On January 12, 2026 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported its strategic priorities and anticipated 2026 milestones.

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"Entering 2026, CRISPR Therapeutics is well positioned, with CASGEVY gaining momentum, and multiple programs with encouraging data advancing rapidly through clinical trials across a diverse set of therapeutic areas," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "Across the portfolio, clinical data demonstrated the transformative potential of CTX310 for patients suffering from severe cardiovascular disease, as well as zugo-cel in oncology and autoimmune diseases. We also added a siRNA pillar through our partnership with Sirius and are advancing our lead siRNA asset, CTX611 targeting Factor XI through the clinic. Beyond these clinical stage programs, we have multiple additional assets in preclinical development that leverage our best-in-class advanced editing platform. Together, our broad portfolio, strong balance sheet and effective operating model reinforce our confidence as we move into the next phase."

Anticipated Key Milestones in 2026
CRISPR Therapeutics anticipates several key milestones across its portfolio:

Continued global commercialization and adoption of CASGEVY, with ongoing quarterly updates.
Global regulatory submissions for CASGEVY in patients ages 5 – 11 are expected to be initiated by Vertex in the first half of 2026.
Updates from CTX310 are expected in the second half of 2026.
Updates from the Lp(a) program are expected in 2026.
Top-line Phase 2 clinical data from CTX611 in patients undergoing total knee arthroplasty (TKA) are expected in the second half of 2026.
Updates across autoimmune disease and immuno-oncology for zugocabtagene geleucel (zugo-cel; formerly CTX112) are expected in the second half of 2026.
The Company expects to initiate a clinical trial for CTX460 in alpha-1 antitrypsin deficiency (AATD) in mid-2026.
The Company expects to initiate a clinical trial for CTX340 in refractory hypertension in the first half of 2026.

Portfolio Highlights and Outlook

Hemoglobinopathies and CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY now approved in the U.S., the United Kingdom, the EU, the Kingdom of Saudi Arabia, the Kingdom of Bahrain, Qatar, Canada, Switzerland, the United Arab Emirates, and Kuwait for patients 12 years and older with sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).
CASGEVY exceeded $100M in revenue in 2025, reflecting more than 60 patients receiving CASGEVY infusions.
Achieved a nearly three-fold increase in patient initiations and first cell collections in 2025 compared to 2024.
Regulatory submissions for CASGEVY in patients aged 5-11 years with SCD and TDT are expected in the first half of 2026.
CASGEVY awarded a Commissioner’s National Priority Voucher for pediatric submissions in SCD and TDT, enabling accelerated regulatory review once submissions are complete.
Continued development of next-generation conditioning approaches with the potential to expand addressable patient populations for SCD and TDT with CASGEVY.
Continued development of a lipid nanoparticle (LNP) based in vivo approach for editing hematopoietic stem cells (HSCs), with the potential to address a broader patient population in SCD and TDT.

In Vivo Liver Editing

CRISPR Therapeutics continues to advance a diversified portfolio of in vivo gene editing programs leveraging its proprietary LNP delivery platform.

In 2025, CRISPR Therapeutics presented data for CTX310, demonstrating deep and durable reductions of triglycerides (TG) and low-density lipoprotein (LDL) following a single-course intravenous infusion, with a well-tolerated safety profile. Based on the positive Phase 1 results, the Company has advanced CTX310, targeting angiopoietin-related protein 3 (ANGPTL3), into Phase 1b clinical trials, prioritizing development in severe hypertriglyceridemia (sHTG) and refractory hypercholesterolemia. The Company expects to provide an update in the second half of 2026.
CTX320, targeting LPA, has demonstrated reductions of up to 73% in the dose escalation phase of the clinical trial. In parallel, the Company is advancing a next-generation LPA program, CTX321, incorporating an updated guide RNA that demonstrates approximately two-fold greater potency in preclinical testing, while utilizing the same LNP delivery system. CTX321 is currently in IND/CTA-enabling studies, with an Lp(a) program update expected in 2026.
In addition to its clinical-stage programs, CRISPR Therapeutics continues to advance several preclinical in vivo gene editing candidates, including:
CTX460, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), is the first investigational candidate to emerge from the Company’s SyNTase editing platform. The Company expects to initiate a clinical trial for CTX460 in mid-2026.
CTX340, targeting angiotensinogen (AGT) for refractory hypertension, is currently in IND/CTA-enabling studies. The Company expects to initiate a clinical trial for CTX340 in the first half of 2026.

siRNA-based Programs
CRISPR Therapeutics’ small interfering RNA (siRNA)-based portfolio includes clinical-stage programs in cardiovascular and thromboembolic diseases, developed in collaboration with Sirius Therapeutics.

