Nuvation Bio Inc Ordinary Shares - Class A

The FDA granted safusidenib fast-track status for the treatment of IDH1‑mutated gliomas based on phase 2 data (confirmed objective response rate 51.9%, median progression‑free survival not yet reached, 36‑month PFS 79.1%). The designation enables more intensive interaction with the agency and a possible rolling review, reducing regulatory risk while the phase 3 SIGMA study continues to enroll. Cantor Fitzgerald initiated coverage with an “Overweight” rating and set a price target of 12 USD, with revenue forecasts of roughly 965 million USD for IBTROZI and about 1.9 billion USD for safusidenib. The news pushed the stock higher intraday (rise to 7.02 USD). » Plus sur de.investing.com

The FDA has granted fast-track designation to safusidenib, an oral investigational candidate from Nuvation Bio for the treatment of IDH1‑mutant gliomas. The decision is based on phase‑2 data (J201) showing a confirmed objective response rate of 51.9% and a 36‑month progression‑free survival of 79.1%; median PFS has not yet been reached. Nuvation is currently recruiting for the registrational phase‑3 SIGMA trial, which will evaluate safusidenib as maintenance therapy versus placebo after standard treatment in IDH1‑mutant astrocytomas with high‑risk features (about 300 patients). Safusidenib is a selective inhibitor of mutant IDH1 designed to penetrate the blood–brain barrier; no new long‑term safety signals have been reported. » Plus sur de.investing.com

Nuvation Bio reports a solid second quarter and cash of $661 million. JPMorgan initiated coverage with an "Overweight" rating and a $13 price target, supported by expected first-line uptake. The bank sees additional revenue potential in prevalence-driven gene sequencing and in the pipeline around Safusidenib; the company remains focused on targeted cancer therapies and has a strengthened capital base. » Plus sur finanzen.net