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 small/mid cap Phase 3 data releases.

August 2016 ~ Small/mid cap Phase 2 and Phase 3 data releases.

January 2016 ~ Large cap releases added (data and regulatory).

Note: Most bankrupt or acquired companies are not included.

Ticker	Drug	Stage	Catalyst
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.
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.
INCY	Epacadostat with Keytruda - ECHO-202/KEYNOTE-037 NSCLC, RCC, Triple-Negative Breast, Ovarian, Urothelial Carcinoma, Solid Tumors	-	05/24/2017
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.
ZFGN	ZGN-1061 Diabetes	Phase 1	05/04/2017 Phase 1 positive safety data released May 4, 2017. Phase 2 initiation due 2H 2017.
ACHN	JNJ-4178 Hepatitis C (HCV)	Phase 2a	04/22/2017 Phase 2a ongoing. Updated data presented at EASL April 22, 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
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
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.
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.
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.
AGN	JUVÉDERM VOLLURE Correction of moderate to severe facial wrinkles and folds	Approved	03/20/2017 Approval announced March 20, 2017.
AKTX	Coversin 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.
GALT	GR-MD-02 Plaque psoriasis	Phase 2	03/06/2017 Phase 2 data released March 6, 2017.
MRK	Odactra (MK-8237) House dust mite allergies	Approved	03/01/2017 Approved March 1, 2017.
PFE	Avelumab Urothelial Carcinoma	Approved	05/09/2017 Approval announced May 9, 2017.
DEPO	GRALISE Postherpetic neuralgia - shingles	Approved	01/28/2011 Approved January 28, 2011.
JAZZ	JZP-6 Fibromyalgia	CRL	10/11/2010 CRL received October 11, 2010.
ARLZ	VIMOVO Gastric ulcers	Approved	04/30/2010 Approved April 30, 2010.
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.
INCY	Jakafi Myelofibrosis	Approved	11/16/2011 Approved November 16, 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.
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.
FCSC	Laviv Wrinkles	CRL	12/18/2009 CRL issued December 18, 2009.
FCSC	Laviv Wrinkles	Approved	06/22/2011 Approved June 22, 2011.
PRTK	Intermezzo Insomnia	CRL	11/02/2009 CRL issued November 2, 2009.
PRTK	Intermezzo Insomnia	Approved	11/23/2011 Approved November 23, 2011.
GTXI	Toremifene Reduce fractures in men with prostate cancer	CRL	11/02/2009 CRL issued November 2, 2009.
SPPI	FUSILEV Colorectal cancer	CRL	10/09/2009 CRL received October 9, 2009.
SPPI	FUSILEV Colorectal cancer	Approved	04/29/2011 Approved April 29, 2011.
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	07/05/2009 CRL received July 5, 2009.
SPPI	ZEVALIN Non-Hodgkin’s lymphoma	Approved	09/04/2009 Approved September 4, 2009.
CRIS	Vismodegib Basal Cell Carcinoma	Approved	01/30/2012 Approved January 30, 2012.
CORT	Corlux - Korlym Cushing's Syndrome	PDUFA	02/17/2012 Approved February 17, 2012.
WINT	Surfaxin Respiratory Distress Syndrome	Approved	03/06/2012 Approved March 6, 2012 - under Discovery Laboratories, Inc.
PLX	Taliglucerase alfa Gaucher disease	CRL	02/25/2011 CRL issued February 25, 2011.
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.
VVUS	Qnexa Obesity	CRL	10/28/2010 October 28, 2010.
VVUS	Qnexa Obesity	Approved	07/17/2012 Approved July 17, 2012.
ARNA	Lorcaserin Obesity	Approved	06/27/2012 Approved June 27, 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.
NAVB	Lymphoseek Lymphatic-tissue tracing agent	CRL	09/10/2012 CRL issued September 10, 2012.
NAVB	Lymphoseek Lymphatic-tissue tracing agent	Approved	03/13/2013 Approved March 13, 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.
TBPH	VIBATIV (telavancin hydrochloride) for injection Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)	Approved	06/21/2013 Approved June 21, 2013.
ABBV	Ibrutinib Relapsed or refractory MCL mantle cell lymphoma	Approved	11/13/2013 Approved November 13, 2013.
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.
ABBV	Imbruvica Deletion 17p	Approved	07/19/2014 Approved July 19, 2014.
ABBV	VIEKIRA PAK HCV - genotype 1	Approved	12/19/2014 Approved December 19, 2014.
ABBV	IMBRUVICA Waldenström’s Macroglobulinemia	Approved	01/29/2015 Approved January 29, 2015 - PCYC
AMGN	Corlanor Chronic Heart Failure	Approved	04/15/2015 Approved April 15, 2015.
TBPH	BREO ELLIPTA Asthma	Approved	04/30/2015 Approved April 30, 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
XBIT	MABp1 Hidradenitis Suppurativa (HS)	Phase 2	02/16/2017 Phase 2 data released February 16, 2017.
AGN	Botox Depression	Phase 2	04/05/2017 Phase 2 top-line data released April 5, 2017 - primary endpoint missed. Phase 3 planned.
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.
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.
PBYI	Roche (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.
MRK	KEYTRUDA First and Second line locally advanced or metastatic urothelial cancer - bladder cancer	Approved	05/18/2017 Approved May 18, 2017.
GEMP	Gemcabene - COBALT-1 Homozygous Familial Hypercholesterolemia (HoFH)	Phase 2b	01/30/2017 Phase 2b interim data released January 30, 2017.
PFE	PF-06425090 C. difficile Infection	Phase 2	01/26/2017 Phase 2 positive data released January 26, 2017.
VRX	Brodalumab Psoriasis	Approved	02/15/2017 Approved February 15, 2017.
SNY	Dupixent (dupilumab) Eosinophilic esophagitis	Phase 2	05/04/2017 Phase 2 data released May 4, 2017.
