Historical Catalyst Calendar

Biotech Stock Historical Catalysts listed from 2009.

What's included?

2009 ~ Most small/mid cap FDA 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	CRL	09/04/2009 Approved September 4, 2009.
SPPI	FUSILEV Colorectal cancer	Approved	10/09/2009 CRL received October 9, 2009.
PRTK	Intermezzo Insomnia	Approved	11/02/2009 CRL issued November 2, 2009.
GTXI	Toremifene Reduce fractures in men with prostate cancer	CRL	11/02/2009 CRL issued November 2, 2009.
HEB	Ampligen CFS	CRL	12/01/2009 CRL issued December 1, 2009.
FCSC	Laviv Wrinkles	Approved	12/18/2009 CRL issued December 18, 2009.
ACOR	Ampyra Improve walking in patients with multiple sclerosis	-	01/22/2010 Approved January 22, 2010.
ALKS	BYDUREON Type 2 diabetes	Approved	01/27/2010 Approved January 27, 2010.
MNKD	AFREZZA Type 1/2 diabetes	Approved	03/15/2010 CRL issued March 15, 2010.
ALKS	BYDUREON Type 2 diabetes	Approved	03/15/2010 CRL received March 15, 2010.
HRTX	APF530 - Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)	Approved	03/19/2010 CRL issued March 19, 2010.
CTIC	PIXUVRI - PIX306 Trial B-cell non-Hodgkin lymphoma	Phase 3	04/09/2010 CRL received April 9, 2010.
ARLZ	VIMOVO Gastric ulcers	Approved	04/30/2010 Approved April 30, 2010.
JAZZ	JZP-6 Fibromyalgia	Approved	10/11/2010 CRL received October 11, 2010.
VVUS	Qnexa Obesity	Approved	10/28/2010 October 28, 2010.
MNKD	AFREZZA Type 1/2 diabetes	Approved	01/19/2011 CRL received January 19, 2011.
PLX	Taliglucerase alfa Gaucher disease	Approved	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.
DRRX	Remoxy Chronic pain	CRL	06/24/2011 CRL received June 24, 2011.
PTIE	Remoxy Chronic pain	CRL	06/24/2011 CRL received June 24, 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.
ALIM	Iluvien Diabetic macular edema	Approved	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.
INSY	SUBSYS Cancer pain	Approved	01/05/2012 Approved January 5, 2012.
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 REDUCE-IT outcomes trial High Triglycerides With Mixed Dyslipidemia	Phase 3	07/26/2012 Approved July 26, 2012.
HALO	HYQVIA Subcutaneous treatment for patients with primary immunodeficiency (PI)	Approved	08/01/2012 CRL issued August 1, 2012.
NAVB	Lymphoseek Lymphatic-tissue tracing agent	Approved	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.
HEB	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	Approved	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)	Approved	03/28/2013 CRL March, 28 2013.
TTNP	Probuphine Opioid dependence	Approved	04/30/2013 CRL issued April 30, 2013.
ENDP	AVEED (testosterone undecanoate) intramuscular injection Men diagnosed with hypogonadism	Approved	05/30/2013 CRL issued September 5, 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	Phase 3	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	Approved	10/17/2013 Second CRL October 17, 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)	Approved	01/22/2014 CRL issued January 22, 2014.
AMAG	Feraheme Adults with iron deficiency anemia (IDA)	PDUFA	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.
ARLZ	YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers	Approved	04/25/2014 CRL issued April 25, 2014.
MDCO	Cangrelor Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)	Approved	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	Phase 3	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.
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	Approved	11/06/2014 CRL issued November 6, 2014.
INCY	Jakafi (ruxolitinib) (RESPONSE) Polycythemia Vera	Approved	12/04/2014 Approved December 4, 2014.
ARLZ	YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers	Approved	12/17/2014 CRL issued December 17, 2014.
ABBV	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	Approved	01/08/2015 First Phase 3 trial met both co-primary endpoints - January 8, 2015.
ABBV	Elagolix Endometriosis	Approved	01/08/2015 First Phase 3 trial met both co-primary endpoints - January 8, 2015.
