Historical Catalyst Calendar

Biotech Stock Historical Catalysts listed from 2009.

What's included?

2009 ~ Most small/mid capFDA Approval and Complete Response Letters.

January 2015 ~ Most key small/mid cap Phase 3 data releases.

August 2016 ~ Most key small/mid cap Phase 2 and Phase 3 data releases.

January 2016 ~ Most key large cap releases (data and regulatory).

Phase 1 events are not listed.

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.

showing 2735 records
Ticker Drug Stage Catalyst
SPPI ZEVALIN
Non-Hodgkin’s lymphoma
CRL
CRL received July 5, 2009.
ZGNX SUMAVEL DosePro (sumatriptan injection)
Migraine
Approved
Approved July 16, 2009.
SPPI ZEVALIN
Non-Hodgkin’s lymphoma
Approved
Approved September 4, 2009.
SPPI FUSILEV (levoleucovorin)
Colorectal cancer
CRL
CRL received October 9, 2009.
AIM Ampligen
CFS
CRL
CRL issued December 1, 2009.
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 SUSTOL (granisetron)
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 (sodium oxybate)
Fibromyalgia
CRL
CRL received October 11, 2010.
VVUS QSYMIA (phentermine/topiramate)
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 (levoleucovorin)
Colorectal cancer
Approved
Approved April 29, 2011.
SGEN ADCETRIS (brentuximab vedotin)
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approval announced August 19, 2011.
TAK ADCETRIS (brentuximab vedotin)
Hodgkin lymphoma and Anaplastic large cell lymphoma
Approved
Approval announced August 19, 2011.
PCRX EXPAREL
Postsurgical pain
Approved
Approved October 31, 2011.
EYPT ILUVIEN (Fluocinolone acetonide)
Diabetic macular edema
CRL
CRL November 11, 2011.
ALIM Iluvien
Diabetic macular edema
CRL
CRL November 2011.
INCY JAKAFI (Ruxolitinib)
Myelofibrosis
Approved
Approved November 16, 2011.
PRTK INTERMEZZO (zolpidem tartrate)
Insomnia
Approved
Approved November 23, 2011.
ATRS Anturol
Overactive bladder
Approved
Approved December 8, 2011.
CRIS ERIVEDGE (Vismodegib)
Basal Cell Carcinoma
Approved
Approved January 30, 2012.
CORT KORLYM (Corlux)
Cushing's Syndrome
Approved
Approved February 17, 2012.
VVUS STENDRA (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.
VVUS QSYMIA (phentermine/topiramate)
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 (technetium Tc 99m tilmanocept)
Lymphatic-tissue tracing agent
CRL
CRL issued September 10, 2012.
SUPN OXTELLAR XR (oxcarbazepine)
Epilepsy
Approved
Approved October 22, 2012.
EXEL CABOMETYX (Cabozantinib)
Medullary thyroid cancer
Approved
Approved November 29, 2012.
TAK CABOMETYX (Cabozantinib)
Medullary thyroid cancer
Approved
Approved November 29, 2012.
AIM Ampligen
CFS
CRL
CRL February 4, 2013.
DVAX HEPLISAV-B
Hepatitis B
CRL
CRL issued February 25, 2013.
NAVB LYMPHOSEEK (technetium Tc 99m tilmanocept)
Lymphatic-tissue tracing agent
Approved
Approved March 13, 2013.
HRTX SUSTOL (granisetron)
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 FOTIVDA (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 XR (topiramate)
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 (Fluocinolone acetonide)
Diabetic macular edema
CRL
Second CRL October 18, 2013.
ZGNX ZOHYDRO ER (hydrocodone)
Moderate to severe pain
Approved
Approved October 25, 2013.
ABBV IMBRUVICA (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 (Ibrutinib)
Cancer - Chronic Lymphocytic Leukemia Who Have Received at Least One Prior Therapy
Approved
Approved February 12, 2014.
BMRN VIMIZIM (elosulfase alfa) (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.
NVS KENGREAL (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 (phenylephrine & ketorolac)
Cataract surgery
Approved
Approved June 2, 2014.
BDSI BEMA Buprenorphine/Naloxone (BNX) - BUNAVAIL
Opioid dependence
Approved
Approved June 6, 2014.
NAVB LYMPHOSEEK (technetium Tc 99m tilmanocept)
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 BELEODAQ (belinostat)
Peripheral T-Cell Lymphoma cancer
Approved
Approved July 7, 2014.
EGRX RYANODEX (dantrolene sodium)
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.
NVS ORBACTIV (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 (Fluocinolone acetonide)
Diabetic macular edema
Approved
Approved Sept 26 2014.
ALIM Iluvien
Diabetic macular edema
Approved
Approved September 26, 2014,
LNTH Subcutaneous RELISTOR
Chronic pain
Approved
Approved September 29, 2014.
AEZS MACRILEN (Macimorelin Acetate)
Adult Growth Deficiency
CRL
CRL issued November 6, 2014.
INCY JAKAFI (Ruxolitinib)
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 (ivacaftor)
Cystic fibrosis (CF) ages 6 and older who have the R117H mutation
Approved
Approved December 29, 2014.
NBIX ORILISSA (Elagolix)
Endometriosis
Phase 3
First Phase 3 trial met both co-primary endpoints - January 8, 2015.
ABBV ORILISSA (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 (Ibrutinib)
Waldenström’s Macroglobulinemia
Approved
Approved January 29, 2015 - PCYC
ZGNX ZOHYDRO ER (hydrocodone)
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 (ivabradine)
Chronic Heart Failure
Approved
Approved April 15, 2015.
JNJ Generic COPAXONE
Multiple sclerosis
Approved
Approved April 16 2015.
