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])

On January 12, 2026 Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported 2025 accomplishments and strategic priorities for 2026.

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"In 2025, we remained steadfast in our goal of helping patients live longer and live well, making meaningful advancements to our pipeline and strengthening the operational capabilities that support our strategic priorities. In addition to the progress we continue to make with zelenectide pevedotin and BT5528, our recently announced collaborations with the United Kingdom Nuclear Decommissioning Authority, United Kingdom National Nuclear Laboratory and SpectronRx provide us with the potential for an end-to-end supply chain for 212Pb, building on the existing supply chains we have established for 177Lu and 68Ga. In summary, by combining these supply collaborations with our proprietary Bicycle technology we have established a unique radiopharmaceutical capability from the identification of Bicycle targeting agents to the potential commercial supply of the radiotherapeutic across multiple radioisotopes," said Bicycle Therapeutics CEO Kevin Lee, Ph.D. "We look forward to providing updates on the potential approval pathway for zelenectide pevedotin and dose selection from the Phase 2/3 Durvelo-2 trial in the first quarter of 2026."

2025 Key Accomplishments

Reported updated topline Phase 1 Duravelo-1 combination data for zelenectide pevedotin plus pembrolizumab in first-line cisplatin-ineligible patients with metastatic urothelial cancer (mUC). The data continue to show zelenectide pevedotin’s promising anti-tumor activity and differentiated safety profile.
Initiated Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer.
Initiated Phase 1/2 Duravelo-4 trial for zelenectide pevedotin in NECTIN4-amplified non-small cell lung cancer.
Reported first human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting EphA2 at the Targeted Radiopharmaceuticals Summit Europe. The data supports the potential of EphA2 as a novel cancer target and demonstrates the positive properties of BRC molecules for radiopharmaceutical use.
Presented additional human imaging data for an early Bicycle Radioconjugate (BRC) molecule targeting MT1-MMP at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2025. The company believes this data further supports the potential of MT1-MMP as a novel target in the treatment of cancer, demonstrates the translatability of BRC preclinical data and highlights the potential of Bicycle molecules for targeted radionuclide therapies and radiopharmaceutical imaging.
2026 Strategic Priorities and Anticipated Milestones

Nectin-4 Pipeline (zelenectide, BT7480)

Provide an update on dose selection for Phase 2/3 Duravelo-2 pivotal trial and zelenectide pevedotin’s potential approval pathway in mUC following meetings with multiple regulatory agencies in the first quarter of 2026.
Report dose selection data from Phase 2/3 Duravelo-2 pivotal trial evaluating zelenectide pevedotin in combination with pembrolizumab in patients with mUC at a scientific conference in the first half of 2026.
Report additional Phase 1 Duravelo-1 combination data with pembrolizumab in first-line cisplatin-ineligible mUC at a scientific conference in the first half of 2026.
Report longer-term follow-up Phase 1 Duravelo-1 monotherapy data in late-line mUC at a scientific conference in the first half of 2026.
Report initial data for Phase 1/2 Duravelo-3 trial for zelenectide pevedotin in NECTIN4-amplified breast cancer at a scientific conference in the second half of 2026.
Report Phase 1 BT7480 combination data with nivolumab at a scientific conference in the first half of 2026.
EphA2 Pipeline (BT5528, EphA2 imaging)

Report Phase 1 BT5528 combination data with nivolumab in mUC patients at a scientific conference in the first half of 2026.
Provide an update on future clinical development plans for BT5528 in the first half of 2026.
Report additional EphA2 human imaging data in the first half of 2026.

(Press release, Bicycle Therapeutics, JAN 12, 2026, View Source [SID1234661939])