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.

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.
ARDM	Sumavel Migraine	Approved	07/16/2009 Approval granted 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.
FCSC	Laviv Wrinkles	CRL	12/18/2009 CRL issued December 18, 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.
FCSC	Laviv Wrinkles	Approved	06/22/2011 Approved June 22, 2011.
SGEN	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.
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	TIVO-3 - 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.
MDCO	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.
MDCO	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,
PGNX	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.
MNTA	Generic Copaxone Multiple sclerosis	Approved	04/16/2015 Approved April 16 2015.
MNK	RAPLIXA Hemostasis	Approved	04/30/2015 Approved April 30, 2015.
MDCO	IONSYS Acute postoperative pain	Approved	04/30/2015 Approved April 30, 2015.
TBPH	BREO ELLIPTA Asthma	Approved	04/30/2015 Approved April 30, 2015.
PTX	TREXIMET Adolescent migraine patients	Approved	05/15/2015 Approved May 15, 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.
TTPH	Eravacycline (TP-434) - IGNITE3 cUTI - complicated urinary tract infections	Phase 3	09/08/2015 Phase 3 trial did not meet endpoints September 8, 2015.
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.
GWPH	Sativex Cancer pain	Phase 3	10/27/2015 Phase 3 trials did not meet endpoints.
SPHS	Topsalysin (PRX302) Benign prostatic hyperplasia	Phase 3	11/10/2015 Phase 3 primary endpoints met - November 10, 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	ADS-5102 Levodopa-Induced Dyskinesia	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.
ZFGN	Beloranib Prader-Willi Syndrome (PWS)	Phase 3	01/20/2016 Phase 3 co-primary endpoints met.
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	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.
PTLA	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.
NLNK	HyperAcute Pancreas - IMPRESS Surgically resected pancreatic cancer	Phase 3	05/09/2016 Phase 3 failed to meet primary endpoint - May 9, 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.
OCUL	DEXTENZA Allergic conjunctivitis	Phase 3	06/06/2016 Phase 3 trial did not meet primary endpoint - June 6, 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.
MRNS	Ganaxolone Focal onset seizures	Phase 3	06/13/2016 Phase 3 data did not meet endpoints - June 13, 2016
RVNC	DAXI (RT002) Lateral Canthal (Crow’s Feet) Lines	Phase 3	06/13/2016 Phase 3 endpoints not met 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.
MDCO	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.
LPCN	TLANDO - LPCN 1021 Men with low testosterone (Low T)	CRL	06/29/2016 CRL issued June 29, 2016.
GSK	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Phase 3	06/29/2016 Phase 3 data met endpoints - June 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
CYTR	Aldoxorubicin with doxorubicin Soft tissue sarcomas refractory cancer	Phase 3	07/11/2016 Phase 3 PFS data released July 2016 showed no significant improvement in PFS. Second analysis released November 29, 2016 showed improvement in population with leiomyosarcoma and liposarcoma.
RARE	MEPSEVII (vestronidase alfa) Mucopolysaccharidosis 7 (MPS 7)	Phase 3	07/14/2016 Phase 3 data released July 2016. Primary endpoint hit. Secondary missed.
PGNX	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	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.
PTLA	Andexxa Factor Xa inhibitor reversal agent	CRL	08/17/2016 CRL August 17 2016.
EARS	AM-101 (Keyzilen) - TACTT2 Acute inner ear tinnitus	Phase 3	08/18/2016 Phase 3 trial did not meet primary endpoints.
ACRS	A-101 THWART-1 and THWART-2 Common warts (verruca vulgaris)	Phase 2	08/18/2016 Phase 2 data released August 2016.
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.
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
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 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.
GILD	Yescarta (axicabtagene ciloleucel) Refractory Non-Hodgkin's Lymphoma (NHL) - cancer	Phase 2	09/26/2016 Phase 2 pivotal top-line data released September 26, 2016. Primary analysis due 1Q 2017. BLA filing due late 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.
ABUS	ARB-1467 Hepatitis B (HBV)	Phase 2	09/29/2016 Phase 2 single dose data released September 2016.
