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Silver Hill Receives Transformational Gift

Silver Hill Receives Transformational Gift

Business Wirea day ago

NEW CANAAN, Conn.--(BUSINESS WIRE)--Silver Hill Hospital, a nationally recognized leader in mental health care for adults and adolescents, is thrilled to announce a $5.5 million gift, the largest contribution in the institution's 94-year history.
This unprecedented gift marks a pivotal moment in the history of Silver Hill, empowering the organization to increase access to its signature, individualized healthcare and ensure clinical excellence advancing its mission to reduce suffering from mental illness and addiction.
The generous contribution was made by a family of past and current volunteers who wish to remain anonymous as they continue their involvement with the hospital. It will enable Silver Hill to further key initiatives through focused program investments, campus infrastructure enhancements, and community and neighborhood programs consistent with a recently adopted strategic plan ensuring accessible, clinical excellence for the future.
In addition to outright support for patient financial aid, patient wellness and employee growth, the contribution supports Silver Hill's long-term financial viability through its endowment.
'This magnificent gift was thoughtfully made by a family who understands Silver Hill's ability to heal and wants to make it accessible to more individuals in need,' said Richard Canning, Silver Hill Board Chair. 'Only half of the 50 million Americans who experience mental illness every year get treatment, and the quality of that treatment can vary wildly. The opportunity to be treated by experienced and empathetic professionals in a healing setting is a gift that we want to make available to as many people as possible.'
The right care at the right time
Silver Hill Hospital's 2025-2030 Strategic Plan recognizes that the rates of mental illness and addiction have risen over the past 50 years. And while there are new and effective treatments available, it is a challenge to connect those in need with the right care at the right time. 'We need institutions that can provide comprehensive treatment at all levels of care, train mental health professionals, conduct research, and advocate for public understanding,' said Andrew J. Gerber, MD, PhD, Silver Hill Hospital President and Medical Director.
'In other areas of medicine, this role has been effectively filled by academic medical centers,' Gerber added. 'However, since the 1990s, these institutions have suffered a dramatic reduction in psychiatric clinical services due to managed care pressures and inadequate insurance reimbursement. As a result, many top clinicians have moved to private practice, making it difficult for the most vulnerable patients to find the care that they need.'
Philanthropy's essential role
As a nonprofit, independent psychiatric hospital, Silver Hill is uniquely positioned to fill the void – providing access to care, sharing best practices through a program of research and education, and advocating for parity in mental health reimbursement. Philanthropy is essential to maintaining excellence, and this gift is a strong expression of support for the leadership and staff and a belief in the signature level of care that has made it one of the nation's top healthcare institutions.
'The donors believe deeply in the importance of high-quality mental health care and in Silver Hill's ability to deliver it,' Gerber said. 'We are extremely grateful for this cornerstone gift and hope it will be a catalyst to inspire further philanthropic investment in our vision of a world free from stigma and isolation where psychiatric care is accessible to all.'
For more information about supporting the Silver Hill mission, please visit www.silverhillhospital.org/give, or contact Tim Dougherty, Chief Advancement Officer at 203.801.2397.
About Silver Hill Hospital
Founded in 1931, Silver Hill Hospital is one of the nation's leading independent, nonprofit psychiatric hospitals dedicated to diagnosing and treating adolescents and adults with a broad range of psychiatric and addiction disorders. Located on an idyllic 44-acre campus in New Canaan, CT, Silver Hill provides inpatient, residential and intensive outpatient treatment with plans tailored to each patient's needs. At Silver Hill, twenty board certified psychiatrists work closely with licensed nurses, social workers, counselors, therapists, and other staff to deliver expert care with commitment and compassion. Through the Silver Hill Academy for Research and Education (SHARE), leading clinicians share best practices through Grand Rounds, blogs, videos, webinars, conferences and publications to reach thousands of practitioners across the country each year. A second location, Silver Hill New York, provides intensive outpatient treatment in the heart of Midtown Manhattan, and is piloting the only data-first mental health and addiction treatment program in the country. For more information, visit silverhillhospital.org and our social media channels.

