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Pumitamig plus docetaxel demonstrated encouraging responses in squamous and non-squamous non-small cell lung cancer across PD-L1 expression levels with a confirmed objective response rate of 36.7% following progression on or after immunotherapy plus chemotherapyAn early median progression-free survival of 6.9 months was observedSignificant unmet need remains for patients who have progressed on an immunotherapy-containing regimen, with the average progression-free survival below 4 months for standard of care docetaxel Data represent the third global Phase 2 dataset for pumitamig in lung cancer and reinforce its potential to improve outcomes over current standards of care  MAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) today announced first data from the global Phase 2 ROSETTA Lung-107 clinical trial (NCT06841055) evaluating pumitamig, an investigational PD-L1xVEGF-A bispecific immunomodulator (BNT327/BMS986545), in combination with docetaxel in patients with metastatic non-small cell lung cancer (“NSCLC”) whose disease progressed on or after first-line immunotherapy plus chemotherapy.

The data showed encouraging antitumor activity, with responses observed in both squamous and non-squamous NSCLC and across PD-L1 expression levels, together with a manageable safety profile consistent with prior global datasets for pumitamig. The data were presented today in a late-breaking rapid oral presentation (abstract #LBA76) at the European Society for Medical Oncology (“ESMO”) Congress 2026 in Madrid, Spain.

“Despite meaningful advances in first-line treatment, outcomes remain poor for the many patients with non-small cell lung cancer whose disease progresses after immunotherapy plus chemotherapy, a setting where docetaxel has remained the standard of care for years,”1 said Byoung Chul Cho, M.D., Ph.D., Trial Investigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea. “These first data from ROSETTA Lung-107 show encouraging response rates and progression-free survival across PD-L1 expression levels and histology, suggesting that pumitamig may help re-engage antitumor immunity in patients who have progressed on prior immunotherapy plus chemotherapy. These findings support continued investigation of pumitamig in this population with high unmet need.”

ROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel every three weeks. The July 10, 2026, data cut-off included 50 patients with a median follow-up of 12.2 weeks, and 33 patients remained on treatment. Among 30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed objective response rate (“cORR”) of 36.7% with a disease control rate (“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels (cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies (cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all subgroups. Median time to response was 1.4 months. In the overall treated population (n=50), median progression-free survival (“PFS”) was 6.9 months (95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%. Historically, standard-of-care docetaxel has delivered a median PFS of approximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC patients, respectively, following prior immunotherapy plus chemotherapy.1

“Our ambition is to improve outcomes for patients across the full spectrum of lung cancer, spanning disease subtypes, stages and lines of therapy,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “These encouraging results for pumitamig plus docetaxel extend the clinical evidence to patients whose disease has progressed after immunotherapy plus chemotherapy, a setting in which treatment options remain limited. Together with our findings in first-line NSCLC and extensive-stage small cell lung cancer, they support our strategy to develop pumitamig across a broad range of lung cancer settings, including those with particularly high unmet medical need.”

“This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short,” said Cristian Massacesi, Executive Vice President, Chief Medical Officer and Head of Development at Bristol Myers Squibb. “Together with BioNTech, we are advancing one of the broadest development programs in the class as we continue to build the growing body of clinical evidence for pumitamig across multiple types and treatment lines of lung cancer, with four ongoing global Phase 3 trials, and we look forward to defining the path forward for pumitamig in second-line NSCLC.”

Across 50 patients in the safety evaluation, pumitamig plus chemotherapy showed a manageable safety profile, with no new safety signals. Pumitamig treatment-related adverse events (“TRAEs”) of any grade were reported in 52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment discontinuation in four (8.0%) patients. Immune- related AEs occurred in 11 (22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients. VEGF-related events were reported in 13 (26.0%) patients; grade 3 events were rare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events occurred in eight (16.0%) patients and were limited to grade 1 or 2 severity. There were no pumitamig-related deaths or dose-limiting toxicities (“DLTs”).

BioNTech and BMS are advancing a broad development plan for pumitamig in multiple cancer types, including lung cancer across disease stages, subgroups and lines of therapy. ROSETTA Lung-107 extends the program into the second-line NSCLC setting, and these data will inform the further development of pumitamig in this underserved patient population.

About ROSETTA Lung-107
The global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055) is evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in patients with stage IV squamous or non-squamous NSCLC whose disease progressed following first-line immunotherapy plus chemotherapy, with any level of PD-L1 expression. Patients with prior exposure to anti-VEGF monoclonal antibodies or PD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in), patients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every three weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig 1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal review committee based on the totality of evidence from Part 1 and the broader pumitamig lung cancer program. The primary endpoints are dose-limiting toxicities (Part 1 only), safety, and objective response rate (“ORR”) per investigator’s assessment (RECIST 1.1). Secondary endpoints include disease control rate (“DCR”), duration of response (“DOR”), depth of response, time to response, progression-free survival (“PFS”), overall survival (“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial enrolled 59 patients at sites in Australia, the Republic of Korea, Spain, Türkiye, the United Kingdom, and the United States.

About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.

More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.

About NSCLC
Non-small cell lung cancer (NSCLC) covers all epithelial lung cancers other than small cell lung cancer and includes squamous cell carcinoma, large cell carcinoma, and adenocarcinoma of the lung. It is the most common type of lung cancer, accounting for approximately 85% of cases, and is the leading cause of cancer-related deaths worldwide.2 Scientific advances have transformed the treatment of NSCLC, improving outcomes for many patients. However, NSCLC remains an aggressive disease with a poor prognosis and a 5-year survival rate of 18 to 22% in advanced stages.3 Patients with low levels of PD-L1 expression typically do not respond well to checkpoint inhibitor-based regimens creating a significant unmet need for new treatment options that provide durable responses to a broad range of patients.

About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: BioNTech’s collaboration with Bristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully co-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545), if approved; the rate and degree of market acceptance of pumitamig, if approved; the initiation, timing, progress, and results of BioNTech’s research and development programs, including BioNTech’s current and future clinical trials, including statements regarding the expected timing of initiation, enrollment, and completion of trials and related preparatory work and the availability of results, and the timing and outcome of applications for regulatory approvals and marketing authorizations, including expectations regarding the potential indications in which pumitamig may be approved, if at all; the targeted timing and number of additional potentially registrational trials, and the registrational potential of any trial BioNTech may initiate; and discussions with regulatory agencies. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with clinical data, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the impact of tariffs and escalations in trade policy; competition related to BioNTech’s product candidates; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s product candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments in the United States and other countries; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

About Bristol Myers Squibb
At Bristol Myers Squibb, our mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. We are pursuing bold science to define what’s possible for the future of medicine and the patients we serve. For more information, visit us at BMS.com and follow us on LinkedIn, X, YouTube, Facebook and Instagram.

Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on current expectations and projections about Bristol Myers Squibb’s future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the expected benefits of, and opportunities related to the collaboration with BioNTech may not be realized by Bristol Myers Squibb or may take longer to realize than anticipated, that future study results may not be consistent with the results to date, that pumitamig (also known as BNT327 or BMS986545) alone or in combination with chemotherapy (such as docetaxel) may not achieve its primary study endpoint or receive regulatory approval for the indications described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether pumitamig alone or in combination with chemotherapy will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2025, as updated by Bristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

CONTACTS

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1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.
2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.
3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.

Germany's BioNTech (22UAy.DE) said on Thursday it had teamed up with Gilead Sciences (GILD.O) to test its experimental ​cancer therapy in combination with the US ‌drugmaker's approved treatment in patients with a form of advanced breast cancer.

Here are some details:

The late-stage trial will test BioNTech's ​pumitamig with Gilead's FDA-approved Trodelvy in patients ​with triple-negative breast cancer

BioNTech plans to update its ⁠late-stage study to compare the combination against treatment with Trodelvy ​alone, replacing its earlier plan to test pumitamig plus ​chemotherapy against chemotherapy

The safety and effectiveness of the combination has not been established, and the planned trial changes would require ​approval from health regulators, BioNTech said

Triple-negative breast cancer ​is an aggressive form of the disease that lacks common treatment ‌targets ⁠and accounts for about 10% to 15% of breast cancer cases, according to BioNTech

The study will include patients with locally advanced or metastatic triple-negative breast cancer ​whose tumors ​have low ⁠or no levels of PD-L1, a biomarker used to guide treatment

BioNTech will sponsor ​and lead the trial, while Gilead will ​supply ⁠Trodelvy

Pumitamig is being developed by BioNTech and Bristol Myers Squibb (BMY.N) and is central to their $11.1 billion collaboratio signed in ⁠2025

The ​drug is designed to help the ​immune system attack cancer cells and limit blood supply to tumors

Late-breaking oral presentation will feature first data from the global ROSETTA Lung-107 Phase 2 clinical trial evaluating pumitamig, a PD-L1×VEGF-A bispecific immunomodulator, plus docetaxel in patients with metastatic non-small cell lung cancer following prior immunotherapy plus chemotherapy Global Phase 2 data for pumitamig plus elfetabart drozuntecan, a B7-H3-targeting antibody-drug conjugate, expand the body of evidence for this novel-novel combination in multiple advanced solid tumors Updates from across the pumitamig clinical development program underscore its pan-tumor potential, including in lung and breast cancer patients with brain metastases and patients with neuroendocrine neoplasms MAINZ, Germany, October 19, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its late-stage oncology pipeline with 16 abstracts spanning the Company’s tumor focus areas, including lung and breast cancer, at the European Society for Medical Oncology (“ESMO”) 2026 Congress held in Madrid, Spain, from October 23–27, 2026.

Key oral presentations will focus on clinical data for pumitamig (BNT327/BMS986545), a PD-L1×VEGF-A bispecific immunomodulator being jointly developed with Bristol Myers Squibb (“BMS”), plus docetaxel in second-line metastatic non-small cell lung cancer (“NSCLC”) as well as pumitamig in combination with elfetabart drozuntecan (elfe-D or BNT324/DB-1311), a B7-H3-targeting antibody-drug conjugate (“ADC”) being jointly developed with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”), across several advanced solid tumors – complementing the data in lung cancer presented earlier this year. This new clinical data advances BioNTech’s differentiated novel-novel combination approach. Additional presentations for pumitamig and ADCs reflect BioNTech’s tumor-focused strategy aimed at addressing significant unmet medical needs across various stages of disease.

“Sixteen abstracts spanning ten tumor types – this is our significant data presence at this year’s ESMO. It demonstrates momentum for our late-stage oncology pipeline across strategic key assets and tumor areas such as lung and breast cancer,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “For our PD-L1xVEGF immunomodulator pumitamig, we will be sharing new data that highlights its pan-tumor potential, including in challenging treatment settings where patients still show limited benefit from current standard of care therapies. Our goal is to establish pumitamig as a potential backbone for future combination regimens across multiple tumor types, including novel-novel treatment combinations. At this year's conference, we will showcase the potential of this approach in two presentations featuring ADC combinations, aimed to further enhance outcomes for patients.”

Highlights from BioNTech’s presentations at ESMO 2026:

Pumitamig – an investigational PD-L1×VEGF-A bispecific immunomodulator:

NSCLC: First data from the global ROSETTA Lung-107 Phase 2 clinical trial (NCT06841055) evaluating pumitamig plus docetaxel in patients with metastatic NSCLC whose disease progressed after immunotherapy plus chemotherapy will be presented in a late-breaking oral presentation. This clinical trial extends evidence for pumitamig’s non-small cell lung cancer development program into the second-line setting where there remains high unmet medical need, representing the third global Phase 2 dataset in lung cancer.SCLC and TNBC with brain metastases: Results from a subgroup analysis of two Phase 2 clinical trials (NCT06449209; NCT06449222) evaluating pumitamig plus chemotherapy in patients with small cell lung cancer (“SCLC”) or triple-negative breast cancer (“TNBC”) showed systemic efficacy generally consistent in patients with and without brain metastases. These early data suggest intracranial efficacy and add to the clinical evidence for pumitamig plus chemotherapy in tumor types where brain metastases often occur and remain challenging to treat as many systemic therapies have limited ability to cross the blood-brain barrier.2L neuroendocrine neoplasms: First results from a Phase 2 clinical trial conducted in China (NCT05879055) evaluating pumitamig plus FOLFIRI (folinic acid, fluorouracil, and irinotecan) chemotherapy in patients with unresectable neuroendocrine neoplasms after first-line platinum-based chemotherapy showed encouraging preliminary antitumor activity and a manageable safety profile. These data broaden the clinical evidence for pumitamig across diverse tumor types. Novel-novel combination of pumitamig and elfetabart drozuntecan, an investigational B7-H3-targeted ADC:

Advanced solid tumors: First results from the global Phase 2 clinical trial (NCT06953089) evaluating pumitamig in combination with elfetabart drozuntecan in patients with advanced solid tumors showed encouraging preliminary antitumor activity across multiple tumor types and a manageable safety profile, with minimal overlapping toxicities observed. These data support the potential of pumitamig as a backbone in novel treatment combinations, furthering BioNTech’s combination strategy across multiple tumor types with high unmet medical need. BioNTech is advancing a diversified oncology pipeline spanning next-generation immunomodulators, ADCs, and mRNA cancer immunotherapies, both as monotherapies and novel-novel combination approaches. With 13 ongoing Phase 3 trials as well as multiple novel-novel combination trials, BioNTech is focused on developing innovative approaches to address the challenges of cancer treatment among the Company’s tumor focus areas from early- to late-stage conditions.

