ELVN-001 Phase 3 Clinical Trial to Start in H2 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 08 2026
0mins
Should l Buy ELVN?
Milestones include: Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trial; Regulatory alignment with the FDA on dose selection and Phase 3 trial design; Initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, in the second half of 2026.
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Analyst Views on ELVN
Wall Street analysts forecast ELVN stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ELVN is 40.20 USD with a low forecast of 35.00 USD and a high forecast of 48.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 26.990
Low
35.00
Averages
40.20
High
48.00
Current: 26.990
Low
35.00
Averages
40.20
High
48.00
About ELVN
Enliven Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help patients with cancer. It is advancing two parallel lead product candidates, ELVN-001 and ELVN-002, and pursuing several additional research stage opportunities that align with its development approach. Its first product candidate, ELVN-001, is a potent, highly selective, small molecule kinase inhibitor designed to specifically target the breakpoint cluster region-Abelson (BCR-ABL) gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. Its second product candidate, ELVN-002, is a potent, highly selective, central nervous system penetrant and irreversible human epidermal growth factor receptor 2 (HER2) inhibitor with activity against wild type HER2 and various HER2 mutations. ELVN-002 is designed to inhibit wild type HER2 and key mutations of HER2, while sparing wild-type EGFR and avoiding EGFR-related toxicities.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Enliven Therapeutics Executive Sells 20,000 Shares
- Executive Sale Details: Chief Scientific Officer Joseph P. Lyssikatos sold 20,000 shares of Enliven Therapeutics on January 20, 2026, for approximately $535,100, indicating a potential shift in confidence regarding the company's stock.
- Transaction Context: This sale exceeds Mr. Lyssikatos's historical median sale of 11,114 shares, suggesting a significant increase in the scale of this transaction, which may raise investor concerns about his future intentions with the stock.
- Company Financial Overview: Enliven Therapeutics has a market capitalization of $1.57 billion, and despite a net loss of $97.21 million, the stock surged approximately 71% in January following positive initial data for its ELVN-001 leukemia treatment, reflecting optimistic market sentiment about its future prospects.
- Clinical Trial Advancements: The company aims to advance ELVN-001 to phase three clinical trials in collaboration with the FDA, and although still in its early stages, the stock is rated as a “strong buy” by most Wall Street analysts, indicating confidence in its growth trajectory.
See More
Enliven Therapeutics COO Anish Patel Sells 48,300 Shares for $1,351,000
- Executive Sell-off: Enliven Therapeutics COO Anish Patel sold 48,300 shares on January 9, 2026, totaling $1,351,000, which may raise concerns about the company's future outlook among investors.
- Market Reaction: Executive sell-offs are often perceived as negative signals for stock performance, potentially leading to a decline in investor confidence in Enliven Therapeutics and affecting its stock price.
- Shareholder Structure Change: This sell-off could alter the company's shareholder structure, impacting investor trust in corporate governance and management, which may affect the company's financing capabilities and market image.
- Future Outlook: While the sell-off raises concerns, the company's future strategic direction and performance will remain focal points for investors, necessitating close monitoring of upcoming earnings reports and market developments.
See More
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- Duration of Response: The median duration of response reached approximately 17 months, far exceeding the standard treatment's 9.5 months, showcasing pelareorep's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Interaction Plan: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss its registration-directed clinical study plan for second-line and later SCAC, with the potential for accelerated approval if data meets expectations.
- Strategic Investment and Expansion: The company is enhancing its expertise in gastrointestinal oncology through the expansion of its Scientific Advisory Board, further validating its Phase 3 study design for first-line metastatic pancreatic cancer, demonstrating its strategic positioning in the oncology immunotherapy landscape.
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- Clinical Trial Advancement: The trial compares adjuvant intravesical treatment versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer, and the earlier data release is expected to attract more investor interest, further propelling the company's growth.
- Positive Market Reaction: This stock price increase not only indicates investor optimism about CG Oncology's potential but may also enhance the company's financing capabilities in the biopharmaceutical sector, strengthening its competitive position.
