BioNTech’s First Cancer Drug Faces FDA as €16.8 Billion War Chest Fuels a Risky Reinvention

The twilight of the Covid era is giving way to a moment of reckoning for BioNTech. The Mainz-based biotech is preparing to file for US approval of its first oncology asset, Trastuzumab Pamirtecan, by the end of 2026. That regulatory submission — targeting a broad swath of HER2-expressing cancers — will be the single most important catalyst in a year already packed with clinical readouts and a sweeping corporate overhaul.

Trastuzumab Pamirtecan has already won breakthrough therapy designation from the FDA after a Phase?2 trial in uterine cancer posted a response rate of nearly 48%. Patients in that study, all heavily pre-treated, recorded a median progression-free survival of 8.1 months. In the high-risk subgroup, tumour shrinkage exceeded 70% of cases. The drug’s edge over rival Enhertu lies in its activity across all HER2 expression levels, not just the highest, potentially closing a treatment gap that has left lower-expressing patients with few options. Approval has already been sought in China since April.

The filing represents far more than a single product launch. It is the centrepiece of a radical pivot that will see BioNTech abandon the Covid-19 vaccine franchise — still its only commercialised asset — and rebrand as a pure-play oncology house. To fund that ambition, the company sits on a cash pile of roughly €16.8 billion as of the end of March. That cushion is sorely needed: first?quarter revenue collapsed 35% year?on?year to €118.1 million, dragging the bottom line to a net loss of almost €532 million. No revenue from cancer drugs is expected before 2027.

Should investors sell immediately? Or is it worth buying BioNTech?

Management is spending aggressively to advance the oncology pipeline. By the end of 2026, BioNTech expects to have 15 Phase?3 studies running in parallel, with seven major data readouts due this year alone. Early signals from the ASCO congress in June have been encouraging: Pumitamig showed promising activity in lung cancer, and Gotistobart delivered stable survival rates in ovarian cancer. Positive Phase?3 results would be a powerful endorsement of the new strategy; disappointments would quickly erode the market’s patience.

To compound the internal restructuring, founders Ugur Sahin and Özlem Türeci are stepping back from the parent company by year?end to lead a separate, independent biotech venture. BioNTech will contribute technology in exchange for a minority stake, sharpening the parent’s focus on late?stage clinical work. In the meantime, a nearly €1 billion share buyback is under way to keep investors engaged while the oncology pipeline remains pre?revenue.

The market’s verdict so far is cautious. At €77.35, the stock has fallen roughly 15% over the past twelve months and trades 27% below its 52?week high of €105.80. The share price sits about 10% below its long?term moving average. Yet analyst pricing paints a more optimistic picture: the average target stands at €106.70. On Wall Street, the polarity is stark. UBS rates the stock a buy with a €118 target, while Canaccord Genuity sees fair value at €144. Bernstein, by contrast, strikes a defensive note with a “market perform” rating and a €87 price target.

The coming months will determine whether BioNTech can transform a fat bank account and a deep pipeline into genuine commercial traction. The FDA submission for Trastuzumab Pamirtecan is the clearest proof point yet that the company is serious about leaving its Covid past behind. Whether the market will ultimately reward that bet depends on the data — and on the ability to execute a reinvention that, by any measure, carries enormous risk alongside enormous promise.

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