CTX611 (SRSD107), a long-acting siRNA targeting Factor XI (FXI), is in an ongoing Phase 2 clinical trial in patients undergoing total knee arthroplasty (TKA). The Company expects to provide an update in the second half of 2026.

CRISPR Therapeutics will lead global Phase 3 development of CTX611, excluding Greater China. The program targets a range of thromboembolic and clotting-related indications and represents a multi-billion-dollar market opportunity, including arterial fibrillation (AF), venous thromboembolism (VTE), ischemic stroke, cancer-associated thrombosis (CAT), chronic kidney disease (CKD), peripheral vascular disease (PVD), chronic coronary artery disease (CAD).

Autoimmune Disease and Immuno-Oncology
Zugocabtagene geleucel (zugo-cel; formerly CTX112) continues to advance in both autoimmune disease and hematologic malignancies.

In autoimmune disease, Phase 1 clinical trials are ongoing across multiple indications, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis and a second Phase 1 trial in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA). The first patient with SLE, refractory to 9 prior therapies with a baseline Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 8, has maintained drug-free DORIS clinical remission through month 9 following CAR-T therapy. The second SLE patient with a baseline SLEDAI-2K score of 8, has sustained B cell depletion with SLEDAI-2K score of 0 through month 2 following CAR-T therapy. The Company expects to provide updates in the second half of 2026.

The Phase 1/2 clinical trial of zugo-cel in B-cell malignancies is ongoing. The Company expects to provide updates in the second half of 2026. CRISPR Therapeutics has also established a collaboration and clinical supply agreement with Lilly to evaluate zugo-cel together with pirtobrutinib in aggressive B-cell lymphomas, further expanding the program’s development in oncology.

Regenerative Medicine
CRISPR Therapeutics continues to advance its regenerative medicine portfolio, including its efforts in diabetes. Clinical data generated from CTX211 were promising, demonstrating detectable C-peptide levels 12 months after implantation. These data have informed the Company’s approach to hypoimmune cell engineering, supporting a transition to a next-generation candidate, CTX213. CTX213 has demonstrated compelling preclinical efficacy and is progressing towards the clinic. The Company expects to provide additional updates as development progresses.

About CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world.

About the CRISPR Therapeutics – Vertex Collaboration for CASGEVY

CRISPR Therapeutics and Vertex established a strategic research collaboration in 2015 to discover and develop therapies using CRISPR/Cas9 technology to address the underlying genetic causes of human disease. CASGEVY is the first approved therapy to emerge from this collaboration. Under an amended collaboration agreement, Vertex leads global development, manufacturing, and commercialization of CASGEVY and shares program costs and profits worldwide 60/40 with CRISPR Therapeutics. Vertex is the manufacturer and exclusive license holder of CASGEVY.

About In Vivo Programs

CRISPR Therapeutics has established a proprietary lipid nanoparticle (LNP) delivery platform to enable gene editing in the liver using both CRISPR/Cas9 and its novel, proprietary SyNTase editing technologies. The Company’s in vivo portfolio includes its lead investigational programs, CTX310 (directed towards angiopoietin-related protein 3 (ANGPTL3)) and CTX320 (directed towards LPA, the gene encoding apolipoprotein(a) (apo(a)), a major component of lipoprotein(a) [Lp(a)]). Both are validated therapeutic targets for cardiovascular disease. CTX310 and CTX320 are being developed for patients with heterozygous familial hypercholesterolemia, homozygous familial hypercholesterolemia, mixed dyslipidemias, or severe hypertriglyceridemia, and in patients with elevated lipoprotein(a), respectively. In addition, the Company’s research and preclinical development candidates include: CTX460, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), CTX340, targeting AGT for the treatment of refractory hypertension and CTX321, targeting LPA for the treatment of patients with elevated lipoprotein(a).

About CTX611 (SRSD107)

CTX611 is a novel double-stranded siRNA, designed to target the human coagulation FXI messenger RNA and inhibit FXI protein expression. Through modulation of the intrinsic coagulation pathway, CTX611 is intended to provide anticoagulant and antithrombotic effects. Supported by clinical experience to date, CTX611 is being developed as a long-acting FXI inhibitor with the potential to support infrequent, including semi-annual, subcutaneous administration.

