SMNR
Industry:
Pharma & Biotech

DESCRIPTION

Semnur Pharmaceuticals is a late-stage clinical biopharmaceutical company with a single pipeline asset: SP-102 (brand name SEMDEXA), a novel injectable gel formulation of dexamethasone sodium phosphate for the treatment of sciatica. Sciatica affects an estimated 4.8 million patients in the U.S., and while over 12 million epidural steroid injections (ESIs) are administered annually in the U.S. for back pain, no FDA-approved ESI product exists for sciatica — physicians instead use generic corticosteroids off-label, many of which carry FDA class warnings about serious neurological risks. SP-102 uses a non-particulate, soluble steroid suspended in a viscous gel that extends the drug's residence time at the injection site, potentially providing pain relief for up to approximately 100 days per injection, while eliminating the neurotoxic preservatives and particulates found in currently used products. SP-102 completed one pivotal Phase 3 trial (CLEAR-1), which met its primary endpoints, but the FDA requested a confirmatory trial. Semnur initiated a second Phase 3 trial (CLEAR-2) in September 2025, expects completion by 2027, and targets an NDA submission and commercial launch in 2028. Semnur has no commercial revenue today. If approved, SP-102 would be administered by pain specialists in clinical settings and reimbursed under a dedicated J-code. Semnur plans to leverage the commercial infrastructure of its majority owner, Scilex Holding, which has an existing sales force calling on over 6,000 pain specialists and neurologists. SP-102's key patents extend to 2036.

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