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).


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

We suggest you visit the BioPharmCatalyst PDUFA Calendar if your focus is on upcoming FDA regulatory events (i.e PDUFA dates and Advisory Committee Meetings).


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
CRL received July 5, 2009.
ZGNX Sumavel
Migraine
Approved
Approved July 16, 2009.
ARDM Sumavel
Migraine
Approved
Approval granted July 16, 2009.
SPPI ZEVALIN
Non-Hodgkin’s lymphoma
CRL
Approved September 4, 2009.
SPPI FUSILEV
Colorectal cancer
Approved
CRL received October 9, 2009.
PRTK Intermezzo
Insomnia
Approved
CRL issued November 2, 2009.
GTXI Toremifene
Reduce fractures in men with prostate cancer
CRL
CRL issued November 2, 2009.
HEB Ampligen
CFS
CRL
CRL issued December 1, 2009.
FCSC Laviv
Wrinkles
Approved
CRL issued December 18, 2009.
ACOR Ampyra
Improve walking in patients with multiple sclerosis
-
Approved January 22, 2010.
ALKS BYDUREON
Type 2 diabetes
Approved
Approved January 27, 2010.
MNKD AFREZZA
Type 1/2 diabetes
Approved
CRL issued March 15, 2010.
ALKS BYDUREON
Type 2 diabetes
Approved
CRL received March 15, 2010.
HRTX APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
CRL issued March 19, 2010.
CTIC PIXUVRI - PIX306 Trial
B-cell non-Hodgkin lymphoma
Phase 3
CRL received April 9, 2010.
ARLZ VIMOVO
Gastric ulcers
Approved
Approved April 30, 2010.
JAZZ JZP-6
Fibromyalgia
Approved
CRL received October 11, 2010.
VVUS Qnexa
Obesity
Approved
October 28, 2010.
MNKD AFREZZA
Type 1/2 diabetes
Approved
CRL received January 19, 2011.
DEPO GRALISE
Postherpetic neuralgia - shingles
Approved
Approved January 28, 2011.
OREX Contrave
Obesity
Approved
CRL issued February 1, 2011.
PLX Taliglucerase alfa
Gaucher disease
Approved
CRL issued February 25, 2011.
SPPI FUSILEV
Colorectal cancer
Approved
Approved April 29, 2011.
FCSC Laviv
Wrinkles
Approved
Approved June 22, 2011.
DRRX Remoxy
Chronic pain
CRL
CRL received June 24, 2011.
PTIE Remoxy
Chronic pain
CRL
CRL received June 24, 2011.
DRRX Remoxy
Chronic pain
PDUFA
CRL received June 24, 2011.
PTIE Remoxy
Chronic pain
PDUFA
CRL received June 24, 2011.
SGEN ADCETRIS
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approval announced August 19, 2011.
PCRX EXPAREL
Postsurgical pain
Approved
Approved October 31, 2011.
ALIM Iluvien
Diabetic macular edema
Approved
CRL November 2011.
PSDV Iluvien
Diabetic macular edema
Approved
CRL November 11, 2011.
INCY Jakafi
Myelofibrosis
Approved
Approved November 16, 2011.
PRTK Intermezzo
Insomnia
Approved
Approved November 23, 2011.
ATRS Anturol
Overactive bladder
Approved
Approved December 8, 2011.
INSY SUBSYS
Cancer pain
Approved
Approved January 5, 2012.
CRIS Vismodegib
Basal Cell Carcinoma
Approved
Approved January 30, 2012.
CORT Corlux - Korlym
Cushing's Syndrome
Approved
Approved February 17, 2012.
VVUS Avanafil
Erectile dysfunction
Approved
Approved April 27, 2012.
PLX Taliglucerase alfa
Gaucher disease
Approved
Approved May 1, 2012.
EBS BioThrax
Anthrax Vaccine
Approved
Approved May 17, 2012.
RGEN RG1068
Detection of pancreatic duct abnormalities
CRL
CRL received June 22, 2012.
ARNA Lorcaserin
Obesity
Approved
Approved June 27, 2012.
VVUS Qnexa
Obesity
Approved
Approved July 17, 2012.
AMRN Vascepa REDUCE-IT outcomes trial
High Triglycerides With Mixed Dyslipidemia
Phase 3
Approved July 26, 2012.
HALO HYQVIA
Subcutaneous treatment for patients with primary immunodeficiency (PI)
Approved
CRL issued August 1, 2012.
NAVB Lymphoseek
Lymphatic-tissue tracing agent
Approved
CRL issued September 10, 2012.
SUPN Oxtellar
Epilepsy
Approved
Approved October 22, 2012.
EXEL Cabozantinib
Medullary thyroid cancer
Approved
Approved November 29, 2012.
HEB Ampligen
CFS
CRL
CRL February 4, 2013.
IMGN Kadcyla
2nd-line HER2+ Metastatic Breast Cancer
Approved
Approved February 22, 2013 - under priority review.
DVAX HEPLISAV-B
Hepatitis B
Approved
CRL issued February 25, 2013.
NAVB Lymphoseek
Lymphatic-tissue tracing agent
Approved
Approved March 13, 2013.
HRTX APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
CRL March, 28 2013.
TTNP Probuphine
Opioid dependence
Approved
CRL issued April 30, 2013.
ENDP AVEED (testosterone undecanoate) intramuscular injection
Men diagnosed with hypogonadism
Approved
CRL issued September 5, 2013.
DEPO SEFELSA
Hot flashes
CRL
CRL issued May 31, 2013.
AVDL Bloxiverz (neostigmine methylsulfate)
Reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery
Approved
Approved June 3, 2013.
AVEO TIVO-3 - tivozanib
Third line treatment of patients with renal cell cancer
Phase 3
CRL issued June 10, 2013.
TBPH VIBATIV (telavancin hydrochloride) for injection
Hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP)
Approved
Approved June 21, 2013.
SUPN Trokendi
Epilepsy
Approved
Approved Aug 19, 2013.
ATRS OTREXUP
Rheumatoid arthritis (RA)
Approved
Approved Oct 14, 2013.
ALIM Iluvien
Diabetic macular edema
Approved
Second CRL October 17, 2013.
PSDV Iluvien
Diabetic macular edema
Approved
Second CRL October 18, 2013.
ZGNX Zohydro ER
Moderate to severe pain
Approved
Approved October 25, 2013.
ABBV Ibrutinib
Relapsed or refractory MCL mantle cell lymphoma
Approved
Approved November 13, 2013.
AMAG Feraheme
Adults with iron deficiency anemia (IDA)
Approved
CRL issued January 22, 2014.
AMAG Feraheme
Adults with iron deficiency anemia (IDA)
PDUFA
CRL issued January 22, 2014.
VNDA HETLIOZ (tasimelteon)
Insomnia
Approved
Approved January 31, 2014.
DRRX Posidur
Post-operative pain relief
CRL
CRL issued February 12, 2014.
ABBV Imbruvica
Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Approved
Approved February 12, 2014.
BMRN Vimizim (GALNS)
(MPS IVA) Morquio A Syndrome
Approved
Approved February 14, 2014.
ENDP AVEED (testosterone undecanoate) intramuscular injection
Men diagnosed with hypogonadism
Approved
Approved March 6, 2014.
ARLZ YOSPRALA (PA32540/PA8140)
Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers
Approved
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
CRL April 30 2014.
OMER Omidria
Cataract surgery
Approved
Approved June 2, 2014.
BDSI BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL
Opioid dependence
Approved
Approved June 6, 2014.
NAVB Lymphoseek
Head and Neck Cancer
Approved
Approved June 13, 2014.
