BioNTech said on Friday that it and its partner, Genentech, a Roche unit, are ending the mid-stage study of autogene cevumeran, used alone after surgery, in certain high-risk stage II or III colorectal cancer patients.
- The company said an independent safety board found that continuing the trial was unlikely to demonstrate efficacy and recommended terminating it.
- A separate mid-stage trial pairing the same vaccine with Roche’s Tecentriq and chemotherapy after pancreatic cancer surgery is continuing as planned.
- Morgan Stanley called the news a negative for BioNTech, while BMO Capital called it “a clear setback.”
Shares of BioNTech (BNTX) tumbled 8% on Friday after the company halted a mid-stage trial of its personalized mRNA cancer vaccine in colorectal cancer, puncturing the optimism that had lifted the stock after Moderna and Merck’s melanoma win last week.
The stock is now on track for its worst day since early March.
What Happened?
In a filing with the Securities and Exchange Commission, BioNTech said it and its partner, Genentech, a Roche unit, are ending the mid-stage study of autogene cevumeran used alone after surgery in high-risk stage II or III colorectal cancer patients who still have circulating tumor DNA — a sign that leftover cancer cells may remain. The trial tested whether an individualized mRNA shot, given alone and without a checkpoint drug such as Tecentriq or Keytruda, could keep the cancer from coming back longer compared with a wait-and-see approach.
The company said an independent safety board found that continuing the trial was unlikely to demonstrate efficacy and recommended terminating it. There were no new safety signals.
In October, BioNTech had noted that the trial might not be effective. However, the independent board then concluded that the data was not sufficiently mature to draw conclusions on efficacy, and BioNTech decided to continue the trial.
Chief Medical Officer Özlem Türeci said the result was not what BioNTech hoped for. The company will analyze the data to refine who might benefit from similar treatments and termed mRNA a core oncology bet, especially in combinations. A separate mid-stage trial pairing the same vaccine with Roche’s Tecentriq and chemotherapy after pancreatic cancer surgery is continuing as planned.
BNTX’s Pipeline Goals
BioNTech is treating cancer as its main business again after the COVID vaccine boom faded. The Mainz company was built as an oncology company before Comirnaty, the Pfizer-partnered COVID shot, turned it into a cash machine. That windfall is now shrinking fast. Second-quarter 2026 revenue fell 59% to €105.6 million, mostly because demand for the COVID vaccine kept sliding in the United States and Europe. Management cut full-year 2026 sales guidance to €1.6–1.9 billion from €2.0–2.3 billion and is operating at a loss as it invests in late-stage cancer programs.
BioNTech does not currently have any approved or commercially available cancer drugs. The first cancer drug launches are slated for later this decade, if approved by regulators.
Wall Street Weighs In
Morgan Stanley called the news a negative for BioNTech, removing some of the pipeline optionality that cevumeran provided. Morgan Stanley has an ‘Overweight’ rating on BioNTech shares.
The firm views the read-through from the discontinued trial to Moderna and Merck as “more limited.” The firm added that the two companies’ mid-stage interim data in renal cell carcinoma, due in the second half of 2026 or 2027, as “the next key catalyst that we are watching” for clarity on the technology.
BMO Capital analyst Evan Seigerman called the discontinued trial “a clear setback.” The “outcome reduces confidence in the therapy and adjuvant monotherapy approach,” according to the analyst, who adds that read-through to the broader program is “negative but limited.”
BMO has an ‘Outperform’ rating and $128 price target on BioNTech.
After The Melanoma Rally, A Harder Test
On August 19, Moderna and Merck said their custom mRNA vaccine plus Keytruda met late-stage goals in melanoma after surgery, delaying the cancer’s return and spread. Moderna soared on the announcement, as did BioNTech’s shares, amid optimism about mRNA technology in cancer treatment. The optimism, however, faded on Friday. MRNA stock also traded down 4% at the time of writing.
How Did BNTX Retail Traders React?
On Stocktwits, retail sentiment around BNTX stock remained ‘bullish’ over the past 24 hours, while message volume was ‘high.’
A Stocktwits user opined that colorectal cancer is the most difficult to treat with mRNA Therapies but voiced optimism for the technology aiding the treatment of other cancers. “BNTX and even MRNA are cheap, given the potential,” they said.
View this Stocktwits post
According to data from Koyfin, 15 of the 20 analysts covering BNTX rate it ‘Buy’ or higher, while four rate it ‘Hold’ and one ‘Strong Sell.’ The stock has a 12-month average price target of $121.33, representing a potential upside of about 9% from its last closing price.
BNTX stock has gained 8% year-to-date.
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