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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
Heron Therapeutics Inc.
(HRTX)
HTX-019 (NDA)
09/17/2022
FDA decision on HTX-019 for prevention of postoperative nausea and vomiting (PONV) in adults
FDA Approves APONVIE (HTX-019) for the Prevention of Postoperative Nausea and Vomiting on Sep 16, 2022-
Regeneron Pharmaceuticals
(REGN)
Libtayo (sBLA)
09/19/2022
FDA decision on Libtayo in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer
FDA approved Libtayo in combination with chemotherapy as first-line treatment for adult patients with advanced non-small cell lung cancer on Sept. 12, 2022-
Sanofi
( SNYNF, SNY)
Libtayo (sBLA)
09/19/2022
FDA decision on Libtayo in combination with chemotherapy as first-line treatment in advanced non-small cell lung cancer
FDA approved Libtayo in combination with chemotherapy as first-line treatment for adult patients with advanced non-small cell lung cancer on Sept. 12, 2022-
Spectrum Pharmaceuticals Inc
(SPPI)
Poziotinib (NDA)
09/22/2022
FDA panel to review Poziotinib for the treatment of patients with previously treated, locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations
FDA panel voted 9-4 that the current benefits of Poziotinib did not outweigh its risk on Sep.22, 2022-
Fennec Pharmaceuticals Inc
(FENC)
PEDMARK (Resubmitted NDA)
09/23/2022
FDA decision on PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients one month to less than 18 years of age with localized, non-metastatic, solid tumors
FDA approved PEDMARK for the prevention of platinum-induced ototoxicity in pediatric patients 1 month or older with localized, non-metastatic solid tumors on Sep.20, 2022.-
TG Therapeutics Inc.
( TGTX, TGTX.OB)
Ublituximab (BLA)
09/28/2022
FDA decision on Ublituximab as a treatment for patients with relapsing forms of Multiple Sclerosis
On May 31, 2022, the FDA extended the decision date on Ublituximab to treat patients with relapsing forms of Multiple Sclerosis to December 28, 2022-
Amylyx Pharmaceuticals, Inc
(AMLX)
AMX0035 (NDA)
09/29/2022
FDA decision on AMX0035 for the treatment of amyotrophic lateral sclerosis
-
Regeneron Pharmaceuticals
(REGN)
Dupixent (sBLA)
09/30/2022
FDA decision on Dupixent for the expanded use in treating adults with prurigo nodularis
-
Sanofi
( SNYNF, SNY)
Dupixent (sBLA)
09/30/2022
FDA decision on Dupixent for treating adults with Prurigo Nodularis
-
Daiichi Sankyo Company Limited
(DSKYF.PK)
Enhertu (sBLA)
Q4 2022
FDA decision on Enhertu for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer
FDA approved Enhertu for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received a prior chemotherapy in the metastatic setting on Aug.6, 2022-

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