This section highlights FDA-related milestones and regulatory updates for drugs developed by Astria Therapeutics (ATXS).
Over the past two years, Astria Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Navenibart, STAR-0215, and STAR-0310. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Navenibart - FDA Regulatory Timeline and Events
Navenibart is a drug developed by Astria Therapeutics for the following indication: For the Treatment of Hereditary Angioedema.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Navenibart
- Announced Date:
- May 23, 2025
- Indication:
- For the Treatment of Hereditary Angioedema
Announcement
Astria Therapeutics, Inc. announced that it will present at the 14th C1 Inhibitor Deficiency and Angioedema Workshop in Budapest, Hungary on May 31, 2025.
AI Summary
Astria Therapeutics, Inc. announced that it will present at the 14th C1 Inhibitor Deficiency and Angioedema Workshop in Budapest, Hungary on May 31, 2025. This event will take place at the Ensana Thermal Hotel Margitsziget, where the company will showcase its latest research findings.
Dr. Marc A. Riedl, a well-known expert from the U.S. HAEA Angioedema Center at the University of California, San Diego, will lead the session. He will present detailed safety and efficacy data from the Phase 1a and Phase 1b/2 trials of navenibart, Astria’s lead program for treating hereditary angioedema. The presentation is titled “Navenibart for Hereditary Angioedema (HAE): Analysis of Safety, Pharmacokinetic, and Pharmacodynamic Data From Phase 1a and Phase 1b/2 ALPHA-STAR Trial.” This presentation highlights Astria’s commitment to developing life-changing therapies for patients with allergic and immunologic diseases.
Read Announcement- Drug:
- Navenibart
- Announced Date:
- May 1, 2025
- Indication:
- For the Treatment of Hereditary Angioedema
Announcement
Astria Therapeutics, Inc. announced that results from a Phase 1a trial in healthy subjects supporting navenibart's potential to provide long-acting, safe, and effective attack prevention for hereditary angioedema (HAE) with dosing every 3 and 6 months have been published in the Annals of Allergy, Asthma & Immunology.
AI Summary
Astria Therapeutics, Inc. announced new Phase 1a trial results for its investigational drug navenibart, published in the Annals of Allergy, Asthma & Immunology. The trial in healthy subjects demonstrated that navenibart, when given in doses of 300 mg or more, has a mean half-life of 82 to 105 days. This supports its potential to be dosed every 3 and 6 months for preventing hereditary angioedema (HAE) attacks.
The study showed that navenibart significantly inhibited plasma kallikrein activity compared to placebo and was well-tolerated, with similar rates of adverse events and no serious side effects observed. These findings provide early proof of concept for navenibart as a long-acting, safe, and effective option for HAE attack prevention, paving the way for further development in the Phase 3 ALPHA-ORBIT trial.
Read Announcement- Drug:
- Navenibart
- Announced Date:
- March 11, 2025
- Indication:
- For the Treatment of Hereditary Angioedema
Announcement
Astria Therapeutics, Inc provided a corporate update.
AI Summary
Astria Therapeutics, Inc. provided a corporate update highlighting its exciting plans for 2025 after a strong 2024. The company is launching its ALPHA-ORBIT Phase 3 trial for navenibart in patients with hereditary angioedema (HAE), testing every 3-month and every 6-month dosing regimens. This trial aims to offer flexible, patient-centric treatment options that could reduce the treatment burden and position navenibart as a market-leading therapy for HAE.
In addition, Astria initiated a Phase 1a trial for STAR-0310, a novel monoclonal antibody OX40 antagonist designed for atopic dermatitis, with early results expected in the third quarter of 2025. CEO Jill C. Milne stated that building on the momentum of 2024, these trials underscore the company’s commitment to advancing life-changing therapies for allergic and immunologic diseases.
Read Announcement- Drug:
- Navenibart
- Announced Date:
- February 27, 2025
- Indication:
- For the Treatment of Hereditary Angioedema
Announcement
Astria Therapeutics, Inc. announced the initiation of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people living with hereditary angioedema (HAE).
