Oct. 7 - Gene therapy optimism, MapLight’s shutdown workaround and Gilead’s Biktarvy deal

MapLight uses workaround to tee up IPO during government shutdown; Gilead delays arrival of Biktarvy copycats; CDC updates vaccine schedule; Biotech IPOs are the industry’s lifeblood. Track how they’re performing.; Skye shares crash as obesity drug falls short in key study

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Oct. 7, 2025 | Today’s news and insights for biopharma leaders

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Lexeo says FDA open to speedier approval of rare disease gene therapy

The agency will consider a submission that includes pooled data from ongoing studies, a decision analysts viewed as a notable, additional sign of regulatory flexibility for gene therapies.

MapLight uses workaround to tee up IPO during government shutdown

The company set terms for an offering with the help of a little-used section of the Securities Act that would enable its IPO to price automatically in 20 days.

News roundup

Gilead delays arrival of Biktarvy copycats; CDC updates vaccine schedule

A settlement could extend the exclusivity of the world’s best-selling HIV medicine to 2036. Elsewhere, an AstraZeneca drug acquisition paid more dividends and a Vertex veteran became Stoke’s full-time CEO.

The advantage of engaging patient recruitment partners as strategic allies, not emergency backups

The secret to on-time trials? Engaging recruitment partners early.

UPDATED

Biotech IPOs are the industry’s lifeblood. Track how they’re performing.

Should it price on the terms outlined Monday, MapLight’s offering would be the third-largest biotech IPO this year and the second consecutive one involving a CNS drug developer.

Skye shares crash as obesity drug falls short in key study

The findings are the latest setback for weight loss medicines that target a specific cannabinoid receptor and are meant to boost the effects of incretin therapies like Wegovy.

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