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BioNTech SE

BNTXFDA catalysts, PDUFA dates & pipeline intelligence
$85.6
▲ +0.56 · +0.66%

Financials

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Total Assets
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52W LOW $79.5252W HIGH $124.00
Volume
844.84 K
Value Traded
72.00 M
Short % Float
0.91%
Days to Cover
2.2
-2.18%Week
-5.1%1 Month
-6.55%3 Month
-3.66%6 Month
-53.35%5 Year
+458.42%All Time

Cash Data

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  • SEC Filing

Key Stats

Market Cap
21.65 B
EPS (TTM)
-5.87
P/E Ratio
-
Ent. Value
6.79 B
Total Shares
252.88 M
Float Shares
246.87 M
Insiders
0.43%
Institutions
19.67%

Upcoming Catalysts

FDA decisions, readouts and PDUFA dates · scored by probability of approval

Catalyst Drug / Treatment Stage Prob. of Approval Description Drug Type Therapeutic Area Source
Phase 3 interim results
T-Pam1
Breast cancer
Phase 3Antibody-Drug Conjugates (ADCs)Oncology
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Every FDA decision, readout and PDUFA date, with drug type, therapeutic area and a PoA score you can trade on.
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PoA blends historical approval base rates, trial design score and FDA review track record.

BNTX Catalyst Timeline

Dated clinical, regulatory and corporate events for BioNTech SE

Catalyst Timeline

Dated clinical, regulatory & corporate events for BioNTech SE

743Total events
13Upcoming
273Tier-1 (high impact)
2019 to 2027Coverage

Upcoming catalysts 2

T2Restructuring Layoffs
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T1Partnership / License
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Event history 50

▲Partnership / LicenseCorporate
PxB Fund makes first investment, launching and financing Emvena Therapeutics
●Quarterly UpdateCorporate
BioNTech reported Q3 2026 financial results
▲Runway Guidance UpdateCorporate
Raised FY2026 revenue guidance to €1.7–1.9 billion
▼Safety Data Updatetrastuzumab pamirtecanClinical Data
Higher ILD rate observed in DYNASTY-Breast02 vs prior trastuzumab pamirtecan trials
HR+/HER2-low metastatic breast cancersource ↗
▲Primary Endpoint Mettrastuzumab pamirtecanClinical Data
DYNASTY-Breast02 met primary PFS endpoint vs investigator's choice chemotherapy
HR+/HER2-low metastatic breast cancersource ↗
▲Topline Readouttrastuzumab pamirtecanClinical Data
Topline results of DYNASTY-Breast02 Phase 3 trial announced
HR+/HER2-low metastatic breast cancersource ↗
▲Late-BreakerPumitamigPresentation
Late-breaking oral presentation of ROSETTA Lung-107 data at ESMO Congress 2026
metastatic non-small cell lung cancer (NSCLC)source ↗
▲Topline ReadoutPumitamigClinical Data
First data from Phase 2 ROSETTA Lung-107 of pumitamig plus docetaxel in 2L NSCLC
metastatic non-small cell lung cancer (NSCLC) after progression on immunotherapy plus chemotherapysource ↗
●Poster PresentationPumitamigPresentation
ePoster presentation of ROSETTA Gastric-204 Phase 2/3 trial design for 1L pumitamig plus chemotherapy at ESMO 2026
gastric cancer, gastroesophageal junction adenocarcinoma, esophageal adenocarcinomasource ↗
●Poster Presentationelfetabart drozuntecanPresentation
Poster presentation of BNT324-03 Phase 3 trial design for elfetabart drozuntecan in taxane-naive mCRPC at ESMO 2026
metastatic castration-resistant prostate cancersource ↗
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Every PDUFA date, readout, approval and corporate move, tiered by market impact and updated daily.
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Past FDA Catalysts and PDUFA Decisions

How BNTX actually traded into and out of each decision

Date Drug Catalyst Stage Reaction Event Move % Best Trade %
2026-10-31BNT113 Phase 3 interim results Phase 3
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Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision

