017.
CLLS	UCART123 - AMELI-01 Acute myeloid leukemia (AML)	Phase 1	09/04/2017 Clinical hold announced September 4, 2017 following one fatality in the BPDCN clinical trial (ABC study).
NVS	Fingolimod Multiple Sclerosis (MS)	Phase 3	09/05/2017 Phase 3 trial met primary endpoint.
VSTM	Duvelisib - DUO Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma	Phase 3	09/06/2017 Phase 3 data released September 6, 2017 - primary endpoint met.
SRPT	Golodirsen - Exon 53 Duchenne muscular dystrophy	Phase 1/2	09/06/2017 Phase 1/2 data released September 6, 2017 - endpoints met.
VRNA	RPL554 COPD	Phase 2a	09/07/2017 Phase 2a positive data released September 7, 2017.
BMY	CM-214 – Opdivo + Yervoy First-line Renal cell carcinoma (RCC)	Phase 3	09/07/2017 Phase 3 trial stopped early due to clear efficacy.
ABBV	Upadacitinib Atopic Dermatitis	Phase 2b	09/07/2017 Phase 2b data released September 7, 2017 - primary endpoint met.
AMGN	Tezepelumab - NAVIGATOR Asthma	Phase 2b	09/07/2017 Phase 2b data released September 7, 2017 - primary endpoint met.
AZN	Tezepelumab - NAVIGATOR Asthma	Phase 2b	09/07/2017 Phase 2b data released September 7, 2017 - primary endpoint met.
KURA	Tipifarnib - (AIM-HN/SEQ-HN) Head and neck squamous cell carcinomas (HNSCC)	Phase 2	09/07/2017 Phase 2 trial met primary endpoint prior to completion of enrollment.
SGEN	Tisotumab Vedotin (innovaTV 204 ) Cervical Cancer	Phase 1/2	09/08/2017 Phase 1/2 data presented at ESMO 2017. Response rate 32%.
GMAB	Tisotumab Vedotin (innovaTV 204 ) Cervical Cancer	Phase 1/2	09/08/2017 Phase 1/2 data presented at ESMO 2017. Response rate 32%.
UTHR	Orenitram Pulmonary arterial hypertension (PAH)	Phase 3	09/08/2017 Phase 3 data due 2H 2018. Independent data monitoring committee (DMC) noted September 8, 2017 that the trial should continue following its interim analysis.
LLY	KEYTRUDA + chemo (KEYNOTE-021) First-Line Nonsquamous Non-small cell lung cancer (NSCLC)	Phase 2	09/08/2017 Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54
MRK	KEYTRUDA + chemo (KEYNOTE-021) First-Line Nonsquamous Non-small cell lung cancer (NSCLC)	Phase 2	09/08/2017 Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54
AZN	Durvalumab (PACIFIC) Lung cancer	Phase 3	09/09/2017 Late breaker at ESMO September 9, 2017 showed PFS 16.8 months v 5.6 months for placebo.
EXEL	Cabozantinib - CABOSUN First-Line RCC - cancer	Phase 2	09/09/2017 Late breaker at ESMO September 2017 showed PFS 8.6 months versus 5.3 months for sunitinib. HR 0.48
BMY	CM-238 – Opdivo (Adjuvant) Melanoma	Phase 3	09/10/2017 Phase 3 interim data released June 6, 2017 - primary endpoint met. Data presented at ESMO September 10, 2017 - HR 0.65 compared to Yervoy.
INO	INO-5150 Prostate cancer	Phase 1b	09/11/2017 Phase 1b interim data presented at ESMO 2017.
REGN	Dupixent (dupilumab) Asthma	Phase 3	09/11/2017 Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. sBLA filing due by end of 2017.
SNY	Dupixent (dupilumab) Asthma	Phase 3	09/11/2017 Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. sBLA filing due by end of 2017.
