Latest news with #Asthma&Immunology
Medscape
15-05-2025
- Health
- Medscape
Tezepelumab Slashes Surgery Risk in Severe Nasal Polyposis
Tezepelumab (Tezspire) has shown significant clinical benefits in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP), including marked reductions in nasal congestion and polyp size and a near elimination of the need for surgical intervention. Findings from the phase 3 WAYPOINT trial were published in The New England Journal of Medicine and presented as a late-breaking oral presentation at the 2025 American Academy of Allergy, Asthma & Immunology/World Allergy Organization annual meeting. Chronic rhinosinusitis with NP is a chronic inflammatory disorder characterized by persistent inflammation of the nasal mucosa and the presence of benign growths (NP). These polyps can obstruct nasal airflow and lead to symptoms such as nasal congestion, loss of smell, rhinorrhea, facial pressure or pain, sleep disturbances, and a substantial reduction in quality of life. Standard therapies include intranasal or systemic corticosteroids, surgical resection, and more recently, biologic agents. Adults With Severe Nasal Polyposis Tezepelumab, developed by AstraZeneca in collaboration with Amgen, is a first-in-class human monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine known to initiate and amplify various inflammatory pathways, including those involved in allergic and eosinophilic airway diseases. Preclinical and clinical data suggest that inhibiting TSLP could be an effective strategy for modulating inflammation in both upper and lower airway diseases. The WAYPOINT study was a randomized, double-blind, placebo-controlled, multicenter, parallel-group trial designed to assess the efficacy and safety of subcutaneous tezepelumab in adults with severe CRSwNP. Participants received either tezepelumab or placebo for a 52-week treatment period, followed by a posttreatment follow-up phase lasting 12-24 weeks. Reduction in Polyp Severity Treatment with tezepelumab resulted in a significant reduction in NP severity, as demonstrated by the co-primary endpoints in the phase 3 WAYPOINT trial. The NP score improved by −2.065 ( P < .0001), and use of systemic corticosteroids was reduced by 88% ( P < .0001) compared with placebo. Improvements in NP score were observed as early as week 4, while improvements in nasal congestion score were noted by week 2, the first posttreatment assessment. These effects were sustained through week 52. Significant and clinically meaningful improvements were also observed across all key secondary endpoints in the overall trial population. Tezepelumab was associated with a 98% reduction in the need for NP surgery ( P < .0001) and again an 88% reduction in systemic corticosteroid use ( P < .0001) compared with placebo. 'The WAYPOINT study confirms the efficacy of tezepelumab in reducing the need for further surgery, systemic corticosteroid use, improving SNOT-22 scores, and restoring olfactory function,' said Geoffrey Mortuaire, MD, PhD, head of the Department of ENT and Head and Neck Surgery at Lille University Hospital, Lille, France. 'The rapid and consistent treatment response observed in patients supports the potential for making tezepelumab more broadly available. We hope to see its approval for this indication in France soon.' Favorable Safety Profile Tezepelumab was generally well tolerated in patients with severe nasal polyposis and demonstrated a safety profile consistent with its current indication for severe asthma. The most frequently reported adverse events in the WAYPOINT study were COVID-19, nasopharyngitis, and upper respiratory tract infections. There were no clinically meaningful differences in safety outcomes between the tezepelumab and placebo groups. Tezepelumab is currently approved as add-on maintenance therapy for severe asthma in adults and adolescents aged 12 years or older who remain uncontrolled despite high-dose inhaled corticosteroids and additional maintenance therapy. It is approved in the United States, Europe, Japan, and nearly 60 countries worldwide. Regulatory applications for tezepelumab in severe nasal polyposis are currently under review by health authorities in several regions, according to AstraZeneca.