Drug Pipeline Intelligence

Pipeline Score
Pipeline Value
Commercial Value
Valuation Signal
32
Drugs Scored
rNPV / MCap
Top Drug
Top 3%
Mid Cap
(rank 22 of 687)
Percentile Rank
Commercial products (revenue basis: latest annual revenue in its 20-F, converted from EUR to USD, to Dec 2025; product lines from the latest annual filing)
ProductRevenuePrior periodChange
COVID-19 vaccine
Showing 70 of 82 assets
DrugIndicationPhasePTRSrNPVStatusEnrollVelocityDesignEst. CompletionML SignalLast Change
BNT323 Antibody-Drug Conjugates (ADCs)NCT06340568Endometrial CancerPhase 3 RECRUITING 480Nov 1, 2029
BNT323 Antibody-Drug Conjugates (ADCs)NCT06018337Metastatic Breast CancerPhase 3 ACTIVE NOT_RECRUITING 541Aug 1, 2028
BNT323 Antibody-Drug Conjugates (ADCs)NCT05150691HER2-positive Advanced Solid TumorPhase 1/2 RECRUITING 796Oct 1, 2027
BNT323 Antibody-Drug Conjugates (ADCs)NCT06827236Locally Advanced Breast CancerPhase 1/2 RECRUITING 380Aug 1, 2029
Pumitamig BiologicsNCT07173751Breast NeoplasmsPhase 3 RECRUITING 558Sep 1, 2030
Pumitamig BiologicsNCT06419621Triple Negative Breast Cancer(TNBC)Phase 3 ACTIVE NOT_RECRUITING 392Jul 1, 2028
Pumitamig BiologicsNCT06449209Extensive-stage Small-cell Lung CancerPhase 3 ACTIVE NOT_RECRUITING 731Feb 1, 2028
Pumitamig BiologicsNCT05879068SCLCPhase 3 ACTIVE NOT_RECRUITING 553Apr 30, 2026
Pumitamig BiologicsNCT06841055Non-small Cell Lung CancerPhase 2/3 RECRUITING 1,640Oct 1, 2028
Pumitamig BiologicsNCT05756972NSCLCPhase 2 ACTIVE NOT_RECRUITING 64Dec 1, 2025
Pumitamig BiologicsNCT06449222Locally Advanced Breast CancerPhase 2 ACTIVE NOT_RECRUITING 83Jun 1, 2029
Pumitamig BiologicsNCT05918133TNBCPhase 1/2 ACTIVE NOT_RECRUITING 42Oct 30, 2026
Pumitamig BiologicsNCT06584071HCCPhase 1/2 NOT YET_RECRUITING 140Dec 1, 2027
Pumitamig BiologicsNCT05918445Malignant NeoplasmPhase 1/2 RECRUITING 380Nov 30, 2025
Pumitamig BiologicsNCT07133750CRC (Colorectal Cancer)Phase 2 RECRUITING 100May 1, 2030
Pumitamig BiologicsNCT07255404Pancreatic Ductal Adenocarcinoma (PDAC)Phase 2 RECRUITING 105Aug 1, 2028
Pumitamig BiologicsNCT07297212Recurrent GlioblastomaPhase 2 RECRUITING 75Jul 1, 2029
Pumitamig BiologicsNCT05879055Neuroendocrine NeoplasmPhase 2 ACTIVE NOT_RECRUITING 31Jan 1, 2028
Gotistobart BiologicsNCT05671510Non Small Cell Lung CancerPhase 3 ACTIVE NOT_RECRUITING 630Aug 31, 2028
BNT168 BiologicsNCT07698600HIV -1 InfectionPhase 1 RECRUITING 126Feb 1, 2028
BNT324 Small MoleculesNCT07365995Metastatic Castration-resistant Prostate CancerPhase 3 RECRUITING 736Feb 1, 2031
BNT324 Small MoleculesNCT05914116Advanced Solid TumorsPhase 1/2 RECRUITING 862May 1, 2028
BNT324 Small MoleculesNCT06953089Solid TumorsPhase 2 RECRUITING 750Jun 30, 2030
BNT324 BiologicsNCT06892548Advanced Lung CancerPhase 1/2 RECRUITING 594May 1, 2032
BNT116 BiologicsNCT05142189Non-Small Cell Lung CancerPhase 1 RECRUITING 320Nov 1, 2031
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PTRS, rNPV, enrollment velocity, trial design quality and ML risk signals for every asset above.
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Clinical Trial Results

