Enliven Therapeutics(ELVN)
Search documents
Enliven Therapeutics Chief Scientific Officer Sells ELVN 20K Shares Worth Over $500k
The Motley Fool· 2026-02-01 05:58
Core Insights - The Chief Scientific Officer of Enliven Therapeutics sold 20,000 shares amid a significant stock price increase of 71% in January 2026 [1][5] - The transaction was valued at approximately $535,100, with the shares sold being part of a pre-arranged trading plan [2][7] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing targeted therapies for cancer, particularly leveraging small molecule drug design [4] - The company has a market capitalization of $1.57 billion and employs 65 people [3] Financial Performance - Enliven Therapeutics reported a net income loss of $97.21 million over the trailing twelve months [3] - The stock price increased by 26.75% over the past year as of January 20, 2026 [3] Recent Developments - The company announced positive initial data from early trials of ELVN-001, a leukemia treatment, contributing to the stock's performance [5] - Enliven aims to advance to phase three of clinical trials for ELVN-001 and is preparing to work with the FDA [6] Investor Considerations - The recent stock performance is closely tied to the progress of the leukemia treatment project, suggesting that investors should monitor FDA approval developments [8]
CG Oncology, Rich Sparkle Holdings, Liquidia And Other Big Stocks Moving Higher On Friday - Aeva Technologies (NASDAQ:AEVA), Allogene Therapeutics (NASDAQ:ALLO)
Benzinga· 2026-01-09 16:25
Core Insights - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by approximately 200 points on Friday [1] Company Highlights - CG Oncology Inc (NASDAQ:CGON) saw its shares rise by 21.8% to $51.05 after announcing an expedited timeline for topline data from the Phase 3 PIVOT-006 clinical trial, now expected in the first half of 2026 [1][2] - Rich Sparkle Holdings Ltd (NASDAQ:ANPA) surged 113.6% to $51.70 following a $39 million offering of 3 million ordinary shares at $13 per share [3] - NovaBay Pharmaceuticals Inc (NYSE:NBY) increased by 34.4% to $12.81 [3] - Quanterix Corp (NASDAQ:QTRX) gained 29.3% to $8.42 after naming Everett Cunningham as President and CEO, effective January 19 [3] - MoonLake Immunotherapeutics (NASDAQ:MLTX) rose 21.7% to $17.45 after receiving FDA feedback on its clinical evidence strategy for Sonelokimab in Hidradenitis Suppurativa [3] - Enliven Therapeutics Inc (NASDAQ:ELVN) increased by 21.5% to $28.24, sharing positive initial data from its Phase 1b ENABLE trial for ELVN-001 in chronic myeloid leukemia [3] - Aeva Technologies Inc (NASDAQ:AEVA) surged 21.2% to $20.47 [3] - Loandepot Inc (NYSE:LDI) rose 20.1% to $2.93 [3] - ASP Isotopes Inc (NASDAQ:ASPI) increased by 19.7% to $7.71 [3] - Allogene Therapeutics Inc (NASDAQ:ALLO) gained 19.5% to $1.78 [3] - Opendoor Technologies Inc (NASDAQ:OPEN) rose 19.2% to $7.67 following a new housing market proposal by President Donald Trump [3] - Liquidia Corp (NASDAQ:LQDA) jumped 14% to $36.22 after announcing preliminary full-year 2025 YUTREPIA net sales [3] - Vistra Corp (NYSE:VST) gained 13.1% to $170.34 after entering into 20-year power purchase agreements for zero-carbon nuclear energy to support Meta's operations [3] - Oklo Inc (NYSE:OKLO) rose 12.6% to $109.95 after announcing an agreement with Meta for a 1.2 gigawatt power campus [3] - Applied Digital Corp (NASDAQ:APLD) surged 11.8% to $35.72, reporting strong second-quarter results and advanced talks with a new hyperscaler tenant [3] - AST SpaceMobile Inc (NASDAQ:ASTS) gained 10% to $99.65 [3] - SanDisk Corp (NASDAQ:SNDK) increased by 9.6% to $366.93 [3] - Mirion Technologies Inc (NYSE:MIR) rose 9.5% to $26.56 [3] - TTM Technologies Inc (NASDAQ:TTMI) gained 9.1% to $72.94 [3] - SoundHound AI Inc (NASDAQ:SOUN) rose 8.5% to $11.96 [3] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) gained 8.3% to $112.64, with B. Riley Securities maintaining a Buy rating and raising the price target from $105 to $128 [3]
Enliven Therapeutics Early Leukemia Drug Results Impress, Stock Soars
Benzinga· 2026-01-08 19:16
