FDA Calendar

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
Otonomy Inc.
FDA decision on OTIPRIO for acute otitis externa
Synergy Pharmaceuticals, Inc.
FDA decision on TRULANCE for the treatment of adults with irritable bowel syndrome with constipation
Ligand Pharmaceuticals Inc
FDA decision on LUXTURNA for inherited retinal disease
Eli Lilly And Co.
Abemaciclib (NDA)
FDA decision on Abemaciclib for the treatment of advanced breast cancer
Intersect ENT Inc
SINUVA implant (NDA)
FDA decision on SINUVA implant for patients with recurrent ethmoid sinus obstruction
AEterna Zentaris Inc
Macrilen (NDA resubmission)
FDA decision on Macrilen for the evaluation of growth hormone deficiency in adults
Valeant Pharmaceuticals International
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.
Mylan N.V.
MYL-1401O (BLA)
FDA decision on MYL-1401O as a proposed biosimilar to Roche's Herceptin
Kite Pharma, Inc.
Axicabtagene ciloleucel (KTE-C19) (BLA)
FDA decision on KTE-C19 for Non-Hodgkin Lymphoma
Ultragenyx Pharmaceutical Inc
Recombinant human beta-glucuronidase (BLA)
FDA decision on rhGUS for the treatment of Mucopolysaccharidosis VII
Dynavax Technologies Corp
HEPLISAV-B (NDA resubmission)
FDA decision on HEPLISAV-B for treatment of hepatitis B
Bristol-Myers Squibb Co.
Sprycel (sNDA)
FDA decision on Sprycel to treat children with Philadelphia chromosome-positive chronic phase chronic myeloid leukemia
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
Johnson & Johnson
FDA decision for a 10 mg dose to reduce the risk of recurrent venous thromboembolism
PTC Therapeutics Inc.
Translarna (NDA)
FDA decision on Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy
Pharma-091417.jpg Today's Daily Dose brings you news about Biohaven's collaboration with Alzheimer's Disease Cooperative Study; CHMP positive opinion on GlaxoSmithKline's Trelegy Ellipta and TESARO's ZEJULA; Orphan Drug designated Motif's investigational drug candidate, Iclaprim, and FDA approval of Neos' third extended release product for the treatment of ADHD.
Logos-Pharma-091517.jpg Halozyme Therapeutics Inc. (HALO) touched a new 52-week high on Thursday, rising as much as 24%, following deals with Bristol-Myers Squibb Co. (BMY) and Swiss drug giant Roche AG involving its ENHANZE drug-delivery technology.
Pharma-091417.jpg Today's Daily Dose brings you news about encouraging interim analysis of Alexion's REGAIN study of Soliris; Fennec's uplisting and preliminary results of SIOPEL 6; Amicus' failed epidermolysis bullosa trial; Vanda's disappointing atopic dermatitis trial results and FDA panel's recommendation for approval of GlaxoSmithKline's investigational shingles vaccine Shingrix.
Vitamin World, a retailer of vitamins and health supplements, filed for bankruptcy protection and said it has identified 51 stores for closure during the bankruptcy process. The company filed for Chapter 11 reorganization in Delaware Bankruptcy Court on Tuesday. It has listed liabilities of more than $43.6 million and estimated assets in a range of $50 million to $100 million.
CVS Pharmacy will be launching health and wellness vending machines across the country to offer healthy snacks, personal care items as well as over-the-counter products to the customers on the go. The automated machines will be placed in airports, hotels, transportation hubs etc. and can be accessed using credit and debit cards.
Drug maker AstraZeneca (AZN) announced the full results of Phase III FLAURA trial, which support TAGRISSO's clear potential as a new standard of care (SoC) in the 1st-line treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung...
comments powered by Disqus