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U.S. FDA Approves Tablet Formulation of BeOne's BRUKINSA
U.S. FDA Approves Tablet Formulation of BeOne's BRUKINSA

Business Wire

time38 minutes ago

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U.S. FDA Approves Tablet Formulation of BeOne's BRUKINSA

SAN CARLOS, Calif.--(BUSINESS WIRE)-- BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has approved a new tablet formulation of BRUKINSA ® (zanubrutinib) for all five approved indications. BRUKINSA remains the leader in new chronic lymphocytic leukemia (CLL) patient starts across all lines of therapy in the U.S., and for the first time, has become the overall BTK inhibitor market share leader. 1 BRUKINSA tablets have the same efficacy and safety as BRUKINSA capsules based on the results of two single-dose, open-label, randomized Phase 1 crossover studies of healthy adults designed to establish bioequivalence. BRUKINSA is the only BTK inhibitor to offer the flexibility of once or twice daily dosing, with the ability to tailor the schedule to patient needs. It also continues to be the only BTK inhibitor with recommended dosing for severe hepatic impairment. 'BRUKINSA's leadership in the U.S. underscores the trust physicians and patients have placed in its differentiated clinical profile,' said Matt Shaulis, General Manager of North America, BeOne. 'With this new tablet formulation, we are making treatment simpler and more convenient—an important step forward for patients facing certain B-cell cancers.' The recommended dose of BRUKINSA remains at 320 mg daily. The new BRUKINSA tablets are 160 mg each, allowing patients to take two tablets daily rather than four of the current 80 mg capsules. Additionally, BRUKINSA tablets are smaller than the capsules and have a film coating, making them easier to swallow. The BRUKINSA tablets will replace capsules starting in October 2025. The European Medicines Agency is currently reviewing a Type II variation marketing authorization application (MAA) for the new tablet formulation of BRUKINSA in all currently approved indications, with approval expected later this year. About BRUKINSA ® (zanubrutinib) BRUKINSA is an orally available, small molecule inhibitor of Bruton's tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues. BRUKINSA has the broadest label globally of any BTK inhibitor and is the only BTK inhibitor to provide the flexibility of once or twice daily dosing. Additionally, BRUKINSA is also the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. The global BRUKINSA clinical development program includes about 7,100 patients enrolled in 30 countries and regions across more than 35 trials. BRUKINSA is approved in more than 75 markets in at least one indication, and more than 200,000 patients have been treated globally. U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib) INDICATIONS BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with: Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Waldenström's macroglobulinemia (WM). Mantle cell lymphoma (MCL) who have received at least one prior therapy. Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy. The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials. IMPORTANT SAFETY INFORMATION Warnings and Precautions Hemorrhage Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients. Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding. Infections Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred. Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately. Cytopenias Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients. Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed. Second Primary Malignancies Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies. Cardiac Arrhythmias Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients. Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment. Hepatotoxicity, Including Drug-Induced Liver Injury Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA. Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA. Embryo-Fetal Toxicity Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus. Adverse Reactions The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%). Drug Interactions CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily. CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers. Specific Populations Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily. Please see full U.S. Prescribing Information including U.S. Patient Information. This information is intended for a global audience. Product indications vary by region. About BeOne BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them. To learn more about BeOne, please visit and follow us on LinkedIn, X, Facebook and Instagram. Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws, including statements regarding physicians and patients trust in BRUKINSA; whether the new tablet formulation for BRUKINSA will result in better patient experience; and BeOne's plans, commitments, aspirations, and goals under the heading 'About BeOne.' Actual results may differ materially from those indicated in the forward-looking statements as a result of various important factors, including BeOne's ability to demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug candidates, which may not support further development or marketing approval; actions of regulatory agencies, which may affect the initiation, timing, and progress of clinical trials and marketing approval; BeOne's ability to achieve commercial success for its marketed medicines and drug candidates, if approved; BeOne's ability to obtain and maintain protection of intellectual property for its medicines and technology; BeOne's reliance on third parties to conduct drug development, manufacturing, commercialization, and other services; BeOne's limited experience in obtaining regulatory approvals and commercializing pharmaceutical products and its ability to obtain additional funding for operations and to complete the development of its drug candidates and maintain profitability; and those risks more fully discussed in the section entitled 'Risk Factors' in BeOne's most recent quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in BeOne's subsequent filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this press release, and BeOne undertakes no duty to update such information unless required by law. To access BeOne media resources, please visit our News & Media site.