About Zugocabtagene Geleucel (zugo-cel; formerly CTX112)

Zugocabtagene geleucel (zugo-cel) is a wholly-owned, allogeneic chimeric antigen receptor (CAR) T cell therapy product candidate targeting Cluster of Differentiation 19 (CD19), in development for both autoimmune and immuno-oncology indications. Zugo-cel is an off-the-shelf allogeneic CAR-T that utilizes CRISPR Cas9 for targeted gene knockout and CAR insertion for immune evasion and enhanced T effector cell potency. Zugo-cel is given following a standard lymphodepletion regimen without the need for HLA matching. Zugo-cel is being investigated in ongoing clinical trials in adult patients with systemic lupus erythematosus, systemic sclerosis, and inflammatory myositis and in adult patients with relapsed or refractory B-cell malignancies.

(Press release, CRISPR Therapeutics, JAN 12, 2026, View Source [SID1234661944])

On January 12, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the company’s key 2026 milestones ahead of its presentation at J.P. Morgan’s 44th annual healthcare conference.

"2025 was marked by exceptional progress at Cogent Biosciences," said Andrew Robbins, President and Chief Executive Officer. "We reported positive results from all three pivotal trials of bezuclastinib in patients with GIST and Systemic Mastocytosis, submitted our first NDA for bezuclastinib in patients with NonAdvSM based on the strength of the SUMMIT data, and put ourselves in a very strong financial position entering the new year. During 2026, we will transform Cogent into a fully integrated commercial stage company with plans to launch bezuclastinib in the second half of the year. In addition, we are investing for the future and plan to submit INDs in 2026 for both our pan-KRAS inhibitor and recently announced JAK2 V617F inhibitor. Our plans are supported by a highly experienced team with proven launch experience backed by a strong balance sheet. We are poised for success and extremely excited about the meaningful impact we can have for patients."

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In 2026, Cogent plans to achieve the following milestones:

Bezuclastinib

Acceptance of the New Drug Application (NDA) for bezuclastinib in NonAdvanced Systemic Mastocytosis (NonAdvSM) by the end of February 2026
Submit an NDA in April 2026 for bezuclastinib in patients with advanced Gastrointestinal Stromal Tumors (GIST) previously treated with imatinib based on the strength of the PEAK pivotal trial
Submit an NDA in 1H 2026 for bezuclastinib in patients with Advanced Systemic Mastocytosis (AdvSM) based on the strength of the APEX pivotal trial
Present detailed, updated clinical data from each of the three pivotal trials (SUMMIT, PEAK, APEX) at major medical meetings during 1H 2026
Commercialize bezuclastinib following potential FDA approval in 2H 2026
Pipeline

Submit Investigational New Drug (IND) applications for CGT1815, Cogent’s novel, selective pan-KRAS(ON) inhibitor and CGT1145, Cogent’s novel, selective JAK2 V617F inhibitor
Present clinical data on CGT4859, Cogent’s selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study in patients with alterations in FGFR2 or FGFR3
Complete dose escalation for both CGT4255, Cogent’s CNS-penetrant, selective mutant ErbB2 inhibitor, and CGT6297, Cogent’s selective PI3Kα inhibitor
Bezuclastinib Expanded Access Programs

Working with the FDA, Cogent has established active Expanded Access Programs for U.S. patients with GIST or SM who meet disease-specific criteria and could benefit from treatment with bezuclastinib or the combination of bezuclastinib and sunitinib. A growing number of investigational sites now offer access to the bezuclastinib EAPs. For more information please visit: View Source

New Leadership Appointment

Cogent also announced today that Abb Hayden has joined Cogent as Senior Vice President, Sales. Mr. Hayden joins Cogent with over 25 years of industry experience. Previously he served as Vice President of Commercial at Syndax Pharmaceuticals. While at Syndax, he played an integral part in building the commercial infrastructure leading the Field Sales, Marketing, and Clinical Education team to launch Revuforj and Niktimvo. Prior to Syndax, he held roles of increasing responsibility at Adaptive Biotechnologies, Onyx Pharmaceuticals, and Eli Lilly. Mr. Hayden is a graduate of the University of Central Arkansas.