TBPH BREO ELLIPTA
Asthma
Approved
Approved April 30, 2015.
MNKKQ RAPLIXA
Hemostasis
Approved
Approved April 30, 2015.
NVS IONSYS
Acute postoperative pain
Approved
Approved April 30, 2015.
VRTX ORKAMBI (lumacaftor/ivacaftor)
Cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation
Approved
Approved July 2, 2015.
NYMX Fexapotide Triflutate (NX-1207)
BPH
Phase 3
Phase 3 endpoints met in extension trial July 2015.
SGEN ADCETRIS (brentuximab vedotin)
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved August 17, 2015 under priority review.
TAK ADCETRIS (brentuximab vedotin)
Post-transplant Hodgkin lymphoma (HL) cancer
Approved
Approved August 17, 2015 under priority review.
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
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.
EXEL ZELBORAF (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 GOCOVRI (amantadine)
Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes
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.
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 ORILISSA (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 ORILISSA (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 TALICIA (RHB-105)
H. pylori
Phase 3
Phase 3 final data released March 8, 2016.
JAZZ EPIDIOLEX (cannabidiol)
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.
ALXN 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 (octreotide)
Acromegaly
CRL
CRL April 15, 2016.
EXEL CABOMETYX (cabozantinib)
Metastatic renal cell cancer (RCC)
Approved
Approved April 25, 2016.
ACAD NUPLAZID (pimavanserin)
Parkinson’s disease psychosis (PDP)
Approved
Approved April 29, 2016.
AVDL Akovaz
Hypotension
Approved
Approved May 2, 2016.
TTNP Probuphine
Opioid dependence
Approved
CRL issued April 30, 2013. Approved May 26, 2016.
VNDA FANAPT (iloperidone)
Maintenance treatment of schizophrenia in adults
Approved
Approved May 26, 2016.
AZN LOKELMA (sodium zirconium cyclosilicate)
Hyperkalaemia
CRL
CRL issued May 26, 2016.
ICPT OCALIVA (obeticholic acid)
Primary biliary cirrhosis (PBC) - POISE
Approved
Approved May 27 2016.
ADMP Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.
CRL
CRL issued March 27 2015. CRL issued again June 6, 2016.
OCUL DEXTENZA
Allergic conjunctivitis
Phase 3
Phase 3 trial did not meet primary endpoint - 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 NUZYRA (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.
NVS VABOMERE (meropenem and 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.
GSK ZEJULA (Niraparib)
Cancer - ovarian
Phase 3
Phase 3 data met endpoints - June 2016.
LPCN TLANDO - 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
RARE MEPSEVII (vestronidase alfa)
Mucopolysaccharidosis 7 (MPS 7)
Phase 3
Phase 3 data released July 2016. Primary endpoint hit. Secondary missed.
LNTH 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.
ADMA ASCENIV (RI-002)
Primary Immune Deficiency Diseases
CRL
CRL issued July 29 2016. Third-party manufacturing issues cited.
MCRB SER-109
Recurrent C. Difficile infection
Phase 2
Phase 2 interim data did not meet primary endpoint.
IONS SPINRAZA (Nusinersen)
Spinal muscular atrophy (SMA)
Phase 3
Phase 3 ENDEAR trial met primary endpoint August 1, 2016.
HRTX SUSTOL (granisetron)
Prevention of acute- and delayed-onset chemotherapy-induced nausea and vomiting (CINV)
Approved
CRL Mar 28 2013. Approved August 10, 2016.
ACRX DSUVIA (Sufentanil)
Moderate-to-severe acute pain following a surgical procedure
Phase 3
Phase 3 data released August 15, 2016.
AUPH LUPKYNIS (Voclosporin)
Lupus
Phase 2b
Phase 2b data released August 2016. Primary endpoint met but with high number of deaths.
ALXN ANDEXXA (Andexanet alfa)
Factor Xa inhibitor reversal agent
CRL
CRL August 17 2016.
ACRS A-101 (THWART-1 and THWART-2)
Common warts (verruca vulgaris)
Phase 2
Phase 2 data released August 2016.
EARS Keyzilen (AM-101) - TACTT2
Acute inner ear tinnitus
Phase 3
Phase 3 trial did not meet primary endpoints.
KMDA Inhaled formulation of AAT
AATD - Alpha-1 Antitrypsin deficiency
Phase 2
Top-line data released August 30, 2016. Primary endpoint met
RIGL TAVALISSE (Fostamatinib)
Immune Thrombocytopenic Purpura (ITP)
Phase 3
Phase 3 data from the first trial released August 30 2016. Primary endpoint met.
GSK VARUBI (Rolapitant)
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
Approved
Approved September 2, 2015.
GSK VARUBI (Rolapitant)
Prevention of chemotherapy induced nausea and vomiting, or CINV
Approved
Approved September 2, 2015.
TNXP Tonmya (TNX-102 SL)
Fibromyalgia
Phase 3
Phase 3 data released September 6, 2016. Primary endpoint not met. Program discontinued
KPTI XPOVIO (selinexor)
Quadruple Refractory Multiple Myeloma
Phase 2
Phase 2 positive top-line data released September 6, 2016
AERI ROCLATAN (netarsudil/latanoprost ophthalmic solution)
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.
SRPT EXONDYS 51 (eteplirsen)
Duchenne muscular dystrophy
Approved
Approved September 19, 2016.
ITCI CAPLYTA (Lumateperone)
Schizophrenia
Phase 3
Phase 3 trial failed - September 28, 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 TAVALISSE (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
ALNY Inclisiran
Hypercholesterolemia
Phase 2
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
NVS Inclisiran
Hypercholesterolemia
Phase 2
Phase 2 Day 180 data presented at AHA Scientific Sessions on November 15, 2016.