RMTI	Soluble Ferric Pyrophosphate Iron deficiency	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	Approved	03/02/2015 CRL March 2, 2015.
PCRX	EXPAREL Post surgical pain	PDUFA	03/02/2015 CRL March 2, 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.
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.
ADMP	Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis.	Approved	03/25/2015 CRL issued March 27 2015.
EBS	Anthrax Immune Globulin Intravenous (Human) [AIGIV] Anthrax	Approved	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.
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.
VTL	VTI-308 Alcohol-induced liver decompensation, or AILD	Phase 3	08/21/2015 Phase 3 VTI-208 trial did not meet endpoints - August 21, 2015.
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.
IMGN	Kadcyla GATSBY trial Cancer - metastatic HER2+ gastric cancer	Phase 3	10/22/2015 Phase 3 endpoint not met - October 22, 2015.
MACK	ONIVYDE Cancer - second line pancreatic	Approved	10/22/2015 Approved October 22, 2015.
SPPI	EVOMELA (melphalan) for Injection Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma	Approved	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	Approved	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	Approved	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	Approved	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 - ERADICATE Hp 2 H. pylori	NDA Filing	03/08/2016 Phase 3 final data released March 8, 2016.
GWPH	Epidiolex Dravet Syndrome and Lennox-Gastaut syndrome	Approved	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	Approved	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	Approved	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.
AZN	Lokelma (ZS-9) Hyperkalaemia	Approved	05/26/2016 CRL issued May 26, 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.
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.	Approved	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	RT001 - REALISE 1 Lateral Canthal (Crow’s Feet) Lines	Phase 3	06/13/2016 Phase 3 endpoints not met June 13, 2016.
KMPH	Apadaz (KP201/APAP) Acute pain	PDUFA	06/13/2016 CRL issued June 13, 2016.
PRTK	Omadacycline Acute bacterial skin and skin structure infections (ABSSSI)	Approved	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)	Approved	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	LPCN 1021 Men with low testosterone (Low T)	-	06/29/2016 CRL issued June 29, 2016.
GSK	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Approved	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
INSY	Dronabinol Oral Solution AIDS-related anorexia	Approved	07/05/2016 Announced approval July 5, 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)	Approved	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	Approved	07/25/2016 CRL July 25 2016 - due to manufacturing deficiencies.
MCRB	SER-109 - ECOSPOR III Recurrent C. Difficile infection	Phase 3	07/29/2016 Phase 2 interim data did not meet primary endpoint.
ADMA	RI-002 Primary Immune Deficiency Diseases	PDUFA	07/29/2016 CRL issued July 29 2016. Third-party manufacturing issues cited.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Approved	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 2b	08/10/2016 Phase 2 data released August 10, 2016. Primary endpoint met.
AUPH	Voclosporin - AURORA Lupus	Phase 3	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	Approved	08/15/2016 Phase 3 data released August 15, 2016.
PTLA	Andexxa Factor Xa inhibitor reversal agent	Approved	08/17/2016 CRL August 17 2016.
ACRS	A-101 THWART-1 and THWART-2 Common warts (verruca vulgaris)	Phase 3	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.
RIGL	Tavalissetm (Fostamatinib) Immune Thrombocytopenic Purpura (ITP)	PDUFA	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
RIGL	Tavalissetm (Fostamatinib) Immune Thrombocytopenic Purpura (ITP)	Approved	08/30/2016 Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
RIGL	Tavalissetm (Fostamatinib) Immune Thrombocytopenic Purpura (ITP)	Approved	08/30/2016 Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
OPK	Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV	Approved	09/02/2016 Approved September 2, 2015.
GSK	Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients	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	PDUFA priority review	09/06/2016 Phase 2 positive top-line data released September 6, 2016
AERI	Roclatan Glaucoma	PDUFA	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.
ARLZ	YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers	Approved	09/15/2016 Approval announced September 15, 2016.
VICL	ASP0113 Vaccine Kidney transplant recipients	Phase 2	09/19/2016 Phase 2 data released September 19, 2016 - did not meet primary endpoint.
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.
DRRX	Remoxy Chronic pain	CRL	09/26/2016 CRL received September 26, 2016.
