Hospital for Special Surgery and General Atlantic Launch National Platform to Expand Access to Orthopedic and Spine Outpatient Care




Hospital for Special Surgery and General Atlantic Launch National Platform to Expand Access to Orthopedic and Spine Outpatient Care

NEW YORK–(BUSINESS WIRE)–Hospital for Special Surgery (“HSS”), the nation’s top-ranked orthopedic hospital, is joining General Atlantic, a leading global investor, in its launch of a new, independently operated national platform of ambulatory surgery centers (“ASCs”) dedicated to delivering advanced, patient-centered orthopedic and spine outpatient care. To support the platform’s buildout, HSS and General Atlantic have also agreed to acquire Legent Health (“Legent”), a portfolio company of BTG Pactual Strategic Capital (“Strat Cap”). Legent is a leading operator of orthopedic and spine facilities, providing an immediate foundation for scale and growth.

The platform represents a significant step forward in expanding patient access to high-quality, accessible orthopedic and spine care nationwide, while addressing rising demand for advanced outpatient solutions. Legent CEO Jordan Fowler will lead the new platform, which combines Legent’s proven operating infrastructure and experienced management team, HSS’s depth of clinical knowledge and community of more than 1,750 alumni surgeons, and General Atlantic’s expertise in building and scaling physician-aligned healthcare platforms.

Many procedures that once required hospital stays can now be performed safely and efficiently in ASCs. The new independent platform aims to expand patient access to advanced orthopedic and spine care closer to home, delivering lower-cost care with improved outcomes in a more comfortable environment. The platform is purpose-built to create lasting partnerships with surgeons and health systems, providing physicians with opportunities for ownership and alignment through meaningful equity participation, clinical autonomy, and special access to HSS’s clinical protocols and advisory services. This will enable physicians and health systems to participate in the site-of-care shift and benefit from ASC-level efficiencies and economics. Over time, HSS and General Atlantic intend to expand the platform nationally through acquisitions, new partnerships, and de novo facilities.

“As the world’s leading academic medical center specializing in musculoskeletal health since 1863, HSS has a special responsibility to deliver the highest-quality care, improve mobility, and enhance quality of life,” said Bryan Kelly, MD, MBA, President, CEO, and Surgeon-in-Chief Emeritus at HSS. “Through this collaboration, we will extend HSS’s clinical expertise and patient-first standards to markets where demand for orthopedic and spine care outpaces supply, and where quality care is limited outside the hospital setting.”

“This platform brings together HSS’s clinical knowledge and General Atlantic’s company-building expertise to create community-based platforms that will expand patient access to premier orthopedic and spine care,” said Robbert Vorhoff, Managing Director and Global Head of Healthcare at General Atlantic. “We are excited to work alongside HSS and Legent to support physicians, deliver quality care, and improve patient outcomes and satisfaction across the country.”

Jordan Fowler, CEO and Chairman of Legent, commented, “Legent was founded on the belief that ambulatory surgery centers can deliver a superior patient and physician experience while lowering costs for everyone involved. We look forward to continuing to provide the highest quality of care and bringing our mission to more patients as part of this pioneering new platform.”

James Frank, Head of Strat Cap at BTG Pactual Global Alternatives, said, “We are proud of the value created through our partnership with the Legent management team. We wish General Atlantic, HSS, and the management team continued success as they embark on this next phase.”

Goodwin Procter LLP and Paul, Weiss, Rifkind, Wharton & Garrison LLP served as legal advisors to HSS and General Atlantic. Ducera Partners LLC served as financial advisor, and Gibson, Dunn & Crutcher LLP and McDermott Will & Schulte LLP served as legal advisors to Legent and Strat Cap.

About Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 16th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2025-2026), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2024-2025). Founded in 1863, the Hospital has the lowest readmission rates in the nation for orthopedics, and among the lowest infection and complication rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. In addition, more than 200 HSS clinical investigators are working to improve patient outcomes through better ways to prevent, diagnose, and treat orthopedic, rheumatic and musculoskeletal diseases. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 165 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

About General Atlantic

General Atlantic is a leading global investor with more than four and a half decades of experience providing capital and strategic support for over 830 companies throughout its history. Established in 1980, General Atlantic continues to be a dedicated partner to visionary founders and investors seeking to build dynamic businesses and create long-term value. Guided by the conviction that entrepreneurs can be incredible agents of transformational change, the firm combines a collaborative global approach, sector-specific expertise, a long-term investment horizon, and a deep understanding of growth drivers to partner with and scale innovative businesses around the world. The firm leverages its patient capital, operational expertise, and global platform to support a diversified investment platform spanning Growth Equity, Credit, Climate, and Sustainable Infrastructure strategies. General Atlantic manages approximately $114 billion in assets under management, inclusive of all strategies, as of June 30, 2025, with more than 900 professionals in 20 countries across five regions. For more information on General Atlantic, please visit: www.generalatlantic.com.

About PSN Group, LLC

PSN is a privately held provider of surgical services through its network of surgical hospitals and ambulatory surgery centers operating under the brand Legent Health. Headquartered in Plano, Texas, PSN aligns closely with physicians and payors to provide high quality, high value surgical care in a manner that prioritizes patient service and experience. For more information: https://www.legenthealth.com.

About BTG Pactual Strategic Capital

​BTG Pactual (BPAC11) is the largest investment bank in Latin America with a market capitalization of ~US$ 30B. Strat Cap is an opportunistic investment strategy focused on hybrid solutions in defensive sectors in the U.S. and is part of BTG Pactual’s ~US$ 9.4B Global Alternatives division. Strat Cap partners with management teams and business owners to create value and is led by a seasoned investment team with relevant experience in private equity, credit, and structured solutions. All figures are as of 2Q2025. For more information, please visit http://www.btgstratcap.com.

Contacts

Media Contacts
Hospital for Special Surgery
Tracy Hickenbottom

Assistant Vice President, Public Relations & Social Media

mediarelations@hss.edu
(212) 606-1197

General Atlantic
media@generalatlantic.com

BTG Pactual Strategic Capital
Elaine.Irvin@Btgpactual.com

ProteinQure Reports Broad Brain Distribution of Peptide-siRNA Conjugates in Non-Human Primates




ProteinQure Reports Broad Brain Distribution of Peptide-siRNA Conjugates in Non-Human Primates

TORONTO–(BUSINESS WIRE)–ProteinQure announced new preclinical results today, demonstrating efficient delivery of small interfering RNA (siRNA) to the central nervous system (CNS) in non-human primates. Using intrathecal administration of proprietary peptide-oligonucleotide conjugates that leverage receptor-mediated transport, the study provides evidence of widespread distribution of siRNA throughout the brain.

The data establishes ProteinQure’s platform as competitive with best-in-class approaches. In the 28-day study, the ProteinQure conjugates were directly compared to lipid-based approaches that are considered leading CNS delivery platforms in clinical development. “These results highlight the potential of our siRNA conjugate technology to overcome long-standing barriers in nucleic acid delivery to the brain,” said Lucas Siow, CEO of ProteinQure. “By coupling optimized peptides to oligonucleotides, we have achieved broad CNS biodistribution in primates, with superiority in certain cell types — a critical step toward advancing oligonucleotide therapeutics for neurological disorders.”

These findings and additional early data on ProteinQure’s blood-brain barrier shuttle program will be presented at the 21st Annual Meeting of the Oligonucleotide Therapeutics Society in Budapest, October 2025.