Trump's EPA announces major rollbacks to power plant pollution limits
Trump's EPA announces major rollbacks to power plant pollution limits

Yahoo

time40 minutes ago

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Trump's EPA announces major rollbacks to power plant pollution limits

US power plants will be allowed to pollute nearby communities and the wider world with more unhealthy air toxins and an unlimited amount of planet-heating gases under new regulatory rollbacks proposed by Donald Trump's administration, experts warned. The US Environmental Protection Agency (EPA) unveiled a plan on Wednesday that would repeal a landmark climate rule that aims to mostly eliminate greenhouse gases from power plants by the 2030s and would, separately, weaken another regulation that restricts power plants' release of hazardous air pollutants such as mercury. 'We choose to both protect the environment and grow the economy,' said Lee Zeldin, administrator of the EPA, at an event to announce the plans. He said the rollbacks will save households money while also defying what he called 'the climate change cult'. The climate rule has 'saddled our critical power sector with expensive, unreasonable and burdensome regulations', Zeldin said. 'American energy suffered and Americans who rely on reliable, affordable energy suffered. The good news is those days are over.' The EPA's proposals will go out for public comment and are likely to face legal challenges. They target a rule crafted last year by the Biden administration to phase out emissions from electricity-producing fossil fuel plants, which are responsible for around a quarter of US greenhouse gases, and a regulation called the Mercury and Air Toxics Standards, which Biden toughened in 2023 to slash harmful pollution suffered by communities. These rollbacks come despite overwhelming scientific evidence of the dire consequences of the worsening climate crisis and the harm caused by pollutants such as mercury, which can seep into water, soils and the air and has been linked to neurological damage in young children as well as heart, lung and immune system ailments in adults. Coal-fired power plants cause nearly half of all mercury emissions in the US, according to the EPA. More than 200 health experts wrote to the EPA on Wednesday warning the moves 'would lead to the biggest pollution increases in decades and is a blatant give-away to polluters'. The experts added the reversals are 'a direct contradiction to the Environmental Protection Agency's mission of protecting public health and the environment'. Trump, however, has vowed to boost fossil fuel production at all costs, having reaped record donations from the oil and gas industry during his election campaign. At Wednesday's EPA event, Zeldin was joined by eight lawmakers, all Republicans – Kevin Cramer, Troy Balderson, Brett Guthrie, Carol Miller, Dan Meuser, Rob Bresnahan, Michael Rulli and Riley Moore – who have collectively received more than $3m from fossil fuel donors in their own election campaigns, a Guardian analysis of the OpenSecrets database shows. Bresnahan, a Pennsylvania representative, holds personal financial interests in more than 20 fossil fuel companies. In justifying the deletion of the Biden climate plan, which the EPA previously estimated would deliver $370bn in net benefits, Zeldin has claimed that US power plants only produce a small and declining fraction of the world's emissions. This is despite the fact that if these power plants were a country, it would be the sixth-largest emitter on the planet. Gina McCarthy, who was EPA administrator under Barack Obama, said that Zeldin's 'dismantling of our nation's protections from power plant pollution is absolutely illogical and indefensible. It's a purely political play that goes against decades of science and policy review.' 'By giving a green light to more pollution, his legacy will forever be someone who does the bidding of the fossil fuel industry at the expense of our health,' she added. 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Experts have warned that sea level rise is on track to cause 'catastrophic inland migration', including to millions of Americans, with climate shocks set to wipe 50% from global GDP by the end of this century. 'It's completely reprehensible that Donald Trump would seek to roll back these lifesaving standards and do more harm to the American people and our planet just to earn some brownie points with the fossil fuel industry,' said Patrick Drupp, climate policy director at the Sierra Club. 'This administration is transparently trading American lives for campaign dollars and the support of fossil fuel companies, and Americans ought to be disgusted and outraged that their government has launched an assault on our health and our future.'