PTIE	Remoxy Chronic pain	CRL	09/26/2016 CRL received September 26, 2016.
ITCI	Lumateperone Schizophrenia	PDUFA	09/28/2016 Phase 3 trial failed - September 28, 2016.
GNCA	GEN-003 Genital herpes	-	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	PDUFA	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)	PDUFA	10/30/2016 Phase 3 data from second trial did not meet the primary endpoint.
RIGL	Tavalissetm (Fostamatinib) Immune Thrombocytopenic Purpura (ITP)	Approved	10/30/2016 Phase 3 data from second trial did not meet the primary endpoint.
AMAG	Vyleesi (Bremelanotide) Female sexual dysfunction (FSD)	PDUFA	11/01/2016 Phase 3 data released November 1, 2016.
PTN	Vyleesi (Bremelanotide) Female sexual dysfunction (FSD)	PDUFA	11/01/2016 Phase 3 data released November 1, 2016.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Approved	11/07/2016 Phase 3 CHERISH data met primary endpoint - November 7, 2016.
DVAX	HEPLISAV-B Hepatitis B	Approved	11/14/2016 CRL November 14, 2016
ALNY	Inclisiran - ORION-9 Hypercholesterolemia	Phase 3	11/15/2016 Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
MDCO	Inclisiran - ORION-9 Hypercholesterolemia	Phase 3	11/15/2016 Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
ACRS	ESKATA (hydrogen peroxide) Seborrheic keratosis (SK)	Approved	11/15/2016 Phase 3 trial met endpoints - November 15, 2016.
BSTC	XIAFLEX (collagenase clostridium histolyticum) - RELEASE Edematous fibrosclerotic panniculopathy (“cellulite”)	BLA Filing	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints
ENDP	XIAFLEX (collagenase clostridium histolyticum) - RELEASE Edematous fibrosclerotic panniculopathy (“cellulite”)	BLA Filing	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	PDUFA	11/28/2016 Phase 3 data from second trial released November 28, 2016. Primary endpoint met.
NOVN	SB206 Human papillomavirus (HPV)	Phase 2	11/29/2016 Phase 2 data released November 29, 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.
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).	CRL	12/01/2016 Phase 3 data released December 1, 2016. One of two trials met primary endpoint.
ARDM	Linhaliq (Pulmaquin) Non-cystic fibrosis bronchiectasis (non-CF BE).	PDUFA priority review	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)	PDUFA	12/09/2016 Phase 3 data from first trial met primary endpoint - December 9, 2016.
SGYP	Trulance (plecanatide) Constipation-predominant irritable bowel syndrome (IBS-C)	Approved	12/09/2016 Phase 3 data from first trial met primary endpoint - December 9, 2016.
AKAO	Plazomicin Complicated urinary tract infections (cUTI)	Approved	12/12/2016 Phase 3 data released December 12, 2016 - primary endpoint met.
OPHT	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.
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.
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 3	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.
NVS	Lutathera Inoperable progressive midgut NETs	PDUFA	12/21/2016 PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
NVS	Lutathera Inoperable progressive midgut NETs	Approved	12/21/2016 PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
LXRX	Sotagliflozin Type 1 Diabetes	PDUFA	12/21/2016 Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
SNY	Sotagliflozin Type 1 Diabetes	PDUFA	12/21/2016 Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
IRWD	Linaclotide Irritable Bowel Syndrome with Constipation (IBS-C)	Phase 3	12/22/2016 Phase 2b data released December 22, 2016.
SGYP	Trulance (plecanatide) Constipation-predominant irritable bowel syndrome (IBS-C)	PDUFA	12/22/2016 Phase 3 data from second trial met primary endpoints - December 9 and 22, 2016.
SGYP	Trulance (plecanatide) Constipation-predominant irritable bowel syndrome (IBS-C)	Approved	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.
PLX	AIR DNase (PRX-110) Cystic Fibrosis	Phase 2	01/03/2017 Phase 2 interim data released January 3, 2017.
AGRX	Twirla Contraceptive patch	NDA Filing	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	Approved	01/04/2017 Phase 3 data released January 4, 2017 - trial failed.
