Latest news with #BiogenInc
Business Wire
6 days ago
- Business
- Business Wire
Stoke Therapeutics and Biogen Announce First Patient Dosed in Phase 3 EMPEROR Study of Zorevunersen, a Potential Disease-Modifying Treatment for Dravet Syndrome
BEDFORD, Mass., & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Stoke Therapeutics, Inc. (Nasdaq: STOK), a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine, and Biogen Inc. (Nasdaq: BIIB), today announced that the first patient has been dosed in the global Phase 3 EMPEROR study of zorevunersen for the treatment of Dravet syndrome. Zorevunersen, an investigational antisense oligonucleotide, has the potential to be the first disease-modifying treatment for Dravet syndrome. 'Our Phase 1/2 and open-label extension studies have provided a large dataset to support our understanding of zorevunersen and guide the EMPEROR study design, including dosing, duration and selection and powering of the endpoints,' said Barry Ticho, M.D., Ph.D., Chief Medical Officer of Stoke Therapeutics. 'Given the severity of this disease and the limitations of current treatments, the substantial and durable reductions in seizures and continuing improvements in cognition and behavior support our belief that zorevunersen may improve outcomes for patients with Dravet syndrome.' 'The initiation of the EMPEROR study is a critical milestone in zorevunersen's development,' said Katherine Dawson, M.D., Head of the Therapeutics Development Unit at Biogen. 'Despite treatment with available anti-seizure medicines, no approved medications currently address the underlying cognitive and behavioral aspects of this rare, genetic disease. Together with Stoke, we look forward to working in collaboration with the hope of bringing forward zorevunersen as the first disease-modifying treatment option, if approved, for Dravet syndrome.' EMPEROR Pivotal Phase 3 Design Summary Anticipated Enrollment: Patients with Dravet syndrome between the ages of 2 and up to 18 years of age with a confirmed variant in the SCN1A gene not associated with gain of function. Duration: Following an 8-week baseline period, participants will be randomized 1:1 to receive either zorevunersen or sham for a 52-week treatment period. Treatment Arms: Patients in the active treatment arm will receive two 70mg loading doses (Day 1 and Week 8) followed by two 45mg maintenance doses (Week 24 and Week 40). All patients will continue to receive standard of care medicines throughout the study. Primary Endpoint: Change in major motor seizure frequency measured at Week 28. Key Secondary Endpoints: Change in major motor seizure frequency measured at Week 52. Change in behavior and cognition as measured by the Vineland-3 subdomains, including expressive communication, receptive communication, interpersonal relationships, coping skills and personal skills measured at Week 52. Eligible participants will be offered ongoing treatment with zorevunersen as part of an open-label extension (OLE) study. 'Dravet syndrome is one of the most well studied genetic epilepsies so we know the significant and life-altering effects it can have on patients and their caregivers,' said Joseph Sullivan, M.D., FAES, principal investigator of the study and Professor of Neurology and Pediatrics and Director of the Pediatric Epilepsy Center of Excellence at the University of California San Francisco. 'Providing additional relief from seizures remains an important clinical outcome, but the potential to address the underlying genetic cause to also address neurodevelopmental symptoms signals a fundamentally new way of treating the disease. The urgent need for treatments is evident in the high degree of interest in the EMPEROR study.' The EMPEROR clinical trial has initiated in the United States, United Kingdom, Japan and is planned for Europe. For more information on the EMPEROR study, please visit and About Stoke Therapeutics Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine. Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke's initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for the Company's proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at Follow us on social media - Facebook, LinkedIn, X, YouTube. About Dravet Syndrome Dravet syndrome is a severe developmental and epileptic encephalopathy (DEE) characterized by severe, recurrent seizures as well as significant cognitive and behavioral impairments. Most cases of Dravet are caused by mutations in one copy of the SCN1A gene, leading to insufficient levels of NaV1.1 protein in neuronal cells in the brain. More than 90 percent of patients continue to experience seizures despite treatment with the best available anti-seizure medicines. Complications of the disease often contribute to a poor quality of life for patients and their caregivers. Developmental and cognitive impairments often include intellectual disability, developmental delays, movement and balance issues, language and speech disturbances, growth defects, sleep abnormalities, disruptions of the autonomic nervous system and mood disorders. Compared with the general epilepsy population, people living with Dravet syndrome have a higher risk of sudden unexpected death in epilepsy, or SUDEP. Dravet syndrome occurs globally and is not concentrated in a particular geographic area or ethnic group. Currently, it is estimated that up to 38,000 people are living with Dravet syndrome in the U.S. (~16,000), UK, EU-4 and Japan. 