July 10 - Cargo agrees to Concentra buyout

July 10 - Cargo agrees to Concentra buyout | A new FDA policy on CRLs

FDA, in policy shift, publishes some drug rejection letters; Protein degraders: chasing undruggable targets

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Gene Therapy weekly

July 10, 2025 | This week’s gene therapy news and insights for biopharma leaders

TRENDLINE

The Bumpy Road Ahead For Cell Therapies

FDA staff cuts and significant turnover at the office regulating cell therapies have heightened pressure on developers. Explore the state of the market and what the future holds in this Trendline.

Cargo agrees to Concentra buyout after trial setback, layoffs

The cell therapy developer, which raised nearly $500 million in 2023 on the promise of its CAR-T work, has floundered since a safety setback forced it to scrap its lead candidate.

FDA, in policy shift, publishes some drug rejection letters

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving medicines that it later cleared.

UPDATED

Protein degraders: chasing undruggable targets

Some two dozen biotech developers of PROTACs, molecular glues and other types of protein-degrading drugs have sprung up over the past two decades.

TRENDLINE

The uphill road ahead for cell therapies

FDA staff cuts and significant turnover at the office regulating cell therapies have heightened pressure on developers, many of whom have already shifted strategies. Explore what the future holds for the market in this Trendline.