SNY	Dupixent (dupilumab) Atopic dermatitis	Approved	03/28/2017 Approved under priority review - March 28, 2017.
SNY	Sarilumab Rheumatoid arthritis	Approved	05/22/2017 CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
REGN	Dupixent (dupilumab) Eosinophilic esophagitis	Phase 2	05/04/2017 Phase 2 data released May 4, 2017.
REGN	Dupixent (dupilumab) Atopic dermatitis	Approved	03/28/2017 Approved under priority review - March 28, 2017.
REGN	Sarilumab Rheumatoid arthritis	Approved	05/22/2017 CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
PFE	hGH-CTP (MOD-4023) Adults - growth hormone deficiency	Phase 3	12/30/2016 Phase 3 data released December 30, 2016 - primary endpoint not met.
PFE	Avelumab Metastatic Merkel cell carcinoma	Approved	03/23/2017 Priority review announced November 29, 2016. Approval announced March 23, 2017.
PFE	IBRANCE (palbociclib) HR+, HER2- Metastatic Breast Cancer	Approved	03/31/2017 sNDA acceptance announced December 21, 2016. Approval announced March 31, 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.
NVS	Rydapt (Midostaurin - PKC412) Acute myeloid leukemia (AML)	Approved	04/28/2017 Priority review granted November 14, 2016. Approval announced April 28, 2017.
NVS	LEE011 HR+/HER2- advanced breast cancer	Approved	03/13/2017 Priority review granted November 1, 2016. Approval announced March 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.
MRK	Keytruda First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer	Approved	05/10/2017 Approved May 10, 2017.
MRK	KEYTRUDA Relapsed or Refractory Classical Hodgkin Lymphoma	Approved	03/14/2017 Approval announced March 14, 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.
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.
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.
LLY	Abemaciclib - MONARCH 2 Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer	Phase 3	03/20/2017 Phase 3 data released March 20, 2017 - PFS primary endpoint met.
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.
JNJ	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.
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.
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.
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.
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.
CELG	Ozanimod - SUNBEAM Relapsing Multiple Sclerosis	Phase 3	02/17/2017 Phase 3 data released February 17, 2017 - primary endpoint met.
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.
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.
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.
CELG	REVLIMID Multiple myeloma (MM) - autologous stem cell transplant (ASCT)	Approved	02/22/2017 Approved February 22, 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.
AZN	Tralokinumab (STRATOS1) Severe, uncontrolled asthma	Phase 3	05/10/2017 Phase 3 trial did not meet primary endpoint - May 10, 2017.
AZN	Lynparza - SOLO 2 Second-line ovarian cancer	Phase 3	03/14/2017 Data presented March 14, 2017 showed significant PFS benefit.
AZN	Lynparza Breast cancer	Phase 3	02/17/2017 Phase 3 data released February 17, 2016 - primary endpoint 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.
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.
AZN	ZS-9 Hyperkalaemia	CRL	05/26/2016 CRL issued May 26, 2016.
AZN	ZS-9 Hyperkalaemia	CRL	03/17/2017 Second CRL issued March 17, 2017.
AZN	Saxagliptin and dapagliflozin Type-2 diabetes	Approved	02/28/2017 Approval announced February 28, 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.
AMGN	Parsabiv Secondary hyperparathyroidism (SHPT)	Approved	02/07/2017 Approved February 7, 2017.
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.
AGN	ESMYA (Venus II) Uterine Fibroids	Phase 3	01/18/2017 Phase 3 data released January 18, 2017 - endpoints met.
AGN	AVYCAZ (ceftazidime and avibactam) Complicated Urinary Tract Infections (cUTI)	Approved	01/30/2017 sNDA approval announced January 30, 2017.
AGN	Oxymetazoline HCl cream 1.0% Facial Erythema (Redness) Associated with Rosacea	Approved	01/19/2017 Approved January 19, 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.
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.
ABBV	Imbruvica Marginal zone lymphoma	Approved	01/19/2017 sNDA filing under priority review approved January 19, 2017.
NTRP	Bryostatin Alzheimer's disease	Phase 3	05/01/2017 Phase 2 data released May 1, 2017 - primary endpoint not met.
NBIX	INGREZZA Tourette syndrome - juvenile	Phase 2	05/23/2017 Phase 2 data released May 23 - primary endpoint not met.
CTIC	PIXUVRI B-cell non-Hodgkin lymphoma	CRL	04/09/2010 CRL received April 9, 2010.
ACOR	Ampyra Improve walking in patients with multiple sclerosis	Approved	01/22/2010 Approved January 22, 2010.
ACOR	Ampyra Improve walking in patients with multiple sclerosis	-	03/09/2017 Decision on Inter Partes Review (IPR) released March 10, 2017 - patents upheld.
AMPH	Naloxone Intranasal Opioid overdose	CRL	02/21/2017 CRL announced February 21, 2017.
AMPH	Primatene Mist (epinephrine inhalation aerosol) Asthma	CRL	12/27/2016 CRL issued December 27, 2016.
NDRM	ND0612H (Trial 006) Severe Parkinson's Disease	Phase 2	03/01/2017 Phase 2 trial met key primary and secondary endpoints - March 1, 2017.
LXRX	Sotagliflozin Type 1 Diabetes	Phase 2	12/05/2016 Phase 2 trial did not meet primary endpoint.
SCYX	Intravenous SCY-078	Phase 1	03/02/2017 Clinical hold placed on the initiation of intravenous (IV) SCY-078 until the FDA completes a review of all data. Clinical hold follows three mild-to-moderate thrombotic events in healthy volunteers - announced March 2, 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.
VRTX	Tezacaftor (VX-661) / 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.