Contacts

Lucas Siow

lucas@proteinqure.com

PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan




PeptiDream, PDRadiopharma and Curium Group Enroll First Patient to Registrational Clinical Trial of 64Cu-PSMA-I&T for Prostate Cancer in Japan

KAWASAKI, Japan–(BUSINESS WIRE)–PeptiDream Inc., a public Kanagawa, Japan-based biopharmaceutical company (President: Patrick C. Reid, hereinafter “PeptiDream”)(Tokyo: 4587), PDRadiopharma Inc. (President: Masato Murakami, Headquarters: Chuo-ku, Tokyo, Japan, “PDRadiopharma”), a wholly owned subsidiary of PeptiDream, and Curium Group, a world leader in nuclear medicine (CEO: Renaud Dehareng, Headquarters: Boston, Massachusetts, the United States), today announced that a registrational Phase 2 clinical trial (jRCT: 2031250225) has been initiated in Japan for ⁶⁴Cu-PSMA-I&T, a PET radiopharmaceutical targeting prostate-specific membrane antigen (PSMA) expressed on prostate cancer cells.

⁶⁴Cu-PSMA-I&T is being assessed as a diagnostic PET imaging agent labeled with the radioisotope Copper-64, being developed with its therapeutic pair, ¹⁷⁷Lu-PSMA-I&T. The development is conducted under the strategic collaboration between PDRadiopharma and Curium aiming at advancing innovative radiopharmaceuticals for prostate cancer in Japan.

The open-label, single-arm Phase 2 study will evaluate the sensitivity, specificity, and safety of ⁶⁴Cu-PSMA-I&T. The trial will enroll approximately 70 patients who have been newly diagnosed with unfavorable intermediate, high or very high-risk prostate cancer and are scheduled for prostatectomy with pelvic lymph node dissection. This study is being conducted as a registrational trial in Japan and will utilize bridging data from Curium’s ongoing global clinical trials.

In parallel, a clinical trial for ¹⁷⁷Lu-PSMA-I&T as a therapeutic agent is being planned to evaluate its efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC).

Patrick C. Reid, President & CEO of PeptiDream commented: “Targeted radiopharmaceuticals are rapidly revolutionizing how we both diagnose and treat cancer. At PeptiDream and PDRadiopharma we are focused on expanding our pipeline of these targeted therapies, and we are thrilled to be able to accelerate those efforts by partnering with Curium to bring their prostate cancer targeting radiopharmaceuticals to patients in Japan.”

Masato Murakami, President of PDRadiopharma & CMO of PeptiDream commented: “We are excited to initiate the development of ⁶⁴Cu-PSMA-I&T in Japan. Both ⁶⁴Cu-PSMA-I&T and ¹⁷⁷Lu-PSMA-I&T are considered potential products for diagnosing and treating PSMA-expressing prostate cancer. There is demand in Japan for PSMA PET diagnosis, as many urologists wish to use this imaging modality in clinical practice. In collaboration with Curium, we aim to address this need and utilize radiopharmaceuticals to provide new medical treatments for patients.”

Renaud Dehareng, CEO of Curium Group commented: “Conducting these registrational trials, in partnership with PeptiDream and PDRadiopharma, marks a significant milestone in our mission to expand access to cutting-edge radiopharmaceuticals to patients with prostate cancer across Asia. By combining Curium’s global development expertise with PDRadiopharma’s deep local knowledge and infrastructure, we are well-positioned to deliver transformative solutions to prostate cancer patients in Japan.”

Global Clinical Trial Progress

For ¹⁷⁷Lu-PSMA-I&T, a PSMA-targeting ligand conjugated with the radioisotope Lutetium-177, has been tested by Curium in a global Phase 3 ECLIPSE trial (ClinicalTrials.gov identifier; NCT05204927). It reported that the primary endpoint was met, demonstrating a statistically significant and clinically meaningful benefit for patients with mCRPC.

For ⁶⁴Cu-PSMA-I&T, trials are being conducted to diagnose biochemical recurrence of prostate cancer (SOLAR RECUR trial, ClinicalTrials.gov identifier NCT06235099) and for men newly diagnosed with unfavorable intermediate to very high-risk prostate cancer, electing to undergo surgery (SOLAR STAGE trial, ClinicalTrials.gov identifier; NCT06235151). The first in human Phase 1/2 SOLAR trial met the co-primary endpoints of region-level correct localization rate and patient-level correct detection rate in patients with histologically-proven metastatic prostate cancer.

Contacts

Inquiries:

PeptiDream Inc.
Contact: Yuko Okimoto, IR & Public Affairs

Email: info@peptidream.com
Website: https://www.peptidream.com/en/
X: https://x.com/PeptidreamInc

PDRadiopharma Inc.
Contact: Noriko Tanaka, General Affairs

Email: s-info-hq@pdradiopharma.com

Curium
Camilla Campell

VP, Head of Global Communications

communications@curiumpharma.com

Genentech Data at ESMO 2025 Showcase Advances in Science and Cancer Care Across Multiple Tumor Types




Genentech Data at ESMO 2025 Showcase Advances in Science and Cancer Care Across Multiple Tumor Types

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that it will present more than 30 abstracts across more than 10 cancer types at the European Society for Medical Oncology (ESMO) Congress 2025, held October 17-21, 2025 in Berlin, Germany. The data underscore Genentech’s commitment to deliver transformative medicines for some of the most challenging cancer types, including breast cancers, lung cancers, gastrointestinal and genitourinary cancers.

Key presentations include:

• Giredestrant: Primary results from the Phase III evERA Breast Cancer study, the first positive head-to-head Phase III trial investigating an all-oral selective estrogen receptor (ER) degrader-containing regimen versus a standard of care combination in the post-cyclin-dependent kinase inhibitor setting for people with ER-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. The study met both co-primary endpoints, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in both the intention-to-treat and ESR1-mutated populations. Data will be presented as a late-breaking oral abstract.

• Tecentriq: Results from the IMvigor011 trial, the first global Phase III study pioneering a circulating tumor DNA (ctDNA)-guided approach to post-surgery treatment in muscle-invasive bladder cancer (MIBC). Topline results show that people who had detectable ctDNA and were treated with Tecentriq^® (atezolizumab) had statistically significant and clinically meaningful improvements in disease-free survival (DFS) and overall survival (OS). Data will be presented as part of the Presidential Symposium.

• Alecensa: Final OS data from the pivotal ALEX study of Alecensa^® (alectinib). Alecensa is an established first-line treatment and a standard of care for people with advanced anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Data will be presented as a late-breaking oral abstract and published simultaneously in the Annals of Oncology.

• Alecensa: Updated results from the Phase III ALINA study, reinforcing the role of adjuvant Alecensa as the standard of care for patients with resected ALK-positive NSCLC. After a median follow-up of approximately four years, Alecensa DFS data compared with chemotherapy will be presented.

Overview of key presentations featuring Genentech medicines:

* Investigator Initiated Study (IIS). The study is sponsored by MEDSIR and supported by Genentech, a member of the Roche Group.

** Investigator Initiated Study (IIS). The study is sponsored by the National Cancer Institute (NCI), conducted by the Alliance for Clinical Trials in Oncology and supported by Genentech, a member of the Roche Group.

What is Itovebi?

Itovebi^® (inavolisib) is a prescription medicine used in combination with the medicines palbociclib and fulvestrant to treat adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has an abnormal phosphatidylinositol-3-kinase catalytic subunit alpha (PIK3CA) gene, and has spread to nearby tissue or lymph nodes (locally advanced), or to other parts of the body (metastatic), and has come back after hormone (endocrine) therapy.

Your healthcare provider will test your cancer for abnormal PIK3CA genes to make sure that Itovebi is right for you.

It is not known if Itovebi is safe and effective in children.

