Past performance does not predict future results. Informational only, not investment advice.
CAPR has a Nov 22 PDUFA but the AdCom voted against the drug and the data hasn't changed. The November options chain prices risk more accurately than December, reflecting the binary ahead, though the stock has underperformed despite positive Phase 3 news.
FDA extended the PDUFA decision to Nov 22 instead of August ruling, accepting a narrowed indication to upper limb function based on amended BLA. With $544M cap, $238M cash, and 22 months runway, the company has no near-term liquidity pressure, though the AdCom still voted against the drug and outcome remains binary.
Capricor collapsed 100% post-negative AdCom (9-3 vote on Deramiocel) but trades near or below net cash (~$230M market cap vs. $279M gross cash). While CRL appears probable, the market appears to assign minimal value to the company's manufacturing platform and exosome pipeline; unexpected approval or regulatory alternative could trigger violent rerating.
End of results.