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
Flexion Therapeutics, Inc.
ZILRETTA (sNDA)
FDA decision on the repeat administration of ZILRETTA for patients with osteoarthritis knee pain
10/14/2019
Intra-Cellular Therapies, Inc.
Lumateperone (NDA)
FDA decision on Lumateperone for the treatment of schizophrenia
09/27/2019
Celgene Corporation
Fedratinib (NDA)
FDA decision on Fedratinib for myelofibrosis
09/03/2019
Roche Holding AG
Tecentriq (sBLA)
FDA decision on Tecentriq plus chemotherapy in metastatic non-squamous non-small cell lung cancer
09/02/2019
Nabriva Therapeutics
Lefamulin (NDA)
FDA decision on oral and IV formulations of Lefamulin for bacterial pneumonia
08/19/2019
VANDA PHARMACEUTICALS
HETLIOZ (sNDA)
FDA decision on HETLIOZ for the expanded indication of jet lag disorder
08/16/2019
Karyopharm Therapeutics Inc.
Selinexor (NDA)
FDA decision on Selinexor for patients with refractory multiple myeloma
07/06/2019
Dova Pharmaceuticals, Inc.
DOPTELET (sNDA)
FDA decision on DOPTELET for chronic immune thrombocytopenia
06/30/2019
Regeneron Pharmaceuticals
Dupixent (sBLA)
FDA decision on Dupixent for severe chronic rhinosinusitis with nasal polyps
06/26/2019
Agios Pharmaceuticals, Inc.
TIBSOVO (sNDA)
FDA decision on TIBSOVO for newly diagnosed acute myeloid leukemia with IDH1 mutation
06/21/2019
Merck & Co Inc.
KEYTRUDA (sBLA)
FDA decision on KEYTRUDA as Monotherapy or in combination with Chemotherapy
06/10/2019
Nektar Therapeutics
NKTR-181 (NDA)
FDA decision on NKTR-181 for chronic low back pain in adult patients new to opioid therapy
05/28/2019
Incyte Corporation
Ruxolitinib (sNDA)
FDA decision on Ruxolitinib for the treatment of steroid-refractory acute GVHD
05/24/2019
Heron Therapeutics Inc.
HTX-011 (NDA)
FDA decision on HTX-011 for postoperative pain management
04/30/2019
Heron Therapeutics Inc.
HTX-011 (NDA)
FDA decision on HTX-011 for the management of postoperative pain
04/30/2019


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