BioNTech has agreed to pay $205 million to acquire an FDA priority review voucher (PRV) from Scholar Rock, securing an opportunity to shorten the regulatory review of a future drug application. The German biotechnology company said the voucher would support a future filing involving its late-stage oncology pipeline but did not identify the candidate.
The voucher allows a drug developer to reduce the FDA’s standard application review period from 10 months to six months. Scholar Rock received it following the September approval of its spinal muscular atrophy therapy Isembyld.
Pumitamig emerges as a potential beneficiary
BioNTech has not disclosed which oncology candidate it intends to use the voucher for. Based on its current pipeline, the PD-L1xVEGF bispecific pumitamig appears to be the most logical possibility.
The company has described pumitamig as a backbone for its oncology portfolio. Bristol Myers Squibb entered a 50-50 co-development and co-commercialization collaboration for the candidate, with BioNTech responsible for U.S. regulatory filings as the market authorization holder.
BioNTech has also changed the design of the Rosetta Lung-02 study, which is evaluating pumitamig in first-line non-small cell lung cancer. Progression-free survival, rather than overall survival, is now the trial’s single primary endpoint. This arrangement allows the company to begin discussions with the FDA about a potential filing before the study’s expected 2029 readout.
The first global phase 3 results for pumitamig are expected from Rosetta Lung-01 in first-line extensive-stage small cell lung cancer in 2028.
T-Pam faces further assessment
Another advanced oncology program is trastuzumab pamirtecan (T-Pam), a HER2-targeted antibody-drug conjugate developed with DualityBio. The candidate has produced two pivotal readouts: a phase 2 study in previously treated endometrial cancer and a phase 3 trial in previously treated HR-positive, HER2-low breast cancer.
The Dynasty-Breast02 trial showed what BioNTech characterized as a modest progression-free survival benefit. It also reported a higher incidence of interstitial lung disease than previously observed, including severe and fatal cases.
During BioNTech’s third-quarter earnings call, outgoing chief medical officer Özlem Türeci said the companies were evaluating the clinical data from both cancer types alongside changes in treatment and unmet medical needs.
“DualityBio and we are discussing plans for [biologics license application] submission and will update the markets accordingly,” she said.
A BioNTech spokesperson subsequently shared that no additional updates were available on T-Pam.
Gotistobart awaits interim analysis
BioNTech also expects an interim overall survival analysis this year from a phase 3 study of gotistobart, its OncoC4-partnered CTLA-4 antibody, in second-line squamous non-small cell lung cancer.
In a Nov. 3 note, Leerink Partners analysts said they had low expectations for the upcoming readout, interpreting BioNTech’s comments as indicating a high bar for success at the interim analysis.
Recent voucher transactions exceed $190 million
PRVs generally sold for approximately $150 million to $160 million last year before Jazz Pharmaceuticals disclosed a $200 million transaction in January 2026.
Ultragenyx recently sold two rare pediatric disease vouchers for $203 million and $210 million. Egetis Therapeutics, which is being acquired by Ani Pharmaceuticals, agreed to divest its voucher for $190 million.
The four recent transactions involve vouchers tied to FDA approvals granted in August or September, highlighting demand for the regulatory incentives.
Congress has extended the FDA’s Rare Pediatric Disease PRV program through Sept. 30, 2029. BioNTech’s disclosed purchase also differs from the usual practice of buyers keeping their identities confidential.
The transaction comes as BioNTech navigates a high-profile C-suite transition ahead of key pipeline milestones.
BioNTech Makes a Major Investment in Its Oncology Pipeline
BioNTech has agreed to acquire a U.S. Food and Drug Administration Priority Review Voucher from Scholar Rock for $205 million in cash. The company intends to use the voucher to support a future regulatory filing for an asset in its late-stage oncology pipeline. The transaction remains subject to customary closing conditions. BioNTech
The agreement highlights the importance of oncology to the long-term strategy of BioNTech. As the company advances multiple cancer programs, securing a potential pathway to a faster regulatory review could become an important advantage for a future product filing.