ACRS ESKATA (hydrogen peroxide)
Seborrheic keratosis (SK)
Phase 3
Phase 3 trial met endpoints - November 15, 2016.
ENDP QWO (collagenase clostridium histolyticum-aaes)
Edematous fibrosclerotic panniculopathy (“cellulite”)
Phase 2b
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.
BXRX 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.
HZNP ACTIMMUNE
Friedreich's Ataxia (FA)
Phase 3
Phase 3 data released December 8, 2016 - primary endpoint not met
ISEE Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
Phase 3 data released December 12, 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 RUBRACA (rucaparib)
Cancer - ovarian second line
Approved
Approved December 19, 2016. Original PDUFA date under priority review was February 23, 2017.
ACAD NUPLAZID (pimavanserin)
Alzheimer’s disease psychosis
Phase 2
Phase 2 top-line data released December 20, 2016. Primary endpoint met. Key secondary endpoint missed.
LXRX Sotagliflozin
Type 1 Diabetes
Phase 3
Phase 3 data from second trial released December 21, 2016 - primary endpoint met.
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 (lutetium Lu 177)
Inoperable progressive midgut NETs
CRL
PDUFA date under priority review was December 28, 2016. CRL issued December 21, 2016.
IRWD LINZESS (Iinaclotide)
Irritable Bowel Syndrome with Constipation (IBS-C)
Phase 2b
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.
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.
AEZS MACRILEN (Macimorelin Acetate)
Adult Growth Deficiency
Phase 3
Phase 3 data released January 4, 2017 - trial failed.
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 VARUBI (Rolapitant) - intravenous
Prevention of chemotherapy induced nausea and vomiting, or CINV in HEC patients
CRL
CRL issued January 11 2017.
FGEN Pamrevlumab (LAPIS)
Pancreatic cancer
Phase 2
Phase 2 abstract released January 17, 2017.
NBIX INGREZZA
Tourette syndrome - adults
Phase 2
Phase 2 data released January 18, 2017 did not meet primary endpoint.
ABBV Oxymetazoline HCl cream 1.0%
Facial Erythema (Redness) Associated with Rosacea
Approved
Approved January 19, 2017.
ABBV IMBRUVICA (Ibrutinib)
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.
IRWD LINZESS (Iinaclotide)
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.
NRBO 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 1/2
Phase 1/2 top-line data released January 31 - primary endpoint not met.
AMGN Parsabiv
Secondary hyperparathyroidism (SHPT)
Approved
Approved February 7, 2017.
JAZZ SATIVEX (nabiximols)
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.
SAGE SAGE-217 - MOUNTAIN
Major Depressive Disorder (MDD)
Phase 2
Phase 2 top-line data from open-label trial released February 13, 2017
ZSAN Qtrypta (M207)
Migraine
Phase 3
Phase 3 trial data due released February 13, 2017 - primary endpoints met.
ARDX Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis
Phase 3
Phase 3 released February 15, 2017 - primary endpoint met.
BHC SILIQ (brodalumab)
Psoriasis
Approved
Approved February 15, 2017.
AZN LYNPARZA (olaparib)
Breast cancer
Phase 3
Phase 3 data released February 17, 2016 - primary endpoint met.
MRK LYNPARZA (olaparib)
Breast cancer
Phase 3
Phase 3 data released February 17, 2016 - primary endpoint met.
TRVN OLINVYK (oliceridine)
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.
AMPH Naloxone Intranasal
Opioid overdose
CRL
CRL announced February 21, 2017.
CDTX Rezafungin (CD101) - RADIANT
Vulvovaginal candidiasis (VVC)
Phase 2
Phase 2 data released February 21, 2017 - efficacy not evident, Development to be discontinued.
BMY 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.
BCRX ORLADEYO (Berotralstat)
Reduce or eliminate attacks in HAE patients
Phase 2
Phase 2 interim data released February 27, 2017.
LJPC GIAPREZA (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.
AZN ONGLYZA (Saxagliptin) and FARXIGA (Dapagliflozin)
Type-2 diabetes
Approved
Approval announced February 28, 2017.
MRK ODACTRA (MK-8237)
House dust mite allergies
Approved
Approved March 1, 2017.
AUPH LUPKYNIS (Voclosporin)
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.
PTCT Translarna
Nonsense mutation cystic fibrosis
Phase 3
Phase 3 data released March 2, 2017 - endpoints not met. Development to be discontinued.
KPTI XPOVIO (selinexor)
Relapsed/Refractory Acute Myeloid Leukemia (AML)
Phase 2
Data Safety Monitoring Board (DSMB) noted March 2, 2017 that trial will not meet primary endpoint.
IONS Volanesorsen - APPROACH
Familial chylomicronemia syndrome (FCS)
Phase 3
Phase 3 data released March 6, 2017 - primary endpoint met. Relative safety concerns noted.
KURA Tipifarnib - (AIM-HN/SEQ-HN)
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
Phase 2 ongoing data released March 6, 2017 - further data due 2H 2017.
NVS KISQALI (ribociclib)
HR+/HER2- advanced breast cancer
Approved
Priority review granted November 1, 2016. Approval announced March 13, 2017.
MRK KEYTRUDA (pembrolizumab)
Relapsed or Refractory Classical Hodgkin Lymphoma
Approved
Approval announced March 14, 2017.
AZN LYNPARZA (olaparib)
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 (amifampridine)
MuSK-antibody positive myasthenia gravis (MuSK-MG)
Phase 2
Phase 2 top-line data met endpoints - March 15, 2017. Pivotal trial planned.
AZN LOKELMA (sodium zirconium cyclosilicate)
Hyperkalaemia
CRL
Second CRL issued March 17, 2017.
