Terns Highlights Additional Positive Phase 1 Clinical Data Supporting TERN-701’s Best-in-Disease Potential in Relapsed/Refractory CML at the 67th ASH Annual Meeting
Rhea-AI Summary
Terns (NASDAQ: TERN) reported updated Phase 1 CARDINAL data for TERN-701 at ASH on December 8, 2025. As of a September 13, 2025 cutoff (n=63), 38 efficacy-evaluable patients showed an overall MMR rate of 64% by 24 weeks across all doses and 75% MMR at doses ≥320mg QD. DMR by 24 weeks reached 29% overall and 36% in the ≥320mg cohort. Median treatment duration was six months with a favorable safety profile; Grade ≥3 neutropenia and thrombocytopenia were each 10% (8%). Company hosted an investor webcast on December 8, 2025.
Positive
- 64% MMR achieved by 24 weeks (all efficacy-evaluable patients)
- 75% MMR by 24 weeks at doses ≥320mg QD
- 36% DMR by 24 weeks in ≥320mg QD cohorts
- Enrollment surpassed 85 patients supporting rapid advancement
- No dose-limiting toxicities; MTD not reached
Negative
- Grade ≥3 neutropenia observed in 8% of patients
- Grade ≥3 thrombocytopenia observed in 8% of patients
- 15% of patients had baseline BCR::ABL1 mutations (10% T315I)
News Market Reaction
On the day this news was published, TERN gained 37.02%, reflecting a significant positive market reaction. Argus tracked a peak move of +45.9% during that session. Our momentum scanner triggered 33 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $1.10B to the company's valuation, bringing the market cap to $4.06B at that time. Trading volume was very high at 3.8x the daily average, suggesting strong buying interest.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TERN gained 7.9% with strong CARDINAL Phase 1 data while peers were mixed: NRIX appeared in momentum scanners, up 19.29%, and RIGL showed downside momentum at -10.83%. Another ASH-related clinical update from NRIX suggests event-driven moves, but the pattern is company-specific rather than a broad biotech surge.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 14 | Conference participation | Positive | +13.3% | Jefferies healthcare conference presentation and webcast announcement. |
| Nov 10 | Quarterly earnings | Positive | +3.5% | Q3 results with strong cash runway and CARDINAL data preview. |
| Nov 04 | Equity grants | Neutral | +4.4% | Inducement stock option grants to new employees under plan. |
| Nov 03 | Clinical data update | Positive | +69.8% | Positive Phase 1 CARDINAL data and ASH oral selection for TERN-701. |
| Oct 21 | Clinical trial results | Negative | -5.8% | Phase 2 TERN-601 obesity data below bar and program discontinuation. |
Recent news events, both positive and negative, have consistently produced price moves in the same direction as the apparent news sentiment.
Over the last few months, Terns has shifted decisively toward oncology, with multiple updates on TERN-701 in CML and de-prioritization of metabolic assets like TERN-601. Prior CARDINAL data releases, including the November 3, 2025 ASH abstract, showed high MMR rates and drove substantial gains. Conference participation and Q3 results in November 2025 also coincided with positive reactions. Today’s expanded ASH Phase 1 data build directly on those earlier CARDINAL readouts and reinforce the CML-focused strategy.
Market Pulse Summary
The stock surged +37.0% in the session following this news. A strong positive reaction aligns with the history of outsized moves on TERN-701 clinical updates, as seen with prior CARDINAL data. The expanded ASH dataset shows high MMR and DMR rates with a favorable safety profile, supporting the CML-focused pivot. However, with shares near the 52-week high of 30.25 and up 7.9% on heavy volume, investors have previously faced sharp swings following trial milestones, so sensitivity to future data and regulatory feedback could remain elevated.
Key Terms
major molecular response medical
deep molecular response medical
tyrosine kinase inhibitor medical
allosteric medical
BCR::ABL1 medical
treatment-emergent adverse events medical
dose-limiting toxicities medical
maximum tolerated dose medical
AI-generated analysis. Not financial advice.
Encouraging safety/tolerability profile maintained with longer duration of treatment
Company to host investor update call today at 4:30pm ET
FOSTER CITY, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Terns Pharmaceuticals, Inc. (Terns or the Company) (Nasdaq: TERN), a clinical-stage oncology company, today announced that updated and expanded data from the ongoing CARDINAL trial of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor, in patients with previously treated chronic myeloid leukemia (CML) are being presented today at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 6-9, 2025 in Orlando, FL. The company will host a conference call and webcast for investors at 4:30pm ET today following the ASH presentation.
