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Arvinas and Pfizer Enter into a Transaction with Rigel Pharmaceuticals for the Exclusive Global Rights of VEPPANU (vepdegestrant)

On May 12, 2026 Arvinas, Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on targeted protein degradation, and Pfizer Inc. (NYSE: PFE) reported to have entered into a license agreement with Rigel Pharmaceuticals, Inc., a commercial stage biotechnology company focused on hematologic disorders and cancer, for the exclusive global development, manufacturing, and commercialization rights for VEPPANU (vepdegestrant). VEPPANU is the first U.S. Food and Drug Administration (FDA) approved PROteolysis TArgeting Chimera (PROTAC), a type of heterobifunctional protein degrader.

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Under the terms of the agreement, Arvinas and Pfizer will receive an upfront payment of $70 million and an additional $15 million upon successful completion of select development and manufacturing transition activities, to be distributed evenly between Arvinas and Pfizer. Arvinas and Pfizer will also be eligible to receive up to $320 million in future development, regulatory, and commercial milestone payments, as well as tiered royalties on net sales in the mid-teens to mid-20s, distributed evenly between Arvinas and Pfizer.

Rigel will be responsible for the launch and commercialization of VEPPANU in the U.S. and will own global rights with the ability to sublicense to potential partners to further develop and commercialize VEPPANU outside of the U.S. Arvinas and Pfizer will be entitled to a percentage of sublicensing revenue generated outside the U.S. Arvinas and Pfizer will continue to be responsible for current ongoing development activities and Rigel will contribute up to $40 million towards these activities.

"We are pleased to announce the selection of Rigel, a partner with an established oncology organization, to help unlock the commercial potential of VEPPANU and provide access to patients as efficiently as possible," said Randy Teel, Ph.D., President and Chief Executive Officer at Arvinas. "For patients living with ESR1-mutant, ER+/HER2- advanced breast cancer, there remains a significant need for new treatment options. VEPPANU represents a meaningful innovation in the way the disease is treated, and we are excited that Rigel is committed to making it available to patients who can benefit from it. At the same time, this agreement allows us to invest in the next wave of innovation across our early-stage pipeline while maintaining a strong and disciplined approach to our cash runway."

Closing of the transaction is subject to the parties’ receipt of any necessary consents or approvals, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. BofA Securities, Inc. is acting as the exclusive financial advisor to Arvinas.

VEPPANU is approved in the U.S. for the treatment of adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

On May 8, 2026, the National Comprehensive Cancer Network (NCCN) added vepdegestrant (VEPPANU) to the latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer. Vepdegestrant (VEPPANU) was added as a Category 2A treatment option for patients with hormone receptor (HR)-positive/HER2-negative, ESR1-mutated advanced or metastatic breast cancer after at least one line of endocrine therapy + cyclin-dependent kinase (CDK) 4/6 inhibitor.*

*NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.

About VEPPANU
VEPPANU (vepdegestrant) is an orally bioavailable PROteolysis TArgeting Chimera (PROTAC), estrogen receptor degrader approved in the U.S. for use as a monotherapy in the treatment of adults with estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

(Press release, Arvinas, MAY 12, 2026, View Source [SID1234665522])

Artios Announces Clinical Trial Collaboration with GSK to Evaluate Alnodesertib in Combination with Risvutatug Rezetecan, a B7-H3-Targeted ADC in Gastrointestinal Tumors

On May 12, 2026 Artios Pharma Limited ("Artios"), a clinical-stage biopharmaceutical company pioneering the development of new classes of DNA Damage Response (DDR) medicines to deliver meaningful survival benefits for patients with cancer, reported a clinical trial collaboration and supply agreement with GSK to evaluate alnodesertib, Artios’ ATR inhibitor, in combination with risvutatug rezetecan (also referred to as Ris-Rez), GSK’s novel investigational B7-H3-targeting topoisomerase-1 (Topo-1) antibody-drug conjugate (ADC), in patients with gastrointestinal tumors.

"We’re excited to collaborate with GSK to investigate the potential of this combination strategy to provide meaningful benefit to patients with GI tumors," said Mike Andriole, Chief Executive Officer of Artios. "As we advance the development of alnodesertib in multiple solid tumors, this collaboration enables Artios to broaden our combinatorial strategy and unlock the full potential of exploiting replication stress biology in cancer."

Under the terms of the agreement, GSK will sponsor and conduct the Phase 1 study and provide its B7-H3 Topo-1 ADC, while Artios will supply alnodesertib. Each party will maintain rights to its respective products, and the agreement is mutually non-exclusive. The clinical study is expected to open by the end of the year.

About risvutatug rezetecan

Ris-Rez is a novel investigational B7-H3-targeted antibody-drug conjugate composed of a fully human anti-B7-H3 monoclonal antibody covalently linked to a topoisomerase inhibitor payload. GSK acquired exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to progress clinical development and commercialisation of Ris-Rez. GSK’s global phase III trial (NCT07099898) for Ris-Rez in relapsed extensive stage small-cell lung cancer (ES-SCLC) began in August 2025.

