Medicus Pharma Files Seamless Phase 2b/3 Protocol for Teverelix, Cutting Enrollment to ~600
MDCX is trading near its 52-week low of $0.144 (7.4% above the low) on light trading volume (0.3× avg).
Summary
Medicus Pharma submitted an optimized seamless Phase 2b/3 protocol to the FDA for Teverelix in advanced prostate cancer. The redesign cuts planned enrollment from ~1,500 to ~600 patients, with a stage-gated approach (~80 then +~528) and a cardio plaque endpoint via 12-month CCTA. This follows the July FDA feedback and IRB approval for an optimized Phase 2 study, and the September decision to narrow SkinJect to Gorlin syndrome. The smaller, gated trial reduces cost and time to registration, and the company explicitly intends to out-license the APC program, aligning with its capital-light strategy amid going concern doubts and a $15.2M cash position. FDA acceptance of the protocol and a signed partnering deal with funding commitments would be the next major milestones.
At the time of this announcement, MDCX was trading at $0.15 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $9.6M. The 52-week trading range was $0.14 to $2.78. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Wiseek News.