AMGN REPATHA (evolocumab)
Cardiovascular disease
Phase 3
Phase 3 cardiovascular outcomes study data released March 17, 2017 - endpoints met but down on expectations.
LLY VERZENIO (Abemaciclib)
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.
BLRX Motixafortide (BL-8040) - (GENESIS)
Stem-cell mobilization for autologous transplantation
Phase 2
Phase 2 trial initiated March 2016. Partial data released March 20, 2017.
NVS RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3
Phase 3 data released March 22, 2017 - primary endpoints not met.
PFE BAVENCIO (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 ZEJULA (Niraparib)
Cancer - ovarian
Approved
PDUFA date under priority review was June 30, 2017. Approved March 27, 2017.
VYNE AMZEEQ (FMX101)
Acne
Phase 3
Phase 3 data released March 27, 2017 - three of four primary endpoints met across two trials.
PRTK Sarecycline
Severe acne vulgaris
Phase 3
Phase 3 data released March 27 2017 - primary endpoints met. NDA filing due 2H 2017.
VRTX SYMDEKO (tezacaftor/ivacaftor and 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.
QLGN 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.
CRBP Lenabasum (Resunab)
Cystic Fibrosis
Phase 2
Phase 2 data released March 30, 2017 - primary endpoint met but some concerns regarding efficacy.
LNTH AZEDRA (iobenguane I 131)
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.
AZN TAGRISSO (Osimertinib)
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-3
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.
PRTK NUZYRA (omadacycline)
Community-acquired bacterial pneumonia (CABP)
Phase 3
Phase 3 data released April 3, 2017 - all endpoints met.
KPTI XPOVIO (selinexor)
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.
NKTR Cipro DPI
Bronchiectasis
Phase 3
Phase 3 second trial did not meet endpoint - April 5, 2017.
SUPN TROKENDI XR (topiramate)
Migraine
Approved
Tentative approval August 19 2016, subject to the pediatric exclusivity which expires March 28, 2017. Final approval announced 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 (IMpactMF)
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.
MESO Rexlemestrocel
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.
NOVN SB208
Fungal infections
Phase 2
Phase 2 data released April 12, 2017. Primary endpoint met.
INCY OLUMIANT (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 OLUMIANT (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.
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).
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 ZOKINVY (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.
LLY VERZENIO (Abemaciclib)
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.
XOMA XOMA 213
Hyperprolactinemia
Phase 2
Phase 2 proof-of-concept results released April 24, 2017.
AKTX Nomacopan
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.
JAZZ XYREM (sodium oxybate)
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.
JAZZ SUNOSI (solriamfetol)
Excessive sleepiness associated with narcolepsy
Phase 3
Phase 3 data released April 26, 2017. NDA to be filed late 2017.
BMRN BRINEURA (cerliponase alfa)
Batten Disease
Approved
PDUFA date extended by three months to April 27 2017. Approval announced April 27, 2017.
TGTX Ublituximab - ULTIMATE I
Multiple Sclerosis
Phase 2
Phase 2 preliminary results presented at American Academy of Neurology (AAN) annual meeting April 28, 2017.
NVS RYDAPT (midostaurin)
Acute myeloid leukemia (AML)
Approved
Priority review granted November 14, 2016. Approval announced 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.
AMAG Feraheme
Adults with iron deficiency anemia (IDA)
Phase 3
Phase 3 trial completion announced May 2, 2017 - endpoints met. sNDA due mid-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.
TXMD IMVEXXY (estradiol vaginal inserts)
Moderate-to-severe vaginal pain
CRL
CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data.
PFE BAVENCIO (avelumab)
Urothelial Carcinoma
Approved
Approval announced May 9, 2017.
LCTX OpRegen
Dry age-related macular degeneration (AMD)
Phase 2
Phase 2 second cohort underway. Interim data presented at May 8, 2017 at ARVO conference.
GSK NUCALA (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.
MRK KEYTRUDA (pembrolizumab)
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.
LLY EMGALITY (galcanezumab)
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 IMFINZI (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 TEGSEDI (inotersen)
NEURO-TTR - familial amyloid polyneuropathy (FAP).
Phase 3
Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns.
MRK KEYTRUDA (pembrolizumab)
First and Second line locally advanced or metastatic urothelial cancer - bladder cancer
Approved
Approved May 18, 2017.
RVNC DAXI (RT002) - ASPEN-1/ASPEN-OLS
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.
BMY ZEPOSIA (Ozanimod)
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.
REGN KEVZARA (sarilumab)
Rheumatoid arthritis
Approved
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
SNY KEVZARA (sarilumab)
Rheumatoid arthritis
Approved
CRL October 28, 2016. Resubmitted with FDA Approval announced May 22, 2017.
LJPC GIAPREZA (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 (pembrolizumab)
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.
NBIX INGREZZA - T-Force GOLD
Tourette syndrome - juvenile
Phase 2
Phase 2 data released May 23 - primary endpoint not met.
AERI ROCLATAN (netarsudil/latanoprost ophthalmic solution)
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 NERLYNX (Neratinib)
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 ORLADEYO (Berotralstat)
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 (ceritinib)
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 REBINYN (nonacog beta pegol)
haemophilia B
Approved
Approval announced May 31, 2017.
RETA Omaveloxolone
Friedreich’s ataxia (FA)
Phase 2
Phase 2 initial data released June 1, 2017. Primary endpoint not met.
LLY VITRAKVI (larotrectinib)
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.
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 (olaparib)
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 (olaparib)
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).
CLSN GEN-1 OVATION 2
Ovarian cancer
Phase 1b
Phase 1b interim data released at ASCO 2017 - ORR 86%.
CRVS Ciforadenant (CPI-444)
Renal cell cancer
Phase 1b
Phase 1/1b preliminary data released November 2016. Further update at ASCO June 5, 2017.
