BioNTech’s Cancer Pipeline Steals the Show as COVID Vaccine Woes Mount

The narrative around BioNTech is undergoing a quiet but decisive shift. While the Mainz-based biotech’s legacy COVID-19 vaccine business sputters, its oncology ambitions are increasingly capturing investor attention. The stock has climbed nearly 17% over the past month, closing Friday at €89.40, as market participants place their bets on a strategic pivot that is starting to deliver tangible results.

The rally marks a notable recovery from the lows seen after a turbulent set of first-quarter numbers in March. For analysts, the move signals that the market is beginning to price in the company’s future as a cancer specialist rather than a pandemic-era vaccine play. Year-to-date, the shares are up more than 8%, though they remain roughly 16% below their 52-week high from April 2025.

Promising Data from the Oncology Front

Fresh momentum arrived last week in the form of positive clinical data. Together with partner DualityBio, BioNTech unveiled encouraging results from a Phase 2 study of its antibody-drug conjugate candidate BNT323/DB-1303, which targets advanced endometrial cancer. The objective response rate across all patient groups hit nearly 48%, while median progression-free survival clocked in at 8.1 months.

The drug already holds Fast Track designation from the U.S. Food and Drug Administration, and the latest efficacy figures bolster the company’s plan to file for approval by the end of 2026. The candidate, known as Trastuzumab Pamirtecan, also carries Breakthrough Therapy status from the FDA, with Phase 3 trials already underway and a Biologics License Application penciled in for next year.

COVID Vaccine Stumbles

On the other side of the ledger, the company’s former flagship business continues to face headwinds. Pfizer and BioNTech recently pulled the plug on a large U.S. study of their updated COVID-19 vaccine in healthy adults aged 50 to 64. The reason: sluggish enrollment made it impossible to generate the placebo-controlled data the FDA had demanded for this age group. The agency had insisted on extensive trials before granting a full recommendation, and the study’s collapse effectively pushes any expanded approval for this demographic far into the future.

“Without the data, there will likely be no presentation. And without a presentation, possibly no specific approval for this age group,” said Jesse Goodman, former chief scientist at the FDA. The setback comes just ahead of a scheduled May meeting of the FDA’s advisory committee, which is expected to influence strain selection for autumn vaccines.

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

The broader COVID franchise is under pressure from weak demand, a net loss for 2025, and a guidance that calls for lower revenue in 2026 alongside rising R&D and sales costs. Currently, no COVID vaccine holds full FDA approval for healthy adults in the 50-to-64 bracket.

Analyst Views Diverge

Wall Street remains split on BioNTech’s trajectory. Morgan Stanley has nudged its price target slightly higher to $126 from $125, maintaining an “Overweight” rating as part of a broader biopharma coverage review. The firm points to industry data that supports the oncology pivot.

But the range of analyst opinions tells a story of deep uncertainty. Canaccord’s John Newman sees a target of $171, while TD Cowen’s Yaron Werber sets the bar at just $94 — two fundamentally different bets on how quickly BioNTech can transition from COVID to cancer.

What’s Next: Earnings and a Shareholder Vote

The next major catalyst arrives on May 5, 2026, when BioNTech reports first-quarter results. Analysts are forecasting a loss of $2.52 per share. The focus will be on whether management reaffirms its full-year guidance, which calls for total revenue of up to $2.5 billion — with the clear caveat that future growth depends heavily on the oncology pipeline.

Meanwhile, the company’s annual general meeting will feature a vote on authorizing the issuance of up to roughly 129.5 million new shares. The move would give management additional flexibility to fund late-stage studies and new programs, signaling that the transformation from vaccine maker to cancer drug developer will require significant capital.

Beyond oncology, BioNTech is also making progress with mRNA-based vaccine programs targeting malaria and Mpox, demonstrating the breadth of its platform. A substantial cash pile, along with strategic partnerships including one with Bristol Myers Squibb, provides a buffer as the company navigates this transition — even if the path ahead is paved with earnings pressure and clinical risk.