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With the failure in chronic spontaneous urticaria, Evommune’s story is now centered on its anti-IL-18 therapy EVO301, Oppenheimer said, which in February elicited a 33% placebo-adjusted improvement in eczema severity.
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Recent approvals for Corcept Therapeutics and Merck have injected momentum into the space, where GSK, Allarity Therapeutics, OSE Immunotherapies and others are advancing their own candidates.
The FDA plans to hold an advisory committee meeting to discuss Capricor Therapeutics’ application for deramiocel, which the agency rejected last July. The news surprised CEO Linda Marbán, who told BioSpace the FDA has not communicated any issues of concern with the company’s resubmitted application.
Dealmaking across biopharma is shifting dramatically as the SEC rolls out new regulations to ease burdens on newly public companies and antitrust review is replaced by drug pricing as the policy concern du jour.
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If cell and gene therapy makers are going to achieve their mission to improve patients’ lives, the industry must come together to share information across stakeholders, from regulators to manufacturers to payers.
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Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026.
Regulatory uncertainty is no longer background noise. It is a material investment risk that reshapes how capital is deployed and pipelines are prioritized.
An analysis finds that pharmas frequently file multiple similar patents on drugs, then use them as the basis for questionable litigation against would-be competitors.
Disc Medicine’s leadership tried to express optimism that its rare disease therapy bitopertin can be approved based on a Phase 3 trial set to begin shortly. However, analysts are worried that the protocol was developed with former FDA leaders.
Evidence of durability of psilocybin-based COMP360 is a key point for the FDA, according to Compass Pathways Chief Medical Officer Guy Goodwin. By providing 26 weeks’ worth of such data instead of the requested 12, the company is delivering “in spades,” he said.
Competing with giants like Takeda and Moderna, the plucky biotech believes it has unlocked a future with an easy, yearly oral vaccine.
Following the successful late-stage study in wet age-related macular degeneration, Ocular plans to meet with the FDA to determine a regulatory path for Axpaxli.
Johns Hopkins’ Thomas Hartung discusses how drug discovery and development will change under evolving regulatory policies that embrace AI technology as well as organoid and other non-animal models of human biology.
The limited supply of this common reagent is set to drive drug prices higher, but there are ways for companies to lessen the impact.
Suppliers are investing in production to support deals with AstraZeneca, Bayer and other drugmakers that are advancing radioisotope-based cancer therapies.