Historical Catalyst Calendar
Biotech Stock Historical Catalysts listed from 2009.
What's included?
2009 ~ Most small/mid cap FDA Approval and Complete Response Letters.
January 2015 ~ Most key small/mid cap Phase 3 data releases.
August 2016 ~ Most key small/mid cap Phase 2 and Phase 3 data releases.
January 2016 ~ Most key large cap releases (data and regulatory).
View the BioPharmCatalyst FDA Calendar for a list of upcoming key catalysts.
Note: Most bankrupt or acquired companies are not included.
Key catalysts are generally inputted at the end of each trading session.
| Ticker | Drug | Stage | Catalyst |
|---|---|---|---|
| SPPI |
ZEVALIN
Non-Hodgkin’s lymphoma
|
CRL |
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
|
Approved |
Approved September 4, 2009.
|
| SPPI |
FUSILEV
Colorectal cancer
|
CRL |
CRL received October 9, 2009.
|
| PRTK |
Intermezzo
Insomnia
|
CRL |
CRL issued November 2, 2009.
|
| HEB |
Ampligen
CFS
|
CRL |
CRL issued December 1, 2009.
|
| FCSC |
Laviv
Wrinkles
|
CRL |
CRL issued December 18, 2009.
|
| ACOR |
Ampyra
Improve walking in patients with multiple sclerosis
|
Approved |
Approved January 22, 2010.
|
| ALKS |
BYDUREON
Type 2 diabetes
|
Approved |
Approved January 27, 2010.
|
| ALKS |
BYDUREON
Type 2 diabetes
|
CRL |
CRL received March 15, 2010.
|
| MNKD |
AFREZZA
Type 1/2 diabetes
|
CRL |
CRL issued March 15, 2010.
|
| HRTX |
APF530 - Sustol
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
|
CRL |
CRL issued March 19, 2010.
|
| CTIC |
PIXUVRI - PIX306 Trial
B-cell non-Hodgkin lymphoma
|
CRL |
CRL received April 9, 2010.
|
| JAZZ |
JZP-6
Fibromyalgia
|
CRL |
CRL received October 11, 2010.
|
| VVUS |
Qnexa
Obesity
|
CRL |
October 28, 2010.
|
| MNKD |
AFREZZA
Type 1/2 diabetes
|
CRL |
CRL received January 19, 2011.
|
| ASRT |
GRALISE
Postherpetic neuralgia - shingles
|
Approved |
Approved January 28, 2011.
|
| PLX |
Taliglucerase alfa
Gaucher disease
|
CRL |
CRL issued February 25, 2011.
|
| SPPI |
FUSILEV
Colorectal cancer
|
Approved |
Approved April 29, 2011.
|
| FCSC |
Laviv
Wrinkles
|
Approved |
Approved June 22, 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.
|
| EYPT |
Iluvien
Diabetic macular edema
|
CRL |
CRL November 11, 2011.
|
| ALIM |
Iluvien
Diabetic macular edema
|
CRL |
CRL November 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.
|
| 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
High Triglycerides With Mixed Dyslipidemia
|
Approved |
Approved July 26, 2012.
|
| HALO |
HYQVIA
Subcutaneous treatment for patients with primary immunodeficiency (PI)
|
CRL |
CRL issued August 1, 2012.
|
| NAVB |
Lymphoseek
Lymphatic-tissue tracing agent
|
CRL |
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
|
CRL |
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)
|
CRL |
CRL March, 28 2013.
|
| TTNP |
Probuphine
Opioid dependence
|
CRL |
CRL issued April 30, 2013.
|
| ENDP |
AVEED (testosterone undecanoate) intramuscular injection
Men diagnosed with hypogonadism
|
CRL |
CRL issued September 5, 2013.
|
| ASRT |
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
|
CRL |
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
|
CRL |
Second CRL October 17, 2013.
|
| EYPT |
Iluvien
Diabetic macular edema
|
CRL |
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)
|
CRL |
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.
|
| MDCO |
Cangrelor
Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)
|
CRL |
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
|
CRL |
CRL issued July 25 2014.
|
| MDCO |
Oritavancin
ABSSSI
|
Approved |
Approved August 6, 2014 under priority review
|
| AKBA |
Auryxia
Hyperphosphatemia
|
Approved |
Approved Sept 5, 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.
|
| EYPT |
Iluvien
Diabetic macular edema
|
Approved |
Approved Sept 26 2014.
|
| ALIM |
Iluvien
Diabetic macular edema
|
Approved |
Approved September 26, 2014,
|
| PGNX |
Subcutaneous RELISTOR
Chronic pain
|
Approved |
Approved September 29, 2014.
|
| AEZS |
Macimorelin Acetate - Macrilen
Adult Growth Deficiency
|
CRL |
CRL issued November 6, 2014.
|
| INCY |
Jakafi (ruxolitinib) (RESPONSE)
Polycythemia Vera
|
Approved |
Approved December 4, 2014.
|
| ABBV |
VIEKIRA PAK
HCV - genotype 1
|
Approved |
Approved December 19, 2014.
|
| ENTA |
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
|
Phase 3 |
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
|
| ABBV |
Elagolix
Endometriosis
|
Phase 3 |
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
|
| RMTI |
Soluble Ferric Pyrophosphate
Anemia
|
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
|
CRL |
CRL March 2, 2015.
|
| VRTX |
KALYDECO (ivacaftor)
Children ages 2 to 5 with cystic fibrosis who have the G551D or one of the eight additional gating mutations
|
Approved |
Approved March 17, 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.
|
| ADMP |
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
|
CRL |
CRL issued March 27 2015.
|
| EBS |
Anthrax Immune Globulin Intravenous (Human) [AIGIV]
Anthrax
|
PDUFA |
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.
|
| MDCO |
IONSYS
Acute postoperative pain
|
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.
|
| TTPH |
Eravacycline (TP-434) - IGNITE3
cUTI - complicated urinary tract infections
|
Phase 3 |
Phase 3 trial did not meet endpoints September 8, 2015.
|
| MACK |
ONIVYDE
Cancer - second line pancreatic
|
Approved |
Approved October 22, 2015.
|
| IMGN |
Kadcyla GATSBY trial
Cancer - metastatic HER2+ gastric cancer
|
Phase 3 |
Phase 3 endpoint not met - October 22, 2015.
|
| SPPI |
EVOMELA (melphalan) for Injection
Conditioning treatment prior to autologous stem cell transplant for patients with multiple myeloma
|
CRL |
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.
|
| 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.