HALO	FOLFIRINOX and PEGPH20 Pancreatic and gastric cancers	Phase 1/2	03/30/2017 Phase 1/2 enrollment closed due to lack of efficacy.
TENX	Levosimendan Septic shock	Phase 2b	10/05/2016 Phase 2b trial did not meet primary endpoint.
NOVN	SB206 Human papillomavirus (HPV)	Phase 2	11/29/2016 Phase 2 data released November 29, 2016. Primary endpoint met.
NOVN	SB208 Fungal infections	Phase 2	04/12/2017 Phase 2 data released April 12, 2017. Primary endpoint met.
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.
VRTX	KALYDECO Cystic fibrosis (CF) ages 6 and older who have the R117H mutation	Approved	12/29/2014 Approved December 29, 2014.
SCMP	Amitiza/Lubiprostone Opioid-induced bowel dysfunction	Approved	04/23/2013 Approved April 23, 2013.
IMGN	Kadcyla 2nd-line HER2+ Metastatic Breast Cancer	Approved	02/22/2013 Approved February 22, 2013 - under priority review.
HEB	Ampligen CFS	CRL	12/01/2009 CRL issued December 1, 2009.
HEB	Ampligen CFS	CRL	02/04/2013 CRL February 4, 2013.
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.
MDCO	Inclisiran Hypercholesterolemia	Phase 2	11/15/2016 Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
VRTX	Tezacaftor (VX-661) / ivacaftor Cystic fibrosis - One Copy of the F508del Mutation and a Second Mutation that Results in Residual CFTR Function	Phase 3	03/28/2017 Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
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.
LPTX	CureXcell Diabetic Foot Ulcers	Phase 3	10/27/2015 Phase 3 trial did not meet primary endpoint.
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.
CHMA	Mycapssa Acromegaly	CRL	04/15/2016 CRL April 15, 2016.
TGTX	TG-1101 Multiple Sclerosis	Phase 2	04/28/2017 Phase 2 preliminary results presented at American Academy of Neurology (AAN) annual meeting April 28, 2017.
SAGE	SAGE-217 Major Depressive Disorder (MDD)	Phase 2	02/13/2017 Phase 2 top-line data from open-label trial released February 13, 2017
SAGE	SAGE-217 Parkinson’s disease (PD)	Phase 2	05/09/2017 Phase 2 initiation announced December 13, 2016. Data from Part A data released May 9, 2017. Part B data due 2H 2017.
OPK	hGH-CTP Adults - growth hormone deficiency	Phase 3	12/30/2016 Phase 3 data released December 30, 2016 - primary endpoint not met.
VICL	ASP0113 Vaccine Kidney transplant recipients	Phase 2	09/19/2016 Phase 2 data released September 19, 2016 - did not meet primary endpoint.
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.
ZSAN	M207 Migraine	Phase 3	02/13/2017 Phase 3 trial data due released February 13, 2017 - primary endpoints met.
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.
ICPT	Obeticholic acid (OCA) Primary biliary cirrhosis (PBC) - POISE	Approved	05/27/2016 Approved May 27 2016.
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.
CORI	Corplex Donepezil Alzheimer's disease	-	05/11/2017 Pilot bioequivalence data due released May 11, 2017. Pivotal trial to commence fall of 2017 with preliminary data due February 2018.
NVCR	Tumor Treating Fields (TTFields) - INNOVATE Ovarian cancer	Phase 2	03/31/2017 Phase 2 data presented December 12, 2016. Further promising PFS data released March 31, 2017.
NLNK	Indoximod in combination with pembrolizumab Melanoma - cancer	Phase 2	04/04/2017 Phase 2 interim analysis released at AACR meeting April 4, 2017.
OCUL	DEXTENZA Allergic conjunctivitis	Phase 3	06/06/2016 Phase 3 trial did not meet primary endpoint - June 6, 2016.
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.
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
LXRX	Sotagliflozin Type 1 Diabetes	Phase 3	12/21/2016 Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
AMRN	Vascepa REDUCE-IT outcomes trial High Triglycerides With Mixed Dyslipidemia	Approved	07/26/2012 Approved July 26, 2012.
KURA	Tipifarnib HRAS mutant solid tumors - cancer	Phase 2	03/06/2017 Phase 2 ongoing data released March 6, 2017 - further data due 2H 2017.
XOMA	XOMA 213 Hyperprolactinemia	Phase 2	04/24/2017 Phase 2 proof-of-concept results released April 24, 2017.
PTIE	Remoxy Chronic pain	CRL	06/24/2011 CRL received June 24, 2011.
PTIE	Remoxy Chronic pain	CRL	09/26/2016 CRL received September 26, 2016.
TXMD	Yuvvexy 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.
KITE	Axicabtagene ciloleucel (KTE-C19) - ZUMA-1 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.
KITE	Axicabtagene ciloleucel (KTE-C19) - ZUMA-1 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.
EIGR	Lonafarnib - LOWR HDV 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.
NVLS	N91115 Cystic Fibrosis - two copies of the F508del mutation	Phase 2	11/28/2016 Phase 2 data released November 28, 2016. Primary endpoint not met.
LXRX	Telotristat etiprate (XERMELO) Carcinoid Syndrome	Approved	02/28/2017 Approved February 28, 2017.
AAAP	Lutathera Inoperable progressive midgut NETs	CRL	12/21/2016 PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
TSRO	Rolapitant - intravenous (IV) Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients	CRL	01/11/2017 CRL issued January 11 2017.
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.
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.
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.
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.
CEMP	Solithera - intravenous Community-acquired bacterial pneumonia (CABP)	CRL	12/29/2016 CRL announced December 29, 2016. Further trials required.
ATRS	OTREXUP Rheumatoid arthritis (RA)	Approved	10/14/2013 Approved Oct 14, 2013.
AUPH	Voclosporin - AURORA Lupus	Phase 2b	08/15/2016 Phase 2b data released August 2016. Primary endpoint met but with high number of deaths.