J.P. Morgan Presentation Details

Cogent will participate in a presentation and Q&A session at the 44th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026, beginning at 8:15 a.m. PT (11:15 a.m. ET). A live webcast will be accessible in the "Investors & Media" section of the company’s website, www.cogentbio.com, and will be archived for 30 days following the event.

Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Cogent also announced today that, on January 9, 2026, the Compensation Committee of Cogent’s Board of Directors, made up entirely of independent directors, approved the grant of "inducement" equity awards to five new employees under the company’s 2020 Inducement Plan with a grant date of January 9, 2026. The awards were approved in accordance with Listing Rule 5635(c)(4) of the corporate governance rules of the Nasdaq Stock Market. The employees received, in the aggregate, (i) nonqualified options to purchase 66,700 shares of Cogent common stock and (ii) 9,700 restricted stock units (RSUs). Each option has a 10-year term, an exercise price equal to the closing price of Cogent’s common stock on the grant date, and a 4-year vesting schedule with 25% vesting on the 1-year anniversary of the grant date and the remainder vesting in equal monthly installments over the subsequent 36 months, provided such employee remains employed through each such vesting date. The RSUs vest annually in equal installments over 4 years from the grant date, provided such employee remains employed through each such vesting date.

(Press release, Cogent Biosciences, JAN 12, 2026, View Source [SID1234661943])

On January 12, 2026 Cerus Corporation (Nasdaq: CERS) reported preliminary product revenue for the fourth quarter and full-year 2025, as well as provided 2026 product revenue guidance and select milestones for 2026.

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"2025 was a remarkable year for Cerus, as patient access to INTERCEPT treated blood components increased meaningfully around the world," said William "Obi" Greenman, Cerus’ president and chief executive officer. "During 2025, based on the number of kits sold, we helped our blood center customers produce approximately 3 million INTERCEPT treated blood component doses for patients in about 40 countries worldwide. We remain focused on supporting blood centers around the globe in their daily mission to ensure robust blood safety and availability. We expect 2026 to be a year rich in milestones for Cerus, as we continue to expand our commercial reach, advance our product development pipeline and continue improving Cerus’ financial performance and position."

Preliminary Fourth Quarter and Full-Year 2025 Financial Results & 2026 Outlook

Preliminary fourth quarter 2025 product revenue totaled $57.8 million representing an increase of 14% compared to the fourth quarter of 2024. Included in these results, preliminary product revenue results from INTERCEPT Fibrinogen Complex, or IFC, were $4.2 million, representing a year-over-year increase of around 40%.
Preliminary full-year 2025 product revenue totaled $206.1 million, representing an increase of 14% over 2024 results. Included in the full-year 2025 preliminary product revenue results were $16.7 million contribution from IFC, representing a year-over-year increase of approximately 80%. The preliminary fourth quarter and full-year 2025 product revenue results have not been audited and are therefore subject to change.
Looking ahead, the Company expects full-year 2026 product revenue to be in the range of $224 million to $228 million, representing year-over-year growth of 9%-11% compared to preliminary unaudited 2025 product revenue. Included in the 2026 guidance range is expected full-year 2026 IFC revenue of $20 million to $22 million, representing year-over-year growth of approximately 20% to 30% from 2025.
Anticipated 2026 development and clinical milestones:

Premarket Approval (PMA) application submission to the FDA for INT200, the next generation LED-based illumination device, expected in mid-2026.
Results from the Phase 3 RedeS study of the INTERCEPT Blood System for Red Blood Cells (RBCs) in anemia patients expected in the second half of 2026.
Cerus plans to provide complete fourth quarter and full-year 2025 financial results and to discuss those results and provide a general business overview on a hosted call in early March 2026.

A comparative breakdown of the preliminary fourth quarter and full-year 2025 product revenue compared to 2024 product revenue is as follows:

CERUS CORPORATION

PRODUCT REVENUE

(in millions, except percentages)

Three Months Ended

Twelve Months Ended

December 31,

Change

December 31,

Change

2025*

2024

$

%

2025*

2024

$

%

Platelets, Plasma, Other

$

53.6

$

47.8

$

5.8

12

%

$

189.4

$

171.1

$

18.3

11

%

IFC

4.2

3.0

1.2

40

%

16.7

9.2

7.5

82

%

Total product revenue

$

57.8

$

50.8

$

7.0

14

%

$

206.1

$

180.3

$

25.8

14

%

*Unaudited preliminary results only.

