BioNTech SE (BNTX)
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BioNTech SE, a biotechnology company, develops and commercializes immunotherapies for cancer and other infectious diseases. The company is developing FixVac product candidates, including BNT111, which is in Phase II clinical trial for advance melanoma; BNT112 that is in Phase I/IIa clinical trial for prostate cancer; BNT113, which is in Phase II clinical trial to treat HPV+ head and neck cancers; BNT114 that is in Phase I clinical trial for triple negative breast cancer; BNT115, which is in Phase I clinical trial in ovarian cancer; and BNT116, a preclinical stage product for non-small cell lung cancer. It also develops neoantigen specific immunotherapies, such as Autogene cevumeran (BNT122), which is in Phase II clinical trial for first-line melanoma, as well as in Phase 1a/1b clinical trial to treat multiple solid tumors; mRNA intratumoral immunotherapy comprising SAR441000 that is in Phase I clinical trial for solid tumors; and BNT141 and BNT142 that are in Phase I clinical trial to treat multiple solid tumors. In addition, the company develops RiboCytokines, which include BNT151, BNT152, and BNT153 to treat solid tumors; chimeric antigen receptor T cell immunotherapies, such as BNT211 to treat multiple solid tumors, and BNT221 for other cancers; and checkpoint immunomodulators consisting of GEN1046 and GEN1042, which are in Phase I/II clinical trial to treat solid tumors. Further, it develops BNT321, an IgG1 monoclonal antibody in Phase II clinical trial for pancreatic cancer; BNT411, a small molecule immunomodulator product candidate for solid tumors; prophylactic vaccine for COVID-19 and Influenza; and infectious disease immunotherapies and rare disease protein replacement therapies. The company has collaborations with Genentech, Inc.; Sanofi S.A.; Genmab A/S; Pfizer Inc.; Shanghai Fosun Pharmaceutical (Group) Co., Ltd.; and Regeneron Pharmaceuticals, Inc. BioNTech SE was incorporated in 2008 and is headquartered in Mainz, Germany.
NEWS

FDA Weighs Black Box Warning For COVID Vaccines, Experts Push Back
feeds.benzinga.com
2025-12-12 13:51:10FDA officials are weighing a black box warning for Covid vaccines, a proposal that has drawn strong criticism from outside experts citing lack of evidence.

Moderna Sounds the Alarm: Is China About to Seize the Biotech Crown from the U.S.?
gurufocus.com
2025-12-11 14:03:00Investors watching the global biotech race may be sensing a shift after Moderna (MRNA) co-founder and chairman Noubar Afeyan suggested the US could be losing mo

BioNTech: Maintaining "Strong Buy" After Part 1 Success Of Next-Gen Anti-CTLA-4 Gotistobart
seekingalpha.com
2025-12-09 17:54:23BioNTech (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.

BioNTech-Bristol Drug Shows Hope For Breast Cancer Patients With Few Options
feeds.benzinga.com
2025-12-09 12:38:20BioNTech and Bristol Myers Squibb share positive data from Phase 2 trial of pumitamig plus chemotherapy for triple-negative breast cancer.

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
globenewswire.com
2025-12-09 07:00:00Global 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

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
globenewswire.com
2025-12-06 15:30:00Gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard chemotherapy and a manageable safety profile in sqNSCLC

BioNTech Achieves Minimum Condition in CureVac Exchange Offer
globenewswire.com
2025-12-03 09:01:00The 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.

Dow Jones Today: Stock Indexes Close Lower to Begin December Trading; Big Tech, Crypto-Tied Shares Drop Amid Risk-Off Sentiment
investopedia.com
2025-12-01 20:00:43Major stock indexes pulled back as the final trading month of the year began, with shares of big tech and cryptocurrency-tied firms falling amid risk-off sentiment.

FDA Plans to Tighten Vaccine Approvals Weigh on These Stocks
investopedia.com
2025-12-01 15:50:42A report that vaccine approvals could be set to get stricter is pressuring shares of major vaccine makers.

Vaccine stocks take a hit as FDA official points to link between COVID-19 vaccines and rare heart condition in young men
marketwatch.com
2025-12-01 12:35:00Memo also reportedly mentions vaccines for flu and pneumonia.

Moderna and Novavax Stocks Drop as FDA Proposes Stricter Vaccine Approvals
barrons.com
2025-12-01 09:59:00The FDA's top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.

BioNTech Shares Progress on Exchange Offer for CureVac Shares and Highlights December 3, 2025, at 9:00 a.m. Eastern Time Expiration
globenewswire.com
2025-11-26 07:30:00MAINZ, 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.

BioNTech SE (BNTX) Discusses Oncology Innovation Strategy, Combination Therapies and Personalized Cancer Immunotherapies Transcript
seekingalpha.com
2025-11-17 18:17:09BioNTech 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.

