logo

FDA Calendar

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
Aurinia Pharmaceuticals Inc.
AUPH, AUP.V
Voclosporin (NDA)
FDA decision on Voclosporin for the treatment of lupus nephritis
01/22/2021
Merck & Co Inc.
Vericiguat(NDA)
FDA decision on Vericiguat in Patients with symptomatic chronic Heart Failure and Reduced Ejection Fraction
01/20/2021
scPharmaceuticals Inc.
FUROSCIX (Resubmitted NDA)
FDA decision on FUROSCIX or the treatment of worsening heart failure due to congestion
12/30/2020
Vertex Pharmaceuticals Inc.
TRIKAFTA (sNDA)
FDA decision on TRIKAFTA for the treatment of cystic fibrosis patients with additional rare CFTR mutations
12/30/2020
Vertex Pharmaceuticals Inc.
SYMDEKO (sNDA)
FDA decision on SYMDEKO for the treatment of cystic fibrosis patients with additional rare CFTR mutations
12/30/2020
Vertex Pharmaceuticals Inc.
KALYDECO (sNDA)
FDA decision on KALYDECO for the treatment of cystic fibrosis patients with additional rare CFTR mutations
12/30/2020
Athenex, Inc.
Tirbanibulin Ointment (NDA)
FDA decision on Tirbanibulin Ointment for the treatment of actinic keratosis
12/30/2020
Osmotica Pharmaceutical Corp
Arbaclofen ER (Resubmitted NDA)
FDA decision on Arbaclofen ER for the treatment of spasticity in patients with MS
12/29/2020
Mylan N.V.
MYL-1402O (BLA)
FDA decision on MYL-1402O, a proposed biosimilar to Avastin
12/27/2020
Urovant Sciences Ltd.
Vibegron (NDA)
FDA decision on Vibegron for the treatment of overactive bladder
12/26/2020
AstraZeneca PLC
AZN.L, AZN
Roxadustat (NDA)
FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
12/20/2020
Myovant Sciences Ltd
Relugolix (NDA)
FDA decision on once-daily, oral Relugolix for the treatment of men with advanced prostate cancer
12/20/2020
FibroGen Inc.
Roxadustat (NDA)
FDA decision on Roxadustat for the treatment of anemia of chronic kidney disease (CKD), in both non-dialysis-dependent and dialysis-dependent patients
12/20/2020
Amgen Inc.
ABP 798 (BLA)
FDA decision on ABP 798 (biosimilar rituximab) for Non-Hodgkin's lymphoma and Rheumatoid arthritis
12/19/2020
MacroGenics Inc.
Margetuximab (BLA)
FDA decision on Margetuximab for the treatment of patients with metastatic HER2-positive breast cancer in combination with chemotherapy
12/18/2020

ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.

Buy this Content


stockmarkets aug16 01oct20 What's moving these stocks in the pre-market hours today?
biotech oct01 Today's Daily Dose brings you news about AMAG reportedly in talks with Covis Pharma about being acquired, Iterum's progress with Sulopenem, Pfizer's stake in CStone, Selecta's Gout trial results, and FDA notification to Zosano over migraine treatment Qtrypta.
stockmarkets dec21 30sep20 What's moving these stocks in the pre-market hours today?
Read More
No relief is reported in coronavirus infections and deaths due to the disease in the United States, the country worst-affected by the pandemic. With the addition of 42,884 coronavirus-related cases in the last 24 hours, total number of infections in the U.S. reached 7233946. 961 deaths in the same period took the total coronavirus death toll in the country to 206959. Meanwhile, thousands of empl
Cannabis company Halo Labs Inc. has launched the sale of cannabis-infused gummies under the Hush brand in California. The Canada-based company said its wholly-owned distribution subsidiary, Mendo Distribution and Transportation LLC, has commenced sales in California of its new 10-piece, cannabis-infused...
Regeneron Pharmaceuticals, Inc. announced positive first data from a descriptive analysis of a seamless Phase 1/2/3 trial of its investigational antibody cocktail REGN-COV2 in COVID-19 patients. REGN-COV2 rapidly reduced viral load and associated symptoms in infected COVID-19 patients. The company said it plans rapidly to discuss results with regulatory authorities.
Read More