Important Safety Information

What are the possible side effects of Itovebi?

Itovebi may cause serious side effects, including:

• High blood sugar levels (hyperglycemia). High blood sugar is common with Itovebi and may be severe or fatal. Untreated severe hyperglycemia can lead to a condition called diabetic ketoacidosis that can happen in people treated with Itovebi. Diabetic ketoacidosis is a serious condition that requires treatment in a hospital and that can lead to death. Your healthcare provider will monitor your blood sugar levels before you start and during treatment with Itovebi. Your blood sugar levels may be monitored more often if you have a history of Type 2 diabetes. Your healthcare provider may also ask you to self-monitor and report your blood sugar levels at home. This will be required more frequently in the first 4 weeks of treatment. If you are not sure how to test your blood sugar levels, talk to your healthcare provider. You should stay well-hydrated during treatment with Itovebi. Tell your healthcare provider right away if you develop symptoms of high blood sugar, including:
  • difficulty breathing
  • nausea and vomiting (lasting more than 2 hours)
  • stomach pain
  • excessive thirst
  • dry mouth
  • more frequent urination than usual or a higher amount of urine than normal
  • blurred vision
  • unusually increased appetite
  • weight loss
  • fruity-smelling breath
  • flushed face and dry skin
  • feeling unusually sleepy or tired
  • confusion
• Mouth sores (stomatitis). Mouth sores are common with Itovebi and may be severe. Tell your healthcare provider if you develop any of the following in your mouth:
  • pain
  • redness
  • swelling
  • ulcers
• Diarrhea. Diarrhea is common with Itovebi and may be severe. Severe diarrhea can lead to the loss of too much body water (dehydration) and kidney injury. Tell your healthcare provider right away if you develop diarrhea, stomach-area (abdominal) pain, or see mucus or blood in your stool during treatment with Itovebi. Your healthcare provider may tell you to drink more fluids or take medicines to treat your diarrhea

Your healthcare provider may tell you to decrease your dose, temporarily stop your treatment, or completely stop your treatment with Itovebi if you develop certain serious side effects.

The most common side effects and abnormal blood test results of Itovebi when used in combination with palbociclib and fulvestrant include:

• decreased white blood cell counts, red blood cell counts, and platelet counts
• decreased blood levels of calcium, potassium, sodium, and magnesium
• increased creatinine blood levels
• tiredness
• increased blood levels of the liver enzyme alanine transaminase (ALT)
• nausea
• rash
• loss of appetite
• COVID-19 infection
• headache

Itovebi may affect fertility in males and in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of Itovebi. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. You may also report side effects to Genentech at (877) 436-3683.

Before you take Itovebi, tell your healthcare provider about all of your medical conditions, including if you:

• have a history of diabetes or high blood sugar
• have kidney problems
• are pregnant or plan to become pregnant. Itovebi can harm your unborn baby.

Females who are able to become pregnant:

• Your healthcare provider will check to see if you are pregnant before you start treatment with Itovebi.
• You should use effective non-hormonal birth control (contraception) during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about what birth control method is right for you during this time.
• Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Itovebi.

Males with female partners who are able to become pregnant:

• You should use effective birth control (contraception) during treatment with Itovebi and for 1 week after your last dose.

• are breastfeeding or plan to breastfeed. It is not known if Itovebi passes into your breastmilk. Do not breastfeed during treatment with Itovebi and for 1 week after your last dose. Talk to your healthcare provider about the best way to feed your baby during treatment with Itovebi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Please see the full Prescribing Information, including Patient Information, for additional Important Safety Information.

Who is Alecensa for?

Alecensa is a prescription medicine used to treat people with non-small cell lung cancer (NSCLC) that is caused by an abnormal anaplastic lymphoma kinase (ALK) gene:

• To help prevent lung cancer from coming back in patients after their tumor has been removed by surgery (adjuvant), or
• As treatment if your lung cancer has spread to other parts of the body (metastatic).

Your doctor will perform a test to make sure that Alecensa is right for you. It is not known if Alecensa is safe and effective in children.

Important Safety Information

Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.

Your doctor may lower the dose or stop treatment with Alecensa if any side effects occur. Contact your doctor right away if you have any of the following side effects.

Alecensa may cause serious side effects, including:

Liver problems (hepatotoxicity). Liver problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first 3 months, and then 1 time each month and as needed during treatment with Alecensa. Tell your doctor right away if you get any of the following signs and symptoms:

• Feeling tired
• Feeling less hungry than usual
• Yellowing of the skin or whites of the eyes
• Dark urine
• Itchy skin
• Nausea or vomiting
• Pain on the right side of stomach area
• Bleeding or bruising more easily than normal

Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including trouble breathing, shortness of breath, cough, or fever.

Kidney problems. Alecensa may cause very slow heartbeats that can be severe. Your doctor will check your heart rate and blood pressure during treatment with ALECENSA. Tell your doctor right away if you feel dizzy, lightheaded, or if you faint during treatment with ALECENSA. Tell your doctor if you take any heart or blood pressure medicines.

Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or if they faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.

Severe muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. Your doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Tell your doctor right away if you have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.

Breakdown of healthy red blood cells earlier than normal (hemolytic anemia). Hemolytic anemia can happen in some people who take Alecensa. If this happens, you may not have enough healthy red blood cells. Your doctor may temporarily stop Alecensa and do blood tests, if needed, to check for this problem. If you develop hemolytic anemia, your doctor may either restart you on Alecensa at a lower dose when the hemolytic anemia goes away, or may stop your treatment with Alecensa. Tell your doctor right away if you experience yellow skin (jaundice), weakness or dizziness, or shortness of breath.

What should I tell my doctor before taking ALECENSA?

Before you take Alecensa, tell your doctor about all of your medical conditions, including if you:

• have liver problems
• have lung or breathing problems
• have a slow heartbeat
• are pregnant or plan to become pregnant. Alecensa can harm an unborn baby.

Females who are able to become pregnant:

• Your doctor will do a test to see if you are pregnant before starting treatment with Alecensa
• You should use effective birth control (contraception) during treatment with Alecensa and for 5 weeks after the last dose of Alecensa
• Tell your doctor right away if you become pregnant during treatment with Alecensa or think you may be pregnant

Males who have female partners that are able to become pregnant should use effective birth control (contraception) during treatment with Alecensa and for 3 months after the last dose of Alecensa

• Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into your breast milk. Do not breastfeed during treatment with Alecensa and for 1 week after the last dose of Alecensa. Talk to your doctor about the best way to feed your baby during this time

Tell your doctor about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while taking Alecensa?

Avoid spending time in the sunlight during treatment with Alecensa and for 7 days after the final dose of Alecensa. Your skin may be sensitive to the sun (photosensitivity) and you may burn more easily and get severe sunburns. Use sun protecting measures, such as sunscreen and lip balm with SPF 50 or greater to help protect against sunburn.

The most common side effects of Alecensa include:

• constipation
• tiredness
• swelling in hands, feet, ankles, face, and eyelids
• rash
• cough

These are not all of the possible side effects of Alecensa. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in full Prescribing Information, including Patient Information.

What is Tecentriq?

Tecentriq is a prescription medicine used to treat:

Adults with a type of lung cancer called “extensive stage small cell lung cancer (SCLC)”, which is SCLC that has spread or grown

• Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment
• Tecentriq may be used with the medicine lurbinectedin as maintenance treatment when your lung cancer:
  • has not progressed after first treatment with TECENTRIQ or atezolizumab and hyaluronidase-tqjs and the chemotherapy medicines carboplatin and etoposide.

