Two setbacks landed in the same day for drug developers, according to Endpoints News.
The US Food and Drug Administration has rejected a narcolepsy drug from Tris Pharma. Regulators laid out their decision in what the industry calls a Complete Response Letter (CRL) — the formal notice that a drug won't be approved in its current form. Endpoints News reports that the FDA's letter said "additional information will be necessary" before the agency can move forward. In plain terms, the drug isn't dead, but Tris Pharma will need to supply more data to get it over the line.
Separately, Agenus is walking away from a late-stage study. Endpoints News reports that the company is abandoning a Phase 3 trial in colorectal cancer (CRC) — the final and most expensive stage of testing before a drug can seek approval. Ending a trial at this point typically signals that the treatment was unlikely to show enough benefit to justify continuing.
Endpoints News notes that the same briefing carried developments involving several other drugmakers, including Insilico, Ipsen, Q32 Bio, GSK's Jemperli, Drug Farm and Padcev, though details on those items were not included here.
Why it matters: regulatory rejections and abandoned late-stage trials are among the costliest moments in drug development, and both news items signal delays or dead ends for treatments that patients and investors had been counting on.