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SOUTH SAN FRANCISCO, Calif., Oct. 24, 2024 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. ("Rigel") (Nasdaq: RIGL), a commercial stage biotechnology company focused on hematologic disorders and cancer, today announced it is issuing a Dear Health Care Provider (DHCP) letter related to a new safety signal for GAVRETO® (pralsetinib) after consultation with the U.S. Food and Drug Administration (FDA). GAVRETO is for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by a FDA approved test and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). The DHCP letter has been posted to the GAVRETO Healthcare Provider website at . Patient safety is Rigel's highest priority. We are committed to ensuring healthcare providers are aware of this update. Healthcare providers and patients are encouraged to report adverse events in patients taking GAVRETO to the Rigel Medical Communications Center at 1-800-983-1329 or [email protected]. You may also report adverse events associated with taking GAVRETO directly to the FDA. Visit or call 1-800-FDA-1088 (1-800-332-1088). Rigel announced the completion of the transfer to Rigel of the New Drug Application (NDA) for GAVRETO from Blueprint Medicines Corporation in June 2024. About GAVRETO® (pralsetinib) INDICATIONS GAVRETO (pralsetinib) is indicated for the treatment of: Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test Adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)* *This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). IMPORTANT SAFETY INFORMATION Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal ILD/pneumonitis can occur in patients treated with GAVRETO. Pneumonitis occurred in 12% of patients who received GAVRETO, including 3.3% with Grade 3-4, and 0.2% with fatal reactions. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Withhold GAVRETO and promptly investigate for ILD in any patient who presents with acute or worsening of respiratory symptoms (e.g., dyspnea, cough, and fever). Withhold, reduce dose or permanently discontinue GAVRETO based on severity of confirmed ILD. Hypertension: Occurred in 35% of patients, including Grade 3 hypertension in 18% of patients. Overall, 8% had their dose interrupted and 4.8% had their dose reduced for hypertension. Treatment-emergent hypertension was most commonly managed with anti-hypertension medications. Do not initiate GAVRETO in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating GAVRETO. Monitor blood pressure after 1 week, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue GAVRETO based on the severity. Hepatotoxicity: Serious hepatic adverse reactions occurred in 1.5% of patients treated with GAVRETO. Increased aspartate aminotransferase (AST) occurred in 49% of patients, including Grade 3 or 4 in 7% and increased alanine aminotransferase (ALT) occurred in 37% of patients, including Grade 3 or 4 in 4.8%. The median time to first onset for increased AST was 15 days (range: 5 days to 2.5 years) and increased ALT was 24 days (range: 7 days to 3.7 years). Monitor AST and ALT prior to initiating GAVRETO, every 2 weeks during the first 3 months, then monthly thereafter and as clinically indicated. Withhold, reduce dose or permanently discontinue GAVRETO based on severity. Hemorrhagic Events: Serious, including fatal, hemorrhagic events can occur with GAVRETO. Grade ≥3 events occurred in 4.1% of patients treated with GAVRETO including one patient with a fatal hemorrhagic event. Permanently discontinue GAVRETO in patients with severe or life-threatening hemorrhage. Tumor Lysis Syndrome (TLS): Cases of TLS have been reported in patients with medullary thyroid carcinoma receiving GAVRETO. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis including hydration, and treat as clinically indicated. Risk of Impaired Wound Healing: Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. Therefore, GAVRETO has the potential to adversely affect wound healing. Withhold GAVRETO for at least 5 days prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of GAVRETO after resolution of wound healing complications has not been established. Embryo-Fetal Toxicity: Based on findings from animal studies and its mechanism of action, GAVRETO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with GAVRETO and for 2 weeks after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with GAVRETO and for 1 week after the last dose. Common adverse reactions (≥25%) were musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, and cough. Common Grade 3/4 laboratory abnormalities (≥2%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased leukocytes, decreased sodium, increased aspartate aminotransferase (AST), increased alanine aminotransferase (ALT), decreased calcium (corrected), decreased platelets, increased alkaline phosphatase, increased potassium, decreased potassium, and increased