Percentages calculated from unrounded figures.

(Press release, Cerus, JAN 12, 2026, View Source [SID1234661942])

On January 12, 2026 Bristol-Myers Squibb presented its corporate presentation.

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(Presentation, Bristol-Myers Squibb, JAN 12, 2026, View Source [SID1234661941])

On January 12, 2026 BioNTech SE (Nasdaq: BNTX, "BioNTech") and OncoC4, Inc. ("OncoC4") reported that the U.S. Food and Drug Administration ("FDA") has granted Orphan Drug Designation to gotistobart (also known as BNT316 or ONC-392) for the treatment of squamous NSCLC, an aggressive subtype of lung cancer with limited therapeutic options in the advanced stage. The FDA grants Orphan Drug Designation to potential new medicines for prevention, diagnosis, or treatment of patients with either a rare disease, or a specific patient population with a non-rare disease. This designation underscores the urgent medical need for new therapeutic options for patients living with this condition.

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Gotistobart is a novel tumor microenvironment-selective regulatory T cell ("Treg") depletion candidate targeting CTLA-4. With its unique mode of action, gotistobart has the potential to address the high unmet medical need in patients with squamous NSCLC, which accounts for around 25% of all lung cancer cases1 and high disease-related mortality2. Squamous NSCLC is a devastating disease with a 5-year relative survival rate of 15%, a median survival time of 11 months in the United States (2000-2017)3, and with limited treatment options in the advanced stage. For advanced or metastatic squamous NSCLC patients, the treatment options for second-line therapy after first-line immunotherapy and chemotherapy are usually limited to chemotherapy or palliative therapy.4

The pivotal Phase 3 clinical trial PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01) is ongoing, evaluating gotistobart in patients with metastatic squamous NSCLC at 160 sites globally. In a data readout from the non-pivotal dose-confirmation stage of the trial, gotistobart demonstrated a clinically meaningful overall survival ("OS") benefit, compared to standard-of-care chemotherapy and a manageable safety profile in squamous NSCLC patients whose disease had progressed following anti-PD-(L)1 therapy and platinum-based chemotherapy. These data were previously announced and presented in an oral presentation at the IASLC ASCO (Free ASCO Whitepaper) 2025 North America Conference on Lung Cancer. In addition to the recently granted Orphan Drug Designation, the FDA granted Fast Track Designation to gotistobart in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy.

About gotistobart (BNT316/ONC-392)
Gotistobart (BNT316/ONC-392) is a tumor microenvironment-selective Treg depletion candidate developed jointly by BioNTech and OncoC4. As a pH-sensitive monoclonal antibody, gotistobart is designed to enable CTLA-4 protein recycling. After binding to the CTLA-4 receptor on the cell surface, the complex is internalized, and the pH change causes the antibody to unbind, allowing CTLA-4 to return to the surface to preserve the immune checkpoint function at peripheral organs and to enhance anti-tumor immunity in the tumor microenvironment5. Gotistobart is currently in late-stage clinical development as monotherapy and as a component of combination therapy in various cancer indications. Gotistobart received Fast Track Designation from the U.S. Food and Drug Administration ("FDA") in 2022 for the treatment of patients with metastatic NSCLC whose disease progressed on prior anti-PD-(L)1 therapy and Breakthrough Therapy Designation from China’s National Medical Products Administration ("NMPA") in 2025.

About PRESERVE-003 Trial
PRESERVE-003 (NCT05671510; EUCT:2023-505311-20-01) is a two-stage, open-label Phase 3 trial evaluating the efficacy and safety of gotistobart as monotherapy compared to the standard-of-care chemotherapy (docetaxel) in sqNSCLC patients, who have progressed on PD-(L)1 inhibitors and platinum-based chemotherapy. The non-pivotal stage of the trial originally included all NSCLC patients. The ongoing pivotal stage is currently enrolling patients with squamous NSCLC. During the ongoing pivotal stage, patients are planned to be enrolled at 160 clinical sites in various countries and regions, including Australia, Belgium, Canada, China, Germany, Italy, the Netherlands, Spain, South Korea, Türkiye, the United Kingdom and the United States. The primary endpoint is overall survival. Secondary endpoints include overall response rate, progression-free survival and safety profile.

(Press release, BioNTech, JAN 12, 2026, View Source [SID1234661940])