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Dive into the Biopharma Space

Stay up-to-date on major biopharma news, deeper dives into specific companies and biopharma themes, and how it all relates to biopharma partners.

    • Aug 28
    • 2 min read

5 FDA Approvals for Small/Mid-sized Biopharma in Sept '24


FDA approvals are particularly important for small and mid-sized biopharma companies. Using our online platform we identified 5 FDA approval (PDUFA) dates for small and mid-sized biopharma in September 2024* (See Table 📸)


FIG 1. 5 Upcoming SMID-CAP PDUFAs



Check out our free PDUFA calendar


See below for more details regarding each of these PDUFAs.


*Bio/pharma companies that have 500 employees or less.



Travere Therapeutics (PDUFA 9/5/24)

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.


FIG. 2. Phase 3 PROTECT Study of FILSPARI.




Avadel Pharmaceuticals (PDUFA 9/7/24)

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.


FIG. 3. LUMRYZ Phase 3 REST-ON Trial Results




Vanda Pharmaceuticals (PDUFA 9/18/24)

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 the Expanded Access program.


FIG. 4. Gastroparesis Pooled Study: Efficacy of Tradipitant




Zevra Therapeutics (PDUFA 9/21/24)

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 a PDUFA date of Sep 21st for its NDA, Arimoclomol is poised to make significant impact on NPC patients.


FIG. 5. Study 002 of Arimoclomol.




Heron Therapeutics (PDUFA 9/23/24)

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.


FIG. 6. ZYNRELEF Vial Access Needle (VAN).



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Article History:

MV/RF (8/28/24)


Not legal, investing, or tax advice.

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