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
Deciphera Pharmaceuticals, Inc.
Ripretinib (NDA)
FDA decision on Ripretinib for advanced gastrointestinal stromal tumors
Gilead Sciences Inc.
FDA decision on KTE-X19 for the treatment of adult patients with relapsed or refractory mantle cell lymphoma
DBV Technologies S.A. -
Viaskin Peanut (BLA)
FDA decision on Viaskin Peanut for treatment of peanut allergy
Ultragenyx Pharmaceutical Inc
UX007 (triheptanoin) (NDA)
FDA decision on for UX007 for treatment of Long-chain Fatty Acid Oxidation Disorders
Verrica Pharmaceuticals Inc.
VP-102 (cantharidin 0.7% Topical Solution) (NDA)
FDA decision on VP-102 for the Treatment of Molluscum Contagiosum
Endo International plc
Collagenase clostridium histolyticum (BLA)
FDA decision on collagenase clostridium histolyticum (CCH) for cellulite in buttocks
GlaxoSmithKline PLC
Belantamab mafodotin (BLA)
FDA decision on Belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma
Evoke Pharma, Inc.
GimotI (NDA resubmission)
FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis.
Viela Bio
Inebilizumab (BLA)
FDA decision on Inebilizumab the treatment of neuromyelitis optica spectrum disorder
Viela Bio
Inebilizumab (BLA)
FDA decision on Inebilizumab for treatment of patients with neuromyelitis optica spectrum disorder (
Foamix Pharmaceuticals Ltd.
FMX103 topical foam (NDA)
FDA decision on FMX103 for the treatment of moderate-to-severe papulopustular rosacea in adults.
Immunomedics Inc.
Sacituzumab Govitecan (Resubmission BLA)
FDA decision on Sacituzumab Govitecan for patients with Metastatic Triple-Negative Breast Cancer
Incyte Corporation
Pemigatinib (NDA)
FDA decision on Pemigatinib for patients with locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on Dupixent as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis
PTC Therapeutics Inc.
Risdiplam (NDA)
FDA decision on Risdiplam for the treatment of spinal muscular atrophy
Buy this Content

europeanstock1-dec30_14feb20.jpg Shares of BioXcel Therapeutics Inc. (BTAI) touched an all-time high of $41.51 in early trading today and are currently up over 55% at $36.
pharma-sept27_12feb20.jpg Today's Daily Dose brings you news about Advaxis' upcoming presentation; Deciphera's date with FDA and Trovagene's update on its phase II study of Onvansertib in metastatic castrate-resistant prostate cancer.
pharma-073117_10feb20.jpg Today's Daily Dose brings you news about an update on Acasti Pharma's TRILOGY 2 study, Biohaven's disappointing results from Generalized Anxiety Disorder trial, Aquestive Therapeutics' date with FDA, the clinical hold on LogicBio Therapeutics' methylmalonic acidemia trial and Mereo BioPharma's funding transactions.
Read More
California-based cannabis company Hollister Biosciences Inc. recently announced that it entered into a licensing agreement with actor and cannabis icon Tommy Chong to manufacture and distribute a cannabis tincture. The tincture, branded Tommy Chong's Cannabis Full Spectrum Elixir 1:1, features a...
Canadian marijuana company Invictus MD Strategies Corp. said Thursday that the Supreme Court of British Columbia has granted the company creditor protection under the Companies' Creditors Arrangement Act or CCAA. The court order also extends protection to Greener Pastures MD Ltd., Acreage Pharms Ltd....
The Colorado State University's Pueblo campus will offer a degree in cannabis after it received state approval for the program on Friday. The Colorado Department of Higher Education said that the Colorado Commission on Higher Education has approved a Bachelor of Science degree program in cannabis...
Read More