Regulatory designations received for Ris-Rez to date include orphan drug designations from the US Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labor and Welfare in SCLC and the European Medicines Agency (EMA) in a category of cancer that includes SCLC, called pulmonary neuroendocrine carcinoma; Priority Medicines (PRIME) Designation from the EMA for relapsed or refractory ES-SCLC; and Breakthrough Therapy Designations for relapsed or refractory ES-SCLC and relapsed or refractory osteosarcoma from the US FDA.

About alnodesertib

Alnodesertib, formerly known as ART0380, is a potential first-in-class, orally administered, selective small molecule inhibitor of ataxia-telangiectasia and Rad3-related protein (ATR). Artios is developing alnodesertib in patients whose tumor harbours high degrees of replication stress using ATM status as a key biomarker. When used in combination with low-dose chemotherapy to further amplify replication stress, alnodesertib demonstrated unprecedented response rates across eight different solid tumors in ATM-deficient patients. Alnodesertib has received U.S. Fast Track designation in combination with a low dose of chemotherapeutic agent irinotecan, for the treatment of adult patients with ATM-negative metastatic colorectal cancer (mCRC) in the third-line setting.

(Press release, Artios Pharma, MAY 12, 2026, View Source [SID1234665521])

Akari Therapeutics Secures Key European Patent For Its Novel RNA Splicing Modulator ADC Payload, Strengthening Global IP Estate For All Major Global Markets

On May 12, 2026 Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing antibody drug conjugates (ADCs) with novel RNA splicing modulator payloads, reported the grant of a major European patent that significantly strengthens its global intellectual property position and underscores the differentiation of its proprietary PH1 ADC payload platform.

The newly granted patent (European Patent No. 3684773B1), titled "Thailanstatin Analogs," provides broad composition-of-matter protection for Akari’s proprietary Thailanstatin-based payloads, engineered for use in highly targeted cytotoxic ADC therapies. The claims encompass novel analogs designed to integrate with advanced linker technologies and enable targeting across multiple tumor-associated antigens.

"This European patent grant further strengthens the foundation of our proprietary payload platform and reinforces our ability to build a differentiated ADC pipeline," said Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics. "Expanding broad composition-of-matter protection across Europe is a critical step in advancing our strategy to develop a new class of ADC therapeutics. We believe this milestone continues to enhance the value of our platform while supporting the advancement of multiple programs across tumor types and key global markets."

This European patent provides protection across a broad range of designated countries, including Albania, Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Iceland, Italy, Lithuania, Luxembourg, Latvia, Monaco, Macedonia, Malta, the Netherlands, Norway, Poland, Portugal, Romania, San Marino, Serbia, Slovenia, the Slovak Republic, Spain, Sweden, Switzerland, Turkey and the United Kingdom, further expanding Akari’s global intellectual property estate.

Akari’s growing pipeline of novel ADCs, including AKTX-101 (targeting TROP2) and AKTX-102 (targeting CEACAM5), leverage its proprietary PH1 payload platform built around this novel IP. By targeting RNA splicing biology, Akari is advancing a novel therapeutic paradigm, disrupting fundamental cancer cell processes while simultaneously enhancing immune activation to potentially drive deeper and more durable responses.

This builds upon Akari’s rapidly expanding global IP portfolio, which includes issued patents across the United States, China, Japan, Australia, India, Mexico and Israel. Together, these protections establish a robust and defensible foundation around the Company’s PH1 payload chemistry and ADC architecture.

Akari’s lead program, AKTX-101, a TROP2-targeting ADC powered by its proprietary PH1 payload, is currently in IND-enabling studies with a targeted Phase 1 first-in-human clinical trial expected by mid-2027.

(Press release, Akari Therapeutics, MAY 12, 2026, View Source [SID1234665520])

Agios to Present New Data at EHA 2026 Reinforcing the Significant Therapeutic Impact of Mitapivat Across Multiple Rare Hemolytic Anemias

On May 12, 2026 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, reported that new data on mitapivat, an oral pyruvate kinase (PK) activator, will be featured in oral and poster presentations during the 31st European Hematology Association (EHA) (Free EHA Whitepaper) Congress (EHA 2026) in Stockholm, Sweden, June 11-14, 2026.

"Our presentations at EHA (Free EHA Whitepaper) 2026 build on over a decade of clinical and preclinical research that has consistently demonstrated the transformative potential of mitapivat as a disease-modifying oral medicine for hemolytic anemias, including sickle cell disease and thalassemia," said Sarah Gheuens, M.D., Ph.D., Chief Medical Officer and Head of R&D, Agios. "The plenary session for our RISE UP Phase 3 trial is an important opportunity to present new data showcasing the strong anti-hemolytic profile of mitapivat and its potential to address the urgent need for novel therapeutic options in sickle cell disease. We look forward to sharing these results and engaging with the hematology community as we continue to drive meaningful progress for patients with rare blood diseases."

