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SAN FRANCISCO - Third Harmonic (NASDAQ:HLIT) Bio, Inc. (NASDAQ:THRD), a clinical-stage biopharmaceutical company with a market capitalization of $209.5 million, today announced positive Phase 1 clinical trial results for its drug candidate THB335, which is being developed for the treatment of chronic spontaneous urticaria (CSU). The company’s stock has faced significant headwinds, declining over 61% in the past six months, according to InvestingPro data. The company also revealed its strategic plans to enhance shareholder value, including a workforce reduction and the potential for strategic transactions.
The recently completed Phase 1 trial assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of THB335 in healthy volunteers. The study showed dose-dependent increases in drug exposure and reductions in serum tryptase levels, a biomarker of mast cell activation, suggesting potential clinical benefits for CSU patients. THB335 was generally well-tolerated, with isolated, transient asymptomatic transaminase elevations in some subjects, which the company does not believe are drug-related.
Following these results, Third Harmonic Bio is preparing for a 12-week, placebo-controlled Phase 2 study in CSU, expected to start by mid-year 2025. The company’s cash and cash equivalents stood at approximately $285 million as of December 31, 2024, and are projected to be between $262 million and $267 million by June 30, 2025. InvestingPro analysis shows the company maintains a strong current ratio of 42.5, with more cash than debt on its balance sheet, suggesting solid financial flexibility for its clinical development programs.
In conjunction with these developments, Third Harmonic Bio is initiating a strategic review to maximize shareholder value, which may include exploring a range of strategic transactions and business combinations. The company has engaged TD Cowen to advise on this process and has decided to halt all non-THB335 related research and discovery activities, leading to a workforce reduction of about 50%.
The full Phase 1 clinical results will be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress on March 2, 2025. Today, management will discuss the clinical results and corporate next steps in a conference call and webcast at 8:00 a.m. EST.
This article is based on a press release statement from Third Harmonic Bio, Inc. Analysts maintain varied price targets for THRD, ranging from $7 to $23 per share. For deeper insights into Third Harmonic Bio’s financial health and growth prospects, including 12 additional ProTips and comprehensive valuation metrics, check out the detailed Pro Research Report available on InvestingPro.
In other recent news, Third Harmonic Bio has been in the spotlight due to significant developments. Jefferies analyst Akash Tewari recently adjusted the price target for Third Harmonic Bio to $7.00, down from the previous target of $15.00 while maintaining a Hold rating on the company’s stock. This decision followed the release of positive Phase 1 data by Blueprint Medicines (NASDAQ:BPMC) Corporation regarding its oral wt-KIT BLU-808.
In addition, Third Harmonic Bio’s own Phase 1 data release for its oral c-KIT inhibitor, THB335, is eagerly anticipated in the first quarter of 2025. This will provide further insights into the company’s position within the competitive landscape. The company’s focus is on treating urticaria, a condition commonly known as chronic hives, with THB335 being one of their key projects.
Moreover, TD Cowen’s analyst Joseph Thome has highlighted several anticipated catalysts for the year 2025, including Third Harmonic Bio. These developments are expected to generate significant investor interest and potentially influence stock movements in the biotech sector. The outcome of these events could provide crucial insights into the potential of Third Harmonic Bio’s drug as a treatment for chronic hives.
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