It is not known if Tecentriq is safe and effective when used:

• In children for the treatment of SCLC.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any new or worse signs or symptoms, including:

Lung problems

• cough
• shortness of breath
• chest pain

Intestinal problems

• diarrhea (loose stools) or more frequent bowel movements than usual
• stools that are black, tarry, sticky, or have blood or mucus
• severe stomach-area (abdomen) pain or tenderness

Liver problems

• yellowing of your skin or the whites of your eyes
• severe nausea or vomiting
• pain on the right side of your stomach area (abdomen)
• dark urine (tea colored)
• bleeding or bruising more easily than normal

Hormone gland problems

• headaches that will not go away or unusual headaches
• eye sensitivity to light
• eye problems
• rapid heartbeat
• increased sweating
• extreme tiredness
• weight gain or weight loss
• feeling more hungry or thirsty than usual
• urinating more often than usual
• hair loss
• feeling cold
• constipation
• your voice gets deeper
• dizziness or fainting
• changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

• decrease in your amount of urine
• blood in your urine
• swelling of your ankles
• loss of appetite

Skin problems

• rash
• itching
• skin blistering or peeling
• painful sores or ulcers in mouth or nose, throat, or genital area
• fever or flu-like symptoms
• swollen lymph nodes

Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Call or see your healthcare provider right away for any new or worse signs or symptoms, including:

• Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
• Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
• Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
• Persistent or severe muscle pain or weakness, muscle cramps
• Low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

• chills or shaking
• itching or rash
• flushing
• shortness of breath or wheezing
• dizziness
• feeling like passing out
• fever
• back or neck pain

Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with Tecentriq. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with Tecentriq. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with Tecentriq if you have severe side effects.

Before you receive Tecentriq, tell your healthcare provider about all of your medical conditions, including if you:

• have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
• have received an organ transplant
• have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
• have received radiation treatment to your chest area
• have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
• are pregnant or plan to become pregnant. Tecentriq can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tecentriq. Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with Tecentriq.
  • You should use an effective method of birth control during your treatment and for at least 5 months after the last dose of Tecentriq.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

• feeling tired or weak
• Nausea
• hair loss
• constipation
• diarrhea
• decreased appetite

Tecentriq may cause fertility problems in females, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all the possible side effects of Tecentriq. Ask your healthcare provider or pharmacist for more information about the benefits and side effects of Tecentriq.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555

Please see full Prescribing Information and Medication Guide for additional Important Safety Information.

About Genentech

Founded nearly 50 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions.

Contacts

Media Contact: Jared Preston, (650) 467-6800

Advocacy Contact: Julie Burns, (860) 881-6594

Investor Contacts: Loren Kalm (650) 225-3217

Bruno Eschli, +41 616875284

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AdvanCell to Present Promising Clinical Trial Results of ADVC001, a Novel Lead-212-based PSMA-targeted Alpha Therapy for Prostate Cancer, at ESMO 2025




AdvanCell to Present Promising Clinical Trial Results of ADVC001, a Novel Lead-212-based PSMA-targeted Alpha Therapy for Prostate Cancer, at ESMO 2025

• Results from the Phase 1b dose escalation of the TheraPb Phase 1/2 trial are the first clinical data for a Lead-212 (212Pb)-based-PSMA radioligand therapy
• The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring its potential to enhance therapeutic options for patients with metastatic prostate cancer
• The upcoming presentation at ESMO will feature updated safety and efficacy results from all seven Phase 1b treatment cohorts

SYDNEY, Australia–(BUSINESS WIRE)–AdvanCell, a clinical-stage radiopharmaceutical company developing innovative targeted alpha therapies for cancer, announces a presentation at the European Society for Medical Oncology (ESMO) Congress, taking place in Berlin, Germany, from October 17-21, 2025.

The presentation will feature promising results from the Phase 1b dose escalation of the Phase 1/2 TheraPb study, evaluating ADVC001, a Lead-212-based PSMA-targeted alpha therapy, in metastatic castration-resistant prostate cancer (mCRPC).

This will be the first presentation of clinical data from a 212Pb-PSMA therapy at a major oncology conference – an important milestone in advancing targeted alpha therapies for prostate cancer and a clear demonstration of AdvanCell’s leadership in radioligand therapy. The abstract presents a favorable safety profile for 212Pb-ADVC001 and promising anti-tumor activity, underscoring the potential of 212Pb-ADVC001 to enhance therapeutic options for patients with metastatic prostate cancer.

The abstract is available online on the ESMO website (link), and features data as of a May 9, 2025 cut-off. The poster to be presented at ESMO will include updated safety and efficacy data and additional treatment cohorts.

Details of the abstract and presentation:

Results from the Phase 1b Dose Escalation of 212Pb-ADVC001 in PSMA-Positive Metastatic Castration-Resistant Prostate Cancer (mCRPC): The TheraPb Trial

• Presenter: Aaron Hansen, MD, BSc, MBBS, FRACP, Princess Alexandra Hospital, Brisbane, Australia
• Presentation Number: 2388P
• Session: Prostate Cancer Poster Session
• Session Time/ Place: Saturday, October 18 / 12:00-12:45 PM CET / Hall 25
• Poster Display Time: 9:00 AM – 5:00 PM CET

About the TheraPb trial

The TheraPb trial (NCT05720130) is a prospective, open-label Phase 1/2 dose-escalation and expansion study designed to determine the safety and tolerability of escalating doses of 212Pb-ADVC001 administered every 6, 4, 2 or 1 week(s) during the dose-finding Phase 1b. The Phase 2 expansion will assess the efficacy and safety of 212Pb-ADVC001 at the recommended Phase 2 doses across three indications. The trial incorporates randomization and dose optimization elements to rigorously evaluate optimal dosing strategies of 212Pb-ADVC001 in PSMA-positive mCRPC and in hormone-sensitive prostate cancer (mHSPC).

About 212Pb-ADVC001

212Pb-ADVC001 is a novel, proprietary and patented small molecule PSMA-targeting radioligand with optimized physicochemical properties labelled with 212Pb, an alpha-emitting payload (radionuclide) with a high dose rate, short half-life (10.6 hours) and simple decay scheme. 212Pb-ADVC001 is designed to deliver radiation at a cellular level to more effectively kill prostate cancer cells while minimizing toxicity.

About AdvanCell

AdvanCell is a vertically integrated, clinical-stage radiopharmaceutical company dedicated to developing innovative cancer therapies that harness the power of targeted alpha-emitting radionuclides. By leveraging its proprietary Lead-212 platform, advanced and scalable manufacturing capabilities, cutting-edge science and world-class clinical development capabilities, AdvanCell aims to deliver novel treatments that improve outcomes for patients with cancer globally.

For more information, visit www.advancell.com.au and follow us on LinkedIn.

Contacts

Andrew Adamovich, CEO

contact@advancell.com.au

For media inquiries, please contact:
MEDiSTRAVA

Mark Swallow, Frazer Hall, Sylvie Berrebi

advancell@medistrava.com
+44 (0)20 3928 6700

Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium




Natera to Present 14 Studies at ESMO, Including IMvigor011 Oral Presentation in Presidential Symposium

Six oral presentations highlight Signatera’s expanding role across solid tumors, including definitive predictive data in adjuvant bladder cancer

AUSTIN, Texas–(BUSINESS WIRE)–Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, today announced that 14 studies featuring its technology will be presented at the European Society for Medical Oncology (ESMO) Congress, taking place October 17–21 in Berlin, Germany. The slate includes six oral presentations, reinforcing Natera’s position as a leader in molecular residual disease (MRD) testing across multiple cancer types.