bilirubin. Avoid coadministration of GAVRETO with strong or moderate CYP3A inhibitors, P-gp inhibitors, or combined P-gp and strong or moderate CYP3A inhibitors. If coadministration cannot be avoided, reduce the GAVRETO dose. Avoid coadministration of GAVRETO with strong or moderate CYP3A inducers. If coadministration cannot be avoided, increase the GAVRETO dose. Lactation: Advise women not to breastfeed during treatment with GAVRETO and for 1 week after the last dose. Pediatric Use: Monitor open growth plates in adolescent patients. Consider interrupting or discontinuing GAVRETO if abnormalities occur. You may report side effects to the FDA at 1-800-FDA-1088 or . Please click here to see the full Prescribing Information and Patient Information for GAVRETO. GAVRETO is a registered trademark of Rigel Pharmaceuticals, Inc. About Rigel Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) is a biotechnology company dedicated to discovering, developing and providing novel therapies that significantly improve the lives of patients with hematologic disorders and cancer. Founded in 1996, Rigel is based in South San Francisco, California. For more information on Rigel, the Company's marketed products and pipeline of potential products, visit . Forward Looking Statements This press release contains forward-looking statements relating to, among other things, safety signal and warnings and precautions regarding the use of GAVRETO (pralsetinib) and has direct reference to a dear doctor letter which further discusses ad hoc analysis from the AcceleRET-Lung trial and corresponding updates to the product label. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements can be identified by words such as "forthcoming," "potential", "may", "expects", "will" and similar expressions in reference to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on Rigel's current beliefs, expectations, and assumptions and hence they inherently involve significant risks, uncertainties and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with the commercialization and marketing of GAVRETO; risks that the FDA or other regulatory authorities may make adverse decisions regarding GAVRETO; risks that GAVRETO may have unintended side effects, adverse reactions or incidents of misuses; the availability of resources to develop market and distribute GAVRETO; risks related to the transition of GAVRETO to Rigel, including risks related to the effectiveness of transition services and drug continuity; market competition for GAVRETO; as well as other risks detailed from time to time in Rigel's reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and subsequent filings. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. Rigel does not undertake any obligation to update forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise, and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein, except as required by law. Contact for Investors & Media: Investors: Rigel Pharmaceuticals, Inc. 650.624.1232 [email protected] Media: David Rosen Argot Partners 646.461.6387 [email protected] SOURCE Rigel Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

New five-year data reinforce long-term safety and efficacy of SPRAVATO® (esketamine) in patients with inadequate response to two or more oral antidepressants (treatment-resistant depression) 23 abstracts highlight data from Company's robust portfolio and pipeline, including clinical insights on major depressive disorder and the significant burden of anhedonia and insomnia symptoms Large real-world analysis highlights the link between reducing relapse and improving survival in schizophrenia TITUSVILLE, N.J., Oct. 24, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that 23 abstracts featuring new real-world and clinical trial data from across its neuropsychiatry portfolio and pipeline will be presented at the annual U.S. Psychiatric and Mental Health Congress (Psych Congress), taking place October 29 to November 2 in Boston, Massachusetts. Presentations include new data supporting the safety and efficacy of SPRAVATO® (esketamine) CIII nasal spray and the Company's innovative portfolio of long-acting injectables (LAIs) for schizophrenia, as well as data highlighting the significant burden people living with major depressive disorder (MDD) and schizophrenia often face. "For nearly seven decades, J&J has been at the forefront of driving scientific progress and innovation in neuroscience," said Bill Martin, Ph.D., Global Neuroscience Therapeutic Area Head, Johnson & Johnson Innovative Medicine. "It is our responsibility and privilege to help advance research and understanding of MDD and schizophrenia so we can continue to deliver transformational therapies that address the greatest unmet patient needs." Key presentations include: New five-year, real-world safety data from nearly 35,000 adults treated with SPRAVATO®, building on more