Enliven Therapeutics' Leukemia Candidate Could Challenge Pfizer, AstraZeneca In Broader Target Market: Analyst

HC Wainwright initiated coverage on Enliven Therapeutics, Inc. ELVN and noted the company as an emerging biotech company developing next-gen precision-oriented small molecules for solid and liquid tumor indications.

Enliven’s pipeline includes:

• ELVN-001— a tyrosine kinase inhibitor (TKI) targeting mutant BCR::ABL. HC Wainwright highlights that ELVN-001 could meaningfully improve on existing TKI drugs used in chronic myelogenous leukemia, with applicability across multiple lines of therapy.
• In April, the company released proof of concept data from the Phase 1 trial of ELVN-001 in patients with chronic myeloid leukemia (CML) who are relapsed, refractory, or intolerant to available TKIs.
• ELVN-001 achieved a cumulative major molecular response (MMR) rate of 44% (7/16) by 12 weeks and demonstrated responses in patients with prior exposure to asciminib and who were TKI-resistant.
• ELVN-002 is being evaluated in combination with trastuzumab plus chemotherapy or as monotherapy in HER2-driven malignancies within non-small cell lung, colorectal, and metastatic breast cancer, among others.

The analyst initiates with a Buy rating and a price target of $37.

CML is a chronic disease requiring multiple years of continuous treatment. Patients frequently switch therapies due to liabilities of the existing approved drugs, including poor tolerability due to off-target effects and inability to dose to maximal efficacy.

Six approved drugs—Novartis AG’s NVS Gleevec (imatinib), Scemblix (asciminib), and Tasigna (nilotinib), Bristol-Myers Squibb & Co’s BMY Sprycel (dasatinib), Pfizer Inc PFE Bosulif (bosutinib), and Takeda Pharmaceutical Co Ltd TAK Iclusig (ponatinib)—generate over $6 billion in annual sales, with each drug bringing in around $500 million. Some even achieve peak annual sales of up to $2 billion despite competition from generic versions.

HC Wainwright analyst projects that positioning ELVN-001 as a third-line treatment could surpass $500 million in peak annual sales.

ELVN-002 has the potential to address unmet needs in HER2-mutant NSCLC, CRC, and mBC, where current treatments have limitations. It could challenge competitors like Pfizer’s Tukysa and tap into the growing post-AstraZeneca Plc AZN Enhertu market, with sales possibly reaching hundreds of millions.

While Enliven focuses on precision oncology, its target market is broader than that of past agents like Bristol-Myers’ Augtyro (repotrectinib) and Roche Holdings AG’s RHHBY Rozlytrek (entrectinib).

Price Action: ELVN stock is up 7.32% at $23.01 at the last check on Monday.

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