BioNTech pays Scholar Rock $205 million to speed a cancer drug review

BioNTech, the German company that made its name on Covid-19 vaccines, is paying $205 million in cash for a single shortcut at the Food and Drug Administration. The Mainz-based drugmaker said on Tuesday it agreed to buy a priority review voucher from Scholar Rock, according to its statement, and plans to use it to support a future filing for a drug in its late-stage oncology pipeline. The price shows how much the company is willing to spend on speed as it bets its future on cancer medicines.

A voucher grants FDA priority review for one application, which shortens the target review timeline and could lead to an earlier approval. BioNTech did not name the drug it intends to use it on. The deal is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino antitrust law.

The purchase lands at a tight moment for BioNTech's budget. Demand for Covid-19 vaccines collapsed after the pandemic, and to pay for its costly pivot to oncology the company is closing its German production sites in Marburg, Idar-Oberstein and Tubingen by the end of 2028 after failing to find buyers, Handelsblatt reported. Cutting up to 1860 jobs is expected to save about 500 million euros a year from 2029, the paper said. BioNTech booked a net loss over the first nine months of the year, though it returned to profit in the third quarter thanks to a milestone payment from partner Bristol Myers Squibb.

Spending $205 million on a review voucher while closing factories is a clear statement of priorities. BioNTech describes its late-stage cancer pipeline as spanning immunomodulators, antibody-drug conjugates and mRNA cancer immunotherapies, and it works with partners including Bristol Myers Squibb, Genentech, Genmab and Pfizer. A faster FDA decision on its lead candidate could bring revenue forward by months, which matters more to a company that is shrinking its vaccine business.

For Scholar Rock, the sale turns a regulatory reward into cash. The FDA awarded the Cambridge, Massachusetts, company a rare pediatric disease voucher on Sept. 11, when it approved Isembyld, its treatment for spinal muscular atrophy, according to a summary of its 8-K filing. Scholar Rock signed the agreement with BioNTech's U.S. unit on Nov. 9. Isembyld is approved for people with SMA who are 2 years of age and older and already receive a treatment targeting the SMN2 gene.

The money arrives as Scholar Rock spends heavily on its launch. The company reported a third-quarter net loss of $107.2 million, compared with $102.2 million a year earlier, as it rolled out Isembyld in the U.S. It said it plans to expand access in up to 50 countries, subject to approvals, with a European opinion expected in the first half of 2027 and a Japanese application under priority review. "The third quarter was a defining period for Scholar Rock," chairman and chief executive David Hallal said in the company's results release, calling Isembyld the world's first and only muscle-targeted therapy for children and adults living with SMA.

As its name suggests, a rare pediatric disease voucher is a reward for bringing a drug for a rare childhood condition to market, and it can be sold. Scholar Rock gets non-dilutive cash without selling shares, and BioNTech gets to choose when to use its shortcut. Neither company disclosed which BioNTech program will benefit or when a filing might come.

What happens next depends on the antitrust waiting period and on BioNTech's oncology readouts. Once the deal closes, the voucher becomes one more tool in the company's push to turn its pandemic windfall into a durable cancer franchise. For more on the deals and approvals shaping medicine, see our Healthcare Sector and our report on Bayer's Sunharbo winning FDA approval.