MNKD AFREZZA
Type 1/2 diabetes
Approved
Approved June 27, 2014.
AVDL VAZCULEP (phenylephrine hydrochloride)
Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia
Approved
Approved June 30, 2014.
EGRX EP-3101 (bendamustine RTD)
Chronic lymphocytic leukemia; Indolent non-Hodgkin's lymphoma - cancer
Approved
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
Approved July 7, 2014.
ABBV Imbruvica
Deletion 17p
Approved
Approved July 19, 2014.
EGRX Ryanodex
Malignant hyperthermia - cancer
Approved
Approved July 23, 2014 under priority review.
ACRX Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
Phase 3
CRL issued July 25 2014.
MDCO Oritavancin
ABSSSI
Approved
Approved August 6, 2014 under priority review
KERX Auryxia
Hyperphosphatemia
Approved
Approved Sept 5, 2014.
OREX Contrave
Obesity
Approved
Approved September 11, 2014.
HALO HYQVIA
Subcutaneous treatment for patients with primary immunodeficiency (PI)
Approved
Approved September 12, 2014.
NKTR MOVANTIK (Naloxegol)
Opioid-induced constipation (OIC)
Approved
Approved September 16, 2014.
ALIM Iluvien
Diabetic macular edema
Approved
Approved September 26, 2014,
PSDV Iluvien
Diabetic macular edema
Approved
Approved Sept 26 2014.
PGNX Subcutaneous RELISTOR
Chronic pain
Approved
Approved September 29, 2014.
AEZS Macimorelin Acetate - Macrilen
Adult Growth Deficiency
Approved
CRL issued November 6, 2014.
INCY Jakafi (ruxolitinib) (RESPONSE)
Polycythemia Vera
Approved
Approved December 4, 2014.
ARLZ YOSPRALA (PA32540/PA8140)
Secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers
Approved
CRL issued December 17, 2014.
ABBV VIEKIRA PAK
HCV - genotype 1
Approved
Approved December 19, 2014.
BCRX RAPIVAB (peramivir)
INFLUENZA ACUTE
Approved
Approved December 22, 2014.
ADMS Namzaric
Moderate to severe dementia of the Alzheimer's type.
Approved
Approved December, 24 2014.
VRTX KALYDECO
Cystic fibrosis (CF) ages 6 and older who have the R117H mutation
Approved
Approved December 29, 2014.
NBIX Elagolix
Endometriosis
PDUFA priority review
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
ABBV Elagolix
Endometriosis
PDUFA priority review
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
RMTI Soluble Ferric Pyrophosphate
Iron deficiency
Approved
Approved January 26, 2015.
ABBV IMBRUVICA
Waldenström’s Macroglobulinemia
Approved
Approved January 29, 2015 - PCYC
ZGNX Abuse deterrent formulations of Zohydro ER
Moderate to severe pain
Approved
Approved January 30, 2015.
PCRX EXPAREL
Post surgical pain
Approved
CRL March 2, 2015.
PCRX EXPAREL
Post surgical pain
PDUFA
CRL March 2, 2015.
NKTR Etirinotecan pegol NKTR-102 (BEACON)
Cancer - Metastatic Breast Cancer
Phase 3
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
Approved March 17, 2015.
ADMP Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
Approved
CRL issued March 27 2015.
EBS Anthrax Immune Globulin Intravenous (Human) [AIGIV]
Anthrax
Approved
Approved March 25, 2015.
AMGN Corlanor
Chronic Heart Failure
Approved
Approved April 15, 2015.
MNTA Generic Copaxone
Multiple sclerosis
Approved
Approved April 16 2015.
MNK RAPLIXA
Hemostasis
Approved
Approved April 30, 2015.
TBPH BREO ELLIPTA
Asthma
Approved
Approved April 30, 2015.
PTX TREXIMET
Adolescent migraine patients
Approved
Approved May 15, 2015.
VRTX Lumacaftor and ivacaftor
Cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation
Approved
Approved July 2, 2015.
NYMX NX-1207 Fexapotide
BPH
Phase 3
Phase 3 endpoints met in extension trial July 2015.
SGEN ADCETRIS - AETHERA
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved August 17, 2015 under priority review.
VTL VTI-308
Alcohol-induced liver decompensation, or AILD
Phase 3
Phase 3 VTI-208 trial did not meet endpoints - August 21, 2015.
TTPH Eravacycline (TP-434) - IGNITE3
cUTI - complicated urinary tract infections
Phase 3
Phase 3 trial did not meet endpoints September 8, 2015.
IMGN Kadcyla GATSBY trial
Cancer - metastatic HER2+ gastric cancer
Phase 3
Phase 3 endpoint not met - October 22, 2015.
MACK ONIVYDE
Cancer - second line pancreatic
Approved
Approved October 22, 2015.
SPPI EVOMELA (melphalan) for Injection
Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
Approved
CRL issued October 23, 2015.
BDSI BEMA Buprenorphine
Pain
Approved
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
Approved October 26, 2015.
GWPH Sativex
Cancer pain
Phase 3
Phase 3 trials did not meet endpoints.
LPTX CureXcell
Diabetic Foot Ulcers
Phase 3
Phase 3 trial did not meet primary endpoint.
SPHS Topsalysin (PRX302)
Benign prostatic hyperplasia
Phase 3
Phase 3 primary endpoints met - November 10, 2015.
EXEL Vemurafenib
BRAF V600 Mutation-Positive Advanced Melanoma - Cancer
Approved
Approved November 10, 2015.
NKTR ADYNOVATE
Hemophilia A
Approved
Approved November 16, 2015.
EBS BioThrax
Anthrax Vaccine Adsorbed
Approved
Approved November 24, 2015.
RPRX Enclomiphene
Secondary hypogonadism
Phase 2
CRL issued December 1, 2015.
OTIC OTIPRIO (ciprofloxacin otic suspension)
Ear Tube Placement Surgery
Approved
Approved December 11, 2015.
ADMS ADS-5102
Levodopa-Induced Dyskinesia
Approved
Phase 3 data released December 23, 2015.
EGRX Docetaxel Injection
Breast, non-small cell lung, prostate gastric adenocarcinoma, and head and neck cancer
Approved
Approved December 24, 2015.
CHRS CHS-0214
Rheumatoid arthritis
Phase 3
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
CRL issued January 14 2016.
ZFGN Beloranib
Prader-Willi Syndrome (PWS)
Phase 3
Phase 3 co-primary endpoints met.
NEOS Adzenys XR-ODT
Attention deficit hyperactivity disorder (ADHD)
Approved
Approved January 27, 2016.
VRTX KALYDECO (ivacaftor)
Cystic fibrosis (CF) ages 2 and older who have one of 23 residual function mutations.
CRL
CRL issued February 5, 2016.
NBIX Elagolix
Endometriosis
PDUFA priority review
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
PDUFA priority review
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
Phase 3
Phase 3 final data released March 8, 2016.
GWPH Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
PDUFA priority review
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
Approved March 15 2016.
EGRX KANGIO (bivalirudin injection)
Percutaneous Coronary Intervention (PCI) and Percutaneous Transluminal Coronary Angioplasty (PTCA)
CRL
CRL March 18 2016. FDA requested further characterization of bivalirudin-related substances in the drug product.
PTLA Bevyxxa (betrixaban)
Venous thromboembolism (VTE) Prevention
Approved
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
CRL issued March 30, 2016.
CHMA Mycapssa
Acromegaly
CRL
CRL April 15, 2016.
EXEL CABOMETYX (cabozantinib)
Metastatic renal cell cancer (RCC)
Approved
Approved April 25, 2016.