All abstracts are available through the ESMO website. Further information on BioNTech’s oncology pipeline can be accessed here.

Full presentation details:

CandidateAbstract TitleAbstract Number/Presentation DetailsPumitamig A global phase 2, open-label trial of pumitamig (PD-L1 × VEGF-A bsAb) + docetaxel post-chemoimmunotherapy in mNSCLC: First data from ROSETTA Lung-107Abstract #LBA76
Rapid Oral Presentation
NSCLC, Metastatic
Oct 25, 2026: 8:30 - 10:00am CETEfficacy of pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in patients with SCLC or TNBC with brain metastases: A subgroup analysis of two phase 2 trialsAbstract #1951RO
Rapid Oral Presentation
Investigational Immunotherapy
Oct 24, 2026: 8:30 - 10:00am CESTFirst results from a phase 2 trial of second-line pumitamig (PD-L1 × VEGF-A bsAb) plus chemotherapy in unresectable neuroendocrine neoplasmsAbstract #2393O
Proffered Paper Presentation
NETs and Endocrine Tumours
Oct 26, 2026: 10:15 - 11:45am CETROSETTA RCC-208: A phase 1/2, open-label, randomized study of pumitamig alone or in combination with ipilimumab or cabozantinib in advanced renal cell carcinoma (RCC)Abstract #3639TiP
Poster Presentation
Renal Cancer
Oct 23, 2026: 3:15 - 4:00pm CESTROSETTA Gastric-204: A randomized, phase 2/3 study of first-line (1L) pumitamig + chemotherapy versus nivolumab (NIVO) + chemotherapy in advanced or metastatic gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJC), or esophageal adenocarcinoma (EAC)Abstract #3081eTiP
ePoster Presentation
Oesophagogastric Cancer
Oct 23 - 27, 2026A phase 1/2 trial of first-line pumitamig monotherapy or pumitamig plus ipilimumab in advanced or unresectable hepatocellular carcinoma (ROSETTA HCC-206)Abstract #1762eTiP
ePoster Presentation
Hepatocellular Carcinoma
Oct 23 - 27, 2026Pumitamig + elfetabart drozuntecanElfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) + pumitamig (PD-L1 x VEGF-A bsAb) in patients with advanced solid tumors: First results from a global phase 2 trialAbstract #999O
Proffered Paper Presentation
Developmental Therapeutics
Oct 24, 2026: 2:45 - 4:15pm CESTPumitamig + trastuzumab pamirtecanPumitamig + trastuzumab pamirtecan (T-Pam) in patients (pts) with HR+, HER2-low advanced/metastatic breast cancer (a/mBC): Phase 1 results of a phase 1/2, open-label trial (BNT323-03)Abstract #1777P
Poster Presentation
HER2+ Breast Cancer
Oct 24, 2026: 12:00 - 12:45pm CESTElfetabart drozuntecanElfetabart drozuntecan (Elfe-D; DB-1311/BNT324 [B7H3 ADC]) in patients with platinum-resistant ovarian cancer (PROC): Efficacy and safety data from a Phase 2 dose optimization cohortAbstract #1255P
Poster Presentation
Gynaecological Cancers
Oct 26, 2026: 12:00 - 12:45pm CETBNT324-03: A phase 3, randomized, open-label trial comparing elfetabart drozuntecan, a B7H3 antibody-drug conjugate (ADC), with docetaxel as treatment of patients (pts) with taxane-naïve metastatic castration-resistant prostate cancer (mCRPC)Abstract #2300TiP
Poster Presentation
Metastatic Prostate Cancer
Oct 23, 2026: 3:15 - 4:00pm CESTGotistobartGotistobart plus pembrolizumab demonstrates durable antitumor activity in advanced melanoma refractory or resistant to both prior anti-CTLA-4 and anti-PD-(L)1 therapiesAbstract #2106P
Poster Presentation
Melanoma
Oct 24, 2026: 12:00 - 12:45 pm CESTBNT317BNT317: An anti–PD-1 × CD39 bispecific antibody demonstrating preclinical antitumor activityAbstract #420P
Poster Presentation
Basic Science
Oct 23, 2026: 3:15 - 4pm CESTBeruzatatug pelitecan (YL202/BNT326)Clinical outcomes of YL202/BNT326 (HER3 ADC) in advanced/metastatic HR+/HER2-null/low breast cancer (BC) in chemotherapy (chemo)-naïve and exposed patients (pts)Abstract #1881P
Poster Presentation
HR+ Breast Cancer
Oct 24, 2026: 12:00 - 12:45pm CESTBNT329A first-in-human phase 1/2 dose-escalation and expansion trial of BNT329 (an anti-carbohydrate antigen 19-9 antibody-drug conjugate [CA19-9 ADC]) in patients (pts) with advanced solid tumors that express CA19-9Abstract #1076TiP
Poster Presentation
Developmental Therapeutics
Oct 23, 2026: 3:15 - 4:00 pm CESTHealth Economics and Outcomes Research (HEOR)Real-world progression-free survival (rwPFS) from chemotherapy initiation in patients with HR+/HER2– metastatic breast cancer (mBC) in the USAbstract #1880P
Poster Presentation
HR+ Breast Cancer
Oct 24, 2026: 12:00 - 12:45pm CESTReal-world outcomes with first-line pembrolizumab-based chemoimmunotherapy in patients with advanced/metastatic non-small cell lung cancer in the USAAbstract #2705P
Poster Presentation
NSCLC, Metastatic
Oct 26, 2026: 12:00 - 12:45pm CET About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545), the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392), the investigational B7H3-targeting ADC elfetabart drozuntecan (BNT324/DB-1311) alone and in combination with pumitamig, the investigational HER2-targeting ADC trastuzumab pamirtecan (BNT323/DB-1303) in combination with pumitamig, the investigational anti-PD-1×CD39 antibody BNT317, the investigational HER3-targeting ADC Beruzatatug pelitecan (Beru-Pel/YL202/BNT326), and the investigational CA19-9-targeting ADC BNT329; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech’s development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

CONTACTS

Media Relations
Jasmina Alatovic
[email protected]

Investor Relations
Douglas Maffei, Ph.D.
[email protected]

Moderna isn't the only mRNA biotech stock that could deliver big gains for investors. BioNTech (BNTX -2.76%) has billions in cash on its books and a cancer treatment pipeline that could transform it from a COVID-19 vaccine maker into a major force in oncology.

With several promising therapies advancing through clinical trials, this biotech could already have the ingredients to fuel its next chapter of growth.

Image source: Getty Images.

The potential starts with its balance sheet.

BioNTech has plenty of cash to develop its candidates As of the end of the second quarter, the German biotech business had 16.6 billion euros in cash, cash equivalents, and securities on its balance sheet. That gives BioNTech significant financial flexibility to fund research, advance clinical trials, enter into partnerships, and develop new medicines for the market.

It also announced a share repurchase program of up to $1 billion. That's an encouraging sign that the company has strong operating cash flows that will allow it to fund that buyback while continuing to invest in its core business.

The bigger question, however, is what the company plans to do with the rest of the money.

Right now, its only commercialized product is Comirnaty, the COVID-19 vaccine that it developed and marketed in partnership with Pfizer. But BioNTech is working toward becoming a multiproduct company focused on oncology by 2030.

That shift could give investors exposure to a much broader business if its research pays off. Plus, unlike a cash-strapped biotech that must keep raising money to fund R&D, BioNTech can finance its development programs with resources already sitting on its balance sheet.

Indeed, what makes BioNTech interesting today is its combination of financial firepower and a pipeline moving beyond early-stage trials.

The cancer pipeline is becoming harder to ignore BioNTech's oncology strategy extends well beyond personalized mRNA cancer vaccines. The company is developing treatments across several categories, including immunomodulators, antibody-drug conjugates (ADCs), and cancer immunotherapies.

This diversification matters because cancer is not one disease with one solution. Different tumor types respond differently to treatment, and even patients with the same type of cancer may need different approaches. Building a broader portfolio gives BioNTech more potential avenues to drive future revenue growth.

For example, BioNTech reported 14 ongoing pivotal clinical trials and more than 10 novel combination approaches across major tumor types. These phase 2/3 and phase 3 trials are especially important because they can provide the evidence needed to support regulatory applications. Positive results could move candidate drugs closer to commercialization, while negative results would help the company narrow down which candidates it's focusing on.

One of BioNTech's most closely watched candidates is pumitamig, a potential cancer treatment developed in collaboration with Bristol Myers Squibb. The company reported encouraging results from a trial that combined the drug with chemotherapy as a treatment regimen for lung cancer.

On top of that, the commercial opportunity could extend well beyond lung cancer. BioNTech's ROSETTA development program includes seven pivotal trials evaluating pumitamig, covering multiple cancer types and treatment settings. It also initiated additional global trials in areas like breast cancer, colorectal cancer, and gastric cancer.

That growing pipeline is one of the strongest reasons to watch BioNTech closely, but valuation matters just as much.

Is BioNTech stock a buy at today's valuation? BNTX BioNTech Se$87.71-$2.49 (-2.76%)

NASDAQ · As of 4:00 PM ET 10/16/26

Wall Street is quite bullish on BioNTech. In fact, among the 20 analysts covering it, 13 rate the stock a strong buy, while the remainder rate it a hold. Their target prices imply potential upside of 5% to 64% over the next year, with an average implied gain of 39%.

On valuation, the stock trades at a price-to-sales ratio of 7, a level that could seem reasonable if the company successfully turns its pipeline into blockbuster drugs.

Of course, there are no guarantees in drug development. Clinical trials can fail, regulatory approvals can be delayed, and even if a company brings an effective treatment to market, competitors may develop treatments that outperform it.

At the same time, declining COVID-19 vaccine revenue and ongoing R&D spending could eat into BioNTech's cash reserves. These factors could weaken the bull case for the company.

Looking ahead, results from BioNTech's pivotal trials will provide fresh insights about whether its pipeline can deliver. If it does, BioNTech's massive cash reserves will give it plenty of dry powder to move beyond its COVID-19 business and fund its next phase of growth.

For long-term investors who are comfortable with the risks, a pipeline this deep and a cash cushion large enough to bring those candidates through the clinical trial process could make BioNTech worth considering.

Moderna stock is shedding 10% after a blistering cancer vaccine run, and the question now is whether profit takers know something the bulls don't ahead of a critical trial readout later this month.

Profit taking is hitting one of biotech’s hottest trades, and the selling is landing heaviest on the stock that ran the furthest. Moderna (NASDAQ:MRNA | MRNA Price Prediction) stock is down 10% to $214.03 in morning trading, giving back part of a steep run tied to its personalized cancer vaccine.

Meanwhile, BioNTech SE (NASDAQ:BNTX) stock is down 2% to $88.59, a much smaller decline. Pfizer (NYSE:PFE) stock is up 0.3% to $29.54, inching higher against the biotech selling.

The iShares Biotechnology ETF (NASDAQ:IBB) is down 2%, a fraction of the slide in Moderna stock. Over the same period, the SPDR S&P 500 ETF Trust (NYSEARCA:SPY) is down 0.1%, leaving the broad market close to flat.

