On Tuesday, H.C. Wainwright maintained a Buy rating on shares of Astria Therapeutics (NASDAQ:ATXS) with a price target of $16.00. The firm's stance comes after Astria's encouraging clinical developments for its therapeutic candidates, navenibart and STAR-0310.
The ALPHA-STAR Phase 1b/2 clinical trial for navenibart in hereditary angioedema (HAE) patients showed promising results, leading to plans for a Phase 3 study set to begin in the first quarter of 2025, with expectations for top-line data by the end of 2026.
The ALPHA-STAR trial indicated that navenibart significantly reduced monthly HAE attack rates by 90-96%, without any treatment discontinuations, suggesting a well-tolerated safety profile. This supports the potential for chronic dosing twice or four times annually.
Further results from the Phase 1b/2 studies are expected in the fourth quarter of 2024. Moreover, patients from ALPHA-STAR are transitioning into the ALPHA-SOLAR trial to assess long-term safety and efficacy, with initial results anticipated in mid-2025.
Astria has selected Ypsomed's YpsoMate autoinjector for navenibart administration, pending regulatory approval. This choice gives patients the option between the autoinjector and a pre-filled syringe, enhancing the flexibility of the treatment regimen.
The company's other asset, STAR-0310, has shown a long half-life and potent binding affinity in preclinical studies for the treatment of atopic dermatitis (AD). A Phase 1a trial for STAR-0310 in healthy subjects is slated to begin in the first quarter of 2025, following an Investigational New Drug (IND) submission by the end of 2024.
H.C. Wainwright's report highlights the potential of navenibart and STAR-0310 to lead the market in their respective indications. The firm is looking forward to upcoming data releases, regulatory feedback, and the commencement of new trials.
In other recent news, Astria Therapeutics has announced a partnership with Ypsomed AG for the development of an autoinjector for its lead drug candidate, STAR-0215. The collaboration aims to provide patients with a user-friendly autoinjector designed to administer STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein, currently in clinical development for the treatment of hereditary angioedema (HAE).
TD Cowen initiated coverage on Astria Therapeutics with a 'Buy' rating, citing high prospects for the company's Phase III trial drug, STAR-0215. The firm's optimism is backed by the drug's potential to ease the administration burden for patients due to its quarterly and biannual dosing schedules.
Oppenheimer has adjusted its outlook on Astria Therapeutics, reducing the price target to $25 from the previous $29, while maintaining an 'Outperform' rating. This revision follows the recent release of Astria's Q1 2024 financial results and subsequent updates.
The company also reported promising data for its STAR-0215 program. Astria Therapeutics is moving forward with its ALPHA-STAR study, with further data expected in the latter half of 2024. The company is also progressing with its early-stage asset for allergic diseases, STAR-0310, and is preparing to submit an Investigational New Drug application by the end of 2024.
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