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Companies will discover and develop novel targets for the potential treatment of neuropsychiatric conditions New discovery program builds upon nearly two decades of partnership between AbbVie and Gedeon Richter NORTH CHICAGO, Ill. and BUDAPEST, Hungary, Oct. 24, 2024 /PRNewswire/ -- AbbVie (NYSE: ABBV) and Gedeon Richter Plc. ('Richter') today announced a new discovery, co-development and license agreement to advance novel targets for the potential treatment of neuropsychiatric conditions. This collaboration expands upon the success of nearly two decades of partnership on central nervous system (CNS) projects, including globally launched products such as cariprazine (VRAYLAR® / REAGILA®) and the discovery of investigational drug candidate ABBV-932 for the treatment of bipolar depression and generalized anxiety disorder. "There remains a large unmet need for people living with neuropsychiatric disorders, making it imperative that we continue to innovate and pursue novel targets and approaches to discover and develop new therapies," said Jonathon Sedgwick, Ph.D., senior vice president and global head of discovery research, AbbVie. "We are excited to expand our longstanding and successful partnership with Richter to help address the complex needs of these patients." "This new agreement builds on years of successful partnership allowing Richter to further support AbbVie's global ambition in neuropsychiatry and validates the quality of science behind our unique discovery platform," said Gábor Orbán, chief executive officer of Gedeon Richter. Under the terms of the agreement, the collaboration includes both preclinical and clinical R&D activities with shared financing by the parties. Richter will receive an upfront cash payment of $25 million, along with potential future development, regulatory and commercialization milestones. In addition, Richter may also receive sales-based royalties. AbbVie will have worldwide commercialization rights except for traditional markets of Richter, such as geographic Europe, Russia, other CIS countries and Vietnam. VRAYLAR® (cariprazine) US Uses and Important Safety Information VRAYLAR is a prescription medicine used in adults: along with antidepressant medicines to treat major depressive disorder (MDD) for short-term (acute) treatment of manic or mixed episodes that happen with bipolar I disorder to treat depressive episodes that happen with bipolar I (bipolar depression) to treat schizophrenia What is the most important information I should know about VRAYLAR? Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking medicines like VRAYLAR are at an increased risk of death. VRAYLAR is not approved for treating patients with dementia-related psychosis. VRAYLAR and antidepressants may increase suicidal thoughts or actions in some children and young adults especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when VRAYLAR or the antidepressant is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. VRAYLAR may cause serious side effects, including: • Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death • Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure. These can be symptoms of a rare but potentially fatal side effect called NMS. VRAYLAR should be stopped if you have NMS. • Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Tardive dyskinesia may also start after you stop taking VRAYLAR. • Late-occurring side effects: VRAYLAR stays in your body for a long time. Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR. • Problems with your metabolism, such as: − High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity. − Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment. − Weight gain: Weight gain has been reported with VRAYLAR. You and your healthcare provider should check your weight before and regularly during treatment. • Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR. This may increase your risk of infection. Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR. • Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position. • Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries. • Seizures (convulsions) • Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you. VRAYLAR may make you drowsy. • Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water. • Difficulty swallowing that can cause food or liquid to get into your lungs Who should not take VRAYLAR? Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). What should I tell my healthcare provider before taking VRAYLAR? Tell your healthcare provider about any medical conditions and if you: • have or have had heart problems or a stroke • have or have had low or high blood pressure • have or have had diabetes or high blood sugar in you or your family • have or have had high levels of total cholesterol, LDL-cholesterol, or triglycerides; or low levels of HDLcholesterol • have or have had seizures (convulsions) • have or have had kidney or liver problems • have or have had low white blood cell count • are pregnant or plan to become pregnant. VRAYLAR may harm your unborn baby. Taking VRAYLAR during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy. If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or . • are breastfeeding or plan to breastfeed. It is not known if VRAYLAR passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with VRAYLAR. Tell your healthcare provider about all medicines that you take, including prescriptions, over-the counter medicines, vitamins, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works. Do not start or stop any medicines while taking VRAYLAR without talking to your healthcare provider. What are the most common side effects of VRAYLAR? • The most common side effects include difficulty moving or slow movements, tremors, uncontrolled body movements, restlessness and feeling like you need to move around, sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, and dizziness. These are not all the possible side effects of VRAYLAR. Please see the full Prescribing Information , including Boxed Warnings, and Medication Guide . You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more. About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on LinkedIn, Facebook, Instagram, X (formerly Twitter), and YouTube. About Gedeon Richter Gedeon Richter Plc. (), headquartered in Budapest/Hungary, is a major pharmaceutical company in Central Eastern Europe, with an expanding direct presence in Western Europe, China, Latin America, and Australia. Having reached a market capitalization of EUR 4.3bn (USD 4.7bn) by the end of 2023, Richter's consolidated sales were approximately EUR 2.1bn (USD 2.3bn) during the same year. The product portfolio of Richter covers many important therapeutic areas, including Women's Healthcare, Central Nervous System, and Cardiovascular areas. Having the largest R&D unit in Central Eastern Europe, Richter's original research activity focuses on CNS disorders. With its widely acknowledged steroid chemistry expertise, Richter is a significant player in the Women's Healthcare field worldwide. Richter is also active in biosimilar product development, manufacture and commercialization. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2023 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 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Cancer research is experiencing a paradigm shift with the introduction of innovative therapies like messenger RNA (mRNA)-based treatments and chimeric antigen receptor T-cell (CAR T) therapy. The development and use of immunotherapy and precision medicine have sparked global interest due to their potential to harness the body's immune system to fight cancer more effectively. Both therapies have demonstrated promising outcomes in clinical trials, particularly in refractory cancers. Advances in targeted cancer therapies are integral to improving overall remission rates and reducing damage to healthy tissues, explains Dr. Beatrice Setnik, PhD, Chief Scientific Officer at Altasciences.Crucial nonclinical data gathered from mRNA and CAR T-studiesNonclinical studies in mRNA and CAR T-cell therapy are essential for evaluating the efficacy and safety of these cutting-edge therapies before they reach first-in-human clinical trials. Assessing endpoints such as potential toxicities, dose-limiting effects, immune responses, on-tumor and off-target activities, biodistribution and persistence, and the presence and severity of cytokine release syndrome (CRS) ensures that the therapies target cancer cells effectively without harming healthy tissues. With a comprehensive understanding of the therapeutic mechanisms and risks, sponsors can prioritize resources for their most viable compound, as well as determine safe dosages and therapeutic windows for their clinical trial design, explains Dr. Norbert Makori, Vice President of Toxicology at Altasciences. Clinical research on CAR T-cell therapy: Changing the dynamic of cancer treatmentIn CAR T-cell therapy, a patients T cells are engineered to express a synthetic receptor (the CAR) that targets specific antigens on cancer cells. The FDA has approved this type of immunotherapy for certain hematologic cancers, and ongoing clinical trials are exploring its application in other malignancies.Several CAR T-cell therapies, such as tisagenlecleucel and axicabtagene ciloleucel, have been FDA-approved for B-cell malignancies like acute lymphoblastic leukemia (ALL) and non-Hodgkin lymphoma. Clinical trials in these cancers have reported long-term remission in patients who had been non-responsive to other treatments. Current developments include:Ongoing Clinical Trials in Solid Tumors: Solid tumors often present a