MLNT	Solithromycin NASH	Phase 2	09/30/2016 Phase 2 interim data released September 30, 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 - ORION-9 Hypercholesterolemia	Phase 2	11/15/2016 Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
MDCO	Inclisiran - ORION-9 Hypercholesterolemia	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	XIAFLEX (collagenase clostridium histolyticum) - RELEASE Edematous fibrosclerotic panniculopathy (“cellulite”)	Phase 2b	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints
ENDP	XIAFLEX (collagenase clostridium histolyticum) - RELEASE Edematous fibrosclerotic panniculopathy (“cellulite”)	Phase 2b	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints
SPPI	QAPZOLA - Apaziquone Bladder cancer	Phase 3	11/17/2016 Failed to meet primary endpoint in Phase 3 trial - Apr 2012. PDUFA date December 11 2016. Advisory Committee Meeting September 14 2016 voted 14 - 0 against approval. CRL issued November 17, 2016. Considering further trials.
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.
REPH	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.
ARDM	Linhaliq (Pulmaquin) Non-cystic fibrosis bronchiectasis (non-CF BE).	Phase 3	12/01/2016 Phase 3 data released December 1, 2016. One of two trials met primary endpoint.
LXRX	Sotagliflozin Type 1 Diabetes	Phase 2	12/05/2016 Phase 2 trial did not meet primary endpoint.
HZNP	ACTIMMUNE Friedreich's Ataxia (FA)	Phase 3	12/08/2016 Phase 3 data released December 8, 2016 - primary endpoint not met
SGYP	Trulance (plecanatide) Constipation-predominant irritable bowel syndrome (IBS-C)	Phase 3	12/09/2016 Phase 3 data from first trial met primary endpoint - December 9, 2016.
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.
ABUS	ARB-1467 Hepatitis B (HBV)	Phase 2	12/12/2016 Phase 2 single dose data released September 2016, multiple dose data released December 12, 2016.
LIFE	Resolaris Limb girdle muscular dystrophy (LGMD) 2B / Adult patients with facioscapulohumeral muscular dystrophy (FSHD)	Phase 1/2	12/13/2016 Phase 1b/2 data released December 13, 2016.
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.
PRTO	Vonapanitase (PRT-201) PATENCY-1 Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)	Phase 3	12/13/2016 Phase 3 data released December 13, 2016 - primary endpoint not met.
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.
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.
LXRX	Sotagliflozin Type 1 Diabetes	Phase 3	12/21/2016 Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
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.
SGYP	Trulance (plecanatide) Constipation-predominant irritable bowel syndrome (IBS-C)	Phase 3	12/22/2016 Phase 3 data from second trial met primary endpoints - December 9 and 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.
MLNT	Solithera - intravenous Community-acquired bacterial pneumonia (CABP)	CRL	12/29/2016 CRL announced December 29, 2016. Further trials required.
OPK	hGH-CTP Adults - growth hormone deficiency	Phase 3	12/30/2016 Phase 3 data released December 30, 2016 - primary endpoint not met.
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.
PLX	AIR DNase (PRX-110) Cystic Fibrosis	Phase 2	01/03/2017 Phase 2 interim data released January 3, 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 (FG-3019) Pancreatic cancer	Phase 2	01/17/2017 Phase 2 abstract released January 17, 2017.
AGN	ESMYA (ulipristal acetate) Uterine Fibroids	Phase 3	01/18/2017 Phase 3 data released January 18, 2017 - endpoints met.
NBIX	INGREZZA Tourette syndrome - adults	Phase 2	01/18/2017 Phase 2 data released January 18, 2017 did not meet primary endpoint.
AGN	Oxymetazoline HCl cream 1.0% Facial Erythema (Redness) Associated with Rosacea	Approved	01/19/2017 Approved January 19, 2017.
SGYP	Trulance (plecanatide) Chronic idiopathic constipation (CIC)	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.
VRTX	VX-150 Osteoarthritis	Phase 2	01/25/2017 Phase 2 primary endpoint met - January 25, 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.
AGN	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.
AGN	AVYCAZ (ceftazidime and avibactam) Complicated Urinary Tract Infections (cUTI)	Approved	01/30/2017 sNDA approval announced January 30, 2017.
GEMP	Gemcabene - COBALT-1 Homozygous Familial Hypercholesterolemia (HoFH)	Phase 2b	01/30/2017 Phase 2b interim data released January 30, 2017.
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.
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.
AMGN	Parsabiv Secondary hyperparathyroidism (SHPT)	Approved	02/07/2017 Approved February 7, 2017.
GWPH	Sativex Spasticity due multiple sclerosis	Phase 2	02/07/2017 Phase 2 trial did not meet primary endpoint - noted 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.