|
| OTIC |
OTIPRIO (ciprofloxacin otic suspension)
Ear Tube Placement Surgery
|
Approved |
Approved December 11, 2015.
|
| ADMS |
ADS-5102
Levodopa-Induced Dyskinesia
|
Phase 3 |
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
|
Phase 3 |
First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints.
|
| ABBV |
Elagolix
Endometriosis
|
Phase 3 |
First Phase 3 trial met both co-primary endpoints - Jan 2015. Data from second Phase 3 released February 2016 also met endpoints.
|
| RDHL |
RHB-105
H. pylori
|
Phase 3 |
Phase 3 final data released March 8, 2016.
|
| GWPH |
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
|
Phase 3 |
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
|
Phase 3 |
Phase 3 data released March 24, 2016 did not meet primary endpoint.
|
| OPK |
RAYALDEE
Secondary hyperparathyroidism (SHPT) in chronic kidney disease (CKD) and vitamin D insufficiency - Stage 3 and 4
|
CRL |
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.
|
| 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.
|
| AZN |
Lokelma (ZS-9)
Hyperkalaemia
|
CRL |
CRL issued 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.
|
CRL |
CRL issued March 27 2015. CRL issued again June 6, 2016.
|
| RVNC |
DAXI (RT002)
Lateral Canthal (Crow’s Feet) Lines
|
Phase 3 |
Phase 3 endpoints not met June 13, 2016.
|
| MRNS |
Ganaxolone
Focal onset seizures
|
Phase 3 |
Phase 3 data did not meet endpoints - June 13, 2016
|
| PRTK |
Omadacycline
Acute bacterial skin and skin structure infections (ABSSSI)
|
Phase 3 |
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)
|
Phase 3 |
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.
|
| LPCN |
TLANDO - LPCN 1021
Men with low testosterone (Low T)
|
CRL |
CRL issued June 29, 2016.
|
| GSK |
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
|
Phase 3 |
Phase 3 data met endpoints - June 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
|
| 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)
|
Phase 3 |
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 2 |
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)
|
Phase 3 |
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 2 |
Phase 2 data released August 10, 2016. Primary endpoint met.
|
| ACRX |
DSUVIA (ARX-04)
Moderate-to-severe acute pain following a surgical procedure
|
Phase 3 |
Phase 3 data released August 15, 2016.
|
| AUPH |
Voclosporin - AURORA
Lupus
|
Phase 2b |
Phase 2b data released August 2016. Primary endpoint met but with high number of deaths.
|
| PTLA |
Andexxa
Factor Xa inhibitor reversal agent
|
CRL |
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 THWART-1 and THWART-2
Common warts (verruca vulgaris)
|
Phase 2 |
Phase 2 data released August 2016.
|
| 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)
|
Phase 3 |
Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
|
| GSK |
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
|
Approved |
Approved September 2, 2015.
|
| OPK |
Rolapitant
Prevention of chemotherapy induced nausea and vomiting, or CINV
|
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
Quadruple Refractory Multiple Myeloma
|
Phase 2 |
Phase 2 positive top-line data released September 6, 2016
|
| AERI |
Roclatan
Glaucoma
|
Phase 3 |
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.
|
| 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.
|
| GILD |
Yescarta (axicabtagene ciloleucel)
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
|
Phase 2 |
Phase 2 pivotal top-line data released September 26, 2016. Primary analysis due 1Q 2017. BLA filing due late 2016.
|
| ITCI |
Lumateperone
Schizophrenia
|
Phase 3 |
Phase 3 trial failed - September 28, 2016.
|
| GNCA |
GEN-003
Genital herpes
|
Phase 2b |
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.
|
| ALKS |
ALKS 5461
Major depressive disorder
|
Phase 3 |
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)
|
Phase 3 |
Phase 3 data from second trial did not meet the primary endpoint.
|
| AMAG |
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
|
Phase 3 |
Phase 3 data released November 1, 2016.
|
| PTN |
Vyleesi (Bremelanotide)
Female sexual dysfunction (FSD)
|
Phase 3 |
Phase 3 data released November 1, 2016.
|
| IONS |
SPINRAZA - Nusinersen
Spinal muscular atrophy (SMA)
|
Phase 3 |
Phase 3 CHERISH data met primary endpoint - November 7, 2016.
|
| DVAX |
HEPLISAV-B
Hepatitis B
|
CRL |
CRL November 14, 2016
|
| ACRS |
ESKATA (hydrogen peroxide)
Seborrheic keratosis (SK)
|
Phase 3 |
Phase 3 trial met endpoints - November 15, 2016.
|
| ALNY |
Inclisiran - ORION-9
Hypercholesterolemia
|
Phase 2 |
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
|
| MDCO |
Inclisiran - ORION-9
Hypercholesterolemia
|
Phase 2 |
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
|
| BSTC |
XIAFLEX (collagenase clostridium histolyticum) - RELEASE
Edematous fibrosclerotic panniculopathy (“cellulite”)
|
Phase 2b |
Phase 2b data released November 17, 2016. Met endpoints
|
| ENDP |
XIAFLEX (collagenase clostridium histolyticum) - RELEASE
Edematous fibrosclerotic panniculopathy (“cellulite”)
|
Phase 2b |
Phase 2b data released November 17, 2016. Met endpoints
|
| 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.
|
| 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
|
Phase 3 |
Phase 3 data from second trial released November 28, 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.
|
| NOVN |
SB206
Human papillomavirus (HPV)
|
Phase 2 |
Phase 2 data released November 29, 2016. Primary endpoint met.
|
| 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).
|
Phase 3 |
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)
|
Phase 3 |
Phase 3 data from first trial met primary endpoint - December 9, 2016.
|
| ISEE |
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.
|
| 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.
|
| VCEL |
MACI
Focal chondral cartilage defects in the knee.
|
Approved |
FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.
|
| PRTO |
Vonapanitase (PRT-201) PATENCY-1
Chronic kidney disease (CKD) patients undergoing surgical placement of an arteriovenous fistula (AVF)
|
Phase 3 |
Phase 3 data released December 13, 2016 - primary endpoint not met.
|
| 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 2 |
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.
|
| LXRX |
Sotagliflozin
Type 1 Diabetes
|
Phase 3 |
Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
|
| SNY |
Sotagliflozin
Type 1 Diabetes
|
Phase 3 |
Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
|
| NVS |
Lutathera
Inoperable progressive midgut NETs
|
CRL |
PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
|
| IRWD |
Linaclotide
Irritable Bowel Syndrome with Constipation (IBS-C)
|
Phase 2b |
Phase 2b data released December 22, 2016.