hostile microenvironment that suppresses immune responses and can cause CAR T-cells to malfunction or become exhausted. They also present physical barriers that make it difficult for CAR T-cells to reach the tumor site. Nevertheless, clinical trials are underway to evaluate the use of CAR T-cells for treating solid tumor cancers, where researchers are focused on identifying suitable targets for CAR T-cell therapy, such as HER2 in breast cancer and EGFR in lung cancer.Next-Generation CAR T-Cells: Clinical research is advancing towards creating next-generation CAR T-cells with enhanced functionality. One field of inquiry is the development of CAR T-cells that target more than one antigen (dual-targeting CARs) or have switch receptors that act against repressing signals from the tumor microenvironment. Another area is the design of allogeneic (off-the-shelf) CAR T-cells, which would allow for the treatment of multiple patients with a single product, without the need for individualized cell engineering.Toxicity and Safety Concerns: Clinical trials have identified two major safety concernsCRS and neurotoxicity. CRS results from an exaggerated immune response, where cytokines are released in large quantities. Severe cases can cause inflammation, rash, low blood pressure, high fever and organ damage. Neurotoxicity can lead to confusion, seizures, or coma in severe cases. Researchers are exploring methods of mitigating these side effects, such as administering drugs like tocilizumab (an IL-6 receptor blocker) or steroids during treatment.Clinical development of mRNA-based cancer therapiesmRNA-based cancer therapies involve delivering synthetic mRNA into cells to instruct them to produce proteins that trigger an immune response. Clinical research in this area is focused on developing mRNA cancer vaccines and immune modulators that enhance the body's natural tumor-defense capabilities.mRNA Cancer Vaccines: Early clinical trials have mainly focused on testing mRNA vaccines against various cancers, including melanoma, lung cancer and colorectal cancer. For example, BioNTech initiated clinical trials with its mRNA-based cancer vaccine BNT111 for advanced melanoma. These trials have demonstrated that mRNA vaccines can stimulate robust immune responses by activating cytotoxic T cells specific to tumor-associated antigens.Moderna is investigating mRNA-4157, a personalized cancer vaccine, which is being administered in combination with immune checkpoint inhibitors such as pembrolizumab, for the treatment of solid tumors. Preliminary results from Phase I trials showed favorable safety profiles and signs of antitumor activity in certain patient groups.Combination Therapies: Research into how mRNA vaccines work in combination with other therapies, like checkpoint inhibitors or CAR T-cell therapy, is in the early phases of clinical testing. The rationale is that mRNA vaccines can induce a strong initial immune response, while checkpoint inhibitors or CAR T-cells can enhance and sustain the attack on the tumor. Challenges in Clinical Trials: Delivery of mRNA into cells, particularly in solid tumors, is a significant hurdle; lipid nanoparticle (LNP) delivery systems are being optimized to improve the stability of mRNA and ensure targeted delivery to the desired cells. Managing the immune response to avoid excessive inflammation or autoimmune reactions is another area where researchers are testing chemical modifications to mRNA molecules to reduce these side effects.Future directions As understanding of personalized and targeted medicine grows, we can except personalized cancer vaccines, sometimes used in combination with other therapies. CAR T-cell therapy will likely expand to target solid tumors, improving precision and reducing side effects in cancer treatment. This research is at the forefront of medical discovery, carrying with it the hope of delivering lasting benefits for people worldwide. '

-- LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy— -- Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 -- DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for LUMRYZ for the treatment of cataplexy or EDS in patients 7 years of age and older with narcolepsy. “This approval represents an important milestone for the narcolepsy community, specifically for younger narcolepsy patients and their caregivers who face significant challenges associated with waking up in the middle of the night to complete treatment regimens. With this label expansion, pediatric patients 7 years and older living with narcolepsy now have the same option that adult patients with narcolepsy have – to choose a once-nightly treatment option that does not disrupt sleep for a middle of the night dose,” said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “In less than two years, Avadel has made great strides in establishing our commitment to