Mereo BioPharma (ADR)

Mereo BioPharma has entered an option and license agreement with Sentynl Therapeutics (a subsidiary of Zydus Lifesciences) for alvelestat, an oral investigational drug for alpha‑1 antitrypsin deficiency‑associated lung disease. Sentynl can acquire U.S. commercial rights and worldwide manufacturing rights; Mereo retains commercial rights for the rest of the world and will lead the global phase‑3 study and regulatory interactions through study completion. If the option is exercised, Mereo will receive a non‑refundable option fee, up to USD 40 million in up‑front/R&D payments, up to USD 435 million in milestones, and tiered double‑digit percentage royalties on U.S. net sales; a study start in early 2027 is possible. As of 30 June 2026 Mereo held USD 30.1 million in cash and reported a net loss of USD 7.0 million for Q2/2026; the company expects funding to last until the end of 2027 without payments from the Sentynl agreement and also reports ongoing regulatory discussions on setrusumab with Ultragenyx. » Mais em de.investing.com

Mereo BioPharma shares plunged about 90% after the phase-3 trials ORBIT and COSMIC for Setrusumab missed their primary endpoints for reducing fracture rates in osteogenesis imperfecta. Secondary endpoints did show significant improvements in bone mineral density but could not prevent investor losses. CEO Dr. Denise Scots-Knight announced further analyses, cost cuts for pre-commercial activities and continued partner talks for other programs such as Alvelestat. Mereo reported a cash balance of $48.7 million as of Q3 2025 and emphasizes strict cost control during the data analysis. » Mais em de.investing.com

Mereo BioPharma and Ultragenyx are proceeding as planned with the phase 3 study of UX143 (setrusumab) for the treatment of osteogenesis imperfecta, after the Data Monitoring Committee confirmed an acceptable safety profile. The final evaluation of the study is expected towards the end of the year, with safety in younger patients consistent with previous findings. Final analyses will be conducted after at least 18 months of patient treatment. » Mais em de.investing.com