Norethindrone

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. View original content to download multimedia: SOURCE Neurocrine Biosciences, Inc. Company Codes: NASDAQ-NMS:NBIX

Camilla Chong, M.D., joins the team with 25 years of experience in the global pharmaceutical industry in drug developmentDr. Chong to lead clinical development of InflaRx’s portfolio of C5a/C5aR inhibitors JENA, Germany, June 28, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company commercializing and developing anti-inflammatory therapeutics that target the complement system, today announced the appointment of Dr. Camilla Chong as Chief Medical Officer (CMO) of InflaRx, effective July 1, 2023. Dr. Chong is a medical doctor with extensive experience in the pharmaceutical industry, including leadership roles in clinical development, medical affairs and overseeing the launch of new drugs across multiple geographies. She will be responsible for all clinical developments related to InflaRx’s portfolio as she joins the C-suite of the company. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: “We are excited to welcome Camilla to our team. She is a highly accomplished executive who brings a wealth of expertise in drug development. At InflaRx, she will lead our clinical development activities. Besides managing our ongoing clinical trials, she will also drive the strategy for future clinical development programs of the company including those for vilobelimab and INF904. She will be a great addition to our team as we bring our first product to market and advance our development programs.” Dr. Camilla Chong commented: "I am thrilled to be joining InflaRx at this transformative stage for the Company following the recent Emergency Use Authorization by the FDA and the ongoing commercial launch of Gohibic (vilobelimab). I believe that our innovative anti-C5a / anti-C5aR programs have the potential to be truly life-changing for patients with acute inflammatory conditions as well as many chronic immunologic diseases. I very much look forward to advancing our clinical programs with the goal of providing patients suffering from these diseases with improved treatments that can truly impact their quality of life." Dr. Chong is a medical doctor with 25 years of experience in the global pharmaceutical industry. She has successfully led clinical development, medical affairs, clinical operations, regulatory and pharmacovigilance teams and has managed global clinical development programs. She has extensive experience in the launch of many new medicines in multiple geographies. She joins InflaRx from Kyowa Kirin Corporation, where she was Vice President & Global Medical Affairs Therapy Area Head - Immunology. Her previous senior management roles have spanned multiple therapeutic areas, including cardiology, immunology, respiratory, dermatology and orphan diseases at Pfizer, GlaxoSmithKline and Teva. Dr. Chong received her MD from the Royal Free Hospital School of Medicine, University College London, UK. She holds a Diploma in Pharmaceutical Medicine and is a Member of the Faculty of Pharmaceutical Medicine (MFPM). About InflaRx InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, “InflaRx”). InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a / C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of C5a and C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. Contacts: InflaRx N.V.Email: IR@inflarx.de MC Services AGKatja Arnold, Laurie Doyle, Dr. Regina LutzEmail: inflarx@mc-services.euEurope: +49 89-210 2280U.S.: +1-339-832-0752 FORWARD-LOOKING STATEMENTSThis press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ability to commercialize and the receptiveness of Gohibic (vilobelimab) as a treatment for COVID-19 by COVID-19 patients and U.S. hospitals or our other product candidates; our expectations regarding the size of the patient populations for, market opportunity for, coverage and reimbursement for and clinical utility of Gohibic (vilobelimab) in its approved or authorized indication or for vilobelimab and any other product candidates, under an EUA and in the future if approved for commercial use in the U.S. or elsewhere; the success of our future clinical trials for vilobelimab and any other product candidates and whether such clinical results will reflect results seen in previously conducted preclinical studies and clinical trials; the timing, progress and results of clinical trials of our product candidates, and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our BLA submission for Gohibic (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or Gohibic (vilobelimab) for any indication; whether the FDA, the EMA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our expectations regarding the scope of any approved indication for vilobelimab; our ability to leverage our proprietary anti-C5a and C5aR technologies to discover and develop therapies to treat complement-mediated autoimmune and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product Gohibic (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval and commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the Securities Exchange Commission. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.