Bladder Cancer Highlights

The IMvigor011 trial, sponsored by Genentech, a member of the Roche Group, has been selected for a Presidential Symposium on October 20. With positive topline results announced in August, this oral presentation will include additional data on Signatera’s ability to predict disease-free survival (DFS) and overall survival (OS) benefit from adjuvant Tecentriq® (atezolizumab) in muscle-invasive bladder cancer (MIBC). IMvigor011 is the first prospective, phase III study in MIBC to be read out that uses a bespoke MRD-guided approach.

MRD analysis from the Phase 3 CheckMate 274 trial will also be shared in an oral presentation on October 17. CheckMate 274 randomized high-risk MIBC patients 1:1 to Opdivo® (nivolumab) or placebo for ≤ 1 year of adjuvant treatment. The results showed that DFS for Signatera-positive patients treated with nivolumab more than doubled compared to placebo (7.4 months vs 2.8 months; HR: 0.35). In contrast, no significant improvement in DFS was observed with the use of nivolumab among Signatera-negative patients.

Additional ESMO Data

Additional oral presentations include results from the SunRISe-4 trial in MIBC, the INTERCEPT trial in colorectal cancer, and Natera’s early cancer detection program.

“Across multiple different Phase 3 trials, we’ve now shown how Signatera MRD can help identify patients with bladder cancer who are most likely to benefit from adjuvant immunotherapy,” said Matthew Galsky, M.D., Lillian and Howard Stratton Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Associate Director for Translational Research at the Tisch Cancer Center. “These key studies are building a powerful foundation for bespoke MRD to guide different forms of treatment, improve outcomes for patients with bladder cancer and change medical practice.”

“We are proud to showcase the breadth of research using Signatera at this year’s ESMO Congress, including oral presentations across bladder, colorectal, breast, and other cancers,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “The diversity of these datasets underscores the growing impact of bespoke MRD assessment in reshaping how we detect and monitor cancer, providing tools to personalize treatment recommendations in oncology–with the ultimate goal of improving outcomes for patients.”

Full list of presentations featuring Natera’s technology at ESMO includes:

October 17, 2:50 PM CEST | 3068O (Oral Presentation)

Presenter: Matthew D. Galsky, M.D.

Adjuvant nivolumab vs placebo for high-risk muscle-invasive urothelial carcinoma: 5-year efficacy and ctDNA results from CheckMate 274

October 17, 4:40 PM CEST | LBA 112 (Mini Oral Presentation)

Presenter: Andrea Necchi, M.D.

Neoadjuvant gemcitabine intravesical system (TAR-200) + cetrelimab (CET) or CET alone in patients (pts) with muscle-invasive bladder cancer (MIBC): SunRISe-4 (SR-4) primary analysis and biomarker results

October 18, 9:00 AM CEST | 185eP

Presenter: Michael Galo

Treatment response using a tumor-informed circulating DNA test (TIctDNA) comparing with radiologic outcomes in non-small cell lung cancer (NSCLC)

October 18, 12:00 PM CEST | 1132P

Presenter: Floortje Backes, M.D.

Utility of circulating tumor DNA (ctDNA) dynamics for evaluating early treatment response in patients with recurrent/metastatic endometrial (rEC) and recurrent/platinum-resistant ovarian cancer (rPROC)

October 18, 12:00 PM CEST | 2609P

Presenter: Arnab Basu, MBBS, MPH, FACP, M.D.

Clinical Performance of a Tumor-Informed Whole Genome-Based (WGS) ctDNA Assay for Recurrence Detection and Treatment Response Monitoring in Localized and Advanced/Metastatic Renal Cell Carcinoma (RCC)

October 19, 12:00 PM CEST | 764P

Presenter: Masaaki Miyo, M.D., Ph.D.

Association of ultrasensitive whole genome sequencing (WGS)-based tumor-informed molecular residual disease (MRD) detection with lymph node metastasis (LNM) after local excision of pathological T1 colorectal cancer: Results from DENEB, a CIRCULATE-Japan GALAXY substudy

October 19, 2:45 PM CEST | 734MO (Mini Oral Presentation)

Presenter: Yoshiaki Nakamura, M.D., Ph.D.

Performance of a blood-based, early cancer detection (ECD) screening test for colorectal cancer (CRC) in cell-free (cf)DNA

October 19, 2:50 PM CEST | 732MO (Mini Oral Presentation)

Presenter: Emerick Osterlund, M.D., Ph.D.

Circulating tumor DNA (ctDNA) clearance and correlation with outcome in the INTERCEPT colorectal cancer (CRC) study

October 19, 12:00 PM CEST | 823P

Presenter: Kozo Kataoka, M.D.

A Phase II Study of mFOLFOXIRI Following Metastasectomy in Oligometastatic Colorectal Cancer: (FANTASTIC)

October 19, 3:40 PM CEST | LBA 31 (Oral Presentation)

Presenter: Yara L. Verschoor

Neoadjuvant immunotherapy induces immune activation and responses in MMR-proficient colon cancers

October 20, 12:00 PM CEST | 620TiP

Presenter: Benjamin Verret, M.D.

HEROES: De-escalation of anti-HER2 therapies in HER2-positive metastatic breast cancer with long-term persistent response and undetectable minimal residual disease in circulating tumor DNA

October 20, 12:00 PM CEST | 354P

Presenter: Adrian Lee, Ph.D.

Hormonal and immune mediators of resistance to primary endocrine therapy

October 20, 12:00 PM CEST | 336P

Presenter: Arielle J. Medford, M.D.

Circulating tumor DNA detection in stage 1 HER2 positive and triple negative breast cancer (SAFE-DE)

October 20, 4:30 PM CEST | LBA 8 (Oral Presentation)

Presenter: Thomas B. Powles, MBBS, MRCP, M.D.

IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer

Notes

Tecentriq® (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 300 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

Forward-Looking Statements

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Contacts

Investor Relations: Mike Brophy, CFO, Natera, Inc., investor@natera.com
Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of Unresectable or Advanced Gastroesophageal Adenocarcinomas in the Phase 2 EDGE-Gastric Study




Anti-TIGIT Domvanalimab Plus Anti-PD-1 Zimberelimab and Chemotherapy Showed 26.7 Months of Median Overall Survival as First-Line Treatment of Unresectable or Advanced Gastroesophageal Adenocarcinomas in the Phase 2 EDGE-Gastric Study

• First overall survival (OS) results from Arm A1 of the Phase 2 EDGE-Gastric study will be presented on October 18 at the European Society for Medical Oncology (ESMO) 2025 Congress
• These data support the ongoing development of domvanalimab plus zimberelimab and chemotherapy in the Phase 3 STAR-221 study in the same patient population

HAYWARD, Calif.–(BUSINESS WIRE)–Arcus Biosciences, Inc. (NYSE: RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, today announced the first OS results from Arm A1 of the Phase 2 EDGE-Gastric study in patients with locally advanced unresectable or metastatic gastric, gastroesophageal junction or esophageal adenocarcinoma. The ongoing, multi-arm, global Phase 2 EDGE-Gastric study is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab plus the anti-PD-1 monoclonal antibody zimberelimab and chemotherapy in this patient population. This study was conducted in partnership with Gilead Sciences. These results will be presented in a mini oral session at the ESMO 2025 Congress (Presentation Number 2112MO).

“It is impressive to see that 50 percent of the patients enrolled in Arm A1 of the EDGE-Gastric study went on to live for more than two years,” said Dr. Sun Young Rha, professor of Medical Oncology in the Department of Internal Medicine and the director of Songdang Institute for Cancer Research, Yonsei University College of Medicine, Yonsei University Health System in Seoul, Korea. “A 26.7-month median overall survival is well beyond what would be required to demonstrate clinically meaningful benefit over standard of care.”