Profit Taking Follows a Steep Cancer Vaccine Run Moderna stock’s pullback reads as profit taking after a steep climb. In August, Moderna reported that intismeran autogene, given alongside Keytruda, met its primary endpoint in a late-stage melanoma trial. That result sent Moderna shares to their best single-day gain ever.

Merck (NYSE:MRK) is Moderna’s partner on intismeran autogene and the maker of Keytruda, the immunotherapy combined with the vaccine. Phase 2b follow-up at five years showed a 49% reduction in the risk of recurrence or death for the combination versus Keytruda alone. Together, Moderna and Merck are now running nine Phase 2 and Phase 3 trials across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.

Goldman Sachs raised its price target on Moderna stock on Thursday while keeping a Neutral rating. The firm pointed to full late-stage melanoma data for intismeran autogene, due at the European Society for Medical Oncology (ESMO) Congress later this month. Selling in Moderna stock arrives with that presentation still ahead.

Respiratory vaccines such as Spikevax, mRESVIA, mNEXSPIKE and the flu-plus-COVID shot mCOMBRIAX still anchor Moderna’s commercial business. A joint procurement contract with the European Commission covers up to 24 million doses of mRESVIA for six countries. Oncology, however, carries most of the recent momentum in Moderna stock.

Selling Stays Concentrated in Moderna Both Moderna and BioNTech use messenger RNA technology. They build vaccines and cancer therapies, while Pfizer is a diverse drugmaker and BioNTech’s longtime partner on the Comirnaty COVID-19 shot. Moderna stock is falling far harder. It is down much more than BioNTech stock and the iShares fund, while Pfizer stock is inching higher, pointing to selling concentrated in the name that ran the furthest.

BioNTech combined its mRNA work with antibodies and antibody-drug conjugates, led by pumitamig, a bispecific candidate in seven global registrational trials. Its pipeline also includes autogene cevumeran, an individualized mRNA cancer immunotherapy that lines up most directly against the Moderna program.

Melanoma Readout Sets Up Moderna’s Next Move The optimistic outlook for Moderna depends on the full melanoma data confirming the August result. On the Q2 2026 earnings call, Moderna management stated that a dedicated Massachusetts facility could support the initial indication and that “we’d be ready to go next year if all went perfectly to plan.” Management also asserted that translational data from the American Society of Clinical Oncology meeting showed “we do see neoantigen-specific T cells, and we know those T cells can kill the tumor.”

A bear case could contend that Moderna stock already prices in a strong readout. Recent results offer little buffer, with Moderna’s Q2 revenue of $145 million and a loss of $1.97 per share that came in line with expectations. Guidance from Moderna calls for up to 10% revenue growth in 2026, leaving the valuation heavily tied to oncology.

Investors can watch for whether the full melanoma data at ESMO matches the August headline. Until that readout arrives, investors should keep their positions in Moderna stock moderate given how much of the recent run rests on oncology.

Contact [email protected] for any questions or corrections.

BioNTech investors absorbed a 7.13% loss when the AHEAD-MERIT trial of BNT113 missed its progression-free survival primary endpoint. An investigation is underway into whether the Company's statements about its mRNA oncology programs gave shareholders an accurate picture.

, /PRNewswire/ -- Every $10,000 held in BioNTech SE (NASDAQ: BNTX) shrank by roughly $713 after the Company announced that its Phase 2/3 AHEAD-MERIT trial of BNT113 plus pembrolizumab did not achieve its progression-free survival primary endpoint versus pembrolizumab alone. Shares fell approximately 7.13%. If that loss landed in your brokerage account, you are encouraged to submit your BNTX loss information now. You may also contact Joseph E. Levi, Esq. via email at [email protected] or by telephone at (888) SueWallSt.

The losses scale with position size. A $50,000 stake lost roughly $3,500. A $250,000 stake lost roughly $17,500. Shareholders who sold into the decline have already realized those losses. Those still holding are carrying them.

Market coverage tied the move to the AHEAD-MERIT result. Reports said the readout reduced investor confidence in BioNTech's oncology pipeline. SueWallSt notifies investors of a pending investigation into potential securities law violations on behalf of BNTX investors who suffered losses.

If the AHEAD-MERIT readout cost you money, have your BNTX losses evaluated or reach Joseph E. Levi, Esq. at [email protected] or (888) SueWallSt.

WHY SUEWALLST: SueWallSt is powered by Levi & Korsinsky LLP. Levi & Korsinsky LLP has established itself as a nationally-recognized securities litigation firm that has secured hundreds of millions of dollars for aggrieved shareholders and built a track record of winning high-stakes cases. The firm has extensive expertise representing investors in complex securities litigation and a team of over 70 employees to serve our clients. For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services' Top 50 Report as one of the top securities litigation firms in the United States.

Frequently Asked Questions About the BNTX Investigation

Q: How much did BNTX stock drop?A: Shares fell approximately 7.13% after the Company disclosed that the Phase 2/3 AHEAD-MERIT trial of BNT113 plus pembrolizumab did not achieve its progression-free survival primary endpoint versus pembrolizumab alone. Investors who purchased shares at allegedly inflated prices and suffered losses may be eligible to seek compensation.

Q: Who is eligible to participate in the BNTX investigation?A: Investors who purchased BNTX stock or securities and suffered financial losses may be eligible. Eligibility is based on purchase date and documented losses -- not on whether you still hold the shares.

Q: Which statements are being investigated as potentially misleading?A: The investigation concerns whether BioNTech made potentially false or misleading statements regarding the clinical prospects and progress of BNT113 and its mRNA cancer immunotherapy programs. When the Company disclosed that AHEAD-MERIT did not achieve its progression-free survival primary endpoint, the stock price declined.

Q: What do BNTX investors need to do right now?A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible to participate in the investigation.

Q: What documents do I need to participate?A: You will need brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.

Q: What if I already sold my BNTX shares -- can I still recover losses?A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought BNTX and sold at a loss may still participate in the investigation.

Q: What if my BNTX losses are small -- is it still worth contacting a lawyer?A: Yes. There is no minimum loss amount required to participate in the investigation.

Q: What if I live outside the United States?A: U.S. securities investigations generally cover purchases on U.S. exchanges regardless of the investor's country of residence. BioNTech's American Depositary Shares trade on the NASDAQ under the ticker BNTX.

Q: What does it cost me to participate?A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in any resulting action, these matters are generally handled on a contingency basis, with any attorneys' fees and expenses subject to court approval.

CONTACT:

Levi & Korsinsky, LLP

Joseph E. Levi, Esq.

33 Whitehall Street, 27th Floor

New York, NY 10004

[email protected]

Tel: (888) SueWallSt

Fax: (212) 363-7171

Attorney Advertising. Prior results do not guarantee similar outcomes.

SOURCE SueWallSt.com

Also from this source

MAINZ, Germany, October 13, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) today announced the first topline results from the AHEAD-MERIT Phase 2/3 clinical trial (NCT04534205) for its investigational mRNA cancer immunotherapy BNT113 (tenumomeran/raplemomeran or “tenu-ra”).

What happened BioNTech SE (NASDAQ: BNTX) said Chief Executive Officer and 10% owner Ugur Sahin sold 63,209 ordinary shares on 2026-10-08 and 2026-10-09.

He sold 27,000 shares at $92.31 on 2026-10-08 and 36,209 shares at $95.37 on 2026-10-09, for about $5.95 million.

The Form 4 says the trades were made under a Rule 10b5-1 trading plan set up on June 3, 2026. After the sales, Sahin held 0 directly owned shares.

Key numbers Metric Latest Change Source Shares sold 63,209 ordinary shares SEC Form 4 Total sale proceeds about $5.95 million SEC Form 4 Lowest sale price $92.31 per share SEC Form 4 Highest sale price $95.37 per share SEC Form 4 Post-sale direct holding 0 shares SEC Form 4 Read more: BioNTech (BNTX) stock analysis and investment case

Why it matters OptimistFi's case is that BioNTech is a cash-rich COVID-windfall reinvestment story.

The stock works only if its mRNA and immunotherapy platform becomes a durable non-COVID oncology business before vaccine cash flows and R&D losses erode value.

This filing does not change that operating test.

It does show that Sahin's direct stake fell to zero.

OptimistFi's calculation shows the 63,209 shares were 100.0% of Sahin's pre-sale direct holding.

That makes this a clean ownership update, not a business update.

The direct sale to zero matters because it removes one visible ownership line from a company whose value still depends on a durable non-COVID business.

BioNTech still has to prove that platform before vaccine cash flows fade.

The filing also still shows 39,218,111 ordinary shares held indirectly through Medine GmbH.

It says 106,721 of the ordinary shares are held for the benefit of an individual under a trust arrangement.

So the ownership picture is mixed. The direct holding is gone, but the indirect block remains.

For investors, that keeps this in the ownership lane while the business case still turns on execution.

Related: BioNTech Ends Cancer-Vaccine Trial, Raising Stakes for Oncology

What's next The June 3, 2026 Rule 10b5-1 plan is the key frame for any later trades.

Any future Form 4 under that plan would show whether Sahin keeps selling or has finished the planned transactions.

More sales would extend the planned-selling signal.

No further sales would leave this as a completed direct exit.

If later filings show no additional sales, the direct exit stays limited to this report.

More from OptimistFi BNTX stock: the BioNTech thesis, its status and the next test to watch Levi Strauss & Co. (NYSE: LEVI) Raises Profit as Wholesale Outruns DTC Park Aerospace Corp. (NYSE: PKE) Expands Profit as Sales Rise Helen of Troy Limited (NASDAQ: HELE) Lifts Profit as Cash Flow Rebounds Stock research on every company OptimistFi covers Latest stock research and investment-case updates OptimistFi: evidence-first equity research Sources SEC Form 4 — Form 4 filed for Ugur Sahin on 2026-10-09 Read the full OptimistFi thesis on BioNTech SE: https://optimistfi.com/stocks/BNTX

See what would break the BioNTech SE thesis and track it live on the OptimistFi Thesis-Break Engine.

Browse every company OptimistFi covers at optimistfi.com/stocks, or read the latest evidence-first research.

The full BioNTech SE investment case, its status and the next test to watch live on the BioNTech SE thesis page.

Originally published on OptimistFi, evidence-first equity research. More at optimistfi.com.

BioNTech SE Sponsored ADR (NASDAQ:BNTX – Get Free Report) CEO Ugur Sahin sold 36,209 shares of the company’s stock in a transaction that occurred on Friday, October 9th. The shares were sold at an average price of $95.37, for a total value of $3,453,252.33. Following the transaction, the chief executive officer directly owned 36,209 shares of the company’s stock, valued at $3,453,252.33. This trade represents a 50.00% decrease in their ownership of the stock. The transaction was disclosed in a legal filing with the SEC, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Ugur Sahin also recently made the following trade(s):

On Thursday, October 8th, Ugur Sahin sold 27,000 shares of BioNTech stock. The stock was sold at an average price of $92.31, for a total value of $2,492,370.00. On Wednesday, October 7th, Ugur Sahin sold 24,000 shares of BioNTech stock. The shares were sold at an average price of $95.86, for a total value of $2,300,640.00. On Tuesday, October 6th, Ugur Sahin sold 21,000 shares of BioNTech stock. The shares were sold at an average price of $96.81, for a total transaction of $2,033,010.00. On Monday, October 5th, Ugur Sahin sold 72,000 shares of BioNTech stock. The shares were sold at an average price of $97.23, for a total value of $7,000,560.00. On Thursday, October 1st, Ugur Sahin sold 17,000 shares of BioNTech stock. The stock was sold at an average price of $97.46, for a total value of $1,656,820.00. On Wednesday, September 30th, Ugur Sahin sold 32,000 shares of BioNTech stock. The stock was sold at an average price of $98.12, for a total value of $3,139,840.00. On Monday, September 28th, Ugur Sahin sold 34,000 shares of BioNTech stock. The stock was sold at an average price of $98.47, for a total value of $3,347,980.00. On Friday, September 25th, Ugur Sahin sold 27,000 shares of BioNTech stock. The stock was sold at an average price of $98.69, for a total value of $2,664,630.00. On Thursday, September 24th, Ugur Sahin sold 39,000 shares of BioNTech stock. The shares were sold at an average price of $98.99, for a total value of $3,860,610.00. On Wednesday, September 23rd, Ugur Sahin sold 30,000 shares of BioNTech stock. The shares were sold at an average price of $99.40, for a total value of $2,982,000.00. BioNTech Stock Up 5.3% Shares of BioNTech stock opened at $96.96 on Friday. The business’s fifty day moving average price is $99.17 and its two-hundred day moving average price is $95.17. The company has a debt-to-equity ratio of 0.01, a current ratio of 7.85 and a quick ratio of 7.80. The company has a market capitalization of $24.52 billion, a P/E ratio of -12.38 and a beta of 1.25. BioNTech SE Sponsored ADR has a 1-year low of $79.52 and a 1-year high of $124.00.

