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Verve Therapeutics , Inc. (NASDAQ:VERV), currently trading at $3.26 and showing signs of being undervalued according to InvestingPro analysis, today announced encouraging initial data from its Heart-2 Phase 1b clinical trial of VERVE-102, a base editing medicine aimed at treating patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD). The company, with a market capitalization of $289 million, has seen its stock decline by 42% year-to-date, potentially presenting an opportunity for investors interested in biotechnology stocks. The trial data revealed a positive safety profile and significant reductions in low-density lipoprotein cholesterol (LDL-C) levels.
The ongoing trial investigates VERVE-102, a single-course treatment designed to permanently inactivate the PCSK9 gene in the liver, leading to sustained decreases in LDL-C, which is associated with heart disease. Administered via a single intravenous infusion, VERVE-102 utilizes a proprietary technology to target liver cells effectively. While the company’s financial health score is rated as "FAIR" by InvestingPro, its strong current ratio of 12.65 indicates robust short-term liquidity to support ongoing research and development efforts.
As of a March 13, 2025 data cutoff, 14 participants across three dose cohorts showed no serious adverse events related to the treatment. The most notable reaction was a Grade 2 infusion-related response that was resolved with standard medication. No significant changes in liver enzymes or platelets were observed.
Preliminary results indicated a dose-dependent reduction in LDL-C and PCSK9 protein levels. In the highest dose cohort, participants experienced up to a 69% reduction in LDL-C. The study also highlighted that the total RNA dose is a key factor in the drug’s pharmacodynamics.
The fourth dose cohort of the trial is currently enrolling participants in several countries, with two individuals already dosed as of April 7, 2025. Verve Therapeutics anticipates releasing final data from the dose escalation phase of the Heart-2 trial in the latter half of 2025.
Verve Therapeutics plans to commence the Phase 2 trial of VERVE-102 in the second half of 2025, pending regulatory approval. The FDA has recently cleared an investigational new drug application for VERVE-102 and granted Fast Track designation, which may expedite the review process for conditions with high unmet medical need.
Additionally, the company has decided to discontinue the development of VERVE-101, including the Heart-1 Phase 1b clinical trial. However, long-term monitoring of participants from the VERVE-101 study will continue. The company maintains a solid financial position with more cash than debt on its balance sheet, though InvestingPro data indicates rapid cash burn - a common characteristic among clinical-stage biotech companies. Analysts have set price targets ranging from $15 to $32, suggesting significant upside potential despite current market challenges. For deeper insights into Verve Therapeutics’ financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro.
Under a collaboration agreement, Eli Lilly and Company (NYSE:LLY) has the option to co-develop and co-commercialize VERVE-102 with shared costs and profits in the United States. Verve Therapeutics expects to present the opt-in package to Lilly and receive a decision in the second half of 2025.
This report is based on a press release statement and contains forward-looking statements subject to risks and uncertainties. The company’s projections are based on current expectations and could be affected by unforeseen developments, which investors should consider when evaluating these announcements.
In other recent news, Verve Therapeutics has reported promising results from a Phase 1b clinical trial for its gene-editing drug, VERVE-102. This experimental treatment demonstrated a mean reduction of 53% in low-density lipoprotein cholesterol (LDL-C) among participants, with the highest dose cohort achieving a peak reduction of 69%. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VERVE-102, aimed at expediting its development for patients with hyperlipidemia and a high risk of cardiovascular disease. Additionally, Verve Therapeutics received clearance from the FDA for its Investigational New Drug (IND) application for VERVE-102, allowing the commencement of its Phase 1b clinical trial in the United States. BMO Capital Markets and Canaccord Genuity have both maintained positive outlooks on Verve, with BMO setting a price target of $30 and Canaccord at $32, citing optimism for upcoming clinical data. The analysts view the FDA’s IND approval as a favorable indicator for the drug’s potential benefit/risk profile and its unmet medical needs. Verve plans to release further data from its Heart-2 trial and initiate a Phase 2 clinical trial in the second half of 2025. The company’s financial position is reportedly strong enough to support operations into mid-2027, including the completion of the Phase 2 trial.
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