ACAD Pimavanserin
Parkinson’s disease psychosis (PDP)
Approved
Approved April 29, 2016.
AVDL Akovaz
Hypotension
Approved
Approved May 2, 2016.
NLNK HyperAcute Pancreas - IMPRESS
Surgically resected pancreatic cancer
Phase 3
Phase 3 failed to meet primary endpoint - May 9, 2016.
AZN Lokelma (ZS-9)
Hyperkalaemia
Approved
CRL issued May 26, 2016.
TTNP Probuphine
Opioid dependence
Approved
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
Approved May 26, 2016.
ICPT Obeticholic acid (Ocaliva)
Primary biliary cirrhosis (PBC) - POISE
Approved
Approved May 27 2016.
OCUL DEXTENZA
Allergic conjunctivitis
Phase 3
Phase 3 trial did not meet primary endpoint - June 6, 2016.
ADMP Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
Approved
CRL issued March 27 2015. CRL issued again June 6, 2016.
MRNS Ganaxolone
Focal onset seizures
Phase 3
Phase 3 data did not meet endpoints - June 13, 2016
RVNC RT001 - REALISE 1
Lateral Canthal (Crow’s Feet) Lines
Phase 3
Phase 3 endpoints not met June 13, 2016.
KMPH Apadaz (KP201/APAP)
Acute pain
PDUFA
CRL issued June 13, 2016.
PRTK Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
PDUFA priority review
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
Announced FDA Approval June 21, 2016.
MDCO Meropenem-vaborbactam
Complicated urinary tract infections (cUTI)
Approved
Phase 3 data met endpoints June 27, 2016.
CLVS Rociletinib
Mutant EGFR T790M-positive lung cancer
CRL
CRL June 28, 2016. Phase 3 TIGER-3 also terminated.
TSRO Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
Approved
Phase 3 data met endpoints - June 2016.
LPCN LPCN 1021
Men with low testosterone (Low T)
CRL
CRL issued June 29, 2016.
AMPE Ampion
Osteoarthritis of the Knee
Phase 3
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
Announced approval July 5, 2016.
CYTR Aldoxorubicin with doxorubicin
Soft tissue sarcomas refractory cancer
Phase 3
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
Phase 3 data released July 2016. Primary endpoint hit. Secondary missed.
PGNX Oral RELISTOR
Chronic pain
Approved
Approved July 19 2016.
OCUL DEXTENZA
Ocular inflammation and pain following cataract surgery
CRL
CRL July 25 2016 - due to manufacturing deficiencies.
MCRB SER-109 - ECOSPOR III
Recurrent C. Difficile infection
Phase 3
Phase 2 interim data did not meet primary endpoint.
ADMA RI-002
Primary Immune Deficiency Diseases
CRL
CRL issued July 29 2016. Third-party manufacturing issues cited.
IONS SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
Approved
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
CRL Mar 28 2013. Approved August 10, 2016.
VTVT TTP399 - AGATA
Type 2 Diabetes
Phase 2b
Phase 2 data released August 10, 2016. Primary endpoint met.
AUPH Voclosporin - AURORA
Lupus
Phase 3
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
PDUFA
Phase 3 data released August 15, 2016.
PTLA Andexanet alfa
Factor Xa inhibitor reversal agent
Approved
CRL August 17 2016.
EARS AM-101 (Keyzilen) - TACTT2
Acute inner ear tinnitus
Phase 3
Phase 3 trial did not meet primary endpoints.
ACRS A-101
Common warts (verruca vulgaris)
Phase 2
Phase 2 data released August 2016.
LPTX CureXcell
Venous Leg Ulcers
Phase 3
Phase 3 endpoint not expected to be met - August 19, 2015.
RIGL Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
PDUFA
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
Top-line data released August 30, 2016. Primary endpoint met
RIGL Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Approved
Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
RIGL Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Approved
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
Approved September 2, 2015.
TSRO Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved September 2, 2015.
TNXP TNX-102 SL
Fibromyalgia
Phase 3
Phase 3 data released September 6, 2016. Primary endpoint not met. Program discontinued
KPTI Selinexor - STORM
Quadruple Refractory Multiple Myeloma
Phase 2b
Phase 2 positive top-line data released September 6, 2016
AERI Roclatan - Mercury trials
Glaucoma
NDA Filing
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
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
Approval announced September 15, 2016.
VICL ASP0113 Vaccine
Kidney transplant recipients
Phase 2
Phase 2 data released September 19, 2016 - did not meet primary endpoint.
SRPT Eteplirsen - Exon 51
Duchenne muscular dystrophy
Approved
Approved September 19, 2016.
DRRX Remoxy
Chronic pain
CRL
CRL received September 26, 2016.
PTIE Remoxy
Chronic pain
CRL
CRL received September 26, 2016.
GILD Yescarta (axicabtagene ciloleucel)
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
Approved
Phase 2 pivotal top-line data released September 26, 2016. Primary analysis due 1Q 2017. BLA filing due late 2016.
DRRX Remoxy
Chronic pain
PDUFA
CRL received September 26, 2016.
PTIE Remoxy
Chronic pain
PDUFA
CRL received September 26, 2016.
ITCI Lumateperone
Schizophrenia
NDA Filing
Phase 3 trial failed - September 28, 2016.
GNCA GEN-003
Genital herpes
-
Phase 2b virologic efficacy data released September 2016.
ABUS ARB-1467
Hepatitis B (HBV)
Phase 2
Phase 2 single dose data released September 2016.
MLNT Solithromycin
NASH
Phase 2
Phase 2 interim data released September 30, 2016.
TENX Levosimendan
Septic shock
Phase 2b
Phase 2b trial did not meet primary endpoint.
ALNY Revusiran ENDEAVOUR
ATTR in patients with familial amyloidotic cardiomyopathy (FAC)
Phase 3
Phase 3 trial discontinued October 2016.
ALKS ALKS 5461
Major depressive disorder
PDUFA
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
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
Phase 3 data from second trial did not meet the primary endpoint.
RIGL Tavalissetm (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Approved
Phase 3 data from second trial did not meet the primary endpoint.
AMAG Rekynda (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
Phase 3 data released November 1, 2016.
PTN Rekynda (Bremelanotide)
Female sexual dysfunction (FSD)
PDUFA
Phase 3 data released November 1, 2016.
IONS SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
Approved
Phase 3 CHERISH data met primary endpoint - November 7, 2016.
ANTH Blisibimod
Lupus
Phase 3
Phase 3 trial did not meet endpoints - November 10, 2016.
CRBP Anabasum (Resunab)
Systemic Sclerosis
Phase 3
Phase 2 data released November 14, 2016.
DVAX HEPLISAV-B
Hepatitis B
Approved
CRL November 14, 2016
ALNY Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
MDCO Inclisiran - ORION-9
Hypercholesterolemia
Phase 3
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
ACRS ESKATA (hydrogen peroxide)
Seborrheic keratosis (SK)
Approved
Phase 3 trial met endpoints - November 15, 2016.
SPPI QAPZOLA - Apaziquone
Bladder cancer
Phase 3
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.
BSTC XIAFLEX (collagenase clostridium histolyticum) - RELEASE
Edematous fibrosclerotic panniculopathy (“cellulite”)
Phase 3
Phase 2b data released November 17, 2016. Met endpoints
ENDP XIAFLEX (collagenase clostridium histolyticum) - RELEASE
Edematous fibrosclerotic panniculopathy (“cellulite”)
Phase 3
Phase 2b data released November 17, 2016. Met endpoints
ACOR Dalfampridine
Post stroke deficits
Phase 3
Phase 3 data released November 21, 2016 - failed to show efficacy, development to be discontinued.
