Plus, news about CSL Vifor, Akebia and Pan Cancer T:
Faron gets FDA go-ahead for streamlined registrational path: The company said the regulator “acknowledged the difficulties” of running a controlled Phase 3 trial in patients with relapsed and refractory myelodysplastic syndromes. It advised Faron to conduct a confirmatory test for bexmarilimab in the “significantly larger” frontline high-risk setting as part of Project FrontRunner, an FDA program that aims to facilitate earlier access to new cancer therapies. — Ayisha Sharma
Cara’s recent trial failure spurs search for options: The company is seeking strategic alternatives a few weeks after a mid-stage trial failed, spurring layoffs of 70% of the team. Cara did not expand on what options were on the table, with CEO Christopher Posner saying in a statement that it will explore “a range of strategic options.” Cara still has about $70 million in cash and equivalents on hand. — Max Bayer
CSL hands back US rights to Akebia’s anemia treatment: Akebia is regaining US rights to its anemia treatment, Vafseo, after CSL terminated an agreement to sell the drug to select dialysis centers. Akebia will still pay high-single-digit royalties of up to $450 million in net annual sales, and mid-single-digit royalties should annual sales exceed $450 million. Akebia has the option to buy down the royalty agreement beginning in July 2027. Vafseo was approved by the FDA in late March. — Max Bayer
Pan Cancer T raised €4.25 million in a seed extension round to support preclinical studies for its lead TCR-T cell product. Investors in the Rotterdam-based company include InnovationQuarter, Van Herk Ventures and Thuja Capital. — Jaimy Lee