Core Viewpoint - Enliven Therapeutics Inc. has reported promising initial data from its Phase 1b ENABLE trial of ELVN-001 for chronic myeloid leukemia, leading to a significant increase in stock price. Group 1: Clinical Data - As of December 22, 2025, 60 heavily pre-treated patients were enrolled in the trial [2] - In the 80 mg QD cohort (n=19), major molecular response (MMR) achievement was 38% and deep molecular response (DMR) was 16%, which is favorable compared to previous Phase 1 trials of approved BCR::ABL1 TKIs [2] - In the randomized 60 mg and 120 mg cohorts (n=41), MMR achievement was 53% and DMR was 35% [3] - Across all Phase 1b cohorts, 100% of evaluable patients who achieved MMR at enrollment maintained or deepened their response [3] Group 2: Safety and Efficacy - Clinical activity was observed at doses from 60 mg to 120 mg QD, with no clear evidence of dose response in efficacy or safety [4] - ELVN-001 demonstrated a favorable safety and tolerability profile across all evaluated doses, consistent with previously reported data, with no maximum tolerated dose and no new safety signals identified [4] Group 3: Future Plans and Market Reaction - The company plans to initiate the ENABLE-2 Phase 3 trial of ELVN-001 in the second half of 2026 [5] - Enliven Therapeutics shares increased by 50.42% to $23.27 at the time of publication [5]
Dow Jumps Over 250 Points; US Initial Jobless Claims Increase
Benzinga· 2026-01-08 17:33
Market Performance - U.S. stocks showed mixed performance, with the Dow Jones index increasing by 0.54% to 49,261.60, while the NASDAQ fell by 0.62% to 23,437.73 and the S&P 500 dropped by 0.05% to 6,917.76 [1] - Industrial shares rose by 1.4% on Thursday, indicating strength in that sector [1] Sector Performance - Information technology stocks decreased by 1.4% on Thursday [2] Commodities - Oil prices increased by 1.8% to $56.98, while gold prices slightly decreased by 0.1% to $4,456.70. Silver fell by 3.6% to $74.820, and copper dropped by 1.7% to $5.7600 [6] European Market - European shares were mixed, with the eurozone's STOXX 600 declining by 0.27%, while Spain's IBEX 35 Index rose by 0.27%. London's FTSE 100 fell by 0.06%, Germany's DAX decreased by 0.08%, and France's CAC 40 increased by 0.06% [7] Asian Market - Asian markets closed lower, with Japan's Nikkei 225 down by 1.63%, Hong Kong's Hang Seng Index declining by 1.17%, China's Shanghai Composite slipping by 0.07%, and India's BSE Sensex falling by 0.92% [10] Company News - Flyexclusive Inc shares surged by 126% to $7.10 after being named an authorized Starlink Aviation dealer [9] - Enliven Therapeutics Inc shares increased by 54% to $23.81 following positive initial data from a clinical trial for chronic myeloid leukemia [9] - MoonLake Immunotherapeutics shares rose by 29% to $14.54 after receiving FDA feedback on its treatment for hidradenitis suppurativa [9] - Immuneering Corp shares dropped by 39% to $5.10 after announcing updated trial data for pancreatic cancer [9] - Acrivon Therapeutics Inc shares fell by 31% to $2.05 after releasing clinical data for endometrial cancer [9] - CorMedix Inc shares decreased by 23% to $8.00 following preliminary revenue results for Q4 and FY25 [9] Economic Indicators - U.S. initial jobless claims rose by 8,000 to 208,000, slightly below market expectations of 210,000 [3][12] - Nonfarm business sector labor productivity increased by 4.9% in Q3, following a revised 4.1% gain in the previous quarter [12] - Unit labor costs in the nonfarm business sector fell by 1.9% in Q3, contrasting with market expectations of a 1.0% increase [12] - The U.S. trade deficit narrowed to $29.4 billion in October, the smallest since June 2009, compared to a revised $48.1 billion in September [12]
Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML and Outlines 2026 Clinical Milestones
Prnewswire· 2026-01-08 14:00
Core Insights - Enliven Therapeutics announced positive initial data from the Phase 1b ENABLE clinical trial for ELVN-001, showing a cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of patients achieving MMR [1][2] - ELVN-001 is positioned as a potentially best-in-class active-site TKI for chronic myeloid leukemia (CML), demonstrating a favorable safety and tolerability profile across all evaluated doses [1][3][11] - The company anticipates multiple key data, regulatory, and operational catalysts in 2026, including the initiation of a Phase 3 trial [1][2][11] Clinical Data Summary - In the Phase 1b trial, 60 patients were enrolled, with 53% having received four or more prior TKIs, indicating a heavily pretreated population [5][6] - The 80 mg QD cohort (n=19) showed an MMR achievement rate of 38% and a deep molecular response (DMR) rate of 16% [5][6] - The randomized 60 mg and 120 mg cohorts (n=41) demonstrated higher rates of MMR achievement at 53% and DMR at 35% [5][6] ELVN-001 Program Updates - ELVN-001 is designed to specifically target the BCR::ABL gene fusion, the oncogenic driver in CML, and has shown activity against the T315I mutation, which is resistant to most approved TKIs [3][8] - The ENABLE trial is a dose escalation and expansion study aimed at evaluating the safety, tolerability, and recommended dose for further clinical evaluation [7] Future Milestones - The company plans to present additional Phase 1 data mid-year 2026 and is preparing for regulatory interactions with the FDA regarding dose selection and Phase 3 trial design [11] - The initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, is expected in the second half of 2026 [11]