BMY BREYANZI (lisocabtagene maraleucel)
Relapsed or refractory (R/R) large B-cell lymphoma
Phase 1/2
Pivotal trial to be initiated in 2017. ASCO Poster Session June 5, 2017 - ORR 86%.
GILD TECARTUS (brexucabtagene autoleucel) - (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%.
BLUE ABECMA (idecabtagene vicleucel)
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%.
BMY ABECMA (idecabtagene vicleucel)
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 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.
IOVA Lifileucel (LN-144)
Refractory metastatic melanoma
Phase 2
Phase 2 second cohort commenced enrollment - May 19, 2017. Initial data presented at ASCO June 5, 2017.
ALKS ARISTADA (aripiprazole lauroxil)
Schizophrenia
Approved
Approved October 5 2015. sNDA filed for 2-month option with approval announced June 6, 2017.
NVS KYMRIAH (tisagenlecleucel)
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.
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.
JNJ INVOKANA (canagliflozin)
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.
RDHL BEKINDA
Gastroenteritis
Phase 3
Phase 3 top-line data released June 14, 2017 - primary endpoint met.
EPZM TAZVERIK (Tazemetostat)
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.
ALDX Reproxalap (ADX-102) - (INVIGORATE)
Allergic conjunctivitis
Phase 2b
Phase 2b data released June 14 2017 - primary endpoint not met. However, Phase 3 trial is planned.
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.
JNJ DARZALEX (Daratumumab) + pomalidomide and dexamethasone
Relapsed or refractory multiple myeloma
Approved
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
GMAB DARZALEX (Daratumumab) + pomalidomide and dexamethasone
Relapsed or refractory multiple myeloma
Approved
Approval announced June 16, 2017 - note: submitted by Janssen Biotech, Inc.
CLVS RUBRACA (rucaparib)
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.
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.
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 BEOVU (brolucizumab)
Wet age-related macular degeneration (AMD)
Phase 3
Phase 3 data released June 20, 2017 - primary and key secondary endpoints met.
PFE Epoetin alfa biosimilar
CRL
CRL issued June 22, 2017.
HALO Subcutaneous RITUXAN (rituximab)
Various blood cancers
Approved
Approval announced June 22, 2017.
NVS TAFINLAR (dabrafenib) + MEKINIST (trametinib)
Non-small cell lung cancer (NSCLC) with BRAF V600E mutation
Approved
FDA 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.
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.
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 Betibeglogene autotemcel (beti-cel) (LentiGlobin) - HGB-207 Northstar-2
non-β0/β0 transfusion-dependent thalassemia (TDT)
Phase 3
Phase 3 early data released at EHA June 23, 2017.
ALXN BEVYXXA (betrixaban)
Venous thromboembolism (VTE) Prevention
Approved
FDA Approval noted June 23, 2017.
AGIO Mitapivat (AG-348) - (ACTIVATE-T)
Pyruvate kinase deficiency
Phase 1/2
Phase 2 updated data released at EHA June 24, 2017.
SGEN ADCETRIS (brentuximab vedotin)
Frontline Hodgkin lymphoma
Phase 3
Phase 3 data released June 26, 2017 - primary endpoint met.
TAK ADCETRIS (brentuximab vedotin)
Frontline Hodgkin lymphoma
Phase 3
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
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.
XENE TV-45070
Postherpetic neuralgia
Phase 2b
Phase 2b data released June 27, 2017. Endpoints not met.
NRBO 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.
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.
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.
UTHR Ralinepag - ADVANCE OUTCOMES
Pulmonary Arterial Hypertension
Phase 2
Phase 2 data released July 10, 2017. Primary endpoint met. Secondary missed.
AMGN BLINCYTO
Ph+ R/R ALL
Approved
PDUFA date under priority review August 14, 2017. Approval announced July 11, 2017.
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).
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.
KDMN Belumosudil (KD025)
Chronic graft-versus-host disease (cGVHD)
Phase 2
Phase 2 interim data presented July 11, 2017. ORR 71%.
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.
SVRA Aironite - INDIE
Heart failure with preserved ejection fraction (HFpEF)
Phase 2
Phase 2 interim data released July 11, 2017.
NVS KYMRIAH (tisagenlecleucel)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
-
Advisory Committee Meeting July 12, 2017 voted 10-0 recommending approval.
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%.
JNJ TREMFYA (Guselkumab)
Plaque psoriasis
Approved
Approval announced July 13, 2017.
AMGN EVENITY (Romosozumab)
Osteoporosis
CRL
CRL issued July 16, 2017.
CBAY Seladelpar (RESPONSE)
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 NERLYNX (Neratinib)
Extended adjuvant HER2-positive early stage breast cancer
Approved
Approval announced July 17, 2017.
PRTK NUZYRA (omadacycline) - oral
Acute bacterial skin and skin structure infections (ABSSSI)
Phase 3
Phase 3 data released July 17, 2017 - all endpoints met.
GILD VOSEVI (Sofosbuvir/Velpatasvir/Voxilaprevir)
Hepatitis C virus (HCV)
Approved
Approval announced July 18, 2017.
TBPH YUPELRI (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.
MRK KEYTRUDA (pembrolizumab)
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.
RETA Bardoxolone methyl
Alport Syndrome
Phase 2
Phase 2/3 trial initiation announced February 23, 2017. Data from Phase 2 part of trial released July 24, 2017.
PCRX EXPAREL
Post surgical pain
Phase 3
Phase 3 data released July 25, 2017. Upper extremity met primary endpoint, lower extremity trial missed endpoint.
LJPC XERAVA (eravacycline)
cIAI (complicated intra-abdominal infections)
Phase 3
Phase 3 data released July 25, 2017 - primary endpoint met. NDA filing due 1Q 2018.