|
| SGYP |
Trulance (plecanatide)
Constipation-predominant irritable bowel syndrome (IBS-C)
|
Phase 3 |
Phase 3 data from second trial met primary endpoints - December 9 and 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.
|
| 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
|
Phase 3 |
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
|
Phase 3 |
Phase 3 data released January 4, 2017 - trial failed.
|
| GNCA |
GEN-003
Genital herpes
|
Phase 2b |
Phase 2b data released January 5, 2017.
|
| HALO |
HALO-301
Pancreatic cancer
|
Phase 2 |
Primary endpoint met.
|
| OTIC |
OTIPRIO
Acute otitis externa
|
Phase 3 |
Phase 3 trial met primary endpoint - January 5, 2017.
|
| CHRS |
CHS-1420
Psoriasis
|
Phase 3 |
Phase 3 top-line data met endpoints August 2016. Full data due released January 10, 2016.
|
| GSK |
Rolapitant - intravenous (IV)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
|
CRL |
CRL issued January 11 2017.
|
| FGEN |
Pamrevlumab (FG-3019)
Pancreatic cancer
|
Phase 2 |
Phase 2 abstract released January 17, 2017.
|
| AGN |
ESMYA (ulipristal acetate)
Uterine Fibroids
|
Phase 3 |
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.
|
| SGYP |
Trulance (plecanatide)
Chronic idiopathic constipation (CIC)
|
Approved |
Approved January 19, 2017.
|
| ABBV |
Imbruvica
Marginal zone lymphoma
|
Approved |
sNDA filing under priority review approved January 19, 2017.
|
| MRNS |
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
|
Phase 2 |
Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
|
| LGND |
Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
|
Phase 2 |
Phase 2 preliminary CDKL5 cohort data released January 23, 2017.
|
| VRTX |
VX-150
Osteoarthritis
|
Phase 2 |
Phase 2 primary endpoint met - January 25, 2017.
|
| IRWD |
Linaclotide 72 mcg dose for use in the treatment of adults
Chronic idiopathic constipation (CIC)
|
Approved |
sNDA approval announced January 26, 2017.
|
| AGN |
Linaclotide 72 mcg dose for use in the treatment of adults
Chronic idiopathic constipation (CIC)
|
Approved |
sNDA approval announced 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.
|
| CATB |
Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
|
Phase 1/2 |
Phase 1/2 top-line data released January 31 - primary endpoint not met.
|
| TENX |
Levosimendan
Reduce the incidence of low cardiac output syndrome during cardiac surgery
|
Phase 3 |
Phase 3 top line data released January 31, 2017 - primary endpoints not met.
|
| AMGN |
Parsabiv
Secondary hyperparathyroidism (SHPT)
|
Approved |
Approved February 7, 2017.
|
| GWPH |
Sativex
Spasticity due multiple sclerosis
|
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.
|
| ACOR |
INBRIJA (CVT-301)
OFF episodes of Parkinson’s disease (PD)
|
Phase 3 |
Phase 3 data released February 9, 2017 - primary endpoint met.
|
| TCON |
TRC105 and Avastin
Glioblastoma - cancer
|
Phase 2 |
Phase 2 data released February 9, 2017 - primary endpoint not met.
|
| SAGE |
SAGE-217 - MOUNTAIN
Major Depressive Disorder (MDD)
|
Phase 2 |
Phase 2 top-line data from open-label trial released February 13, 2017
|
| ZSAN |
M207
Migraine
|
Phase 3 |
Phase 3 trial data due released February 13, 2017 - primary endpoints met.
|
| 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 - PHREEDOM
Hyperphosphatemia in end-stage renal disease (ESRD) patients
|
Phase 3 |
Phase 3 released February 15, 2017 - primary endpoint met.
|
| ALKS |
ALKS 6428
Opioid dependence
|
Phase 3 |
Phase 3 trial did not meet endpoint - February 2017 (exact date unsure).
|
| BHC |
Brodalumab
Psoriasis
|
Approved |
Approved February 15, 2017.
|
| AZN |
Lynparza
Breast cancer
|
Phase 3 |
Phase 3 data released February 17, 2016 - primary endpoint met.
|
| MRK |
Lynparza
Breast cancer
|
Phase 3 |
Phase 3 data released February 17, 2016 - primary endpoint met.
|
| TRVN |
Oliceridine (TRV130)
Moderate to severe acute pain
|
Phase 3 |
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.
|
| AMPH |
Naloxone Intranasal
Opioid overdose
|
CRL |
CRL announced February 21, 2017.
|
| CELG |
REVLIMID
Multiple myeloma (MM) - autologous stem cell transplant (ASCT)
|
Approved |
Approved February 22, 2017.
|
| CMRX |
Brincidofovir - Advise trial
Adenovirus Infection
|
Phase 3 |
Phase 3 interim analysis released May 2016. Final data released February 22, 2017.
|
| MLNT |
Taksta - Fusidic acid
Acute bacterial skin and skin structure infections (ABSSSI)
|
Phase 3 |
Phase 3 data released February 24, 2017 - endpoints met.
|
| BCRX |
BCX7353 - APeX-2
Reduce or eliminate attacks in HAE patients
|
Phase 2 |
Phase 2 interim data released February 27, 2017.
|
| LJPC |
GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
|
Phase 3 |
Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. NDA filing due 2H 2017.
|
| GILD |
Yescarta (axicabtagene ciloleucel)
Refractory Non-Hodgkin's Lymphoma (NHL) - cancer
|
Phase 2 |
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.
|
| AZN |
Saxagliptin and dapagliflozin
Type-2 diabetes
|
Approved |
Approval announced 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 2b |
Phase 2b data released August 2016. Primary endpoint met but with high number of deaths. Further data released March 1, 2017 - no additional deaths and endpoints met.
|
| MRK |
Odactra (MK-8237)
House dust mite allergies
|
Approved |
Approved March 1, 2017.
|
| PTCT |
Translarna
Nonsense mutation cystic fibrosis
|
Phase 3 |
Phase 3 data released March 2, 2017 - endpoints not met. Development to be discontinued.
|
| HALO |
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.
|
| 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.
|
| 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.
|
| KURA |
Tipifarnib
Head and neck squamous cell carcinomas (HNSCC)
|
Phase 2 |
Phase 2 ongoing data released March 6, 2017 - further data due 2H 2017.