GNCA	GEN-003 Genital herpes	-	01/05/2017 Phase 2b data released January 5, 2017.
OTIC	OTIPRIO Acute otitis externa	PDUFA	01/05/2017 Phase 3 trial met primary endpoint - January 5, 2017.
HALO	PEGPH20 - HALO-301 Pancreatic cancer	Phase 3	01/05/2017 Primary endpoint met.
OTIC	OTIPRIO Acute otitis externa	Approved	01/05/2017 Phase 3 trial met primary endpoint - January 5, 2017.
EGLT	ARYMO ER Abuse-Deterrent Morphine	Approved	01/09/2017 Approved January 9, 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	Approved	01/11/2017 CRL issued January 11 2017.
FGEN	Pamrevlumab (FG-3019) Pancreatic cancer	Phase 1/2	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.
AGN	ESMYA (ulipristal acetate) Uterine Fibroids	CRL	01/18/2017 Phase 3 data released January 18, 2017 - endpoints met.
AGN	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.
SGYP	Trulance (plecanatide) Chronic idiopathic constipation (CIC)	Approved	01/19/2017 Approved January 19, 2017.
MRNS	Ganaxolone CDKL5 disorder	Phase 3	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.
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.
PFE	PF-06425090 C. difficile Infection	Phase 2	01/26/2017 Phase 2 positive data released 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 3	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)	Approved	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.
SAGE	SAGE-217 Major Depressive Disorder (MDD)	Phase 3	02/13/2017 Phase 2 top-line data from open-label trial released February 13, 2017
ZSAN	M207 Migraine	Phase 3	02/13/2017 Phase 3 trial data due released February 13, 2017 - primary endpoints met.
AXON	Nelotanserin Visual hallucinations in subjects with Lewy body dementia	Phase 2	02/13/2017 Phase 2 preliminary data released February 13, 2017. Primary endpoint hit, secondary endpoints missed. Full study to be completed mid-2017. Phase 3 trial to be initiated 2H 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 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).
AZN	Lynparza Breast cancer	Approved	02/17/2017 Phase 3 data released February 17, 2016 - primary endpoint met.
MRK	Lynparza Breast cancer	Approved	02/17/2017 Phase 3 data released February 17, 2016 - primary endpoint met.
AMPH	Naloxone Intranasal Opioid overdose	CRL	02/21/2017 CRL announced February 21, 2017.
TRVN	Oliceridine (TRV130) Moderate to severe acute pain	CRL	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.
CMRX	Brincidofovir - Advise trial Adenovirus Infection	Phase 3	02/22/2017 Phase 3 interim analysis released May 2016. Final data released February 22, 2017.
CELG	REVLIMID Multiple myeloma (MM) - autologous stem cell transplant (ASCT)	Approved	02/22/2017 Approved 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 3	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	Approved	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.
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.
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 3	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.
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.
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.
GALT	GR-MD-02 Plaque psoriasis	Phase 2a	03/06/2017 Phase 2 data released March 6, 2017.
IONS	Volanesorsen - APPROACH Familial chylomicronemia syndrome (FCS)	CRL	03/06/2017 Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
AKCA	Volanesorsen - APPROACH Familial chylomicronemia syndrome (FCS)	CRL	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.
KURA	Tipifarnib 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.
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.
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.
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	Approved	03/14/2017 Data presented March 14, 2017 showed significant PFS benefit.
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.
AMGN	Repatha Cardiovascular disease	Approved	03/17/2017 Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations.
AZN	Lokelma (ZS-9) Hyperkalaemia	Approved	03/17/2017 Second CRL issued March 17, 2017.
BLRX	BL-8040 GENESIS Stem-cell mobilization for autologous transplantation	Phase 3	03/20/2017 Phase 2 trial initiated March 2016. Partial data released 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.
AGN	JUVÉDERM VOLLURE Correction of moderate to severe facial wrinkles and folds	Approved	03/20/2017 Approval announced March 20, 2017.
NKTR	NKTR-181 Lower back pain	PDUFA	03/20/2017 Phase 3 data released March 20, 2017 - endpoints met.
