BioNTech has agreed to pay $205 million to purchase an FDA priority review voucher to support a future filing of a drug in its “late-stage oncology pipeline.”
The PRV currently belongs to Scholar Rock, granted through the FDA’s approval of the Massachusetts biotech’s spinal muscular atrophy therapy Isembyld in September. An FDA PRV allows a drug developer to shorten the FDA’s review timeline for an application from the standard 10 months to six months.
BioNTech declined to specify which oncology candidate it plans to use the PRV for. Based on the German company’s current pipeline, the PD-L1xVEGF bispecific pumitamig appears to be the most logical choice.
BioNTech has described pumitamig as a backbone for its oncology portfolio, having attracted Bristol Myers Squibb in a 50-50 co-development and co-commercialization collaboration. As the market authorization holder in the U.S., BioNTech will be responsible for regulatory filings to the FDA.
As a crowded list of PD-(L)1xVEGF bispecifics races for immuno-oncology dominance in the post-Keytruda era, BioNTech has been looking to accelerate pumitamig’s path to market as much as possible. These include revising the design for the high-stakes Rosetta Lung-02 study in first-line non-small cell lung cancer to make progression-free survival—rather than overall survival—the single primary endpoint. The set-up allows BioNTech to at least start a conversation with the FDA about a potential filing early.
As the Rosetta-Lung02 trial is advancing toward a potential readout in 2029, pumitamig’s first global phase 3 data are expected from the Rosetta Lung-01 trial in first-line extensive-stage small cell lung cancer in 2028.
Besides pumitamig, the most advanced program in BioNTech’s oncology pipeline is DualityBio-partnered trastuzumab pamirtecan (T-Pam). The HER2-targeted antibody-drug conjugate already has two pivotal readouts, one from a phase 2 trial in previously treated endometrial cancer and the other a phase 3 in previously treated HR-positive, HER2-low breast cancer.
However, the ADC’s future remains uncertain after lackluster results from the phase 3 Dynasty-Breast02 trial showed what BioNTech described as a “modest” progression-free survival benefit but a higher rate of interstitial lung disease than previously observed, including severe and fatal events.
During its third-quarter earnings call last week, BioNTech’s outgoing chief medical officer, Özlem Türeci, M.D., said the company and DualityBio are assessing the totality of clinical data for T-Pam across endometrial and breast cancer “within the context of the evolving treatment landscape and areas of unmet medical need” to determine its next steps.
“We and DualityBio are discussing plans for [biologics license application] submission and will update the markets accordingly,” she said.
A BioNTech spokesperson told Fierce on Tuesday that no additional updates are available on T-Pam.
Before the breast cancer readout, BioNTech’s chief commercial officer Annemarie Hanekamp told Fierce this summer that the company planned to leverage T-Pam to build out its oncology commercial capabilities and lay the groundwork for pumitamig.
Behind T-Pam, BioNTech also expects the first overall survival interim analysis this year from a phase 3 trial of its OncoC4-partnered CTLA-4 antibody gotistobart in second-line squamous NSCLC.
In a Nov. 3 note, Leerink Partners analysts said their expectations were low for this upcoming readout as BioNTech’s comment suggests a very high bar for success at this interim analysis.
Neither T-Pam nor gotistobart carries enough commercial significance to justify a $205 million PRV purchase just to shave four months off an FDA review.
Even though Congress recently extended the FDA’s Rare Pediatric Disease PRV program through Sept. 30, 2029, PRVs remain scarce on the market. By obtaining Scholar Rock’s freshly awarded voucher, BioNTech is seemingly securing regulatory acceleration for a key pipeline asset, pumitamig, years ahead of a potential FDA filing. The move could also remove uncertainties over potential future bidding wars over a limited supply of PRVs.
The cost of PRVs appears to be on the rise. PRVs were mostly sold at around $150 million to $160 million last year until Jazz Pharmaceuticals unveiled a $200 million sale in January 2026.
Before the BioNTech-Scholar Rock deal, Ultragenyx recently sold a pair of rare pediatric disease PRVs for $203 million and $210 million, respectively. Edetis Therapeutics, which is being acquired by Ani Pharmaceuticals, has also agreed to divest its PRV for $190 million.
All tied to FDA approvals granted in August or September, the four recent PRV transactions highlight the high demand for these regulatory accelerators.
The BioNTech deal also stands out as most PRV buyers keep their identity confidential for competitive reasons. The disclosure offers implicit reassurance to investors as the German biotech navigates a surprise, high-profile C-suite transition ahead of key pipeline milestones.