Readouts, endpoints and source filings for every BNTX program

Drug Name Indication Phase Date Trial Results SummaryTitleSource
trastuzumab pamirtecan HR+/HER2-low metastatic breast cancerPhase 32026-10-26statistically significant, yet modest improvement in progression-free survivalRead MoreBioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast CancerRead More
Scroll for more · summaries link to the source press release
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Inside Trades

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Monthly insider buys and sells against the stock price, with the insider sentiment reading.
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InsiderSideSharesPriceValueDate
Sahin UgurOfficer (Chief Executive Officer), 10% OwnerSell -36,209 $95.37 10/09/2026
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Hedge Fund 13F Activity

Fund % of Portfolio Current MV Shares Owned Activity
Logos Global Management LP 4.1 % (28.1 %) 94.45 M 1.01 M 407.5% ( 815.00 K)
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Shares held by hedge funds each quarter, and who bought or sold.

Ownership Trends

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Insider and institutional ownership, quarter by quarter.

BNTX Short Interest

Shares sold short, counted twice a month.

0.91%
Short % of Float
of tradable shares sold short
2.2M
Shares Sold Short
-1.2% vs prior count
2.2 Moderate
Days to Cover
trading days of normal volume to buy every short share back
1.0M
Avg Daily Volume
the average used for days to cover
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Two years of days to cover and shares sold short, with every count and its change.
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Options Data

Option Volume

Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg

Option Chain Statistics

ExpiryCall VolPut VolVol P/CCall OIPut OIOI P/CIV CallIV Call OI-WtdIV Call Vol-WtdIV PutIV Put OI-WtdIV Put Vol-Wtd
2026-11-20
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Real-Time Option Chain

CallsStrikePuts
LastVolOILastVolOI
No data available
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Calls vs Puts by Expiry

CallsPutsLog scale
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Competitive positioning

How BNTX ranks across every disease it competes in

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See how BNTX ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
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BNTX News

BNTX
Nov 4, 2026
BNTXGeneral

Penn-BioNTech Innovative Therapeutics Seed Fund Announces First Investment

The Penn-BioNTech Innovative Therapeutics Seed Fund has invested in Emvena Therapeutics, which focuses on placenta-targeted mRNA medicines for serious maternal and fetal conditions. Emvena's lead program targets preeclampsia, a significant complication affecting pregnancies. The fund aims to support the translation of University of Pennsylvania research into viable treatments.

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BNTX
Nov 3, 2026
BNTXGeneral

BioNTech Announces Third Quarter 2026 Financial Results and Corporate Update

BioNTech reported third quarter 2026 revenues of €1,289.2 million, a decrease from the previous year. The company raised its full-year revenue guidance to €1.7–1.9 billion, citing strong performance in oncology and COVID-19 vaccine sales. Notable clinical advancements include a global Phase 3 trial for pumitamig in triple-negative breast cancer.

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BNTX
Oct 26, 2026
BNTXPhases

BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast Cancer

BioNTech and DualityBio announced that their DYNASTY-Breast02 Phase 3 trial met its primary endpoint, showing a statistically significant improvement in progression-free survival for trastuzumab pamirtecan in HR+/HER2-low metastatic breast cancer. However, a higher incidence of interstitial lung disease was reported, and the overall survival data remains immature. Next steps will be discussed based on these findings.

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BNTX
Oct 25, 2026
BNTXPhases

BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy

BioNTech and Bristol Myers Squibb reported promising Phase 2 data for pumitamig in advanced non-small cell lung cancer (NSCLC). The combination with docetaxel achieved a confirmed objective response rate of 36.7% and a median progression-free survival of 6.9 months. This trial addresses a significant unmet need for patients post-immunotherapy and chemotherapy.