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	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.
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.
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	Approved	03/27/2017 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
AGN	Sarecycline Severe acne vulgaris	Approved	03/27/2017 Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
GSK	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Approved	03/27/2017 PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
FOMX	FMX101 - FX2017-22 Acne	Phase 3	03/27/2017 Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
VRTX	Tezacaftor (VX-661) / ivacaftor Cystic fibrosis - Two Copies of the F508del Mutation	PDUFA priority review	03/28/2017 Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
RTTR	RP-G28 Lactose intolerance	Phase 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.
VRTX	Tezacaftor (VX-661) / ivacaftor Cystic fibrosis - Two Copies of the F508del Mutation	Approved	03/28/2017 Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
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 2b	03/30/2017 Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
PGNX	Azedra Pheochromocytoma	Approved	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.
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 Ovarian cancer	Phase 3	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.
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.
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)	Approved	04/03/2017 Phase 3 data released April 3, 2017 - all endpoints met.
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.
KPTI	Selinexor - SADAL Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)	NDA Filing	04/04/2017 Phase 2b additional interim data released April 4, 2017 at AACR. Final top-line data due mid-2018.
NLNK	Indoximod in combination with KEYTRUDA or Opdivo - Indigo301 Melanoma - cancer	Phase 3	04/04/2017 Phase 2 interim analysis released at AACR meeting April 4, 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.
NKTR	Cipro DPI Bronchiectasis	Phase 3	04/05/2017 Phase 3 second trial did not meet endpoint - April 5, 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
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.
GERN	Imetelstat - IMbarkStudy Myelofibrosis	Phase 2	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.
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.
NOVN	SB208 Fungal infections	Phase 2	04/12/2017 Phase 2 data released April 12, 2017. Primary endpoint met.
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.
INCY	Baricitinib Rheumatoid arthritis	Approved	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	Approved	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.
OMED	Tarextumab - PINNACLE trial Small cell lung cancer	Phase 2	04/17/2017 Phase 2 data released April 17, 2017 - primary endpoint not met.
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)	Approved	04/18/2017 Phase 3 data released April 18, 2017 - primary endpoint met, two of three secondary endpoints met (missed on pain).
RARE	Crysvita (Burosumab) X-Linked Hypophosphatemia (XLH)	PDUFA priority review	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.
EIGR	Lonafarnib 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.
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.
ACHN	JNJ-4178 Hepatitis C (HCV)	Phase 2a	04/22/2017 Phase 2a ongoing. Updated data presented at EASL April 22, 2017.
JAZZ	Xyrem Pediatric narcolepsy patients with cataplexy	Approved	04/24/2017 Phase 2/3 positive data released April 24, 2017. sNDA filing due 4Q 2017.
AKTX	Coversin - CAPSTONE Paroxysmal nocturnal hemoglobinuria (PNH)	Phase 3	04/24/2017 Phase 2 interim data released April 24, 2017. Phase 3 program to commence 4Q 2017 with initial data due 1Q 2019.
LLY	Abemaciclib - MONARCH 3 HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)	Approved	04/24/2017 Phase 3 interim analysis April 24, 2017 met primary endpoint. Detailed data due 2H 2017 with regulatory filings due 3Q 2017.
XOMA	XOMA 213 Hyperprolactinemia	Phase 2	04/24/2017 Phase 2 proof-of-concept results released April 24, 2017.
LLY	Abemaciclib - MONARCH 3 HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)	PDUFA priority review	04/24/2017 Phase 3 interim analysis April 24, 2017 met primary endpoint. Detailed data due 2H 2017 with regulatory filings due 3Q 2017.
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	PDUFA	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.
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.
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 3	04/28/2017 Phase 2 preliminary results presented at American Academy of Neurology (AAN) annual meeting April 28, 2017.
NTRP	Bryostatin Alzheimer's disease	Phase 2	05/01/2017 Phase 2 data released May 1, 2017 - primary endpoint not met.
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.
AMAG	Feraheme Adults with iron deficiency anemia (IDA)	Approved	05/02/2017 Phase 3 trial completion announced May 2, 2017 - endpoints met. sNDA due mid-2017.
