September 18, 2025

The need-to-know this morning

Arvinas said it was abandoning efforts to market a breast cancer drug that it had originally developed with Pfizer, and that is currently under review by the FDA. Together, the companies will try to sell the drug, called vepdegestrant, to another company that might want to commercialize it.
Michael Langer, son of Bob Langer, raised $78 million for T.Rx Capital, his new venture capital fund.
Biogen acquired a small company called Alcyone Therapeutics that is developing an implantable device capable of delivering drugs into the spinal column. If successful, the device could become an alternative to repeated spine injections. Biogen is testing the device as a way to more conveniently deliver Spinraza, its medicine for spinal muscular atrophy.

pharma

Trump pressure on prices comes amid pharma tensions in U.K.

As President Trump pushes the U.K. to pay more for medicines, pharma giants are retreating from the country, with Merck, AstraZeneca, and others all bailing on or pausing major projects in short order.

“It’s looking like there’s a sort of contagion,” one Parliament member said this week of pharma’s retreat in a hearing called to discuss the country’s life sciences industry.

Industry argues that the U.K.’s cost-effectiveness agency undervalues cutting-edge drugs and rollout is too slow. Meanwhile, U.K. officials counter that National Health Service budgets are already stretched.

The standoff highlights a deeper shift as global drugmakers prioritize the U.S. and China, leaving the U.K. scrambling to keep its life sciences sector competitive, STAT’s Andrew Joseph writes.

artificial intelligence

AI helps GSK rethink drug development in COPD, MASH

GSK is using COPD as a proving ground for its AI-driven R&D strategy, STAT’s Brittany Trang writes. It’s using machine learning to blend trial data with genomic and single-cell analyses to uncover new mechanisms, shape combo therapies, refine trial design, and spot disease subtypes.

The same approach extends to liver diseases like MASH, where AI tools from the AI pathology company PathAI are replacing crude biopsy scores with continuous, granular readouts. This allows the creation of models that can predict long-term patient outcomes from short trials. The result, GSK executive Kaivan Khavandi told Brittany, is not just faster “go/no-go” drug decisions but sharper insights into which patients benefit, and how to improve or combine therapies for maximum impact.

Ultimately, AI helps GSK make better decisions on this basic question, according Khavandi. As he put it, it helps answer a key question: “Is this drug good and should it be advanced?”

gene therapy

Sangamo's Fabry gene therapy may face grim odds

Sangamo Therapeutics has failed to land a pharma partner for its Fabry gene therapy after two years of trying. Existing enzyme and “chaperone” drugs are blunting demand, FDA leadership shifts are casting doubt on accelerated approval, and the overall business case for gene therapy remains shaky, STAT’s Adam Feuerstein writes.

With cash running out by year’s end, a departing CFO, and a reputation for losing partners rather than securing them, CEO Sandy Macrae has little leverage, leaving investors skeptical that a deal will ever materialize, Adam says.

For more on this and other such things, sign up for Adam’s Biotech Scorecard here. (But you have to be a STAT+ subscriber.)

BIOTECH

Arsenal Bio lays off half of staff

From my colleague Jason Mast: CAR-T developer Arsenal Bio yesterday confirmed it has laid off 50% of its staff, part of a wave of cuts and closures faced by cell therapy companies over the last few years.

Launched in 2019 and partnered with Bristol Myers Squibb, Arsenal had announced a $325 million raise just last November. The company is developing CAR-Ts, an approach that has proven highly effective in certain blood cancers and in solid tumors in diseases such as kidney and prostate cancer. It has one program in trials but has yet to announce data. A spokesperson for Arsenal said the cuts were required to conserve resources to push its programs through clinical trials.

A raft of cell therapy biotechs have shuttered, laid off staff, sold themselves, or seen top executives leave as investor interest in speculative technologies has waned and as many of these startups struggled to show they could either push their CAR-Ts into new areas, such solid tumors, or demonstrate improvements over the first generation of blood cancer treatments.

real estate

Biogen breaks ground on new Kendall Square headquarters

Biogen this week broke ground on a 16-story, 580,000-square-foot headquarters in Cambridge’s Kendall Square, a milestone that coincides with the company’s upcoming 50th anniversary. The $1.3 billion project, part of MIT’s Kendall Common redevelopment, underscores Massachusetts’ role as a global biotech hub even amid industry headwinds and federal funding uncertainties.

Governor Maura Healey and MIT President Sally Kornbluth hailed the move as a vote of confidence in the state’s innovation economy, while CEO Christopher Viehbacher framed it as Biogen’s bet on the future of medicine and the company’s own transformation.

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