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BNTX
Oct 22, 2026
BNTXPhases

BioNTech Advances Phase 3 Clinical Trial of Pumitamig in Combination with Gilead’s TROP2-Directed ADC Sacituzumab Govitecan in Triple-Negative Breast Cancer

BioNTech announced a collaboration with Gilead to advance the ROSETTA Breast-01 trial, evaluating pumitamig with sacituzumab govitecan for treating PD-L1 low or negative triple-negative breast cancer. This trial aims to replace chemotherapy with an antibody-drug conjugate, reflecting the evolving treatment standards. The combination is expected to improve patient outcomes significantly.

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BNTX
Oct 20, 2026
BNTXConferences/Events

BioNTech to Report Third Quarter 2026 Financial Results and Corporate Update on November 3, 2026

BioNTech SE will announce its financial results for Q3 2026 on November 3, 2026. The company will also host a conference call and webcast for investors and analysts to discuss these results and provide a corporate update. The event is accessible via registration, and a replay will be available afterward.

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BNTX
Oct 19, 2026
BNTXConferences/Events

BioNTech to Showcase Oncology Late-Stage Pipeline Progress and Pumitamig Novel-Novel Combination Data at ESMO 2026

BioNTech will present new clinical data from its oncology pipeline at ESMO 2026, including results from the Phase 2 ROSETTA Lung-107 trial evaluating pumitamig in metastatic non-small cell lung cancer. The company will also showcase data on pumitamig's combination with elfetabart drozuntecan in advanced solid tumors. These findings underscore the potential of pumitamig across various tumor types and treatment settings.

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BNTX
Oct 13, 2026
BNTXPhases
▼ -7.1%on this news

BioNTech Provides Update on Phase 2/3 Clinical Trial for mRNA Cancer Immunotherapy Candidate BNT113 in Metastatic HPV16-positive Head and Neck Cancer

BioNTech's AHEAD-MERIT Phase 2/3 trial for BNT113 in metastatic HPV16-positive head and neck cancer did not achieve its primary endpoint of progression-free survival. However, the trial will proceed to assess overall survival, which could still yield a positive outcome. The mRNA immunotherapy aims to enhance treatment for patients with limited options.

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BNTX
Sep 14, 2026
BNTXPhases

BioNTech and OncoC4 Present Updated Data Showing Gotistobart Nearly Doubled Median Overall Survival versus Standard-of-Care Chemotherapy in Previously Treated Squamous Non-Small Cell Lung Cancer Patients

BioNTech and OncoC4 reported updated data from the PRESERVE-003 Phase 3 trial, showing that gotistobart significantly improves median overall survival in previously treated squamous non-small cell lung cancer patients. The investigational treatment achieved a median survival of 18.5 months compared to 10.0 months with standard chemotherapy. This data suggests a promising shift in treatment options for patients facing limited alternatives.

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BNTX
Aug 27, 2026
BNTXFDA Updates
▼ -8.4%on this news

Pfizer and BioNTech Receive U.S. FDA Approval for XFG-adapted COVID-19 Vaccine

Pfizer and BioNTech have received FDA approval for their new COVID-19 vaccine formula designed to target the XFG variant. This approval aligns with FDA guidance to ensure the vaccine matches currently circulating variants. Shipping of the vaccine will commence immediately, facilitating rapid access for the upcoming season.

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BNTX
Aug 20, 2026
BNTXPhases

BioNTech Highlights Late-Stage Lung Cancer Pipeline Momentum and First Global Data for Pumitamig/Elfetabart Drozuntecan Novel-Novel Combination at WCLC 2026

BioNTech SE is showcasing its advancements in lung cancer treatment at the IASLC 2026 World Conference on Lung Cancer. Key highlights include the first clinical data for a novel combination of pumitamig and elfetabart drozuntecan, as well as updated survival data for gotistobart from the PRESERVE-003 Phase 3 trial. The company is committed to addressing unmet medical needs in lung cancer through a diversified clinical pipeline.

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BNTX
Aug 4, 2026
BNTXGeneral

BioNTech Announces Second Quarter 2026 Financial Results and Corporate Update

BioNTech SE reported its second quarter 2026 financial results, highlighting the appointment of Guido Oelkers as CEO and the initiation of six pivotal clinical trials. The company achieved several milestones, including the approval of a new COVID-19 vaccine variant. However, it also faced challenges with a significant net loss and decreased revenues due to lower demand for its vaccines, prompting a revision of its financial guidance for the year.