MRNS	Ganaxolone - Marigold CDKL5 Deficiency Disorder (CDD)	Phase 2	09/11/2017 Phase 2 top-line data released September 11, 2017.
LGND	Ganaxolone - Marigold CDKL5 Deficiency Disorder (CDD)	Phase 2	09/11/2017 Phase 2 top-line data released September 11, 2017.
SAGE	SAGE-547 SRSE	Phase 3	09/12/2017 Phase 3 data released September 12, 2017 - primary endpoint not met.
ALDX	ADX-102 - Reproxalap Dry eye syndrome	Phase 2a	09/12/2017 Phase 2a data released September 11, 2017 - noted statistically and clinically significant activity.
GSK	Shingrix Shingles	-	09/13/2017 Advisory Committee Meeting September 13, 2017 voted 11-0 in favor. PDUFA estimate October 24, 2017.
VNDA	Tradipitant - EPIONE 1 Atopic dermatitis	Phase 2	09/13/2017 Phase 2 data released September 13, 2017 - primary endpoint not met.
AGEN	Shingrix Shingles	-	09/13/2017 Advisory Committee Meeting September 13, 2017 voted 11-0 in favor. Shingrix, containing Agenus' adjuvant, QS-21 Stimulon.
FOLD	SD-101 Epidermolysis Bullosa (EB)	Phase 3	09/13/2017 Phase 3 top-line data released September 13, 2017 - endpoints not met.
AMGN	MVASITM (bevacizumab-awwb) Biosimilar candidate to Avastin (bevacizumab)	Approved	09/14/2017 Approved September 14, 2017.
ABBV	MVASITM (bevacizumab-awwb) Biosimilar candidate to Avastin (bevacizumab)	Approved	09/14/2017 Approved September 14, 2017.
AZN	Bydureon Type 2 Diabetes	Phase 3	09/14/2017 Phase 3 Cardiovascular Outcome trial data released September 14, 2017 - primary efficacy objective of a superior reduction in MACE missed statistical significance (p=0.061).
PFE	XTANDI (PROSPER) Non-metastatic high risk hormone-sensitive prostate cancer	Phase 3	09/14/2017 Phase 3 data released September 14, 2017 - primary endpoint met.
NEOS	NT-0201 Attention deficit hyperactivity disorder (ADHD)	Approved	09/15/2017 Approval announced September 15, 2017.
OPTN	XHANCE Nasal polyps	Approved	09/17/2017 Approval announced September 18, 2017 (prior to IPO).
GSK	Trelegy Ellipta (FF/UMEC/VI) Chronic obstructive pulmonary disease (COPD)	Approved	09/18/2017 Approval announced September 18, 2017.
INVA	Trelegy Ellipta (FF/UMEC/VI) Chronic obstructive pulmonary disease (COPD)	Approved	09/18/2017 Approval announced September 18, 2017.
SUPN	SPN-810 Impulsive Aggression in ADHD	Phase 3	09/18/2017 Noted September 18, 2017 that the lower of the two doses will be discontinued following interim analysis.
ABBV	Venclexta (MURANO) Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)	Phase 3	09/18/2017 Phase 3 data released September 18, 2017 - PFS primary endpoint met.
RHHBY	Venclexta (MURANO) Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)	Phase 3	09/18/2017 Phase 3 data released September 18, 2017 - PFS primary endpoint met.
NBRV	Lefamulin - Intravenous and Oral Moderate to severe Community Acquired Bacterial Pneumonia (CABP)	Phase 3	09/18/2017 Phase 3 data released September 18, 2017 - primary endpoints met.
PFE	Sutent (Sunitinib) Renal cell carcinoma (RCC)	-	09/19/2017 Advisory Committee Meeting September 19, 2017 voted 6-6 the benefits outweigh risks.
ALNY	Patisiran Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR	Phase 3	09/20/2017 Phase 3 top-line data released September 20, 2017 - all endpoints met. NDA filing due by end of 2017.
