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Business Wire
6 days ago
- Business
- Business Wire
Vistagen on Track to Deliver Topline Data From Fasedienol PALISADE-3 Phase 3 Trial for Acute Treatment of Social Anxiety Disorder in the Fourth Quarter of This Year
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience with nose-to-brain neurocircuitry to develop and commercialize a new class of intranasal product candidates called pherines, today provides an update on the timeline for the ongoing clinical trials in its U.S. registration-directed PALISADE Phase 3 Program evaluating fasedienol for acute treatment of social anxiety disorder (SAD). The Company's PALISADE-3 Phase 3 clinical trial remains on track for expected topline data in the fourth quarter of this year. Topline results for its PALISADE-4 Phase 3 clinical trial are expected in the first half of 2026. 'We are very encouraged by the progress of our PALISADE-3 trial, which remains on track for a topline readout in the fourth quarter of this year, and our PALISADE-4 trial, for which we expect topline results in the first half of 2026,' said Shawn Singh, President and Chief Executive Officer of Vistagen. 'Patient and physician enthusiasm for our PALISADE trials continues to be strong, and we remain focused on meticulous patient recruitment. With social anxiety affecting millions and rising, we are energized by fasedienol's potential to meet the clear and growing unmet need and bring meaningful relief to patients, all while delivering long-term value to shareholders.' Vistagen reported positive results from its PALISADE-2 Phase 3 trial of fasedienol for acute treatment of SAD in 2023. The Company's ongoing PALISADE-3 and PALISADE-4 Phase 3 trials involve the same public speaking challenge study design as its successful PALISADE-2 Phase 3 trial, as well as certain protocol and operational enhancements related to site training, surveillance and subject selection. These strategic enhancements, which have extended certain timelines in the PALISADE Phase 3 program, were designed with the objective of replicating the success of PALISADE-2. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD. About Social Anxiety Disorder Social anxiety disorder (SAD) is a highly prevalent, serious, and sometimes life-threatening psychiatric mental health disorder affecting over 30 million adults in the U.S. With onset typically early in life, usually during adolescence, SAD persists for many years thereafter, with a reported mean duration of about 20 years. While often a long-term disorder, SAD can manifest acutely when triggered by anxiety-provoking social and performance situations during which individuals with SAD experience extreme anxiety, distress, fear, and impairment due to their feelings of embarrassment, judgment, humiliation, negative evaluation, and scrutiny. The disorder can significantly disrupt family and social life, diminish self-esteem, and hinder work performance. Anxiety associated with SAD often results in avoidance of everyday interactions and opportunities in academic, social, and vocational settings and an increased risk of serious and life-threatening co-morbid depression, substance abuse, suicidal ideation, and suicide. About Fasedienol Nasal Spray for the Acute Treatment of Social Anxiety Disorder Fasedienol is Vistagen's potential first-in-class, investigational neurocircuitry-focused pherine nasal spray designed to have rapid onset with a novel mechanism of action (MOA) that is differentiated from all currently approved anxiety medications. Fasedienol is designed to regulate the olfactory-amygdala neural circuits of fear and anxiety and attenuate the tone of the sympathetic autonomic nervous system without systemic absorption, potentiation of GABA-A receptors, or binding to neurons in the brain. The U.S. FDA has granted Fast Track designation for the development of fasedienol for the acute treatment of SAD. About Vistagen's U.S. Registration-directed PALISADE Phase 3 Program for Acute Treatment of Social Anxiety Disorder The ongoing clinical trials in Vistagen's U.S. registration-directed PALISADE Phase 3 Program for fasedienol for the acute treatment of SAD include its PALISADE-3 and PALISADE-4 Phase 3 trials and a small Phase 2 repeat dose study, which is being conducted at the FDA's request to further elucidate fasedienol's dose response and MOA. PALISADE-3 and PALISADE-4 are multi-center, randomized, double-blind, placebo-controlled Phase 3 trials designed similarly to PALISADE-2 to evaluate the efficacy, safety, and tolerability of the acute administration of fasedienol to relieve anxiety symptoms in subjects with SAD induced by a public speaking challenge conducted in a clinical setting. PALISADE-3 remains on track for topline data in the fourth quarter of 2025. Topline results for PALISADE-4 and the repeat dose study are expected in the first half of 2026. Vistagen believes either PALISADE-3 or PALISADE-4, if successful, together with the positive results from PALISADE-2, may establish substantial evidence of the effectiveness of fasedienol in support of a potential fasedienol New Drug Application (NDA) submission to the U.S. FDA for the acute treatment of SAD. About Vistagen Headquartered in South San Francisco, CA, Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company leveraging a deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of clinical-stage product candidates from a new class of intranasal therapies called pherines. Pherines specifically and selectively bind as agonists to peripheral receptors on human nasal chemosensory neurons, and are designed to rapidly activate olfactory bulb-to-brain neurocircuits believed to regulate brain areas involved in behavior and autonomic nervous system activity. They are designed to achieve therapeutic benefits