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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.

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Company Name
Ticker
Drug
Event
Date
Outcome
Details
Mylan N.V.
YUPELRI (NDA)
FDA decision on YUPELRI for moderate to very severe COPD
11/13/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as a treatment for previously treated patients with advanced hepatocellular carcinoma
11/09/2018
EyePoint Pharmaceuticals, Inc.
YUTIQ (NDA)
FDA decision on YUTIQt for non-infectious posterior segment uveitis
11/05/2018
AcelRx Pharmaceuticals Inc.
DSUVIA (Resubmitted NDA)
FDA decision on DSUVIA for the management of acute moderate to severe pain in adults in medically monitored settings
11/03/2018
Coherus Biosciences, Inc.
CHS-1701 (resubmitted NDA)
FDA decision on CHS-1701 for Neulasta
11/03/2018
Coherus Biosciences, Inc.
CHS-1701 (Resubmitted BLA)
FDA decison on CHS-1701, a biosimilar version of Neulasta
11/03/2018
Trevena, Inc.
OLINVO (NDA)
FDA decision on OLINVO for the management of moderate to severe acute pain
11/02/2018
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous NSCLC
10/30/2018
TherapeuticsMD
TX-001HR (NDA)
FDA decision on TX-001HR for vasomotor symptoms due to menopause
10/28/2018
Regeneron Pharmaceuticals
cemiplimab (BLA)
FDA decision on cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC
10/28/2018
Regeneron Pharmaceuticals
Cemiplimab (BLA)
FDA decision on Cemiplimab for treating cutaneous squamous cell carcinoma
10/28/2018
Jazz Pharmaceuticals plc
Xyrem oral solution, CIII (sNDA)
FDA decision on Xyrem oral solution, CIII, to treat cataplexy and excessive daytime sleepiness in pediatric narcolepsy patients
10/27/2018
Merck & Co Inc.
Doravirine (NDA)
FDA decision for use of Doravirine with lamivudine and tenofovir disoproxil fumarate for HIV
10/23/2018
Regeneron Pharmaceuticals
DUPIXENT (sBLA)
FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018
Sanofi
DUPIXENT (sBLA)
FDA decision on DUPIXENT for moderate-to-severe asthma
10/20/2018
pharma-030618_16sep18.jpg Today's Daily Dose brings you news about results from Allergan's clinical study evaluating higher doses of BOTOX Cosmetic; CEL-SCI's better capitalization, following exercise of warrants; Kiniksa's phase 1a/1b clinical trial of KPL-716 in moderate-to-severe atopic dermatitis, and FDA approval of Teva's preventive treatment of migraine.
pharma-021617_13sep18.jpg Today's Daily Dose brings you news about disappointing results of Progenics Pharma's 1404, an imaging compound targeting prostate specific membrane antigen,trial; stock offerings of Galapagos and Xenon Pharma and Hetlioz's edge over Zopiclone in driving impairment.
pharma-010517_12sep18.jpg Today's Daily Dose brings you news about AcelRx Pharma's regulatory catalyst in October; positive acne trial results of Foamix; Galapagos' rheumatoid arthritis trial results; trading halt in OPKO and Viveve Medical's progress in stress urinary incontinence studies.
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