The ASH presentation will be made available on the Terns Pharmaceuticals website simultaneously with the oral presentation by Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and lead investigator on the TERN-701 Phase 1 CARDINAL study. Presentation details are summarized below.
"We are delighted that our investigators can share these unprecedented Phase 1 data for TERN-701 with patient groups and the broader hematology community at ASH. The
"We are particularly encouraged to see unprecedented rates of MMR in a highly refractory population, including compelling response achievement in patients with lack of efficacy on prior asciminib, ponatinib, and/or other marketed and investigational TKIs. In the RP2D dose range, we see a
"While therapies for CML have come a long way since imatinib, there remains an unmet need for new drugs that achieve early, broad and deep responses with a safety/tolerability profile that allows long-term maintenance of response with improved quality of life for patients. Based on the data to date, TERN-701 represents an innovative treatment option that has the potential to achieve this important goal. I am excited to help advance this therapy for the benefit of CML patients," said Dr. Jabbour.
The ASH oral presentation today reports data from the ongoing dose escalation and dose expansion parts of the CARDINAL study of TERN-701 in patients with previously treated CML. As of the September 13, 2025 cutoff date, 63 patients were enrolled.
Assessment of all dose cohorts (160mg - 500mg, n=63)
- Of 38 efficacy-evaluable patients:
- Overall (cumulative) MMR rate of
74% (28/38) by 24 weeks, with64% (18/28) achieving MMR and100% (10/10) maintaining MMR - MMR overall and achieved by 24 weeks in difficult to treat patient subgroups:
- Lack of efficacy to last tyrosine kinase inhibitor (TKI):
65% (13/20) overall;63% (12/19) achieved - Lack of tolerability to prior TKI:
88% (14/16) overall;71% (5/7) achieved - Prior asciminib:
60% (6/10) overall;43% (3/7) achieved - Prior asciminib, ponatinib and/or investigational TKI:
67% (8/12) overall;50% (4/8) achieved
- Lack of efficacy to last tyrosine kinase inhibitor (TKI):
- Deep molecular response (DMR) achievement rate by 24 weeks of
29% (10/34) - No patients had lost MMR at the time of data cutoff
- Overall (cumulative) MMR rate of
- Enrolled patients had heavily pretreated, refractory disease:
- Median of 3 prior TKIs;
60% had ≥3 prior TKIs 57% and44% had baseline BCR::ABL1 >1% and >10% , respectively64% discontinued their last TKI due to lack of efficacy38% had prior asciminib treatment (75% had lack of efficacy and25% had lack of tolerability)22% had prior ponatinib treatment (79% had lack of efficacy and21% had lack of tolerability)15% with BCR::ABL1 mutations (10% with T315I and5% with non-T315I mutations)
- Median of 3 prior TKIs;
- Encouraging safety profile:
87% (55/63) of patients remained on treatment as of the data cutoff; with discontinuations due to disease progression (n=4), adverse events (n=1), and physician / patient decision or lost to follow up (n=3)- No dose-limiting toxicities (DLTs) were observed in dose escalation, and a maximum tolerated dose (MTD) was not reached
- The majority of treatment-emergent adverse events (TEAEs) were low grade with no apparent dose relationship
- Rates of cytopenia were generally low with less than
10% Grade 3 thrombocytopenia and neutropenia - Most common non-hematologic TEAEs were diarrhea (
21% ), headache (19% ) and nausea (19% ), all Grade 1 or 2 - Grade 3 or higher TEAEs were all less than
10% , most commonly neutropenia (8% ) and thrombocytopenia (8% ) - TERN-701 exposures were approximately dose proportional across the dose range
- Encouraging MMR achievement rates in patients with lack of efficacy to prior asciminib:
| Subgroup | Baseline Characteristics | MMR achieved by 24 weeks | |
| Prior asciminib (n=10) | No MMR at baseline | 7/10 ( | 3/7 ( |
| Prior lack of efficacy | 6/7 ( | 2/6 ( | |
| Prior intolerance only | 1/7 ( | 1/1 ( | |
Assessment of patient cohorts at doses ≥ 320mg QD (n=53)
- Similar overall baseline characteristics to the full study population:
- Median of 3 prior TKIs
56% and47% had baseline BCR::ABL1 >1% and >10% , respectively38% had prior asciminib treatment,21% had prior ponatinib treatment68% discontinued their last TKI due to efficacy
- In 30 efficacy evaluable patients, overall MMR rate of
80% (24/30) by 24 weeks, with75% (18/24) achieving MMR and100% maintaining MMR (6/6) - DMR achievement rate by 24 weeks of
36% (10/28) - Molecular responses observed across full spectrum of baseline BCR::ABL1 transcripts
| Baseline BCR::ABL1 (Patients at doses ≥ 320mg QD) | ||||||||
| MR5 (n=0) | MR4.5 (n=1) | MR4 (n=1) | MR3 (n=4) | MR2 (n=11) | MR1 (n=4) | > (n=9) | ||
| Post-treatment BCR::ABL1 | MR5 (DMR) | 1 | 1 | 1 | 1 | 1 | 1 | |
| MR4.5 (DMR) | 3 | |||||||
| MR4 (DMR) | 1 | 1 | 1 | |||||
| MR3 (MMR) | 2 | 6 | 4 | |||||
| MR2 | 1 | |||||||
| MR1 | 1 | 1 | ||||||
| BCR::ABL > | 3 | |||||||
