After a tough rejection from federal regulators, Watertown biopharmaceutical player Disc Medicine, the company behind experimental EPP drug bitopertin, has cut roughly one in five jobs as it pulls back on commercial plans. Employees and local reporting say the reductions amount to about 20 percent of the company's headcount and include members of the commercial and corporate teams. The move comes on the heels of a regulatory setback in which the U.S. Food and Drug Administration declined to accept Disc’s accelerated application for the drug.
According to the Boston Business Journal, Disc told staff on March 2 that roughly 20 percent of roles would be eliminated, with the reductions primarily hitting commercial operations and corporate functions. The outlet reported that the cuts follow the agency's review outcome earlier this month and noted that the company did not immediately provide a more detailed headcount breakdown to local reporters.
FDA setback leaves APOLLO as the path forward
The FDA issued a Complete Response Letter for the bitopertin NDA, concluding that earlier trials showed the drug lowered the PPIX biomarker but did not demonstrate a clear association between PPIX reductions and the sunlight-exposure outcomes measured in those studies. As detailed in a company press release via GlobeNewswire, Disc said the ongoing Phase 3 APOLLO trial could provide the evidence the FDA wants and that topline APOLLO results are expected in Q4 2026, with an updated FDA decision possible by mid-2027.
Cash, commercial build and local impact
Disc has told investors it ended 2025 with about $791.2 million in cash, cash equivalents and marketable securities and that this position gives the company runway into 2029, according to company materials filed with the SEC. At the same time, management acknowledged higher selling, general and administrative spending to establish a commercialization infrastructure last year, an expense base the company now appears to be trimming with targeted staff reductions. For Watertown, that means a pause in the hiring surge that accompanied the company’s pre-launch buildout.
What to watch next
Patients, investors and local employees will be watching the APOLLO topline readout and any follow-up meeting with the FDA for signs the program can be salvaged and commercial plans restarted. CEO John Quisel said in the company release that the CRL “will delay the potential approval of bitopertin, but we have confidence in the ongoing APOLLO trial,” underscoring that management plans to press on with the study. In the near term, the cuts shrink the commercial footprint Disc had assembled while regulators wait for more definitive Phase 3 evidence.
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