BioNTech pays US$205M for FDA voucher amid competition in oncology market

GERMANY—BioNTech has agreed to pay US$205 million to acquire an FDA priority review voucher (PRV) from Scholar Rock, securing a faster regulatory review for a future filing from its late-stage oncology pipeline.

The FDA awarded the voucher to Scholar Rock after approving Isembyld, its therapy for spinal muscular atrophy, in September.

It allows a drugmaker to reduce the FDA’s standard review period from 10 months to six months, potentially bringing a new treatment to market sooner.

BioNTech has not disclosed which candidate will benefit from the voucher.

However, its PD-L1xVEGF bispecific antibody pumitamig appears to be the most likely candidate.

Pumitamig emerges as the likely beneficiary

BioNTech considers pumitamig a central component of its oncology strategy.

The candidate attracted Bristol Myers Squibb (BMS) into a 50-50 co-development and co-commercialisation partnership.

BioNTech will lead US regulatory submissions as the market authorisation holder.

The acquisition comes as several pharmaceutical companies compete to develop PD-(L)1xVEGF bispecific antibodies for the immuno-oncology market, particularly as competition intensifies ahead of the post-Keytruda era.

BioNTech has also adjusted the design of its pivotal Rosetta Lung-02 trial in first-line non-small cell lung cancer (NSCLC), making progression-free survival, rather than overall survival, its sole primary endpoint.

This could allow the company to engage the FDA earlier on a potential regulatory submission.

The trial is expected to produce results in 2029, while the first global Phase III data for pumitamig are anticipated in 2028 from the Rosetta Lung-01 study in first-line extensive-stage small cell lung cancer.

Uncertainty surrounds other oncology candidates

Another advanced programme is trastuzumab pamirtecan (T-Pam), a HER2-targeted antibody-drug conjugate developed with DualityBio.

The candidate has generated pivotal data from a Phase II trial in previously treated endometrial cancer and a Phase III study in previously treated HR-positive, HER2-low breast cancer.

However, its commercial prospects have become less certain following disappointing results from the Dynasty-Breast02 trial.

BioNTech reported a modest progression-free survival benefit alongside higher rates of interstitial lung disease, including severe and fatal cases.

During its third-quarter earnings call, outgoing Chief Medical Officer Özlem Türeci said BioNTech and DualityBio were reviewing the full set of T-Pam’s clinical data across both indications to determine next steps.

The partners are also discussing a potential biologics licence application submission.

BioNTech’s other advanced candidate, gotistobart, a CTLA-4 antibody developed with OncoC4, is awaiting its first interim overall survival analysis from a Phase III trial in second-line squamous NSCLC.

Leerink Partners analysts expressed limited expectations for the upcoming results in a November 3 research note.

PRV prices rise amid limited supply

Neither T-Pam nor gotistobart appears to offer sufficient commercial justification for a US$205 million voucher purchase solely to shorten regulatory review.

This strengthens the possibility that BioNTech intends to reserve the voucher for pumitamig ahead of its anticipated regulatory milestones.

PRV prices have also increased amid sustained demand and limited supply.

Vouchers generally sold for US$150 million to $160 million last year, before Jazz Pharmaceuticals announced a $200 million transaction in January 2026.

More recently, Ultragenyx sold two rare paediatric disease vouchers for US$203 million and US$210 million, while Edetis Therapeutics agreed to sell its voucher for US$190 million.

These transactions, alongside the BioNTech deal, reflect growing demand for regulatory incentives that can accelerate drug development and market entry.

Although Congress extended the FDA’s Rare Pediatric Disease PRV programme through September 30, 2029, vouchers remain limited, supporting higher transaction values.

BioNTech’s decision to publicly identify itself as a buyer also provides investors with greater visibility into its regulatory strategy as the company navigates senior leadership changes and prepares for key clinical milestones.

Sign up HERE to receive our email newsletters with the latest news and insights from Africa and around the world, and follow us on LinkedIn for updates.