without requiring absorption into the blood or uptake into the brain, giving them the potential to be a safer alternative to other pharmacological options. Vistagen's neuroscience pipeline also includes an oral prodrug with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent indications, including social anxiety disorder, major depressive disorder, and multiple women's health conditions, including vasomotor symptoms (hot flashes) associated with menopause. Connect at Forward-looking Statements This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as 'may,' 'could,' 'expect,' 'project,' 'outlook,' 'strategy,' 'intend,' 'plan,' 'seek,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'potential,' 'strive,' 'goal,' 'continue,' 'likely,' 'will,' 'would' and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization, and actual results or developments may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that any of Vistagen's product candidates, including fasedienol, will successfully complete ongoing or future clinical trials within estimated timelines or at all, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to conducting and/or completing ongoing clinical trials, including that are a part of Vistagen's PALISADE Phase 3 program, as currently expected or at all; submission of a NDA to the U.S. FDA for any of Vistagen's product candidate, including fasedienol; the ability of any clinical trial information submitted by Vistagen to the U.S. FDA to successfully support a NDA; Vistagen's dependence on third-party collaborators for the development, regulatory approval, and/or commercialization of its product candidates and other aspects of its business, which are outside of Vistagen's full control; risks associated with current and potential future healthcare reforms; the scope and enforceability of Vistagen's patents, including patents related to Vistagen's pherine product candidates and AV-101; fluctuating costs of materials and other resources and services required to conduct Vistagen's ongoing and/or planned clinical and non-clinical trials; market conditions; the impact of general economic, industry or political conditions in the United States or internationally; and other technical and unexpected hurdles in the development, manufacture and commercialization of Vistagen's product candidates. These risks are more fully discussed in the section entitled 'Risk Factors' in Vistagen's Annual Report on Form 10-K for the fiscal year ended March 31, 2024, and Quarterly Report on Form 10-Q for the period ended December 31, 2024, as well as discussions of potential risks, uncertainties, and other important factors in our other filings with the U.S. Securities and Exchange Commission (SEC). Vistagen's SEC filings are available on the SEC's website at You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release and should not be relied upon as representing Vistagen's views as of any subsequent date. Vistagen explicitly disclaims any obligation to update any forward-looking statements other than as may be required by law. If Vistagen does update one or more forward-looking statements, no inference should be made that Vistagen will make additional updates with respect to those or other forward-looking statements.
Business Wire
12-05-2025
- Business
- Business Wire
Arrowhead Pharmaceuticals Reports Fiscal 2025 Second Quarter Results
PASADENA, Calif.--(BUSINESS WIRE)--Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced financial results for its fiscal 2025 second quarter ended March 31, 2025. The Company is hosting a conference call today, May 12, 2025, at 4:30 p.m. ET to discuss the results. Arrowhead is in a strong and stable position as a business, and we have made meaningful progress towards our long-term goal of developing and ultimately commercializing new innovative medicines for millions of patients. Share 'Arrowhead is in a strong and stable position as a business, and we have made meaningful progress towards our long-term goal of developing and ultimately commercializing new innovative medicines for millions of patients. We are on schedule to launch plozasiran this year, pending regulatory approval, with what we think is a best-in-class profile with meaningful differentiation from currently available therapies in FCS. We are also well on our way to fully enrolling Phase 3 studies designed to support regulatory submissions for the large SHTG patient population,' said Christopher Anzalone, Ph.D., President and CEO at Arrowhead. 'Following the closing last quarter of the agreement with Sarepta Therapeutics, Arrowhead is now funded into 2028 with no current needs for further cash infusions from an equity raise or other sources. During that period, we see the potential for multiple commercial launches of both wholly owned programs that we intend to launch independently, and programs being developed and commercialized by partners. In addition, we believe our TRiM TM technology platform is the broadest and best in the field, giving us many opportunities to receive additional capital inflows from business development in areas that are outside of our core commercial focus.' Selected Recent Events Closed a licensing and collaboration agreement with Sarepta Therapeutics and received $825 million, consisting of $500 million cash and $325 million as an equity investment priced at $27.25, representing a 35% premium to the 30-day volume weighted average price. Arrowhead will also receive $250 million to be paid over five years. Arrowhead is also eligible to receive an additional $300 million in near-term payments, royalties on commercial sales, and approximately $10 billion in potential milestone payments. Announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for investigational plozasiran for the treatment of familial chylomicronemia syndrome (FCS), a severe and rare genetic disease. The clinical basis of the NDA submission is comprised of the positive findings from the Phase 3 PALISADE study with supportive confirmatory evidence from the Phase 2 clinical studies of the SUMMIT program. PALISADE successfully met its primary endpoint and all multiplicity-controlled key secondary endpoints, including statistically significant reductions in triglycerides, apolipoprotein C-III, and the incidence of acute pancreatitis. The FDA provided a Prescription Drug User Fee Act (PDUFA) action date of November 18, 2025, and indicated it is not currently planning to hold an advisory committee meeting. Launched new patient-centric resources for those affected by FCS. New Patient Resource Hub: Arrowhead expands its We'll Get There Soon campaign with the launch of a dedicated patient website, providing education, tools, and support for those living with FCS and extremely high triglycerides. Amplifying Patient Voices: The Spotlight on FCS white paper shares real patient experiences, highlighting the challenges of managing this ultra-rare disease and the need for greater awareness. Commitment to the FCS Community: On Rare Disease Day and beyond, Arrowhead remains dedicated to elevating patient voices and fostering community engagement. #ForFCS. Presented preclinical data supporting the advancement of two first-in-class clinical stage, RNAi-based investigational therapeutics being developed for the treatment of obesity and metabolic diseases. ARO-INHBE and ARO-ALK7 both target a known pathway that signals the body to store fat in adipose tissue with a novel mechanism of action that may better preserve lean muscle mass compared to currently approved obesity therapies. Data highlight Arrowhead's leadership in the use of RNA interference to potentially treat obesity. Announced topline results from Part 2 of a Phase 1/2 Study of ARO-C3 in patients with IgA nephropathy ARO-C3 achieved deep and sustained reductions in alternative pathway complement activity and proteinuria Mean sustained reductions in C3 of greater than 87%, AH50 of greater than 76%, and Wieslab AP of greater than 89% through week 24 Mean reduction in spot urine protein-to-creatinine ratio (UPCR) of 41% by week 24 Announced that, effective May 13, 2025, Arrowhead's Chief Financial Officer, Ken Myszkowski, will retire after 16 years of service to the company and will be succeeded by Daniel Apel, who has been appointed as the company's new Chief Financial Officer. Selected Fiscal 2025 Second Quarter Financial Results Webcast and Conference Call and Details Investors may access a live audio webcast on the Events and Presentations page under the Investors section of the Arrowhead website. A replay of the webcast will be available approximately two hours after the conclusion of the call. For analysts that wish to participate in the conference call, please register at Once registered, you will receive the dial-in number and a personalized PIN code that will be required to access the call. About Arrowhead Pharmaceuticals Arrowhead Pharmaceuticals develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. For more information, please visit or follow us on X (formerly Twitter) at @ArrowheadPharma, LinkedIn, Facebook, and Instagram. To be added to the Company's email list and receive news directly, please visit Safe Harbor Statement under the Private Securities Litigation Reform Act: This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this release except for historical information may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as 'may,' 'will,' 'expect,' 'believe,' 'anticipate,' 'hope,' 'intend,' 'plan,' 'project,' 'could,' 'estimate,' 'continue,' 'target,' 'forecast' or 'continue' or the negative of these words or other variations thereof or comparable terminology are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, trends in our business, expectations for our product pipeline or product candidates, including anticipated regulatory submissions and clinical program results, prospects or benefits of our collaborations with other companies, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of our preclinical studies and clinical trials, and our research and development programs; our expectations regarding the potential benefits of the partnership, licensing and/or collaboration arrangements and other strategic arrangements and transactions we have entered into or may enter into in the future; our beliefs and expectations regarding milestone, royalty or other payments that could be due to or from third parties under existing agreements; and our estimates regarding future revenues, research and development expenses, capital requirements and payments to third parties. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of numerous factors and uncertainties, including the impact of the ongoing COVID-19 pandemic on our business, the safety and efficacy of our product candidates, decisions of regulatory authorities and the timing thereof, the duration and impact of regulatory delays in our clinical programs, our ability to finance our operations, the likelihood and timing of the receipt of future milestone and licensing fees, the future success of our scientific studies, our ability to successfully develop and commercialize drug candidates, the timing for starting and completing clinical trials, rapid technological change in our markets, the enforcement of our intellectual property rights, and the other risks and uncertainties described in our most recent Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and other documents filed with the Securities and Exchange Commission from time to time. We assume no obligation to update or revise forward-looking statements to reflect new events or circumstances. Source: Arrowhead Pharmaceuticals, Inc.