Yahoo
01-05-2025
- Health
- Yahoo
Astria Therapeutics Announces Publication of Navenibart Phase 1a Healthy Subject Results in the Annals of Allergy, Asthma & Immunology
BOSTON, May 01, 2025--(BUSINESS WIRE)--Astria Therapeutics, Inc. (Nasdaq:ATXS), a biopharmaceutical company focused on developing life-changing therapies for allergic and immunologic diseases, today 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. "We are thrilled by our publication in the Annals of Allergy, Asthma & Immunology and the opportunity to provide additional information that affirms our belief in navenibart's potential to become the first-choice therapy for HAE," said Christopher Morabito, M.D., Chief Medical Officer at Astria Therapeutics. "The Phase 1a trial in healthy subjects laid the foundation for the advancement of navenibart and charted a path toward initiating ALPHA-ORBIT, our currently enrolling pivotal Phase 3 trial. The Phase 3 program, designed to introduce a potentially life-changing HAE therapy to eligible participants around the globe, is underway." Overview of results from the Phase 1a trial of navenibart in healthy subjects: For all doses ≥300 mg, navenibart mean half-life ranged from 82 to 105 days, supporting the potential for administration every 3 and 6 months. Navenibart's inhibition of plasma kallikrein activity versus placebo was statistically significant (P<0.05). Navenibart was well-tolerated, with similar rates of adverse events between navenibart and placebo, and no serious adverse events were observed. Results demonstrated early proof of concept for navenibart as a potential long-acting therapy for HAE. The publication can be found at the following link: About Navenibart:Navenibart is an investigational monoclonal antibody inhibitor of plasma kallikrein in Phase 3 development for the treatment of HAE. Our goal with navenibart is to provide rapid and sustained HAE attack prevention with a validated mechanism and trusted modality administered every 3 and 6 months. We aim to empower people with HAE to live without limitations from their disease. About Astria Therapeutics:Astria Therapeutics is a biopharmaceutical company, and our mission is to bring life-changing therapies to patients and families affected by allergic and immunologic diseases. Our lead program, navenibart (STAR-0215), is a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema. Our second program, STAR-0310, is an investigational monoclonal antibody OX40 antagonist in clinical development for the treatment of atopic dermatitis. Learn more about our company on our website, or follow us on Instagram @AstriaTx and on Facebook and LinkedIn. Forward Looking Statements:This press release contains forward-looking statements within the meaning of applicable securities laws and regulations including, but not limited to, statements regarding: our expectations about the potential significance of the results of the Phase 1a trial of navenibart; the goals of the design of the navenibart Phase 3 program; the potential for navenibart in the HAE market, including the potential to be the market leading treatment and a life changing therapy, other potential therapeutic and other benefits of navenibart as a treatment for HAE, and our vision and goals for the program; and the goal of bringing life changing therapies to patients and families affected by allergic and immunological diseases and to become a leading allergy and immunology company. The use of words such as, but not limited to, "anticipate," "believe," "continue," "could," "estimate," "expect," "goals," "intend," "may," "might," "plan," "potential," "predict," "project," "should," "target," "will," "would," or "vision," and similar words expressions are intended to identify forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Astria's current beliefs, expectations and assumptions regarding the future of its business, future plans and strategies, future financial performance, results of preclinical and clinical results of Astria's product candidates and other future conditions. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the following risks and uncertainties: changes in applicable laws or regulations; the possibility that we may be adversely affected by other economic, business, and/or competitive factors; risks inherent in pharmaceutical research and development, such as: adverse results in our drug discovery, preclinical and clinical development activities, the risk that the results of preclinical studies, including of navenibart and STAR-0310, may not be replicated in clinical trials, that the preliminary or interim results from clinical trials may not be indicative of the final results, that the results of early stage clinical trials, such as the results from the Phase 1a clinical trial and the ALPHA-STAR trial, may not be replicated in later stage clinical trials, including the navenibart Phase 3 program; the risk that we may not be able to enroll sufficient patients in our clinical trials on a timely basis, and the risk that any of our clinical trials may not commence, continue or be completed on time, or at all; decisions made by, and feedback received from, the FDA and other regulatory