1 About Zorevunersen Zorevunersen is an investigational antisense oligonucleotide that is designed to treat the underlying cause of Dravet syndrome by increasing NaV1.1 protein production in brain cells from the non-mutated (wild-type) copy of the SCN1A gene. This highly differentiated mechanism of action aims to reduce seizure frequency beyond what has been achieved with anti-seizure medicines and to improve neurodevelopment, cognition, and behavior. Zorevunersen has demonstrated the potential for disease modification and has been granted orphan drug designation by the FDA and the EMA. The FDA has also granted zorevunersen rare pediatric disease designation and Breakthrough Therapy Designation for the treatment of Dravet syndrome with a confirmed mutation not associated with gain-of-function, in the SCN1A gene. Stoke has a strategic collaboration with Biogen to develop and commercialize zorevunersen for Dravet syndrome. Under the collaboration, Stoke retains exclusive rights for zorevunersen in the United States, Canada, and Mexico; Biogen receives exclusive rest of world commercialization rights. About the EMPEROR Study The EMPEROR Phase 3 Study (NCT06872125) is a global, double-blind, sham-controlled study evaluating the efficacy, safety and tolerability of zorevunersen in children ages 2 to <18 with Dravet syndrome with a confirmed variant in the SCN1A gene not associated with gain of function. The trial is expected to enroll participants across the United States, Japan, United Kingdom and European Union, with participants being randomized 1:1 to receive either zorevunersen via intrathecal administration or a sham comparator for a 52-week treatment period following an 8-week baseline period. Following the completion of the study, eligible participants will be offered ongoing treatment with zorevunersen as part of an OLE study. The primary endpoint of the study is percent change from baseline in major motor seizure frequency at week 28 in patients receiving zorevunersen as compared to sham. The key secondary endpoints are the durability of effect on major motor seizure frequency and improvements in behavior and cognition as measured by Vineland-3 subdomains, including expressive communication, receptive communication, interpersonal relationships, coping skills and personal skills. Additional endpoints include safety, Clinician Global Impression of Change (CGI-C), Caregiver Global Impression of Change (CaGI-C), and the Bayley Scales of Infant Development (BSID-IV). For more information, visit Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the ability of zorevunersen to treat the underlying causes of Dravet syndrome and reduce seizures or show improvements in behavior and cognition at the indicated dosing levels or at all; the design, timing and results of the Phase 3 EMPEROR study; and the expectations and potential benefits of Stoke's collaboration with Biogen. Statements including words such as 'anticipate,' 'could,' 'expect,' 'plan,' 'will,' or 'may' and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they prove incorrect or do not fully materialize, could cause Stoke's results to differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, risks and uncertainties related to: Stoke's ability to advance, obtain regulatory approval and ultimately commercialize its product candidates; that if Stoke's collaborators were to breach or terminate their agreements, it would not obtain the anticipated financial or other benefits; the possibility that Stoke and Biogen may not be successful in their development of zorevunersen and that, even if successful, they may be unable to successfully commercialize zorevunersen; positive results in a clinical trial may not be replicated in subsequent trials or successes in early stage clinical trials may not be predictive of results in later stage trials; Stoke's ability to protect its intellectual property; Stoke's ability to fund development activities and achieve development goals through mid-2028; and the other risks and uncertainties described under the heading 'Risk Factors' in Stoke's Annual Report on Form 10-K for the year ended December 31, 2024, its quarterly reports on Form 10-Q, and the other documents it files with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and Stoke undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Biogen Safe Harbor This news release contains forward-looking statements, including relating to the potential, benefits, safety and efficacy of Zorevunersen; the potential of Biogen's commercial business and pipeline programs, including Zorevunersen; the anticipated benefits and potential of Biogen's collaboration arrangement with Stoke Therapeutics; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; the successful execution of our strategic and growth initiatives, including acquisitions; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise. Reference: Based on Stoke Therapeutics' preliminary estimates, which scaled annual incidence to prevalence using country-specific live birth rates over the past 85 years and adjusted for Dravet-specific mortality. The estimate is based on incidence rates published by .