EGRX RYANODEX (dantrolene sodium)
Exertional heat stroke (EHS)
CRL
CRL issued July 26, 2017. Additional trial required.
AZN IMFINZI (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.
RDHL RHB-104 MAP
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.
ICPT Obeticholic acid (OCA) AESOP
Primary Sclerosing Cholangitis (PSC)
Phase 2
Phase 2 data released July 31, 2017 - primary endpoint met.
AGIO IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
Approved
Approval announced August 1, 2017.
BMY IDHIFA (enasidenib) - AG-221
Advanced hematologic malignancies with an IDH2 mutation
Approved
Approval announced August 1, 2017.
BMY OPDIVO (nivolumab)
(dMMR) or microsatellite instability high (MSI-H) metastatic colorectal cancer (CRC)
Approved
Approval announced August 1, 2017.
ACRX Zalviso
Post-operative pain following open abdominal surgery and hip or knee replacement surgery
Phase 3
Phase 2 data released 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.
JNJ IMBRUVICA (Ibrutinib)
Second-line Chronic graft-versus-host disease (GVHD)
Approved
Approval announced August 2, 2017.
ABBV IMBRUVICA (Ibrutinib)
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.
PFE XELJANZ (tofacitinib)
Psoriatic arthritis
-
PDUFA date December 2017. No exact date given. December 31, 2017 noted as last possible date using guidance of "December 31". Advisory Committee Meeting August 3, 2017 voted 10-1 in favor of recommending approval.
JAZZ VYXEOS (daunorubicin and cytarabine)
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.
LLY REYVOW (lasmiditan
Migraine
Phase 3
Phase 3 data released August 4, 2017 - endpoints met. NDA filing due 2H 2018.
ZYNE Zygel (ZYN002)
Adult Epilepsy Patients with Refractory Focal Seizures
Phase 2
Phase 2 data released August 7, 2017 - endpoints not met.
BHC VYZULTA (Latanoprostene bunod)
Open angle glaucoma (OAG) or ocular hypertension (OHT)
CRL
CRL issued August 7, 2017.
BMY Mavacamten (MYK-461) - EXPLORER-HCM
Hypertrophic cardiomyopathy (HCM)
Phase 2
Phase 2 data released August 7, 2017 - primary endpoint met.
FGEN Pamrevlumab - (ZEPHYRUS)
Idiopathic pulmonary fibrosis
Phase 2
Phase 2 data released August 7, 2017 - primary endpoint met.
ESPR NEXLETOL (bempedoic acid) / Ezetimibe
Hypercholesterolemia
Phase 2
Phase 2 data released August 8, 2017. Primary endpoint met.
ABIO Gencaro
Chronic Heart Failure
Phase 2b
Phase 2b interim analysis August 9, 2018 - trial to continue to completion. Data 1Q 2018.
TGTX UKONIQ (umbralisib)
Follicular lymphoma (FL)
Phase 2b
Phase 2b enrollment commenced June 2016. First interim analysis August 10, 2017 determined that enrollment in TGR-1202 arm will stop but continue in TG-1101 + TGR-1202 arm. TGR-1202 arm replaced by combo of TG-1101, TGR-1202, and bendamustine.
CVM Multikine
Head and Neck cancer
Phase 3
Initiated Dec 2010. Announced partial clinical hold September 27, 2016. Full clinical hold noted May 2017. Clinical hold released - August 14, 2017.
ISEE Fovista
Wet age-related macular degeneration (Wet-AMD)
Phase 3
Phase 3 data released December 12, 2016 - primary endpoint not met. Data from third trial released August 14, 2017- primary endpoint not met.
ZYNE Zygel (ZYN002) - STOP
Osteoarthritis
Phase 2
Phase 2 data released August 14, 2017 - primary endpoint not met. However, company still intends to initiate Phase 3 trial pending discussions with FDA.
REGN REGN2222
Respiratory syncytial virus (RSV)
Phase 3
Phase 3 data released August 14, 2017 - primary endpoint not met.
BMY OPDIVO (nivolumab) + YERVOY (ipilimumab)
First-line Renal cell carcinoma (RCC)
Phase 3
Phase 3 data released August 15, 2017 - one of two co-primary endpoints met.
AZN LYNPARZA (olaparib)
Second-line ovarian cancer
Approved
Approval announced August 17, 2017.
PFE BESPONSA (inotuzumab ozogamicin)
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
Approved
Approval announced August 17, 2017.
IRWD DUZALLO (LESINURAD AND ALLOPURINOL)
Hyperuricemia associated with gout
Approved
Approval announced August 21, 2017.
RARE Aceneuramic acid extended release (Ace-ER)
GNE Myopathy
Phase 3
Phase 3 data released August 22, 2017 - endpoints not met.
ADMS GOCOVRI (amantadine)
Levodopa-Induced Dyskinesia + Parkinson's disease patients receiving levodopa and experiencing OFF episodes
Approved
Approval announced August 24, 2017.
NVO VICTOZA (liraglutide)
Type 2 diabetes
Approved
Approval announced August 25, 2017.
KMDA KamRAB
Prophylaxis of rabies disease
Approved
Approval announced August 25, 2017.
XOMA ACZ885 (canakinumab)
CV risk reduction
Phase 3
Data presented August 27, 2017 showed a 77% reduction in lung cancer mortality.
NVS ACZ885 (canakinumab)
CV risk reduction
Phase 3
Data presented August 27, 2017 showed a 77% reduction in lung cancer mortality.
AZN FASLODEX (fulvestrant)
Monotherapy for expanded use in women with HR+, HER2- advanced breast cancer
Approved
Expanded approval announced August 28, 2017.