BioNTech (NASDAQ:BNTX – Get Free Report) last announced its quarterly earnings results on Tuesday, August 4th. The company reported ($2.53) earnings per share (EPS) for the quarter, missing analysts’ consensus estimates of ($2.40) by ($0.13). BioNTech had a negative return on equity of 6.86% and a negative net margin of 63.54%. The business had revenue of $122.31 million for the quarter, compared to analyst estimates of $180.18 million. During the same quarter last year, the firm posted ($1.60) EPS. The company’s revenue was down 59.5% compared to the same quarter last year. As a group, research analysts forecast that BioNTech SE Sponsored ADR will post -6.33 EPS for the current year. Institutional Inflows and Outflows Several large investors have recently added to or reduced their stakes in BNTX. Farther Finance Advisors LLC lifted its position in BioNTech by 31.5% during the 3rd quarter. Farther Finance Advisors LLC now owns 493 shares of the company’s stock worth $48,000 after buying an additional 118 shares in the last quarter. Quintet Private Bank Europe S.A. grew its holdings in shares of BioNTech by 232.8% in the 3rd quarter. Quintet Private Bank Europe S.A. now owns 1,917 shares of the company’s stock valued at $188,000 after acquiring an additional 1,341 shares in the last quarter. Engineers Gate Manager LP increased its position in shares of BioNTech by 17.3% in the second quarter. Engineers Gate Manager LP now owns 12,433 shares of the company’s stock valued at $1,157,000 after acquiring an additional 1,833 shares during the last quarter. Integrated Wealth Concepts LLC acquired a new stake in shares of BioNTech in the second quarter valued at about $39,000. Finally, Nykredit A S acquired a new stake in shares of BioNTech in the second quarter valued at about $293,000. Institutional investors and hedge funds own 15.52% of the company’s stock.

Wall Street Analysts Forecast Growth BNTX has been the subject of several research analyst reports. UBS Group reaffirmed a “buy” rating on shares of BioNTech in a report on Wednesday, September 16th. Canaccord Genuity Group decreased their target price on shares of BioNTech from $142.00 to $136.00 and set a “buy” rating for the company in a research report on Monday, August 31st. Citigroup lowered their target price on shares of BioNTech from $130.00 to $125.00 and set a “buy” rating on the stock in a research note on Wednesday, August 5th. Wall Street Zen cut shares of BioNTech from a “hold” rating to a “sell” rating in a research note on Saturday, August 8th. Finally, Weiss Ratings restated a “sell (d-)” rating on shares of BioNTech in a research report on Friday, October 2nd. One investment analyst has rated the stock with a Strong Buy rating, twelve have given a Buy rating, six have given a Hold rating and one has issued a Sell rating to the stock. Based on data from MarketBeat.com, the company has a consensus rating of “Moderate Buy” and an average price target of $125.69.

Get Our Latest Analysis on BioNTech

BioNTech News Roundup Here are the key news stories impacting BioNTech this week:

Positive Sentiment: Biotech-sector momentum offered a modest tailwind after Moderna’s inclusion in the Nasdaq-100 triggered a sharp move in its shares, while BioNTech also traded higher alongside other major vaccine companies. Moderna Climbs 5% on NASDAQ 100 Entry; Pfizer Inches Higher, BioNTech Ticks Up Neutral Sentiment: Argus initiated coverage with a Hold rating, adding a cautious view but no immediate change to the company’s fundamentals. Argus coverage reference Neutral Sentiment: A report stating that short interest totaled zero shares implies no measurable short-squeeze pressure. The figure may reflect a reporting or data issue and should be interpreted cautiously. Negative Sentiment: CEO Ugur Sahin sold 36,209 shares for approximately $3.45 million on October 9 and another 27,000 shares for about $2.49 million on October 8. The transactions were executed under a pre-arranged Rule 10b5-1 plan, which reduces their significance as discretionary signals, but the sales substantially reduced his direct ownership. BioNTech CEO SEC filing Negative Sentiment: The latest quarterly results showed continuing commercial pressure: revenue fell 59.5% year over year to $122.31 million, below the $180.18 million consensus estimate, while the company reported a loss of $2.53 per share. Analysts expect a full-year loss, underscoring the need for BioNTech’s pipeline to offset declining COVID-19 vaccine revenue. BioNTech Company Profile (Get Free Report)

BioNTech SE is a biotechnology company headquartered in Mainz, Germany, focused on developing therapies and vaccines for cancer and other serious diseases. The company’s research platform includes messenger RNA (mRNA), individualized cancer vaccines, immune-modulating therapies, cell therapies, and protein-based therapeutics.

BioNTech is best known for developing the Comirnaty COVID-19 vaccine in collaboration with Pfizer. Comirnaty uses mRNA technology to help stimulate an immune response against COVID-19 and has been distributed in markets around the world.

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BioNTech SE (BNTX -2.47%) is still widely viewed as a COVID-19 vaccine maker, but that picture is quickly changing. The company has quietly built a broad late-stage cancer pipeline spanning multiple promising treatments for different cancer types.

With the stock trading below $100, investors may be overlooking the significant upside the company can deliver by expanding its oncology portfolio.

Image source: Getty Images.

From COVID vaccine maker to multi-product cancer company BioNTech is a very different company following the COVID-19 pandemic, having expanded its oncology portfolio, which now spans multiple cancer types.

That pipeline has moved much further along than many investors realize. BioNTech said it has more than 25 phase 2 and phase 3 oncology trials underway and is targeting 15 phase 3 trials by the end of 2026. It's now approaching the point where several of these programs could potentially become commercial products.

And that brings us to the most important piece of BioNTech's pipeline: pumitamig. The opportunity is broad because the company isn't developing this exciting new drug for just one cancer. Specifically, it's being tested across multiple types of solid tumors, including lung, breast, gastric, and kidney cancers, to name a few.

The company is also combining pumitamig with other therapies rather than treating it as a stand-alone product. Should the trials be successful, the drug could become an overall game changer in cancer therapy.

The late-stage pipeline keeps expanding across tumor types One interesting aspect of BioNTech's pipeline is its novel-novel combination strategy. The company is testing pumitamig alongside other kinds of cancer therapies. Essentially, the goal is to build combinations that attack tumors in different ways.

That matters because BioNTech isn't trying to win with one blockbuster drug alone. Instead, it's positioning itself around a portfolio of cancer medicines that can potentially be combined.

In a recent publication, BioNTech identified at least 17 late-stage data readouts through 2030 and beyond, spanning lung, breast, gastrointestinal, and other cancers. The company sees these programs as building blocks for becoming a multi-product oncology company.

Notably, BioNTech is still developing its nRNA oncology platform. BNT113 is in phase 3 development for HPV16-positive head and neck cancer, while autogene cevumeran is being developed as a personalized cancer vaccine for colorectal, pancreatic, and other cancers.

That means investors don't need every program to succeed, since a diversified pipeline can create significant value if several drugs prove effective as they move toward commercialization. The upside could be even greater if some of those drugs are used for multiple tumor types or in combination with one another.

Partnerships add another layer of support. BioNTech has collaborated with companies such as Bristol Myers Squibb, Duality Biologics, and Genentech, enabling it to share development capabilities across its portfolio.

BioNTech's pivot away from COVID hasn't been painless. Revenue fell by about 60% year over year in its latest quarter, and losses widened as the company poured more money into oncology research, even as it named incoming CEO Guido Oelkers to help steer that transition.

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But the good news is that BioNTech's balance sheet gives the company plenty of room to move ahead. The company ended the quarter with more than 16 billion euros in cash and securities, providing a cushion to fund its pipeline while it waits on catalysts, including roughly 600 million euros in Bristol Myers Squibb collaboration revenue expected later this year.

What matters now is what the company's oncology portfolio could become. Investors today are gaining exposure to a deep late-stage oncology pipeline, with multiple cancer drugs that offer real diversification. If pumitamig and other late-stage candidates continue to deliver positive data, BioNTech could be closer to becoming a major oncology player than the market realizes.

And with the stock trading below $100, now could be a compelling entry point for investors willing to look past the COVID-era narrative.

Citigroup just told investors to sell Moderna and the stock responded by climbing 3%, raising one pointed question about whether pipeline optimism has fully broken free from Wall Street's valuation warnings.

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Buyers are stepping into Moderna (NASDAQ:MRNA | MRNA Price Prediction) shares, evidently. The move comes one session after a Citigroup (NYSE:C) downgrade to Sell, a sign the market still prizes the company’s cancer vaccine pipeline over the valuation warning. Moderna stock is climbing 3% to $198.71 in morning trading. Such a bounce sets up a clear test of whether pipeline optimism can survive a bearish call from a major bank.

Meanwhile, BioNTech (NASDAQ:BNTX) stock is inching up 0.6% to $98.93, a far smaller gain from the other big name in messenger RNA. Pfizer (NYSE:PFE) shares are slipping 0.2% to $28.46, leaving BioNTech’s vaccine partner flat water. Both moves look small next to the gain in Moderna stock, which keeps the focus on one name.

The sector fund is in the red as the iShares Biotechnology ETF (NASDAQ:IBB) drops 0.3% to $209.96. At the same time, the SPDR S&P 500 ETF Trust (NYSEARCA:SPY) is slipping 0.3% to $760.64. That split marks the rally in Moderna stock as a single-name repricing while the broad market drifts lower.

Citigroup Downgrade Rests on Valuation In the previous session, Citigroup downgraded Moderna stock to Sell from Neutral and lifted its price target to $80 in the same note. Citigroup built the call on valuation, pointing out that Moderna shares had climbed 222% since the melanoma trial results were reported. This framing leaves the underlying science unchallenged and moves the whole debate onto the price investors are paying for Moderna.

Under Citigroup’s reading, the melanoma win is already reflected in Moderna stock, which leaves less room for gains without fresh evidence. Geoff Meacham of Citigroup cautioned in August that full validation of the result depends on Moderna’s complete data. A higher target paired with a lower rating signals a firm that respects the science and still balks at the price.

Melanoma Vaccine Keeps Buyers Interested Intismeran autogene is the personalized cancer vaccine at the center of the debate, and Moderna is building it on messenger RNA technology with Merck (NYSE:MRK) as the development partner on the program, and the vaccine was tested in combination with Merck’s Keytruda. In a pivotal trial, the treatment hit its primary endpoint in patients whose melanoma tumors had already been surgically removed.

Moderna’s complete data hasn’t been presented publicly yet, and it’s expected at a European oncology conference in Madrid in late October. Until those numbers are out, read-across to other tumor types remains an open question for Moderna, and it is still the variable that moves Moderna stock most, because it determines how far the platform could reach.

What to Watch Next Late October brings the next scheduled test, when Moderna’s complete data is due in Madrid. Shareholders can watch for evidence of read-across to other tumor types in Moderna’s full results, since that upside sits beyond the melanoma win Citigroup argues Moderna stock already reflects. Detailed findings that support broader use could reinforce that upside view for Moderna.

Moderna’s upside argument rests on a pipeline that could extend well beyond melanoma, while the downside view leans on Citigroup’s $80 target for Moderna stock and a share price that already bakes in the trial win. Investors should watch whether BioNTech stock continues to track Moderna’s direction or settles back toward the biotechnology fund. Each side has a strong case, and that balance favors a patient approach.

Contact [email protected] for any questions or corrections.

