Benzinga
Published Nov 01, 2022 20:01
Updated Nov 01, 2022 21:10
Provention Bio's Second Try, Apellis's Eye Disorder Drug Review, 3 Adcom Verdicts And More: November's Key PDUFA Catalysts Biotech Investors Must Know
October proved to be a mixed month for the Food and Drug Administration’s regulatory decisions. Two new molecular entities, or NMEs, were approved during the month, bringing the tally for the year-to-date period to 28.
Among the NME approvals were Johnson & Johnson (NYSE: JNJ (NYSE:JNJ)) unit Janssen’s Tecvayli, a BCMA-targeting bispecific, for treating multiple myeloma in patients who have tried at least four prior lines of therapy. AstraZeneca (NASDAQ:AZN) plc’s (NASDAQ: AZN) tremelimumab-durvalumab combo received the nod for treating adult patients with inoperable hepatocellular carcinoma.
On the other hand, Amicus Therapeutics, Inc.'s (NASDAQ: FOLD) two-component drug for treating Pompe disease, characterized by severe muscle weakness, was rejected by the FDA.
Adcom decisions were mostly negative, with a panel postponing the meeting scheduled for discussing Ispen S.A.’s (OTC: IPSEY) palovarotene capsules to treat a condition in which muscle and connective tissue such as tendons and ligaments will be gradually replaced by bones. Shares of Y-mAbs Therapeutics, Inc. (NASDAQ: YMAB) plunged about 60% on Monday on a negative Adcom verdict.
A PDUFA, or Prescription Drug User Fee Act, date is the deadline fixed by the FDA to announce its verdict regarding the approvability or non-approvability of a drug. It is a binary catalyst that can trigger big stock swings.
Seagen Seeks Another Label Expansion For Its Blood Cancer Drug
Seagen is now seeking another expanded use for the drug. Adcetris is being evaluated in children and young adults with previously untreated, high-risk Hodgkin lymphoma.
In the recent quarter that ended in September, Adcetris fetched sales of $428 billion, up 17% year-over-year.
Can Travere Win FDA Nod For Rare Kidney Disorder Drug?
IgAN, aka Berger’s disease, is a rare kidney disorder characterized by the build-up of immunoglobin, which causes a breakdown of the normal filtering mechanisms, leading to blood and protein in the urine. It is the leading cause of primary glomerulonephritis, an end-stage kidney disease. More than 100,000 people in the U.S. are estimated to be suffering from the disorder.
Travere in-licensed the drug from Ligand, and an NDA submission by Travere will kick in a potential milestone payment of about $5.9 million for Ligand.
Provention Shrugs Off Hiccups And Looks To Take Its Diabetes Drug Past Finish Line:
The company resubmitted the application in January 2022, and it was accepted for review in March with a new PDUFA goal date of Aug. 17. In late June, the regulator came back and said it is extending the review period by three months.
Will FDA Overlook Panel Verdict On Spectrum’s Lung Cancer Drug?
There is no FDA-approved therapy for this condition. The product has a Fast Track designation. An FDA panel, which reviewed the drug in late September, voted 9-4 that its benefits do not outweigh the risks.
‘Go’ or ‘no-Go’ For Apellis’ Eye Disorder Drug?
Apellis said, citing estimates, that GA affects more than five million people worldwide and is the leading cause of blindness. It also noted that there is no currently approved therapy for GA.
See also: During The Pandemic Tuberculosis Deaths Increased, Reversing Years Of Decline: WHO Report
ImmunoGen Knocks FDA Altar For Antibody-Drug Conjugate To Treat Ovarian Cancer
The FDA accepted ImmunoGen’s BLA for review in late May.
SCYNEXIS Seeks To Expand The Use Of Vaginal Yeast Infection Drug:
Can FDA Lift Y-mAbs Stock That Plunged On Adcom Verdict?
Nevertheless, the FDA will look into the application; therefore, the PDUFA action date of Nov. 30 stays intact. The regulator typically takes into account Adcom’s discussions while making its decision, but is not bound to go with it.
Adcom Calendar
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