NVS VABOMERE (meropenem and vaborbactam)
Complicated urinary tract infections (cUTI)
Approved
Approved August 29, 2017.
OTIC OTO-104 AVERTS-1
Meniere's disease
Phase 3
Phase 3 data released August 30 failed to meet primary and key secondary endpoints.
NVS KYMRIAH (tisagenlecleucel)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
Approved
PDUFA date under priority review announced March 29, 2017. Approval announced early - August 30, 2017.
OTIC OTIVIDEX
Ménière's disease
Phase 3
Phase 3 development suspended following failure of AVERTS-1 trial - August 30, 2017.
UTHR Trevyent
Pulmonary Arterial Hypertension (PAH)
-
Refusal to file Letter (RTF) issued August 31, 2017 in response to NDA filing.
PFE MYLOTARG (gemtuzumab ozogamicin)
Acute myeloid leukemia (AML)
Approved
Approval announced September 1, 2017.
CLLS UCART123 - AMELI-01
Acute myeloid leukemia (AML)
Phase 1
Clinical hold announced September 4, 2017 following one fatality in the BPDCN clinical trial (ABC study).
NVS GILENYA (Fingolimod)
Multiple Sclerosis (MS)
Phase 3
Phase 3 trial met primary endpoint.
VSTM COPIKTRA (duvelisib)
Chronic lymphocytic leukemia (CLL)//Small Lymphocytic Lymphoma (SLL)/Follicular Lymphoma
Phase 3
Phase 3 data released September 6, 2017 - primary endpoint met.
SRPT Golodirsen - Exon 53
Duchenne muscular dystrophy
Phase 1/2
Phase 1/2 data released September 6, 2017 - endpoints met.
AMGN Tezepelumab - NAVIGATOR
Asthma
Phase 2b
Phase 2b data released September 7, 2017 - primary endpoint met.
AZN Tezepelumab - NAVIGATOR
Asthma
Phase 2b
Phase 2b data released September 7, 2017 - primary endpoint met.
VRNA Ensifentrine (RPL554)
COPD
Phase 2a
Phase 2a positive data released September 7, 2017.
KURA Tipifarnib - (AIM-HN/SEQ-HN)
Head and neck squamous cell carcinomas (HNSCC)
Phase 2
Phase 2 trial met primary endpoint prior to completion of enrollment.
ABBV RINVOQ (Upadacitinib)
Atopic Dermatitis
Phase 2b
Phase 2b data released September 7, 2017 - primary endpoint met.
LLY KEYTRUDA (pembrolizumab) + chemo
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54
MRK KEYTRUDA (pembrolizumab) + chemo
First-Line Nonsquamous Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2 data presented at ESMO 2017 - ORR 57%, PFS 19 months, HR 0.54
SGEN Tisotumab Vedotin (innovaTV 301)
Cervical Cancer
Phase 1/2
Phase 1/2 data presented at ESMO 2017. Response rate 32%.
GMAB Tisotumab Vedotin (innovaTV 301)
Cervical Cancer
Phase 1/2
Phase 1/2 data presented at ESMO 2017. Response rate 32%.
UTHR Orenitram
Pulmonary arterial hypertension (PAH)
Phase 3
Phase 3 data due 2H 2018. Independent data monitoring committee (DMC) noted September 8, 2017 that the trial should continue following its interim analysis.
AZN IMFINZI (Durvalumab) - (PACIFIC)
Lung cancer
Phase 3
Late breaker at ESMO September 9, 2017 showed PFS 16.8 months v 5.6 months for placebo.
EXEL CABOMETYX (cabozantinib)
First-Line RCC - cancer
Phase 2
Late breaker at ESMO September 2017 showed PFS 8.6 months versus 5.3 months for sunitinib. HR 0.48
BMY OPDIVO (nivolumab)
Melanoma
Phase 3
Phase 3 interim data released June 6, 2017 - primary endpoint met. Data presented at ESMO September 10, 2017 - HR 0.65 compared to Yervoy.
MRNS Ganaxolone - Marigold
CDKL5 Deficiency Disorder (CDD)
Phase 2
Phase 2 top-line data released September 11, 2017.
REGN DUPIXENT (dupilumab)
Asthma
Phase 3
Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. sBLA filing due by end of 2017.
SNY DUPIXENT (dupilumab)
Asthma
Phase 3
Phase 3 data released September 11, 2017 - primary endpoints met. 46% improvement after 52 weeks in 300 mg group. sBLA filing due by end of 2017.
SAGE SAGE-547
SRSE
Phase 3
Phase 3 data released September 12, 2017 - primary endpoint not met.
ALDX Reproxalap (ADX-102) - (TRANQUILITY)
Dry eye syndrome
Phase 2a
Phase 2a data released September 11, 2017 - noted statistically and clinically significant activity.
VNDA Tradipitant - EPIONE 1
Atopic dermatitis
Phase 2
Phase 2 data released September 13, 2017 - primary endpoint not met.
FOLD SD-101
Epidermolysis Bullosa (EB)
Phase 3
Phase 3 top-line data released September 13, 2017 - endpoints not met.
PFE XTANDI (Enzalutamide) - (PROSPER)
Non-metastatic high risk hormone-sensitive prostate cancer
Phase 3
Phase 3 data released September 14, 2017 - primary endpoint met.
AMGN MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved September 14, 2017.
ABBV MVASITM (bevacizumab-awwb)
Biosimilar candidate to Avastin (bevacizumab)
Approved
Approved September 14, 2017.
NEOS NT-0201
Attention deficit hyperactivity disorder (ADHD)
Approved
Approval announced September 15, 2017.
OPTN XHANCE
Nasal polyps
Approved
Approval announced September 18, 2017 (prior to IPO).