|
| IONS |
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
|
Phase 3 |
Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
|
| AKCA |
Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
|
Phase 3 |
Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
|
| TGTX |
TG-1101 and IMBRUVICA (GENUINE trial)
Chronic Lymphocytic Leukemia (CLL) cancer
|
Phase 3 |
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.
|
| MRK |
KEYTRUDA
Relapsed or Refractory Classical Hodgkin Lymphoma
|
Approved |
Approval announced March 14, 2017.
|
| AZN |
Lynparza - SOLO 2
Second-line ovarian cancer
|
Phase 3 |
Data presented March 14, 2017 showed significant PFS benefit.
|
| 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.
|
| CPRX |
Firdapse
MuSK-antibody positive myasthenia gravis (MuSK-MG)
|
Phase 2 |
Phase 2 top-line data met endpoints - March 15, 2017. Pivotal trial planned.
|
| AZN |
Lokelma (ZS-9)
Hyperkalaemia
|
CRL |
Second CRL issued March 17, 2017.
|
| AMGN |
Repatha
Cardiovascular disease
|
Phase 3 |
Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations.
|
| LLY |
Abemaciclib - MONARCH 1 and 2
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
|
Phase 3 |
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.
|
| AGN |
JUVÉDERM VOLLURE
Correction of moderate to severe facial wrinkles and folds
|
Approved |
Approval announced March 20, 2017.
|
| GNMX |
NFC-1 - SAGA
mGluR mutation positive ADHD
|
Phase 2/3 |
Phase 2/3 data released March 20, 2017 - primary endpoint not met.
|
| BLRX |
BL-8040 GENESIS
Stem-cell mobilization for autologous transplantation
|
Phase 2 |
Phase 2 trial initiated March 2016. Partial data released March 20, 2017.
|
| NKTR |
NKTR-181
Lower back pain
|
Phase 3 |
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.
|
| GSK |
Niraparib - NOVA (Niraparib Ovarian)
Cancer - ovarian
|
Approved |
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
|
| AUPH |
Voclosporin - AURION trial
Lupus
|
Phase 2 |
48-week data from open-label AURION study presented March 27, 2017 - primary endpoint met.
|
| PRTK |
Sarecycline
Severe acne vulgaris
|
Phase 3 |
Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
|
| AGN |
Sarecycline
Severe acne vulgaris
|
Phase 3 |
Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
|
| FOMX |
FMX101
Acne
|
Phase 3 |
Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
|
| VRTX |
Tezacaftor / ivacaftor
Cystic fibrosis - Two Copies of the F508del Mutation
|
Phase 3 |
Phase 3 data released March 28, 2017 - primary endpoint met. NDA filing due 3Q 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.
|
| 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.
|
| PGNX |
Azedra
Pheochromocytoma
|
Phase 2b |
Pivotal Phase 2 trial resumed January 2015 following suspension of trial in 2010 due to lack of funding. Primary endpoint met - March 30, 2017. NDA filing due mid-2017.
|
| CRBP |
Anabasum (Resunab)
Cystic Fibrosis
|
Phase 2 |
Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
|
| NVCR |
Tumor Treating Fields (TTFields) - INNOVATE-3
Ovarian cancer
|
Phase 2 |
Phase 2 data presented December 12, 2016. Further promising PFS data released March 31, 2017.
|
| AZN |
Tagrisso
Epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC)
|
Approved |
Approval announced March 31, 2017.
|
| PFE |
IBRANCE (palbociclib)
HR+, HER2- Metastatic Breast Cancer
|
Approved |
sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
|
| BMY |
CM-143 – Opdivo
Second-line Glioblastoma (GBM) cancer
|
Phase 3 |
Phase 3 data released April 3, 2017 - primary endpoint not met.
|
| 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)
|
Phase 3 |
Phase 3 data released April 3, 2017 - all endpoints met.
|
| XBIT |
514G3
Staphylococcus Aureus Bacteremia
|
Phase 1/2 |
Phase 1/2 top-line data released April 3, 2017. 4 patient deaths noted.
|
| 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 2 |
Phase 2 interim analysis released at AACR meeting April 4, 2017.
|
| NKTR |
Cipro DPI
Bronchiectasis
|
Phase 3 |
Phase 3 second trial did not meet endpoint - April 5, 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.
|
| 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 2/3 |
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
Heart failure
|
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.
|
| 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.
|
| NOVN |
SB208
Fungal infections
|
Phase 2 |
Phase 2 data released April 12, 2017. Primary endpoint met.
|
| INCY |
Baricitinib
Rheumatoid arthritis
|
CRL |
Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017.
|
| LLY |
Baricitinib
Rheumatoid arthritis
|
CRL |
Announced January 19 2016 that NDA Filing had been submitted. Three month delay announced January 13, 2017. CRL received April 14, 2017.
|
| MTFB |
Iclaprim -REVIVE-1
Acute bacterial skin and skin structure infections (ABSSSI)
|
Phase 3 |
Phase 3 data released April 18, 2017 - primary endpoint of non-inferiority met.
|
| RARE |
Crysvita (Burosumab)
X-Linked Hypophosphatemia (XLH)
|
Phase 3 |
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.
|
| 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.
|
| EIGR |
Lonafarnib - D-LIVR
Chronic hepatitis delta virus (HDV)
|
Phase 2 |
Phase 2 end of trial data released April 21, 2017. Meeting with FDA scheduled for 4Q 2017.
|
| ACHN |
JNJ-4178
Hepatitis C (HCV)
|
Phase 2a |
Phase 2a ongoing. Updated data presented at EASL April 22, 2017.
|
| LLY |
Abemaciclib - MONARCH 3
HR+, HER2-locoregionally recurrent or metastatic breast cancer (MBC)
|
Phase 3 |
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.
|
| XOMA |
XOMA 213
Hyperprolactinemia
|
Phase 2 |
Phase 2 proof-of-concept results released April 24, 2017.
|
| AKTX |
Coversin - CAPSTONE
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.
|
| 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.
|
| JAZZ |
JZP-110
Excessive sleepiness associated with narcolepsy
|
Phase 3 |
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.
|
| NVS |
Rydapt (Midostaurin - PKC412)
Acute myeloid leukemia (AML)
|
Approved |
Priority review granted November 14, 2016. Approval announced April 28, 2017.
|
| TGTX |
TG-1101 - ULTIMATE I
Multiple Sclerosis
|
Phase 2 |
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.
|
| 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.
|
| NTRP |
Bryostatin
Alzheimer's disease
|
Phase 3 |
Phase 2 data released May 1, 2017 - primary endpoint not met.
