After talking with the FDA, Atox will file an NDA for its necrotizing soft tissue infections therapy despite missing primary endpoints in a pivotal trial, the biotech’s CEO tells Scrip.
Atox Bio aims to submit an New Drug Application for its necrotizing soft tissue infections (NSTI) therapy to US regulators in September under the accelerated approval pathway there despite the drug missing a composite primary endpoint in a pivotal study, results from which have just been released, the biotech’s CEO told Scrip.
Atox’s lead asset reltecimod is being evaluated in a Phase III trial called ACCUTE, which stands for AB103 Clinical Composite...
After posting encouraging Phase II results, the company plans to meet with the US FDA about using data from an ongoing Phase III study for an accelerated approval.
The UK firm's chronic obstructive pulmonary drug Ohtuvayre has been enjoying a stellar launch.
Coartem Baby to be rolled out in eight African countries in the autumn.
Apogee Therapeutics reports data from Phase II APEX trial of its long-acting antibody against atopic dermatitis, showing similar efficacy to Regeneron/Sanofi’s Dupixent and Eli Lilly’s Ebglyss.
KalVista’s Ekterly obtains US approval as the first oral, on-demand therapy for hereditary angioedema. It will compete with established injectables.
The biotech announced positive topline results from the Phase II SUMMIT study in non-advanced systemic mastocytosis, with data for advanced SM and GIST expected later this year.
Still holding out hope after multiple rejections for the tyrosine kinase inhibitor.
