On Wednesday, H.C. Wainwright maintained a Buy rating on Enliven Therapeutics (NASDAQ:ELVN) with a steady price target of $37.00. The firm's endorsement follows Enliven's recent presentation of updated Phase 1 results for its drug ELVN-001, which showed promising outcomes in treating chronic myeloid leukemia (CML).
Enliven reported the results at the ESH-iCMLf 26th Annual John Goldman Conference, demonstrating a 44% cumulative major molecular response (MMR) rate at 24 weeks in a study involving 39 heavily pretreated CML patients. These patients had previously undergone multiple lines of therapy, with a significant portion having been treated with asciminib and ponatinib.
The data revealed that ELVN-001 was effective even in patients with prior asciminib exposure, achieving a 40% cumulative MMR rate by 24 weeks. Additionally, in patients resistant to tyrosine kinase inhibitors (TKIs), the drug achieved a 41.7% cumulative MMR rate by the same time frame. The firm highlighted that these results are particularly noteworthy given the patients' extensive prior treatments.
ELVN-001's safety profile was also emphasized, with no dose reductions and no discontinuations due to treatment-emergent adverse events at doses of 40 mg or higher. The coverage provided by the 80mg once-daily dose of ELVN-001 was noted to be superior to that of second-generation TKIs and comparable to asciminib 40mg twice daily.
H.C. Wainwright anticipates additional Phase 1 data in 2025, which will include a larger patient population and extended follow-up. The firm also expects initial discussions with the FDA to clarify the regulatory pathway for a pivotal trial.
InvestingPro Insights
Enliven Therapeutics' (NASDAQ:ELVN) recent positive clinical results align with its strong market performance. According to InvestingPro data, the company has seen impressive price returns, with a 90.06% increase over the past year and an 87.86% year-to-date gain. This momentum is further reflected in its current trading price, which is 93.95% of its 52-week high.
Despite these gains, InvestingPro Tips highlight that Enliven is not yet profitable and analysts do not anticipate profitability this year. This is consistent with the company's focus on drug development, as evidenced by the promising ELVN-001 results. However, the company's financial position appears stable, with InvestingPro Tips noting that Enliven holds more cash than debt on its balance sheet and its liquid assets exceed short-term obligations.
For investors interested in a deeper analysis, InvestingPro offers 11 additional tips for Enliven Therapeutics, providing a more comprehensive view of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.