German COVID‑19 vaccine maker BioNTech (22UAy.DE) said on Monday it would close ​sites in Germany and Singapore because ‌it failed to find buyers after pivoting away from pandemic-era manufacturing.

"Despite the best efforts of ​all those involved and a wide-ranging ​sales process, it has unfortunately not ⁠been possible to finalise a sale," said ​a spokesperson.

The spokesperson added that the biotech ​firm had agreed with the works council on socially responsible solutions and supplementary redundancy terms for ​affected staff.

BioNTech said in May it would ​seek buyers for its German sites in Idar-Oberstein, ‌Marburg ⁠and Tuebingen, as well as in Singapore, or otherwise wind them down.

The restructuring, affecting up to 1,860 jobs, was part ​of a ​production transfer ⁠of its COVID-19 vaccine to partner Pfizer (PFE.N).

BioNTech, the initial inventor ​of the Western world's most commonly ​used ⁠immunisation shot during the pandemic, said in March that its two co-founders would leave by ⁠the ​end of this year ​to start a new venture.

($1 = 0.8554 euros)

BioNTech SE Sponsored ADR (NASDAQ:BNTX – Get Free Report) CEO Ugur Sahin sold 30,000 shares of the stock in a transaction on Wednesday, September 23rd. The stock was sold at an average price of $99.40, for a total value of $2,982,000.00. Following the sale, the chief executive officer owned 380,209 shares in the company, valued at approximately $37,792,774.60. This represents a 7.31% decrease in their position. The transaction was disclosed in a filing with the Securities & Exchange Commission, which is accessible through this link. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Ugur Sahin also recently made the following trade(s):

On Thursday, September 24th, Ugur Sahin sold 39,000 shares of BioNTech stock. The stock was sold at an average price of $98.99, for a total value of $3,860,610.00. On Tuesday, September 22nd, Ugur Sahin sold 46,000 shares of BioNTech stock. The shares were sold at an average price of $100.72, for a total value of $4,633,120.00. On Monday, September 21st, Ugur Sahin sold 33,000 shares of BioNTech stock. The shares were sold at an average price of $97.81, for a total value of $3,227,730.00. On Friday, September 18th, Ugur Sahin sold 30,000 shares of BioNTech stock. The stock was sold at an average price of $96.22, for a total value of $2,886,600.00. On Thursday, September 17th, Ugur Sahin sold 34,000 shares of BioNTech stock. The stock was sold at an average price of $98.60, for a total value of $3,352,400.00. On Wednesday, September 16th, Ugur Sahin sold 15,000 shares of BioNTech stock. The shares were sold at an average price of $96.09, for a total value of $1,441,350.00. On Tuesday, September 15th, Ugur Sahin sold 34,000 shares of BioNTech stock. The shares were sold at an average price of $96.49, for a total value of $3,280,660.00. On Monday, September 14th, Ugur Sahin sold 41,000 shares of BioNTech stock. The shares were sold at an average price of $99.45, for a total value of $4,077,450.00. On Friday, September 11th, Ugur Sahin sold 45,000 shares of BioNTech stock. The stock was sold at an average price of $96.93, for a total transaction of $4,361,850.00. On Thursday, September 10th, Ugur Sahin sold 20,500 shares of BioNTech stock. The stock was sold at an average price of $96.31, for a total transaction of $1,974,355.00. BioNTech Price Performance BNTX stock opened at $98.52 on Friday. The firm has a 50 day moving average of $98.17 and a 200-day moving average of $94.79. The firm has a market capitalization of $24.91 billion, a P/E ratio of -12.58 and a beta of 1.29. BioNTech SE Sponsored ADR has a 12 month low of $79.52 and a 12 month high of $124.00. The company has a current ratio of 7.85, a quick ratio of 7.80 and a debt-to-equity ratio of 0.01.

BioNTech (NASDAQ:BNTX – Get Free Report) last posted its earnings results on Tuesday, August 4th. The company reported ($2.53) earnings per share for the quarter, missing analysts’ consensus estimates of ($2.40) by ($0.13). BioNTech had a negative return on equity of 6.86% and a negative net margin of 63.54%.The firm had revenue of $122.31 million for the quarter, compared to the consensus estimate of $180.18 million. During the same period last year, the company posted ($1.60) EPS. The business’s revenue was down 59.5% on a year-over-year basis. As a group, sell-side analysts predict that BioNTech SE Sponsored ADR will post -6.37 earnings per share for the current fiscal year. Wall Street Analysts Forecast Growth BNTX has been the topic of several research analyst reports. Morgan Stanley decreased their price target on shares of BioNTech from $126.00 to $119.00 and set an “overweight” rating on the stock in a report on Wednesday, July 8th. BMO Capital Markets cut BioNTech from an “outperform” rating to a “market perform” rating and reduced their target price for the stock from $128.00 to $105.00 in a research report on Tuesday, September 8th. Berenberg Bank set a $140.00 target price on BioNTech in a research report on Wednesday, September 16th. Canaccord Genuity Group decreased their target price on BioNTech from $142.00 to $136.00 and set a “buy” rating on the stock in a research note on Monday, August 31st. Finally, UBS Group reaffirmed a “buy” rating on shares of BioNTech in a report on Wednesday, September 16th. One investment analyst has rated the stock with a Strong Buy rating, twelve have issued a Buy rating, five have given a Hold rating and one has given a Sell rating to the company’s stock. Based on data from MarketBeat.com, BioNTech currently has a consensus rating of “Moderate Buy” and an average target price of $126.00.

Check Out Our Latest Stock Report on BNTX

Institutional Trading of BioNTech Institutional investors and hedge funds have recently made changes to their positions in the stock. Larson Financial Group LLC lifted its stake in BioNTech by 86.4% during the fourth quarter. Larson Financial Group LLC now owns 274 shares of the company’s stock worth $26,000 after purchasing an additional 127 shares during the last quarter. Integrated Wealth Concepts LLC purchased a new position in shares of BioNTech in the 2nd quarter worth about $39,000. Caitong International Asset Management Co. Ltd increased its position in shares of BioNTech by 1,012.0% during the 4th quarter. Caitong International Asset Management Co. Ltd now owns 556 shares of the company’s stock valued at $53,000 after purchasing an additional 506 shares during the last quarter. Vestcor Inc bought a new position in shares of BioNTech during the 4th quarter valued at about $153,000. Finally, Rockefeller Capital Management L.P. raised its holdings in shares of BioNTech by 328.6% during the 4th quarter. Rockefeller Capital Management L.P. now owns 1,856 shares of the company’s stock valued at $177,000 after buying an additional 1,423 shares in the last quarter. Hedge funds and other institutional investors own 15.52% of the company’s stock.

About BioNTech (Get Free Report)

BioNTech SE is a biotechnology company focused on developing immunotherapies and vaccines for cancer and other serious diseases. Its research platforms include messenger RNA, cell therapies, protein-based therapeutics, antibody therapies and small-molecule immunomodulators.

The company is best known for Comirnaty, its COVID-19 vaccine developed and commercialized globally in collaboration with Pfizer. BioNTech is also advancing a broad oncology pipeline that includes individualized and off-the-shelf cancer vaccines, antibody-based treatments, cell therapies and combination approaches designed to stimulate or direct the immune system against tumors.

BioNTech was founded in 2008 and is headquartered in Mainz, Germany.

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BioNTech SE Sponsored ADR (NASDAQ:BNTX – Get Free Report) CEO Ugur Sahin sold 46,000 shares of BioNTech stock in a transaction that occurred on Tuesday, September 22nd. The shares were sold at an average price of $100.72, for a total value of $4,633,120.00. Following the sale, the chief executive officer directly owned 410,209 shares in the company, valued at approximately $41,316,250.48. The trade was a 10.08% decrease in their ownership of the stock. The transaction was disclosed in a filing with the SEC, which is accessible through this hyperlink. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Ugur Sahin also recently made the following trade(s):

On Monday, September 21st, Ugur Sahin sold 33,000 shares of BioNTech stock. The stock was sold at an average price of $97.81, for a total value of $3,227,730.00. On Friday, September 18th, Ugur Sahin sold 30,000 shares of BioNTech stock. The shares were sold at an average price of $96.22, for a total value of $2,886,600.00. On Thursday, September 17th, Ugur Sahin sold 34,000 shares of BioNTech stock. The shares were sold at an average price of $98.60, for a total value of $3,352,400.00. On Wednesday, September 16th, Ugur Sahin sold 15,000 shares of BioNTech stock. The shares were sold at an average price of $96.09, for a total value of $1,441,350.00. On Tuesday, September 15th, Ugur Sahin sold 34,000 shares of BioNTech stock. The stock was sold at an average price of $96.49, for a total value of $3,280,660.00. On Monday, September 14th, Ugur Sahin sold 41,000 shares of BioNTech stock. The stock was sold at an average price of $99.45, for a total value of $4,077,450.00. On Friday, September 11th, Ugur Sahin sold 45,000 shares of BioNTech stock. The shares were sold at an average price of $96.93, for a total value of $4,361,850.00. On Thursday, September 10th, Ugur Sahin sold 20,500 shares of BioNTech stock. The shares were sold at an average price of $96.31, for a total value of $1,974,355.00. On Wednesday, September 9th, Ugur Sahin sold 36,000 shares of BioNTech stock. The shares were sold at an average price of $97.78, for a total transaction of $3,520,080.00. On Tuesday, September 8th, Ugur Sahin sold 37,000 shares of BioNTech stock. The stock was sold at an average price of $99.20, for a total transaction of $3,670,400.00. BioNTech Stock Up 2.9% Shares of BioNTech stock opened at $100.87 on Wednesday. The company has a debt-to-equity ratio of 0.01, a current ratio of 7.85 and a quick ratio of 7.80. The company has a 50-day moving average of $97.75 and a 200 day moving average of $94.80. The firm has a market cap of $25.51 billion, a price-to-earnings ratio of -12.88 and a beta of 1.29. BioNTech SE Sponsored ADR has a 1 year low of $79.52 and a 1 year high of $124.00.

BioNTech (NASDAQ:BNTX – Get Free Report) last issued its quarterly earnings results on Tuesday, August 4th. The company reported ($2.53) earnings per share (EPS) for the quarter, missing analysts’ consensus estimates of ($2.40) by ($0.13). BioNTech had a negative net margin of 63.54% and a negative return on equity of 6.86%. The business had revenue of $122.31 million for the quarter, compared to analysts’ expectations of $180.18 million. During the same period last year, the business earned ($1.60) earnings per share. The company’s revenue was down 59.5% on a year-over-year basis. As a group, sell-side analysts anticipate that BioNTech SE Sponsored ADR will post -6.37 earnings per share for the current fiscal year. Hedge Funds Weigh In On BioNTech Several hedge funds and other institutional investors have recently added to or reduced their stakes in the business. Flossbach Von Storch SE bought a new stake in shares of BioNTech in the 2nd quarter worth $207,142,000. BNP Paribas Financial Markets boosted its position in shares of BioNTech by 43.0% during the fourth quarter. BNP Paribas Financial Markets now owns 1,578,094 shares of the company’s stock valued at $150,235,000 after buying an additional 474,796 shares during the last quarter. Bank of America Corp DE boosted its position in shares of BioNTech by 22.6% during the first quarter. Bank of America Corp DE now owns 903,029 shares of the company’s stock valued at $80,261,000 after buying an additional 166,432 shares during the last quarter. First Trust Advisors LP increased its holdings in BioNTech by 116.0% in the 1st quarter. First Trust Advisors LP now owns 839,991 shares of the company’s stock worth $74,658,000 after buying an additional 451,124 shares in the last quarter. Finally, Assenagon Asset Management S.A. bought a new stake in BioNTech in the 2nd quarter worth about $39,385,000. 15.52% of the stock is owned by institutional investors.