than a decade of research and reinforcing its well-studied, consistent safety profile (Poster 151). Novel insights into the clinical, humanistic and economic burden of anhedonia in adults with MDD (Poster 113). Results from an analysis of more than 30,000 adults with schizophrenia highlighting the link between symptom relapse and risk of death, which can occur 15‐20 years prematurely for adults living with schizophrenia compared to the general population due to many different causes.1 (Poster 42). "Serious mental illness is one of the most complex health challenges of our time," said Pearl Pugh, President, U.S. Neuroscience, Johnson & Johnson Innovative Medicine. "Understanding the patient experience is at the core of our mission to develop breakthrough solutions that can help improve care and make a difference in the lives of those living with challenging-to-treat mental illnesses." J&J will present the following posters at Psych Congress on October 31 from 1:30-3:30 p.m. ET and November 1 from 1:30-3:30 p.m. ET in the Exhibit Hall. ABOUT TREATMENT-RESISTANT DEPRESSION Depression is a common mental health disorder that impacts an estimated 280 million people worldwide.2 In the U.S., approximately 21 million adults have had at least one major depressive episode, and approximately one-third of medication-treated adults are considered to have TRD.3,4 People living with MDD are often considered to have TRD if they have not responded adequately to at least two different antidepressants of adequate dose and duration in the current depressive episode.4 TRD has a significant negative impact on the lives of those affected and has one of the highest economic burdens of all psychiatric disorders.4 ABOUT SPRAVATO® SPRAVATO® (esketamine) CIII nasal spray is approved by the U.S. Food and Drug Administration in combination with an oral antidepressant for adults with TRD and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. It is the first treatment to use a new mechanism of action in decades for the treatment of TRD. SPRAVATO® is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor and is believed to work differently by acting on a pathway in the brain that affects glutamate. To date, SPRAVATO® has been approved in 79 countries and administered to more than 100,000 patients worldwide. ABOUT MAJOR DEPRESSIVE DISORDER WITH INSOMNIA SYMPTOMS MDD is one of the most common psychiatric disorders and leading causes of disability worldwide,5 with an estimated 280 million people living with the disorder around the world.2 MDD is often accompanied by sleep disturbances such as insomnia or hypersomnia, affecting up to 60 percent of patients with MDD.6 Disturbed sleep and insomnia symptoms have a significant impact on a patient's quality of life and exacerbate the risk of depressive relapse and suicide.7,8 ABOUT SELTOREXANT Seltorexant, an investigational potential first-in-class therapy, is a selective antagonist of the human orexin-2 receptor currently being developed as an adjunctive treatment for adults with MDD with insomnia symptoms. Seltorexant is believed to selectively antagonize the orexin-2 receptors, potentially improving mood and sleep symptoms associated with depression. When orexin-2 receptors are stimulated for too long or at inappropriate times, their activation can cause hyperarousal manifestations, including insomnia and excessive cortisol release, which may contribute to depression and insomnia. ABOUT SCHIZOPHRENIA Schizophrenia is a chronic and severe brain disorder affecting approximately 20 million people worldwide and an estimated 2.4 million adults in the U.S.9-11 The disease is characterized by distortions in thinking, perception, emotions, language, sense of self, and behavior.9 It can also lead to neurological impairment and severe disability.12 Antipsychotic medication is recognized as an essential component in the treatment of schizophrenia, and adherence to medication plays a critical role in controlling symptoms and costly relapses.13 ABOUT J&J'S U.S. LONG-ACTING INJECTABLES The J&J U.S. portfolio of long-acting injectable treatments for adults with schizophrenia provides the most varied range of dosing options and the longest-lasting schizophrenia treatments with each dose available. Our portfolio includes INVEGA SUSTENNA® (1-month paliperidone palmitate), INVEGA TRINZA® (3-month paliperidone palmitate), and INVEGA HAFYERA® (6-month paliperidone palmitate), all of which are administered in a clinical setting by a medical professional. Long-acting injectables (LAIs) allow for the slow release of medicine into the bloodstream and have been available and studied for more than 50 years. Based on clinical guidance, the National Council for Mental Wellbeing and the American Psychiatric Association have updated their guidance and practice guidelines to recommend the use of LAIs for appropriate patients.14-16 SPRAVATO® IMPORTANT