November 17, 2025

The need-to-know this morning

Johnson & Johnson said it is acquiring Halda Therapeutics, a developer of cancer drugs, for $3.05 billion. Halda's lead pipeline product is a treatment for prostate cancer.

china

WuXi AppTec thrives as U.S. eases pressure

After nearly two years under threat from Congress, WuXi AppTec is emerging stronger: U.S. lawmakers ultimately stripped company names from the BIOSECURE Act, defusing fears the Chinese contract research giant would be blacklisted. In fact, the company’s U.S. revenues surged 31.9% in the first nine months of 2025 even as China sales stalled, STAT contributor Brian Yang writes.

The growth reflects a broader reality — the American biopharma industry remains deeply reliant on WuXi’s R&D and manufacturing infrastructure and pushed hard against any rapid “decoupling.”

WuXi used the uncertainty to streamline, shedding several U.S. and European units, cutting headcount by 7%, and improving margins in its core chemistry business. It also continued to prioritize cross-border drug development as Chinese-sourced molecules increasingly fill Western pipelines.

cancer

Nuvalent's new ALK drug shows durable responses

Nuvalent said this morning that its next-generation ALK inhibitor, neladalkib, shrank tumors in about a third of patients with ALK-positive lung cancer who had exhausted other targeted treatments — and most of those responses were still holding a year later. In a 253-patient study, there was a 31% response rate among those taking the drug, with 64% of responses ongoing at 12 months, STAT’s Matthew Herper writes.

The data position neladalkib as a potential fast-follow option in a crowded but lucrative space long dominated by medicines like Roche’s Alcensa and Pfizer’s lorlatinib.

Nuvalent — which is also awaiting an FDA decision on its ROS1-targeted therapy — saw its shares jump in postmarket trading Friday after announcing it would be releasing new data today.

venture capital

European firms raise two big funds for early biotech

Two of Europe’s leading life sciences investors just closed sizable new funds, underscoring sustained global appetite for early-stage biotech despite a choppy fundraising climate. Sofinnova Partners raised €650 million (about $750 million) for its Capital XI fund — far above its initial target — to seed and scale young biotech and med tech companies across Europe and the U.S., pushing its total capital raised over the past year to €1.5 billion.

And Medicxi closed its own €500 million ($580 million) Fund V, meant to back and build drug development startups and support existing portfolio companies. Both firms drew strong commitments from blue-chip institutional investors worldwide, signaling confidence in Europe’s venture ecosystem.

gene editing

Scaling CRISPR trials calls for a new platform model

Bespoke gene-editing for ultra-rare diseases is edging toward viability — but only if regulators and industry embrace a true platform model, opines Fyodor Urnov, director of UC Berkeley’s Innovative Genomics Institute.

Recent FDA guidance inspired by Baby KJ, the young child who received a tailored CRISPR therapy at Children’s Hospital of Philadelphia, could let children with the same clinical syndrome be treated under one trial, even if each receives a slightly different editor.

“Today, there is fresh wind in our sails,” Urnov writes: Early approvals for liver and blood-based disorders may arrive within three years. But there’s still a bottleneck in AAV manufacturing, as well as in regulation. And the industry is still a bit hesitant. So to give “millions of families living with genetic diseases a better answer to the question ‘when will my child be next?’” he writes, “we cannot rest on any laurels for even a fraction of a second."