Cogent Biosciences Announces Anticipated 2026 Commercial and Clinical Milestones for Bezuclastinib and Precision Therapies Portfolio

Rhea-AI Summary

Cogent Biosciences (NASDAQ: COGT) outlined key 2026 commercial and clinical milestones for bezuclastinib and its precision therapies pipeline.

Planned regulatory and clinical milestones include NDA acceptance for NonAdvSM by end-February 2026, an NDA submission for GIST in April 2026, an NDA submission for AdvSM in 1H 2026, and presentations of pivotal trial data (SUMMIT, PEAK, APEX) at major medical meetings in 1H 2026. The company targets a commercial launch of bezuclastinib in 2H 2026 if approved. Pipeline actions include IND submissions in 2026 for a pan-KRAS(ON) inhibitor and a selective JAK2 V617F inhibitor. Cogent reported a cash balance of ~ $900 million entering 2026 and noted active expanded access programs and a new SVP, Sales hire.

Positive

• ~$900 million cash position entering 2026
• NDA acceptance target for NonAdvSM by end-February 2026
• NDA submission for GIST planned in April 2026
• NDA submission for AdvSM planned in 1H 2026
• Planned commercial launch of bezuclastinib in 2H 2026 if approved
• IND submissions for pan-KRAS(ON) and JAK2 V617F inhibitors expected in 2026

Negative

• None.

News Market Reaction

-1.67%

1 alert

-1.67% News Effect

-$92M Valuation Impact

$5.42B Market Cap

0.8x Rel. Volume

On the day this news was published, COGT declined 1.67%, reflecting a mild negative market reaction. This price movement removed approximately $92M from the company's valuation, bringing the market cap to $5.42B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Cash balance: ~$900 million NonAdvSM NDA timing: December 2025 AdvSM NDA window: 1H 2026 +5 more

8 metrics

Cash balance ~$900 million Cash to begin 2026, funding operations well into 2028

NonAdvSM NDA timing December 2025 New Drug Application for bezuclastinib in NonAdvSM submitted

AdvSM NDA window 1H 2026 Planned NDA submission for bezuclastinib in Advanced SM

GIST NDA timing April 2026 Planned NDA submission for second-line GIST

IND applications 2026 Planned INDs for pan-KRAS(ON) and JAK2 V617F inhibitors

Inducement options 66,700 shares Nonqualified stock options granted to five new employees

Inducement RSUs 9,700 RSUs Restricted stock units granted to five new employees

Option term 10 years Term of inducement nonqualified stock options

Market Reality Check

Price: $35.91 Vol: Volume 2201560 vs 20-day ...

normal vol

$35.91 Last Close

Volume Volume 2201560 vs 20-day average 2537623 suggests no unusual trading ahead of this update. normal

Technical Shares trade above the 200-day moving average of 15.69, reflecting a pre-existing uptrend into this milestone update.

Peers on Argus

COGT was down 0.62% while several biotech peers like CLDX, AUPH, DYN, and IMCR a...

1 Down

COGT was down 0.62% while several biotech peers like CLDX, AUPH, DYN, and IMCR also traded lower, and MESO was higher, indicating mixed sector action rather than a clear group move.

Historical Context

5 past events · Latest: Jan 06 (Neutral)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Jan 06	Conference presentation	Neutral	+1.5%	Announced CEO presentation timing at the J.P. Morgan conference.
Dec 30	NDA submission	Positive	-2.1%	Filed NDA for bezuclastinib in NonAdvSM based on positive SUMMIT data.
Dec 08	Clinical results	Positive	+4.0%	Reported positive APEX Part 2 results in Advanced Systemic Mastocytosis.
Nov 14	Conference participation	Neutral	-0.9%	Confirmed participation in Jefferies Global Healthcare Conference webcast.
Nov 11	Financing/offering	Negative	+3.0%	Priced common stock and convertible notes offerings for funding and debt repayment.

Pattern Detected

Recent history shows some divergence: the stock fell after a positive NDA filing and rose on a dilutive financing, while generally aligning with clinical data updates and conference news.

Recent Company History

Over the last few months, Cogent advanced bezuclastinib and strengthened its balance sheet ahead of commercialization. A November 2025 offering of equity and 1.625% notes due 2031 coincided with a 2.96% gain, while positive APEX AdvSM results on Dec 8, 2025 saw a 3.95% rise. The NonAdvSM NDA submission on Dec 30, 2025 led to a 2.11% decline, showing occasional sell-the-news behavior. Conference participation news in November 2025 and early January 2026 produced modest moves around ±1–2%, suggesting routine event updates have limited impact.