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.
AVEO	TIVO-3 - tivozanib Third line treatment of patients with renal cell cancer	CRL	06/10/2013 CRL issued June 10, 2013.
AVIR	BTA585 Respiratory syncytial virus (RSV)	Phase 2a	02/01/2017 Phase 2a data released February 1, 2017 - primary endpoint not met.
AVIR	Vapendavir - SPIRITUS trial Human rhinovirus (HRV)	Phase 2b	02/13/2017 Phase 2b top-line data released February 13, 2017 - primary endpoint not 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.
BCRX	BCX7353 - APeX-1 Reduce or eliminate attacks in HAE patients	Phase 2	02/27/2017 Phase 2 interim data released February 27, 2017.
BCRX	Peramivir - Study 303 INFLUENZA ACUTE	Approved	12/22/2014 Approved December 22, 2014.
BDSI	Clonidine gel Painful diabetic neuropathy (PDN)	Phase 2b	12/13/2016 Phase 2b data released December 13, 2016 - primary endpoints not met.
BDSI	BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL Opioid dependence	Approved	06/06/2014 Approved June 6, 2014.
BLPH	INOpulse delivery device Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF)	Phase 2	05/21/2017 Phase 2 initiated May 2016. Data presented at American Thoracic Society (ATS) Conference, May 21 2017. Phase 2b planned.
BMRN	Vimizim (GALNS) (MPS IVA) Morquio A Syndrome	Approved	02/14/2014 Approved February 14, 2014.
BPMX	BPX-01 Acne	Phase 2b	05/03/2017 Phase 2b data released May 3, 2017 - primary endpoint met, secondary missed.
BTX	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.
CAPR	CAP-1002 HOPE-Duchenne Duchenne Muscular Dystrophy (DMD)	Phase 1/2	04/25/2017 Phase 1/2 data released April 25, 2017. Noted improvement in certain measures of cardiac and upper limb function. 12-month data due 4Q 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.
CATB	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.
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.
CEMP	Solithromycin NASH	Phase 2	09/30/2016 Phase 2 interim data released September 30, 2016.
CEMP	Solithromycin NASH	Phase 2	02/28/2017 Noted February 28, 2017 that development has been suspended due to lack of efficacy.
CEMP	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.
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.
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.
CLVS	Rociletinib Mutant EGFR T790M-positive lung cancer	CRL	06/28/2016 CRL June 28, 2016. Phase 3 TIGER-3 also terminated.
CMRX	Brincidofovir - Advise trial Adenovirus Infection	Phase 3	02/22/2017 Phase 3 interim analysis released May 2016. Final data released February 22, 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.
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.
DCTH	CHEMOSAT system Unresectable metastatic ocular melanoma in the liver	CRL	09/13/2013 CRL September 13, 2013.
DEPO	SEFELSA Hot flashes	CRL	05/31/2013 CRL issued May 31, 2013.
DERM	Cimzia Moderate-to-severe plaque psoriasis	Phase 3	01/19/2017 Phase 3 data from first trial released October 2016 - endpoints met. Second trial data released December 8, 2016 - endpoints met. Data from third and final trial met primary endpoint - January 19, 2017.
DMTX	DTX101 hemophilia B	Phase 1/2	01/31/2017 Phase 1/2 initial data released January 31, 2017.
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
DVAX	HEPLISAV-B Hepatitis B	CRL	02/25/2013 CRL issued February 25, 2013.
DVAX	HEPLISAV-B Hepatitis B	CRL	11/14/2016 CRL November 14, 2016
EBIO	Isunakinra (EBI-005) Moderate to severe dry eye disease	Phase 3	05/18/2015 Phase 3 top-line data showed endpoints not met May 18, 2015.
EBS	BioThrax Anthrax Vaccine Adsorbed	Approved	11/24/2015 Approved November 24, 2015.
EBS	Anthrax Immune Globulin Intravenous (Human) [AIGIV] Anthrax	PDUFA	03/25/2015 Approved March 25, 2015.
Polymyxin B Hemoperfusion (PMX) Endotoxemic septic shock	Phase 3	10/03/2016 Phase 3 trial failed to meet endpoints.
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.
EGRX	Docetaxel Injection Breast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancer	Approved	12/24/2015 Approved December 24, 2015.
EGRX	Ryanodex Malignant hyperthermia - cancer	Approved	07/23/2014 Approved July 23, 2014 under priority review.
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.
ENDP	AVEED (testosterone undecanoate) intramuscular injection Men diagnosed with hypogonadism	CRL	05/30/2013 CRL issued September 5, 2013.
ENDP	AVEED (testosterone undecanoate) intramuscular injection Men diagnosed with hypogonadism	Approved	03/06/2014 Approved March 6, 2014.
ENTA	VIEKIRA PAK HCV - genotype 1	Approved	12/19/2014 Approved December 19, 2014.
EXEL	CABOMETYX (cabozantinib) Metastatic renal cell cancer (RCC)	Approved	04/25/2016 Approved April 25, 2016.
EXEL	Vemurafenib BRAF V600 Mutation-Positive Advanced Melanoma - Cancer	Approved	11/10/2015 Approved November 10, 2015.
FGEN	Roxadustat FG-4592 Anemia in chronic kidney disease	Phase 3	01/30/2017 Phase 3 data from China trial released January 30, 2017. Primary endpoints met.
AVDL	Akovaz Hypotension	Approved	05/02/2016 Approved May 2, 2016.
AVDL	VAZCULEP (phenylephrine hydrochloride) Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia	Approved	06/30/2014 Approved June 30, 2014.
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.
FOMX	FMX101 Acne	Phase 3	03/27/2017 Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
GALE	NeuVax (E75) - PRESENT Low-to-intermediate HER2+ breast cancer	Phase 3	06/29/2016 Phase 3 trial terminated due to poor efficacy.
