logo

FDA Calendar

Share SHARE
PDUFA dates and FDA Panel Review dates are very important because they are make or break events for biostocks when the decisions are announced. Also, usually biostocks experience a run-up going into the scheduled decision/review dates. So having prior knowledge of the catalysts goes a long way toward maximizing profit or minimizing loss while trading volatile biotech stocks.

Listed below are large cap, mid cap and small cap stocks with pending regulatory catalysts.

Get in-depth analysis and insight on investing in the high-stakes biotech and pharma sectors. Check out our
premium biotech research product and our biotech home page.
Company Name
Ticker
Drug
Event
Date
Outcome
Details
Synergy Pharmaceuticals, Inc.
TRULANCE (sNDA)
FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
01/24/2018
Ligand Pharmaceuticals Inc
LUXTURNA (BLA)
FDA decision on LUXTURNA for inherited retinal disease
01/12/2018
Eli Lilly And Co.
Abemaciclib (NDA)
FDA decision on Abemaciclib for the treatment of advanced breast cancer
01/10/2018
Intersect ENT Inc
SINUVA implant (NDA)
FDA decision on SINUVA implant for patients with recurrent ethmoid sinus obstruction
01/07/2018
AEterna Zentaris Inc
AEZ.TO, AEZS
Macrilen (NDA resubmission)
FDA decision on Macrilen for the evaluation of growth hormone deficiency in adults
12/30/2017
Valeant Pharmaceuticals International
VRX, VRX.TO
Luminesse (NDA)
FDA decision on Luminesse to be used Over-the-Counter as an eye drop to relieve redness of the eye due to minor eye irritations.
12/27/2017
Kite Pharma, Inc.
Axicabtagene ciloleucel (KTE-C19) (BLA)
FDA decision on KTE-C19 for Non-Hodgkin Lymphoma
11/29/2017
Ultragenyx Pharmaceutical Inc
Recombinant human beta-glucuronidase (BLA)
FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
11/16/2017
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
11/10/2017
Bristol-Myers Squibb Co.
Sprycel (sNDA)
FDA decision on Sprycel to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia
11/09/2017
Eagle Pharmaceuticals Inc
Pemetrexed Injection (NDA)
FDA decision on Pemetrexed for the treatment of Locally Advanced or Metastatic Nonsquamous Non-Small Cell Lung Cancer, and Mesothelioma
10/30/2017
Johnson & Johnson
XARELTO (sNDA)
FDA decision for a 10 mg dose to reduce the risk of recurrent venous thromboembolism
10/28/2017
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
10/24/2017
Antares Pharma Inc.
QuickShot Testosterone (NDA)
FDA decision on QST as treatment for low testosterone associated with hypogonadism
10/20/2017
AcelRx Pharmaceuticals Inc.
DSUVIA (NDA)
FDA decision on DSUVIA for the treatment of patients with moderate-to-severe acute pain in a medically supervised setting
10/12/2017
Pharma-081817.jpg Today's Daily Dose brings you news about expanded FDA approval of AstraZeneca's ovarian cancer drug Lynparza; positive results from Endologix's LEOPARD trial; Fluidigm's licensing agreement with Baylor Genetics; Humana and Amgen's partnership to improve health outcomes and efficiency and Pfizer's Besponsa getting thumbs up from the U.S. regulatory agency.
Slide0-Alzheimers-081717.jpg The development of Alzheimer's drugs has been marred by a high failure rate. A U.S. study, which analyzed how the Alzheimer's clinical trials fared during the period of 2002 to 2012, revealed a failure rate of 99.6% compared to a failure rate of 81% for cancer drugs.
Pharma-081717.jpg Today's Daily Dose brings you news about Acadia Healthcare's secondary offering; ARCA's progress in GENETIC-AF trial; Iovance's milestone that has boosted investor optimism; Psychemedics' role to play testing of drugs of abuse; Seattle Genetics' upcoming regulatory catalyst and inspection classification of Valeant's Bausch + Lomb manufacturing facility in Tampa, Florida.
More
Hahn Brothers, Inc., a ham manufacturer, is recalling about 115,773 pounds of ready-to-eat ham products as they contained malted barley, a known allergen, which was not declared on the final product label. The U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS said that the recall was due to misbranding and an undeclared allergen.
Rolling Stones guitarist Ronnie Wood recently struggled to overcome what he called a "touch of lung cancer." The rock icon revealed his health scare with the Mail on Sunday, telling the U.K. paper that he had an operation to take out part of his lung.
More
comments powered by Disqus