Market Pulse Summary

This announcement outlines a dense 2026 catalyst calendar, including NDA submissions for bezuclastin...

Analysis

This announcement outlines a dense 2026 catalyst calendar, including NDA submissions for bezuclastinib in NonAdvSM, AdvSM, and GIST, with clinical data from the SUMMIT, PEAK, and APEX trials planned for major meetings in 1H 2026. Cogent also targets 2026 IND filings for pan-KRAS(ON) and JAK2 V617F inhibitors and reports starting 2026 with roughly $900 million in cash. Investors may track regulatory milestones, pivotal data quality, and execution on commercial build-out to gauge how this plan translates into future performance.

Key Terms

new drug application (nda), investigational new drug (ind), pan-kras(on), jak2 v617f, +4 more

8 terms

new drug application (nda) regulatory

"New Drug Application (NDA) for NonAdvSM submitted in December 2025"

A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.

investigational new drug (ind) regulatory

"Investigational New Drug (IND) applications expected in 2026"

An investigational new drug (IND) is a drug or biologic that is being tested but has not yet been approved for general use; it is the application and formal status that allows a company to begin human clinical trials under regulator oversight. Investors care because an IND marks the transition from lab work to human testing — like getting a permit to run real-world experiments — which creates important milestones, costs, timelines and regulatory risk that drive a development-stage company's value.

pan-kras(on) medical

"pan-KRAS(ON) and selective JAK2 V617F inhibitors"

Pan-KRAS(on) describes a class of cancer therapies designed to block the activity of the KRAS protein across many different activating mutations and tumor types, rather than only one specific variant. For investors, these drugs matter because they promise a broader potential customer base and bigger market opportunity—like a universal key that fits many locks—while also concentrating therapy development risk and potential reward into a single drug approach.

jak2 v617f medical

"selective JAK2 V617F inhibitor"

A single, well-known change in the JAK2 gene that acts like a stuck “on” switch in blood-cell growth control, causing certain chronic blood disorders and some blood cancers. It matters to investors because detecting this mutation guides diagnosis, patient selection for targeted drugs, and demand for companion diagnostics and therapies; advances or setbacks in tests or treatments tied to the mutation can affect the commercial value of related medical companies.

fgfr 2/3 medical

"selective and potent FGFR 2/3 inhibitor, from its Phase 1/2 study"

FGFR 2/3 are two members of a family of cell-surface proteins called fibroblast growth factor receptors that act like locks on a cell’s surface; when the matching keys (growth signals) fit, they tell cells to grow and divide. Changes or overactivity in FGFR2 or FGFR3 can drive certain cancers, so medicines that block these receptors or tests that detect their changes can be valuable assets for drug developers and affect clinical, regulatory, and commercial prospects.

pi3kα medical

"CGT6297, Cogent’s selective PI3Kα inhibitor"

PI3Kα is a specific form of an enzyme that acts like a cellular switchboard controlling signals for cell growth, survival and movement; think of it as a traffic controller that helps decide when cells divide or stay alive. It matters to investors because drugs that block or modify this enzyme can slow tumor growth or cause side effects, so clinical trial results, approvals or safety concerns around PI3Kα-targeting therapies can significantly affect company value.

expanded access programs regulatory

"established active Expanded Access Programs for U.S. patients with GIST or SM"

Expanded access programs let patients who are seriously ill and ineligible for clinical trials receive an investigational drug or therapy outside the trial system, often when no approved treatment exists. For investors, these programs matter because they can provide early real-world use that affects demand, public perception, regulatory scrutiny and safety data—like letting a handful of customers test a prototype product before full market approval, with both potential upside and risk.

restricted stock units (rsus) financial

"nonqualified options to purchase 66,700 shares of Cogent common stock and (ii) 9,700 restricted stock units (RSUs)"

Restricted stock units (RSUs) are a type of company promise to give employees shares of stock in the future, usually after certain conditions like working for a set time. They are like a gift promised today that you receive later, which can become valuable if the company's stock price goes up. RSUs matter because they are a way companies reward employees and can be a significant part of compensation.

AI-generated analysis. Not financial advice.

