5 Upcoming Smid-cap PDUFAs in September
We used our BPIQ platform to identify upcoming smid-cap biopharma PDUFAs next month. We found 5 of them! See the table and text below for more details, including which of those we think will be the biggest stock movers.
FILSPARI (sparsentan) could become a key treatment for IgA nephropathy (IgAN). FDA has granted Priority Review to its sNDA, with PDUFA target action date of Sep 5th. It demonstrated significant reductions in proteinuria & preservation of kidney function in the PROTECT study. FILSPARI inhibits both endothelin and angiotensin II receptors.
LUMRYZ (sodium oxybate) is a GABA-B receptor agonist and a once-nightly treatment already approved for narcolepsy in adults. FDA is currently reviewing an sNDA for its use in pediatric narcolepsy with Sep 7th assigned PDUFA . If approved, LUMRYZ could offer a more convenient treatment option for children and their families.
Tradipitant, a novel NK-1R antagonist for gastroparesis awaits FDA approval by Sep 18th. If approved, it will be the first new drug for gastroparesis in over 40 yrs. NDA submission includes results from efficacy studies, evidence from large 12-week open label study & data from Expanded Access program.
Arimoclomol, a potential first-line treatment for Niemann-Pick disease type C (NPC). It works as a Heat-Shock Protein (HSP) amplifier to help reduce lipid buildup in cells and improve lysosomal function. With favorable GeMDAC vote on Aug 2nd and PDUFA date of Sep 21st for its NDA, Arimoclomol is poised to make significant impact on NPC patients.
FDA accepted Heron’s Prior Approval Supplement (PAS) application for the ZYNRELEF Vial Access Needle (VAN) with PDUFA goal date of Sep 23rd. If approved, VAN could simplify the preparation and administration of ZYNRELEF, which is a dual-acting local anesthetic approved for various surgical procedures to reduce postoperative pain.
Which 2 of these September 2024 PDUFAs do we think will move these stocks the most? 👇
📌 VNDA (Tradipitant)
📌 ZVRA (Arimoclomol)
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This article is not investment, tax, or legal advice. Please do your own diligence and seek advice from professional advisors representing your interests.
Article history:
First published 08/28/24 AV & EJV