AI Summary
Astria Therapeutics, Inc. announced the start of its ALPHA-ORBIT Phase 3 clinical trial to test navenibart for people living with hereditary angioedema (HAE). This global, randomized, double-blind, placebo-controlled study will review how well navenibart works and how safe it is over a 6‐month treatment period. The trial will include up to 135 adults and 10 adolescents, with dosing options that allow for an administration every three months or every six months. The aim is to show that navenibart can quickly and sustainably prevent HAE attacks while keeping treatment burdens low.
Physicians believe the flexibility of two or four doses per year could give patients a better quality of life by reducing the time spent managing their disease. The trial is expected to provide important insights into using navenibart for long-term HAE treatment, with top-line results anticipated in early 2027.
Read Announcement- Drug:
- Navenibart
- Announced Date:
- January 13, 2025
- Indication:
- For the Treatment of Hereditary Angioedema
Announcement
Astria Therapeutics, Inc announced its planned design of the ALPHA-ORBIT Phase 3 clinical trial of navenibart in people with hereditary angioedema (HAE), which will include both every 3- (Q3M) and every 6-month (Q6M) treatment arms with the primary analysis at 6 months. .
AI Summary
Astria Therapeutics has announced the planned design of its ALPHA-ORBIT Phase 3 clinical trial for navenibart in people suffering from hereditary angioedema (HAE). The trial will assess two dosing schedules—administering the drug every 3 months (Q3M) and every 6 months (Q6M)—with the main analysis conducted at 6 months. This dual dosing strategy is aimed at providing greater flexibility for patients and reducing the frequency of HAE attacks while keeping the treatment burden low.
The trial will be global, randomized, double-blinded, and placebo-controlled, involving up to 145 patients with Type 1 or Type 2 HAE. The design reflects input from regulators and collaboration with both patients and physicians, ensuring that the study meets the needs of a diverse patient population. Initiation is expected in Q1 2025 with top-line results anticipated early in 2027.
Read Announcement
STAR-0215 - FDA Regulatory Timeline and Events
STAR-0215 is a drug developed by Astria Therapeutics for the following indication: Hereditary angioedema (HAE).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STAR-0215
- Announced Date:
- June 13, 2025
- Indication:
- Hereditary angioedema (HAE)
Announcement
Astria Therapeutics, Inc announced positive initial results from the target enrollment group in the ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients.
AI Summary
Astria Therapeutics announced positive initial findings from its ongoing ALPHA-SOLAR long-term open-label trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein for treating hereditary angioedema (HAE) patients. In this target enrollment group, the study showed a robust reduction in monthly HAE attacks with a 92% mean and 97% median decrease overall. The trial tested two dosing regimens: every three months (Q3M) and every six months (Q6M), which demonstrated 95% and 86% reductions in the mean monthly attack rate, respectively. Navenibart was well-tolerated with a favorable safety profile and no severe treatment-related adverse events, while all enrolled patients remained in the study. These promising results support the potential of navenibart to provide long-lasting protection from HAE attacks with a low treatment burden, supporting its market-leading potential as it advances to further evaluation in the Phase 3 ALPHA-ORBIT trial.
Read Announcement- Drug:
- STAR-0215
- Announced Date:
- December 11, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
Astria Therapeutics, Inc announced positive final results from the target enrollment group of 16 patients in the ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart (STAR-0215), a monoclonal antibody inhibitor of plasma kallikrein, in hereditary angioedema (HAE) patients.
AI Summary
Astria Therapeutics, Inc. announced positive final results from the target enrollment group of 16 patients in its ALPHA-STAR Phase 1b/2 clinical trial evaluating navenibart (STAR-0215) for hereditary angioedema (HAE). Navenibart is a monoclonal antibody that works by inhibiting plasma kallikrein, a key driver of HAE attacks. The study showed that after one or two doses over six months, patients experienced a 90-95% reduction in their mean monthly attack rates, with up to 67% of patients remaining completely attack-free during this period.
The results highlight a rapid onset of robust and durable efficacy, along with a favorable safety and tolerability profile. With these encouraging findings, Astria Therapeutics is set to advance navenibart into Phase 3 trials, aiming for trial initiation in the first quarter of 2025, which could offer a new preventative treatment option for HAE patients.
Read Announcement- Drug:
- STAR-0215
- Announced Date:
- September 30, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
Astria Therapeutics, Inc announced that navenibart (STAR-0215) has been granted Orphan Drug Designation for the treatment of hereditary angioedema (HAE) by the U.S. Food and Drug Administration (FDA).