ARDX	Tenapanor - PHREEDOM Hyperphosphatemia in end-stage renal disease (ESRD) patients	Phase 3	02/15/2017 Phase 3 released February 15, 2017 - primary endpoint met.
ALKS	ALKS 6428 Opioid dependence	Phase 3	02/15/2017 Phase 3 trial did not meet endpoint - February 2017 (exact date unsure).
BHC	Brodalumab Psoriasis	Approved	02/15/2017 Approved February 15, 2017.
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.
XBIT	Xilonix Colorectal cancer	Phase 3	02/21/2017 Phase 3 interim analysis announced February 21, 2017 - trial to continue as planned.
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.
CELG	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.
MLNT	Taksta - Fusidic acid Acute bacterial skin and skin structure infections (ABSSSI)	Phase 3	02/24/2017 Phase 3 data released February 24, 2017 - endpoints met.
BCRX	BCX7353 - APeX-2 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.
GILD	Yescarta (axicabtagene ciloleucel) Refractory Non-Hodgkin's Lymphoma (NHL) - cancer	Phase 2	02/28/2017 Phase 2 primary analysis released February 28, 2017 showed trial met primary endpoint. 31% CR for DLBCL.
LXRX	Telotristat etiprate (XERMELO) Carcinoid Syndrome	Approved	02/28/2017 Approved February 28, 2017.
AZN	Saxagliptin and dapagliflozin Type-2 diabetes	Approved	02/28/2017 Approval announced February 28, 2017.
MLNT	Solithromycin NASH	Phase 2	02/28/2017 Noted February 28, 2017 that development has been suspended due to lack of efficacy.
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.
HALO	Perjeta + Herceptin (APHINITY) Adjuvant HER2+ breast cancer	Phase 3	03/02/2017 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. The event was likely to have a significant impact on the share price of Puma (e.g. positive data would likely have a negative impact on Puma and vice versa). Data were released March 2, 2017 - primary endpoint was met.
RHHBY	Perjeta + Herceptin (APHINITY) Adjuvant HER2+ breast cancer	Phase 3	03/02/2017 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. The event was likely to have a significant impact on the share price of Puma (e.g. positive data would likely have a negative impact on Puma and vice versa). Data were released March 2, 2017 - primary endpoint was met.
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.
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.
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.
AKCA	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.
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.
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.
AGN	JUVÉDERM VOLLURE Correction of moderate to severe facial wrinkles and folds	Approved	03/20/2017 Approval announced March 20, 2017.
GNMX	NFC-1 - SAGA mGluR mutation positive ADHD	Phase 2/3	03/20/2017 Phase 2/3 data released March 20, 2017 - primary endpoint not 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.
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.
AUPH	Voclosporin - AURION trial Lupus	Phase 2	03/27/2017 48-week data from open-label AURION study presented March 27, 2017 - primary endpoint met.
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.
AGN	Sarecycline Severe acne vulgaris	Phase 3	03/27/2017 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
FOMX	FMX101 Acne	Phase 3	03/27/2017 Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
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.
RTTR	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.
CRBP	Anabasum (Resunab) Cystic Fibrosis	Phase 2	03/30/2017 Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
PGNX	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.
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.
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.
PFE	IBRANCE (palbociclib) HR+, HER2- Metastatic Breast Cancer	Approved	03/31/2017 sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
BMY	CM-143 – Opdivo Second-line Glioblastoma (GBM) cancer	Phase 3	04/03/2017 Phase 3 data released April 3, 2017 - primary endpoint not met.
BMY	CM - 067 Opdivo in combination with Yervoy Melanoma	Phase 3	04/03/2017 Phase 3 first overall survival (OS) positive data released April 3, 2017
PRTK	Omadacycline Community-acquired bacterial pneumonia (CABP)	Phase 3	04/03/2017 Phase 3 data released April 3, 2017 - all endpoints met.
XBIT	514G3 Staphylococcus Aureus Bacteremia	Phase 1/2	04/03/2017 Phase 1/2 top-line data released April 3, 2017. 4 patient deaths noted.
NLNK	Indoximod in combination with KEYTRUDA or Opdivo - Indigo301 Melanoma - cancer	Phase 2	04/04/2017 Phase 2 interim analysis released at AACR meeting April 4, 2017.
KPTI	Selinexor - SADAL Cancer - 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.
AGN	Botox Depression	Phase 2	04/05/2017 Phase 2 top-line data released April 5, 2017 - primary endpoint missed. Phase 3 planned.