REPH Intravenous (IV) meloxicam
Acute pain following bunionectomy surgery
CRL
Phase 3 data from second trial released November 28, 2016. Primary endpoint met.
NOVN SB206
Human papillomavirus (HPV)
Phase 2
Phase 2 data released November 29, 2016. Primary endpoint met.
CERC CERC-301
Major depressive disorder (MDD)
Phase 2
Phase 2 top-line data released November 29, 2016 failed to meet primary endpoint.
HTBX HS-410
Bladder cancer
Phase 2
Phase 2 trial did not meet primary endpoint - November 30, 2016.
ARDM Linhaliq (Pulmaquin)
Non-cystic fibrosis bronchiectasis (non-CF BE).
CRL
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
Phase 3 data released December 1, 2016. One of two trials met primary endpoint.
LXRX Sotagliflozin
Type 1 Diabetes
Phase 2
Phase 2 trial did not meet primary endpoint.
HZNP ACTIMMUNE
Friedreich's Ataxia (FA)
Phase 3
Phase 3 data released December 8, 2016 - primary endpoint not met
SGYP Trulance (plecanatide)
Constipation-predominant irritable bowel syndrome (IBS-C)
PDUFA
Phase 3 data from first trial met primary endpoint - December 9, 2016.
SGYP Trulance (plecanatide)
Constipation-predominant irritable bowel syndrome (IBS-C)
Approved
Phase 3 data from first trial met primary endpoint - December 9, 2016.
OPHT Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
Phase 3 data released December 12, 2016 - primary endpoint not met.
ABUS ARB-1467
Hepatitis B (HBV)
Phase 2
Phase 2 single dose data released September 2016, multiple dose data released December 12, 2016.
AKAO Plazomicin
Complicated urinary tract infections (cUTI)
PDUFA priority review
Phase 3 data released December 12, 2016 - primary endpoint met.
LIFE Resolaris
Limb girdle muscular dystrophy (LGMD) 2B / Adult patients with facioscapulohumeral muscular dystrophy (FSHD)
Phase 1/2
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
Phase 3 data released December 13, 2016 - primary endpoint not met.
VCEL MACI
Focal chondral cartilage defects in the knee.
Approved
FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.
BDSI Clonidine gel
Painful diabetic neuropathy (PDN)
Phase 2b
Phase 2b data released December 13, 2016 - primary endpoints not met.
VTVT TTP273 - LOGRA
Type 2 Diabetes
Phase 2
Phase 2 primary endpoint met - December 14, 2016.
CLVS Rucaparib ARIEL2
Cancer - ovarian second line
Approved
Approved December 19, 2016. Original PDUFA date under priority review was February 23, 2017.
ACAD Pimavanserin - Harmony
Alzheimer’s disease psychosis
Phase 3
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
Phase 2 trial discontinued December 21, 2016 due to poor efficacy.
NVS Lutathera
Inoperable progressive midgut NETs
PDUFA
PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
NVS Lutathera
Inoperable progressive midgut NETs
Approved
PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
LXRX Sotagliflozin
Type 1 Diabetes
PDUFA
Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
SNY Sotagliflozin
Type 1 Diabetes
PDUFA
Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
IRWD Linaclotide Colonic Release
Irritable Bowel Syndrome with Constipation (IBS-C)
Phase 2b
Phase 2b data released December 22, 2016.
SGYP Trulance (plecanatide)
Constipation-predominant irritable bowel syndrome (IBS-C)
PDUFA
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
Phase 3 data from second trial met primary endpoints - December 9 and 22, 2016.
IRWD Linaclotide Colonic Release
Irritable Bowel Syndrome with Constipation (IBS-C)
Phase 3
Phase 2b data released December 22, 2016.
IONS SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
Approved
Approved December 23, 2016.
AMPH Primatene Mist (epinephrine inhalation aerosol)
Asthma
CRL
CRL issued December 27, 2016.
ANTH Sollpura (liprotamase)
Cystic fibrosis who suffer from exocrine pancreatic insufficiency
Phase 3
Top-line data released December 27, 2016 - missed primary endpoint.
MLNT Solithera - intravenous
Community-acquired bacterial pneumonia (CABP)
CRL
CRL announced December 29, 2016. Further trials required.
OPK hGH-CTP
Adults - growth hormone deficiency
Phase 3
Phase 3 data released December 30, 2016 - primary endpoint not met.
AGRX Twirla
Contraceptive patch
CRL
CRL issued 2013. Phase 3 top-line data released January 3, 2017 - poor data but intends to reflile NDA 1H 2017.
PLX AIR DNase (PRX-110)
Cystic Fibrosis
Phase 2
Phase 2 interim data released January 3, 2017.
AEZS Macimorelin Acetate - Macrilen
Adult Growth Deficiency
Approved
Phase 3 data released January 4, 2017 - trial failed.
HALO PEGPH20 - HALO-301
Pancreatic cancer
Phase 3
Primary endpoint met.
GNCA GEN-003
Genital herpes
-
Phase 2b data released January 5, 2017.
OTIC OTIPRIO
Acute otitis externa
PDUFA
Phase 3 trial met primary endpoint - January 5, 2017.
OTIC OTIPRIO
Acute otitis externa
Approved
Phase 3 trial met primary endpoint - January 5, 2017.
EGLT ARYMO ER
Abuse-Deterrent Morphine
Approved
Approved January 9, 2017.
CHRS CHS-1420
Psoriasis
Phase 3
Phase 3 top-line data met endpoints August 2016. Full data due released January 10, 2016.
TSRO Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
CRL issued January 11 2017.
FGEN Pamrevlumab (FG-3019)
Pancreatic cancer
Phase 1/2
Phase 2 abstract released January 17, 2017.
AGN ESMYA (ulipristal acetate)
Uterine Fibroids
PDUFA
Phase 3 data released January 18, 2017 - endpoints met.
NBIX INGREZZA
Tourette syndrome - adults
Phase 2
Phase 2 data released January 18, 2017 did not meet primary endpoint.
AGN Oxymetazoline HCl cream 1.0%
Facial Erythema (Redness) Associated with Rosacea
Approved
Approved January 19, 2017.
ABBV Imbruvica
Marginal zone lymphoma
Approved
sNDA filing under priority review approved January 19, 2017.
SGYP Trulance (plecanatide)
Chronic idiopathic constipation (CIC)
Approved
Approved January 19, 2017.
MRNS Ganaxolone
CDKL5 disorder
Phase 3
Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
VRTX VX-150
Osteoarthritis
Phase 2
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
sNDA approval announced January 26, 2017.
PFE PF-06425090
C. difficile Infection
Phase 2
Phase 2 positive data released January 26, 2017.
NOVN SB204
Acne vulgaris
Phase 3
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
sNDA approval announced January 30, 2017.
GEMP Gemcabene - COBALT-1
Homozygous Familial Hypercholesterolemia (HoFH)
Phase 2b
Phase 2b interim data released January 30, 2017.
TENX Levosimendan
Reduce the incidence of low cardiac output syndrome during cardiac surgery
Phase 3
Phase 3 top line data released January 31, 2017 - primary endpoints not met.
CATB Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
Phase 3
Phase 1/2 top-line data released January 31 - primary endpoint not met.
AMGN Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
Approved February 7, 2017.
GWPH Sativex
Spasticity due to cerebral palsy
Phase 2
Phase 2 trial did not meet primary endpoint - noted February 7, 2017.
JNJ XARELTO (rivaroxaban)
Coronary Artery Disease or Peripheral Artery Disease
Phase 3
Phase 3 trial stopped early due to positive efficacy - February 8, 2017.