|
| AMAG |
Feraheme
Adults with iron deficiency anemia (IDA)
|
Phase 3 |
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.
|
| ZFGN |
ZGN-1061
Diabetes
|
Phase 1 |
Phase 1 positive safety data released May 4, 2017. Phase 2 initiation due 2H 2017.
|
| 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.
|
| 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.
|
| TXMD |
Yuvvexy - TX-004HR
Moderate-to-severe vaginal pain
|
CRL |
CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data.
|
| BTX |
OpRegen
Dry age-related macular degeneration (AMD)
|
Phase 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.
|
| ABBV |
ABT-494
Crohn’s Disease
|
Phase 2 |
Phase 2 positive data at DDW Meeting May 9, 2017. Phase 3 trial to be initiated later in 2017.
|
| MRK |
Keytruda
First-Line Treatment of Metastatic Non-Squamous Non-Small Cell Lung Cancer
|
Approved |
Approved May 10, 2017.
|
| GSK |
Mepolizumab
Chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype
|
Phase 3 |
Phase 3 METREX trial met primary endpoint. Phase 3 METREO failed to meet endpoint.
|
| AZN |
Tralokinumab (STRATOS1)
Severe, uncontrolled asthma
|
Phase 3 |
Phase 3 trial did not meet primary endpoint - May 10, 2017.
|
| LLY |
Galcanezumab - EVOLVE-1, EVOLVE-2 and REGAIN
Migraine prevention
|
Phase 3 |
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.
|
| AZN |
Durvalumab (PACIFIC)
Lung cancer
|
Phase 3 |
Phase 3 interim analysis released May 12, 2017 - PFS primary endpoint already met. OS endpoint to be assessed.
|
| ARDX |
Tenapanor (T3MPO-1)
Constipation-predominant irritable bowel syndrome (IBS-C)
|
Phase 3 |
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
|
| IONS |
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
|
Phase 3 |
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns.
|
| PTCT |
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
|
Phase 3 |
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns.
|
| AKCA |
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
|
Phase 3 |
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.
|
| RVNC |
DAXI (RT002) - ASPEN
Cervical dystonia
|
Phase 2 |
Phase 2 additional data released May 18, 2017 with oral presentation June 7, 2017 at International Congress of Parkinson's Disease and Movement Disorders.
|
| MRK |
KEYTRUDA
First and Second line locally advanced or metastatic urothelial cancer - bladder cancer
|
Approved |
Approved May 18, 2017.
|
| CELG |
Ozanimod - RADIANCE
Relapsing Multiple Sclerosis
|
Phase 3 |
Phase 3 data due released May 22, 2017 - primary endpoint met, disability endpoint not met.
|
| AMGN |
EVENITY (Romosozumab)
Osteoporosis
|
Phase 3 |
PDUFA date July 19, 2017. However, likely to be delayed due to safety data from ARCH trial released May 22, 2017.
|
| SNY |
Sarilumab
Rheumatoid arthritis
|
Approved |
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
|
| REGN |
Sarilumab
Rheumatoid arthritis
|
Approved |
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
|
| LJPC |
GiaprezaTM (angiotensin II)
Increase blood pressure in adults with septic or other distributive shock
|
Phase 3 |
Phase 3 data released February 27, 2016 - primary endpoint hit. Secondary endpoints not mentioned. Data released May 22, 2017 confirmed primary endpoint was met but with lack of mortality improvement.
|
| MRK |
KEYTRUDA
Microsatellite Instability-High Cancer
|
Approved |
PDUFA date March 8, 2017 extended to June 9, 2017 due to submission of extra data. Approved May 23, 2017.
|
| SBPH |
Inarigivir and Vemlidy - ACHIEVE
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 2 |
Phase 2 data released May 23 - primary endpoint not met.
|
| AERI |
Roclatan
Glaucoma
|
Phase 3 |
Phase 3 Mercury 1 data released September 14, 2016. Primary endpoint met. Mercury 2 trial data released may 24, 2017 - primary endpoint also hit with NDA filing due 1H 2018.
|
| PBYI |
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
|
- |
Announced acceptance of NDA Filing September 20, 2016. PDUFA estimate July 20, 2017. Advisory Committee Meeting May 24, 2017 voted 12-4 in favor of recommending approval.
|
| BCRX |
BCX7353 - APeX-2
Reduce or eliminate attacks in HAE patients
|
Phase 2 |
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.
|
| MRK |
ISENTRESS
HIV-1
|
Approved |
Approval announced May 30, 2017.
|
| GILD |
Bictegravir/F/TAF
HIV
|
Phase 3 |
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%.
|
| IMDZ |
CMB305
Soft tissue sarcomas
|
Phase 2 |
Phase 2 data at ASCO June 2, 2017.
|
| NLNK |
Indoximod + taxane
Cancer - breast
|
Phase 2 |
Phase 2 trial did not meet endpoints - noted June 2, 2017.
|
| DVAX |
SD-101 + Pembrolizumab
Melanoma and head and neck squamous cell carcinoma (HNSCC)
|
Phase 1/2 |
Phase 1b/2 poster at ASCO June 3, 2017. Noted June 2 ORR of 7/7 in anti-PD-1/L1-naïve patients
|
| LLY |
Larotrectinib (LOXO-101)
Solid tumors that harbor a TRK fusion.
|
Phase 2 |
Announced 76% ORR at ASCO - June 3, 2017. Primary analysis by the end of 2017 with NDA filing late 2017 or early 2018.
|
| JNJ |
ZYTIGA (abiraterone acetate) - LATITUDE
metastatic hormone-naïve prostate cancer (mHNPC)
|
Phase 3 |
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.
|
| 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.
|
| GSK |
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.
|
| ARQL |
Derazantinib (ARQ 087)
intrahepatic cholangiocarcinoma (iCCA)
|
Phase 2 |
Phase 2 data at ASCO June 3, 2017 - ORR 21%. Phase 3 trial planned for 3Q 2017.
|
| PBYI |
Neratinib
HER2-positive metastatic breast cancer patients with brain metastases
|
Phase 2 |
Phase 2 data released at ASCO June 3, 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.
|
| 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.
|
| HALO |
HALO-301
Pancreatic cancer
|
Phase 2 |
Phase 2 data released January 5, 2017. Oral presentation of Phase 2 data at ASCO June 4, 2017 showed ORR of 45%.