ONCE	SPK-9001 Hemophilia B	Phase 1/2	04/06/2017 Phase 1/2 updated data at ASH 2016. Further update released 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 - IMbarkStudy 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	MPC-150-IM - Class 2/3 Heart failure	Phase 3	04/10/2017 Noted April 10, 2017 that interim analysis has been completed - trial to continue as planned.
CELG	Demcizumab plus Abraxane - YOSEMITE First-line pancreatic cancer	Phase 2	04/10/2017 Phase 2 data released April 10, 2017 - primary endpoint not met.
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.
MTFB	Iclaprim -REVIVE-1 Acute bacterial skin and skin structure infections (ABSSSI)	Phase 3	04/18/2017 Phase 3 data released April 18, 2017 - primary endpoint of non-inferiority met.
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.
ACHN	JNJ-4178 Hepatitis C (HCV)	Phase 2a	04/22/2017 Phase 2a ongoing. Updated data presented at EASL April 22, 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	Coversin - CAPSTONE 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	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.
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.
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.
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.
BPMX	BPX-01 Acne	Phase 2b	05/03/2017 Phase 2b data released May 3, 2017 - primary endpoint met, secondary missed.
ZFGN	ZGN-1061 Diabetes	Phase 1	05/04/2017 Phase 1 positive safety data released May 4, 2017. Phase 2 initiation due 2H 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.
CELG	Demcizumab plus carboplatin and pemetrexed - DENALI First-line non-squamous Non-small cell lung cancer (NSCLC)	Phase 2	05/08/2017 Announced November 1, 2016 that it has discontinued further enrollment. Phase 2 data released May 8, 2017 - endpoints not met.
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.
ABBV	ABT-494 Crohn’s Disease	Phase 2	05/09/2017 Phase 2 positive data at DDW Meeting May 9, 2017. Phase 3 trial to be initiated later in 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.
PTCT	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.
AKCA	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.
FOLD	ATB200 Pompe Disease	Phase 1/2	05/15/2017 Phase 1/2 additional data released February 15, 2017. Further data released May 15, 2017.
MRK	KEYTRUDA First and Second line locally advanced or metastatic urothelial cancer - bladder cancer	Approved	05/18/2017 Approved May 18, 2017.
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.
CELG	Ozanimod - RADIANCE 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.
SBPH	Inarigivir and Vemlidy Hepatitis B (HBV)	Phase 2a	05/23/2017 Phase 2a initial data released May 23, 2017. Second cohort enrolling with top-line results due 4Q 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	BCX7353 - APeX-2 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 - MOXIe Friedreich’s ataxia (FA)	Phase 2	06/01/2017 Phase 2 initial data released June 1, 2017. Primary endpoint not met.
BMY	CM-358 – Opdivo Cervical, vaginal and vulvar cancers	Phase 1/2	06/02/2017 Phase 1/2 preliminary data presented at ASCO June 2, 2017. ORR=21%.
IMDZ	CMB305 Soft tissue sarcomas	Phase 2	06/02/2017 Phase 2 data at ASCO June 2, 2017.
NLNK	Indoximod + taxane Cancer - breast	Phase 2	06/02/2017 Phase 2 trial did not meet endpoints - noted June 2, 2017.
DVAX	SD-101 + Pembrolizumab Melanoma and head and neck squamous cell carcinoma (HNSCC)	Phase 1/2	06/02/2017 Phase 1b/2 poster at ASCO June 3, 2017. Noted June 2 ORR of 7/7 in anti-PD-1/L1-naïve patients
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.
BMY	BMS-986016 - LAG-3 + Opdivo Melanoma	Phase 1/2	06/03/2017 Phase 1/2 ORR rate of 12.5% noted at ASCO June 3, 2017.
INCY	Epacadostat with Keytruda - ECHO-202/KEYNOTE-037 NSCLC, RCC, Triple-Negative Breast, Ovarian, Urothelial Carcinoma, Solid Tumors	Phase 1/2	06/03/2017 Phase 1/2 data presented at ASCO 2017. 35% ORR noted in NSCLC arm. UC, RCC, SCCHN data also presented June 5.
MRK	Epacadostat with Keytruda - ECHO-202/KEYNOTE-037 NSCLC, RCC, Triple-Negative Breast, Ovarian, Urothelial Carcinoma, Solid Tumors	Phase 1/2	06/03/2017 Phase 1/2 data presented at ASCO 2017. 35% ORR noted in NSCLC arm. UC, RCC, SCCHN data also presented June 5.