- Significant Industry Impact: CG Oncology's progress could influence treatment standards for non-muscle invasive bladder cancer, prompting other companies in the industry to accelerate their R&D efforts, thereby boosting overall market vitality.
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ScinoPharm Secures FDA Approval for Glatiramer Acetate Injection in Multiple Sclerosis
- FDA Approval: ScinoPharm Taiwan (TWSE:1789) received FDA approval for its Glatiramer Acetate Injection for treating adult multiple sclerosis patients, marking the company's first finished drug approval and paving the way for regulatory submissions in Europe and Asia for broader commercialization.
- Market Reaction: Following this announcement, ScinoPharm's stock price rose by 3.08% to NT$23.40 on January 8, 2025, reflecting positive market sentiment regarding the product's prospects.
- Clinical Trial Progress: The approval supports the company's competitiveness in the global market, as Glatiramer Acetate remains a key product despite revenue erosion from generics, highlighting its ongoing relevance in the biotech sector.
- Strategic Positioning: This approval not only strengthens ScinoPharm's position in the biopharmaceutical landscape but also lays the groundwork for future market expansions, demonstrating the company's commitment to innovative drug development.
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Enliven Therapeutics Reports Promising Phase 1b Data for ELVN-001 in CML Patients
- Clinical Trial Progress: Enliven Therapeutics reported promising initial data from the ongoing Phase 1b ENABLE trial for ELVN-001 in chronic myeloid leukemia patients, with 38% achieving major molecular response (MMR) and 16% achieving deep molecular response (DMR) among 60 heavily pre-treated patients, indicating competitive efficacy compared to existing therapies.
- Dose Response Observation: In the randomized 60 mg and 120 mg cohorts, MMR reached 53% and DMR 35%, with all evaluable patients maintaining or deepening their responses, demonstrating robust clinical activity across different dosing regimens.
- Safety Assessment: ELVN-001 exhibited a favorable safety and tolerability profile across doses from 60 mg to 120 mg, with no new safety signals identified and consistent with previously reported data, highlighting its potential market viability.
- Future Plans: The company plans to initiate the ENABLE-2 Phase 3 trial in the second half of 2026, further validating the efficacy and safety of ELVN-001, marking a strategic move in the treatment landscape for chronic myeloid leukemia.
See More
Enliven Therapeutics Executive Sells 20,000 Shares
- Executive Sale Details: Chief Scientific Officer Joseph P. Lyssikatos sold 20,000 shares of Enliven Therapeutics on January 20, 2026, for approximately $535,100, indicating a potential shift in confidence regarding the company's stock.
- Transaction Context: This sale exceeds Mr. Lyssikatos's historical median sale of 11,114 shares, suggesting a significant increase in the scale of this transaction, which may raise investor concerns about his future intentions with the stock.
- Company Financial Overview: Enliven Therapeutics has a market capitalization of $1.57 billion, and despite a net loss of $97.21 million, the stock surged approximately 71% in January following positive initial data for its ELVN-001 leukemia treatment, reflecting optimistic market sentiment about its future prospects.
- Clinical Trial Advancements: The company aims to advance ELVN-001 to phase three clinical trials in collaboration with the FDA, and although still in its early stages, the stock is rated as a “strong buy” by most Wall Street analysts, indicating confidence in its growth trajectory.
See More
Enliven Therapeutics COO Anish Patel Sells 48,300 Shares for $1,351,000
- Executive Sell-off: Enliven Therapeutics COO Anish Patel sold 48,300 shares on January 9, 2026, totaling $1,351,000, which may raise concerns about the company's future outlook among investors.
- Market Reaction: Executive sell-offs are often perceived as negative signals for stock performance, potentially leading to a decline in investor confidence in Enliven Therapeutics and affecting its stock price.
- Shareholder Structure Change: This sell-off could alter the company's shareholder structure, impacting investor trust in corporate governance and management, which may affect the company's financing capabilities and market image.