|
| AZN |
Lynparza
Breast cancer
|
Phase 3 |
Phase 3 data released February 17, 2016 - primary endpoint met. Late breaker at ASCO June 4, 2017 showed HR of 0.58 (42% reduction of risk of disease progression or death).
|
| MRK |
Lynparza
Breast cancer
|
Phase 3 |
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).
|
| RNN |
RX-3117
Bladder cancer
|
Phase 2a |
Phase 2a 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.
|
| PIRS |
PRS-080
Anemia of chronic disease
|
Phase 1b |
Phase 1b data released at ERA-EDTA June 4, 2017.
|
| CALA |
CX-1158-101
Solid tumors - cancer
|
Phase 1 |
Phase 1 oral presentation 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.
|
| GILD |
Axicabtagene ciloleucel - (ZUMA-3)
Adult patients with r/r ALL - cancer
|
Phase 1 |
Phase 2 data due 2018. Phase 1 data released at ASCO June 5, 2017. Complete remission 73%.
|
| GLYC |
Uproleselan (GMI-1271)
Acute myeloid leukemia (AML) newly diagnosed and refractory - cancer
|
Phase 2 |
Phase 2 enrollment completed - announced May 31, 2017. Data updates at ASCO June 5, 2017.
|
| HALO |
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.
|
| 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.
|
| CLSN |
GEN-1 OVATION 2
Ovarian cancer
|
Phase 1b |
Phase 1b interim data released at ASCO 2017 - ORR 86%.
|
| BLUE |
bb2121 - KarMMa
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 - KarMMa
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 |
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%.
|
| CRVS |
CPI-444
Solid tumors - cancer
|
Phase 1b |
Phase 1/1b preliminary data released November 2016. Further update at ASCO June 5, 2017.
|
| IOVA |
LN-144 - lifileucel
Refractory metastatic melanoma
|
Phase 2 |
Phase 2 second cohort commenced enrollment - May 19, 2017. Initial data presented 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.
|
| NVS |
Kymriah (CTL019 )- JULIET
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
|
Phase 2 |
Phase 2 pivotal primary analysis due International Conference on Malignant Lymphoma (ICML) on June 14, 2017. Abstract released June 7, 2017. ORR 45%.
|
| LXRX |
Sotagliflozin
Type 1 Diabetes
|
Phase 3 |
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
|
Phase 3 |
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.
|
| JNJ |
INVOKANA CANVAS
Type 2 diabetes
|
Phase 3 |
Cardiovascular Outcomes trial data released June 12, 2017 - 14% reduction in the risk of the composite primary endpoint of CV mortality.
|
| XLRN |
Dalantercept - DART Study
Renal Cell Carcinoma (RCC) - cancer
|
Phase 2 |
Phase 2 data released June 12, 2017 - primary endpoint not met.
|
| CHRS |
CHS-1701
Pegfilgrastim biosimilar
|
CRL |
CRL announced June 12, 2017.
|
| EPZM |
Tazemetostat
Follicular lymphoma
|
Phase 2 |
Phase 2 data released June 14, 2017 - DLBCL ORR 29%.
|
| ALDX |
Reproxalap (ADX-102)
Allergic conjunctivitis
|
Phase 2b |
Phase 2b data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned.
|
| 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.
|
| RDHL |
BEKINDA -GUARD
Gastroenteritis
|
Phase 3 |
Phase 3 top-line data released June 14, 2017 - primary endpoint met.
|
| 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.
|
| SELB |
SEL-212 (COMPARE) - Head to head trial vs Krystexxa
Tophaceous gout
|
Phase 2 |
Phase 2 dosing commenced late October 2016. Initial data released at EULAR June 15, 2017.
|
| PTLA |
Cerdulatinib (PRT2070)
Refractory non-Hodgkin lymphoma and chronic lymphocytic leukemia - cancer
|
Phase 2 |
Phase 2 enrollment commenced May 2016. Interim data released June 15, 2017 - noted CLL/SLL 67% partial responese rate + two patient deaths.
|
| JNJ |
DARZALEX (Daratumumab) + pomalidomide and dexamethasone
Relapsed or refractory multiple myeloma
|
Approved |
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
|
| LPCN |
TLANDO - LPCN 1021
Men with low testosterone (Low T)
|
- |
CRL issued June 2016. Flexibility trial data announced June 19, 2017 - primary endpoint met with NDA fiing due 3Q 2017.
|
| CLVS |
Rucaparib ARIEL3
Ovarian cancer patients with a BRCA-like mutation
|
Phase 3 |
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.
|
| NEOS |
Cotempla XR-ODT
Attention deficit hyperactivity disorder (ADHD)
|
Approved |
Approval announced June 19, 2017.
|
| NVS |
RTH258 (brolucizumab)
Neovascular AMD
|
Phase 3 |
Phase 3 data released June 20, 2017 - primary and key secondary endpoints met.
|
| CARA |
IV CR845
Acute pain
|
Phase 3 |
Interim conditional power analysis conducted June 21, 2017 - trial completion due 4Q 2017.
|
| IMUC |
ICT-107 dendritic cell vaccine
Glioblastoma antigens and cancer stem cells
|
Phase 3 |
Phase 2b failed to meet primary endpoint. Phase 3 initiated dosing June 2016 - noted June 21, 2017 that further enrollment to be suspended.
|
| PFE | Epoetin alfa biosimilar | CRL |
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.
|
| XOMA |
ACZ885 (canakinumab)
CV risk reduction
|
Phase 3 |
Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
|
| NVS |
ACZ885 (canakinumab)
CV risk reduction
|
Phase 3 |
Phase 3 trial met primary endpoint - data to be presented later in 2017 at a medical congress.
|
| GBT |
GBT440 HOPE-KIDS 1
Sickle cell disease - children age 6-17.
|
Phase 1/2 |
Phase 2a initiated June 2016. Preliminary data released at European Hematology Association (EHA) - June 23, 2017.
|
| BLUE |
LentiGlobin - HGB-210
Sickle Cell Disease (SCD)
|
Phase 1/2 |
Phase 1/2 data presented at EHA June 23, 2017.
|
| PTLA |
Bevyxxa (betrixaban)
Venous thromboembolism (VTE) Prevention
|
Approved |
FDA Approval noted June 23, 2017.
|
| BLCM |
BPX-501 Rivo-cel
Adjunct T-cell therapy administered after allogeneic HSCT - (hematopoietic stem cell transplantation) - cancer
|
Phase 1/2 |
Phase 1/2 update June 23, 2017.
