With accelerated approval in advanced urothelial cancer, the sponsors now have data that could support full approval plus a move into first-line therapy.

Plus deals involving Debiopharm/SunRock, RefleXion/3B Pharmaceuticals, Pharmanovia/Sanofi and more.

After a multi-year lull, NASH R&D has picked up this past year with key data readouts, several programs advancing toward Phase III and Madrigal's resmetirom under FDA review with a March 2024 action. This graphic provides a look at the overall status of NASH drug R&D.

BI’s global head of innovation Michel Pairet tells In Vivo that while unmet medical need is the pharma’s R&D priority, its main focus is bringing breakthrough therapy potential to patients, and it is taking aim at competitive spaces like metabolic health and cancer.

With a pair of Phase III setbacks due to high placebo response, Relmada reports positive efficacy and safety data from an open-label trial while awaiting data from two ongoing pivotal studies for REL-1017, an NMDA antagonist.

With a Phase II study stopped for efficacy in bleeding reduction, Anthos hopes to bring abelacimab, a dual Factor XI/XIa inhibitor to market to prevent strokes in a-fib patients and to treat cancer patients with thrombosis.