SAFETY INFORMATION What is SPRAVATO® (esketamine) CIII nasal spray? SPRAVATO® is a prescription medicine, used along with an antidepressant taken by mouth to treat: Adults with treatment-resistant depression (TRD) Depressive symptoms in adults with major depressive disorder (MDD) with suicidal thoughts or actions SPRAVATO® is not for use as a medicine to prevent or relieve pain (anesthetic). It is not known if SPRAVATO® is safe or effective as an anesthetic medicine. It is not known if SPRAVATO® is safe and effective for use in preventing suicide or in reducing suicidal thoughts or actions. SPRAVATO® is not for use in place of hospitalization if your healthcare provider determines that hospitalization is needed, even if improvement is experienced after the first dose of SPRAVATO®. It is not known if SPRAVATO® is safe and effective in children. IMPORTANT SAFETY INFORMATION Do not take SPRAVATO® if you: have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs) have an abnormal connection between your veins and arteries (arteriovenous malformation) have a history of bleeding in the brain are allergic to esketamine, ketamine, or any of the other ingredients in SPRAVATO®. If you are not sure if you have any of the above conditions, talk to your healthcare provider before taking SPRAVATO®. Before you take SPRAVATO®, tell your healthcare provider about all of your medical conditions, including if you: have heart or brain problems, including: high blood pressure (hypertension) slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting history of heart attack history of stroke heart valve disease or heart failure history of brain injury or any condition where there is increased pressure in the brain have liver problems have ever had a condition called "psychosis" (see, feel, or hear things that are not there, or believe in things that are not true). are pregnant or plan to become pregnant. SPRAVATO® may harm your baby. You should not take SPRAVATO® if you are pregnant. Tell your healthcare provider right away if you become pregnant during treatment with SPRAVATO®. If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with SPRAVATO®. There is a pregnancy registry for women who are exposed to SPRAVATO® during pregnancy. The purpose of the registry is to collect information about the health of women exposed to SPRAVATO® and their baby. If you become pregnant during treatment with SPRAVATO®, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or online at . are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with SPRAVATO®. Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Taking SPRAVATO® with certain medicine may cause side effects. Especially tell your healthcare provider if you take central nervous system (CNS) depressants, psychostimulants, or monoamine oxidase inhibitors (MAOIs) medicine. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine. How will I take SPRAVATO®? You will take SPRAVATO nasal spray yourself, under the supervision of a healthcare provider in a healthcare setting. Your healthcare provider will show you how to use the SPRAVATO® nasal spray device. Your healthcare provider will tell you how much SPRAVATO® you will take and when you will take it. Follow your SPRAVATO® treatment schedule exactly as your healthcare provider tells you to. During and after each use of the SPRAVATO® nasal spray device, you will be checked by a healthcare provider who will decide when you are ready to leave the healthcare setting. You will need to plan for a caregiver or family member to drive you home after taking SPRAVATO®. If you miss a SPRAVATO® treatment, your healthcare provider may change your dose and treatment schedule. Some people taking SPRAVATO® get nausea and vomiting. You should not eat for at least 2 hours before taking SPRAVATO® and not drink liquids at least 30 minutes before taking SPRAVATO®. If you take a nasal corticosteroid or nasal decongestant medicine take these medicines at least 1 hour before taking SPRAVATO®. What should I avoid while taking SPRAVATO? Do not drive, operate machinery, or do anything where you need to be completely alert after taking SPRAVATO®. Do not take part in these activities until the next day following a restful sleep. See "What is the most important information I should know about SPRAVATO® ?" What are the possible side effects of SPRAVATO®? SPRAVATO® may cause serious side effects including: See "What is the most important information I should know about SPRAVATO?" Increased blood pressure. SPRAVATO® can cause a temporary increase in your blood pressure that may last for about 4 hours after taking a dose. Your healthcare provider will check your blood pressure before taking SPRAVATO® and for at least 2 hours after you take SPRAVATO®. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe headache, change in vision, or seizures after taking SPRAVATO®. Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering. Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when urinating, or urinating frequently at night. The most common side effects of SPRAVATO when used along with an antidepressant taken by mouth include: If these common side effects occur, they usually happen right after taking SPRAVATO and go away the same day. These are not all the possible side effects of SPRAVATO®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088. Please see full Prescribing Information , including Boxed WARNINGS, and Medication Guide for SPRAVATO® and discuss any questions you may have with your healthcare provider. cp-170363v3 INVEGA® IMPORTANT SAFETY INFORMATION INDICATIONS INVEGA HAFYERA® (6-month paliperidone palmitate) is a prescription medicine given by injection every 6 months by a healthcare professional and used to treat schizophrenia. INVEGA HAFYERA® is used in adults who have been treated with either: INVEGA SUSTENNA® (paliperidone palmitate) a 1-time-each-month paliperidone palmitate extended-release injectable suspension for at least 4 months INVEGA TRINZA® (paliperidone palmitate) a 1-time-every-3-months paliperidone palmitate extended-release injectable suspension for at least 3 months INVEGA TRINZA® is a prescription medicine given by injection every 3 months by a healthcare professional and used to treat schizophrenia. INVEGA TRINZA® is used in people who have been adequately treated with INVEGA SUSTENNA® for at least 4 months. INVEGA SUSTENNA® is a prescription medicine given by injection by a healthcare professional. INVEGA SUSTENNA® is used to treat schizophrenia in adults. IMPORTANT SAFETY INFORMATION Do not receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® if you are allergic to paliperidone, paliperidone palmitate, risperidone, or any of the ingredients in INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. See the end of the Patient Information leaflet in the full Prescribing Information for a complete list of INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® ingredients. Before you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, tell your healthcare professional about all your medical conditions, including if you: have had Neuroleptic Malignant Syndrome (NMS) have or have had heart problems, including a heart attack, heart failure, abnormal heart rhythm, or long QT syndrome have or have had low levels of potassium or magnesium in your blood have or have had uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) have or have had kidney or liver problems have diabetes or have a family history of diabetes have Parkinson's disease or a type of dementia called Lewy Body Dementia have had a low white blood cell count have had problems with dizziness or fainting or are being treated for high blood pressure have or have had seizures or epilepsy have any other medical conditions are pregnant or plan to become pregnant. It is not known if INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® will harm your unborn baby If you become pregnant while taking INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®, talk to your healthcare professional about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit . Infants born to women who are treated with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may experience symptoms such as tremors, irritability, excessive sleepiness, eye twitching, muscle spasms, decreased appetite, difficulty breathing, or abnormal movement of arms and legs. Let your healthcare professional know if these symptoms occur. are breastfeeding or plan to breastfeed. INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® can pass into your breast milk. Talk to your healthcare professional about the best way to feed your baby if you receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. Tell your healthcare professional about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect the way other medicines work, and other medicines may affect how INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® works. Your healthcare provider can tell you if it is safe to receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® with your other medicines. Do not start or stop any medicines during treatment with INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show to your healthcare professional or pharmacist when you get a new medicine. Patients (particularly the elderly) taking antipsychotics with certain health conditions or those on long-term therapy should be evaluated by their healthcare professional for the potential risk of falls. How will I receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? Follow your treatment schedule exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much you will receive and when you will receive it. What should I avoid while receiving INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®? INVEGA