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.
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Company Name
Drug
Event
Outcome
Details
Kadmon Holdings Inc.
(
KDMN)
Belumosudil (NDA)
08/30/2021
FDA decision on Belumosudil for the treatment of chronic graft-versus-host disease
FDA approved Belumosudil for the treatment of chronic graft-versus-host disease on Jul.16, 2021-
Teva Pharmaceutical Industries Limited
(
TEVA)
AVT02 (BLA)
Sep 2021
FDA decision on AVT02, a proposed biosimilar to AbbVie’s Humira
-
Keytruda (sBLA)/Lenvima (sNDA)
09/03/2021
FDA decision on Keytruda plus Lenvima for the treatment of patients with advanced endometrial carcinoma
FDA approved the combination of Keytruda and Lenvima for the treatment of patients with advanced endometrial carcinoma on Jul.22, 2021-
Eisai Co. Ltd.
(ESALF.PK)
LENVIMA (sBLA)/KEYTRUDA (sBLA)
09/03/2021
FDA decision on Keytruda plus Lenvima for the treatment of patients with advanced endometrial carcinoma
FDA approved the combination of Keytruda and Lenvima for the treatment of patients with advanced endometrial carcinoma on Jul.22, 2021-
Bristol-Myers Squibb Co.
(
BMY)
Opdivo (sBLA)
09/03/2021
FDA decision on Opdivo as Adjuvant Treatment for Patients with Muscle-Invasive Urothelial Carcinoma
FDA approved Opdivo for the adjuvant treatment of patients with high-risk urothelial carcinoma on Aug.20, 2021-
IMPEL NEUROPHARMA INC
(
IMPL)
INP104 (NDA)
09/06/2021
FDA decision on TRUDHESA for acute treatment of migraine headaches with or without aura in adult patients
FDA approved TRUDHESA Nasal Spray for acute treatment of migraine on Sep.3, 2021
-
KEYTRUDA (sBLA)
09/09/2021
FDA decision on KEYTRUDA the treatment of patients with locally advanced cutaneous squamous cell carcinoma
FDA approved Keytruda as monotherapy for the treatment of patients with locally advanced cutaneous squamous cell carcinoma on Jul.6, 2021 -
Calliditas Therapeutics AB (publ)
(
CALT)
Nefecon (NDA)
09/15/2021
FDA decision on Nefecon for patients with IgA nephropathy
On Sep.14, 2021, the FDA notified the company that the decision on Nefecon has been extended to Dec.15, 2021-
Belzutifan (NDA)
09/15/2021
FDA decision on HIF-2a inhibitor belzutifan for patients with von Hippel-Lindau (VHL) disease-associated renal cell carcinoma (RCC), not requiring immediate surgery
FDA approved Belzutifan, under brand name Welireg to treat to treat von Hippel-Lindau (VHL) disease-associated tumors on Aug.16, 2021-
COMIRNATY (sBLA)
09/17/2021
FDA panel to review COMIRNATY for administration of a third dose, or “booster” dose, of the COVID-19 vaccine, in individuals 16 years of age and older.
On Sep.17, 2021, FDA panel recommended against approval of a third dose of COMIRNATY for general population but backed the the booster shot for people age 65 and older and other vulnerable Americans-
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.