U.S. Food and Drug Administration Approves Nuvation Bio's IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer
U.S. Food and Drug Administration Approves Nuvation Bio's IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer

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U.S. Food and Drug Administration Approves Nuvation Bio's IBTROZI™ (taletrectinib), a Next-Generation Oral Treatment for Advanced ROS1-Positive Non-Small Cell Lung Cancer

Approval follows Priority Review and is supported by the robust TRUST clinical program, in which IBTROZI treatment demonstrated high, durable response rates and brain-penetrant efficacy across different lines of therapy The safety and tolerability of IBTROZI have been well established in the pivotal program, with one of the largest safety datasets in ROS1+ NSCLC showing a favorable and consistent profile Company to host conference call tomorrow, June 12 at 7:30 a.m. EDT NEW YORK, June 11, 2025--(BUSINESS WIRE)--Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC). IBTROZI is a highly selective, next-generation oral ROS1 tyrosine kinase inhibitor (TKI) designed to address some of the outstanding challenges of treating ROS1+ NSCLC. It has demonstrated high response rates with durable benefit and intracranial activity and is generally well tolerated, providing a new treatment option for patients with advanced ROS1+ NSCLC. "The FDA approval of IBTROZI marks a major milestone in the evolution of targeted therapy for advanced ROS1-positive NSCLC," said David Hung, M.D., Founder, President and Chief Executive Officer of Nuvation Bio. "We believe one of the greatest threats to ROS1-positive lung cancer patients is disease progression, especially in the first-line setting. In pivotal trials, IBTROZI delivered high response rates with sustained durability—truly meaningful benefits for patients. With its clinically proven efficacy and safety profile, we believe IBTROZI has the potential to become a new standard for what targeted therapies can achieve in this type of lung cancer. With approvals for IBTROZI now in the U.S. and China, and additional global filings underway, we remain committed to delivering innovative therapies that help patients stay ahead of their disease." ROS1+ NSCLC is a rare and aggressive form of lung cancer, accounting for approximately 2% of new NSCLC cases, or about 3,000 new diagnoses of advanced disease annually in the U.S. The median age at diagnosis for patients with this type of lung cancer is approximately 50 years old, and the disease is more likely to occur in people who have never smoked. Brain metastases are common and a leading cause of disease progression and mortality in this population. "For people living with advanced ROS1-positive lung cancer, who tend to be diagnosed at a younger age, having another treatment option can make a real difference for them and their loved ones," said Janet Freeman-Daily, Co-Founder and President of The ROS1ders. "The approval of this new targeted therapy is a meaningful step forward for the advanced ROS1+ lung cancer community and offers hope for patients facing the added challenge of cancer spreading to the brain." The FDA approval of IBTROZI is supported by one of the largest global clinical trial programs in ROS1+ NSCLC to date, with over 300 patients enrolled in the pivotal TRUST-I and TRUST-II studies. In TRUST-I, IBTROZI achieved a confirmed overall response rate (cORR) of 90% in TKI-naïve patients. These findings were reinforced by the TRUST-II results, with a cORR of 85% in TKI-naïve patients. The median duration of response (DOR) was not yet reached for either trial, based on a cutoff date that is nearly five months later than that of the pooled TRUST-I and TRUST-II analysis published in April in the Journal of Clinical Oncology. For TRUST-I, with a median follow-up for responses of 40 months, the longest DOR was observed at 46.9 months and ongoing. For TRUST-II, with a median follow-up for responses of 19 months, the longest DOR was observed at 30.4 months and ongoing as of October 2024. Given the single-arm nature of the TRUST clinical studies, median progression-free survival (PFS) is not provided in the label. Across the