HAFYERA®, INVEGA TRINZA® and INVEGA SUSTENNA® may affect your ability to make decisions, think clearly, or react quickly. Do not drive, operate heavy machinery, or do other dangerous activities until you know how INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® affects you. Avoid getting overheated or dehydrated. INVEGA HAFYERA® , INVEGA TRINZA® and INVEGA SUSTENNA® may cause serious side effects, including: See "What is the most important information I should know about INVEGA HAFYERA® , INVEGA TRINZA® and INVEGA SUSTENNA®?" stroke in elderly people (cerebrovascular problems) that can lead to death Neuroleptic Malignant Syndrome (NMS). NMS is a rare but very serious problem that can happen in people who receive INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. NMS can cause death and must be treated in a hospital. Call your healthcare professional right away if you become severely ill and have any of these symptoms: high fever; severe muscle stiffness; confusion; loss of consciousness; changes in your breathing, heartbeat, and blood pressure. problems with your heartbeat. These heart problems can cause death. Call your healthcare professional right away if you have any of these symptoms: passing out or feeling like you will pass out, dizziness, or feeling as if your heart is pounding or missing beats. uncontrolled movements of your tongue, face, mouth, or jaw (tardive dyskinesia) metabolic changes. Metabolic changes may include high blood sugar (hyperglycemia), diabetes mellitus and changes in the fat levels in your blood (dyslipidemia), and weight gain. low blood pressure and fainting changes in your blood cell counts high level of prolactin in your blood (hyperprolactinemia). INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® may cause a rise in the blood levels of a hormone called prolactin (hyperprolactinemia) that may cause side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection. problems thinking clearly and moving your body seizures difficulty swallowing that can cause food or liquid to get into your lungs prolonged or painful erection lasting more than 4 hours. Call your healthcare professional or go to your nearest emergency room right away if you have an erection that lasts more than 4 hours. problems with control of your body temperature, especially when you exercise a lot or spend time doing things that make you warm. It is important for you to drink water to avoid dehydration. The most common side effects of INVEGA HAFYERA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. The most common side effects of INVEGA TRINZA® include: injection site reactions, weight gain, headache, upper respiratory tract infections, feeling restlessness or difficulty sitting still, slow movements, tremors, stiffness and shuffling walk. The most common side effects of INVEGA SUSTENNA® include: injection site reactions; sleepiness or drowsiness; dizziness; feeling of inner restlessness or needing to be constantly moving; abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of your eyes. Tell your healthcare professional if you have any side effect that bothers you or does not go away. These are not all the possible side effects of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA®. For more information, ask your healthcare professional or pharmacist. Call your healthcare professional for medical advice about side effects. You may report side effects of prescription drugs to the FDA at 1-800-FDA-1088. General information about the safe and effective use of INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® for a condition for which it was not prescribed. You can ask your pharmacist or healthcare professional for information about INVEGA HAFYERA®, INVEGA TRINZA® or INVEGA SUSTENNA® that is written for healthcare professionals. For more information, go to , or or call 1-800-526-7736. Please click to read the full Prescribing Information, including Boxed WARNING, for INVEGA HAFYERA ® , INVEGA TRINZA ® and INVEGA SUSTENNA® and discuss any questions you have with your healthcare professional. cp-256259v4 ABOUT JOHNSON & JOHNSON At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and where solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at or at . Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of nipocalimab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at , or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. Correll C, Solmi, M, Croatto G, et al. Mortality in people with schizophrenia: a systematic review and meta-analysis of relative risk and aggravating or attenuating factors. World Psychiatry. 