GSK	Niraparib and Keytruda (TOPACIO) Triple-negative Breast Cancer or Ovarian Cancer	Phase 1/2	06/03/2017 Phase 1/2 enrolling. Initial data presented at ASCO investor event. ORR 4/13 patients. Further data due 2H 2017.
ARQL	Derazantinib (ARQ 087) intrahepatic cholangiocarcinoma (iCCA)	Phase 2	06/03/2017 Phase 2 data at ASCO June 3, 2017 - ORR 21%. Phase 3 trial planned for 3Q 2017.
PBYI	Neratinib HER2-positive metastatic breast cancer patients with brain metastases	Phase 2	06/03/2017 Phase 2 data released at ASCO June 3, 2017.
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%.
MRK	Keytruda - KEYNOTE-045 Bladder Cancer	Phase 3	06/04/2017 Phase 3 trial met its primary endpoint - October 2016. Updated data presented at ASCO 2017. HR 0.70. OS 10.3 months.
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.
CALA	CX-1158-101 Solid tumors - cancer	Phase 1	06/05/2017 Phase 1 oral presentation at ASCO, June 5, 2017.
NLNK	Indoximod + Sipuleucel-T Metastatic castration resistant prostate cancer (mCRPC)	Phase 2	06/05/2017 Phase 2 poster presentation at ASCO June 5, 2017.
BMY	Opdivo + Yervoy Malignant pleural mesothelioma (MPM)	Phase 2	06/05/2017 Phase 2 late breaker at ASCO June 5, 2017. Control rate 44%. ORR 19%.
INCY	Epacadostat with Opdivo (nivolumab) - (ECHO-204) Solid tumors	Phase 1/2	06/05/2017 Phase 1/2 trial enrolling. Oral presentation at ASCO June 5, 2017.
BMY	Epacadostat with Opdivo (nivolumab) - (ECHO-204) Solid tumors	Phase 1/2	06/05/2017 Phase 1/2 trial enrolling. Oral presentation at ASCO June 5, 2017.
CELG	Lico-cel (CD-19 JCAR017) - TRANSCEND r/r B cell non-Hodgkin lymphoma - cancer	Phase 1/2	06/05/2017 Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017 - ORR 86%.
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.
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.
BLUE	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%.
CELG	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%.
HALO	Perjeta + Herceptin (APHINITY) Adjuvant HER2+ breast cancer	Phase 3	06/05/2017 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. Primary endpoint was met March 2, 2017. Data released June 5, 2017 - HR 0.81. Disease-free-survival +0.9% over Herceptin.
RHHBY	Perjeta + Herceptin (APHINITY) Adjuvant HER2+ breast cancer	Phase 3	06/05/2017 Note this trial is conducted by competitor Roche (RHHBY), NOT by Puma. Primary endpoint was met March 2, 2017. Data released June 5, 2017 - HR 0.81. Disease-free-survival +0.9% over Herceptin.
CLSN	GEN-1 OVATION 2 Ovarian cancer	Phase 1b	06/05/2017 Phase 1b interim data released at ASCO 2017 - ORR 86%.
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.
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.
XBIT	Xilonix Colorectal cancer	Phase 3	06/09/2017 Phase 3 interim analysis announced June 9, 2017 - trial to be terminated due to lack of efficacy.
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.
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.
EPZM	Tazemetostat Follicular lymphoma	Phase 2	06/14/2017 Phase 2 data released June 14, 2017 - DLBCL ORR 29%.
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.
RDHL	BEKINDA -GUARD Gastroenteritis	Phase 3	06/14/2017 Phase 3 top-line data released June 14, 2017 - primary endpoint met.
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.
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.
PTLA	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.
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.
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.
NEOS	Cotempla XR-ODT Attention deficit hyperactivity disorder (ADHD)	Approved	06/19/2017 Approval announced June 19, 2017.
NVS	RTH258 (brolucizumab) Neovascular 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.
IMUC	ICT-107 dendritic cell vaccine Glioblastoma antigens and cancer stem cells	Phase 3	06/21/2017 Phase 2b failed to meet primary endpoint. Phase 3 initiated dosing June 2016 - noted June 21, 2017 that further enrollment to be suspended.
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.
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.
PTLA	Bevyxxa (betrixaban) Venous thromboembolism (VTE) Prevention	Approved	06/23/2017 FDA Approval noted 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.
