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Phase 2b study demonstrated topical Sildenafil Cream, 3.6% improved outcomes among women with female sexual arousal disorder (FSAD), particularly in an exploratory subset of women with FSAD with or without concomitant decreased desire There are currently no FDA-approved therapies for FSAD SAN DIEGO, June 24, 2024 (GLOBE NEWSWIRE) -- DARÉ Bioscience Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced the publication in Obstetrics & Gynecology, the official publication of the American College of Obstetricians and Gynecologists (ACOG), of the Phase 2b study efficacy results of topical Sildenafil Cream 3.6% (Sildenafil Cream), which is being developed for the treatment of female sexual arousal disorder (FSAD). The Phase 2b clinical study was designed as an exploratory, multi-center, double-blind, placebo-controlled study to evaluate the preliminary efficacy and safety of Sildenafil Cream, 3.6% in premenopausal patients with FSAD. Topical Sildenafil Cream improved outcomes among women with FSAD, most significantly in a subset of women both with and without concomitant decreased desire. In an exploratory post-hoc analysis of this group, topical Sildenafil Cream significantly increased sexual arousal sensation and reduced sexual distress, as well as improved desire and orgasm. “Arousal disorder represents a significant unmet need, impacting approximately 20% of women in the U.S.¹,” said Dr. Annie Thurman, MD, FACOG, Medical Director at Daré Bioscience. “Publication of this efficacy manuscript in an important peer-reviewed medical journal validates the importance of these findings for the field, shedding light for the first time on which women with FSAD and symptoms can be expected to benefit most from the increased genital blood flow that Sildenafil Cream mechanistically provides, and further underscores the potential of Sildenafil Cream to address the unmet need and improve outcomes for women with FSAD.” “We are so pleased that this manuscript has been accepted in the official publication of the American College of Obstetricians and Gynecologists,” added Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “It truly underscores the importance of these groundbreaking data and can hopefully continue to advance the field with the insights these data provide into this patient population as well as the patient reported outcome measures that are most meaningful to them in measuring their improvement.” Daré Bioscience previously announced a positive end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) supporting advancement of Sildenafil Cream for the treatment of FSAD and has continued to interact with the FDA as the FDA reviews, specifically, the data generated on the proposed endpoints to take forward into Phase 3 development. The FDA has indicated that it aims to complete its review of the Phase 2b study data and provide comments this quarter on the proposed primary and secondary patient reported outcome endpoints for the planned Phase 3 pivotal trials of Sildenafil Cream to support potential product registration and labeling. The in-press accepted manuscript, entitled “Preliminary Efficacy of Topical Sildenafil Cream for the Treatment of Female Sexual Arousal Disorder: A Randomized Controlled Trial” is available online at . About FSAD and Sildenafil Cream, 3.6% FSAD, as described in the DSM-IV, is a condition characterized as primarily by a persistent or recurrent inability to attain or maintain sufficient genital arousal (an adequate lubrication-swelling response) during sexual activity, frequently resulting in distress or interpersonal difficulty, and, of the various types of female sexual dysfunction disorders, FSAD is clinically analogous to erectile dysfunction (ED) in men. As with ED in men, FSAD is associated with insufficient blood flow to the genitalia. Sildenafil, a phosphodiesterase-5 (PDE-5) inhibitor, is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra® for the treatment of ED in men. Sildenafil Cream is an investigational, proprietary cream formulation of sildenafil designed for topical administration to the vulvar-vaginal tissue on demand to increase genital blood flow and provide improvements in the female genital arousal response, while avoiding systemic side effects observed with oral formulations of sildenafil. Market research suggests that 16% of women in the U.S. ages 21 to 60, or approximately 10 million women, are distressed from experiencing symptoms associated with FSAD, including lack of or low sexual arousal, and are actively seeking solutions to improve their condition. In comparison, the prevalence of complete ED in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Organon commenced U.S. marketing of XACIATO in the fourth quarter of 2023. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s mission to deliver differentiated therapies for women, please visit . Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website ( ), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Sildenafil Cream’s potential as a safe and effective therapy for FSAD, Daré’s plans for continued clinical development of Sildenafil Cream, the timing of FDA comments on Sildenafil Cream Phase 3 clinical study design, the potential for Sildenafil Cream to be the first FDA-approved treatment of FSAD, and the potential market opportunity for Sildenafil Cream. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; the risk that data from the Phase 2b study may not be predictive of positive results of any future clinical study; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding the study data; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Media and Investors on behalf of Daré Bioscience, Inc: Camilla White / Simona Kormanikova Dentons Global Advisors DareBioscience@dentonsglobaladvisors.com / 1.212.466.6450 Source: Daré Bioscience, Inc. ____________________________________ ¹ Laumann EO, Michael RT and Gagnon JH. A political history of the national sex survey of adults. Fam PlannPerspect 1994; 26: 34-38. Witherow-Parkanyi M. Female sexual interest/arousal disorder: history of diagnostic considerations and their implications for clinical practice. Psychiatr Hung 2022; 37: 133-149. Jayne C and Gago BA. Diagnosis and treatment of female sexual arousal disorder. Clin Obstet Gynecol 2009; 52: 675-681. DOI: 10.1097/GRF.0b013e3181bf4982.

Board of Directors appoints Kyle Gano, Ph.D., Chief Business Development and Strategy Officer, as CEO-elect, effective October 11, 2024 Kevin Gorman, Ph.D., to continue to serve on the Neurocrine Board of Directors SAN DIEGO, May 28, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX), today announced that Kevin Gorman, Ph.D., will retire as Chief Executive Officer of Neurocrine on October 11, 2024. Kyle Gano, Ph.D., currently Neurocrine's Chief Business Development and Strategy Officer, will succeed him in the CEO role. Dr. Gano will also join the Company's Board of Directors at that time, and Dr. Gorman will continue to serve on the Neurocrine Board. Dr. Gorman founded Neurocrine in 1992 and held numerous positions across the Company, including Chief Operating Officer, Chief Business Officer, and Senior Vice President of Business Development, before being appointed CEO in 2008. Under Dr. Gorman's three decades of leadership, Neurocrine has emerged as a fully integrated biopharmaceutical enterprise with a broad, mature pipeline, strong financial position, and highly successful commercial product, INGREZZA® (valbenazine). Dr. Gorman's vision to focus on areas that lack recent innovation or have limited treatment options has provided the Company with meaningful momentum in its mission to discover and develop new medicines that relieve patient suffering. Notably, in late April, Neurocrine submitted to the FDA two New Drug Applications for crinecerfont as a treatment for adult and pediatric patients with classic congenital adrenal hyperplasia (CAH). In addition, the Company now has 17 clinical development programs in its pipeline focusing on helping patients across neurology, neuroendocrinology, and neuropsychology. With a growing multi-billion-dollar medicine in INGREZZA, a rich and diverse pipeline, and a strong financial profile, Neurocrine is well positioned to execute on a bold vision for future growth and impact. "It has been a privilege to lead the Neurocrine team in developing life-changing treatments for patients in need," Dr. Gorman said. "When I took on the role of CEO in 2008, Neurocrine was a clinical stage company with a limited pipeline and no approved products. Together, we have built a diverse pipeline and a leading R&D innovation engine designed to rapidly deliver up to four INDs per year. We successfully launched INGREZZA, which has driven strong financial results while improving the treatment of tardive dyskinesia and chorea associated with Huntington's disease. Importantly, we are working diligently to be prepared to bring crinecerfont to patients with CAH next year, if approved. I couldn't be prouder of all that this team has accomplished, and I have never been more confident in Neurocrine's future." Dr. Gorman continued, "With the foundation of a world-class team, compelling science, and clear vision, it is the right time to initiate this well-planned leadership transition. The Board of Directors is confident Kyle is the ideal CEO to lead Neurocrine's next chapter of growth, as am I. We have worked closely together for more than 20 years. He has been instrumental in Neurocrine's success and is an exceptional leader of the organization. I look forward to supporting him in my continuing role as a member of the Neurocrine Board." "I believe deeply in Neurocrine's values and mission, and I am honored to take the reins from an amazing leader and mentor," Dr. Gano said. "This is an important year for our organization, as we look to help even more patients with tardive dyskinesia and Huntington's disease through INGREZZA, while potentially bringing crinecerfont to CAH patients in 2025 – all while advancing our pipeline. I look forward to continuing to work closely with our leadership team and the Board to capitalize on our momentum and advance our vision to be a true global leader in neuroscience." "On behalf of the Board, I thank Kevin for his unwavering dedication to Neurocrine Biosciences over the past three decades and wish him the very best in his well-deserved retirement," said William H. Rastetter, Ph.D., Chairman of the Board of Neurocrine Biosciences. "Having worked closely with Kevin on succession planning, and knowing Kyle well, we're thrilled to appoint Kyle as Neurocrine's CEO-elect and look forward to welcoming him to the Board. We are confident that, with Kyle's deep substantive expertise, broad experience working with functions throughout