Yahoo
04-08-2025
- Business
- Yahoo
Biogen Inc. (BIIB): A Bull Case Theory
We came across a bullish thesis on Biogen Inc. on r/Valueinvesting subreddit by U/Lobyous. In this article, we will summarize the bulls' thesis on BIIB. Biogen Inc.'s share was trading at $131.52 as of July 25th. BIIB's trailing and forward P/E were 13.00 and 8.85 respectively according to Yahoo Finance. A scientist in a lab, researching for a breakthrough treatment for Alzheimer's disease, diabetes nephropathy, asthma, COPD, NASH, and Type 1 Diabetes. Biogen (BIIB) remains deeply unloved by the market, largely due to its missteps with the FDA on Alzheimer's drug Aduhelm, yet it continues to generate substantial and durable cash flows from its existing portfolio, with visibility for at least the next 5–10 years. The company's legacy blockbusters Tecfidera and Tysabri face erosion from generics, but overall revenue has proven more resilient than expected, while growth drivers like Leqembi are set to gain traction, potentially contributing over $5 billion in revenue over the next four years. Management has sought to bolster its relatively thin pipeline through acquisitions, most notably Reata Pharmaceuticals and its drug Skyclarys, and now has six Phase III candidates, with at least two—Tofersen and Felzartamab—showing strong prospects to become blockbusters by 2030. Despite recent challenges, Biogen delivered $2.72 billion in 2024 free cash flow, equating to a compelling 16% yield at the current market cap, with even a conservative forecast—assuming a 3% annual revenue decline through 2030 and excluding any pipeline or acquisition upside—suggesting a 10% margin of safety. Broader market conditions may also work in Biogen's favor, as the healthcare sector trades at historically low valuations, and a shift in sentiment could re-rate the stock. Near-term catalysts include stronger Leqembi uptake and one to two solid quarters that could draw institutional investors back. With shares trading in the $115–$130 range, Biogen offers an asymmetric risk/reward profile, and at sub-$115 levels appears highly attractive given its durable cash flows, undervalued pipeline, and potential for sector-wide recovery. Previously, we covered a bullish thesis on Gilead Sciences, Inc. (GILD) by Disruptive Analytics in February 2025, which highlighted resilience in profitability despite headwinds from the Inflation Reduction Act, currency impacts, and declining COVID sales. The company's stock price has appreciated by approximately 11.64% since our coverage, as the thesis played out. The thesis still stands as Gilead's fundamentals remain intact. u/Lobyous shares a similar view but emphasizes Biogen's undervaluation and catalysts from Leqembi. Biogen Inc. is not on our list of the 30 Most Popular Stocks Among Hedge Funds. As per our database, 52 hedge fund portfolios held BIIB at the end of the first quarter which was 52 in the previous quarter. While we acknowledge the potential of BIIB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 8 Best Wide Moat Stocks to Buy Now and 30 Most Important AI Stocks According to BlackRock. Disclosure: None. Sign in to access your portfolio
Toronto Star
25-07-2025
- Health
- Toronto Star
ZURZUVAE® (zuranolone) Receives Positive Opinion from CHMP for the Treatment of Women with Postpartum Depression
CAMBRIDGE, Mass., July 25, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for ZURZUVAE® (zuranolone) for the treatment of postpartum depression (PPD) in adults following childbirth. If approved by the European Commission (EC), ZURZUVAE will be the first treatment authorized within the European Union specifically indicated to treat depressive symptoms for women with PPD. ZURZUVAE is a once-daily, oral, 14-day treatment which was approved by the U.S. Food and Drug Administration (FDA) in 2023. 'This is an important milestone for maternal health in the European Union,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'ZURZUVAE represents a novel therapeutic approach for the targeted treatment of postpartum depression, with data demonstrating potential for symptom improvement as early as day three of a 14-day course. If approved, this represents a significant opportunity to advance the treatment of a serious condition that remains both underdiagnosed and undertreated.'
Toronto Star
22-07-2025
- Health
- Toronto Star
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
Lecanemab presentations to include long-term Clarity AD data, real-world treatment insights, and a subcutaneous formulation for continued care Presentations on tau to explore its biological role, the development of targeted therapies and biomarkers, and the future integration of these innovations into clinical practice CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau.