STML	SL-401 (Elzonris) Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer	Phase 2	06/23/2017 Phase 2 update on patients enrolled in Stages 1 and 2 presented at EHA June 23, 2017.
AGIO	AG-348 (ACTIVATE) 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.
MTNB	MAT2203 Vulvovaginal candidiasis (VVC)	Phase 2	06/26/2017 Phase 2 top-line data released June 26, 2017. Not successful in demonstrating meaningful clinical response.
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.
MRK	Anacetrapib (MK-0859) Raising HDL-C and reducing LDL-C	Phase 3	06/27/2017 Phase 3 data due released June 27, 2017. Primary endpoint met.
ALDR	ALD403 - PROMISE 1 Frequent episodic migraine	Phase 3	06/27/2017 Phase 3 PROMISE 1 top-line data released June 27, 2017, Primary and key secondary endpoints met but competitive concerns raised.
XENE	TV-45070 Postherpetic neuralgia	Phase 2b	06/27/2017 Phase 2b data released June 27, 2017. Endpoints not met.
GEMP	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.
MRK	KEYTRUDA - KEYNOTE-183 Multiple myeloma	Phase 3	07/05/2017 Phase 3 clinical hold announced July 6, 2017 - also applies to KEYNOTE-185.
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.
ALNY	Fitusiran Hemophilia A and B	Phase 2	07/10/2017 Phase 2 Open-label Extension Study data released July 10, 2017 at ISTH.
ONCE	SPK-9001 Hemophilia B	Phase 1/2	07/10/2017 Phase 1/2 updated data released July 10, 2017. 99% fall in infusion rate.
ARNA	Ralinepag Pulmonary Arterial Hypertension	Phase 2	07/10/2017 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
UTHR	Ralinepag 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.
BMRN	Valoctocogene roxaparvovec (BMN 270) Hemophilia A	Phase 1/2	07/11/2017 Phase 1/2 updated data released July 11, 2017. 97% reduction in Annualized Bleed Rate (ABR).
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 - ROCKstar (KD025-213) Chronic graft-versus-host disease (cGVHD)	Phase 2	07/11/2017 Phase 2 interim data presented July 11, 2017. ORR 71%.
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.
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.
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.
GILD	Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir) Hepatitis C virus (HCV)	Approved	07/18/2017 Approval announced July 18, 2017.
VRTX	VX-440 in combination with tezacaftor and ivacaftor Cystic fibrosis who have one F508del mutation and one minimal function mutation and patients with two copies of the F508del mutation	Phase 2	07/18/2017 Phase 2 data released July 18, 2017. ppFEV1 of 12.0 percentage points.
VRTX	VX-152 in combination with tezacaftor and ivacaftor Cystic fibrosis who have one F508del mutation and one minimal function mutation and patients with two copies of the F508del mutation	Phase 2	07/18/2017 Phase 2 data released July 18, 2017. ppFEV1 of 9.7 percentage points.
VRTX	VX-659 in combination with tezacaftor and ivacaftor Cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min)	Phase 1	07/18/2017 Phase 1 data released July 18, 2017. ppFEV1 of 9.6 percentage points.
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.
BVXV	M-001 Universal flu vaccine	Phase 2b	07/20/2017 Phase 2b data released July 20, 2017 - endpoints met.
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.
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.
NVAX	RSV F Vaccine immunogenicity trial Respiratory Syncytial Virus (RSV) in older adults	Phase 2	07/24/2017 Phase 2 safety and immunogenicity data released July 24, 2017 - efficacy trial to be initiated 2018.
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.
TTPH	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.
RDHL	RHB-104 MAP US 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.
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.
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).
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.
AGIO	IDHIFA (enasidenib) - AG-221 Advanced hematologic malignancies with an IDH2 mutation	Approved	08/01/2017 Approval announced August 1, 2017.
CELG	IDHIFA (enasidenib) - AG-221 Advanced hematologic malignancies with an IDH2 mutation	Approved	08/01/2017 Approval announced August 1, 2017.
BMY	CM-142 – Opdivo (dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)	Approved	08/01/2017 Approval announced 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.
ONCE	SPK-8011 Hemophilia A	Phase 1/2	08/02/2017 Phase 1/2 promising initial data released from first two patients - August 2, 2017. 11% and 14% Factor VIII.
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.
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.
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.
LLY	Lasmiditan - SPARTAN 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