authorities on our regulatory and clinical trial submissions and other feedback from potential clinical trial sites, including investigational review boards at such sites, and other review bodies with respect to navenibart, STAR-0310, and any other future development candidates, and devices for such product candidates; our ability to manufacture sufficient quantities of drug substance and drug product for navenibart, STAR-0310, and any other future product candidates, and devices for such product candidates, on a cost-effective and timely basis, and to develop dosages and formulation for navenibart, STAR-0310, and any other future product candidates that are patient-friendly and competitive; our ability to develop biomarker and other assays, along with the testing protocols therefore; our ability to obtain, maintain and enforce intellectual property rights for navenibart, STAR-0310, and any other future product candidates; our potential dependence on collaboration partners; competition with respect to navenibart, STAR-0310, or any of our other future product candidates; the risk that survey results and market research may not be accurate predictors of the commercial landscape for HAE, the ability of navenibart to compete in HAE, and the anticipated position and attributes of navenibart in HAE based on clinical data to date, its preclinical profile, pharmacokinetic modeling, market research and other data; risks with respect to the ability of STAR-0310 to compete in AD and the anticipated position and attributes of STAR-0310 in atopic dermatitis based on its preclinical profile; our ability to manage our cash usage and the possibility of unexpected cash expenditures; our ability to obtain necessary financing to conduct our planned activities and to manage unplanned cash requirements; the risks and uncertainties related to our ability to recognize the benefits of any additional acquisitions, licenses or similar transactions; and general economic and market conditions; as well as the risks and uncertainties discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the period ended December 31, 2024, and in other filings that we may make with the Securities and Exchange Commission. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Astria may not actually achieve the forecasts or expectations disclosed in our forward-looking statements, and investors and potential investors should not place undue reliance on Astria's forward-looking statements. Neither Astria, nor its affiliates, advisors or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing Astria's views as of any date subsequent to the date hereof. View source version on Contacts Investor Relations and Media: Elizabeth Higginsinvestors@ Sign in to access your portfolio
Time Magazine
30-04-2025
- Health
- Time Magazine
Are Allergy Shots Worth It?
Nearly a third of American adults have some kind of allergy. If you're one of them, you're probably eager to find a solution. Allergy shots can provide long-lasting relief for certain non-food allergies, but there are some downsides. Is the time commitment, discomfort, and cost worth it? To help make that decision, here's the latest science behind allergy immunotherapy, how long the effects of the shots last, and what the future of allergy shots may hold. How do allergy shots work? Allergy shots have been around in one form or another since the 1910s. The idea is to desensitize an allergic person to a specific allergen, like pollen or cat dander. Your allergist will determine exactly what you're allergic to and then 'they make a specialized cocktail of allergens for that person,' says Dr. David Morris, chief of allergy and immunology at Dayton Children's Hospital. This cocktail contains very small, diluted amounts of those allergens and is then injected under your skin. 'This stimulates the immune system to feel like these things are normal and not foreign,' says allergist Dr. J. Allen Meadows, executive director of advocacy and governmental affairs at the American College of Allergy, Asthma & Immunology (ACAAI) and a pediatric allergist at the University of Alabama at Birmingham. After your shot, you'll be observed for about 30 minutes. 'This is because you do have the potential to have a reaction; we're giving you something injectable that you're allergic to,' Morris says. Serious reactions are rare but can be life-threatening, according to the American Academy of Allergy, Asthma, and Immunology (AAAAI). For the next several months, you'll get one or two shots a week containing increasing amounts of your allergens. This process helps you slowly build a tolerance to those allergens, Meadows says. After about seven months, your doctor will be able to space out your doses to every two weeks. Eventually, you get to what's considered a maintenance dose, which is when you can move to 'a shot a month at a high dose of what you're allergic to,' says otolaryngologist Dr. Marc Dubin, chief medical officer at ENT Speciality Partners. You'll likely stick to that once-a-month shot for three to five years. It can take as long as 12 months on your maintenance dose before you notice your symptoms are improving. In other words, allergy shots are definitely a time commitment. If you can make the time, however, then comes the payoff: 'It changes your immune system on a long-term basis,' Meadows says. You don't have to take any more shots, and you're free of your allergy symptoms—often for decades, he says. 