Hamilton Spectator
22-07-2025
- Health
- Hamilton Spectator
Biogen to Highlight Scientific Progress Across Alzheimer's Disease at the Alzheimer's Association International Conference 2025
CAMBRIDGE, Mass., July 21, 2025 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced upcoming scientific presentations at the 2025 Alzheimer's Association International Conference (AAIC), taking place July 27-31 in Toronto, Canada. Data on LEQEMBI® (lecanemab) will include 48-month results from the Clarity AD open-label extension, real-world evidence, and new insights into a subcutaneous formulation for maintenance dosing. Presentations on tau will explore tau-targeted therapies and biomarkers, including baseline characteristics of participants from CELIA, a Phase 2 trial evaluating the efficacy, safety, and tolerability of BIIB080, an investigational antisense oligonucleotide (ASO) therapy that targets tau. 'At AAIC, we are sharing data that underscore our ongoing efforts to advance both how Alzheimer's is treated and how care is delivered, including 48-month findings from the LEQEMBI Clarity AD open-label extension and new insights into the potential of subcutaneous maintenance dosing for LEQEMBI. We are also excited to share baseline characteristics from CELIA, our Phase 2 study of BIIB080, an investigational ASO therapy targeting tau,' said Priya Singhal, M.D., M.P.H., Head of Development at Biogen. 'As we deepen our understanding of this complex disease, we remain committed to pushing the science forward and evolving care to better meet the needs of patients and families.' Key Scientific Sessions and Presentations: Educational Program on Tau in Alzheimer's Disease At AAIC, Biogen will host an interactive booth offering an immersive journey into the role of tau in Alzheimer's disease, from pathology to clinical presentation. Biogen is also expanding its educational efforts with a new e-learning module on , building on the resources already available. For more information, please see the AAIC 2025 program and visit the Biogen AAIC booth. About BIIB080 BIIB080 is an investigational antisense oligonucleotide (ASO) therapy designed to target microtubule-associated protein tau (MAPT) mRNA to reduce the production of tau protein. Abnormal accumulation of tau in the brain is a hallmark of Alzheimer's disease and is associated with neurodegeneration and cognitive decline. BIIB080 is currently being evaluated in a Phase 2 clinical study (NCT05399888) in individuals with early Alzheimer's disease. In December 2019, Biogen exercised a license option with Ionis Pharmaceuticals and obtained a worldwide, exclusive, royalty-bearing license to develop and commercialize BIIB080 (tau ASO). BIIB080 was discovered by Ionis. About LEQEMBI ® (lecanemab) LEQEMBI (lecanemab) is the result of a strategic research alliance between Eisai and BioArctic. LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). LEQEMBI is an amyloid beta-directed antibody for the treatment for Alzheimer's disease (AD) in the U.S. The U.S. Food and Drug Administration (FDA) granted LEQEMBI traditional approval on July 6, 2023. LEQEMBI is indicated for the treatment of Alzheimer's disease. Treatment with LEQEMBI should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. Eisai and Biogen have been collaborating on the joint development and commercialization of AD treatments since 2014. Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both companies co-commercializing and co-promoting the product and Eisai having final decision-making authority. Please see full U.S. Prescribing Information for LEQEMBI, including Boxed WARNING and Medication Guide . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients' lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at . Follow us on social media - Facebook , LinkedIn , X , YouTube . Biogen Safe Harbor This news release contains forward-looking statements, including about the potential clinical effects of lecanemab and BIIB080; the potential benefits, safety and efficacy of lecanemab and BIIB080; potential regulatory discussions, submissions and approvals and the timing thereof; the treatment of Alzheimer's disease; the anticipated risks, benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab and BIIB080; and risks and uncertainties associated with drug development and commercialization. These forward-looking statements may be accompanied by such words as 'aim,' 'anticipate,' 'assume,' 'believe,' 'contemplate,' 'continue,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'guidance,' 'hope,' 'intend,' 'may,' 'objective,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'prospect,' 'should,' 'target,' 'will,' 'would,' and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. Given their forward-looking nature, these statements involve substantial risks and uncertainties that may be based on inaccurate assumptions and could cause actual results to differ materially from those reflected in such statements. These forward-looking statements are based on management's current beliefs and assumptions and on information currently available to management. Given their nature, we cannot assure that any outcome expressed in these forward-looking statements will be realized in whole or in part. We caution that these statements are subject to risks and uncertainties, many of which are outside of our control and could cause future events or results to be materially different from those stated or implied in this document, including, among others, uncertainty of long-term success in developing, licensing, or acquiring other product candidates or additional indications for existing products; expectations, plans and prospects relating to product approvals, approvals of additional indications for our existing products, sales, pricing, growth, reimbursement and launch of our marketed and pipeline products; our ability to effectively implement our corporate strategy; risks associated with third party collaborations; the risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events, restrictions on use with our products, or product liability claims; risks of unexpected costs or delays or other unforeseen hurdles; and any other risks and uncertainties that are described in other reports we have filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this press release and are based on information and estimates available to us at this time. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in our subsequent reports on Form 10-Q and Form 10-K, in each case including in the sections thereof captioned 'Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in our subsequent reports on Form 8-K. Except as required by law, we do not undertake any obligation to publicly update any forward-looking statements whether as a result of any new information, future events, changed circumstances or otherwise.