pivotal studies, consistent results were also observed among patients who were previously treated with a ROS1 TKI (TKI-pretreated). In TRUST-I, treatment with IBTROZI achieved a cORR of 52% and median DOR of 13.2 months for TKI-pretreated patients, with median follow-up for responses of 33 months. In TRUST-II, treatment with IBTROZI achieved a cORR of 62%, and as of October 2024 the median DOR was 19.4 months in these patients, with a median follow-up for responses of 19 months. Brain metastases are among the most common and devastating complications in advanced ROS1+ NSCLC. IBTROZI was designed to penetrate the central nervous system (CNS) and has demonstrated consistent intracranial responses in patients with measurable brain metastases at baseline. An intracranial response was achieved in 73% of TKI-naive patients (11/15) and 63% of TKI-pretreated patients (15/24). "Patients living with advanced ROS1+ non-small cell lung cancer and their healthcare providers are in need of new treatment options," added Nathan Pennell, M.D., Ph.D., TRUST study investigator and Professor of Medicine at the Cleveland Clinic. "IBTROZI's durability of response and ability to effectively penetrate the brain, coupled with a well-characterized and manageable safety profile, further addresses these critical needs for patients. I believe this now-approved therapy offers providers and patients a promising new option for the treatment of advanced ROS1+ non-small cell lung cancer." Dr. Pennell is a compensated member of Nuvation Bio's advisory committee. IBTROZI was generally well-tolerated, with most adverse events being low grade, transient and manageable. Patients infrequently (7%) discontinued treatment due to treatment-emergent adverse events (TEAEs). The most common adverse reactions (≥20%) included diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). Overall, the majority of CNS events were mild to moderate (~90%) and resolved within days, and dose modifications due to these events were low (~5%). Approximately 90% of reported cases of dizziness were Grade 1 (mild) and transient. Liver enzyme elevations (AST 87%/ALT 85%) and QT prolongation (19%) were manageable with standard monitoring and dose modifications. IBTROZI is approved as a 600 mg once-daily oral dose, supported by a half-life of approximately 66 hours and broad tissue distribution, including the brain, enabling sustained systemic and CNS exposure. Nuvation Bio also announced the launch of NuvationConnect, a program designed to support patients prescribed IBTROZI. The program will offer financial assistance, access to resources and personalized support for eligible patients. Prescribers can learn more at or by calling 1-877-NUV-CON1 (1-877-688-2661). Conference Call & Business Update Nuvation Bio will host a conference call on June 12, 2025 at 7:30 a.m. EDT / 4:30 a.m. PDT, where company executives will provide an overview of the FDA approval of IBTROZI and our plans to now bring this medicine to patients. As a reminder to investors, the approval, together with the first commercial sale, makes the funding secured from Sagard Healthcare Partners in March fully available to the company. Nuvation Bio expects that this finances the launch of IBTROZI in full and provides further resources to continue advancing our pipeline in areas of unmet need. Investors and the general public are invited to register and listen to a live webcast of the event through the company website at Those unable to register can access the live conference call by dialing +1 833-470-1428 (U.S. toll-free) and entering access code 783971. A replay of the event will be available shortly after the conclusion. About ROS1+ NSCLC Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. About 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that have spread to their brain. The brain is also the most common site of disease progression, with about 50% of previously treated patients developing CNS metastases. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options. About IBTROZI IBTROZI is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive non-small cell lung cancer. Learn more at About the TRUST Clinical Program The TRUST clinical program evaluating IBTROZI for the treatment of adult patients with advanced ROS1+ NSCLC included two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, which enrolled 173 patients, and TRUST-II (NCT04919811), a global study, which enrolled 164 patients. The primary endpoint of these registrational studies is confirmed objective response rate (cORR) as assessed by an independent review committee (IRC). Key secondary endpoints include intracranial cORR, duration of response, progression-free survival, and safety. Indication IBTROZI is indicated for the treatment of adult patients with locally advanced or metastatic ROS1+ non-small cell lung cancer (NSCLC). IMPORTANT SAFETY INFORMATION FOR IBTROZITM (taletrectinib) WARNINGS AND PRECAUTIONS Hepatotoxicity: Hepatotoxicity, including drug-induced liver injury and fatal adverse reactions, can occur. 88% of patients experienced increased AST, including 10% Grade 3/4. 85% of patients experienced increased ALT, including 13% Grade 3/4. Fatal liver events occurred in 0.6% of patients. Median time to first onset of AST or ALT elevation was 15 days (range: 3 days to 20.8 months). Increased AST or ALT each led to dose interruption in 7% of patients and dose reduction in 5% and 9% of patients, respectively. Permanent discontinuation was caused by increased AST, ALT, or bilirubin each in 0.3% and by hepatotoxicity in 0.6% of patients. Concurrent elevations in AST or ALT ≥3 times the ULN and total bilirubin ≥2 times the ULN, with normal alkaline phosphatase, occurred in 0.6% of patients. Interstitial Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, or fatal ILD or pneumonitis can occur. ILD/pneumonitis occurred in 2.3% of patients, including 1.1% Grade 3/4. One fatal ILD case occurred at the 400 mg daily dose. Median time to first onset of ILD/pneumonitis was 3.8 months (range: 12 days to 11.8 months). ILD/pneumonitis led to dose interruption in 1.1% of patients, dose reduction in 0.6% of patients, and permanent discontinuation in 0.6% of patients. QTc Interval Prolongation: QTc interval prolongation can occur, which can increase the risk for ventricular tachyarrhythmias (e.g., torsades de pointes) or sudden death. IBTROZI prolongs the QTc interval in a concentration-dependent manner. In patients who received IBTROZI and underwent at least one post baseline ECG, QTcF increase of >60 msec compared to baseline and QTcF >500 msec occurred in 13% and 2.6% of patients, respectively. 3.4% of patients experienced Grade ≥3. Median time from first dose of IBTROZI to onset of ECG QT prolongation was 22 days (range: 1 day to 38.7 months). Dose interruption and dose reduction each occurred in 2.8% of patients. Significant QTc interval prolongation may occur when IBTROZI is taken with food, strong and moderate CYP3A inhibitors, and/or drugs with a known potential to prolong QTc. Administer IBTROZI on an empty stomach. Avoid concomitant use with strong and moderate CYP3A inhibitors and/or drugs with a known potential to prolong QTc.​ Hyperuricemia: Hyperuricemia can occur and was reported in 14% of patients, with 16% of these requiring urate-lowering medication without pre-existing gout or hyperuricemia. 0.3% of patients experienced Grade ≥3. Median time to first onset was 2.1 months (range: 7 days to 35.8 months). Dose interruption occurred in 0.3% of patients. Myalgia with Creatine Phosphokinase (CPK) Elevation: Myalgia with or without CPK elevation can occur. Myalgia occurred in 10% of patients. Median time to first onset was 11 days (range: 2 days to 10 months). Concurrent myalgia with increased CPK within a 7-day time period occurred in 0.9% of patients. Dose interruption occurred in 0.3% of patients with myalgia and concurrent CPK elevation. Skeletal Fractures: IBTROZI can increase the risk of fractures. ROS1 inhibitors as a class have been associated with skeletal fractures. 