the development of transformative medicines for sleep disorders. This includes successfully launching LUMRYZ for the adult narcolepsy population, initiating a Phase 3 pivotal trial evaluating LUMRYZ for the treatment of idiopathic hypersomnia, and now the expansion of LUMRYZ into the pediatric narcolepsy population.” "I have been prescribing sodium oxybate for children and adolescents with narcolepsy for years as I have seen how effective this medication is and can safely be used," said Anne Marie Morse, DO, a board-certified and fellowship-trained pediatric neurologist and sleep medicine specialist at Geisinger Health System. “And before this, although numerous families have also witnessed the transformation in their children's lives, I have also had many families turn down the medication, or discontinue after starting, because of the challenge experienced or feared to experience with a forced awakening causing a purposeful nightly disruption, many times met with an exhausting fight, to take the second dose of first-generation oxybates. The expanded FDA approval for LUMRYZ allows me to now share with my patients and their families that there is an FDA-approved treatment that offers a single bedtime dose of medication, provided in a pre-filled packet. I can now offer more options to more patients which allows me to continue my role as a partner in my patients' journeys." Narcolepsy is a chronic neurological condition that impairs the brain's ability to regulate the sleep-wake cycle. The condition affects approximately 1 in 2,000 people in the United States, where roughly 5% of patients are under the age of 18. Symptoms of narcolepsy are EDS and may also include a sudden loss of muscle tone usually triggered by strong emotion (cataplexy), disrupted nighttime sleep, sleep paralysis and hallucinations when falling asleep or waking up. LUMRYZ is a once-at-bedtime formulation extended-release sodium oxybate and was first approved by the FDA on May 1, 2023, for the treatment of cataplexy or EDS in adult patients with narcolepsy. LUMRYZ was approved by the FDA for use in the treatment of cataplexy or EDS in the pediatric narcolepsy population 7 years and older on October 16, 2024, and was granted Orphan Drug Exclusivity through October 16, 2031. LUMRYZ has a boxed warning as a central nervous system depressant, and for its potential for abuse and misuse. LUMRYZ is available only through a restricted program under a Risk Evaluation and Mitigation Strategy called the LUMRYZ REMS. Most common adverse reactions (incidence > 5% and greater than placebo) reported for all doses of LUMRYZ combined in a trial of adults with narcolepsy were nausea, dizziness, enuresis, headache, and vomiting. Similarly, in a trial of pediatric narcolepsy patients receiving immediate-release sodium oxybate, the most commonly observed adverse reactions (incidence ≥5%) were nausea, enuresis, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. About LUMRYZ™ (sodium oxybate) for extended-release oral suspensionLUMRYZ is an extended-release sodium oxybate medication approved by the FDA on May 1, 2023, as the first and only once-at-bedtime treatment for cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.  On October 16, 2024, LUMRYZ was additionally approved as a once-at-bedtime treatment for cataplexy or EDS in patients 7 years of age and older with narcolepsy.  The FDA approval of LUMRYZ was supported by results from REST-ON, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial in adults with narcolepsy. LUMRYZ demonstrated statistically significant and clinically meaningful improvements in the three co-primary endpoints: EDS (MWT), clinicians’ overall assessment of patients’ functioning (CGI-I), and cataplexy attacks, for all three evaluated doses when compared to placebo.   With its approval in May 2023, the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ for the treatment of cataplexy or EDS in adults with narcolepsy due to a finding of clinical superiority of LUMRYZ relative to currently available oxybate treatments. In particular, the FDA found that LUMRYZ makes a major contribution to patient care over currently available, twice-nightly oxybate products by providing a once-nightly dosing regimen that avoids nocturnal arousal to take a second dose. About Avadel Pharmaceuticals plc Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions to the development of medications that address the challenges patients face with current treatment options. Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food & Drug Administration (FDA) as the first and only once-at-bedtime oxybate for the treatment of cataplexy or EDS in both adults and pediatrics with narcolepsy. For more information, please visit www.avadel.com. INDICATIONSLUMRYZ (sodium oxybate) for extended-release oral suspension is a prescription medicine used to treat the following symptoms in patients 7 years of age and older with narcolepsy: sudden onset of weak or paralyzed muscles (cataplexy)excessive daytime sleepiness (EDS) IMPORTANT SAFETY INFORMATION WARNING: Taking LUMRYZ™ (sodium oxybate) with other central nervous system (CNS) depressants, such as medicines used to make you fall asleep, including opioid analgesics, benzodiazepines, sedating antidepressants, antipsychotics, sedating anti-epileptic medicines, general anesthetics, muscle relaxants, alcohol or street drugs, may cause serious medical problems, including trouble breathing (respiratory depression), low blood pressure (hypotension), changes in alertness (drowsiness), fainting (syncope) and death.The active ingredient of LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a controlled substance. Abuse or misuse of illegal GHB alone or with other CNS depressants (drugs that cause changes in alertness or consciousness) have caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), changes in alertness (drowsiness), coma and death. Call your doctor right away if you have any of these serious side effects.Because of these risks, LUMRYZ is available only by prescription and filled through certified pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ REMS to receive LUMRYZ. Further information is available at www.LUMRYZREMS.com or by calling 1-877-453-1029. Do not take LUMRYZ if you take or your child takes other sleep medicines or sedatives (medicines that cause sleepiness), drink alcohol or have a rare problem called succinic semialdehyde dehydrogenase deficiency. Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling or giving away LUMRYZ may harm others and is against the law. Tell your doctor if you or your child have ever abused or been dependent on alcohol, prescription medicines or street drugs. Anyone who takes LUMRYZ should not do anything that requires them to be fully awake or is dangerous, including driving a car, using heavy machinery or flying an airplane, for at least six (6) hours after taking LUMRYZ. Those activities should not be done until you know how LUMRYZ affects you. Falling asleep quickly, including while standing or while getting up from the bed, has led to falls with injuries that have required some people to be hospitalized. LUMRYZ can cause serious side effects, including the following: Breathing problems, including slower breathing, trouble breathing and/or short periods of not breathing while sleeping (e.g., sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they take LUMRYZ.Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, thoughts of killing yourself or trying to kill yourself, increased tiredness, feelings of guilt or worthlessness and difficulty concentrating. Tell your doctor if you or your child have or had depression or have tried to harm yourself. Call your doctor right away if you or your child have symptoms of mental health problems or a change in weight or appetite.Sleepwalking. Sleepwalking can cause injuries. Call your doctor if you or your child start sleepwalking. Tell your doctor if you or your child are on a salt-restricted diet or have high blood pressure, heart failure or kidney problems. LUMRYZ contains a lot of sodium (salt) and may not be right for you.The most common side effects of LUMRYZ in adults include nausea, dizziness, bedwetting, headache and vomiting. Your side effects may increase when you take higher doses of LUMRYZ. The most common side effects in children include nausea, bedwetting, vomiting, headache, decreased weight, decreased appetite, dizziness, and sleepwalking. LUMRYZ can cause physical dependence and craving for the medicine when it is not taken as directed. These are not all the possible side effects of LUMRYZ. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Please see full Prescribing Information, including BOXED Warning. Cautionary Disclosure Regarding Forward-Looking StatementsThis press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects or other events. Such forward-looking statements include, but are not limited to, expectations regarding the safety and potential therapeutic benefit of, and market and prescriber preference for, LUMRYZ in treating cataplexy and EDS in patients 7 years of age and older with narcolepsy; and the pediatric Orphan Drug Exclusivity for LUMRYZ and potential benefits resulting from such exclusivity. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions and the negatives thereof (if applicable). The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the Securities and Exchange Commission (SEC) on February 29, 2024, and subsequent SEC filings.Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law. Investor Contact:Courtney MogerleyPrecision AQCourtney.Mogerley@precisionaq.com(212) 698-8687 Media Contact:Lesley StanleyReal Chemistrylestanley@realchemistry.com(609) 273-3162