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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
Sol-Gel Technologies Ltd.
(SLGL)
Epsolay topical cream (NDA)
04/26/2021
FDA decision on Epsolay for the treatment of inflammatory lesions of rosacea
-
Roche Holding AG
(RHHBY)
TECENTRIQ (sBLA)
04/27/2021
FDA panel review of granting full approval to TECENTRIQ in combination with paclitaxel protein-bound PD-L1 positive unresectable locally advanced or metastatic triple-negative breast cancer
FDA Oncologic Drugs Advisory Committee voted 7 to 2 in favour of maintaining accelerated approval of Tecentriq for PD-L1-positive, metastatic triple-negative breast cancer-
Protalix BioTherapeutics Inc.
(PLX)
PRX–102 (BLA)
04/27/2021
FDA decision on PRX–102 for the treatment of Fabry disease
Protalix Receives Complete Response Letter from FDA For PRX-102 on Apr 28, 2021-
Roche Holding AG
(RHHBY)
TECENTRIQ (sBLA)
04/28/2021
FDA panel review of granting full approval of TECENTRIQ for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy
FDA Oncologic Drugs Advisory Committee voted 10 to 1 in
favour of maintaining accelerated approval of Tecentriq
-
Merck & Co Inc.
(MRK)
Keytruda (sBLA)
04/28/2021
FDA panel review of granting full approval to Keytruda for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy
On April 28, an FDA panel voted 5-3 in favor of maintaining accelerated approval of KEYTRUDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy -
Ardelyx, Inc
(ARDX)
Tenapanor (NDA)
04/29/2021
FDA decision on Tenapanor for control of serum phosphorus in adult patients with chronic kidney disease on dialysis
FDA decision date extended to Jul.29, 2021-
Merck & Co Inc.
(MRK)
Keytruda (sBLA)
04/29/2021
FDA panel review of granting full approval to Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1
On Apr.29, an FDA panel voted 6 to 2 against the continued approval of Keytruda for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1-
Merck & Co Inc.
(MRK)
Keytruda (sBLA)
04/29/2021
FDA panel review of granting full approval to Keytruda for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
On April 29, an FDA panel voted 8-0 in favor of maintaining accelerated approval of KEYTRUDA for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib-
Bristol-Myers Squibb Co.
(BMY)
Opdivo (sBLA)
04/29/2021
FDA panel review of granting full approval to Opdivo as a single agent for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Four Committee members voted in favor and five voted against maintaining the accelerated approval of Opdivo while awaiting the results of potential alternate confirmatory trials.-
Roche Holding AG
(RHHBY)
Esbriet (sNDA)
May 2021
FDA decision on Esbriet for the treatment of unclassifiable interstitial lung disease
-

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