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
Nabriva Therapeutics
CONTEPO (NDA)
FDA decision on CONTEPO IV for the treatment of complicated urinary tract infections
04/30/2019
Sanofi
Praluent (sBLA)
FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019
Regeneron Pharmaceuticals
Praluent (sBLA)
FDA decision to include the effect of Praluent in reducing overall risk of major adverse cardiovascular events
04/28/2019
AbbVie
Risankizumab (BLA)
FDA decision on Risankizumab for moderate to severe plaque psoriasis.
04/25/2019
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on Keytruda as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous NSCLC
04/11/2019
FDA Approves Keytruda
ADMA BIOLOGICS, INC.
RI-002 (BLA resubmission)
FDA decision on RI-002 to treat primary immune deficiency disease
04/02/2019
FDA approves RI-002 on Apr 1
Evoke Pharma, Inc.
Gimoti (NDA)
FDA decision on Gimoti for the relief of symptoms in adult women with acute and recurrent diabetic gastroparesis
04/01/2019
FDA issues Complete Response Letter for Gimoti on Apr 2
INTELGENX TECHNOLOGS
IGXT.OB
RIZAPORT (NDA resubmission)
FDA decision on RIZAPORT for the treatment of acute migraine
04/01/2019
FDA issues Complete Response Letter for RIZAPORT on Apr 2
Recro Pharma Inc.
Resubmitted IV Meloxicam (NDA)
FDA decision on resubmitted IV Meloxicam for management of moderate to severe pain
03/24/2019
FDA issued Complete Response Letter for IV Meloxicam on Mar.22, 2019
Lexicon Pharmaceuticals Inc.
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019
FDA issues Complete Response Letter for Sotagliflozin
Sanofi
Sotagliflozin (NDA)
FDA decision on Sotagliflozin for type 1 diabetes
03/22/2019
FDA issues Complete Response Letter for Sotagliflozin
Jazz Pharmaceuticals plc
Solriamfetol (NDA)
FDA decision on Solriamfetol for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea
03/20/2019
FDA approves Solriamfetol
SAGE Therapeutics, Inc.
Brexanolone IV (NDA)
FDA decision on Brexanolone IV for the treatment of postpartum depression
03/19/2019
FDA approved Zulresso (brexanolone) on Mar.19, 2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq in combination with Chemotherapy for the initial treatment of extensive-stage small cell lung cancer
03/18/2019
FDA Approves Tecentriq on Mar 18
Aerie Pharmaceuticals, Inc.
Rocklatan (NDA)
FDA decision on Rocklatan for patients with open-angle glaucoma, retina diseases
03/14/2019
FDA approves Rocklatan on Mar 12


famousfive-041019.jpg The biotech sector got off to a good start in 2019, and the iShares Nasdaq Biotechnology ETF (IBB), a bellwether of investor sentiment, has so far gained 17 percent.
pharma-030718_09apr19.jpg Today's Daily Dose brings you news about the inter partes review decision on Concert Pharma's patents related to CTP-543; the proposed public offering of Daré Bioscience and Zosano Pharma; United Therapeutics' decision to discontinue the development of a PAH drug and FDA's refusal to review Zogenix' seizure drug candidate FINTEPLA.
pharma-030617_05apr19.jpg Today's Daily Dose brings you news about the upcoming key milestones of Stealth BioTherapeutics; the extended partnership between Natural Alternatives and The Juice Plus+ Company; Merrimack's discontinuation of phase I study of MM-310 for the treatment of solid tumors; and Sangamo's pricing of its public offering.
Read More
The conventional wisdom is that if the brain cells of humans and other mammals are deprived of oxygen for 4-5 min, they begin to die, and that the loss of brain functions after death is irreversible. But the findings of a study conducted by Yale University researchers challenge these long-held assumptions.
Canadian marijuana producer Aurora Cannabis Inc. (ACB, ACB.TO) has agreed to acquire the remaining 48 percent stake in Hempco Food and Fiber Inc. (HEMP.V) that it does not already own, in a deal that values Hempco at about C$63.4 million. Shares of Hempco gained more than 10 percent in Tuesday's trading. Aurora...
Canadian cannabis company Aphria Inc. (APHA) on Monday reported a net loss for the third quarter and also said it has entered into a series of transactions to accelerate the expiry date of the hostile takeover bid launched by Green Growth Brands Inc. The company's shares lost more than 14 percent in...
Read More