|
| STML |
SL-401 (Elzonris)
Blastic plasmacytoid dendritic cell neoplasm (BPDCN) cancer
|
Phase 2 |
Phase 2 update on patients enrolled in Stages 1 and 2 presented at 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.
|
| AGIO |
AG-348 (ACTIVATE)
Pyruvate kinase deficiency
|
Phase 1/2 |
Phase 2 updated data released at EHA June 24, 2017.
|
| AMAG |
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
|
Phase 2 |
sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
|
| ATRS |
Makena - auto injector
Reduce the risk of preterm birth in women with a singleton pregnancy
|
Phase 2 |
sNDA filing announced April 17, 2017. PDUFA date February 14, 2018. 10-month review despite initial expectations of a 6-month review.
|
| MTNB |
MAT2203
Vulvovaginal candidiasis (VVC)
|
Phase 2 |
Phase 2 top-line data released June 26, 2017. Not successful in demonstrating meaningful clinical response.
|
| SGEN |
ADCETRIS in combination with chemotherapy ECHELON-1
Frontline Hodgkin lymphoma
|
Phase 3 |
Phase 3 data released June 26, 2017 - primary endpoint met.
|
| MRK |
Anacetrapib (MK-0859)
Raising HDL-C and reducing LDL-C
|
Phase 3 |
Phase 3 data due released June 27, 2017. Primary endpoint met.
|
| ALDR |
ALD403 - PROMISE 1
Frequent episodic migraine
|
Phase 3 |
Phase 3 PROMISE 1 top-line data released June 27, 2017, Primary and key secondary endpoints met but competitive concerns raised.
|
| XENE |
TV-45070
Postherpetic neuralgia
|
Phase 2b |
Phase 2b data released June 27, 2017. Endpoints not met.
|
| GEMP |
Gemcabene - COBALT-1
Homozygous Familial Hypercholesterolemia (HoFH)
|
Phase 2b |
Phase 2b data released June 28, 2017 - primary endpoint met.
|
| AMGN |
Vectibix (Panitumumab)
Wild-Type RAS Metastatic Colorectal Cancer
|
Approved |
sBLA approval announced June 29, 2017.
|
| ALKS |
ALKS 3831 - ENLIGHTEN-1
Schizophrenia
|
Phase 3 |
Phase 3 preliminary data released June 30, 2017. Primary endpoint met - adverse events included weight gain.
|
| CARA |
CR845
Osteoarthritis (OA)
|
Phase 2b |
Phase 2b data released June 29, 2017 - trial failed.
|
| MRK |
KEYTRUDA - KEYNOTE-183
Multiple myeloma
|
Phase 3 |
Phase 3 clinical hold announced July 6, 2017 - also applies to KEYNOTE-185.
|
| BMY |
ORENCIA
Psoriatic Arthritis (PsA)
|
Approved |
Approval announced July 6, 2017.
|
| RCKT |
Trabodenoson and latanoprost
Glaucoma
|
Phase 2 |
Phase 2 trial failed - noted July 7, 2017.
|
| ALNY |
Fitusiran
Hemophilia A and B
|
Phase 2 |
Phase 2 Open-label Extension Study data released July 10, 2017 at ISTH.
|
| ONCE |
SPK-9001
Hemophilia B
|
Phase 1/2 |
Phase 1/2 updated data released July 10, 2017. 99% fall in infusion rate.
|
| ARNA |
Ralinepag
Pulmonary Arterial Hypertension
|
Phase 2 |
Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
|
| UTHR |
Ralinepag
Pulmonary Arterial Hypertension
|
Phase 2 |
Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
|
| IMRN |
IMM-124E
Nonalcoholic steatohepatitis (NASH)
|
Phase 2 |
Phase 2 top-line data due 4Q 2017. Interim analysis July 10, 2017 showed no statistical difference with placebo.
|
| PFE |
Mylotarg (gemtuzumab ozogamicin)
Acute myeloid leukemia (AML)
|
- |
Advisory Committee Meeting July 11, 2017 voted in favor 6-1 of a favorable risk:benefit profile.
|
| BMRN |
Valoctocogene roxaparvovec (BMN 270)
Hemophilia A
|
Phase 1/2 |
Phase 1/2 updated data released July 11, 2017. 97% reduction in Annualized Bleed Rate (ABR).
|
| AMGN |
BLINCYTO
Ph+ R/R ALL
|
Approved |
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
|
| OCUL |
DEXTENZA
Ocular inflammation and pain following cataract surgery
|
CRL |
CRL July 25 2016 - due to manufacturing deficiencies. NDA resubmitted, PDUFA date July 19, 2017. Further CRL issued July 11, 2017 with FDA noting deficiencies in manufacturing processes and analytical testing.
|
| KDMN |
KD025 - ROCKstar (KD025-213)
Chronic graft-versus-host disease (cGVHD)
|
Phase 2 |
Phase 2 interim data presented July 11, 2017. ORR 71%.
|
| SVRA |
Aironite - INDIE
Heart failure with preserved ejection fraction (HFpEF)
|
Phase 2 |
Phase 2 interim data released July 11, 2017.
|
| AMGN |
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
|
Phase 3 |
Phase 3 trial met primary endpoint. HR 79%.
|
| LGND |
KYPROLIS (ASPIRE)
Relapsed Multiple Myeloma
|
Phase 3 |
Phase 3 trial met primary endpoint. HR 79%.
|
| NVS |
Kymriah (CTL019)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
|
- |
Advisory Committee Meeting July 12, 2017 voted 10-0 recommending approval.
|
| JNJ |
Guselkumab
Plaque psoriasis
|
Approved |
Approval announced July 13, 2017.
|
| AMGN |
EVENITY (Romosozumab)
Osteoporosis
|
CRL |
CRL issued July 16, 2017.
|
| PRTK |
Omadacycline - oral
Acute bacterial skin and skin structure infections (ABSSSI)
|
Phase 3 |
Phase 3 data released July 17, 2017 - all endpoints met.
|
| CBAY |
Seladelpar
Primary biliary cholangitis (PBC)
|
Phase 2 |
Phase 2 top-line data released late May 2016. Positive interim data from second trial data released July 17, 2017.
|
| PBYI |
Neratinib (NERLYNX)
Extended adjuvant HER2-positive early stage breast cancer
|
Approved |
Approval announced July 17, 2017.
|
| GILD |
Vosevi (Sofosbuvir/Velpatasvir/Voxilaprevir)
Hepatitis C virus (HCV)
|
Approved |
Approval announced July 18, 2017.