TCON TRC105 and Avastin
Glioblastoma - cancer
Phase 2
Phase 2 data released February 9, 2017 - primary endpoint not met.
ACOR INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
NDA Filing
Phase 3 data released February 9, 2017 - primary endpoint met.
ACOR INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
PDUFA
Phase 3 data released February 9, 2017 - primary endpoint met.
ZSAN M207
Migraine
Phase 3
Phase 3 trial data due released February 13, 2017 - primary endpoints met.
SAGE SAGE-217
Major Depressive Disorder (MDD)
Phase 3
Phase 2 top-line data from open-label trial released February 13, 2017
AXON Nelotanserin
Visual hallucinations in subjects with Lewy body dementia
Phase 2
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
Phase 3 trial stopped due to lack of efficacy - February 14, 2017.
ARDX Tenapanor
Hyperphosphatemia in end-stage renal disease (ESRD) patients
Phase 3
Phase 3 released February 15, 2017 - primary endpoint met.
VRX Brodalumab
Psoriasis
Approved
Approved February 15, 2017.
ALKS ALKS 6428
Opioid dependence
Phase 3
Phase 3 trial did not meet endpoint - February 2017 (exact date unsure).
XBIT MABp1
Hidradenitis Suppurativa (HS)
Phase 2
Phase 2 data released February 16, 2017.
AZN Lynparza
Breast cancer
Approved
Phase 3 data released February 17, 2016 - primary endpoint met.
MRK Lynparza
Breast cancer
Approved
Phase 3 data released February 17, 2016 - primary endpoint met.
AMPH Naloxone Intranasal
Opioid overdose
CRL
CRL announced February 21, 2017.
TRVN Oliceridine (TRV130)
Moderate to severe acute pain
PDUFA
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
Phase 3 interim analysis announced February 21, 2017 - trial to continue as planned.
CDTX CD101 Topical - RADIANT
Vulvovaginal candidiasis (VVC)
Phase 2
Phase 2 data released February 21, 2017 - efficacy not evident, Development to be discontinued.
CMRX Brincidofovir - Advise trial
Adenovirus Infection
Phase 3
Phase 3 interim analysis released May 2016. Final data released February 22, 2017.
CELG REVLIMID
Multiple myeloma (MM) - autologous stem cell transplant (ASCT)
Approved
Approved February 22, 2017.
ARGS rocapuldencel-T (AGS-003) ADAPT Trial
Metastatic renal cell carcinoma (mRCC)
Phase 3
Phase 3 trial recommended trial be discontinued for futility - February 22, 2016.
MLNT Taksta - Fusidic acid
Acute bacterial skin and skin structure infections (ABSSSI)
Phase 3
Phase 3 data released February 24, 2017 - endpoints met.
LJPC GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
Approved
Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. NDA filing due 2H 2017.
BCRX BCX7353 - APeX-2
Reduce or eliminate attacks in HAE patients
Phase 3
Phase 2 interim data released February 27, 2017.
AZN Saxagliptin and dapagliflozin
Type-2 diabetes
Approved
Approval announced February 28, 2017.
GILD Yescarta (axicabtagene ciloleucel)
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
Approved
Phase 2 primary analysis released February 28, 2017 showed trial met primary endpoint. 31% CR for DLBCL.
LXRX Telotristat etiprate (XERMELO)
Carcinoid Syndrome
Approved
Approved February 28, 2017.
MLNT Solithromycin
NASH
Phase 2
Noted February 28, 2017 that development has been suspended due to lack of efficacy.
AUPH Voclosporin - AURORA
Lupus
Phase 3
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.
NDRM ND0612H (Trial 006)
Severe Parkinson's Disease
Phase 2
Phase 2 trial met key primary and secondary endpoints - March 1, 2017.
MRK Odactra (MK-8237)
House dust mite allergies
Approved
Approved March 1, 2017.
KPTI Selinexor SOPRA
Cancer - Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase 2
Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.
PTCT Translarna
Nonsense mutation cystic fibrosis
Phase 3
Phase 3 data released March 2, 2017 - endpoints not met. Development to be discontinued.
PBYI Roche (RHHBY) - Perjeta + Herceptin (APHINITY)
Adjuvant HER2+ breast cancer
Phase 3
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.
SCYX Intravenous SCY-078
Invasive candidiasis
Phase 2
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.
IONS Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
PDUFA
Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
AKCA Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
PDUFA
Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
GALT GR-MD-02
Plaque psoriasis
Phase 2a
Phase 2 data released March 6, 2017.
KURA Tipifarnib
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
Phase 2 ongoing data released March 6, 2017 - further data due 2H 2017.
TGTX TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
Phase 3
Phase 3 trial met primary endpoint - March 6, 2017, meeting with FDA in 2H 2017.
ACOR Ampyra
Improve walking in patients with multiple sclerosis
-
Decision on Inter Partes Review (IPR) released March 10, 2017 - patents upheld.
NVS LEE011
HR+/HER2- advanced breast cancer
Approved
Priority review granted November 1, 2016. Approval announced March 13, 2017.
ENDP OPANA ER
Management of pain
-
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
Approval announced March 14, 2017.
AZN Lynparza - SOLO 2
Second-line ovarian cancer
Approved
Data presented March 14, 2017 showed significant PFS benefit.
CPRX Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)
Phase 2
Phase 2 top-line data met endpoints - March 15, 2017. Pivotal trial planned.
AMGN Repatha
Cardiovascular disease
Approved
Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations.
AZN Lokelma (ZS-9)
Hyperkalaemia
Approved
Second CRL issued March 17, 2017.
GNMX NFC-1 - SAGA
mGluR mutation positive ADHD
Phase 2/3
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
Approval announced March 20, 2017.
BLRX BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
Phase 3
Phase 2 trial initiated March 2016. Partial data released March 20, 2017.
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
Phase 3 data released March 20, 2017 - PFS primary endpoint met.
JAZZ JZP-110
Excessive sleepiness associated with obstructive sleep apnea
Phase 3
Phase 3 data released March 20, 2017 - primary endpoints met.
NKTR NKTR-181
Lower back pain
NDA Filing
Phase 3 data released March 20, 2017 - endpoints met.
NVS RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3
Phase 3 data released March 22, 2017 - primary endpoints not met.
PFE Avelumab
Metastatic Merkel cell carcinoma
Approved
Priority review announced November 29, 2016. Approval announced March 23, 2017.
XENE XEN801
Acne
Phase 2
Phase 2 data released March 24 2017 - endpoints not met.
AUPH Voclosporin - AURION trial
Lupus
Phase 2
48-week data from open-label AURION study presented March 27, 2017 - primary endpoint met.
TSRO Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
Approved
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
FOMX FMX101 - FX2017-22
Acne
Phase 3
Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
PRTK Sarecycline
Severe acne vulgaris
PDUFA
Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
AGN Sarecycline
Severe acne vulgaris
PDUFA
Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
VRTX Tezacaftor (VX-661) / ivacaftor
Cystic fibrosis - Two Copies of the F508del Mutation
PDUFA priority review
Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
CARA IV CR845
Uremic pruritus
Phase 2/3
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.
RTTR RP-G28
Lactose intolerance
Phase 2/3
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
Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 2017.
REGN Dupixent (dupilumab)
Atopic dermatitis
Approved
Approved under priority review - March 28, 2017.
SNY Dupixent (dupilumab)
Atopic dermatitis
Approved
Approved under priority review - March 28, 2017.
CARA IV CR845
Uremic pruritus
Phase 3
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.
