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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
BeiGene
(BGNE)
Tislelizumab (BLA)
07/12/2022
FDA decision on Tislelizumab as a treatment for unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma
On Jul.14, 2022, the FDA announced that since it has been unable to conduct required inspections in China due to COVID-19 related travel restrictions, it is deferring the decision on Tislelizumab -
Regeneron Pharmaceuticals
(REGN)
REGEN-COV (BLA)
07/13/2022
FDA decision on REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals
-
Bristol-Myers Squibb Co.
(BMY)
Opdivo (sBLA)
07/13/2022
FDA decision on Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer
FDA approved Opdivo plus chemotherapy for the neoadjuvant treatment of patients with resectable non-small cell lung cancer on Mar.4, 2022 -
Alnylam Pharmaceuticals Inc.
(ALNY)
Vutrisiran (NDA)
07/14/2022
FDA decision on Vutrisiran for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults
FDA approved Vutrisiran, under brand name Amvuttra, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults on Jun.14, 2022-
Incyte Corporation
(INCY)
Opzelura (sNDA)
07/18/2022
FDA decision on Opzelura for the extended use as a topical treatment for adolescents and adults with vitiligo
FDA approves Opzelura for extended use as a topical treatment for adolescents and adults with vitiligo on July 18, 2022-
Eton Pharmaceuticals, Inc
(ETON)
Zonisamide Oral Suspension (Resubmitted NDA)
07/18/2022
FDA decision on Zonisamide Oral Suspension for partial seizures
FDA approved Zonisamide Oral Suspension, under the brand name ZONISADE for partial seizures -
Arcutis Biotherapeutics Inc.
(ARQT)
Roflumilast Cream (NDA)
07/29/2022
FDA decision on Roflumilast Cream for the treatment of psoriasis in adults and adolescents
FDA approved Roflumilast Cream, under brand name ZORYVE, for the treatment of plaque psoriasis on Jul.29, 2022 -
Amicus Therapeutics Inc.
(FOLD)
Cipaglucosidase alfa (BLA)
07/29/2022
FDA decision on Cipaglucosidase alfa, a component of AT-GAA, for Pompe disease
On May 10, 2022, the FDA notified the company that the decision date has been extended by 3 months-
Coherus Biosciences, Inc.
(CHRS)
CHS-201 (BLA)
08/02/2022
FDA decision on CHS-201, a biosimilar candidate of Lucentis
FDA approved CIMERLI, formerly CHS-201, as a biosimilar product interchangeable with Lucentis on Aug.3, 2022 -
Sanofi
( SNYNF, SNY)
Dupixent (sBLA)
08/03/2022
FDA decision on Dupixent in the expanded use of treating adult and pediatric patients aged 12 years and older with eosinophilic esophagitis
FDA approved Dupixent as first treatment for adults and children aged 12 and older with eosinophilic esophagitis on May 20, 2022-

ALSO READ - COVID-19 Drugs In Development Calendar which lists Companies that are in Race to find a Treatment or Vaccine for the Novel Coronavirus.

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