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Rare disease clinical timelines slip without ceremony, and the specialty pharma sector absorbed another example on August 28.
Cumberland Pharmaceuticals (CPIX), listed on the NASDAQ Global Select Market, filed a Regulation FD disclosure with the SEC stating that long-term safety and efficacy data from the ongoing open-label extension of its Phase 2 FIGHT DMD trial of ifetroban, a novel oral therapy targeting Duchenne muscular dystrophy heart disease, is not yet available and will not be presented in August 2026, as the company had indicated at a patient advocacy conference two months prior.
Cumberland set the August expectation publicly at the annual Parent Project Muscular Dystrophy conference in Orlando, Florida on June 26.
A slide shown during that presentation indicated the open-label extension data was expected this month. Chief Financial Officer John Hamm signed the August 28 corrective filing. The company provided no revised date.
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