“These survival results add to the totality of data for domvanalimab and the role of anti-TIGIT-based combinations for the treatment of different cancers and reinforce our conviction that an Fc-silent anti-TIGIT antibody may provide differentiated efficacy and safety,” said Richard Markus, M.D., Ph.D., chief medical officer of Arcus. “These promising results reinforce our confidence in the ongoing Phase 3 STAR-221 study.”

In addition to describing OS data, this presentation also includes updated progression-free survival (PFS) and objective response rate (ORR) data, which are consistent with prior reports on this study. At data cutoff (DCO, March 3, 2025), safety and efficacy were evaluated in all patients enrolled and treated (n=41), and median study follow-up was 26.4 months. Efficacy was observed across all PD-L1 subgroups. With a median time on treatment of 49 weeks (range: <1-117 weeks), the domvanalimab plus zimberelimab and chemotherapy regimen demonstrated sustained efficacy with longer follow-up.

Summary of EDGE-Gastric Arm A1 Efficacy Results:

No unexpected safety signals were observed at the time of data cutoff. The regimen of domvanalimab plus zimberelimab and chemotherapy was generally well tolerated and had a safety profile that is consistent with that of anti-PD-1 plus chemotherapy. Immune-mediated treatment-emergent adverse events related to domvanalimab and/or zimberelimab occurred in 9 patients (22%), and infusion-related reactions occurred in 3 patients (7%).

Domvanalimab and zimberelimab are investigational molecules, and neither Gilead nor Arcus has received approval from any regulatory authority for any use globally, and their safety and efficacy have not been established.

About the EDGE-Gastric Study

The ongoing, multi-arm, multi-cohort global Phase 2 EDGE-Gastric trial (NCT05329766) is evaluating the safety and efficacy of various combinations of the Fc-silent anti-TIGIT antibody domvanalimab and the anti-PD-1 antibody zimberelimab in patients with locally advanced unresectable or metastatic gastric (G), gastroesophageal junction (GEJ) or esophageal (E) adenocarcinoma. Patients in Arm A1, with previously untreated G/GEJ/E adenocarcinoma, received 1600mg of domvanalimab intravenously (IV) every four weeks (Q4W) plus 480mg of zimberelimab IV Q4W + FOLFOX (oxaliplatin 85 mg/m2 IV, leucovorin 400mg/m2 IV, fluorouracil 400mg/m2 IV bolus + 2400mg/m2 continuous 46-48-hour IV infusion) every two weeks.

About the STAR-221 Study

The ongoing, global STAR-221 trial (NCT05568095) enrolled approximately 1,050 participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma. The primary endpoints of the study are overall survival in PD-L1-high tumors, PD-L1-positive tumors and in the intent-to-treat population (all PD-L1 levels); secondary endpoints include progression-free survival, objective response rate and duration of response. Participants were randomized 1:1 between two arms:

• 1600mg of domvanalimab intravenously (IV) every four weeks plus 480mg of zimberelimab IV every four weeks plus FOLFOX (oxaliplatin, leucovorin, fluorouracil) every two weeks or 1200mg of domvanalimab plus 360mg of zimberelimab every three weeks plus CAPOX (capecitabine and oxaliplatin) every three weeks
• 240mg of nivolumab IV every two weeks plus FOLFOX every two weeks or 360mg of nivolumab plus CAPOX every three weeks

About Domvanalimab

Domvanalimab is the first and most clinically advanced Fc-silent investigational monoclonal antibody that is specifically designed with Fc-silent properties to block and bind to the T-cell immunoreceptor with Ig and ITIM domains (TIGIT), a checkpoint receptor on immune cells that acts as a brake on the anticancer immune response. By binding to TIGIT with Fc-silent properties, domvanalimab is believed to work by freeing up immune-activating pathways and activate immune cells to attack and kill cancer cells without depleting the peripheral regulatory T cells important in avoiding immune-related toxicity.

Combined inhibition of both TIGIT and programmed cell death protein-1 (PD-1) is believed to significantly enhance immune cell activation, as these checkpoint receptors play distinct, complementary roles in anti-tumor activity. Domvanalimab is being evaluated in combination with anti-PD-1 monoclonal antibodies, including zimberelimab in multiple ongoing and planned early and late-stage clinical studies in various tumor types.

About Zimberelimab

Zimberelimab is an anti-programmed cell death protein-1 (PD-1) monoclonal antibody that binds PD-1, with the goal of restoring the antitumor activity of T cells. Zimberelimab has demonstrated high affinity, selectivity and potency in various tumor types.

Zimberelimab is being evaluated in the U.S. and globally as a foundational anti-PD-1 treatment option in multiple ongoing clinical studies in combination with other immunotherapies. Guangzhou Gloria Biosciences Co. Ltd., which holds commercialization rights for zimberelimab in greater China, has obtained approval for zimberelimab for the treatment of recurrent or metastatic cervical cancer and for relapsed or refractory classical Hodgkin’s lymphoma. Zimberelimab is not approved for any use in the U.S. or other regions outside of China. Gloria conducts its development and commercialization activities independent of Arcus and Gilead.

About Arcus Biosciences

Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- and/or best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has advanced multiple investigational medicines into registrational clinical trials including domvanalimab, an Fc-silent anti-TIGIT antibody being studied in combination with zimberelimab, an anti-PD-1 antibody, for upper gastrointestinal and non-small cell lung cancer, casdatifan, a HIF-2a inhibitor for clear cell renal cell carcinoma, and quemliclustat, a small-molecule CD73 inhibitor for pancreatic cancer. For more information about Arcus Biosciences’ clinical and preclinical programs, please visit www.arcusbio.com.

Arcus Forward-Looking Statements

This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements on the potential for differentiation with domvanalimab. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’s actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to risks associated with: interim data not being replicated in other studies evaluating the same investigational molecules or regimen; the unexpected emergence of adverse events or other undesirable side effects from studies evaluating domvanalimab and/or zimberelimab; Arcus’s ability to complete ongoing studies; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release except to the extent required by law.

The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.

Contacts

Investor Inquiries:
Pia Eaves

VP of Investor Relations & Strategy

(617) 459-2006

peaves@arcusbio.com

Media Inquiries:
Holli Kolkey

VP of Corporate Affairs

(650) 922-1269

hkolkey@arcusbio.com

Maryam Bassiri

AD, Corporate Communications

(510) 406-8520

mbassiri@arcusbio.com

Data from Incyte’s TGFβR2×PD-1 Bispecific Antibody and KRAS G12D Inhibitor to be Presented at the European Society of Medical Oncology (ESMO) Congress 2025




Data from Incyte’s TGFβR2×PD-1 Bispecific Antibody and KRAS G12D Inhibitor to be Presented at the European Society of Medical Oncology (ESMO) Congress 2025

WILMINGTON, Del.–(BUSINESS WIRE)–$INCY #ESMO2025–Incyte (Nasdaq:INCY) today announced that results from Phase 1 proof-of-concept studies of INCA33890, a promising TGFβR2×PD-1-directed bispecific antibody, and INCB161734, a novel, selective and orally bioavailable KRAS G12D inhibitor, will be highlighted as oral presentations at the upcoming European Society of Medical Oncology (ESMO) Congress 2025 in Berlin.

“We are encouraged by the positive findings being presented with our TGFβR2×PD-1 and KRAS G12D inhibitor programs, which validate our rationale for advancing the development of these novel investigational compounds,” said Pablo J. Cagnoni, M.D., President and Head of Research and Development, Incyte. “There remains a significant need for new treatment options for patients with advanced solid tumors like colorectal cancer and pancreatic ductal adenocarcinoma and we look forward to providing updates on these clinical development programs.”