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.
GNCA	GEN-003 Genital herpes	Phase 2b	09/29/2016 Phase 2b virologic efficacy data released September 2016.
GNCA	GEN-003 Genital herpes	Phase 2b	01/05/2017 Phase 2b data released January 5, 2017.
GWPH	Sativex Cancer pain	Phase 3	10/27/2015 Phase 3 trials did not meet endpoints.
HALO	PEGPH20 Pancreatic cancer	Phase 2	01/05/2017 Primary endpoint met.
HALO	HYQVIA Subcutaneous treatment for patients with primary immunodeficiency (PI)	CRL	08/01/2012 CRL issued August 1, 2012.
HALO	HYQVIA Subcutaneous treatment for patients with primary immunodeficiency (PI)	Approved	09/12/2014 Approved September 12, 2014.
HRTX	APF530 - Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)	CRL	03/19/2010 CRL issued March 19, 2010.
HRTX	APF530 - Sustol Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)	CRL	03/28/2013 CRL March, 28 2013.
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.
HTBX	HS-410 Bladder cancer	Phase 2	11/30/2016 Phase 2 trial did not meet primary endpoint - November 30, 2016.
HZNP	ACTIMMUNE Friedreich's Ataxia (FA)	Phase 3	12/08/2016 Phase 3 data released December 8, 2016 - primary endpoint not met
IMGN	Kadcyla GATSBY trial Cancer - metastatic HER2+ gastric cancer	Phase 3	10/22/2015 Phase 3 endpoint not met - October 22, 2015.
INCY	Jakafi (ruxolitinib) (RESPONSE) Polycythemia Vera	Approved	12/04/2014 Approved December 4, 2014.
INNL	Cogenzia Diabetic foot ulcer infections	Phase 3	11/03/2016 Phase 3 data did not meet endpoints - November 3, 2016.
INSY	Dronabinol Oral Solution AIDS-related anorexia	Approved	07/05/2016 Announced approval July 5, 2016.
IONS	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.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Phase 3	08/01/2016 Phase 3 ENDEAR trial met primary endpoint August 1, 2016.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Phase 3	11/07/2016 Phase 3 CHERISH data met primary endpoint - November 7, 2016.
IONS	SPINRAZA - Nusinersen Spinal muscular atrophy (SMA)	Approved	12/23/2016 Approved December 23, 2016.
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.
IPXL	IPX066 Parkinson's	CRL	01/21/2013 CRL issued January 21, 2013.
IPXL	IPX066 Parkinson's	Approved	01/08/2015 Approved January 8, 2015.
IRWD	Linaclotide Colonic Release Irritable Bowel Syndrome with Constipation (IBS-C)	Phase 2b	12/22/2016 Phase 2b data released December 22, 2016.
ITCI	ITI-007-302 Schizophrenia	Phase 3	09/28/2016 Phase 3 trial failed - September 28, 2016.
KERX	Auryxia Hyperphosphatemia	Approved	09/05/2014 Approved Sept 5, 2014.
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
KPTI	Selinexor - STORM Quadruple Refractory Multiple Myeloma	Phase 2	09/06/2016 Phase 2 positive top-line data released September 6, 2016
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.
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.
LJPC	LJPC-501 Catecholamine-resistant hypotension (CRH)	Phase 3	02/27/2017 Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. NDA filing due 2H 2017.
LJPC	LJPC-501 Catecholamine-resistant hypotension (CRH)	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.
LPCN	LPCN 1021 Men with low testosterone (Low T)	CRL	06/29/2016 CRL issued June 29, 2016.
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.
MACK	ONIVYDE Cancer - second line pancreatic	Approved	10/22/2015 Approved October 22, 2015.
MCRB	SER-109 Recurrent C. Difficile infection	Phase 2	07/29/2016 Phase 2 interim data did not meet primary endpoint.
MDCO	CARBAVANCE Complicated urinary tract infections (cUTI)	Phase 3	06/27/2016 Phase 3 data met endpoints June 27, 2016.
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.
MDCO	RAPLIXA Hemostasis	Approved	04/30/2015 Approved April 30, 2015.
MDCO	IONSYS Acute postoperative pain	Approved	04/30/2015 Approved April 30, 2015.
MDCO	Oritavancin ABSSSI	Approved	08/06/2014 Approved August 6, 2014 under priority review
MESO	MPC-150-IM Chronic heart failure (CHF)	Phase 3	04/10/2017 Noted April 10, 2017 that interim analysis has been completed - trial to continue as planned.
MNKD	AFREZZA Type 1/2 diabetes	CRL	03/15/2010 CRL issued March 15, 2010.
MNKD	AFREZZA Type 1/2 diabetes	CRL	01/19/2011 CRL received January 19, 2011.
MNKD	AFREZZA Type 1/2 diabetes	Approved	06/27/2014 Approved June 27, 2014.
MNTA	Generic Copaxone Multiple sclerosis	Approved	04/16/2015 Approved April 16 2015.
MRNS	Ganaxolone Focal onset seizures	Phase 3	06/13/2016 Phase 3 data did not meet endpoints - June 13, 2016
NAVB	Lymphoseek Head and Neck Cancer	Approved	06/13/2014 Approved June 13, 2014.
NBIX	INGREZZA Tourette syndrome - adults	Phase 2	01/18/2017 Phase 2 data released January 18, 2017 did not meet primary endpoint.
NEOS	Adzenys XR-ODT Attention deficit hyperactivity disorder (ADHD)	Approved	01/27/2016 Approved January 27, 2016.
NEOT	LIPO-202 Reduction of central abdominal bulging	Phase 3	12/14/2015 Phase 3 endpoints not met December 14, 2015.
NKTR	NKTR-181 Lower back pain	Phase 3	03/20/2017 Phase 3 data released March 20, 2017 - endpoints met.