- Future Outlook: While the sell-off raises concerns, the company's future strategic direction and performance will remain focal points for investors, necessitating close monitoring of upcoming earnings reports and market developments.
See More
Oncolytics Biotech Advances Immunotherapy for Accelerated Approval in Oncology
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in GOBLET Cohort 4, significantly surpassing the historical benchmark of 10%, indicating substantial clinical value in third-line anal cancer patients with no FDA-approved treatment options.
- Duration of Response: The median duration of response reached approximately 17 months, far exceeding the standard treatment's 9.5 months, showcasing pelareorep's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Interaction Plan: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss its registration-directed clinical study plan for second-line and later SCAC, with the potential for accelerated approval if data meets expectations.
- Strategic Investment and Expansion: The company is enhancing its expertise in gastrointestinal oncology through the expansion of its Scientific Advisory Board, further validating its Phase 3 study design for first-line metastatic pancreatic cancer, demonstrating its strategic positioning in the oncology immunotherapy landscape.
See More
CG Oncology Accelerates Phase 3 Data Readout to First Half of 2026
- Significant Stock Surge: Shares of CG Oncology Inc soared 21.8% to $51.05 after the announcement of an expedited topline data readout for the PIVOT-006 clinical trial, reflecting strong market confidence in the company's future prospects.
- Clinical Trial Advancement: The trial compares adjuvant intravesical treatment versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer, and the earlier data release is expected to attract more investor interest, further propelling the company's growth.
- Positive Market Reaction: This stock price increase not only indicates investor optimism about CG Oncology's potential but may also enhance the company's financing capabilities in the biopharmaceutical sector, strengthening its competitive position.
- Significant Industry Impact: CG Oncology's progress could influence treatment standards for non-muscle invasive bladder cancer, prompting other companies in the industry to accelerate their R&D efforts, thereby boosting overall market vitality.
See More
ScinoPharm Secures FDA Approval for Glatiramer Acetate Injection in Multiple Sclerosis
- FDA Approval: ScinoPharm Taiwan (TWSE:1789) received FDA approval for its Glatiramer Acetate Injection for treating adult multiple sclerosis patients, marking the company's first finished drug approval and paving the way for regulatory submissions in Europe and Asia for broader commercialization.
- Market Reaction: Following this announcement, ScinoPharm's stock price rose by 3.08% to NT$23.40 on January 8, 2025, reflecting positive market sentiment regarding the product's prospects.
- Clinical Trial Progress: The approval supports the company's competitiveness in the global market, as Glatiramer Acetate remains a key product despite revenue erosion from generics, highlighting its ongoing relevance in the biotech sector.
- Strategic Positioning: This approval not only strengthens ScinoPharm's position in the biopharmaceutical landscape but also lays the groundwork for future market expansions, demonstrating the company's commitment to innovative drug development.
See More
Enliven Therapeutics Reports Promising Phase 1b Data for ELVN-001 in CML Patients
- Clinical Trial Progress: Enliven Therapeutics reported promising initial data from the ongoing Phase 1b ENABLE trial for ELVN-001 in chronic myeloid leukemia patients, with 38% achieving major molecular response (MMR) and 16% achieving deep molecular response (DMR) among 60 heavily pre-treated patients, indicating competitive efficacy compared to existing therapies.
- Dose Response Observation: In the randomized 60 mg and 120 mg cohorts, MMR reached 53% and DMR 35%, with all evaluable patients maintaining or deepening their responses, demonstrating robust clinical activity across different dosing regimens.
- Safety Assessment: ELVN-001 exhibited a favorable safety and tolerability profile across doses from 60 mg to 120 mg, with no new safety signals identified and consistent with previously reported data, highlighting its potential market viability.
- Future Plans: The company plans to initiate the ENABLE-2 Phase 3 trial in the second half of 2026, further validating the efficacy and safety of ELVN-001, marking a strategic move in the treatment landscape for chronic myeloid leukemia.
See More