AMAG	Feraheme Adults with iron deficiency anemia (IDA)	PDUFA	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.
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.
ZFGN	ZGN-1061 Diabetes	Phase 2	05/04/2017 Phase 1 positive safety data released May 4, 2017. Phase 2 initiation due 2H 2017.
TXMD	Yuvvexy - TX-004HR Moderate-to-severe vaginal pain	Approved	05/08/2017 CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data.
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.
ABBV	ABT-494 Crohn’s Disease	Phase 2b	05/09/2017 Phase 2 positive data at DDW Meeting May 9, 2017. Phase 3 trial to be initiated later in 2017.
BTX	OpRegen Dry age-related macular degeneration (AMD)	Phase 1/2	05/09/2017 Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference.
ABBV	ABT-494 Crohn’s Disease	Phase 3	05/09/2017 Phase 2 positive data at DDW Meeting May 9, 2017. Phase 3 trial to be initiated later in 2017.
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	CRL	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.
CORI	Corplex Donepezil Alzheimer's disease	Phase 1	05/11/2017 Pilot bioequivalence data due released May 11, 2017. Pivotal trial to commence fall of 2017 with preliminary data due February 2018.
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.
LLY	Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN Migraine prevention	Approved	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	Approved	05/12/2017 Phase 3 interim analysis released May 12, 2017 - PFS primary endpoint already met. OS endpoint to be assessed.
IONS	Inotersen (IONIS-TTRRx) NEURO-TTR - familial amyloid polyneuropathy (FAP).	Approved	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).	Approved	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).	Approved	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.
RVNC	RT002 - ASPEN Cervical dystonia	Phase 3	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.
LJPC	GiaprezaTM (angiotensin II) Increase blood pressure in adults with septic or other distributive shock	Approved	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.
CELG	Ozanimod - RADIANCE Relapsing Multiple Sclerosis	NDA Filing	05/22/2017 Phase 3 data due released May 22, 2017 - primary endpoint met, disability endpoint not met.
SNY	Sarilumab Rheumatoid arthritis	Approved	05/22/2017 CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
AMGN	EVENITY (Romosozumab) Osteoporosis	PDUFA	05/22/2017 PDUFA date July 19, 2017. However, likely to be delayed due to safety data from ARCH trial released May 22, 2017.
NBIX	INGREZZA - T-Force GOLD Tourette syndrome - juvenile	Phase 2b	05/23/2017 Phase 2 data released May 23 - primary endpoint not met.
SBPH	Inarigivir - ACHIEVE 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.
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.
PBYI	Neratinib (NERLYNX) Extended adjuvant HER2-positive early stage breast cancer	Approved	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.
AERI	Roclatan Glaucoma	PDUFA	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.
BCRX	BCX7353 - APeX-2 Reduce or eliminate attacks in HAE patients	Phase 3	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.
GILD	Bictegravir/F/TAF HIV	Approved	05/30/2017 Phase 3 data released May 30 - primary endpoint met. NDA filing due 2Q 2017.
MRK	ISENTRESS HIV-1	Approved	05/30/2017 Approval announced May 30, 2017.
GILD	Bictegravir/F/TAF HIV	PDUFA priority review	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.
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
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%.
NLNK	Indoximod + taxane Cancer - breast	Phase 2	06/02/2017 Phase 2 trial did not meet endpoints - noted June 2, 2017.
ECYT	EC1169 Castrate-resistant prostate cancer (mCRPC)	Phase 1	06/02/2017 Phase 1 data due by end of 2017. Noted June 2, 2017 decision to only assess taxane-exposed patients and ending treatment of taxane-naïve patients.
ECYT	EC1456 Solid tumors (NSCLC)	Phase 1	06/02/2017 Phase 1 enrollment to be stopped - announced June 2, 2017.
IMDZ	CMB305 Soft tissue sarcomas	Phase 3	06/02/2017 Phase 2 data at ASCO June 2, 2017.
JNJ	ZYTIGA (abiraterone acetate) - LATITUDE metastatic hormone-naïve prostate cancer (mHNPC)	sNDA Filing	06/03/2017 Phase 3 data presented at ASCO June 3, 2017 - PFS 33 months.
