Nuvation Bio Inc Ordinary Shares - Class A

At the Cantor Fitzgerald Healthcare Conference, Nuvation Bio said IBTROZI reached roughly 20% of the theoretical ROS1 market in its first year and uptake in first-line therapy continues to grow. The company holds $700 million in cash and considers itself well positioned financially to fund commercialization and its pipeline. Safusidenib showed a 79% non‑progression rate and a 52% response rate at 3 years, and multiple studies are planned through 2029. Management forecasts a peak sales potential for IBTROZI of $4–5 billion at full market penetration, while warning of development risks and emphasizing disciplined capital deployment. » Więcej na de.investing.com

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). » Więcej na 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. » Więcej na de.investing.com