July 23, 2025

The need-to-know this morning

Roche is following its partner Sarepta Therapeutics and stopping shipments of the Duchenne muscular dystrophy gene therapy Elevidys in some countries, amid rising safety concerns surrounding the treatment.
An experimental oral treatment from Abivax helped ease symptoms at compelling rates in patients with a type of bowel disease in a pair of Phase 3 trials. Shares of the Paris-based drugmaker are soaring this morning.

financing

Sean Parker and ARCH launch a cancer biotech

A new biotech called Dispatch Bio launched today with the goal of developing a new, universal approach to try to treat any cancer using immunotherapy.

It just raised a Series A round, bringing in a total of $216 million to date. It's primarily backed by the Parker Institute for Cancer Immunotherapy, founded by entrepreneur Sean Parker, and ARCH Venture Partners.

The key to Dispatch's approach is a synthetic protein, called the "flare" antigen, which the company's therapy aims to install on every cancer cell in a patient's body. The company can then direct immunotherapies to attack that protein and kill the cancer carrying it, wherever it is in the body.

Read more from STAT's Angus Chen and Allison DeAngelis.

exclusive

FDA official suggests Sarepta unlikely to get drug back on market

Sarepta Therapeutics faces an "arduous and treacherous path" to try to get its gene therapy for Duchenne muscular dystrophy back onto the market, a senior FDA official exclusively told STAT, suggesting the treatment's license could be revoked.

Sarepta earlier this week said it would suspend shipments of the therapy, called Elevidys, following a request by the FDA amid concerns about liver safety.

The agency official, who spoke on condition of anonymity, did not rule out the possibility that Elevidys could eventually be brought back on the market. But it would be difficult for Sarepta to prove that any new safety protocols could eliminate the risk of liver injuries, the official added.

Read more from STAT's Adam Feuerstein and Jason Mast.

policy

FDA opens applications for new voucher program

The FDA posted a webpage yesterday allowing drug companies to indicate their interest in participating in a pilot voucher program that aims to cut product review times down to just one to two months. The agency will be choosing five companies in the first round.

The FDA announced last month that it would launch this program to reward companies whose actions align with certain policy priorities, including addressing unmet public health needs, beefing up domestic production of drugs, and delivering more innovative cures.

The webpage states that another "program priority" is increasing affordability, such as lowering drug prices in line with President Trump's most favored nation policy.

Critics say the voucher program raises concerns that the FDA is injecting politics into drug review decisions that should be centered around science, and that one to two months is not a sufficient amount of time to review new drugs.

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