AI Summary
Astria Therapeutics announced that its drug navenibart (STAR-0215) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for the treatment of hereditary angioedema (HAE). This designation is given to drugs intended to treat rare conditions affecting fewer than 200,000 people in the United States, and it offers incentives that help speed up drug development and commercialization. Navenibart is a monoclonal antibody that works by inhibiting plasma kallikrein and is designed to offer long-acting prevention of HAE attacks with infrequent dosing. Initial clinical trial findings have shown promising results, reducing monthly attack rates by 90-96% with one or two doses over six months. Astria believes that this drug could become a leading treatment option for individuals living with HAE by providing significant relief and convenience.
Read Announcement- Drug:
- STAR-0215
- Announced Date:
- September 19, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
Astria Therapeutics, Inc announced that it will present initial navenibart ALPHA-STAR data at the upcoming European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam, the Netherlands on September 26, 2024.
AI Summary
Astria Therapeutics, Inc. announced that it will debut initial navenibart ALPHA-STAR data at the upcoming European Academy of Dermatology and Venereology (EADV) Congress in Amsterdam on September 26, 2024. The company, known for developing innovative treatments for allergic and immunologic diseases, is set to highlight new findings from its navenibart (STAR-0215) program—a monoclonal antibody inhibitor in development for hereditary angioedema. At the conference, Dr. Raffi Tachdjian from UCLA will present a poster detailing the early safety and efficacy outcomes from a Phase 1b/2 clinical trial involving single and multiple doses of the therapy.
Astria Therapeutics is focused on providing life-changing treatments, with its current programs targeting hereditary angioedema and atopic dermatitis. The upcoming presentation at EADV serves as an important milestone in showcasing progress and gathering insights, potentially paving the way for future advancements in managing these challenging conditions.
Read Announcement- Drug:
- STAR-0215
- Announced Date:
- August 12, 2024
- Indication:
- Hereditary angioedema (HAE)
Announcement
Astria Therapeutics, Inc. announced that it has chosen Ypsomed as its partner for the development of an autoinjector for STAR-0215.
AI Summary
Astria Therapeutics, Inc. has announced its decision to team up with Ypsomed for developing an autoinjector for its therapy, STAR-0215. This move is aimed at providing patients with a more convenient and user-friendly option when receiving treatment. The new autoinjector, called the YpsoMate, is designed to be easy to use with features like needle shielding and built-in safety cues that ensure proper delivery of the drug while protecting patients from needle exposure.
If approved by regulators, STAR-0215 will be available with both the YpsoMate autoinjector and a pre-filled syringe, giving patients the flexibility to choose the method that suits their lifestyle best. This collaboration reflects Astria’s commitment to reducing the treatment burden for patients by combining effective disease management with a practical, patient-friendly delivery system.
Read Announcement
STAR-0310 - FDA Regulatory Timeline and Events
STAR-0310 is a drug developed by Astria Therapeutics for the following indication: Treatment of Atopic Dermatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- STAR-0310
- Announced Date:
- January 23, 2025
- Indication:
- Treatment of Atopic Dermatitis
Announcement
Astria Therapeutics announced that Early Proof-of-Concept Results from the Phase 1a Trial Anticipated in Q3 2025
AI Summary
Astria Therapeutics has initiated a Phase 1a clinical trial of its STAR-0310 drug in about 40 healthy adult participants. STAR-0310 is a high affinity monoclonal antibody OX40 antagonist that uses YTE technology and is being developed for the treatment of atopic dermatitis and possibly other conditions. The trial will evaluate the drug’s safety, tolerability, pharmacokinetics, and immunogenicity, aiming to provide crucial insights into its performance in humans.
The company expects to release early proof-of-concept results from this trial in the third quarter of 2025. CEO Jill C. Milne stated that the trial is an important step to distinguish STAR-0310's clinical profile. The improved design, which reduces antibody-dependent cellular cytotoxicity compared to other similar drugs, might offer a better safety profile and a wider therapeutic window.