3.4% of patients experienced fractures, including 1.4% Grade 3. Some fractures occurred in the setting of a fall or other predisposing factors. Median time to first onset of fracture was 10.7 months (range: 26 days to 29.1 months). Dose interruption occurred in 0.3% of patients. Embryo-Fetal Toxicity: Based on literature, animal studies, and its mechanism of action, IBTROZI can cause fetal harm when administered to a pregnant woman. ADVERSE REACTIONS Among patients who received IBTROZI, the most frequently reported adverse reactions (≥20%) were diarrhea (64%), nausea (47%), vomiting (43%), dizziness (22%), rash (22%), constipation (21%), and fatigue (20%). ​ The most frequently reported Grade 3/4 laboratory abnormalities (≥5%) were increased ALT (13%), increased AST (10%), decreased neutrophils (5%), and increased creatine phosphokinase (5%). ​ DRUG INTERACTIONS Strong and Moderate CYP3A Inhibitors/CYP3A Inducers and Drugs that Prolong the QTc Interval: Avoid concomitant use. Gastric Acid Reducing Agents: Avoid concomitant use with PPIs and H2 receptor antagonists. If an acid-reducing agent cannot be avoided, administer locally acting antacids at least 2 hours before or 2 hours after taking IBTROZI. OTHER CONSIDERATIONS Pregnancy: Please see important information in Warnings and Precautions under Embryo-Fetal Toxicity. ​ Lactation: Advise women not to breastfeed during treatment and for 3 weeks after the last dose. Effect on Fertility: Based on findings in animals, IBTROZI may impair fertility in males and females. The effects on animal fertility were reversible. Pediatric Use: The safety and effectiveness of IBTROZI in pediatric patients has not been established. Photosensitivity: IBTROZI can cause photosensitivity. Advise patients to minimize sun exposure and to use sun protection, including broad-spectrum sunscreen, during treatment and for at least 5 days after discontinuation. Please see accompanying full Prescribing Information. About Nuvation Bio Nuvation Bio is a global oncology company focused on tackling some of the toughest challenges in cancer treatment by developing therapies that create a profound, positive impact on patients' lives. Our diverse pipeline includes IBTROZI (taletrectinib), a next-generation ROS1 inhibitor; safusidenib, a brain-penetrant IDH1 inhibitor for glioma; NUV-1511, an innovative drug-drug conjugate (DDC) designed for targeted cancer treatment; and NUV-868, a BD2-selective BET inhibitor. Nuvation Bio was founded in 2018 by biopharma industry veteran David Hung, M.D., who previously founded Medivation, Inc., which brought to patients one of the world's leading prostate cancer medicines. Nuvation Bio has offices in New York, San Francisco, Boston, and Shanghai. For more information, visit or follow the company on LinkedIn and X (@nuvationbioinc). Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," "should," "would," "plan," "predict," "potential," "seem," "seek," "future," "outlook" and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, our expectations regarding IBTROZI's therapeutic potential in advanced ROS1+ NSCLC and its potential to become a new standard of care. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of the management team of Nuvation Bio and are not predictions of actual performance. These forward-looking statements are subject to a number of risks and uncertainties that may cause actual results to differ from those anticipated by the forward-looking statements, including but not limited to the challenges associated with conducting drug discovery and initiating or conducting clinical studies due to, among other things, difficulties or delays in the regulatory process, enrolling subjects or manufacturing or acquiring necessary products; the emergence or worsening of adverse events or other undesirable side effects; risks associated with preliminary and interim data, which may not be representative of more mature data; and competitive developments. Risks and uncertainties facing Nuvation Bio are described more fully in its Form 10-Q filed with the SEC on May 7, 2025 under the heading "Risk Factors," and other documents that Nuvation Bio has filed or will file with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Nuvation Bio disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release. View source version on Contacts Media and Investor ContactsNuvation Bio Investor Contact ir@ Nuvation Bio Media Contact media@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data

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