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FDA Calendar

PDUFA dates and FDA Panel Review dates are very important catalysts because they are ‘make or break events’ for biotech stocks.

The goal date set by the FDA for announcing its decision on a company’s New Drug Application/ Biologics License Application/sBLA/sNDA after reviewing the applications is known as the PDUFA date.

Usually, the stocks experience a run-up going into the scheduled FDA Approval decision/FDA Panel review events. So, having prior knowledge of the key dates goes a long way toward maximizing profit or minimizing loss while investing in the 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 RTT Biotech Investor and our Biotech Home Page.
Company Name
Drug
Event
Outcome
Details
Axsome Therapeutics, Inc.
(AXSM)
AXS-07 (NDA)
04/30/2022
FDA decision on AXS-07 for acute treatment of migraine
FDA issues Complete Response Letter for AXS-07 NDA for Acute Treatment of Migraine on May 2, 2022-
Hutchison China Meditech Ltd
(HCM)
Surufatinib (NDA)
04/30/2022
FDA decision on Surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors
FDA denies approval for Surufatinib, proposed for treating neuroendocrine tumors, on May 2, 2022-
Coherus Biosciences, Inc.
(CHRS)
Toripalimab (BLA)
04/30/2022
FDA decision on Toripalimab for the treatment of Nasopharyngeal Carcinoma
FDA issues Complete Response Letter for Toripalimab for the treatment of Nasopharyngeal Carcinoma on May 02, 2022-
Incyte Corporation
(INCY)
Parsaclisib (NDA)
04/30/2022
FDA decision on Parsaclisib for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen.
The company withdrew the Parsaclisib NDA seeking approval in the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen in Jan.2022-
United Therapeutics Corp
(UTHR)
Tyvaso DPI (Resubmitted NDA)
May 2022
FDA decision on Tyvaso DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease
FDA approves of Tyvaso DPI for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease on May 24, 2022-
MannKind Corp.
(MNKD)
Tyvaso DPI (Resubmitted NDA)
May 2022
FDA decision on Tyvaso DPI for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease
FDA approves Tyvaso DPI for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease on May 24, 2022-
Eton Pharmaceuticals, Inc
(ETON)
Lamotrigine for Oral Suspension (NDA)
May 2022
FDA decision on Lamotrigine for the treatment of partial on-set seizures, primary generalized tonic-clonic seizures, and seizures of Lennox-Gastaut syndrome in patients two year of age and older
-
Phathom Pharmaceuticals Inc
(PHAT)
Vonoprazan (NDA)
05/03/2022
FDA decision on Vonoprazan for treating adults with H. pylori infection
FDA approved Vonoprazan treatment regimens under brand name VOQUEZNA for the treatment of H. pylori infection in adults on May 3, 2022-
Pfizer Inc.
(PFE)
MYFEMBREE (sNDA)
05/06/2022
FDA decision on MYFEMBREE management of moderate to severe pain associated with endometriosis.
On May 5, the FDA notified the company that the decision date has been postponed to Aug.6, 2022-
Myovant Sciences Ltd
(MYOV)
MYFEMBREE (sNDA)
05/06/2022
FDA decision on MYFEMBREE management of moderate to severe pain associated with endometriosis.
On May 5, the FDA notified the company that the decision date has been postponed to Aug.6, 2022-

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