Details on INCA33890 and INCB161734 oral presentations at ESMO include:

INCA33890 (PD-1/TGFβR2)​

A Phase 1 Study Of INCA33890, A PD-1/TGFβR2 Bispecific Antibody, For Advanced Solid Tumours​

(Session Title: Mini oral session: Investigational immunotherapy. [October 17, 8:00 – 9:30 a.m. ET [2:00 – 3:30 p.m. CEST]. Abstract #1522.)

INCB161734 (KRAS G12D)​

Preliminary Phase 1 Results Of INCB161734, A Novel Oral KRAS G12D Inhibitor, In Patients With Advanced Or Metastatic Solid Tumors​

(Session Title: Proffered paper session: Developmental therapeutics. [October 19, 8:45 – 10:20 a.m. ET [2:45 – 4:20 p.m. CEST]. Abstract #916O.)

Analyst Event and Webcast

The data from the ESMO oral presentations and additional results from the INCA33890 in patients with microsatellite stable (MSS) colorectal cancer and INCB161734 in pancreatic ductal adenocarcinoma (PDAC) will also be discussed at an in-person analyst and investor event on Sunday, October 19, 2025, from 1:30 – 3:00 p.m. ET (7:30 – 9:00 p.m. CEST) at ESMO.

The event will be webcasted and can be accessed via the Events and Presentations tab of the Investor section of Incyte.com and it will be available for replay for 30 days.

More information regarding the 2025 ESMO Congress can be found at: https://www.esmo.org/meeting-calendar/esmo-congress-2025.

About Incyte

A global biopharmaceutical company on a mission to Solve On., Incyte follows the science to find solutions for patients with unmet medical needs. Through the discovery, development and commercialization of proprietary therapeutics, Incyte has established a portfolio of first-in-class medicines for patients and a strong pipeline of products in Oncology and Inflammation & Autoimmunity. Headquartered in Wilmington, Delaware, Incyte has operations in North America, Europe and Asia.

For additional information on Incyte, please visit Incyte.com or follow us on social media: LinkedIn, X, Instagram, Facebook, YouTube.

Incyte Forward-Looking Statements

Except for the historical information set forth herein, the matters set forth in this press release, including statements regarding the presentation of data from Incyte’s clinical development pipeline, the potential offered by INCB161734, whether or when any development compounds or combinations will be approved or commercially available for use in humans anywhere in the world outside of the already approved indications in specific regions, and Incyte’s goal of improving the lives of patients, contain predictions, estimates and other forward-looking statements.

These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to: unanticipated delays; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA, EMA, and other regulatory authorities; the efficacy or safety of Incyte and its partners’ products; the acceptance of Incyte and its partners’ products in the marketplace; market competition; sales, marketing, manufacturing and distribution requirements; and other risks detailed from time to time in our reports filed with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K and our quarterly report on Form 10-K for the quarter ended June 30, 2025. Incyte disclaims any intent or obligation to update these forward-looking statements.

Contacts

Media
media@incyte.com

Investors
ir@incyte.com

AHF Commends Gov. Newsom for Signing PBM Reform Bill (SB 41, Weiner)




AHF Commends Gov. Newsom for Signing PBM Reform Bill (SB 41, Weiner)

Legislation reforms will rein in drug middlemen abuses

LOS ANGELES–(BUSINESS WIRE)–AIDS Healthcare Foundation (AHF) thanked California Governor Gavin Newsom for signing SB 41, a bill which will further regulate pharmacy benefit managers (PBMs) and prevent inflated prescription drug prices. AHF also thanked Senator Scott Weiner (D-San Francisco), who authored and successfully carried the bill.

According to a statement issued by the governor, SB 41 “… enacts a sweeping reform of the allowable business practices for PBMs, … (and) represents the most aggressive effort in the country to lower prescription drug costs. California continues to lead the way in lowering costs, increasing transparency, and ensuring that the savings are passed on to payers and consumers.”

“For too long, PBMs have been inflating healthcare costs by sitting as a middleman between drug companies, health plans, and the pharmacies that dispense drugs to patients. Among other things, SB 41 prevents PBMs from profiting off of the spread between what health plans pay and pharmacies are reimbursed for their services. It also prevents PBMs from favoring their own pharmacies over pharmacies in the networks that the PBMs administer – a blatant conflict of interest. AHF has been in the forefront of PBM reform, and SB 41 represents a major victory that we and others fought long and hard for,” said Laura Boudreau, Chief of Operations, Risk Management and Quality Control for AHF. “Reining in PBM abuse remains an important issue nationwide, but today we celebrate passage of this bill and thank Senator Weiner for authoring and carrying this bill and Governor Newsom for signing it.”

AIDS Healthcare Foundation (AHF), the world’s largest HIV/AIDS healthcare organization, provides cutting-edge medicine and advocacy to more than 2.6 million individuals across 49 countries, including the U.S. and in Africa, Latin America/Caribbean, the Asia/Pacific Region, and Eastern Europe. To learn more about AHF, visit us online at AIDShealth.org, find us on Facebook, and follow us on Instagram, Twitter, and TikTok.

Contacts

MEDIA CONTACT:

Ged Kenslea, Senior Director, Communications, AHF

+1.323.791.5526 mobile ged.kenslea@ahf.org

Bristol Myers Squibb and TV Host Gail Simmons Tackle Stigma in Schizophrenia with New Initiative Spotlighting the Power of Support and Connection




Bristol Myers Squibb and TV Host Gail Simmons Tackle Stigma in Schizophrenia with New Initiative Spotlighting the Power of Support and Connection

The initiative features the perspectives of adults living with schizophrenia and taking COBENFY™ (xanomeline and trospium chloride), their care partners and a psychiatrist

PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #COBENFY—Bristol Myers Squibb (NYSE: BMY) today announced the launch of its COBENFY Connections™ initiative in partnership with culinary expert, TV host and author Gail Simmons.* Launching on World Mental Health Day, the initiative features real stories from people affected by schizophrenia, including Simmons, who shares her perspective through her brother Alan’s journey with the condition. The initiative aims to shift the narrative around schizophrenia, one of the most misunderstood and stigmatized mental illnesses, through honest conversation. Sharing her family’s experience and inviting others to do the same, Simmons emphasizes how connection and community can help people living with schizophrenia feel seen, supported, and hopeful, as well as the importance of finding the treatment that’s right for them.

Known for bringing people together around the table, Simmons recently hosted an intimate gathering with people living with schizophrenia and taking COBENFY™ (xanomeline and trospium chloride), along with their care partners and a psychiatrist. The gathering provided a rare, yet important space for open conversations about living with schizophrenia, highlighting how advocating for yourself and your treatment goals, exploring options, and finding a medicine that works for you can make a real difference.

“My older brother’s diagnosis with schizophrenia affected my family in so many ways, and we struggled to find the right medicines and resources,” said Simmons. “Hearing others share their experiences was an inspiring reminder of the power of community. Through COBENFY Connections, I hope to empower others to open up and explore what’s possible with the right support and treatment.”

The initiative also features the perspectives of Avary and Chanel, both living with schizophrenia and taking COBENFY, and their care partners.** COBENFY is an oral prescription medicine used to treat adults with schizophrenia. It is not known if COBENFY is safe and effective in children. See additional Important Safety Information below.