'Some allergists will say the results last 'forever,' but forever is a long time, so I'm not as comfortable with that.' Who gets the best results? Anyone older than 5 can benefit from allergy shots, according to the AAAAI. People with pollen allergies tend to really appreciate the treatment effects, Morris says. 'For a patient's quality of life, pollen is the [most] noticeable one, because people are miserable during pollen season, and they notice they're no longer miserable,' he says. But if your symptoms are severe to start with, you might not see as much relief, Dubin says. You shouldn't get allergy shots if you currently have severe asthma symptoms, or if you're taking certain medications, including beta-blockers for high blood pressure and certain antidepressants, he adds. Allergy shots can also be used for people who are allergic to insect stings, but the process often takes longer and comes with more risks, Dubin says. If your symptoms start to come back after a course of allergy shots, you can go for another round. In fact, that's quite common in Morris' practice, considering he treats children: They might complete allergy shots in childhood and repeat the process in their 30s, he says. How much do allergy shots cost? Insurance coverage varies from person to person, but most people can expect to have some out-of-pocket costs for allergy shots—anywhere from $1,000 to $4,000 for office-visit copays and the treatment itself, Morris says. 'I have seen some of the insurers charge a copay for every shot,' Morris says. 'So if you're getting 28 shots—one a week for six months—and you've got a $25 copay, you start to do the math.' The cost alone can make allergy shots unrealistic for some people. What advancements are in the pipeline? Some health care providers are using shorter timelines for administering allergy shots, sometimes referred to as rapid desensitization or cluster or rush immunotherapy. Instead of getting one shot a week during your build-up phase, you might get several shots a week—even more than one shot in a day, Morris says. This expedites the time it takes to reach the maintenance phase to a few weeks or months. However, people generally have a higher risk of having a reaction on a faster allergy shot schedule, he adds. There is also a tablet form of allergen immunotherapy that works for people who are allergic to ragweed, some grasses, and dust. You let the tablet dissolve under your tongue at least three days a week. While under-the-tongue tablets and drops have been popular in Europe for some time, this method hasn't really caught on in the U.S., where most insurance providers don't cover it without prior authorization, Meadows says. While the tablets can make your mouth itchy, the risk of serious side effects is low. So another plus of this technique is you can do it yourself at home without needing to be monitored by your doctor, Dubin says. Although it's still in early research phases, Morris is intrigued by a new technique involving injecting allergens into a lymph node, where immune cells live, rather than under the skin, called intralymphatic immunotherapy. This approach kicks in quickly: It takes just three injections over two months. However, it requires an ultrasound to deliver the shot, so it takes some technical skill and the right equipment, he says. It's currently available at a limited number of health care facilities, but it's not yet approved by the U.S. Food and Drug Administration. 'Not all these are going to be right for every patient, [but] I'm excited for patients to get some quality-of-life improvements,' Morris says. 'I recommend people see a board-certified allergist and discuss these treatments and the risks and benefits and decide what's right for them.'
Yahoo
03-03-2025
- Health
- Yahoo
Injectable asthma drug resolves dangerous food allergies in one-third of children
More than a third of food-allergic kids were able to eat full servings of their trigger foods after treatment with an injectable asthma drug, new clinical trial findings report. In all, 36% of children treated with omalizumab (Xolair) for a year successfully ate full servings of allergy-triggering foods, according to phase 2 trial results presented Sunday at a meeting of the American Academy of Allergy, Asthma & Immunology in San Diego. By comparison, only 19% of children could do the same when given a shorter round of omalizumab followed by months of oral immunotherapy, a treatment through which patients build tolerance by eating gradually increasing amounts of food allergens. Further, early stage 3 results from the clinical trial found that children retained some resistance to food allergies even after they stopped taking omalizumab, researchers reported. "This is the first time we've been able to directly compare these two treatments for multiple food allergies, and our study shows omalizumab was superior to oral immunotherapy," principal