SNY	Patisiran Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR	Phase 3	09/20/2017 Phase 3 top-line data released September 20, 2017 - all endpoints met. NDA filing due by end of 2017.
KPTI	Selinexor - SEAL Dedifferentiated liposarcoma	Phase 2/3	09/20/2017 Phase 2/3 trial initiated January 2016.Topline data for the Phase 2 portion released September 20, 2017 - PFS HR 0.60. Phase 3 data due 2019.
ARAV	VRS-317 VELOCITY Growth hormone deficiency, or GHD - pediatric	Phase 3	09/21/2017 Phase 3 top-line data released September 21, 2017 - primary endpoint not met.
BCRX	RAPIVAB (peramivir injection) Acute uncomplicated influenza to pediatric patients	Approved	09/21/2017 Approved September 21, 2017.
MRK	Keytruda Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma	Approved	09/22/2017 Approved September 22, 2017 - under priority review.
JNJ	Sirukumab Rheumatoid arthritis	CRL	09/22/2017 CRL issued September 22, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
BMY	Opdivo and Yervoy Previously Treated Hepatocellular Carcinoma	Approved	09/22/2017 Approved under priority review September 22, 2017.
GNCA	GEN-003 Genital herpes	-	09/25/2017 Announced September 25, 2017 that development will be ceased.
PRQR	QR-010 Cystic Fibrosis	Phase 1b	09/25/2017 Phase 1b top-line data released September 25, 2017. FEV levels not significant across four doses. One of four doses showed significance in subgroup.
PTCT	Translarna Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)	-	09/28/2017 Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017 voted that although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
ZYNE	Zygel ZYN002 Fragile X syndrome	Phase 2	09/28/2017 Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label.
PRTA	PRX003 Psoriatic Arthritis	Phase 1b	09/28/2017 Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
ZGNX	FINTEPLA (ZX008) Dravet syndrom	Phase 3	09/29/2017 Phase 3 data released September 29, 2017 - primary endpoint met.
NVO	Fiasp (fast-acting insulin aspart) Type 1 and type 2 diabetes	Phase 3	09/29/2017 Approved September 29, 2017.
MCRB	SER-287 Mild-to-Moderate Ulcerative Colitis	Phase 1b	10/02/2017 Phase 1b data released October 2, 2017 - did not perform better than placebo.
ABBV	Botox Forehead lines	Approved	10/03/2017 Approval (third indication) announced October 3, 2017.
RIGL	Fostamatinib Warm Autoimmune hemolytic anemia (WAIHA)	Phase 2	10/03/2017 Phase 2 data from Stage 1 of trial released October 3, 2017 - sufficient efficacy shown to progress to Stage 2.
RDHL	BEKINDA IBS-D	Phase 2	10/03/2017 Phase 2 top-line data released October 3, 2017 - primary endpoint met (borderline) - p=0.05.
LLY	Abemaciclib - MONARCH 1 and 2 Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer	Approved	10/04/2017 Approved October 4, 2017.
BLUE	Lenti-D - ALD-102 Childhood cerebral adrenoleukodystrophy (CCALD)	Phase 2/3	10/04/2017 Phase 2/3 trial initiated October 2013. Interim top-line data released June 26, 2017. Further data released October 4, 2017 - 88% free of free of major functional disabilities.
CATB	Edasalonexent (CAT-1004) Duchenne muscular dystrophy (DMD)	Phase 1/2	10/04/2017 Phase 1/2 data from open-label extension trial presented October 4, 2017 - deemed sufficient to proceed to Phase 3 development.
MYL	Glatiramer Acetate Injection - Generic for Copaxone Multiple sclerosis (MS)	Approved	10/04/2017 Approval announced October 4, 2017.
NBIX	INGREZZA Tardive dyskinesia	Approved	10/05/2017 Approval for sNDA 80 mg capsules announced October 5, 2017.
FLXN	Zilretta - FX006 Osteoarthritis of the knee	Approved	10/06/2017 Approval announced October 6, 2017.