“We often take sitting at the table with loved ones for granted. Partnering with Gail let us create a space where people living with schizophrenia and their families could connect and share their experiences,” said Carlos Dortrait, senior vice president of Neuroscience Commercialization at Bristol Myers Squibb. “Our goal is simple: to create more spaces where experiences are shared, courage is celebrated, and stories like those of Chanel and Avary bring hope—showing how connection, community, and the right treatment can make a difference.”

Learn more about COBENFY Connections by visiting connections.bms.com.

Please see Important Safety Information for COBENFY below, including serious and most common side effects.

*Gail does not have schizophrenia and is not taking COBENFY. Gail’s brother Alan did not take COBENFY.

**Gail, Avary, Ashleigh, Chanel, Fines and Dr. Patricia Ares-Romero were compensated for their time.

About Schizophrenia

Schizophrenia is a persistent and often disabling mental illness impacting how a person thinks, feels and behaves. There are three main symptom domains of schizophrenia, which include positive symptoms (e.g., hallucinations, delusions, disordered thinking and speech), negative symptoms (e.g., lack of motivation, lack of emotional expression/flat affect, social withdrawal) and cognitive dysfunction (e.g., impaired attention, deficits in memory, concentration and decision-making). The symptoms of schizophrenia can affect all areas of people’s lives, making it difficult to maintain employment, live independently and manage relationships. Schizophrenia affects nearly 24 million people worldwide, including 2.8 million people in the United States, and is one of the top 15 leading causes of disability worldwide.

About COBENFY™ (xanomeline and trospium chloride)

COBENFY™ (xanomeline and trospium chloride), formerly KarXT, is an oral medication for the treatment of schizophrenia in adults. It is not known if COBENFY is safe and effective in children. COBENFY combines xanomeline, a dual M₁– and M₄-preferring muscarinic receptor agonist, with trospium chloride, a muscarinic receptor antagonist that does not appreciably cross the blood-brain barrier, primarily confining its effects to peripheral tissues. While the exact mechanism of action of COBENFY is unknown, its efficacy is thought to be due to the agonist activity of xanomeline at M₁ and M₄ muscarinic acetylcholine receptors in the central nervous system.

INDICATION

COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

COBENFY is contraindicated in patients with:

• urinary retention
• moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment
• gastric retention
• history of hypersensitivity to COBENFY or trospium chloride. Angioedema has been reported with COBENFY and trospium chloride.
• untreated narrow-angle glaucoma

WARNINGS AND PRECAUTIONS

Risk of Urinary Retention: COBENFY can cause urinary retention. Geriatric patients and patients with clinically significant bladder outlet obstruction and incomplete bladder emptying (e.g., patients with benign prostatic hyperplasia (BPH), diabetic cystopathy) may be at increased risk of urinary retention.

COBENFY is contraindicated in patients with pre-existing urinary retention and is not recommended in patients with moderate or severe renal impairment.

In patients taking COBENFY, monitor for symptoms of urinary retention, including urinary hesitancy, weak stream, incomplete bladder emptying, and dysuria. Instruct patients to be aware of the risk and promptly report symptoms of urinary retention to their healthcare provider. Urinary retention is a known risk factor for urinary tract infections. In patients with symptoms of urinary retention, consider reducing the dose of COBENFY, discontinuing COBENFY, or referring patients for urologic evaluation as clinically indicated.

Risk of Use in Patients with Hepatic Impairment: Patients with hepatic impairment have higher systemic exposures of xanomeline, a component of COBENFY, compared to patients with normal hepatic function, which may result in increased incidence of COBENFY-related adverse reactions.

COBENFY is contraindicated in patients with moderate or severe hepatic impairment. COBENFY is not recommended in patients with mild hepatic impairment.

Assess liver enzymes prior to initiating COBENFY and as clinically indicated during treatment.

Risk of Use in Patients with Biliary Disease: In clinical studies with COBENFY, transient increases in liver enzymes with rapid decline occurred, consistent with transient biliary obstruction due to biliary contraction and possible gallstone passage.

COBENFY is not recommended for patients with active biliary disease such as symptomatic gallstones. Assess liver enzymes and bilirubin prior to initiating COBENFY and as clinically indicated during treatment. The occurrence of symptoms such as dyspepsia, nausea, vomiting, or upper abdominal pain should prompt assessment for gallbladder disorders, biliary disorders, and pancreatitis, as clinically indicated.

Discontinue COBENFY in the presence of signs or symptoms of substantial liver injury such as jaundice, pruritus, or alanine aminotransferase levels more than five times the upper limit of normal or five times baseline values.

Decreased Gastrointestinal Motility: COBENFY contains trospium chloride. Trospium chloride, like other antimuscarinic agents, may decrease gastrointestinal motility. Administer COBENFY with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention. Use COBENFY with caution in patients with conditions such as ulcerative colitis, intestinal atony, and myasthenia gravis.

Risk of Angioedema: Angioedema of the face, lips, tongue, and/or larynx has been reported with COBENFY and trospium chloride, a component of COBENFY. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life-threatening. If involvement of the tongue, hypopharynx, or larynx occurs, discontinue COBENFY and initiate appropriate therapy and/or measures necessary to ensure a patent airway. COBENFY is contraindicated in patients with a history of hypersensitivity to trospium chloride.

Risk of Use in Patients with Narrow-angle Glaucoma: Pupillary dilation may occur due to the anticholinergic effects of COBENFY. This may trigger an acute angle closure attack in patients with anatomically narrow angles. In patients known to have anatomically narrow angles, COBENFY should only be used if the potential benefits outweigh the risks and with careful monitoring.

Increases in Heart Rate: COBENFY can increase heart rate. Assess heart rate at baseline and as clinically indicated during treatment with COBENFY.

Anticholinergic Adverse Reactions in Patients with Renal Impairment: Trospium chloride, a component of COBENFY, is substantially excreted by the kidney. COBENFY is not recommended in patients with moderate or severe renal impairment (estimated glomerular filtration rate (eGFR) <60 mL/min). Systemic exposure of trospium chloride is higher in patients with moderate and severe renal impairment. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate and severe renal impairment.

Central Nervous System Effects: Trospium chloride, a component of COBENFY, is associated with anticholinergic central nervous system (CNS) effects. A variety of CNS anticholinergic effects have been reported with trospium chloride, including dizziness, confusion, hallucinations, and somnolence. Monitor patients for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how COBENFY affects them. If a patient experiences anticholinergic CNS effects, consider dose reduction or drug discontinuation.

Most Common Adverse Reactions (≥5% and at least twice placebo): nausea, dyspepsia, constipation, vomiting, hypertension, abdominal pain, diarrhea, tachycardia, dizziness, and gastroesophageal reflux disease.

Use in Specific Populations:

• Moderate or Severe Renal Impairment: Not recommended
• Mild Hepatic Impairment: Not recommended

Pregnancy and Lactation: There is a pregnancy exposure registry that monitors outcomes in women exposed to psychiatric medications, including COBENFY, during pregnancy. Healthcare providers are encouraged to advise patients to register by calling 1-866-961-2388 or visiting https://womensmentalhealth.org/research/pregnancyregistry/atypicalantipsychotic/.

There are no available data on COBENFY use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Additionally, there are no data on the presence of xanomeline or trospium in human milk, the effects on the breastfed infant, or the effects on milk production. However, xanomeline and trospium are present in animal milk, suggesting they may also be present in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for COBENFY and any potential adverse effects on the breastfed infant from COBENFY or the underlying maternal condition.

COBENFY (xanomeline and trospium chloride) is available in 50mg/20mg, 100mg/20mg, and 125mg/30mg capsules.

Please see U.S. Full Prescribing Information, including Patient Information.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, X, YouTube, Facebook and Instagram.

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