CRBP Anabasum (Resunab)
Cystic Fibrosis
Phase 2b
Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
PGNX Azedra
Pheochromocytoma
PDUFA priority review
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.
HALO FOLFIRINOX and PEGPH20
Pancreatic and gastric cancers
Phase 1/2
Phase 1/2 enrollment closed due to lack of efficacy.
AZN Tagrisso
Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
Approved
Approval announced March 31, 2017.
NVCR Tumor Treating Fields (TTFields) - INNOVATE
Ovarian cancer
Phase 2
Phase 2 data presented December 12, 2016. Further promising PFS data released March 31, 2017.
PFE IBRANCE (palbociclib)
HR+, HER2- Metastatic Breast Cancer
Approved
sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
XBIT 514G3
Staphylococcus Aureus Bacteremia
Phase 1/2
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
Phase 3 first overall survival (OS) positive data released April 3, 2017
PRTK Omadacycline
Community-acquired bacterial pneumonia (CABP)
PDUFA priority review
Phase 3 data released April 3, 2017 - all endpoints met.
BMY CM-143 – Opdivo
Second-line Glioblastoma (GBM) cancer
Phase 3
Phase 3 data released April 3, 2017 - primary endpoint not met.
KPTI Selinexor - SADAL
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
Phase 2b
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
Phase 2 interim analysis released at AACR meeting April 4, 2017.
SUPN Trokendi
Migraine
Approved
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
Phase 3 second trial did not meet endpoint - April 5, 2017.
AGN Botox
Depression
Phase 2
Phase 2 top-line data released April 5, 2017 - primary endpoint missed. Phase 3 planned.
ONCE SPK-9001
Hemophilia B
Phase 1/2
Phase 1/2 updated data at ASH 2016. Further update released April 6, 2017.
MRK Januvia (Sitagliptin)
Type 2 Diabetes
CRL
CRL issued April 7 2017. sNDA for approved drug requested to include data on cardiovascular effects
GERN Imetelstat - IMbarkStudy
Myelofibrosis
Phase 2
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.
JNJ Imetelstat - IMbarkStudy
Myelofibrosis
Phase 2
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
Phase 2 data released April 10, 2017 - primary endpoint not met.
MESO MPC-150-IM - Class 2/3
Chronic heart failure (CHF)
Phase 3
Noted April 10, 2017 that interim analysis has been completed - trial to continue as planned.
NBIX INGREZZA
Tardive dyskinesia
Approved
Approved April 11, 2017.
NOVN SB208
Fungal infections
Phase 2
Phase 2 data released April 12, 2017. Primary endpoint met.
PLX AIR DNase (PRX-110)
Cystic Fibrosis
Phase 2
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
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
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
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
Phase 3 data released April 18, 2017 - primary endpoint of non-inferiority met.
RARE Crysvita (Burosumab)
X-Linked Hypophosphatemia (XLH)
Approved
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
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
Phase 3 trial did not meet primary endpoints - April 19, 2017.
EIGR Lonafarnib - LOWR HDV
Chronic hepatitis delta virus (HDV)
Phase 2
Phase 2 end of trial data released April 21, 2017. Meeting with FDA scheduled for 4Q 2017.
EIGR Lonafarnib - LOWR HDV
Chronic hepatitis delta virus (HDV)
Phase 3
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
BLA acceptance announced May 23, 2016 by partner Samsung Bioepis. Approval annuonced April 21, 2017.
ACHN JNJ-4178
Hepatitis C (HCV)
Phase 2a
Phase 2a ongoing. Updated data presented at EASL April 22, 2017.
AKTX Coversin
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 2
Phase 2 interim data released April 24, 2017. Phase 3 program to commence 4Q 2017 with initial data due 1Q 2019.
AKTX Coversin
Paroxysmal nocturnal hemoglobinuria (PNH)
Phase 3
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
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
Phase 2 proof-of-concept results released April 24, 2017.
JAZZ Xyrem
Pediatric narcolepsy patients with cataplexy
sNDA Filing
Phase 2/3 positive data released April 24, 2017. sNDA filing due 4Q 2017.
LLY Abemaciclib - MONARCH 3
HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)
PDUFA priority review
Phase 3 interim analysis April 24, 2017 met primary endpoint. Detailed data due 2H 2017 with regulatory filings due 3Q 2017.
JAZZ Xyrem
Pediatric narcolepsy patients with cataplexy
Phase 2/3
Phase 2/3 positive data released April 24, 2017. sNDA filing due 4Q 2017.
REGN Praluent (alirocumab)
High low-density lipoprotein (LDL) cholesterol
Approved
sBLA Approval announced April 25, 2017.
SNY Praluent (alirocumab)
High low-density lipoprotein (LDL) cholesterol
Approved
sBLA Approval announced April 25, 2017.
CAPR CAP-1002 HOPE-Duchenne
Duchenne Muscular Dystrophy (DMD)
Phase 2
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 HOPE-Duchenne
Duchenne Muscular Dystrophy (DMD)
Phase 1/2
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.
JAZZ JZP-110
Excessive sleepiness associated with narcolepsy
PDUFA
Phase 3 data released April 26, 2017. NDA to be filed late 2017.
BMRN Cerliponase alfa
Batten Disease
Approved
PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.
TGTX TG-1101 - ULTIMATE I
Multiple Sclerosis
Phase 3
Phase 2 preliminary results presented at American Academy of Neurology (AAN) annual meeting April 28, 2017.
RDUS TYMLOS (Abaloparatide)
Osteoporosis
Approved
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
Priority review granted November 14, 2016. Approval announced April 28, 2017.
NTRP Bryostatin
Alzheimer's disease
Phase 2
Phase 2 data released May 1, 2017 - primary endpoint not met.
AEZS Zoptrex
Endometrial cancer
Phase 3
Phase 3 trial did not meet primary endpoint - May 1, 2017.
AZN Urothelial carcinoma - Bladder cancer
Bladder cancer
Approved
BLA acceptance announced December 9, 2017. PDUFA under priority review. Approval announced May 1, 2017.
AMAG Feraheme
Adults with iron deficiency anemia (IDA)
Approved
Phase 3 trial completion announced May 2, 2017 - endpoints met. sNDA due mid-2017.
AMAG Feraheme
Adults with iron deficiency anemia (IDA)
PDUFA
Phase 3 trial completion announced May 2, 2017 - endpoints met. sNDA due mid-2017.
BPMX BPX-01
Acne
Phase 2b
Phase 2b data released May 3, 2017 - primary endpoint met, secondary missed.
REGN Dupixent (dupilumab)
Eosinophilic esophagitis
Phase 2
Phase 2 data released May 4, 2017.
SNY Dupixent (dupilumab)
Eosinophilic esophagitis
Phase 2
Phase 2 data released May 4, 2017.
ZFGN ZGN-1061
Diabetes
Phase 2
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
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
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
Phase 2 positive data at DDW Meeting May 9, 2017. Phase 3 trial to be initiated later in 2017.
ABBV ABT-494
Crohn’s Disease
Phase 3
Phase 2 positive data at DDW Meeting May 9, 2017. Phase 3 trial to be initiated later in 2017.
SAGE SAGE-217
Parkinson’s disease (PD)
Phase 2
Phase 2 initiation announced December 13, 2016. Data from Part A data released May 9, 2017. Part B data due 2H 2017.
BTX OpRegen
Dry age-related macular degeneration (AMD)
Phase 1/2
Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference.
PFE Avelumab
Urothelial Carcinoma
Approved
Approval announced May 9, 2017.
GSK Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
BLA Filing
Phase 3 METREX trial met primary endpoint. Phase 3 METREO failed to meet endpoint.