SRPT	Golodirsen - Exon 53 Duchenne muscular dystrophy	Phase 1/2	10/07/2017 Phase 1/2 late breaking poster presented at World Muscle Society October 7, 2017.
LLY	Abemaciclib - JUNIPER Thrid line KRAS mutation positive Non-small cell lung cancer (NSCLC)	Phase 3	10/10/2017 Phase 3 data released October 10, 2017 - primary endpoint not met
MYL	MYL-1401H Neulasta biosimilar	CRL	10/10/2017 CRL issued October 10, 2017.
ANAB	ANB020 - etokimab Moderate-to-severe adult atopic dermatitis	Phase 2a	10/10/2017 Phase 2a positive data released October 10, 2017
ARDX	Tenapanor (T3MPO-2) Constipation-predominant irritable bowel syndrome (IBS-C)	Phase 3	10/11/2017 Phase 3 data released October 11, 2017. Primary endpoint met but with relatively high rates of diarrhea.
ACRX	DSUVIA (ARX-04) Moderate-to-severe acute pain following a surgical procedure	CRL	10/12/2017 CRL issued October 12, 2017.
PFE	LYRICA (pregabalin) Postherpetic neuralgia (PHN)	Approved	10/12/2017 Approval announced October 12, 2017.
ATRS	XYOSTED (testosterone enanthate) Testosterone deficiency	-	10/12/2017 PDUFA date October 20, 2017. Noted October 12, 2017 that the FDA has identified deficiencies with the NDA.
JNJ	STELARA (USTEKINUMAB) Plaque psoriasis	Approved	10/13/2017 Approval announced October 13, 2017.
AERI	Rhopressa Glaucoma	-	10/13/2017 PDUFA date February 28, 2018. Advisory Committee meeting October 13, 2017 voted 9-1 in favor that efficacy outweighs safety risks,
EXEL	Cabozantinib (CELESTIAL) Advanced hepatocellular cancer (HCC)	Phase 3	10/16/2017 Phase 3 data released October 16, 2017 - primary endpoint met. sNDA filing due 1Q 2018.
TAK	Cabozantinib (CELESTIAL) Advanced hepatocellular cancer (HCC)	Phase 3	10/16/2017 Phase 3 data released October 16, 2017 - primary endpoint met. sNDA filing due 1Q 2018.
FENC	Pedmark (sodium thiosulfate) Cisplatin-Induced Hearing Loss	Phase 3	10/16/2017 Phase 3 trial met primary endpoint - full data released October 16, 2017.
NVO	Semaglutide Type 2 diabetes	-	10/18/2017 Advisory Committee Meeting October 18, 2017 voted 16-0 in favor.
RHHBY	Entrectinib Solid tumors and ROS1-positive non-small cell lung cancer (NSCLC)	Phase 2	10/18/2017 Updated promising data released October 18, 2017.ORR 69%, PFS 29.6 months.
CRBP	Lenabasum (resunab) - DETERMINE Dermatomyositis	Phase 2	10/19/2017 Phase 2 data released October 19, 2017 - primary endpoint met.
DRRX	POSIMIR Post-operative pain relief	Phase 3	10/19/2017 CRL Feb 12 2014. Phase 3 commenced November 2015 in response to CRL. Noted October 19, 2017 that primary endpoint was not met.
JNJ	SIMPONI ARIA Psoriatic arthritis (PsA)	Approved	10/20/2017 Approval announced October 20, 2017.
JNJ	SIMPONI ARIA Ankylosing Spondylitis	Approved	10/20/2017 Approval announced October 20, 2017.
GSK	Shingrix Shingles	Approved	10/20/2017 Approval announced October 20, 2017.
ATRS	XYOSTED (testosterone enanthate) Testosterone deficiency	CRL	10/20/2017 CRL issued October 20, 2017.
AGEN	Shingrix