Astria reports positive results from HAE drug trial

BOSTON - Astria Therapeutics, Inc. (NASDAQ:ATXS), a clinical-stage biotech company with a market capitalization of $316 million, announced positive initial results from its ongoing ALPHA-SOLAR long-term trial of navenibart, a monoclonal antibody treatment for hereditary angioedema (HAE). According to InvestingPro data, while the company maintains strong liquidity with a current ratio of 17.4x, it faces ongoing operational challenges with significant cash burn.

The trial showed a 92% mean reduction in monthly attack rates across all participants, with patients receiving the drug every three months demonstrating a 95% reduction and those on a six-month dosing schedule showing an 86% reduction.

According to data presented at the European Academy of Allergy and Clinical Immunology Annual Congress on Friday, half of the 16 participants remained attack-free over a six-month period. All patients have continued in the trial.

The company reported that navenibart was well-tolerated with no severe or serious treatment-related adverse events. Only one participant experienced mild injection site reactions that resolved without treatment.

"These results are consistent with navenibart’s profile that we saw in the ALPHA-STAR Phase 1b/2 trial," said Christopher Morabito, Chief Medical Officer at Astria Therapeutics, in the press release statement.

The drug is being developed as a potential long-acting preventative treatment for HAE, a rare genetic disorder characterized by unpredictable episodes of severe swelling. The company is currently enrolling patients in its Phase 3 ALPHA-ORBIT trial, which will evaluate both quarterly and biannual dosing regimens.

The latest results represent 10.1 months of mean follow-up across all participants, with some patients having received navenibart for up to 18 months between this and previous trials.

Astria Therapeutics is focused on developing treatments for allergic and immunologic diseases, with navenibart being its lead program.

In other recent news, Astria Therapeutics has made significant progress with its lead candidate, navenibart, in the treatment of hereditary angioedema (HAE). The company recently published results from its Phase 1a trial in the Annals of Allergy, Asthma & Immunology, indicating that navenibart could be administered every three to six months, offering a long-acting treatment option. The trial showed statistically significant inhibition of plasma kallikrein activity and a favorable safety profile. Cantor Fitzgerald maintains an Overweight rating on Astria with a $47 price target, citing confidence in navenibart’s potential to outperform existing HAE treatments.

JMP Securities also maintains a Market Outperform rating but adjusted its price target for Astria to $25, emphasizing the importance of upcoming data from the Phase 1b/2 trial and the new Phase 3 ALPHA-ORBIT trial. These trials are expected to provide further insights into the drug’s long-term safety and efficacy. Meanwhile, Citizens JMP analyst Jonathan Wolleben reaffirmed a $25 target, highlighting the potential for navenibart to offer a more tolerable injection experience compared to its competitor, Takhzyro. Astria’s financial position appears stable, with approximately $295 million in capital reported as of the first quarter of 2025, expected to fund operations through mid-2027. The market is closely watching Astria’s development milestones, particularly the anticipated topline data from the ongoing Phase 3 study set for release in early 2027.

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