• New Drug Application (NDA) for NonAdvSM submitted in December 2025, NDA submission for AdvSM on track for 1H 2026
  
• NDA submission for GIST on track for April 2026; bezuclastinib has the potential to be the first new therapy for second-line GIST in over 20 years
• Clinical data presentations from all three pivotal trials, PEAK, SUMMIT and APEX, expected at major medical meetings in 1H 2026
  
• Investigational New Drug (IND) applications expected in 2026 for potentially best-in-class pan-KRAS(ON) and selective JAK2 V617F inhibitors
  
• Strong financial position with ~$900 million cash to begin 2026, sufficient to fund commercial launches and operations well into 2028
  
• Company to present at the 44^th Annual J.P. Morgan Healthcare Conference on Tuesday, January 13, 2026 at 8:15 am PT/11:15 am ET
  

WALTHAM, Mass. and BOULDER, Colo., Jan. 12, 2026 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today highlighted the company’s key 2026 milestones ahead of its presentation at J.P. Morgan’s 44^th 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.” 

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: https://www.cogentbio.com/bezuclastinib-program-development/#our-expanded-access-policy

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 44^th 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.

About Cogent Biosciences, Inc.
Cogent Biosciences is a biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis, a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2/3 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα, KRAS and JAK2. Cogent Biosciences is based in Waltham, MA and Boulder, CO. Visit our website for more information at www.cogentbio.com. Follow Cogent Biosciences on social media: X (formerly known as Twitter) and LinkedIn. Information that may be important to investors will be routinely posted on our website and X.

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding: the expectation that the FDA will accept our NDA for bezuclastinib in NonAdvSM by the end of February 2026 and approve it for commercial use in the second half of 2026; plans to submit an NDA in April 2026 for bezuclastinib in GIST; plans to submit an NDA in the first half of 2026 for bezuclastinib in AdvSM; plans to present updated clinical data from each of the SUMMIT, PEAK and APEX trials at major medical meetings in the first half of 2026; plans to launch bezuclastinib commercially in the second half of 2026 following FDA approval; plans to submit INDs in 2026 for both our pan-KRAS and JAK2 V617F inhibitors; the potential for bezuclastinib to be the first new therapy for second-line GIST in over 20 years; the expectation that our cash runway is sufficient to fund commercial launches and operations well into 2028; the expectation that Cogent will transform into a fully integrated commercial stage company in 2026; plans to present clinical data in 2026 on CGT4859 and plans to complete dose escalation in 2026 for both CGT4255 and CGT6297. The use of words such as, but not limited to, “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar words or expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our clinical results, the rate of enrollment in our clinical trials and other future conditions. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. We may not actually achieve the forecasts or milestones disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to those set forth under the caption “Risk Factors” in Cogent’s most recent Quarterly Report on Form 10-Q filed with the SEC. Any forward-looking statement speaks only as of the date on which it was made. Neither we, nor our affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

Contact:
Christi Waarich
Senior Director, Investor Relations
christi.waarich@cogentbio.com
617-830-1653

FAQ

What regulatory milestones did Cogent (COGT) schedule for bezuclastinib in 2026?

Cogent targets NDA acceptance for NonAdvSM by end-February 2026, an NDA submission for GIST in April 2026, and an NDA submission for AdvSM in 1H 2026.

When does Cogent (COGT) plan to commercialize bezuclastinib if approved?

The company plans to commercialize bezuclastinib in 2H 2026 following potential FDA approval.

How much cash did Cogent (COGT) report entering 2026 and how long is it expected to fund operations?

Cogent reported approximately $900 million in cash entering 2026, stated sufficient to fund launches and operations well into 2028.

What clinical data presentations for bezuclastinib are expected from Cogent (COGT) in 1H 2026?

Detailed updated clinical data from the SUMMIT, PEAK, and APEX pivotal trials are expected to be presented at major medical meetings in 1H 2026.

Which pipeline INDs does Cogent (COGT) plan to submit in 2026?

Cogent plans IND submissions in 2026 for CGT1815 (selective pan-KRAS(ON)) and CGT1145 (selective JAK2 V617F).

Does Cogent (COGT) offer expanded access to bezuclastinib for eligible patients?

Yes. Cogent has active U.S. Expanded Access Programs for patients with GIST or systemic mastocytosis who meet disease-specific criteria.