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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
U.S. stocks were higher, with the Dow Jones index gaining around 200 points on Friday.Shares of CG Oncology Inc (NASDAQ:CGON) rose sharply during Friday's session after the company announced an expedited timeline for the topline data readout now expected in the first half of 2026 for the Phase 3 PIVOT-006 clinical trial comparing adjuvant intravesical cretostimogene grenadenorepvec versus surveillance in patients with intermediate-risk non-muscle invasive bladder cancer.CG Oncology shares jumped 21.8% to $5 ...
Enliven Therapeutics Early Leukemia Drug Results Impress, Stock Soars
Benzinga· 2026-01-08 19:16
Enliven Therapeutics Inc. (NASDAQ:ELVN) stock is trading higher on Thursday, with a session volume of 6.61 million compared to the average volume of 631.52 thousand as per data from Benzinga Pro.The clinical-stage biopharmaceutical company shared encouraging initial data from the ongoing Phase 1b ENABLE trial of ELVN-001 in patients with chronic myeloid leukemia (CML) that is relapsed, refractory, or intolerant to available tyrosine kinase inhibitors (TKIs).DataAs of the cutoff date of December 22, 2025, 60 ...
Dow Jumps Over 250 Points; US Initial Jobless Claims Increase
Benzinga· 2026-01-08 17:33
U.S. stocks traded mixed midway through trading, with the Dow Jones index gaining more than 250 points on Thursday.The Dow traded up 0.54% to 49,261.60 while the NASDAQ declined 0.62% to 23,437.73. The S&P 500 also fell, dropping, 0.05% to 6,917.76.Check This Out: Delta Air Lines Earnings Are Imminent; These Most Accurate Analysts Revise Forecasts Ahead Of Earnings CallLeading and Lagging SectorsIndustrials shares gained by 1.4% on Thursday.In trading on Thursday, information technology stocks dipped by 1.4 ...
Enliven Reports Positive Initial Phase 1b Data for ELVN-001 in CML and Outlines 2026 Clinical Milestones
Prnewswire· 2026-01-08 14:00
Cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of patients achieving MMR by 24 weeks in ongoing randomized Phase 1b cohorts ELVN-001 continues to demonstrate a favorable safety and tolerability profile across all dose levels evaluated, consistent with previously reported data Data further reinforce ELVN-001's positioning as the potentially best-in-class active-site TKI in CML Multiple key data, regulatory and operational catalysts expected in 2026 BOULDER, Colo., Jan. 8, 2026 / ...
Enliven Therapeutics Bolsters Board to Prepare for Next Phase of Development
Prnewswire· 2026-01-07 14:00
Scott Garland, a seasoned biopharma executive with a strong track record of leading successful companies and drug launches, joins Enliven's Board of Directors Building on positive data reported in 2025, Enliven continues to prepare for Phase 3 trial initiation in 2026 and the commercialization of ELVN-001 BOULDER, Colo., Jan. 7, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of smal ...
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].
Does Enliven Therapeutics, Inc. (ELVN) Have the Potential to Rally 87.49% as Wall Street Analysts Expect?
ZACKS· 2025-11-17 15:56
Core Viewpoint - Enliven Therapeutics, Inc. (ELVN) shows significant upside potential, with a mean price target of $41.38 indicating an 87.5% increase from the current trading price of $22.07 [1] Price Targets - The average of eight short-term price targets ranges from a low of $33.00 to a high of $52.00, with a standard deviation of $6.52, suggesting a variability in analyst estimates [2] - The lowest estimate indicates a potential increase of 49.5%, while the highest suggests a 135.6% upside [2] Analyst Consensus and Earnings Estimates - 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 stock price movements [4][11] - The Zacks Consensus Estimate for the current year has increased by 4.1% over the past month, with one estimate rising 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 estimate factors, indicating strong potential for near-term upside [13] Price Movement Guidance - While consensus price targets may not be entirely reliable, the direction they imply appears to be a good guide for potential price movement [14]