Key Headlines Impacting BioNTech Here are the key news stories impacting BioNTech this week:

Positive Sentiment: Berenberg raised its price target on BioNTech following the stock’s recent pullback, signaling improved potential upside and helping support the shares. Berenberg lifts BioNTech price target Positive Sentiment: BioNTech benefited from broader enthusiasm for mRNA-based cancer treatments after Moderna’s positive melanoma-related news drove gains across the sector. Investors may view BioNTech’s cancer pipeline as an important longer-term growth opportunity. Moderna, Merck and BioNTech sector reaction Neutral Sentiment: CEO Ugur Sahin sold a combined 79,000 BioNTech shares for approximately $7.86 million across September 21 and 22. Both transactions were executed under a pre-arranged Rule 10b5-1 trading plan, which reduces their significance as a signal of current management expectations; Sahin still retained 410,209 shares after the sales. BioNTech SEC insider trading filing Negative Sentiment: BMO Capital Markets downgraded BioNTech and lowered its price target after the company reduced its 2027 guidance and suffered a clinical setback. The downgrade highlights near-term execution and pipeline risks, although the report questioned whether Wall Street may be undervaluing BioNTech’s cancer portfolio. BioNTech downgrade and cancer pipeline analysis Wall Street Analyst Weigh In A number of research firms recently weighed in on BNTX. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of BioNTech in a research report on Monday, July 6th. Berenberg Bank set a $140.00 target price on BioNTech in a research note on Wednesday, September 16th. Sanford C. Bernstein restated a “market perform” rating on shares of BioNTech in a report on Friday, June 5th. UBS Group restated a “buy” rating on shares of BioNTech in a report on Wednesday, September 16th. Finally, Citigroup lowered their price target on BioNTech from $130.00 to $125.00 and set a “buy” rating for the company in a research report on Wednesday, August 5th. One investment analyst has rated the stock with a Strong Buy rating, twelve have given a Buy rating, five have given a Hold rating and one has given a Sell rating to the company. According to data from MarketBeat, the company currently has a consensus rating of “Moderate Buy” and an average target price of $126.00.

Check Out Our Latest Stock Analysis on BioNTech

BioNTech Company Profile (Get Free Report)

BioNTech SE is a biotechnology company focused on developing immunotherapies and vaccines for cancer and other serious diseases. Its research platforms include messenger RNA, cell therapies, protein-based therapeutics, antibody therapies and small-molecule immunomodulators.

The company is best known for Comirnaty, its COVID-19 vaccine developed and commercialized globally in collaboration with Pfizer. BioNTech is also advancing a broad oncology pipeline that includes individualized and off-the-shelf cancer vaccines, antibody-based treatments, cell therapies and combination approaches designed to stimulate or direct the immune system against tumors.

BioNTech was founded in 2008 and is headquartered in Mainz, Germany.

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BMO (BMO +1.55%) Capital Markets has been quite bullish about BioNTech SE (BNTX +2.02%) this year. However, that's no longer the case.

On Sept. 8, 2026, BioNTech's shares dipped after BMO downgraded the biotech stock from an "outperform" rating to a "market perform" rating. BMO also lowered its 12-month price target for BioNTech from $128 to $105.

There's a simple explanation for BMO's new take on BioNTech. But is Wall Street underestimating the company's cancer pipeline?

Image source: Getty Images.

What the downgrade got right -- and wrong It isn't all that surprising that BMO Capital Markets is now significantly less optimistic about BioNTech's near-term prospects than it once was. The global demand for BioNTech's COVID-19 vaccines continues to wane.

BMO's downgrade also followed a key setback in BioNTech's pipeline. On Aug. 28, 2026, the company announced that it was canceling a Phase 2 clinical trial evaluating the personalized mRNA cancer vaccine BNT122-01 for the treatment of colorectal cancer. There weren't any safety concerns, but the experimental therapy didn't demonstrate statistically significant efficacy. As a result of the bad news, the company lowered its full-year revenue guidance to €1.6 billion to €1.9 billion from its previous forecast of €2 billion to €2.3 billion.

Investors were excited about BioNTech after Moderna (MRNA +12.27%) and Merck (MRK +1.79%) reported positive results from a late-stage study of Moderna's personalized mRNA cancer vaccine intismeran autogene, in combination with Merck's blockbuster immunotherapy Keytruda. However, the momentum has now nearly evaporated.

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Moneyball Superscore

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But the rest of BioNTech's oncology pipeline shouldn't be ignored. The company has over 25 Phase 2 and Phase 3 clinical studies evaluating experimental cancer therapies underway. It recently announced encouraging results from one of them, with gotistobart nearly doubling median overall survival compared with standard-of-care chemotherapy in previously treated patients with squamous non-small cell lung cancer (NSCLC).

BioNTech expects to report data from 11 other late-stage clinical studies by the end of 2029. These trials focus on multiple types of tumors, including breast cancer, gastrointestinal cancer, and lung cancer. Data from three studies will be announced before the end of this year.

A biotech stock that's still worth buying Meanwhile, BioNTech's market cap hovers around $24 billion. As of June 30, 2026, the company's cash, cash equivalents, and security investments totaled roughly €16.6 billion (around $19 billion). This arguably puts BioNTech in value stock territory.

Yes, BioNTech has experienced a big clinical setback and cut its full-year guidance. On the surface, the stock might seem to deserve a downgrade. However, investing in BioNTech right now amounts to getting a robust pipeline essentially for free. This biotech stock is still worth buying, in my view.

BioNTech (NASDAQ: BNTX - Get Free Report) and TScan Therapeutics (NASDAQ: TCRX - Get Free Report) are both healthcare companies, but which is the better stock? We will contrast the two businesses based on the strength of their dividends, profitability, risk, analyst recommendations, valuation, earnings and institutional ownership. Earnings and Valuation This table compares BioNTech and TScan

Moderna has nearly tripled in a single month without a single new trial result or analyst upgrade to explain Thursday's continued surge, and the one clue hiding in a quiet peer stock reveals exactly what kind of bet the market…

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Cancer vaccine momentum is doing the work for Moderna (NASDAQ:MRNA | MRNA Price Prediction) once again on Thursday, extending one of the sharpest one-month runs in large-cap biotech this year without a fresh disclosure attached to it.

Moderna stock is up 6% to $154 in morning trading, and the stock is up 137% over the past month. That extended rally traces back to the late-stage adjuvant melanoma readout reported in August, and the tape is still repricing off that single event for Moderna.

The sector backdrop isn’t providing the lift. The iShares Biotechnology ETF (NASDAQ:IBB) is up 1% to $204.5, a modest bid rather than a sector melt-up. Meanwhile, the SPDR S&P 500 ETF Trust (NYSEARCA:SPY) is up 1% to $763.49, so the broad tape is essentially matching biotech’s pace and Moderna stock is doing this on its own.

Riding a Wave of Confidence No Moderna announcement, filing, analyst action or trial result landed this morning to explain the move. What’s still driving the tape is the five-year Phase 2b adjuvant melanoma data presented at ASCO 2026, which showed intismeran autogene plus KEYTRUDA delivered a 49% reduction in risk of recurrence or death versus KEYTRUDA alone.

Merck (NYSE:MRK) is Moderna’s partner on that individualized neoantigen program, which now spans nine Phase 2/3 trials across melanoma, non-small cell lung cancer, bladder and renal cell carcinoma. Moderna’s chief development officer, David Berman, stated on the second-quarter call that “the data that we’ve shown at ASCO confirms that when we give the neoantigen vaccine, we do see neoantigen-specific T cells, and we know those T cells can kill the tumor.”

Moderna also guided to an interim analysis from its Phase 3 adjuvant melanoma trial in the second half of 2026, with management saying it is “highly confident” the interim will be conducted this year. That is the pipeline event the past-month move in Moderna is really underwriting.

What the Peer Tape Says BioNTech (NASDAQ:BNTX) stock is up 1% to $97.00, a muted response given BioNTech runs its own individualized messenger RNA cancer vaccine program alongside Genentech. The gap matters here, because the closest peer using the same underlying technology is barely moving, which suggests the market is paying for Moderna’s specific asset rather than the messenger RNA cancer vaccine category as a whole.

Management at BioNTech has downplayed cross-read on the melanoma result. On the second-quarter call, chief medical officer Özlem Türeci stated that “in terms of biology and indication, we don’t see any Read through opportunities. Melanoma versus colorectal cancer, these are very different biologies and indications and responsiveness to immunotherapy and in particular antigen-specific T-cell antigens.” That framing from BioNTech helps explain why the stock isn’t running with Moderna today.

Also catching a sympathy bid, Novavax (NASDAQ:NVAX) stock is up 2% to $9.5 as a vaccine-sector name in the group. Novavax isn’t a participant in the messenger RNA cancer vaccine program described here, and its move today reads as group beta more than a discrete company catalyst.

Weighing the Cases on Moderna The bull case for Moderna stock rests on optionality the market hasn’t yet seen data for. The adjuvant melanoma result is in hand, and the read across bladder, renal cell and lung has to be earned, not assumed, since checkpoint biology and neoantigen response can vary sharply across tumor types.

Moderna’s own outlook fits that framing. For 2026, the company guided to up to 10% revenue growth and year-end cash of $4.7 billion to $5.2 billion, numbers that fund the pipeline but don’t on their own justify the stock’s month. Chief executive Stéphane Bancel described oncology as a key focus for the second half of 2026, which puts more weight on the intismeran interim than on the base vaccine franchise for Moderna.

The complication is priced into that 137% one-month figure. A stock that has more than doubled in a month has priced a broad franchise off one indication, and the muted move in BioNTech is the tell that buyers are underwriting Moderna’s specific program rather than the platform. Until the full dataset arrives, Moderna stock is trading on a thesis rather than on a disclosure.

What to Watch The full dataset from the August readout hasn’t yet been presented publicly, and the oncology congress in Madrid in late October is the next scheduled opportunity for it. Investors can watch for whether Moderna and Merck use that venue to release the underlying survival curves, subgroup detail and safety picture behind the headline number.

Ahead of that, the interim analysis from Moderna’s Phase 3 adjuvant melanoma trial is the swing factor for the next leg. Traders may want to check for whether Moderna issues that readout before Madrid, and whether management pairs it with accelerated-review language rather than waiting for the full analysis.

For position sizing on Moderna stock, a name that has traveled this fast in a month carries elevated give-back risk on any dataset that lands short of the setup that built the run. A cautious approach to fresh Moderna share exposure will keep one’s position small enough that a single conference slide can’t dictate the outcome for their portfolio.

Contact [email protected] for any questions or corrections.

BioNTech SE Sponsored ADR (NASDAQ:BNTX – Get Free Report) CEO Ugur Sahin sold 41,000 shares of the stock in a transaction on Monday, September 14th. The stock was sold at an average price of $99.45, for a total transaction of $4,077,450.00. Following the completion of the sale, the chief executive officer directly owned 602,209 shares of the company’s stock, valued at approximately $59,889,685.05. This trade represents a 6.37% decrease in their ownership of the stock. The sale was disclosed in a filing with the Securities & Exchange Commission, which is available at the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan.

Ugur Sahin also recently made the following trade(s):

On Friday, September 11th, Ugur Sahin sold 45,000 shares of BioNTech stock. The stock was sold at an average price of $96.93, for a total transaction of $4,361,850.00. On Thursday, September 10th, Ugur Sahin sold 20,500 shares of BioNTech stock. The shares were sold at an average price of $96.31, for a total value of $1,974,355.00. On Wednesday, September 9th, Ugur Sahin sold 36,000 shares of BioNTech stock. The shares were sold at an average price of $97.78, for a total value of $3,520,080.00. On Tuesday, September 8th, Ugur Sahin sold 37,000 shares of BioNTech stock. The stock was sold at an average price of $99.20, for a total value of $3,670,400.00. On Friday, September 4th, Ugur Sahin sold 31,500 shares of BioNTech stock. The stock was sold at an average price of $103.52, for a total value of $3,260,880.00. On Thursday, September 3rd, Ugur Sahin sold 45,000 shares of BioNTech stock. The shares were sold at an average price of $102.85, for a total transaction of $4,628,250.00. BioNTech Stock Performance BNTX opened at $96.69 on Wednesday. The company has a debt-to-equity ratio of 0.01, a quick ratio of 7.80 and a current ratio of 7.85. The stock has a market capitalization of $24.45 billion, a price-to-earnings ratio of -12.35 and a beta of 1.29. The company has a fifty day moving average of $97.13 and a 200 day moving average of $95.10. BioNTech SE Sponsored ADR has a fifty-two week low of $79.52 and a fifty-two week high of $124.00.