Allianz SE Buys 5,080 Shares of BioNTech SE Sponsored ADR $BNTX
defenseworld.net
2025-11-14 04:03:19Allianz SE grew its position in BioNTech SE Sponsored ADR (NASDAQ: BNTX) by 635.0% in the second quarter, according to its most recent filing with the SEC. The fund owned 5,880 shares of the company's stock after acquiring an additional 5,080 shares during the period. Allianz SE's holdings in BioNTech were worth $626,000

Pfizer sheds BioNTech stake years after blockbuster COVID vaccine tie-up
reuters.com
2025-11-13 17:20:40Pfizer Inc said on Thursday said that it will sell 54.7% of its stake in German drugmaker BioNTech SE , over five years after both firms formed an alliance that yielded a vaccine to combat the deadly COVID-19 pandemic.

Pfizer Seeks To Exit BioNTech Investment After Lucrative Covid Vaccine Run
benzinga.com
2025-11-13 11:10:21Pfizer (NYSE: PFE) is reportedly offloading its remaining stake in Covid-19 vaccine partner BioNTech SE (NASDAQ: BNTX).

FDA Weighs Black Box Warning For COVID Vaccines, Experts Push Back
feeds.benzinga.com
2025-12-12 13:51:10FDA officials are weighing a black box warning for Covid vaccines, a proposal that has drawn strong criticism from outside experts citing lack of evidence.

Moderna Sounds the Alarm: Is China About to Seize the Biotech Crown from the U.S.?
gurufocus.com
2025-12-11 14:03:00Investors watching the global biotech race may be sensing a shift after Moderna (MRNA) co-founder and chairman Noubar Afeyan suggested the US could be losing mo

BioNTech: Maintaining "Strong Buy" After Part 1 Success Of Next-Gen Anti-CTLA-4 Gotistobart
seekingalpha.com
2025-12-09 17:54:23BioNTech (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.

BioNTech-Bristol Drug Shows Hope For Breast Cancer Patients With Few Options
feeds.benzinga.com
2025-12-09 12:38:20BioNTech and Bristol Myers Squibb share positive data from Phase 2 trial of pumitamig plus chemotherapy for triple-negative breast cancer.

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
globenewswire.com
2025-12-09 07:00:00Global 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

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
globenewswire.com
2025-12-06 15:30:00Gotistobart demonstrated a clinically meaningful overall survival benefit compared to standard chemotherapy and a manageable safety profile in sqNSCLC

BioNTech Achieves Minimum Condition in CureVac Exchange Offer
globenewswire.com
2025-12-03 09:01:00The 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.

Dow Jones Today: Stock Indexes Close Lower to Begin December Trading; Big Tech, Crypto-Tied Shares Drop Amid Risk-Off Sentiment
investopedia.com
2025-12-01 20:00:43Major stock indexes pulled back as the final trading month of the year began, with shares of big tech and cryptocurrency-tied firms falling amid risk-off sentiment.

FDA Plans to Tighten Vaccine Approvals Weigh on These Stocks
investopedia.com
2025-12-01 15:50:42A report that vaccine approvals could be set to get stricter is pressuring shares of major vaccine makers.

Vaccine stocks take a hit as FDA official points to link between COVID-19 vaccines and rare heart condition in young men
marketwatch.com
2025-12-01 12:35:00Memo also reportedly mentions vaccines for flu and pneumonia.

Moderna and Novavax Stocks Drop as FDA Proposes Stricter Vaccine Approvals
barrons.com
2025-12-01 09:59:00The FDA's top vaccine regulator outlines proposed changes to the vaccine evaluation process in an internal memo.

BioNTech Shares Progress on Exchange Offer for CureVac Shares and Highlights December 3, 2025, at 9:00 a.m. Eastern Time Expiration
globenewswire.com
2025-11-26 07:30:00MAINZ, 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.

BioNTech SE (BNTX) Discusses Oncology Innovation Strategy, Combination Therapies and Personalized Cancer Immunotherapies Transcript
seekingalpha.com
2025-11-17 18:17:09BioNTech 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.

Allianz SE Buys 5,080 Shares of BioNTech SE Sponsored ADR $BNTX
defenseworld.net
2025-11-14 04:03:19Allianz SE grew its position in BioNTech SE Sponsored ADR (NASDAQ: BNTX) by 635.0% in the second quarter, according to its most recent filing with the SEC. The fund owned 5,880 shares of the company's stock after acquiring an additional 5,080 shares during the period. Allianz SE's holdings in BioNTech were worth $626,000

Pfizer sheds BioNTech stake years after blockbuster COVID vaccine tie-up
reuters.com
2025-11-13 17:20:40Pfizer Inc said on Thursday said that it will sell 54.7% of its stake in German drugmaker BioNTech SE , over five years after both firms formed an alliance that yielded a vaccine to combat the deadly COVID-19 pandemic.

Pfizer Seeks To Exit BioNTech Investment After Lucrative Covid Vaccine Run
benzinga.com
2025-11-13 11:10:21Pfizer (NYSE: PFE) is reportedly offloading its remaining stake in Covid-19 vaccine partner BioNTech SE (NASDAQ: BNTX).










