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After launching in April, Hunter syndrome drug Avlayah surprised analysts with a strong first quarter, as patients rush to get access to Denali Therapeutics’ new option.
Original title: “Denali climbs past Avlayah expectations with $3.6M in revenue”
Submission readiness extends beyond content. Early regulatory operations planning supports a compliant, high-quality application.
Original title: “Regulatory operations: The overlooked half of submission readiness”
Despite the recent emergence of a new drug class, schizophrenia remains one of the most challenging neuropsychiatric diseases to treat—and Cobenfy's first steps into the market indicate there is still room to grow.
Original title: “As BMS’ Cobenfy struggles to gain traction, MapLight knocks on the door”
While there are several FDA-approved psychiatric medicines on the market, many patients still struggle to achieve lasting symptom relief. Psychedelics could help fill this gap.
Original title: “Psychedelics on the cusp of market breakthrough as clinical, policy support grow”
Early indicators from a compassionate use plan led analysts to hike projections for daraxonrasib. Elsewhere, Intellia believes it’s answered a key safety question and Arrowhead moved to catch a rival.
Original title: “‘Significant’ demand for Revolution drug; Intellia pinpoints liver toxicity culprit”
Bristol Myers Squibb is the latest major drugmaker to tap Nvidia for more computing power, betting that larger models and AI agents can speed drug discovery.
Original title: “Why Big Pharma is chasing the industry’s most-powerful supercomputer”
Job postings increase and competition dips, according to BioSpace data.
Original title: “2026 Q2 Job Market Report: Job postings keep rising as fewer companies cut employees”
Alkeus brought to late-stage testing a Stargardt disease therapy that former executive chairman and Vertex founder Josh Boger once called, “if it works, the most perfect drug I’ve ever seen.”
Original title: “Alkeus, an unorthodox eye drug startup, acquired by Tarsus for up to $800M”
Schwartz will step into an agency that has been without a permanent leader for almost a year amid RFK Jr.’s tumultuous tenure as HHS chief.
Original title: “Erica Schwartz confirmed as next CDC director”
Led by serial biotech entrepreneur Greg Verdine, the startup mined fungi genomes to find a safer alternative to the drugs widely used to prevent the body from rejecting transplanted organs.
Original title: “With $263M, LifeMine unearths a new drug for organ transplants”
Since stepping in as Sanofi’s CEO in April, Belén Garijo has launched a deep look at the pharma’s pipeline, reassessing assets based on “scientific merit” and potential for long-term value in the quest for a Dupixent follow-up.
Original title: “Sanofi pauses mid-stage lung study amid new CEO’s ‘rigorous portfolio prioritization’”