BioNTech Buys a Faster FDA Lane for $205 Million While a Dutch Court Finds Its Vaccine Infringes GSK's RNA Patent
Published on 11/13/2026 at 13:41 | Editorial boerse-global.de
BioNTech has agreed to pay $205 million in cash to acquire a priority review voucher from Scholar Rock, a regulatory asset the German biotech intends to attach to a future marketing application for a late-stage oncology candidate. The deal, announced Tuesday, remains subject to customary closing conditions, including antitrust clearance under the HSR Act.
The company has not disclosed which oncology program will carry the voucher, according to media reports from Wednesday. Scholar Rock came by the voucher through the FDA's approval of its Apitegromab therapy. The arrangement covers a voucher earmarked for a future filing — not an approval already granted for a cancer medicine.
A Patent Setback in The Hague
Separately, the Hague division of the Unified Patent Court ruled Tuesday that BioNTech and Pfizer infringed a GSK patent covering RNA delivery with their Comirnaty vaccine. The court ordered the two companies to pay provisional damages of €2 million.
Enforcement of the injunction has been deferred pending a final decision, with a three-month window factored in for the parties to reach a licensing agreement, according to media reports. The judgment therefore pairs the provisional damages with an injunction that is not immediately enforceable.
Should investors sell immediately? Or is it worth buying BioNTech?
BioNTech shares slipped 2.7% yesterday. The report on the patent ruling does not establish a causal link between that decline and the court's decision.
Third-Quarter Earnings and a Raised Outlook
Last week BioNTech published results for the third quarter of 2026, posting revenue of €1.29 billion and a net profit of €184.5 million under IFRS. Alongside those figures, the company lifted its full-year revenue guidance and now expects between €1.7 billion and €1.9 billion for 2026 — an upgraded range, distinct from the quarterly results already booked.
The nine-month picture is less flattering. BioNTech reported revenue of €1.51 billion for the first three quarters and an IFRS net loss of €1.17 billion. Guidance for adjusted research and development costs and for adjusted selling and general administrative expenses was left unchanged.
BioNTech at a turning point? This analysis reveals what investors need to know now.
Handelsblatt linked Tuesday's agreed payment to BioNTech's cost-reduction program and to the loss recorded over the first nine months of the year.
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