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BNTX
Aug 3, 2026
BNTXGeneral

BioNTech Announces Appointment of Guido Oelkers to Management Board as Chief Executive Officer

BioNTech has appointed Guido Oelkers as its new CEO, effective by February 1, 2027. Oelkers, who has over 30 years of experience in the biotechnology sector, succeeds Prof. Ugur Sahin. His appointment follows a comprehensive selection process and is expected to enhance BioNTech's growth and innovation in the biopharmaceutical industry.

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BNTX
Jul 29, 2026
BNTXFDA Updates

European Commission Authorizes Pfizer and BioNTech XFG-adapted COVID-19 Vaccine in the European Union

The European Commission has authorized Pfizer and BioNTech's 2026-2027 COVID-19 vaccine, which targets the XFG variant. This decision follows a recommendation from the EMA's Emergency Task Force, citing strong immune responses against current SARS-CoV-2 lineages. The vaccine is approved for individuals aged six months and older, with manufacturing already underway to meet anticipated demand.

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BNTX
Jul 21, 2026
BNTXConferences/Events

BioNTech to Report Second Quarter 2026 Financial Results and Corporate Update on August 4, 2026

BioNTech SE will announce its financial results for the second quarter of 2026 on August 4, 2026. A conference call and webcast will be held at 8:00 a.m. ET to discuss these results and provide a corporate update. The event is open to investors and the public, with materials available on the company's website.

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BNTX
Jun 1, 2026
BNTXPhases

Global Data for BioNTech and Bristol Myers Squibb’s PD-L1xVEGF-A Bispecific Pumitamig Shows Encouraging Efficacy in Patients with Non-Small Cell Lung Cancer in ROSETTA Lung-02 Trial

BioNTech and Bristol Myers Squibb announced promising interim Phase 2 data from the ROSETTA Lung-02 trial, showing high response rates for the bispecific immunomodulator pumitamig in patients with advanced non-small cell lung cancer. The trial demonstrated significant anti-tumor activity across different PD-L1 expression levels, with manageable safety profiles. The companies are advancing further studies to evaluate pumitamig's efficacy.

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BNTX
May 22, 2026
BNTXConferences/Events

BioNTech to Showcase Progress Across Late-Stage Oncology Pipeline at the 2026 ASCO Annual Meeting

BioNTech will present new clinical data from its late-stage oncology pipeline at the 2026 ASCO Annual Meeting. Key highlights include promising results for pumitamig in non-small cell lung cancer and gotistobart in platinum-resistant ovarian cancer. The company is advancing over 25 Phase 2 and Phase 3 trials, focusing on innovative treatment combinations.

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BNTX
May 15, 2026
BNTXGeneral

BioNTech SE Shareholders Approve All Agenda Items at the Annual General Meeting 2026

BioNTech SE held its Annual General Meeting where shareholders approved all agenda items, including the expansion of the Supervisory Board. New members with expertise in oncology and clinical development were elected. The company aims to enhance its late-stage oncology pipeline while continuing early research efforts.

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BNTX
May 7, 2026
BNTXGeneral

BioNTech Announces New ADS Repurchase Program

BioNTech has announced a new share repurchase program allowing for the repurchase of up to $1 billion in American Depositary Shares until May 6, 2027. This initiative is part of the company's strategy to enhance capital efficiency and support long-term growth. The program will be funded using existing cash resources and is designed to operate within regulatory safe harbors.

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BNTX
May 5, 2026
BNTXGeneral

UNAUDITED INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Interim Condensed Consolidated Statements of Profit or Loss 1 Interim Condensed Consolidated Statements of Comprehensive Income 2 Interim Condensed Consolidat

BioNTech SE has released its unaudited interim condensed consolidated financial statements for the three months ended March 31, 2026. The company reported a net loss of €531.9 million, a decline from €415.8 million in the same period last year. Revenues also fell significantly, amounting to €118.1 million compared to €182.8 million in the prior year. Additionally, total assets decreased from €21,988.6 million to €21,074.1 million over the same time frame.

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About BioNTech SE

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