GSK TRELEGY ELLIPTA (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approval announced September 18, 2017.
INVA TRELEGY ELLIPTA (FF/UMEC/VI)
Chronic obstructive pulmonary disease (COPD)
Approved
Approval announced September 18, 2017.
SUPN SPN-810
Impulsive Aggression in ADHD
Phase 3
Noted September 18, 2017 that the lower of the two doses will be discontinued following interim analysis.
NBRV XENLETA (lefamulin)
Moderate to severe Community Acquired Bacterial Pneumonia (CABP)
Phase 3
Phase 3 data released September 18, 2017 - primary endpoints met.
ABBV VENCLEXTA (venetoclax) (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 3
Phase 3 data released September 18, 2017 - PFS primary endpoint met.
RHHBY VENCLEXTA (venetoclax) (MURANO)
Relapsed or refractory Chronic Lymphocytic Leukemia (CLL)
Phase 3
Phase 3 data released September 18, 2017 - PFS primary endpoint met.
PFE SUTENT (sunitinib)
Renal cell carcinoma (RCC)
-
Advisory Committee Meeting September 19, 2017 voted 6-6 the benefits outweigh risks.
ALNY ONPATTRO (patisiran)
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Phase 3
Phase 3 top-line data released September 20, 2017 - all endpoints met. NDA filing due by end of 2017.
SNY ONPATTRO (patisiran)
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR
Phase 3
Phase 3 top-line data released September 20, 2017 - all endpoints met. NDA filing due by end of 2017.
KPTI XPOVIO (selinexor)
Dedifferentiated liposarcoma
Phase 2/3
Phase 2/3 trial initiated January 2016.Topline data for the Phase 2 portion released September 20, 2017 - PFS HR 0.60. Phase 3 data due 2019.
ARAV VRS-317 VELOCITY
Growth hormone deficiency, or GHD - pediatric
Phase 3
Phase 3 top-line data released September 21, 2017 - primary endpoint not met.
BCRX RAPIVAB (peramivir injection)
Acute uncomplicated influenza to pediatric patients
Approved
Approved September 21, 2017.
MRK KEYTRUDA (pembrolizumab)
Cancer - Third-line Gastric or Gastroesophageal Junction Adenocarcinoma
Approved
Approved September 22, 2017 - under priority review.
JNJ Sirukumab
Rheumatoid arthritis
CRL
CRL issued September 22, 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.
BMY OPDIVO (nivolumab) and YERVOY (ipilimumab)
Previously Treated Hepatocellular Carcinoma
Approved
Approved under priority review September 22, 2017.
PTCT Translarna
Duchenne muscular dystrophy caused by nonsense mutations (nmDMD)
-
Received a Refusal to File letter for their NDA Filing - February 23 2016. Appeal rejected October 17, 2016. Decision made to resubmit NDA during 1Q 2017 under protest. New PDUFA date October 24, 2017. Advisory Committee Meeting September 28, 2017 voted that although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.
ZYNE Zygel (ZYN002) - (RECONNECT)
Fragile X syndrome
Phase 2
Phase 2 data released September 28, 2017. Company noted data were positive with primary endpoint met. Note though that trial was uncontrolled/open-label.
PRTA PRX003
Psoriatic Arthritis
Phase 1b
Phase 1b data released September 28, 2017 - insufficient meaningful clinical effect for further development.
NVO FiASP (fast-acting insulin aspart)
Type 1 and type 2 diabetes
Phase 3
Approved September 29, 2017.
ZGNX FINTEPLA (fenfluramine)
Dravet syndrom
Phase 3
Phase 3 data released September 29, 2017 - primary endpoint met.
MCRB SER-287
Mild-to-Moderate Ulcerative Colitis
Phase 1b
Phase 1b data released October 2, 2017 - did not perform better than placebo.
RIGL TAVALISSE (Fostamatinib)
Warm Autoimmune hemolytic anemia (WAIHA)
Phase 2
Phase 2 data from Stage 1 of trial released October 3, 2017 - sufficient efficacy shown to progress to Stage 2.
RDHL BEKINDA
IBS-D
Phase 2
Phase 2 top-line data released October 3, 2017 - primary endpoint met (borderline) - p=0.05.
ABBV BOTOX
Forehead lines
Approved
Approval (third indication) announced October 3, 2017.
LLY VERZENIO (Abemaciclib)
Second-line hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer and HR+, HER2- breast cancer
Approved
Approved October 4, 2017.
VTRS GLATOPA (Glatiramer Acetate Injection)
Multiple sclerosis (MS) - Generic for Copaxone
Approved
Approval announced October 4, 2017.
CATB Edasalonexent (CAT-1004)
Duchenne muscular dystrophy (DMD)
Phase 1/2
Phase 1/2 data from open-label extension trial presented October 4, 2017 - deemed sufficient to proceed to Phase 3 development.
BLUE Lenti-D (Elivaldogene Autotemcel / Eli-Cel) - ALD-102
Childhood cerebral adrenoleukodystrophy (CCALD)
Phase 2/3
Phase 2/3 trial initiated October 2013. Interim top-line data released June 26, 2017. Further data released October 4, 2017 - 88% free of free of major functional disabilities.
NBIX INGREZZA
Tardive dyskinesia
Approved
Approval for sNDA 80 mg capsules announced October 5, 2017.
FLXN ZILRETTA
Osteoarthritis of the knee
Approved
Approval announced October 6, 2017.
SRPT Golodirsen - Exon 53
Duchenne muscular dystrophy
Phase 1/2
Phase 1/2 late breaking poster presented at World Muscle Society October 7, 2017.
VTRS FULPHILA (Neulasta biosimilar)
Neulasta biosimilar
CRL
CRL issued October 10, 2017.
ARDX Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
Phase 3