|
| VRTX |
VX-440 in combination with tezacaftor and ivacaftor
Cystic fibrosis who have one F508del mutation and one minimal function mutation and patients with two copies of the F508del mutation
|
Phase 2 |
Phase 2 data released July 18, 2017. ppFEV1 of 12.0 percentage points.
|
| VRTX |
VX-152 in combination with tezacaftor and ivacaftor
Cystic fibrosis who have one F508del mutation and one minimal function mutation and patients with two copies of the F508del mutation
|
Phase 2 |
Phase 2 data released July 18, 2017. ppFEV1 of 9.7 percentage points.
|
| VRTX |
VX-659 in combination with tezacaftor and ivacaftor
Cystic fibrosis (CF) who have one F508del mutation and one minimal function mutation (F508del/Min)
|
Phase 1 |
Phase 1 data released July 18, 2017. ppFEV1 of 9.6 percentage points.
|
| TBPH |
Revefenacin
COPD
|
Phase 3 |
12 month safety trial data released July 19, 2017 with NDA filing due 4Q 2017.
|
| MYL |
Revefenacin
COPD
|
Phase 3 |
12 month safety trial data released July 19, 2017 with NDA filing due 4Q 2017.
|
| IRWD |
IW-3718
Gastroesophageal reflux disease (GERD)
|
Phase 2b |
Phase 2b data released July 20, 2017. Primary endpoint met but data below expectations.
|
| BVXV |
M-001
Universal flu vaccine
|
Phase 2b |
Phase 2b data released July 20, 2017 - endpoints met.
|
| GSK |
Benlysta (belimumab) - subcutaneous
Systemic lupus erythematosus (SLE)
|
Approved |
Approval announced July 21, 2017.
|
| CYTX |
ECCS-50
Scleroderma
|
Phase 3 |
Pivotal trial data released June 24, 2017 - endpoints not met.
|
| GNCA |
GEN-003
Genital herpes
|
Phase 2b |
Phase 2b data released January 6, 2017. 12-month data released July 24, 2017. Phase 3 to commence 4Q 2017.
|
| RETA |
Bardoxolone methyl - CARDINAL
Chronic Kidney Disease Caused by Alport Syndrome
|
Phase 2 |
Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial released July 24, 2017.
|
| NVAX |
RSV F Vaccine immunogenicity trial
Respiratory Syncytial Virus (RSV) in older adults
|
Phase 2 |
Phase 2 safety and immunogenicity data released July 24, 2017 - efficacy trial to be initiated 2018.
|
| MRK |
KEYNOTE-040 KEYTRUDA
Recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)
|
Phase 3 |
Phase 3 trial did not meet primary endpoint - July 24, 2017. Awarded accelerated approval in 2016.
|
| TTPH |
Eravacycline (TP-434) - IGNITE4
cIAI (complicated intra-abdominal infections)
|
Phase 3 |
Phase 3 data released July 25, 2017 - primary endpoint met. NDA filing due 1Q 2018.
|
| PCRX |
EXPAREL
Post surgical pain
|
Phase 3 |
Phase 3 data released July 25, 2017. Upper extremity met primary endpoint, lower extremity trial missed endpoint.
|
| EGRX |
Ryanodex
Exertional heat stroke (EHS)
|
CRL |
CRL issued July 26, 2017. Additional trial required.
|
| AZN |
Durvalumab +/- tremelimumab (MYSTIC)
Lung cancer
|
Phase 3 |
Phase 3 data released July 27, 2017 - primary endpoint not met.
|
| DVAX |
HEPLISAV-B
Hepatitis B
|
- |
Advisory Committee Meeting July 28, 2017 voted 11 -1 in favor of recommending approval.
|
| NVIV |
Neuro-Spinal Scaffold: INSPIRE 2.0
Complete Thoracic AIS A Spinal Cord Injury
|
Phase 3 |
Noted July 31, 2017 that enrollment has been temporarily halted as it discusses potential changes to patient enrollment criteria due to patient deaths - enrollment now due to be completed 1H 2018 with Humanitarian Device Exemption (HDE) application due 2H 2018.
|
| ICPT |
Obeticholic acid (OCA) AESOP
Primary Sclerosing Cholangitis (PSC)
|
Phase 2 |
Phase 2 data released July 31, 2017 - primary endpoint met.
|
| ICPT |
Obeticholic acid (OCA) - CONTROL
NASH patients taking statins
|
Phase 2 |
Phase 2 primary endpoint met - July 31, 2017. One patient death noted but DSMB noted unlikely to be related to OCA (company unsure).
|
| RDHL |
RHB-104 MAP US
Crohn’s disease
|
Phase 3 |
Phase 3 DSMB safety analysis released December 13, 2016 - trial to continue as planned. Further analysis July 31, 2017 recommended trial continue as planned.
|
| ACRX |
Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
|
Phase 3 |
Phase 2 data released August 1, 2017.
|
| AGIO |
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
|
Approved |
Approval announced August 1, 2017.
|
| CELG |
IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
|
Approved |
Approval announced August 1, 2017.
|
| BMY |
CM-142 – Opdivo
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
|
Approved |
Approval announced August 1, 2017.
|
| JNJ |
Sirukumab
Rheumatoid arthritis
|
- |
BLA filing announced September 23, 2016. PDUFA estimate September 23, 2017. Advisory Committee Meeting August 2, 2017 voted 12-1 against that safety data is adequate to support approval. 13-0 in favor of efficacy.
|
| ONCE |
SPK-8011
Hemophilia A
|
Phase 1/2 |
Phase 1/2 promising initial data released from first two patients - August 2, 2017. 11% and 14% Factor VIII.
|
| ABBV |
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
|
Approved |
Approval announced August 2, 2017.
|
| TBPH |
Velusetrag (TD-5108)
Gastroparesis
|
Phase 2b |
Phase 2b data released August 2, 2017. Primary endpoint not met.
|
| JNJ |
Imbruvica
Second-line Chronic graft-versus-host disease (GVHD)
|
Approved |
Approval announced August 2, 2017.
|
| JAZZ |
Vyxeos
Acute myeloid leukemia
|
Approved |
Approval announced August 3, 2017.
|
| ENTA |
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
|
Approved |
Approval announced August 3, 2017.
|
| ABBV |
Glecaprevir/Pibrentasvir (G/P)
Hepatitis C virus (HCV)
|
Approved |
Approval announced August 3, 2017.
|
| CRIS |
Fimepinostat (CUDC-907) and venetoclax
Diffuse-large B-cell lymphoma (DLBCL)
|
Phase 2 |
Pha |