investigator Dr. Robert Wood, director of the Eudowood Division of Allergy, Immunology and Rheumatology at Johns Hopkins Children's Center, said in a news release. Food allergies are common, affecting 8% of U.S. children and 10% of adults, researchers said in background notes. Omalizumab works by binding to the antibodies that promote allergic reactions, rendering them inactive, researchers said in background notes. The drug has been on the market since 2003, first approved by the U.S. Food and Drug Administration as a preventive treatment for allergic asthma, according to And based on early results from this clinical trial, the FDA approved omalizumab as a treatment for food allergies in adults and children as young as 1 year old, researchers said in background notes. The stage 2 clinical trial involved 117 children with an average age of 7 who were allergic to peanuts and at least two other common food allergens -- milk, egg, cashew, wheat, walnut or hazelnut. At week 44, the children were fed all three of their food allergens in amounts equivalent to about 20 peanuts or a half-cup of milk. The lower results for children on oral immunotherapy were driven by the fact that more of these kids had to drop out of the study due to adverse reactions, researchers said. About 88% of children treated with omalizumab finished the stage 2 trial, compared with 51% of those receiving oral immunotherapy, results show. No children taking omalizumab experienced serious adverse reactions, compared with more than 30% of those treated with oral immunotherapy. "We have demonstrated that there are multiple paths to living a safe life with food allergies," senior researcher Dr. Sharon Chinthrajah, acting director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford Medicine, said in a news release. "This study is very encouraging because it shows that we have treatment choices for our patients that are safe and not too burdensome," she added. Researchers at the AAAAI meeting also presented preliminary results from stage 3 of the clinical trial, which focused on the first 60 children in the study. Stage 3 focused on different pathways that children with food allergies might take in real-world settings, after they've gained tolerance to trigger foods through omalizumab therapy. Each of the children was assigned one of three strategies for each of their food allergens -- start eating the food, continue with oral immunotherapy or avoid the food. These strategies were assigned based on how the kids responded to a food challenge following omalizumab treatment. More than 80% of the plans began with the kids eating the foods to which they'd been allergic, results show. The kids were then tracked for a year to see how they fared. Preliminary results show that consumption of milk, egg and wheat had a greater success rate (61% to 70%) than peanuts and tree nuts (38% to 56%). In most cases, kids ate declining amounts of their allergens during the follow-up period. Some adverse events occurred, including food reactions severe enough to require an epinephrine shot. Stage 3 is ongoing, with completion expected this summer, researchers said. "While the results of Stage 3 are still preliminary, the majority of the first 60 participants were able to successfully introduce allergenic foods into their diet after stopping omalizumab," lead researcher Dr. Jennifer Dantzer, a pediatric allergist at Johns Hopkins Children's Center, said in a news release. "Omalizumab is currently approved in the U.S. for the reduction of allergic reactions that may occur with accidental exposures," Dantzer said. "These results indicate that omalizumab may have additional uses that may be valuable for patients, but the potential risks should be recognized." Funding for the clinical trial came from Genentech and Novartis, the makers of omalizumab. Findings presented at medical meetings should be considered preliminary until published in a peer-reviewed journal. More information The American Academy of Allergy, Asthma & Immunology has more about food allergies. Copyright © 2025 HealthDay. All rights reserved.
Yahoo
03-03-2025
- Health
- Yahoo
KalVista Pharmaceuticals Shares Latest Sebetralstat Findings at the American Academy of Allergy, Asthma & Immunology 2025 Annual Meeting
–Sebetralstat enabled prompt treatment of laryngeal HAE attacks with median time of 1 hour and 16 minutes to onset of symptom relief– –Pooled data analysis showed adolescents treated with sebetralstat in median 4 minutes compared to over 3 hours in surveys – CAMBRIDGE, Mass. & SALISBURY, England, March 03, 2025--(BUSINESS WIRE)--KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced the presentation of novel sebetralstat data related to laryngeal hereditary angioedema (HAE) attacks and adolescents with HAE at the American Academy of Allergy, Asthma & Immunology (AAAAI) / World Allergy Organization (WAO) 2025 Joint Congress taking place in San Diego, CA from February 28–March 3, 2025. "The growing body of data from the KONFIDENT-S study consistently demonstrate that sebetralstat enabled early treatment and fast symptom relief from HAE attacks, regardless of age, attack location, or severity," said