Read Announcement- Drug:
- STAR-0310
- Announced Date:
- January 23, 2025
- Indication:
- Treatment of Atopic Dermatitis
Announcement
Astria Therapeutics, Inc. announced initiation of a Phase 1a clinical trial of STAR-0310 in healthy subjects.
AI Summary
Astria Therapeutics, Inc. recently announced the start of a Phase 1a clinical trial for its investigational drug STAR-0310, a high affinity monoclonal antibody designed as an OX40 antagonist. The trial will enroll about 40 healthy adult participants to examine the drug’s safety, tolerability, pharmacokinetics, and immunogenicity. STAR-0310 is being developed with the hope of offering a new treatment option for atopic dermatitis and possibly other related conditions. Early proof-of-concept results from the trial are expected in the third quarter of 2025. According to company leaders, this initial clinical investigation is a crucial step to differentiate STAR-0310, which they believe has the potential to become a best-in-class therapy due to its promising safety profile and efficacy. This Phase 1a study marks an important milestone for Astria Therapeutics in its mission to develop life-changing therapies.
Read Announcement- Drug:
- STAR-0310
- Announced Date:
- December 10, 2024
- Indication:
- Treatment of Atopic Dermatitis
Announcement
Astria Therapeutics, Inc announced the U.S. Food and Drug Administration (FDA) clearance of its Investigational New Drug (IND) application for STAR-0310, a monoclonal antibody OX40 antagonist, the company is developing as a potential treatment for atopic dermatitis (AD) and potentially other indications.
AI Summary
Astria Therapeutics has reached an important milestone with the FDA’s clearance of its Investigational New Drug application for STAR-0310. This experimental drug is a monoclonal antibody OX40 antagonist and is being developed as a potential treatment for atopic dermatitis, with the possibility of addressing other conditions in the future.
The clearance allows Astria to move forward with a Phase 1a trial in healthy volunteers, scheduled to begin in the first quarter of 2025. The company expects to gather initial proof-of-concept results by the third quarter of 2025 and later plans to evaluate the drug’s effects in patients with atopic dermatitis. This progress marks a promising step in the search for new therapies for allergic and immunologic diseases.
Read Announcement- Drug:
- STAR-0310
- Announced Date:
- December 10, 2024
- Estimated Event Date Range:
- January 1, 2025 - March 31, 2025
- Target Action Date:
- Q1 2025
- Indication:
- Treatment of Atopic Dermatitis
Announcement
Astria Therapeutics, Inc announced that Phase 1a Trial of STAR-0310 in Healthy Volunteers Expected to Initiate in Q1 2025
AI Summary
Astria Therapeutics has received FDA clearance for its Investigational New Drug application for STAR-0310, a monoclonal antibody OX40 antagonist. This clearance paves the way for a Phase 1a clinical trial in healthy volunteers, which is expected to start in the first quarter of 2025. The trial will evaluate the safety and overall tolerability of STAR-0310. In addition, the company plans to share early proof-of-concept results by the third quarter of 2025, providing initial insights into the drug’s potential. STAR-0310 is being developed as a possible treatment for atopic dermatitis and may be useful in treating other conditions as well. Astria Therapeutics is excited about this opportunity to explore a new treatment option and to advance its understanding of how the OX40 pathway can be targeted for better patient outcomes.
Read Announcement- Drug:
- STAR-0310
- Announced Date:
- December 10, 2024
- Estimated Event Date Range:
- July 1, 2025 - September 30, 2025
- Target Action Date:
- Q3 2025
- Indication:
- Treatment of Atopic Dermatitis
Announcement
Astria Therapeutics, Inc. announced that Early Proof-of-Concept Results Expected in Q3 2025 -
AI Summary
Astria Therapeutics announced that early proof-of-concept results for its STAR-0310 program are expected in the third quarter of 2025. STAR-0310 is a monoclonal antibody designed to block the OX40 receptor, which is being explored as a potential treatment for atopic dermatitis and other conditions. The company is moving forward with this program to address allergic and immunologic diseases by utilizing insights from earlier OX40 research, aiming to offer a wider therapeutic window and reduced dosing frequency.
The upcoming proof-of-concept results will be an important milestone for the drug’s development. If successful, these early findings could set the stage for further studies in atopic dermatitis patients and bring Astria closer to providing a new treatment option for those suffering from these challenging conditions.
Read Announcement
