Bosutinib Monohydrate

Merck (NYSE: MRK) has entered into a definitive agreement to acquire Terns Pharmaceuticals (Nasdaq: TERN), a clinical-stage oncology company, for USD 53.00 per share in an all-cash transaction valued at approximately USD 6.7 billion. The Merck Terns Pharmaceuticals acquisition positions the pharma company to consolidate its presence in hematology through TERN-701, an oral allosteric BCR::ABL1 tyrosine kinase inhibitor currently in Phase I/II development for chronic myeloid leukemia. The transaction represents approximately USD 5.7 billion net of acquired cash and carries a premium of 31% to the 60-day and 42% to the 90-day volume-weighted average stock price as of March 24, 2026. The deal contains no disclosed milestone payments, contingent value rights, or earn-out provisions. Merck will execute the acquisition through a tender offer requiring a majority of Terns stockholders to tender their shares, with closing expected in Q2 2026 following expiration of the Hart-Scott-Rodino waiting period. The transaction will be accounted for as an asset acquisition, resulting in an approximately USD 5.8 billion charge (approximately USD 2.35 per share) recognized in both Q2 and full-year 2026 GAAP and non-GAAP results. The asset acquisition classification means the acquired in-process R&D will be expensed immediately rather than capitalized. TERN-701: Mechanism and clinical status TERN-701 is a BCR-ABL1 tyrosine kinase inhibitor designed to bind to the ABL myristoyl pocket, an allosteric site distinct from the ATP-binding domain targeted by earlier-generation TKIs. CML is driven by the Philadelphia chromosome, a translocation between chromosomes 9 and 22 that produces constitutive activation of the BCR::ABL1 fusion protein, which fuels malignant white blood cell proliferation. The compound is being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and expansion study enrolling patients with Ph+ chronic phase CML who experienced treatment failure, suboptimal response, or intolerance to at least one prior TKI. The dose escalation portion completed in January 2025 with no dose-limiting toxicities observed up to 500 mg QD. Dose expansion initiated in April 2025 across two cohorts (320 mg and 500 mg QD), and in January 2026 an additional cohort was added to evaluate activity against BCR::ABL1 resistance mutations including T315I, M244V, and F359I/C/V. The FDA granted Orphan Drug Designation for TERN-701 in CML in March 2024. Clinical data reported to date indicate rates of major molecular response and deep molecular response by week 24, including in patients with high disease burden who had received multiple prior therapy lines, with low rates of severe adverse events and discontinuations. Specifically, Terns reported a 75% cumulative MMR rate by 24 weeks in 32 efficacy-evaluable patients. The strategic context The TERN-701 CML program joins a Merck hematology pipeline that already includes three Phase III candidates: bomedemstat (LSD1 inhibitor), nemtabrutinib (non-covalent BTK inhibitor), and zilovertamab vedotin (ROR1-targeting ADC), along with MK-1045 (CD19×CD3 T-cell engager) in Phase Ib/II. The Terns buyout extends a pattern of aggressive deal-making driven by the approaching Keytruda patent cliff (~2028). Merck’s recent transactions include the USD 9 billion purchase of influenza-focused Cidara Therapeutics, Inc. (Nasdaq: CDTX), the USD 10 billion purchase of Verona Pharma for a COPD therapy, and the USD 10.8 billion acquisition of immunology-focused Prometheus Biosciences. In the chronic myeloid leukemia treatment landscape, TERN-701 enters a competitive field. Novartis markets asciminib (Scemblix), the first approved allosteric BCR::ABL1 inhibitor, which received FDA approval in 2022 for Ph+ CML after two or more prior TKIs and gained a first-line CML indication based on the ASC4FIRST trial. Sun Pharma Advanced Research is developing denimsertib, another allosteric BCR::ABL1 inhibitor in clinical development. Earlier-generation ATP-competitive TKIs from Novartis (imatinib, nilotinib), Bristol Myers Squibb (dasatinib), and Pfizer (bosutinib) remain standards of care, though resistance mutations and tolerability limitations persist across these agents. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

CARDINAL Phase 1/2 trial of TERN-701 enrolling well, with multiple important milestones in 2026 Planned milestones include pivotal dose selection, EOP2 regulatory interaction in mid-2026, updated and expanded CARDINAL data by 2H26, and initiation of 2L+ pivotal trial in late 2026/early 2027 TERN-701 was granted U.S. FDA Fast Track designation for the treatment of CML in Q4 2025 Year-end 2025 unaudited cash, cash equivalents and marketable securities of approximately $1.0 billion, expected to provide runway into 2031 FOSTER CITY, Calif., Jan. 07, 2026 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (“Terns” or the “Company”) (Nasdaq: TERN), a clinical-stage oncology company, today announced that management will provide an update on 2026 priorities and program milestones during the Company’s presentation at the 44 th Annual J.P. Morgan Healthcare Conference on January 12 th , 2026 at 3:45pm in San Francisco, CA. “Last year was transformative for Terns as we completed our transition to an oncology company anchored by our allosteric BCR-ABL inhibitor, TERN-701, for CML. Following compelling TERN-701 data at ASH in December, and our subsequent capital raise, we are in a strong position to advance TERN-701 towards pivotal trial initiation. Based on accelerating momentum in our CARDINAL trial, our goal for pivotal trials is to enroll patients more quickly than historical precedents in CML and to generate data that further strengthen the position of TERN-701 as a potential best-in-disease therapy across all lines of CML treatment,” said Amy Burroughs, chief executive officer of Terns. “We believe that reaffirming clinical differentiation and advancing to product launch rapidly will be key factors to maximize the therapeutic and commercial potential of TERN-701,” added Ms. Burroughs. Anticipated 2026 Priorities and Key Milestones TERN-701: Oral, allosteric BCR-ABL tyrosine kinase inhibitor (TKI) for chronic myeloid leukemia (CML) Anticipated 2026 milestones for TERN-701 include: Selection of