JNJ	ZYTIGA (abiraterone acetate) - LATITUDE metastatic hormone-naïve prostate cancer (mHNPC)	Approved	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.
MTNB	MAT2203 Refractory mucocutaneous candidiasis	Phase 2a	06/03/2017 Phase 2a open label data due released June 3, 2017 at ASM Microbe.
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.
ARQL	Derazantinib (ARQ 087) intrahepatic cholangiocarcinoma (iCCA)	Phase 3	06/03/2017 Phase 2 data at ASCO June 3, 2017 - ORR 21%. Phase 3 trial planned for 3Q 2017.
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.
LOXO	Larotrectinib (LOXO-101) Solid tumors that harbor a TRK fusion.	Approved	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.
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.
PIRS	PRS-080 Anemia of chronic disease	Phase 2a	06/04/2017 Phase 1b data released at ERA-EDTA June 4, 2017.
FPRX	Cabiralizumab (FPA008) Pigmented Villonodular Synovitis (PVNS)	Phase 1/2	06/04/2017 Phase 1/2 initial data released at ASCO June 4, 2017.
RNN	RX-3117 Advanced bladder cancer - 3rd line	Phase 2a	06/04/2017 Phase 2a initial presented at ASCO June 4, 2017.
HALO	PEGPH20 - HALO-301 Pancreatic cancer	Phase 3	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	Approved	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	Approved	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).
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.
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%.
GLYC	Uproleselan (GMI-1271) Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer	Phase 3	06/05/2017 Phase 2 enrollment completed - announced May 31, 2017. Data updates at ASCO June 5, 2017.
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.
IOVA	LN-144 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.
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.
GILD	Axicabtagene ciloleucel - KTE-C19 (ZUMA-3) Adult patients with r/r ALL - cancer	Phase 1/2	06/05/2017 Phase 2 data due 2018. Phase 1 data released at ASCO June 5, 2017. Complete remission 73%.
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%.
CLSN	GEN-1 OVATION 2 Ovarian cancer	Phase 1/2	06/05/2017 Phase 1b interim data released at ASCO 2017 - ORR 86%.
BLUE	bb2121 - KarMMa Relapsed/refractory multiple myeloma	Phase 2	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 2	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%.
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)	PDUFA priority review	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%.
NVS	Kymriah (CTL019 )- JULIET Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)	Approved	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%.
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.
LXRX	Sotagliflozin Type 1 Diabetes	PDUFA	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.
SNY	Sotagliflozin Type 1 Diabetes	PDUFA	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	Approved	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	Approved	06/12/2017 CRL announced June 12, 2017.
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.
BTX	Renevia Restoring normal skin contours in for patients with HIV	Phase 3	06/14/2017 Pivotal trial data released June 14, 2017 - primary endpoint met.
EPZM	Tazemetostat Follicular lymphoma	Phase 2	06/14/2017 Phase 2 data released June 14, 2017 - DLBCL ORR 29%.
RDHL	BEKINDA -GUARD Gastroenteritis	Phase 3	06/14/2017 Phase 3 top-line data released June 14, 2017 - primary endpoint met.
ALDX	Reproxalap (ADX-102) Allergic conjunctivitis	Phase 3	06/14/2017 Phase 2b data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned.
SELB	SEL-212 Tophaceous gout	Phase 2	06/15/2017 Phase 2 dosing commenced late October 2016. Initial data released at EULAR June 15, 2017.
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.
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.
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.
CLVS	Rucaparib ARIEL3 Ovarian cancer patients with a BRCA-like mutation	Approved	06/19/2017 Phase 3 data released June 20 2017 - primary endpoint met. sNDA filing due 3Q or early 4Q 2017.
NEOS	Cotempla XR-ODT Attention deficit hyperactivity disorder (ADHD)	Approved	06/19/2017 Approval announced June 19, 2017.
CLVS	Rucaparib ARIEL3 Ovarian cancer patients with a BRCA-like mutation	PDUFA priority review	06/19/2017 Phase 3 data released June 20 2017 - primary endpoint met. sNDA filing due 3Q or early 4Q 2017.