the Company, and clear vision for the future, Neurocrine will continue to grow and succeed as a leading neuroscience-focused company for the benefit of patients, employees, and shareholders." About Kyle Gano Kyle W. Gano, Ph.D., is a proven executive who joined Neurocrine Biosciences more than 23 years ago. After beginning his career at Neurocrine in a market research and analytics role, Dr. Gano has spent the better part of the last two decades focused on business and corporate development, assuming the position of Chief Business Development Officer in 2011 and Chief Business Development and Strategy Officer in 2020. In his current role, Dr. Gano oversees the Company's strategic collaborations across multiple therapeutic areas that bring critical treatments to patients suffering from neurological, neuroendocrine, and neuropsychiatric disorders. During his tenure, he has executed and managed many robust partnerships, including those that are currently active with AbbVie, Idorsia Ltd, Mitsubishi Tanabe Pharma, Nxera Pharma (formerly Sosei Heptares), Sanofi S.A., Takeda Pharmaceutical Company Limited, Voyager Therapeutics, and Xenon Pharmaceuticals. He also led the acquisition of Diurnal Group Plc in 2021, expanding Neurocrine's presence to the United Kingdom and European Union. Beyond his business development and strategy portfolio, Dr. Gano has led numerous high-impact operational and business priorities. These include having been the lead inventor on the patent to the valbenazine molecule, having served as Team Lead for both the elagolix development program and VMAT2 Franchise Team, and currently holding oversight responsibility for all muscarinic development teams and activities. He also played key leadership roles in the development of three FDA-approved medicines – INGREZZA® (valbenazine), ORILISSA® (elagolix), and ORIAHNN® (elagolix, estradiol, and norethindrone). Dr. Gano serves on the Board of Directors of California Life Sciences (CLS). He received his B.S. in Chemistry from the University of Oregon, B.S. in Biochemistry from the University of Washington, and his Ph.D. in Organic Chemistry and M.B.A from the University of California, Los Angeles. About Neurocrine Biosciences, Inc. Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The Company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis*, and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie) NEUROCRINE BIOSCIENCES Logo Lockup, NEUROCRINE, YOU DESERVE BRAVE SCIENCE, and INGREZZA are registered trademarks of Neurocrine Biosciences, Inc. About INGREZZA® (valbenazine) Capsules INGREZZA is the only one-capsule, once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of adults with tardive dyskinesia and the treatment of chorea associated with Huntington's disease (HD). INGREZZA, developed by Neurocrine Biosciences, selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic or muscarinic receptors. While the specific way INGREZZA works to treat TD and HD chorea is not fully understood, INGREZZA selectively targets VMAT2 to inhibit the release of dopamine, a chemical in the brain that helps control movement. INGREZZA is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. Additionally, INGREZZA can be taken as one capsule, once daily together with most psychiatric medications such as antipsychotics or antidepressants. INGREZZA dosages approved for use are 40 mg, 60 mg and 80 mg capsules. INGREZZA is not approved in any other dosage form. Important Information Approved Uses INGREZZA® (valbenazine) capsules or INGREZZA® SPRINKLE (valbenazine) capsules are prescription medicines used to treat adults with: movements in the face, tongue, or other body parts that cannot be controlled (tardive dyskinesia). involuntary movements (chorea) of Huntington's disease. INGREZZA or INGREZZA SPRINKLE do not cure the cause of involuntary movements, and do not treat other symptoms of Huntington's disease, such as problems with thinking or emotions. It is not known if INGREZZA or INGREZZA SPRINKLE is safe and effective in children. IMPORTANT SAFETY INFORMATION VMAT2 inhibitors, including INGREZZA and INGREZZA SPRINKLE, can cause serious side effects in people with Huntington's disease, including: depression, suicidal thoughts, or suicidal actions. Tell your healthcare provider before you start taking INGREZZA or INGREZZA SPRINKLE if you have Huntington's disease and are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when INGREZZA or INGREZZA SPRINKLE is started and when the dose is changed. Call your healthcare provider right away if you become depressed, have unusual changes in mood or behavior, or have thoughts of hurting yourself. Do not take INGREZZA or INGREZZA SPRINKLE if you: are allergic to valbenazine, or any of the ingredients in INGREZZA or INGREZZA SPRINKLE. INGREZZA or INGREZZA SPRINKLE can cause serious side effects, including: Allergic reactions. Allergic reactions, including an allergic reaction that causes sudden swelling called angioedema, can happen after taking the first dose or after many doses of INGREZZA or INGREZZA SPRINKLE. Signs and symptoms of allergic reactions and angioedema include: trouble breathing or shortness of breath, swelling of your face, lips, eyelids, tongue, or throat, or other areas of your skin, trouble with swallowing, or rash, including raised, itchy red areas on your skin (hives). Swelling in the throat can be life-threatening and can