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BioNTech and OncoC4 Report Positive Phase 3 Trial Results for Gotistobart in Lung Cancer

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BioNTech and OncoC4 Report Positive Phase 3 Trial Results for Gotistobart in Lung Cancer

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BioNTech SE ( (BNTX) ) has provided an update.

On December 6, 2025, BioNTech SE and OncoC4, Inc. presented promising data from the non-pivotal dose-confirmation stage of their global Phase 3 trial, PRESERVE-003, for gotistobart, a tumor microenvironment-selective regulatory T cell depletion candidate. The trial demonstrated that gotistobart significantly reduced the risk of death by more than half compared to standard chemotherapy in patients with metastatic squamous non-small cell lung cancer (sqNSCLC), showing a clinically meaningful overall survival benefit and a manageable safety profile. The median overall survival for patients treated with gotistobart had not been reached at nearly 15 months of follow-up, compared to 10 months for those on chemotherapy. This development positions gotistobart as a potential chemotherapy-free alternative for sqNSCLC patients with high unmet medical needs, enhancing BioNTech’s standing in the oncology field.

The most recent analyst rating on (BNTX) stock is a Buy with a $151.00 price target. To see the full list of analyst forecasts on BioNTech SE stock, see the BNTX Stock Forecast page.

Spark’s Take on BNTX Stock

According to Spark, TipRanks’ AI Analyst, BNTX is a Neutral.

BioNTech’s overall stock score reflects a challenging financial performance with recent losses, offset by a strong balance sheet and strategic advancements in oncology. Technical indicators suggest a neutral trend, while valuation remains unattractive due to negative earnings. The earnings call provided positive guidance, but regulatory delays and financial losses remain concerns.

To see Spark’s full report on BNTX stock, click here.

More about BioNTech SE

Biopharmaceutical New Technologies (BioNTech) is a global next-generation immunotherapy company pioneering novel investigative therapies for cancer and other serious diseases. BioNTech utilizes a wide array of computational discovery and therapeutic modalities to rapidly develop novel biopharmaceuticals, with a diversified portfolio of oncology product candidates including mRNA cancer immunotherapies, next-generation immunomodulators, and targeted therapies.

Average Trading Volume: 1,004,629

Technical Sentiment Signal: Strong Sell

Current Market Cap: $23.14B

Find detailed analytics on BNTX stock on TipRanks’ Stock Analysis page.

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