Note: Table includes response evaluable non-T315Im patients that have ≥1 baseline assessment with at least six months of treatment at visit cutoff, achievement of MMR or better prior to six months or treatment discontinuation prior to six months for any reason (n=30). Diagonal, bolded cells represent stable disease. Up/right of diagonal, bolded cells represents improvement in molecular response (MR) category, while down/left represents loss of efficacy. MR represents a decrease in the number of cells in the blood with the BCR::ABL1 gene and is quantified as a percentage. MR5: ≤
Details for the ASH oral presentation are as follows:
Title: CARDINAL: A Phase 1 study of TERN-701, a novel investigational allosteric BCR::ABL1 inhibitor for patients with previously treated CML
Presenter: Elias Jabbour, MD, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Session Name: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Therapeutic agents to enhance patient outcomes
Session Date: December 8, 2025 at 2:45pm ET
Company Conference Call and Webcast Information
Terns will host a conference call and webcast for investors at 4:30pm ET on December 8, 2025 following the oral presentation at the ASH Annual Meeting. Members of the Terns management team will discuss additional TERN-701 data from CARDINAL, including patient vignettes, benchmarking comparisons and next steps for the development of TERN-701. The conference call will conclude with a Q&A session.
The webcast can be accessed in the investor relations section of the Company's website. A replay of the event will be archived and available for a limited time.
About TERN-701 and CARDINAL Clinical Trial
TERN-701 is currently being evaluated in the CARDINAL trial (NCT06163430), a global multi-center dose escalation and dose-expansion clinical trial to assess safety, tolerability and efficacy in patients with previously treated chronic phase CML. The dose escalation portion of the CARDINAL trial completed in January 2025 with no DLTs observed up to the maximum dose of 500mg QD. Terns initiated the dose expansion portion of the trial in April 2025 with patients randomized to one of two dose cohorts (320mg or 500mg QD) with up to 40 patients per arm.
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, oral, allosteric BCR-ABL inhibitor with a potentially best-in-disease profile that could meaningfully improve upon the efficacy, safety and convenience of existing treatments for chronic myeloid leukemia. For more information, please visit: www.ternspharma.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about the Company within the meaning of the federal securities laws that involve substantial risks and uncertainties. Forward-looking statements include statements related to or in connection with expectations, timing and potential results of clinical trials and other development activities, including with respect to the CARDINAL trial; the potential indications to be targeted by the Company with its product candidates; the therapeutic potential of the Company's 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 applicability of expected parameters and benchmarks on which to assess clinical trial results; the Company's clinical development plans and activities, including potential future dosing regimens and trial designs, milestones and results of any interactions with regulatory authorities on its programs; the Company's expectations regarding the profile and potential beneficial characteristics and therapeutic effects of its product candidates, including with respect to efficacy, tolerability, safety, convenience and pharmacokinetic profile; the potential differentiation of the Company's product candidates compared to similar, competitive or other products or product candidates; the best-in-disease potential of TERN-701; and the Company's plans for and ability to continue to execute on its current development strategy. 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, projected costs, prospects, plans, objectives of management and expected industry and market trends, 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," "develop," "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 reports filed with the Securities and Exchange Commission, including but not limited to its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q. New risk factors emerge from time to time and it is not possible for Company management to predict all risk factors, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. 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
CG Life
media@ternspharma.com
FAQ
What MMR rate did Terns report for TERN-701 at ASH 2025 (TERN)?
What deep molecular response (DMR) rates did TERN-701 achieve by 24 weeks (TERN)?
What safety signals were reported for TERN-701 in the CARDINAL Phase 1 update (TERN)?
Which doses did Terns select as recommended Phase 2 doses for TERN-701 (TERN)?
How many prior TKIs had patients received in the CARDINAL study cutoff cohort (TERN)?
Did Terns report accelerated enrollment for the CARDINAL study before December 2025 (TERN)?