Ben Palleiko, CEO of KalVista. "This is especially critical for vulnerable populations, such as those experiencing laryngeal attacks or adolescents whose only approved options are injectable on-demand treatments. Sebetralstat, if approved, would be the first oral on-demand treatment for HAE attacks, with the potential to address some of the most significant unmet needs in HAE and become the foundational therapy for HAE management." Effectiveness of Sebetralstat for the On-demand Treatment of Laryngeal Hereditary Angioedema Attacks: Interim Analysis from KONFIDENT-S was presented by Jonathan Bernstein, MD, FAAAAI, Professor of Clinical Medicine in the Department of Internal Medicine, Division of Allergy and Immunology at the University of Cincinnati College of Medicine; Partner at Bernstein Allergy Group and Clinical Research Center. 32 laryngeal attacks were treated with sebetralstat (September 14, 2024 cutoff) Median time to treatment with sebetralstat: 11.5 minutes after attack onset Median time to beginning of symptom relief: 1.27 hours 96% of those achieving beginning of symptom relief within 12 hours did so with a single dose No reports of difficulty swallowing film-coated tablet "Laryngeal attacks are often unpredictable and can progress rapidly, potentially leading to asphyxiation," said Dr. Bernstein. "Any attack involving the larynx must be considered a medical emergency and treated as quickly as possible after onset before symptoms worsen. Despite this, recent U.S. survey data showed the mean time to treatment for laryngeal attacks with injectable on-demand therapies was 2.5 hours. Patients in the KONFIDENT-S study treated their attacks with sebetralstat, with a median time to treatment of just under 12 minutes, followed by symptom relief with a median time of 1 hour and 16 minutes. These results show that in the time it takes many patients to decide whether to treat, prepare and administer an injectable on-demand treatment, most patients in KONFIDENT-S were already experiencing symptom relief. If approved, sebetralstat could represent a therapeutic advance over injectables." On-demand Treatment of Hereditary Angioedema Attacks with Sebetralstat In Adolescents: Pooled Analysis From KONFIDENT And KONFIDENT-S was presented by Professor Danny Cohn, Head of the HAE clinic at Amsterdam University Medical Center (UMC), University of Amsterdam, Netherlands. 149 attacks were treated with sebetralstat across KONFIDENT/KONFIDENT-S (September 14, 2024 cutoff) Median time from attack onset to treatment: 4 minutes Safety and efficacy consistent with adults; no serious adverse events or adverse events leading to discontinuation "Adolescents face considerable challenges in treating their HAE attacks, with substantially longer delays to treatment than adults. This challenge is compounded in the U.S., where the only approved treatments options require either intravenous administration or subcutaneous administration by an HCP," said Dr. Cohn. "The pooled data from the KONFIDENT and KONFIDENT-S studies show that adolescents administered sebetralstat in a median of 4 minutes after attack onset, which compares favorably to a median of 3 hours and mean of 5.2 hours based on international survey data that was presented at AAAAI by Dr. Paula Busse titled, 'Burden of Injectable On-Demand Treatment for Hereditary Angioedema Attacks in Adolescents'. Importantly, the safety and effectiveness of sebetralstat were consistent with what was observed in adults. The portability and ease of administration of sebetralstat, along with the elimination of injection-site reactions and associated anxiety, has the potential to bring transformative change to this underserved patient population." Links to all posters and presentations shared at AAAAI can be found on the KalVista website under Publications. About Sebetralstat Sebetralstat is an investigational, novel oral plasma kallikrein inhibitor for the treatment of hereditary angioedema (HAE). We have filed multiple regulatory applications seeking approval of sebetralstat as the first oral, on-demand treatment for HAE in individuals aged 12 and older, with ongoing studies exploring its use in children aged 2 to 11. If approved, sebetralstat has the potential to become the foundational therapy for HAE management worldwide. About Hereditary Angioedema Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. All currently approved on-demand treatment options require either intravenous or subcutaneous administration. About KalVista Pharmaceuticals, Inc. KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities. For more information about KalVista, please visit or follow us on social media at @KalVista and LinkedIn. Forward-Looking Statements This press release contains "forward-looking" statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "goal," "seek," "believe," "project," "estimate," "expect," "strategy," "future," "likely," "may," "should," "will" and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2024, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on Contacts Ryan BakerHead, Investor Relations(617) Molly CameronDirector, Corporate Communications(978) Sign in to access your portfolio