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.
NKTR	ADYNOVATE Hemophilia A	Approved	11/16/2015 Approved November 16, 2015.
NKTR	MOVANTIK (Naloxegol) Opioid-induced constipation (OIC)	Approved	09/16/2014 Approved September 16, 2014.
NLNK	HyperAcute Pancreas - IMPRESS Surgically resected pancreatic cancer	Phase 3	05/09/2016 Phase 3 failed to meet primary endpoint - May 9, 2016.
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.
NYMX	NX-1207 Fexapotide BPH	Phase 3	07/27/2015 Phase 3 endpoints met in extension trial July 2015.
OCRX	OCR-002 (IV) Hepatic encephalopathy	Phase 2b	01/30/2017 Phase 2b data released January 30, 2017 - primary endpoint not met.
OCUL	DEXTENZA Ocular inflammation and pain following cataract surgery	CRL	07/25/2016 CRL July 25 2016 - due to manufacturing deficiencies.
OMED	Demcizumab plus Abraxane - YOSEMITE First-line pancreatic cancer	Phase 2	04/10/2017 Phase 2 data released April 10, 2017 - primary endpoint not met.
OMED	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.
OMED	Tarextumab - PINNACLE trial Small cell lung cancer	Phase 2	04/17/2017 Phase 2 data released April 17, 2017 - primary endpoint not met.
OMER	Omidria Cataract surgery	Approved	06/02/2014 Approved June 2, 2014.
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.
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.
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.
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.
OREX	Contrave Obesity	CRL	02/01/2011 CRL issued February 1, 2011.
OREX	Contrave Obesity	Approved	09/11/2014 Approved September 11, 2014.
OTIC	OTIPRIO (ciprofloxacin otic suspension) Ear Tube Placement Surgery	Approved	12/11/2015 Approved December 11, 2015.
PBMD	IMP321 Breast cancer	Phase 2b	12/22/2016 Phase 2b interim data released December 22, 2016.
PCRX	EXPAREL Single-dose injection femoral nerve block for total knee arthroplasty surgery	CRL	03/02/2015 CRL March 2, 2015.
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.
PGNX	Oral RELISTOR Chronic pain	Approved	07/19/2016 Approved July 19 2016.
PGNX	Subcutaneous RELISTOR Chronic pain	PDUFA	09/29/2014 Approved September 29, 2014.
PLX	AIR DNase (PRX-110) Cystic Fibrosis	Phase 2	01/03/2017 Phase 2 interim data released January 3, 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.
PRTK	Omadacycline Community-acquired bacterial pneumonia (CABP)	Phase 3	04/03/2017 Phase 3 data released April 3, 2017 - all endpoints 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.
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.
PSDV	Iluvien Diabetic macular edema	CRL	11/11/2011 CRL November 11, 2011.
PSDV	Iluvien Diabetic macular edema	CRL	10/18/2013 Second CRL October 18, 2013.
PSDV	Iluvien Diabetic macular edema	Approved	09/26/2014 Approved Sept 26 2014.
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.
PTLA	Betrixaban (The APEX Study) Venous thromboembolism (VTE) Prevention	Phase 3	03/24/2016 Phase 3 data released March 24, 2016 did not meet primary endpoint.
PTLA	Andexanet alfa Factor Xa inhibitor reversal agent	CRL	08/17/2016 CRL August 17 2016.
PTN	Rekynda (Bremelanotide) Female sexual dysfunction (FSD)	Phase 3	11/01/2016 Phase 3 data released November 1, 2016.
PTX	TREXIMET Adolescent migraine patients	Approved	05/15/2015 Approved May 15, 2015.
RARE	rhGUS Mucopolysaccharidosis 7 (MPS 7)	Phase 3	07/14/2016 Phase 3 data released July 2016. Primary endpoint hit. Secondary missed.
RARE	KRN23 Burosumab X-Linked Hypophosphatemia (XLH) - adult	Phase 3	04/18/2017 Phase 3 data released April 18, 2017 - primary endpoint met, two of three secondary endpoints met (missed on pain).
RDHL	RHB-105 H. pylori	Phase 3	03/08/2016 Phase 3 final data released March 8, 2016.
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.
RMTI	Soluble Ferric Pyrophosphate Iron deficiency	Approved	01/26/2015 Approved January 26, 2015.
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.
RVNC	RT001 - REALISE 1 Lateral Canthal (Crow’s Feet) Lines	Phase 3	06/13/2016 Phase 3 endpoints not met June 13, 2016.
RVNC	RT002 Cervical dystonia	Phase 2	05/18/2017 Phase 2 additional data released May 18, 2017 with oral presentation June 8, 2017 at International Congress of Parkinson's Disease and Movement Disorders.
SBPH	SB 9200 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.
SGEN	ADCETRIS - AETHERA Post-transplant Hodgkin lymphoma (HL) cancer	Approved	08/17/2015 Approved August 17, 2015 under priority review.
SGYP	Trulance (plecanatide) Chronic idiopathic constipation (CIC)	Approved	01/19/2017 Approved January 19, 2017.
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.
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.
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.
SPPI	Belinostat Peripheral T-Cell Lymphoma cancer	PDUFA	07/07/2014 Approved July 7, 2014.
SRPT	Eteplirsen Duchenne muscular dystrophy	Approved	09/19/2016 Approved September 19, 2016.
SUPN	Trokendi Epilepsy	Approved	08/19/2013 Approved Aug 19, 2013.
TCON	TRC105 and Avastin Glioblastoma - cancer	Phase 2	02/09/2017 Phase 2 data released February 9, 2017 - 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.
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.
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.
TSRO	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Phase 3	06/29/2016 Phase 3 data met endpoints - June 2016.