21(2),248–271. doi:10.1002/wps.20994 World Health Organization. Depressive disorder (depression). Accessed October 2024. who.int/news-room/fact-sheets/detail/depression National Institute of Mental Health. Major depression. Accessed October 2024. nimh.nih.gov/health/statistics/major-depression Zhdanava M, Pilon D, Ghelerter I, et al. The prevalence and national burden of treatment-resistant depression and major depressive disorder in the United States. J Clin Psychiatry. (2021);82(2):20m13699. World Health Organization. "Depression: let's talk" says WHO, as depression tops list of causes of ill health. Accessed October 2024. Sakurai, H, Suzuki, T, Yoshimura, K, et al. Predicting relapse with individual residual symptoms in major depressive disorder: a reanalysis of the STAR*D data. Psychopharmacology. (2017);234(16): 2453–2461 . Psychopharmacology Institute. Understanding the relationship between insomnia disorder and MDD.. Accessed October 2024. Taddei-Allen, P. Economic burden and managed care considerations for the treatment of insomnia. Am J Manag Care. (2020);26:S91-S96. doi.org/10.37765/ajmc.2020.43008 World Health Organization. Schizophrenia. Accessed October 2024. Regier DA, Farmer ME, Rae DS, et al. One–month prevalence of mental disorders in the United States and sociodemographic characteristics: the epidemiologic catchment area study. Acta Psychiatr Scand. (1993);88(1):35-47. doi:10.1111/j.1600-0447.1993.tb03411.x US Census Bureau. 2010 US Census. Accessed October 2024. Andreasen N, Nopoulos P, Magnotta V, et al. Progressive brain change in schizophrenia: a prospective longitudinal study of first-episode schizophrenia. Biol Psychiatry. (2011);70(7):672-679. doi:10.1016/j.biopsych.2011.05.017 Higashi K, Medic G, Littlewood K, et al. Medication adherence in schizophrenia: factors influencing adherence and consequences of nonadherence, a systemic literature review. Ther Adv Psychopharmacol. (2013);3(4):200-218. doi:10.1177/2045125312474019 American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Accessed October 2024. American Psychiatric Association. APA releases new practice guideline on treatment of patients with schizophrenia. Accessed October 2024. National Council for Mental Wellbeing. Guide to long-acting medications. Accessed October 2024. © Johnson & Johnson 2024. All rights reserved. SOURCE Johnson & Johnson WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Enrollment on track in registrational Phase 2 portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors; more than 75% of sites activated across the U.S., Europe, and Asia-Pacific; interim analysis expected by mid-2025 Dose-limiting toxicities observed in rezatapopt and Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) combination arm of Phase 1b PYNNACLE trial; rezatapopt 500 mg once-daily in combination with pembrolizumab 200 mg every three weeks established as maximum tolerated dose; due to limited clinical benefit at this dose, PMV is discontinuing enrollment in the Phase 1b combination arm PMV Pharmaceuticals is collaborating with MD Anderson Cancer Center (MDACC) and Memorial Sloan Kettering Cancer Center (MSK) to support an investigator-initiated Phase 1b study evaluating rezatapopt monotherapy and in combination with azacitidine in patients with recurrent or refractory AML/MDS harboring a TP53 Y220C mutation PRINCETON, N.J., Oct. 23, 2024 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today provided an update on the Phase 2 monotherapy and Phase 1b combination portions of the ongoing PYNNACLE clinical trial. PYNNACLE Phase 2 Monotherapy Update Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational, tumor-agnostic Phase 2 trial is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The primary endpoint of the trial is overall response rate per blinded independent central review. The trial is designed to enroll 114 patients across five cohorts at approximately 60 sites. More than 75% of sites have been activated across the U.S., Europe, and Asia-Pacific. PMV plans to provide data from the interim analysis of the Phase 2 monotherapy portion of the PYNNACLE trial by mid-2025 and anticipates submitting a New Drug Application by the end of 2026. PYNNACLE Phase 1b Rezatapopt in Combination with Pembrolizumab Update PMV has decided to discontinue enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Nineteen patients were enrolled in the combination arm of the trial. This decision was driven by dose-limiting toxicities (DLTs) observed at the 1000 mg dose of rezatapopt once-daily plus pembrolizumab 200 mg every three weeks. The DLTs were Grade 2 and 3 and included AST increase, platelet count decrease, pancreatitis, dehydration, and rash. No Grade 4 or 5 adverse events were observed. The safety profile of the rezatapopt and pembrolizumab combination has been consistent with each agent as monotherapy with no new safety signals observed. Per protocol, these observations established rezatapopt 500 mg once-daily in combination with pembrolizumab 200 mg every three weeks as the maximum tolerated dose. Patients dosed with rezatapopt 500 mg once-daily in combination with pembrolizumab did not experience a clinically meaningful