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
Port Delivery System with Ranibizumab (BLA)
10/23/2021
FDA decision on Port Delivery System with Ranibizumab for the treatment of wet, or neovascular, age-related macular degeneration
FDA approved Port Delivery System with Ranibizumab, undwer brand name Susvimo, for wet age-related Macular Degeneration-
Takeda Pharmaceutical Company Limited
(TKPHF.PK,
TAK)
Mobocertinib (NDA)
10/26/2021
FDA decision on Mobocertinib for the treatment of adult patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutation-positive (insertion+) metastatic non-small cell lung cancer
FDA approved Mobocertinib, under brand name Exkivity, as a therapy for locally advanced or metastatic non-small-cell lung cancer in adults with EGFR exon20 insertion mutations on Sep.15, 2021-
MydCombi (NDA)
10/28/2021
FDA decision on pupil dilation agent MydCombi
FDA issued Complete Response Letter on Oct.25, 2021; MydCombi has been reclassified as a drug-device combination product-
ANI Pharmaceuticals, Inc.
(
ANIP,
BPAX)
Purified Cortrophin Gel(sNDA)
10/29/2021
FDA decision on Purified Cortrophin Gel for multiple indications including Multiple Sclerosis, Rheumatoid Arthritis, and Nephrotic Syndrome
FDA approved Purified Cortrophin Gel for multiple indications including Multiple Sclerosis, Rheumatoid Arthritis and Nephrotic Syndrome on Nov.1, 2021-
Bausch Health Companies Inc.
(
BHC, BHC.TO)
XIPERE (Resubmitted NDA)
10/30/2021
FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
FDA approved XIPERE for suprachoroidal use for the treatment of macular edema associated with uveitis on Oct.25, 2021 -
Clearside Biomedical, Inc.
(
CLSD)
XIPERE (Resubmitted NDA)
10/30/2021
FDA decision on XIPERE for Suprachoroidal Injection for macular edema associated with uveitis
FDA approved XIPERE for suprachoroidal use for the treatment of macular edema associated with uveitis on Oct.25, 2021 -
Eton Pharmaceuticals, Inc
(
ETON)
Topiramate oral solution (NDA)
11/06/2021
FDA decision on Topiramate oral solution for 3 indications
FDA approved EPRONTIA (topiramate) oral solution for 3 indications on Nov.08, 2021-
Liquidia Technologies Inc.
(
LQDA)
YUTREPIA (Resubmitted NDA)
11/07/2021
FDA decision on LIQ861 to treat pulmonary arterial hypertension
FDA granted tentative approval for YUTREPIA inhalation Powder (formerly LIQ861) on Nov.08, 2021-
Adamis Pharmaceuticals Corp
(
ADMP)
ZIMHI (naloxone) Injection (Resubmitted NDA)
11/12/2021
FDA decision on ZIMHI for the treatment of opioid overdose
FDA Approved ZIMHI for the treatment of opioid overdose on Oct 18, 2021.-
Biomarin Pharmaceutical Inc.
(
BMRN)
Vosoritide (NDA)
11/20/2021
FDA decision on Vosoritide for children with achondroplasia
FDA granted accelerated approval to Vosoritide, under brand name VOXZOGO, on Nov.19, 2021-
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