TSRO	Niraparib - NOVA (Niraparib Ovarian) Cancer - ovarian	Approved	03/27/2017 PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
TSRO	Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients	Approved	09/02/2016 Approved September 2, 2015.
TTNP	Probuphine Opioid dependence	CRL	04/30/2013 CRL issued April 30, 2013.
TTNP	Probuphine Opioid dependence	Approved	05/26/2016 CRL issued April 30, 2013. Approved May 26, 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.
VNDA	Fanapt Supplemental New Drug Application (sNDA) as a maintenance treatment of schizophrenia in adults.	Approved	05/26/2016 Approved May 26, 2016.
VNDA	HETLIOZ (tasimelteon) Insomnia	Approved	01/31/2014 Approved January 31, 2014.
VRTX	VX-150 Osteoarthritis	Phase 2	01/25/2017 Phase 2 primary endpoint met - January 25, 2017.
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.
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.
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.
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.
VTVT	TTP399 - AGATA Type 2 Diabetes	Phase 2	08/10/2016 Phase 2 data released August 10, 2016. Primary endpoint met.
VTVT	TTP273 - LOGRA Type 2 Diabetes	Phase 2	12/14/2016 Phase 2 primary endpoint met - December 14, 2016.
VVUS	Avanafil Erectile dysfunction	Approved	04/27/2012 Approved April 27, 2012.
XBIT	Xilonix Colorectal cancer	Phase 3	02/21/2017 Phase 3 interim analysis announced February 21, 2017 - trial to continue as planned.
XENE	XEN801 Acne	Phase 2	03/24/2017 Phase 2 data released March 24 2017 - endpoints not met.
ZGNX	Zohydro ER Moderate to severe pain	Approved	10/25/2013 Approved October 25, 2013.
AAAP	Somakit-TATE Neuroendocrine tumor diagnosis	Approved	06/01/2016 Approved June 1, 2016.
ABUS	ARB-1467 Hepatitis B (HBV)	Phase 2	09/29/2016 Phase 2 single dose data released September 2016.
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.
ACAD	Pimavanserin Parkinson’s disease psychosis (PDP)	Approved	04/29/2016 Approved April 29, 2016.
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.
ACOR	CVT-301 OFF episodes of Parkinson’s disease (PD)	Phase 3	02/09/2017 Phase 3 data released February 9, 2017 - primary endpoint met.
ACRS	A-101 Seborrheic keratosis (SK)	Phase 3	11/15/2016 Phase 3 trial met endpoints - November 15, 2016.
ACRX	ARX-04 (SAP303) Moderate-to-severe acute pain following a surgical procedure	Phase 3	08/15/2016 Phase 3 data released August 15, 2016.
ACRX	Zalviso Post-operative pain following open abdominal surgery and hip or knee replacement surgery	CRL	07/25/2014 CRL issued July 25 2014.
ADHD	MDX (Metadoxine Extended Release (MG01CI)) Adult ADHD	Phase 3	01/17/2017 Phase 3 data released January 17, 2017 - failed to meet primary endpoint.
ADMA	RI-002 Primary Immune Deficiency Diseases	CRL	07/29/2016 CRL issued July 29 2016. Third-party manufacturing issues cited.
ADMP	Epinephrine Pre-filled Syringe (PFS) Emergency treatment of anaphylaxis.	CRL	03/25/2015 CRL issued March 27 2015.
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.
ADMS	Namzaric Moderate to severe dementia of the Alzheimer's type.	Approved	12/24/2014 Approved December, 24 2014.
AERI	Roclatan - Mercury trials Glaucoma	Phase 3	09/14/2016 Phase 3 Mercury 1 data released September 14, 2016. Primary endpoint met.
AEZS	Macimorelin Acetate - Macrilen Adult Growth Deficiency	CRL	11/06/2014 CRL issued November 6, 2014.
AEZS	Macimorelin Acetate - Macrilen Adult Growth Deficiency	Phase 3	01/04/2017 Phase 3 data released January 4, 2017 - trial failed.
AEZS	Zoptrex Endometrial cancer	Phase 3	05/01/2017 Phase 3 trial did not meet primary endpoint - May 1, 2017.
AKAO	Plazomicin - EPIC trial Complicated urinary tract infections (cUTI)	Phase 3	12/12/2016 Phase 3 data released December 12, 2016 - 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).
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.
ALKS	Aristada Schizophrenia	Approved	10/05/2015 Approved October 5, 2015.
ALNY	Revusiran ENDEAVOUR ATTR in patients with familial amyloidotic cardiomyopathy (FAC)	Phase 3	10/05/2016 Phase 3 trial discontinued October 2016.
AMAG	Feraheme Adults with iron deficiency anemia (IDA)	CRL	01/22/2014 CRL issued January 22, 2014.
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
ANTH	Sollpura (liprotamase) Cystic fibrosis who suffer from exocrine pancreatic insufficiency	Phase 3	12/28/2016 Top-line data released December 27, 2016 - missed primary endpoint.
ARDM	Pulmaquin - ORBIT-3 and ORBIT-4 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.
ARGS	AGS-003 ADAPT Trial Metastatic renal cell carcinoma (mRCC)	Phase 3	02/22/2017 Phase 3 trial recommended trial be discontinued for futility - February 22, 2016.
ARLZ	YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers	CRL	04/25/2014 CRL issued April 25, 2014.
ARLZ	YOSPRALA (PA32540/PA8140) Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers	CRL	12/17/2014 CRL issued December 17, 2014.
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.
ZFGN	Beloranib Prader-Willi Syndrome (PWS)	Phase 3	01/20/2016 Phase 3 co-primary endpoints met.
ZGNX	Abuse deterrent formulations of Zohydro ER Moderate to severe pain	Approved	01/30/2015 Approved January 30, 2015.
SPHS	Topsalysin (PRX302) Benign prostatic hyperplasia	Phase 3	11/10/2015 Phase 3 primary endpoints met - November 10, 2015.