BioNTech (NASDAQ:BNTX – Get Free Report) last issued its quarterly earnings data on Tuesday, August 4th. The company reported ($2.53) earnings per share for the quarter, missing analysts’ consensus estimates of ($2.40) by ($0.13). BioNTech had a negative net margin of 63.54% and a negative return on equity of 6.86%. The firm had revenue of $122.31 million for the quarter, compared to analysts’ expectations of $180.18 million. During the same quarter in the previous year, the business earned ($1.60) EPS. The company’s revenue for the quarter was down 59.5% on a year-over-year basis. As a group, sell-side analysts forecast that BioNTech SE Sponsored ADR will post -6.33 earnings per share for the current fiscal year. Institutional Investors Weigh In On BioNTech Institutional investors have recently made changes to their positions in the company. Flossbach Von Storch SE bought a new position in shares of BioNTech during the 2nd quarter worth $207,142,000. BNP Paribas Financial Markets increased its stake in shares of BioNTech by 43.0% during the fourth quarter. BNP Paribas Financial Markets now owns 1,578,094 shares of the company’s stock valued at $150,235,000 after buying an additional 474,796 shares during the period. First Trust Advisors LP raised its holdings in shares of BioNTech by 116.0% in the first quarter. First Trust Advisors LP now owns 839,991 shares of the company’s stock valued at $74,658,000 after acquiring an additional 451,124 shares in the last quarter. Assenagon Asset Management S.A. bought a new stake in shares of BioNTech in the second quarter valued at about $39,385,000. Finally, SEB Asset Management AB purchased a new stake in BioNTech in the first quarter worth about $17,804,000. Institutional investors own 15.52% of the company’s stock.

Wall Street Analysts Forecast Growth BNTX has been the subject of a number of research reports. Canaccord Genuity Group lowered their target price on BioNTech from $142.00 to $136.00 and set a “buy” rating for the company in a research report on Monday, August 31st. UBS Group upgraded shares of BioNTech from a “neutral” rating to a “buy” rating and boosted their price target for the stock from $117.00 to $135.00 in a research report on Wednesday, May 27th. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of BioNTech in a research note on Monday, July 6th. Citigroup lowered their price objective on shares of BioNTech from $130.00 to $125.00 and set a “buy” rating for the company in a research report on Wednesday, August 5th. Finally, BMO Capital Markets cut shares of BioNTech from an “outperform” rating to a “market perform” rating and dropped their price objective for the stock from $128.00 to $105.00 in a research note on Tuesday, September 8th. One analyst has rated the stock with a Strong Buy rating, twelve have given a Buy rating, five have issued a Hold rating and one has given a Sell rating to the company’s stock. According to data from MarketBeat.com, BioNTech currently has a consensus rating of “Moderate Buy” and an average price target of $126.00.

View Our Latest Stock Report on BNTX

Trending Headlines about BioNTech Here are the key news stories impacting BioNTech this week:

Positive Sentiment: BioNTech and partner OncoC4 reported that investigational drug gotistobart nearly doubled median overall survival versus standard chemotherapy in previously treated patients with squamous non-small-cell lung cancer. The results came from the Phase 3 PRESERVE-003 trial and strengthen the case for BioNTech’s strategy to diversify beyond COVID-19 vaccines. BioNTech and OncoC4 gotistobart trial data Positive Sentiment: The strength of the survival data led to reports that BNTX shares increased approximately 6.4% in recent trading. Investors appear to view gotistobart, also known as BNT316 or ONC-392, as a potentially important oncology asset that could support future growth if regulatory and commercial milestones are achieved. Reuters report on BioNTech lung-cancer drug Neutral Sentiment: Gotistobart is an investigational CTLA-4-targeting immunotherapy designed to reduce regulatory T cells within tumors and restore antitumor immune activity. While the clinical results are encouraging, the drug remains subject to additional regulatory review and further development before it can produce commercial revenue. Gotistobart overall-survival report Negative Sentiment: CEO Ugur Sahin sold 45,000 shares for about $4.36 million on September 11 and another 41,000 shares for approximately $4.08 million on September 14. The combined 86,000-share sale reduced his direct holdings by roughly 13%; however, both transactions were made under a pre-arranged Rule 10b5-1 plan, which reduces their significance as a discretionary bearish signal. SEC insider transaction filing BioNTech Company Profile (Get Free Report)

BioNTech SE is a biotechnology company focused on developing immunotherapies and vaccines for cancer and other serious diseases. Its research platforms include messenger RNA, cell therapies, protein-based therapeutics, antibody therapies and small-molecule immunomodulators.

The company is best known for Comirnaty, its COVID-19 vaccine developed and commercialized globally in collaboration with Pfizer. BioNTech is also advancing a broad oncology pipeline that includes individualized and off-the-shelf cancer vaccines, antibody-based treatments, cell therapies and combination approaches designed to stimulate or direct the immune system against tumors.

BioNTech was founded in 2008 and is headquartered in Mainz, Germany.

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BioNTech (22UAy.DE) said on Monday ​that a late-stage ‌trial showed its drug candidate gotistobart ​led to a ​clinically meaningful overall survival ⁠benefit in ​a certain form of ​lung cancer compared with standard treatment.

It added ​that results from ​the PRESERVE-003 Phase 3 ‌clinical ⁠trial involved patients with squamous non-small cell lung cancer ​whose ​disease ⁠had progressed despite prior immunotherapy ​and chemotherapy.

Gotistobart ​nearly ⁠doubled survival compared with standard-of-care chemotherapy, ⁠the ​biotech firm ​said.

BioNTech (BNTX +1.54%) has lagged the market this year. The company's shares have climbed just 6% as of writing, compared with the S&P 500's 12% gain. The biotech's performance looks even worse once we zoom out. Over the past five years, BioNTech has lost 70% of its value. Could BioNTech bounce back soon, or is the company more likely to continue sinking over the next few years? Let's find out whether it's time to buy the stock after years of underperformance.

Image source: Getty Images.

What's going on with BioNTech? BioNTech developed Comirnaty, a leading coronavirus vaccine, in combination with Pfizer (PFE +1.72%). This product was highly popular in the first few years of the pandemic. It generated almost $38 billion in sales at its peak and helped BioNTech post strong financial performances. However, the pandemic waned, demand for the vaccine declined, and some governments made it harder for people to get vaccinated. As a result, Comirnaty's sales have been unimpressive over the past few years.

That's why BioNTech has been lagging the market. In the second quarter, the company's revenue was 105.6 million euros ($122.7 million), down almost 60% year over year. The biotech's adjusted loss per share was €2.22 ($2.58), worse than the €1.45 ($1.68) loss per share recorded in the year-ago period. BioNTech will likely continue generating some revenue from its coronavirus vaccine franchise, but it is unlikely to be a meaningful, consistent growth driver in the medium term. So, the company needs to look elsewhere for growth.

A landmark clinical trial win BioNTech stock was in the red year-to-date until an important clinical trial win sent it soaring. Of note, it wasn't BioNTech's own clinical success. It was Moderna's (MRNA -2.21%) and Merck's (MRK +1.26%). The two corporations are collaborating to develop intismeran autogene, a personalized cancer vaccine. In a phase 3 study, intismeran autogene, in combination with Keytruda, significantly reduced the risk of recurrence and death in patients with melanoma compared to Keytruda alone. This clinical win showed the potential of Moderna's mRNA vaccine platform beyond infectious diseases and into the lucrative oncology market.

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BioNTech, another company that specializes in mRNA vaccines, suddenly became more attractive to many investors. BioNTech has several mRNA-based candidates in phase 2 or phase 3 studies. For instance, the company's BNT113 is being developed for head and neck cancer, while BNT116 is being investigated in patients with lung cancer. Over the next five years, BioNTech could record important clinical and regulatory wins, significantly improve its approved portfolio, and post much better financial results.

Perhaps BioNTech's most promising candidate is pumitamig, a cancer medicine it is developing in collaboration with Bristol Myers Squibb (BMY +0.90%). Pumitamig is a bispecific antibody, a newer class of drugs that could become increasingly important in oncology. BioNTech is hoping pumitamig can become a pipeline in a drug: The medicine is being developed to treat cancers of the lung, breast, liver, colon, and rectum, and more. Clinical trial wins across several of these niches, particularly in lung cancer -- the leading cause of cancer death worldwide -- would likely send BioNTech stock much higher. But does any of that make the stock a strong buy? "No-brainer" is likely too optimistic.

A lot could go wrong with BioNTech stock, including clinical and regulatory setbacks for some of its leading candidates. The vaccine maker also has a market cap of $25.4 billion as of writing. For a biotech company that generates little revenue and is consistently unprofitable, that can seem like a lot. But the market is betting on BioNTech's deep pipeline, so if the company fails to meet Wall Street's expectations, the stock will fall off a cliff. But even accounting for potential clinical setbacks, BioNTech looks somewhat attractive, especially given Moderna's clinical win that makes BioNTech's entire mRNA pipeline far more valuable. Given the breadth of BioNTech's pipeline, which gives it multiple shots at developing blockbuster products, the company could survive a few clinical trial failures. All good reasons why the stock looks attractive.

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the companies' 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY® XFG; COVID-19 Vaccine, mRNA) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying con.

BioNTech SE (NASDAQ:BNTX) shares are dropping Friday after the company announced it will terminate its Phase 2 clinical trial of autogene cevumeran in resected colorectal cancer. Here’s what you should know.

BioNTech stock is feeling bearish pressure. What’s behind BNTX decline? BioNTech Ends Phase 2 Colorectal Cancer TrialBioNTech is shutting down BNT122-01, a mid-stage study testing autogene cevumeran, its experimental personalized mRNA cancer treatment, as a solo therapy for patients whose colorectal cancer had been surgically removed but still showed circulating tumor DNA. Roche unit Genentech co-developed the treatment alongside BioNTech, and the two companies reached the termination decision together.

The trial had already tripped a futility threshold back in October 2025, but the study’s independent safety monitors felt the data was too premature at the time to draw firm conclusions, so BioNTech kept the trial running. A more recent review changed that: the safety board found a gap in overall survival between treated and untreated patients and concluded that continuing wouldn’t meaningfully change the outcome, leading it to recommend ending the study.

The trial was testing whether the mRNA treatment, used alone without a checkpoint inhibitor, could prevent cancer recurrence better than standard monitoring in this high-risk group.

BioNTech Co-Founder and Chief Medical Officer Özlem Türeci said the outcome wasn’t what the company hoped for, but that it offers useful insight into treating immune-resistant tumors and will help guide future mRNA cancer research. She said BioNTech remains committed to mRNA as a core part of its oncology strategy, including combination approaches, and thanked those involved in the study.

BioNTech Plans Further Analysis, Other Trial UnaffectedBioNTech said it plans to analyze the trial data further to inform future mRNA cancer treatment development, with results to be shared publicly later. Separately, the company’s other autogene cevumeran trial, IMcode003, which pairs the drug with checkpoint inhibitors and chemotherapy for pancreatic cancer, is unaffected and will continue as planned.

BNTX Shares Are TumblingBNTX Price Action: BioNTech shares were down 6.94% at $103.68 at the time of publication on Friday, according to Benzinga Pro.

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BioNTech SE maintains a Strong Buy rating, driven by robust late-stage oncology pipeline momentum and strategic partnerships. BNTX's next-gen anti-CTLA-4 gotistobart and PD-L1xVEGF-A bispecific antibody pumitamig have multiple pivotal trial catalysts, with key data readouts expected at WCLC 2026. COMIRNATY's XFG variant expansion provides near-term revenue, but COVID-19 vaccine sales face competitive and demand headwinds, reflected in lowered 2026 guidance.

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The mRNA trade is whipsawing for a third straight session as the market keeps repricing a single trial readout with no fresh clinical information hitting the tape Friday. Friday’s swing is happening while the broader market barely moves, with the S&P 500 up 0.3% and the NASDAQ 100 up 0.1%. That backdrop shows the volatility is being generated entirely inside the biotech complex, not by any macro shift.

Moderna (NASDAQ:MRNA | MRNA Price Prediction) stock is up 8% to $143.79 Friday morning, extending a violent two-way pattern that has defined the week. Also, BioNTech (NASDAQ:BNTX) shares are up 4% to $114.97, tracking the broader mRNA platform trade. Meanwhile, Merck (NYSE:MRK) stock sits at $149.36 as investors weigh how much of the melanoma readout accrues to the Keytruda franchise.