lead to death. Stop taking INGREZZA or INGREZZA SPRINKLE and go to the nearest emergency room right away if you develop these signs and symptoms of allergic reactions and angioedema. Sleepiness and tiredness that could cause slow reaction times (somnolence and sedation). Do not drive a car or operate dangerous machinery until you know how INGREZZA or INGREZZA SPRINKLE affects you. Drinking alcohol and taking other medicines may also cause sleepiness during treatment with INGREZZA or INGREZZA SPRINKLE. Heart rhythm problems (QT prolongation). INGREZZA or INGREZZA SPRINKLE may cause a heart rhythm problem known as QT prolongation. You have a higher chance of getting QT prolongation if you also take certain other medicines during treatment with INGREZZA or INGREZZA SPRINKLE. Tell your healthcare provider right away if you develop any signs or symptoms of QT prolongation, including: fast, slow, or irregular heartbeat (heart palpitations), shortness of breath, dizziness or lightheadedness, or fainting or feeling like you are going to faint. Neuroleptic Malignant Syndrome (NMS). NMS is a serious condition that can lead to death. Call a healthcare provider right away or go to the nearest emergency room if you develop these symptoms and they do not have another obvious cause: high fever, stiff muscles, problems thinking, irregular pulse or blood pressure, increased sweating, or very fast or uneven heartbeat. Parkinson-like symptoms. Symptoms include: body stiffness, drooling, trouble moving or walking, trouble keeping your balance, shaking (tremors), or falls. Before taking INGREZZA or INGREZZA SPRINKLE, tell your healthcare provider about all of your medical conditions including if you: have liver or heart problems, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Make sure you tell all of your healthcare providers that you are taking INGREZZA or INGREZZA SPRINKLE. Taking INGREZZA or INGREZZA SPRINKLE with certain other medicines may cause serious side effects. Especially tell your healthcare provider if you: take digoxin or take or have taken a monoamine oxidase inhibitor (MAOI) medicine. You should not take INGREZZA or INGREZZA SPRINKLE if you are taking, or have stopped taking, a MAOI within the last 14 days. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with tardive dyskinesia are sleepiness and tiredness. The most common side effects of INGREZZA or INGREZZA SPRINKLE in people with chorea associated with Huntington's disease include sleepiness and tiredness, raised itchy red areas on your skin (hives), rash, and trouble getting to sleep or staying asleep. These are not all of the possible side effects of INGREZZA or INGREZZA SPRINKLE. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at or call 1-800-FDA-1088. Dosage Forms and Strengths: INGREZZA and INGREZZA SPRINKLE are available in 40 mg, 60 mg, and 80 mg capsules. Please see full Prescribing Information, including Boxed Warning, and Medication Guide. Forward-Looking Statements In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. These statements include, but are not limited to, statements related to: our pipeline, financial position, commercial product strength, momentum, vision and future growth; the ability of our R&D innovation engine to deliver INDs; the continued success of INGREZZA; the regulatory approval and commercialization of crinecerfont; and the impact of our CEO succession on our future growth and success. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are: our future financial and operating performance; risks and uncertainties associated with the commercialization of INGREZZA; risks related to the development of our product candidates; risks associated with our dependence on third parties for development, manufacturing, and commercialization activities for our products and product candidates, and our ability to manage these third parties; risks that the FDA or other regulatory authorities may make adverse decisions regarding our products or product candidates; risks that clinical development activities may not be initiated or completed on time or at all, or may be delayed for regulatory, manufacturing, or other reasons, may not be successful or replicate previous clinical trial results, may fail to demonstrate that our product candidates are safe and effective, or may not be predictive of real-world results or of results in subsequent clinical trials; risks that the potential benefits of the agreements with our collaboration partners may never be realized; risks that our products, and/or our product candidates may be precluded from commercialization by the proprietary or regulatory rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; risks associated with government and third-party regulatory and/or policy efforts which may, among other things, impose sales and pharmaceutical pricing controls on our products or limit coverage and/or reimbursement for our products; risks associated with competition from other therapies or products, including potential generic entrants for our products; risks associated with management transitions; and other risks described in our periodic reports filed with the SEC, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2024. Neurocrine Biosciences disclaims any obligation to update the statements contained in this press release after the date hereof other than as required by law. SOURCE Neurocrine Biosciences, Inc.