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.
TNXP	TNX-102 SL Fibromyalgia	Phase 3	09/06/2016 Phase 3 data released September 6, 2016. Primary endpoint not met. Program discontinued
OPK	Rolapitant Prevention of chemotherapy induced nausea and vomiting, or CINV	Approved	09/02/2016 Approved September 2, 2015.
OTIC	OTIPRIO Acute otitis externa	Phase 3	01/05/2017 Phase 3 trial met primary endpoint - January 5, 2017.
RARE	UX007 (triheptanoin) Glucose Transporter Type-1 Deficiency Syndrome (Glut1 DS)	Phase 2	03/22/2017 Phase 2 initiated March 2014. Data released March 22, 2017 - primary endpoint not met.
RIGL	Fostamatinib Immune Thrombocytopenic Purpura (ITP)	Phase 3	08/30/2016 Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
RIGL	Fostamatinib Immune Thrombocytopenic Purpura (ITP)	Phase 3	10/30/2016 Phase 3 data from second trial did not meet the primary endpoint.
RPRX	Enclomiphene Secondary hypogonadism	CRL	12/01/2015 CRL issued December 1, 2015.
LPTX	CureXcell Venous Leg Ulcers	Phase 3	08/19/2016 Phase 3 endpoint not expected to be met - August 19, 2015.
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.
MRNS	Ganaxolone CDKL5 disorder	Phase 2	01/23/2017 Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
NBIX	Elagolix Endometriosis	Phase 3	01/08/2015 First Phase 3 trial met both co-primary endpoints - January 8, 2015.
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.
NBIX	INGREZZA Tardive dyskinesia	Approved	04/11/2017 Approved April 11, 2017.
NKTR	Fovista Wet-AMD	Phase 3	12/12/2016 Phase 3 data released December 12, 2016 - primary endpoint not met.
GWPH	Epidiolex Dravet Syndrome	Phase 3	03/14/2016 Top line Phase 3 data released March 14, 2016 met primary endpoint.
GWPH	Epidiolex Lennox-Gastaut syndrome (LGS)	Phase 3	06/27/2016 First Phase 3 trial data released June 27, 2016.
GWPH	Epidiolex Lennox-Gastaut syndrome (LGS)	Phase 3	09/26/2016 Second Phase 3 trial data met endpoint - September 2016.
GWPH	Sativex Spasticity due to cerebral palsy	Phase 2	02/07/2017 Phase 2 trial did not meet primary endpoint - noted February 7, 2017.
DERM	Glycopyrronium tosylate (DRM04) Primary axillary hyperhidrosis	Phase 3	06/01/2016 ATMOS-2 trial - co-primary endpoints and both secondary endpoints met. ATMOS-1 trial - one of the co-primary endpoints and both secondary endpoints met.
DRRX	Remoxy Chronic pain	CRL	06/24/2011 CRL received June 24, 2011.
DRRX	Remoxy Chronic pain	CRL	09/26/2016 CRL received September 26, 2016.
EARS	AM-101 (Keyzilen) - TACTT2 Acute inner ear tinnitus	Phase 3	08/18/2016 Phase 3 trial did not meet primary endpoints.
EGLT	Egalet-001 (ARYMO ER) Abuse-Deterrent Morphine	Approved	01/09/2017 Approved January 9, 2017.
ENDP	XIAFLEX Edematous fibrosclerotic panniculopathy (“cellulite”)	Phase 2b	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints. Phase 3 planned.
FGEN	Pamrevlumab (FG-3019) Pancreatic cancer	Phase 2	01/17/2017 Phase 2 abstract released January 17, 2017.
BLRX	BL-8040 Mobilization and collection of bone marrow stem cells	Phase 2	03/20/2017 Phase 2 trial initiated March 2016. Partial data released March 20, 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.
BMRN	Kyndrisa Duchenne Muscular Dystrophy (DMD)	CRL	01/14/2016 CRL issued January 14 2016.
BSTC	XIAFLEX Edematous fibrosclerotic panniculopathy (“cellulite”)	Phase 2b	11/17/2016 Phase 2b data released November 17, 2016. Met endpoints
CARA	IV CR845 Uremic pruritus	Phase 2/3	03/28/2017 Phase 2/3 top-line data from Part A portion of trial released March 28, 2017 - endpoints met. Part B to be initiated later in 2017.
CERU	CRLX101 and Avastin - RCC Trial 3rd and 4th line Relapsed Renal Cell Carcinoma cancer	Phase 2	08/17/2016 Phase 2 data released August 2016 failed to meet primary endpoint
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.
CRBP	Anabasum (Resunab) Systemic Sclerosis	Phase 2	11/14/2016 Phase 2 data released November 14, 2016.
ADMS	ADS-5102 Levodopa-Induced Dyskinesia	Phase 3	12/23/2015 Phase 3 data released December 23, 2015.
ALIM	Iluvien Diabetic macular edema	CRL	11/11/2011 CRL November 2011.
ALIM	Iluvien Diabetic macular edema	CRL	10/17/2013 Second CRL October 17, 2013.
ALIM	Iluvien Diabetic macular edema	Approved	09/26/2014 Approved September 26, 2014,
ANTH	Blisibimod Lupus	Phase 3	11/10/2016 Phase 3 trial did not meet endpoints - November 10, 2016.
ARDX	Tenapanor Hyperphosphatemia in end-stage renal disease (ESRD) patients	Phase 3	02/15/2017 Phase 3 released February 15, 2017 - primary endpoint met.
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.
BDSI	BEMA Buprenorphine Pain	Approved	10/25/2015 Approved October 26, 2015.
ACAD	Pimavanserin 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.
ACRS	A-101 Common warts (verruca vulgaris)	Phase 2	08/18/2016 Phase 2 data released August 2016.