pivotal dose in mid-2026 End of Phase 2 regulatory interaction with U.S. FDA in mid-2026 Updated and expanded CARDINAL data by second half of 2026 Initiation of first pivotal trial (2L+ population) in late 2026 / early 2027 Preliminary study design anticipates evaluation of TERN-701 vs control arm of investigator’s choice 2 nd generation TKI (dasatinib, nilotinib, bosutinib) with major molecular response (MMR) at six months as the primary endpoint New cohort added to the ongoing CARDINAL Phase 1/2 study to evaluate TERN-701 500mg QD in approximately 20 patients with BCR-ABL resistance mutations including T315I, M244V, F359I/C/V and others At the 67 th ASH Annual Meeting in December 2025, Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, presented unprecedented safety and efficacy data from the CARDINAL trial CARDINAL enrolled a predominantly 3L+ patient population with 38% of patients having received prior asciminib of whom 75% discontinued due to lack of efficacy TERN-701 showed an encouraging safety profile (N=63) 87% (55/63) of patients remained on treatment as of the data cutoff No dose-limiting toxicities were observed in dose escalation, and a maximum tolerated dose was not reached The majority of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship Grade 3 or higher TEAEs were all less than 10%, most commonly neutropenia (8%) and thrombocytopenia (8%) Unprecedented efficacy with MMR achievement rate by 24 weeks of 75% (18/24) in evaluable patients enrolled at the recommended phase 2 dose range of > 320mg QD, trending 2-3X higher than asciminib in Phase 1 and Phase 3 studies evaluating a 3L+ patient population Deep molecular response (DMR) achievement rate by 24 weeks of 36% (10/28) Encouraging MMR rates in patients with prior asciminib (n=10) Overall MMR rate of 60% (6/10), with 43% (3/7) achieving MMR and 100% (3/3) maintaining MMR Enrollment has accelerated with 85+ patients enrolled as of December 8, 2025 Other Pipeline Programs Discovery efforts are underway on undisclosed targets for oncology indications Terns is seeking a strategic partner to advance the TERN-501 and TERN-801 legacy metabolic programs Corporate Updates In December 2025, Terns completed an upsized public offering of 18,687,500 shares of its common stock, generating gross proceeds of approximately $747.5 million before deducting underwriting discounts and commissions and other offering expenses Unaudited cash, cash equivalents and marketable securities for the year ended December 31, 2025, of approximately $1.0 billion expected to provide cash runway into 2031, including the first potential approval and launch of TERN-701 A live webcast of the Company’s J.P. Morgan Healthcare Conference presentation will be available on the investor relations page of Terns’ website at . A replay of the webcast will be archived on Terns’ website for at least 30 days following the presentation. About Terns Pharmaceuticals Terns Pharmaceuticals is a clinical-stage oncology company reimagining known biology to deliver high impact medicines. Our lead program TERN-701 is a highly selective, allosteric BCR-ABL inhibitor with a potentially best-in-disease pro could meaningfully improve upon the efficacy, safety and convenience of existing treatments for CML. For more information, please visit: . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements about Terns Pharmaceuticals, Inc. (the “Company,” “we,” “us,” or “our”) within the meaning of the federal securities laws, including those related to the Company’s expectations of timing and potential results of the clinical trials and other development activities of the Company and its partners; the potential indications to be targeted by the Company with its small-molecule product candidates; the therapeutic potential of the Company’s small-molecule product candidates; the potential for the mechanisms of action of the Company’s product candidates to be therapeutic targets for their targeted indications; the potential utility and progress of the Company’s product candidates in their targeted indications, including the clinical utility of the data from and the endpoints used in the Company’s clinical trials; the Company’s clinical development plans and activities; the Company’s expectations regarding the pro its product candidates, including efficacy, tolerability, safety, metabolic stability and pharmacokinetic pro potential differentiation as compared to other products or product candidates; the Company’s plans for and ability to continue to execute on its current development strategy, including potential combinations involving multiple product candidates; and the Company’s expectations with regard to its cash runway and sufficiency of its cash resources. All statements other than statements of historical facts contained in this press release, including statements regarding the Company’s strategy, future financial condition, future operations, future trial results, future approvals, future launches, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. The Company has based these forward-looking statements largely on its current expectations, estimates, forecasts and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. In light of the significant uncertainties in these forward-looking statements, you should not rely upon forward-looking statements as predictions of future events. These statements are subject to risks and uncertainties that could cause the actual results and the implementation of the Company’s plans to vary materially, including the risks associated with the initiation, cost, timing, progress, results and utility of the Company’s current and future research and development activities and preclinical studies and clinical trials. These risks are not exhaustive. For a detailed discussion of the risk factors that could affect the Company’s actual results, please refer to the risk factors identified in the Company’s SEC reports, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2024 and its Quarterly Report on Form 10-Q for the periods ended March 31, 2025, June 30, 2025 and September 30, 2025. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason. Contacts for Terns Investors Justin Ng investors@ternspharma.com Media Jenna Urban Berry & Company Public Relations media@ternspharma.com