Enliven Therapeutics Bolsters Board to Prepare for Next Phase of Development
Prnewswire· 2026-01-07 14:00
Core Insights - Enliven Therapeutics has appointed Scott Garland to its Board of Directors as it transitions to late-stage development and commercialization of its drug ELVN-001, while Andrew Phillips, Ph.D., has resigned from the board [1][3] Leadership Changes - Scott Garland brings over 30 years of commercial leadership experience in the pharmaceutical industry, having held significant roles in companies such as PACT Pharma, Portola Pharmaceuticals, Relypsa, Exelixis, Genentech, Amgen, and Merck [2] - Rick Fair, CEO of Enliven, emphasized Garland's experience in oncology and hematology commercialization as crucial for advancing ELVN-001 into a pivotal Phase 3 trial [2] - Andrew Phillips expressed pride in the progress made during his tenure and acknowledged the need for board evolution as the company moves towards late-stage development [3] Clinical Development Focus - Following positive clinical data for ELVN-001 reported in 2025, Enliven is preparing to initiate a Phase 3 pivotal trial in 2026, aiming for potential commercialization [1][3] - The leadership changes, including the appointment of Rick Fair as CEO and Scott Garland to the board, reflect Enliven's commitment to aligning experienced governance with its transition into late-stage development [3] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving survival and overall well-being through precision oncology [5]
Enliven Therapeutics Announces New CEO to Drive Next Phase of Development
Prnewswire· 2025-12-11 14:00
Core Insights - Enliven Therapeutics has appointed Rick Fair as the new Chief Executive Officer, effective December 11, 2025, while co-founder Sam Kintz transitions to Head of Pipeline [1][2][4] - The leadership change is aimed at advancing the company's pivotal Phase 3 trial for ELVN-001 in chronic myeloid leukemia (CML) and enhancing the focus on early pipeline assets [1][4] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics to improve patient outcomes and address unmet medical needs [5][6] - The company employs a precision oncology approach, leveraging insights into biological targets and differentiated chemistry to create potentially first-in-class or best-in-class therapies [6] Leadership Experience - Rick Fair brings over 25 years of experience in product development and commercialization, including significant roles at Bellicum Pharmaceuticals and Roche/Genentech, where he led the Global Product Strategy for Oncology/Hematology [3] - Fair's expertise includes overseeing the launch of five new therapies and managing a $23 billion business portfolio during his tenure at Roche/Genentech [3] Strategic Focus - The transition in leadership is designed to enhance Enliven's ability to execute a successful Phase 3 trial for ELVN-001, which is expected to begin in 2026 [2][4] - The company aims to deliver long-term value to shareholders through the commercialization of ELVN-001, which is positioned as a potential best-in-class treatment for CML [4]
Wall Street Analysts Believe Enliven Therapeutics, Inc. (ELVN) Could Rally 101.26%: Here's is How to Trade
ZACKS· 2025-12-03 15:55
Core Viewpoint - Enliven Therapeutics, Inc. (ELVN) has seen an 8.2% increase in share price over the past four weeks, closing at $20.56, with a potential upside of 101.3% based on Wall Street analysts' mean price target of $41.38 [1][12]. Price Targets - The average price target consists of eight estimates ranging from a low of $33.00 to a high of $52.00, with a standard deviation of $6.52, indicating a potential increase of 60.5% to 152.9% from the current price [2][9]. - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement, which can serve as a starting point for further research [2][9]. Analyst Sentiment - Analysts are optimistic about ELVN's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which has shown a strong correlation with near-term stock price movements [4][11]. - The Zacks Consensus Estimate for the current year has increased by 9% over the past month, with two estimates revised upward and no negative revisions [12]. Zacks Rank - ELVN holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates, which further supports the stock's potential upside [13]. Conclusion on Price Targets - While the consensus price target may not be a reliable indicator of the extent of ELVN's potential gains, it does provide a useful guide for the direction of price movement [14].