Moderna rallied 177% on Wednesday after the Phase 3 melanoma win, gave back 18% on Thursday, and was indicated sharply lower Friday before reversing into today’s gain — a repricing exercise as traders reset exposures around a single event.

Third-Session Whipsaw With No New Data Friday’s session lacks a fresh clinical trigger. The underlying story is unchanged. Moderna and Merck reported that intismeran, their individualized mRNA cancer vaccine, met its primary endpoint in a Phase 3 melanoma trial, showing improvement in recurrence-free and metastasis-free survival when combined with Merck’s Keytruda in patients whose tumors had been surgically removed. It’s the first successful late-stage trial of its kind, and the complete dataset has not been presented publicly and could come at the ESMO conference in Madrid running October 23 to 27.

Sentiment got a boost earlier in the week when Tesla (NASDAQ:TSLA) CEO Elon Musk posted on X that “Despite its obvious misuse during Covid, mRNA has tremendous promise for curing diseases,” adding that “Artificial RNA essentially makes curing diseases a software problem.” Musk was replying to Eric Topol, scientist and founder of the Scripps Research Translational Institute, who framed the melanoma result as building on signs of success in personalized mRNA work against pancreatic, triple-negative breast, and non-small cell lung cancers.

Retail flows have amplified the volatility. One widely shared WallStreetBets post titled “$500k overnight $MRNA” drew 4,914 upvotes and 476 comments, and Reddit sentiment on Moderna currently reads as very bullish across 52 qualified mentions.

Why the Names Are Moving Differently Moderna owns the readout outright. A credible oncology franchise reshapes the company on top of its infectious-disease base, so Moderna stock carries the full weight of every reassessment. That’s why the stock is up 352% year to date and swinging in double digits between sessions.

BioNTech is running its own individualized mRNA cancer immunotherapy, autogene cevumeran, with Genentech in adjuvant colorectal and pancreatic settings. BioNTech stock trades on broader platform read-across, which is why its move is a fraction of Moderna’s and its year-to-date gain sits at 16%.

Merck co-owns the same pivotal trial, yet Keytruda already anchors a broad approved oncology portfolio. Incremental economics of a single adjuvant melanoma indication are small next to that franchise, though Merck stock is up 44% year to date. The iShares Biotechnology ETF (NASDAQ:IBB) is at $212.28 and up 25% year to date, and Moderna’s presence inside the fund means a single constituent swinging this hard pulls on the ETF’s tape.

What to Watch Now The positioning tells the story today. Moderna’s full-chain put/call ratio sits at 0.86, with individual expirations swinging from 0.79 near-dated to 8.54 in early October, the kind of chain that produces two-way violence. BioNTech’s chain is 0.28 overall, calmer and call-tilted, which fits its smaller move.

Watch for whether Moderna holds its Friday bid into the close after two prior sessions of full reversals, and whether the ESMO calendar in late October pulls positioning forward, since the complete dataset is the next hard information event for the mRNA trade. Position sizing should reflect that Moderna can still deliver double-digit moves on no news at all (we wrote a free playbook on speculating with just 5% of a portfolio, sizing and exit rules included, here).

Contact [email protected] for any questions or corrections.

Pumitamig plus B7H3-targeting elfetabart drozuntecan delivers the first data in lung cancer for any PD-(L)1xVEGF bispecific immunomodulator combined with an antibody-drug conjugate, underscoring BioNTech’s leadership in novel-novel combination treatment strategiesUpdated overall survival data for gotistobart from the PRESERVE-003 Phase 3 clinical trial will add to the growing body of evidence for this chemotherapy-free treatment approach in the second- and later-line treatment of advanced squamous non-small cell lung cancer following prior immunotherapyBioNTech is advancing a diversified development program in lung cancer treatment spanning more than 16 ongoing clinical trials across subtypes, biomarkers and treatment settings, including five ongoing Phase 3 clinical trials and two novel-novel combination trials  MAINZ, Germany, August 20, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) will present new clinical data from its diversified development program in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer (“WCLC”) in Seoul, Republic of Korea, from September 12-15, 2026.

The breadth of data highlights the latest progress across key strategic assets, pumitamig (BNT327/BMS986545) and gotistobart (BNT316/ONC-392), as well as BioNTech’s mRNA-based immunotherapy approaches, highlighting the strength of BioNTech’s lung cancer treatment pipeline. Additionally, a late breaking oral presentation will detail data from the novel-novel combination trial of pumitamig with the investigational B7H3-targeted antibody-drug conjugate (“ADC”) elfetabart drozuntecan (elfe-D or BNT324/DB-1311), representing the first combination data for any PD-(L)1xVEGF bispecific immunomodulator and an ADC in lung cancer.

“Progress in lung cancer care means both improving treatment outcomes for patients and, importantly, finding better options for more patients who still do not sufficiently benefit from current standard therapies,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. “The data we are presenting at this year’s WCLC provide further clinical evidence for our late-stage assets, gotistobart and pumitamig, and help to define the role of next-generation immunomodulators in addressing unmet medical needs in lung cancer. We are also presenting the first clinical evidence from a novel-novel treatment combination in lung cancer as part of our evaluation of pumitamig as a potential backbone for combination strategies of complementary mechanisms. Taken together, these data will inform the next steps in our clinical development programs and our broader efforts to expand treatment options for patients.”

Highlights from BioNTech’s presentations at WCLC 2026:

Novel-novel combination trial of pumitamig, developed in collaboration with Bristol Myers Squibb Company (“BMS”), and elfetabart drozuntecan, developed in collaboration with Duality Biologics (Suzhou) Co. Ltd. (“DualityBio”):

Advanced/metastatic SCLC and NSCLC: First data from the global Phase 1/2 trial (NCT06892548) evaluating pumitamig in combination with the B7H3-targeting ADC elfetabart drozuntecan in patients with advanced or metastatic small cell lung cancer (“SCLC”) and NSCLC will be presented for this novel-novel treatment combination approach, underlining BioNTech’s leadership in novel-novel combination treatment strategies. Gotistobart – a tumor microenvironment-selective regulatory T cell depletion candidate targeting CTLA-4, developed in collaboration with OncoC4, Inc. (“OncoC4”):

2L+ squamous NSCLC: Updated overall survival data from stage 1 of the PRESERVE-003 Phase 3 clinical trial (NCT05671510) of gotistobart in patients with squamous non-small cell lung cancer (“NSCLC”) who progressed on prior PD-(L)1 inhibitor treatment will be presented. The results further contribute to the growing body of evidence for this chemotherapy-free treatment approach. The pivotal stage 2 part of the trial is ongoing. All abstracts are available through the WCLC website. Further information on BioNTech’s lung cancer pipeline can be accessed here.

Full presentation details:

CandidateAbstract TitleAbstract Number/Presentation DetailsPumitamig + elfetabart drozuntecanPumitamig (PD-L1 x VEGF-A bsAb) + Elfetabart Drozuntecan (Elfe-D, B7H3 ADC) in Patients with Advanced/Metastatic Lung Cancer (NSCLC or SCLC)Abstract # OA14.01
Oral Presentation
The Breakthrough Immunotherapy for Advanced NSCLC
Sep 15, 2026: 12:30 - 01:45pm KSTPumitamigFirst-line Pumitamig (PD-L1 × VEGF-A bsAb) Plus Chemotherapy in Unresectable Malignant Mesothelioma: Long-term PFS and OSAbstract #MO04.09
Mini Oral
Novel Therapeutics and Molecular Insights in Thymic Malignancies and Pleural Mesothelioma
Sep 13, 2026: 4:45 - 6:00pm KSTROSETTA Lung‑201: A Phase 3 Trial of Pumitamig Monotherapy vs Durvalumab in Unresectable Stage III NSCLC Post-ChemoradiationAbstract #P2.330
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am - 12:00pm KSTROSETTA Lung-202: A Phase 3 trial of first-line pumitamig monotherapy vs pembrolizumab in locally advanced/metastatic NSCLCAbstract #P2.355
Poster
Clinical Trials in Progress
Sep 14, 2026: 10:30am - 12:00pm KSTGotistobartGotistobart vs Docetaxel in Metastatic Squamous NSCLC After PD-(L)1 Progression: Updated Overall Survival of the stage 1 of PRESERVE-003Abstract #MO07.04
Mini Oral
Novel Immunotherapeutic Strategies in mNSCLC
Sep 14, 2026: 5:00 - 6:15pm KSTBNT116Neoadjuvant BNT116 + Cemiplimab + Carboplatin + Paclitaxel in Resectable NSCLC: Preliminary Results From a Phase I TrialAbstract #MO06.03
Mini Oral
Emerging Precision Approaches in Perioperative Therapy for Resectable NSCLC Integrating Targeted Therapy, Immunotherapy, Biomarkers, and Multimodal Strategies
Sep 14, 2026: 3:30 - 4:45pm KST
About BioNTech in Lung Cancer Treatment
Lung cancer is one of BioNTech’s key focus areas. Through a diversified portfolio of investigational next-generation immunomodulators, ADCs and mRNA-based cancer immunotherapies, the Company is pursuing multiple approaches designed to address significant unmet needs for patients across lung cancer subtypes, histologies and treatment settings. BioNTech’s clinical pipeline encompasses both monotherapies and combinations with standard of care treatments, as well as novel-novel combination regimens aimed at delivering differentiated therapeutic profiles for the treatment of patients with lung cancer. With 16 ongoing lung cancer trials, including five pivotal Phase 3 and two novel-novel combination trials, BioNTech is advancing a comprehensive development strategy with the aim of improving outcomes for patients across the continuum of lung cancer.

About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.

For more information, please visit www.BioNTech.com.

BioNTech Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the initiation, timing, progress and results of BioNTech’s research and development programs in oncology, including the targeted timing and number of additional potentially registrational trials; BioNTech’s and its collaborators’ current and future preclinical and clinical trials in oncology, including the investigational bispecific immunomodulator pumitamig (BNT327/BMS986545) in unresectable malignant mesothelioma, the investigational anti-CTLA-4 antibody gotistobart (BNT316/ONC-392) in metastatic squamous NSCLC, the investigational B7H3-targeted ADC elfetabart drozuntecan (BNT324/DB-1311) in combination with pumitamig in (N)SCLC, and the investigational mRNA cancer immunotherapy candidate BNT116 in resectable NSCLC; the nature and characterization of and timing for release of clinical data across BioNTech’s platforms, which is subject to peer review, regulatory review and market interpretation; the planned next steps in BioNTech’s pipeline programs, including, but not limited to, statements regarding timing or plans for initiation or enrollment of clinical trials, or submission for and receipt of product approvals and potential commercialization with respect to BioNTech’s product candidates; and the potential safety and efficacy of BioNTech’s product candidates. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words.

The forward-looking statements in this press release are based on BioNTech’s current expectations and beliefs of future events and are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond BioNTech’s control, and which could cause actual results to differ materially and adversely from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, projected data release timelines, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the data discussed in this release, and including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the ability to produce comparable clinical results in future clinical trials; the timing of and BioNTech’s ability to obtain and maintain regulatory approval for its product candidates; discussions with regulatory agencies regarding timing and requirements for additional clinical trials; the impact of tariffs and escalations in trade policy; BioNTech’s ability to identify research opportunities and discover and develop investigational medicines; the ability and willingness of BioNTech’s third-party collaborators to continue research and development activities relating to BioNTech's development candidates and investigational medicines; unforeseen safety issues and potential claims that are alleged to arise from the use of products and product candidates developed or manufactured by BioNTech; BioNTech’s and its collaborators’ ability to commercialize and market its product candidates, if approved; BioNTech’s ability to manage its development and related expenses; regulatory and political developments; BioNTech’s ability to effectively scale its production capabilities and manufacture its products and product candidates; risks relating to the global financial system and markets; and other factors not known to BioNTech at this time.

You should review the risks and uncertainties described under the heading “Risk Factors” in BioNTech’s Report on Form 6-K for the period ended June 30, 2026 and in subsequent filings made by BioNTech with the SEC, which are available on the SEC’s website at www.sec.gov. These forward-looking statements speak only as of the date hereof. Except as required by law, BioNTech disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise.

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