MRK Keytruda
First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
Approved
Approved May 10, 2017.
AZN Tralokinumab (STRATOS1)
Severe, uncontrolled asthma
Phase 3
Phase 3 trial did not meet primary endpoint - May 10, 2017.
CORI Corplex Donepezil
Alzheimer's disease
Phase 1
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
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
AZN Durvalumab (PACIFIC)
Lung cancer
Approved
Phase 3 interim analysis released May 12, 2017 - PFS primary endpoint already met. OS endpoint to be assessed.
LLY Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN
Migraine prevention
PDUFA
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
Phase 2 data released May 12, 2017 - primary endpoint unlikely to be met.
IONS Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
PDUFA priority review
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns.
FOLD ATB200
Pompe Disease
Phase 1/2
Phase 1/2 additional data released February 15, 2017. Further data released May 15, 2017.
MRK KEYTRUDA
First and Second line locally advanced or metastatic urothelial cancer - bladder cancer
Approved
Approved May 18, 2017.
RVNC RT002 - ASPEN
Cervical dystonia
Phase 3
Phase 2 additional data released May 18, 2017 with oral presentation June 7, 2017 at International Congress of Parkinson's Disease and Movement Disorders.
BLPH INOpulse delivery device
Pulmonary Hypertension associated with Idiopathic Pulmonary Fibrosis (PH-IPF)
Phase 2
Phase 2 initiated May 2016. Data presented at American Thoracic Society (ATS) Conference, May 21 2017. Phase 2b planned.
AMGN EVENITY (Romosozumab)
Osteoporosis
CRL
PDUFA date July 19, 2017. However, likely to be delayed due to safety data from ARCH trial released May 22, 2017.
LJPC GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
Approved
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.
SNY Sarilumab
Rheumatoid arthritis
Approved
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
CELG Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
Phase 3
Phase 3 data due released May 22, 2017 - primary endpoint met, disability endpoint not met.
SBPH SB 9200
Hepatitis B (HBV)
Phase 2a
Phase 2a initial data released May 23, 2017. Second cohort enrolling with top-line results due 4Q 2017.
NBIX INGREZZA - T-Force GOLD
Tourette syndrome - juvenile
Phase 2b
Phase 2 data released May 23 - primary endpoint not met.
MRK KEYTRUDA
Microsatellite Instability-High Cancer
Approved
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
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 - Mercury trials
Glaucoma
NDA Filing
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
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
Priority review granted February 22, 2017. Approval announced May 26, 2017.
GILD Bictegravir/F/TAF
HIV
Approved
Phase 3 data released May 30 - primary endpoint met. NDA filing due 2Q 2017.
MRK ISENTRESS
HIV-1
Approved
Approval announced May 30, 2017.
GILD Bictegravir/F/TAF
HIV
PDUFA priority review
Phase 3 data released May 30 - primary endpoint met. NDA filing due 2Q 2017.
NVO Nonacog beta pegol
haemophilia B
Approved
Approval announced May 31, 2017.
RETA Omaveloxolone - MOXIe
Friedreich’s ataxia (FA)
Phase 2
Phase 2 initial data released June 1, 2017. Primary endpoint not met.
BMY CM-358 – Opdivo
Cervical, vaginal and vulvar cancers
Phase 1/2
Phase 1/2 preliminary data presented at ASCO June 2, 2017. ORR=21%.
NLNK Indoximod + taxane
Cancer - breast
Phase 2
Phase 2 trial did not meet endpoints - noted June 2, 2017.
ECYT EC1169
Castrate-resistant prostate cancer (mCRPC)
Phase 1
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
Phase 1 enrollment to be stopped - announced June 2, 2017.
DVAX SD-101 + Pembrolizumab
Melanoma and head and neck squamous cell carcinoma (HNSCC)
Phase 1/2
Phase 1b/2 poster at ASCO June 3, 2017. Noted June 2 ORR of 7/7 in anti-PD-1/L1-naïve patients
IMDZ CMB305
Soft tissue sarcomas
Phase 2
Phase 2 data at ASCO June 2, 2017.
JNJ ZYTIGA (abiraterone acetate) - LATITUDE
metastatic hormone-naïve prostate cancer (mHNPC)
sNDA Filing
Phase 3 data presented at ASCO June 3, 2017 - PFS 33 months.
JNJ ZYTIGA (abiraterone acetate) - LATITUDE
metastatic hormone-naïve prostate cancer (mHNPC)
Approved
Phase 3 data presented at ASCO June 3, 2017 - PFS 33 months.
BMY BMS-986016 - LAG-3 + Opdivo
Melanoma
Phase 1/2
Phase 1/2 ORR rate of 12.5% noted at ASCO June 3, 2017.
MTNB MAT2203
Refractory mucocutaneous candidiasis
Phase 2a
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
Phase 2 data released at ASCO June 3, 2017.
TSRO Niraparib and Keytruda (TOPACIO)
Triple-negative Breast Cancer or Ovarian Cancer
Phase 1/2
Phase 1/2 enrolling. Initial data presented at ASCO investor event. ORR 4/13 patients. Further data due 2H 2017.
TGTX TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
Phase 3
Phase 3 trial met primary endpoint - March 6, 2017. Data presented at ASCO 2017. Meeting with FDA in 2H 2017.
LOXO Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
PDUFA priority review
Announced 76% ORR at ASCO - June 3, 2017. Primary analysis by the end of 2017 with NDA filing late 2017 or early 2018.
ARQL Derazantinib (ARQ 087)
intrahepatic cholangiocarcinoma (iCCA)
Phase 3
Phase 2 data at ASCO June 3, 2017 - ORR 21%. Phase 3 trial planned for 3Q 2017.
INCY Epacadostat with Keytruda - ECHO-202/KEYNOTE-037
NSCLC, RCC, Triple-Negative Breast, Ovarian, Urothelial Carcinoma, Solid Tumors
Phase 1/2
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
Phase 1/2 data presented at ASCO 2017. 35% ORR noted in NSCLC arm. UC, RCC, SCCHN data also presented June 5.
ZYME ZW25
HER2-expressing Cancers - ovarian, breast, gastric
Phase 1
Phase 1 initial presented at ASCO June 4, 2017.
FPRX Cabiralizumab (FPA008)
Pigmented Villonodular Synovitis (PVNS)
Phase 1/2
Phase 1/2 initial data released at ASCO June 4, 2017.
HALO PEGPH20 - HALO-301
Pancreatic cancer
Phase 3
Phase 2 data released January 5, 2017. Oral presentation of Phase 2 data at ASCO June 4, 2017 showed ORR of 45%.
PIRS PRS-080
Anemia of chronic disease
Phase 2a
Phase 1b data released at ERA-EDTA June 4, 2017.
RNN RX-3117
Advanced bladder cancer - 3rd line
Phase 2a
Phase 2a initial presented at ASCO June 4, 2017.
MRK Keytruda - KEYNOTE-045
Bladder Cancer
Phase 3
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
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
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).
BLUE bb2121
Relapsed/refractory multiple myeloma
Phase 1
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
Relapsed/refractory multiple myeloma
Phase 1
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%.
GLYC GMI-1271
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer
Phase 1/2
Phase 2 enrollment completed - announced May 31, 2017. Data updates at ASCO June 5, 2017.
CLSN GEN-1 OVATION 2
Ovarian cancer
Phase 1/2
Phase 1b interim data released at ASCO 2017 - ORR 86%.
CELG Lico-cel (CD-19 JCAR017) - TRANSCEND
r/r B cell non-Hodgkin lymphoma - cancer
Phase 1/2
Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017 - ORR 86%.