Enliven Therapeutics (NasdaqGS:ELVN) 2025 Conference Transcript
2025-11-18 17:02
Summary of Enliven Therapeutics Conference Call Company Overview - **Company**: Enliven Therapeutics (NasdaqGS:ELVN) - **Focus**: Development of an ATP-competitive, highly selective BCR-ABL inhibitor for chronic myeloid leukemia (CML) treatment [5][4] Industry Context - **CML Treatment Landscape**: CML has evolved from a severe diagnosis to a manageable chronic condition due to the introduction of tyrosine kinase inhibitors (TKIs). New agents are being developed to improve tolerability, convenience, and efficacy [5][4]. Key Mechanism and Differentiation - **Mechanism of Action**: Enliven's drug targets the BCR-ABL fusion protein, differentiating itself from existing treatments like Novartis' Semblix (asciminib) by binding to the orthosteric site, which may address resistance issues seen with allosteric inhibitors [7][8]. - **Resistance Management**: The company anticipates a significant unmet need for patients who develop resistance to allosteric inhibitors, positioning their drug as a potential solution for this patient population [9][15]. Clinical Data and Efficacy - **Efficacy Data**: Enliven reported a 32% achievement of major molecular response (MMR) in heavily pretreated late-line patients, with over half previously treated with asciminib and 70% being refractory or resistant [10][12]. - **Comparison with Semblix**: Initial data suggests that Enliven's drug shows response rates similar to Semblix in a more challenging patient population, providing confidence as they move towards phase three trials [11][12]. Competitive Landscape - **TURN701 Comparison**: TURN701 recently reported a 64% MMR achievement. Enliven acknowledges the need for TURN701 to demonstrate statistically significant superiority to compete effectively against Semblix, which has a long history of safety and efficacy [13][14]. - **Resistance Mutations**: The emergence of new resistant mutations to allosteric inhibitors is expected to drive demand for Enliven's ATP-competitive inhibitor, as it has shown strong performance against these mutations in preclinical studies [21][22]. Tolerability and Quality of Life - **Tolerability Issues**: Tolerability is a critical factor in treatment decisions. Enliven's drug is expected to have a favorable tolerability profile compared to existing treatments, which may lead to better patient adherence [17][18]. - **Switching Behavior**: Patients may switch treatments due to tolerability issues, and Enliven's drug aims to minimize these adverse effects [19][20]. Future Plans and Pipeline - **Phase Three Study**: Enliven plans to initiate a phase three study next year, targeting 400-500 patients, focusing on second-line plus treatment [45][49]. - **New Indications**: The company is exploring non-oncology indications and may announce new assets in 2026 [50]. Financial Position - **Cash Position**: Enliven ended the last quarter with approximately $480 million in cash, providing a runway into the first half of 2029 to support ongoing and upcoming trials [52]. Conclusion - Enliven Therapeutics is positioned to address significant unmet needs in the CML treatment landscape with its innovative ATP-competitive inhibitor, backed by promising early clinical data and a strong financial position to support future growth and development [5][52].
Enliven Therapeutics: Notable Early Signals, But Too Many Assumptions To Justify A Buy
Seeking Alpha· 2025-11-18 12:55
Core Insights - The market has shown a willingness to engage with Enliven Therapeutics (ELVN) over the past few years, indicating potential interest in the company's developments [1]. Company Analysis - Enliven Therapeutics has been under observation for several years, suggesting that the company is in a phase of scrutiny and evaluation by analysts [1]. - The author possesses a PhD in biochemistry and has extensive experience in analyzing clinical trials and biotech companies, which adds credibility to the insights shared about Enliven Therapeutics [1]. Industry Context - The article emphasizes the importance of understanding the science behind biotech investments, highlighting the complexities and potential pitfalls in the industry [1].