LPCN	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.
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.
EGLT	OXAYDO Acute and chronic moderate to severe pain	CRL	06/20/2017 CRL announced June 20, 2017.
NVS	RTH258 (brolucizumab) Neovascular AMD	Phase 3	06/20/2017 Phase 3 data released June 20, 2017 - primary and key secondary endpoints met.
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.
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	CRL	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	CRL	06/22/2017 Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
STML	SL-401 (Elzonris) Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer	Approved	06/23/2017 Phase 2 update on patients enrolled in Stages 1 and 2 presented at EHA June 23, 2017.
BLUE	HGB-205 Transfusion-Dependent β-Thalassemia (TDT) and Severe Sickle Cell Disease (SCD)	Phase 1/2	06/23/2017 Phase 1/2 data presented at EHA June 23, 2017.
BLCM	BPX-501 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.
GBT	GBT440 HOPE-KIDS 1 Sickle cell disease - children age 6-17.	Phase 2a	06/23/2017 Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (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.
NVO	Semaglutide (NN9536) Obesity	Phase 2	06/23/2017 Phase 2 data released June 23, 2017 with Phase 3 trial to commence 2018.
AGIO	AG-348 (ACTIVATE) Pyruvate kinase deficiency	Phase 3	06/24/2017 Phase 2 updated data released at EHA June 24, 2017.
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	PDUFA priority review	06/26/2017 Phase 3 data released June 26, 2017 - primary endpoint met.
SGEN	ADCETRIS in combination with chemotherapy ECHELON-1 Frontline Hodgkin lymphoma	Approved	06/26/2017 Phase 3 data released June 26, 2017 - primary endpoint met.
AMAG	Makena - auto injector Reduce the risk of preterm birth in women with a singleton pregnancy	Approved	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	Approved	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.
AMAG	Makena - auto injector Reduce the risk of preterm birth in women with a singleton pregnancy	PDUFA	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	PDUFA	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.
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.
XENE	TV-45070 Postherpetic neuralgia	Phase 2b	06/27/2017 Phase 2b data released June 27, 2017. Endpoints not met.
RARX	RA101495 Paroxysmal nocturnal hemoglobinuria (PNH)	Phase 2	06/27/2017 Phase 2 initial data from two patients released June 27, 2017.
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.
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.
CARA	CR845 Osteoarthritis (OA)	Phase 2b	06/29/2017 Phase 2b data released June 29, 2017 - trial failed.
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.
MRK	KEYTRUDA - KEYNOTE-183 Multiple myeloma	Phase 2	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.
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.
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 3	07/10/2017 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
UTHR	Ralinepag Pulmonary Arterial Hypertension	Phase 3	07/10/2017 Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
SVRA	Aironite - INDIE Heart failure with preserved ejection fraction (HFpEF)	Phase 2	07/11/2017 Phase 2 interim data released July 11, 2017.
AMGN	BLINCYTO Ph+ R/R ALL	Approved	07/11/2017 PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
PFE	Mylotarg (gemtuzumab ozogamicin) Acute myeloid leukemia (AML)	Approved	07/11/2017 Advisory Committee Meeting July 11, 2017 voted in favor 6-1 of a favorable risk:benefit profile.
OCUL	DEXTENZA Ocular inflammation and pain following cataract surgery	Approved	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.
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%.
BMRN	Valoctocogene roxaparvovec (BMN 270) Hemophilia A	Phase 3	07/11/2017 Phase 1/2 updated data released July 11, 2017. 97% reduction in Annualized Bleed Rate (ABR).
AMGN	KYPROLIS (ASPIRE) Relapsed Multiple Myeloma	Approved	07/12/2017 Phase 3 trial met primary endpoint. HR 79%.
NVS	Kymriah (CTL019) Relapsed/Refractory B-Cell Acute lymphoblastic leukemia	Approved	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	PDUFA	07/16/2017 CRL issued July 16, 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.
CBAY	Seladelpar Primary biliary cholangitis (PBC)	Phase 3	07/17/2017 Phase 2 top-line data released late May 2016. Positive interim data from second trial data released July 17, 2017.
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