benefit, informing the decision to discontinue enrollment in the combination arm of the PYNNACLE trial. MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center to Initiate a Phase 1b Study in Recurrent/Refractory AML/MDS PMV Pharma is collaborating with MD Anderson Cancer Center (MDACC) and Memorial Sloan Kettering Cancer Center (MSK) to support an investigator-initiated Phase 1b study. The study is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy and in combination with azacitidine in approximately 25 patients with recurrent or refractory acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS) harboring a TP53 Y220C mutation. Enrollment is planned to begin in the first quarter of 2025 across two sites. “There is an important need for new treatment options for patients with recurrent or refractory AML or MDS harboring a TP53 Y220C mutation, as this mutation is often associated with poorer prognosis and resistance to conventional therapies” said Courtney DiNardo M.D., MSCE, Department of Leukemia, Division of Cancer Medicine at MDACC. “Based on proof-of-concept data demonstrating the ability of rezatapopt to selectively reactivate p53 in locally advanced/metastatic solid tumor patients with a TP53 Y220C mutation, we believe that rezatapopt in combination with azacitidine has the potential to significantly benefit this patient population.” Eytan M. Stein, M.D., Chief, Leukemia Service at MSK commented, “Patients with p53 mutant AML currently have no effective standard of care treatment options that lead to long term survival, so this important trial using rezatapopt is the first step in developing a focused, mutation specific strategy, for this patient population.” David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma commented, “While we are disappointed to discontinue enrollment of the trial evaluating rezatapopt in combination with pembrolizumab, we look forward to the initiation of the AML/MDS study and evaluating rezatapopt in other settings. I would like to thank the patients and investigators for their time and commitment to the Phase 1b combination portion of the PYNNACLE study. We remain excited by the potential for rezatapopt as a monotherapy in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type and look forward to providing interim data in the middle of next year.” KEYTRUDA® (pembrolizumab) is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Rezatapopt Rezatapopt (PC14586) is a first-in-class, small molecule p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation. About the PYNNACLE Clinical Trial The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics, and effects on biomarkers were also assessed. In Phase 1, an overall response rate of 38% (6/16 evaluable patients) was achieved at the RP2D of 2000 mg daily reflective of the Phase 2 patient population (TP53 Y220C and KRAS wild-type). The median duration of response was seven months. The Phase 2 monotherapy portion is a registrational, single-arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750). About PMV Pharma PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize over four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit www.pmvpharma.com. Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our future plans or expectations for rezatapopt, including our ability to obtain approval as a treatment option on a tumor-agnostic basis and as a monotherapy or in combination with other agents, expectations regarding timing for interim data readouts and success of the Phase 2 portion of the PYNNACLE trial, our expectation and timing of NDA filing(s) with the FDA for the current clinical trial for rezatapopt, the current and future enrollment of patients in our clinical trials, the timing, progress and activation of sites for our clinical trials, and plans for MDACC and MSKCC’s investigator-initiated study assessing rezatapopt as monotherapy and in combination with azacitidine for treatment of recurrent or refractory AML/MDS patients. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of our product candidate development activities and planned clinical trials, our ability to execute on our strategy and operate as a clinical stage company, the potential for clinical trials of rezatapopt or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, our ability to fund operations, and the impact that a global pandemic, other public health emergencies or geopolitical tensions or conflicts may have on our clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024, our Quarterly Report on Form 10-Q for the three months ended March 31, 2024, filed with the SEC on May 9, 2024, and our other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Investors Contact:Tim SmithSenior Vice President, Head of Corporate Development and Investor Relationsinvestors@pmvpharma.com Media Contact:Kathy VincentGreig Communicationskathy@greigcommunications.com