BioNTech: Maintaining "Strong Buy" After Part 1 Success Of Next-Gen Anti-CTLA-4 Gotistobart

BioNTech (BNTX) maintains a "Strong Buy" rating, driven by positive phase 3 data for gotistobart in 2nd-line squamous NSCLC patients. BNTX's gotistobart delivered a 63.1% 12-month OS rate versus 30.3% for docetaxel, reducing risk of death by 54%. Upcoming pivotal phase 3 PRESERVE-003 data in 2026 and expansion into ovarian and prostate cancers offer significant pipeline catalysts.

Seeking Alpha • Dec 9, 2025

BioNTech and Bristol Myers Squibb Present First Global Phase 2 Data for PD-L1xVEGF-A Bispecific Antibody Pumitamig Showing Encouraging Efficacy in Advanced Triple-Negative Breast Cancer

Global interim Phase 2 data in locally advanced/metastatic triple-negative breast cancer (”TNBC”) show encouraging antitumor activity for investigational therapy pumitamig (BNT327/BMS986545) plus chemotherapy in first- and second-line patients Pumitamig plus chemotherapy achieved confirmed objective response rate (cORR) of 61.5%, unconfirmed ORR (uORR) of 71.8% and disease control rate (DCR) of 92.3% irrespective of PD-L1 expression levels Data highlight the potential of pumitamig for patients with TNBC, including PD-L1 low or negative (CPS

GlobeNewsWire • Dec 9, 2025

BioNTech and OncoC4 Announce Clinically Meaningful Overall Survival Benefit for Selective Treg Modulator Gotistobart in Patients with Previously Treated Squamous Non-Small Cell Lung Cancer

Gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard chemotherapy and a manageable safety profile in sqNSCLC

GlobeNewsWire • Dec 6, 2025

BioNTech Achieves Minimum Condition in CureVac Exchange Offer

The minimum condition for the offer has been satisfied, with 184,071,410 shares of CureVac, representing approximately 81.74% of CureVac's issued and outstanding shares, tendered prior to the expiration of the initial offering period The subsequent offering period has commenced and will expire at 12:01 a.m. Eastern Time on Thursday, December 18, 2025   MAINZ, Germany, December 3, 2025 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that 184,071,410 shares of CureVac N.V.

GlobeNewsWire • Dec 3, 2025

Vaccine stocks take a hit as FDA official points to link between COVID-19 vaccines and rare heart condition in young men

Memo also reportedly mentions vaccines for flu and pneumonia.

Market Watch • Dec 1, 2025

FDA Plans to Tighten Vaccine Approvals Weigh on These Stocks

A report that vaccine approvals could be set to get stricter is pressuring shares of major vaccine makers.

Investopedia • Dec 1, 2025

Moderna, BioNTech Slammed After FDA Links Covid Shots To 10 Deaths

Moderna and other vaccine stocks tumbled Monday after an FDA director reportedly issued a memo that says Covid shots killed 10 children.

Investors Business Daily • Dec 1, 2025

BioNTech Shares Progress on Exchange Offer for CureVac Shares and Highlights December 3, 2025, at 9:00 a.m. Eastern Time Expiration

MAINZ, Germany, November 26, 2025 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced the approval of matters relating to the exchange offer (the “Offer”) for all outstanding shares of CureVac N.V. (Nasdaq: CVAC, “CureVac”) at the extraordinary general meeting (“EGM”) held by CureVac on November 25, 2025. At the EGM, over 99.16% of votes cast by CureVac shareholders were in favor of the proposals relating to the Offer. BioNTech expects to complete the pending Offer as soon as reasonably practicable.

GlobeNewsWire • Nov 26, 2025

BioNTech SE (BNTX) Discusses Oncology Innovation Strategy, Combination Therapies and Personalized Cancer Immunotherapies Transcript

BioNTech SE ( BNTX ) Discusses Oncology Innovation Strategy, Combination Therapies and Personalized Cancer Immunotherapies November 11, 2025 9:00 AM EST Company Participants Ugur Sahin - Co-Founder, CEO & Chair of the Management Board Özlem Türeci - Co-Founder, Chief Medical Officer & Member of Management Board Ilhan Celik Michael Wenger Ramón Zapata-Gomez - CFO & Member of Management Board Douglas Maffei - Vice President of Strategy & Investor Relations Annemarie Hanekamp - Chief Commercial Officer & Member of Management Board Conference Call Participants Daina Graybosch - Leerink Partners LLC, Research Division Tazeen Ahmad - BofA Securities, Research Division Jay Lee - Morningstar Inc., Research Division Akash Tewari - Jefferies LLC, Research Division Terence Flynn - Morgan Stanley, Research Division William Maughan - Clear Street LLC., Research Division Jae-Young Park Malcolm Hoffman - BMO Capital Markets Equity Research Asthika Goonewardene - Truist Securities, Inc., Research Division William Zhang Presentation Unknown Executive [Audio Gap] by Annemarie Hanekamp, our Chief Commercial Officer.

Seeking Alpha • Nov 17, 2025

BioNTech says collaboration with Pfizer remains unchanged

BioNTech said on Thursday that its collaboration with Pfizer has not changed, when asked to comment on a report that Pfizer is looking to sell its stake in the German biotech firm.

Reuters • Nov 13, 2025