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With positive feedback on a Phase 3 trial design, Ollin Biosciences has collected a $330 million series B to advance its VEGF/Ang2 antibody, which bested Genentech’s therapy in a head-to-head study.

Right after reporting a major Phase 3 LAG-3 miss that has rattled analysts, Regeneron Pharmaceuticals revealed a back-loaded partnership with Parabilis Medicines aimed at adding a new drug class to its early-stage pipeline.

The late-stage miss shakes analyst confidence in Regeneron’s clinical execution, according to BMO Capital Markets, also noting last year’s Phase 3 failure in chronic obstructive pulmonary disease.

Viridian Therapeutics’ elegrobart normalized the degree of eye protrusion and improved double vision in a Phase 3 study. The company plans to file for approval in the first quarter of 2027.

Corcept Therapeutics’ amyotrophic lateral sclerosis drug was linked to an 87% reduction in the risk of death, a result the biotech hopes to replicate in an upcoming Phase 3 trial.

• Confirmatory Phase 3 trial to commence prior to BLA grant under Accelerated Approval Program in the U.S. and Conditional MAA in the U.K., Europe and Australia • Patent pending pharmacodynamic response biomarker accepted as surrogate clinical efficacy endpoint • TGA and MHRA agree to allow utilization of remaining Phase 2b drug product for initiation of confirmatory Phase 3 • FDA and EMA fully align with Company on Chemistry, Manufacturing and Controls (CMC) • Market access process initiated with UK NICE and EU JCA

Many of the FDA’s decisions this quarter involve applications that have previously been delayed, declined or outright rejected, including one for an mRNA vaccine that became the center of controversy earlier this year.