Regeneron reports Phase 1/2 data for ubamatamab in low‑grade serous ovarian cancer
Regeneron Pharmaceuticals announced initial results from a Phase 1/2 trial of its bispecific antibody ubamatamab in 19 patients with recurrent, platinum‑resistant low‑grade serous ovarian cancer. Seventy‑three percent of patients receiving an 800 mg dose achieved an objective response, while all participants experienced treatment‑related adverse events. The company said it will discuss the data with the FDA and plans a single‑arm trial for regulatory approval followed by a Phase 3 study.
Why it matters
Regeneron’s stock fell after the data release, reflecting investor concern over the safety profile despite the high response rate. The company expects to file with the FDA and launch a Phase 3 trial, which could drive future revenue if the therapy gains approval.
Key facts
- 1The trial enrolled 19 patients with recurrent, platinum‑resistant serous ovarian cancer. gurufocus.com
- 2Patients receiving an 800 mg dose showed a 73% objective response rate. gurufocus.com
- 3All 19 participants experienced treatment‑related adverse events. tradingview.com
- 4Regeneron plans to initiate a single‑arm trial aimed at regulatory approval and a subsequent Phase 3 trial. gurufocus.com
- 5Regeneron’s current share price is $736.30. gurufocus.com
- 6GuruFocus assigns REGN a GF Value of $907.43, indicating an 18.9% margin of safety. gurufocus.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.