CALA CX-1158-101
Solid tumors - cancer
Phase 1
Phase 1 oral presentation at ASCO, June 5, 2017.
BGNE BGB-A317
Solid tumors
Phase 1/2
Phase 1/2 preliminary data presented at ASCO June 5, 2017.
IOVA LN-144
Refractory metastatic melanoma
Phase 2
Phase 2 second cohort commenced enrollment - May 19, 2017. Initial data presented at ASCO June 5, 2017.
NLNK Indoximod + Sipuleucel-T
Metastatic castration resistant prostate cancer (mCRPC)
Phase 2
Phase 2 poster presentation at ASCO June 5, 2017.
BMY Opdivo + Yervoy
Malignant pleural mesothelioma (MPM)
Phase 2
Phase 2 late breaker at ASCO June 5, 2017. Control rate 44%. ORR 19%.
INCY Epacadostat with Opdivo (nivolumab) - (ECHO-204)
Solid tumors
Phase 1/2
Phase 1/2 trial enrolling. Oral presentation at ASCO June 5, 2017.
BMY Epacadostat with Opdivo (nivolumab) - (ECHO-204)
Solid tumors
Phase 1/2
Phase 1/2 trial enrolling. Oral presentation at ASCO June 5, 2017.
PBYI Roche (RHHBY) - Perjeta + Herceptin (APHINITY)
Adjuvant HER2+ breast cancer
Phase 3
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.
GILD Axicabtagene ciloleucel - KTE-C19 (ZUMA-3)
Adult patients with r/r ALL - cancer
Phase 1/2
Phase 2 data due 2018. Phase 1 data released at ASCO June 5, 2017. Complete remission 73%.
CRVS CPI-444
Solid tumors - cancer
Phase 1b
Phase 1/1b preliminary data released November 2016. Further update at ASCO June 5, 2017.
ALKS Aristada
Schizophrenia
Approved
Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
ABBV ABT-494 (upadacitinib) - SELECT-NEXT
Rheumatoid arthritis
Phase 3
Phase 3 top-line data released June 7, 2017 - primary endpoints met.
NVS Kymriah (CTL019 )- JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
PDUFA priority review
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
Phase 2 pivotal primary analysis due International Conference on Malignant Lymphoma (ICML) on June 14, 2017. Abstract released June 7, 2017. ORR 45%.
LXRX Sotagliflozin
Type 1 Diabetes
PDUFA
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
Phase 3 data released September 9, 2016 met primary endpoint. Secondary endpoint data due May 2017. Data from second trial released December 21, 2016 - primary endpoint met. Data from third trial also met primary endpoint - June 9, 2017.
XBIT Xilonix
Colorectal cancer
Phase 3
Phase 3 interim analysis announced June 9, 2017 - trial to be terminated due to lack of efficacy.
CHRS CHS-1701
Pegfilgrastim biosimilar
PDUFA
CRL announced June 12, 2017.
RGLS RG-101
Hepatitis C virus (HCV)
Phase 2
Clinical hold placed June 2016. Noted June 12, 2017 that it plans to discontinue program.
XLRN Dalantercept - DART Study
Renal Cell Carcinoma (RCC) - cancer
Phase 2
Phase 2 data released June 12, 2017 - primary endpoint not met.
JNJ INVOKANA CANVAS
Type 2 diabetes
sNDA Filing
Cardiovascular Outcomes trial data released June 12, 2017 - 14% reduction in the risk of the composite primary endpoint of CV mortality.
PSDV Medidur
Posterior uveitis
Phase 3
Phase 3 data released December 2015. Second Phase 3 trial data released June 13, 2017 also met endpoint with NDA to be filed 4Q 2017.
PSDV Medidur
Posterior uveitis
PDUFA
Phase 3 data released December 2015. Second Phase 3 trial data released June 13, 2017 also met endpoint with NDA to be filed 4Q 2017.
ALDX Reproxalap (ADX-102)
Allergic conjunctivitis
Phase 3
Phase 2b data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned.
BTX Renevia
Restoring normal skin contours in for patients with HIV
Phase 3
Pivotal trial data released June 14, 2017 - primary endpoint met.
RDHL BEKINDA -GUARD
Gastroenteritis
Phase 3
Phase 3 top-line data released June 14, 2017 - primary endpoint met.
EPZM Tazemetostat
Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma
Phase 2
Phase 2 data released June 14, 2017 - DLBCL ORR 29%.
KURA Tipifarnib
Relapsed or refractory peripheral T-cell lymphoma
Phase 2
Phase 2 data presented at ICML conference on June 14, 2017 - 3/18 partial responses.
PTLA Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
Phase 2
Phase 2 enrollment commenced May 2016. Interim data released June 15, 2017 - noted CLL/SLL 67% partial responese rate + two patient deaths.
SELB SEL-212
Tophaceous gout
Phase 2
Phase 2 dosing commenced late October 2016. Initial data released at EULAR June 15, 2017.
ADMP Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
Approved
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
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
CLVS Rucaparib ARIEL3
Ovarian cancer patients with a BRCA-like mutation
Approved
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
Approval announced June 19, 2017.
CLVS Rucaparib ARIEL3
Ovarian cancer patients with a BRCA-like mutation
PDUFA priority review
Phase 3 data released June 20 2017 - primary endpoint met. sNDA filing due 3Q or early 4Q 2017.
SGEN Vadastuximab Talirine (CASCADE)
Acute myeloid leukemia (AML) - cancer
Phase 3
Phase 3 trial discontinued due to higher rate of deaths - June 19, 2017.
LPCN LPCN 1021
Men with low testosterone (Low T)
CRL
CRL issued June 2016. Flexibility trial data announced June 19, 2017 - primary endpoint met with NDA fiing due 3Q 2017.
EGLT OXAYDO
Acute and chronic moderate to severe pain
CRL
CRL announced June 20, 2017.
NVS RTH258 (brolucizumab)
Neovascular AMD
Phase 3
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
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
Interim conditional power analysis conducted June 21, 2017 - trial completion due 4Q 2017.
PFE Epoetin alfa biosimilar
CRL
CRL issued June 22, 2017.
NVS Tafinlar (dabrafenib) and Mekinist (trametinib)
Non-small cell lung cancer (NSCLC) with BRAF V600E mutation
Approved
FDA Approval announced June 22, 2017.
HALO Subcutaneous rituximab
Various blood cancers
Approved
Approval announced June 22, 2017.
NVS ACZ885 (canakinumab) - CANTOS
CV risk reduction
Phase 3
Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
BLUE HGB-205
Transfusion-Dependent β-Thalassemia (TDT) and Severe Sickle Cell Disease (SCD)
Phase 1/2
Phase 1/2 data presented at EHA June 23, 2017.
PTLA Bevyxxa (betrixaban)
Venous thromboembolism (VTE) Prevention
Approved
FDA Approval noted June 23, 2017.
STML SL-401
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer
BLA Filing
Phase 2 update on patients enrolled in Stages 1 and 2 presented at EHA June 23, 2017.
GBT GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
Phase 2a
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
Phase 3 early data released at EHA June 23, 2017.
BLCM BPX-501
Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer
Phase 1/2
Phase 1/2 update June 23, 2017.
NVO Semaglutide (NN9536)
Obesity
Phase 2
Phase 2 data released June 23, 2017 with Phase 3 trial to commence 2018.
AGIO AG-348
Pyruvate kinase deficiency
Phase 3
Phase 2 updated data released at EHA June 24, 2017.
MTNB MAT2203
Vulvovaginal candidiasis (VVC)
Phase 2
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
Phase 3 data released June 26, 2017 - primary endpoint met.
SGEN ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
Approved
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
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