Select presentations at EHA (Free EHA Whitepaper) 2026 will include:

An oral presentation during the Plenary Abstracts Session on detailed efficacy and safety data from the global 52-week, randomized, double-blind, placebo-controlled RISE UP Phase 3 trial of mitapivat in patients aged 16 years or older with sickle cell disease. Results demonstrate that treatment with mitapivat significantly improved hemoglobin response (a ≥1.0 g/dL increase from baseline in average hemoglobin from Week 24 through Week 52) and reduced markers of hemolysis (red blood cell destruction). Additional analyses, including measures of clinical benefit and patient-reported outcomes that were not previously disclosed in the company’s November 2025 topline report, will also be presented. The RISE UP abstract was one of only six selected for this distinguished plenary session from thousands of submissions.
An oral presentation on long-term data from the ENERGIZE Phase 3 trial of mitapivat in adult patients with non-transfusion-dependent alpha- or beta-thalassemia. Of the 192 patients who received at least one dose of mitapivat or placebo in the double-blind period of ENERGIZE, 95% (n=182) opted to transition into the corresponding open-label extension (OLE) period, during which all patients receive mitapivat. The results show the durability of mitapivat treatment, with clinically meaningful hemoglobin improvements sustained for up to 127 weeks across the double-blind and OLE periods. During the OLE, nearly half (n=30/61) of non-responders who switched from placebo achieved a hemoglobin improvement (a ≥1 g/dL increase from baseline in average hemoglobin during any two consecutive OLE study visits), supporting a consistent treatment effect with mitapivat. Additionally, about one-third (n=23/68) of non-responders who received mitapivat during the double-blind period achieved a hemoglobin improvement during the OLE, suggesting a potential benefit of continued long-term treatment.

A related poster will highlight a subset of patients with higher baseline hemoglobin levels (≥9.5 g/dL) in ENERGIZE. Among these patients, 38.9% (n=7/18) in the mitapivat arm achieved a hemoglobin response (a ≥1 g/dL increase from baseline in average hemoglobin from Week 12 through Week 24) in the double-blind period, compared with 0% (n=0/11) in the placebo arm. Additionally, patients in the mitapivat arm showed a 5.1-point improvement in patient-reported fatigue scores compared with 0.8 points among those in the placebo arm, as measured by the least squares mean change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue from Week 12 to Week 24.
An oral presentation on the collaborator-led SATISFY Phase 2 trial of mitapivat in 24 patients with one of three rare hemolytic anemias: hereditary spherocytosis, hereditary xerocytosis, or congenital dyserythropoietic anemia type II. Treatment resulted in sustained hemoglobin improvements over 56 weeks. Notably, patients who achieved a hemoglobin response (a ≥1 g/dL increase from baseline in average hemoglobin during at least two consecutive study visits) also showed significant decreases in liver iron content, an important marker of downstream complications in hemolytic anemias.
In total, 10 presentations and publications led by Agios and external collaborators will be shared at EHA (Free EHA Whitepaper) 2026.

EHA 2026 Accepted Abstracts

Title Number Date/Time Presenter Acceptance
Sickle Cell Disease
Efficacy and Safety of Mitapivat in Sickle Cell Disease: Results From the Global, Randomized, Phase 3 RISE UP Trial S102 Saturday, June 13, 12:00 – 1:30 p.m. CEST Biree Andemariam, M.D., University of Connecticut Health Oral Plenary Session
Metabolic Profiles Associated With Point of Sickling Reflect Immunoregulation, Oxidative Stress, and Compensatory Mechanisms in Patients With Sickle Cell Anemia PF1264 Friday, June 12, 6:45 – 7:45 p.m. CEST

Amira Idrizovic, Ph.D., Vall d’Hebron Research Institute, Barcelona, Spain Poster
Impaired Function of Pyruvate Kinase Is Associated With Hemolysis‑Related Inflammation, Ineffective Erythropoiesis, and Endothelial Dysfunction in Adults With Sickle Cell Anemia PF1269 Friday, June 12, 6:45 – 7:45 p.m. CEST Marissa J.M. Traets, M.D., University Medical Center Utrecht, Netherlands Poster
Thalassemia
Long‑Term Hemoglobin Improvements in Non-Transfusion‑Dependent Alpha‑ or Beta‑Thalassemia: Results From the Open‑Label Extension of the Ongoing Phase 3 ENERGIZE Trial S440 Saturday, June 13, 5:15 – 6:30 p.m. CEST Hanny Al‑Samkari, M.D., Mass General Brigham Cancer Institute

Oral
Efficacy of Mitapivat in Patients With Non-Transfusion‑Dependent Alpha‑ or Beta‑Thalassemia With Baseline Hemoglobin ≥9.5 g/dL: Subgroup Analysis From the Phase 3 ENERGIZE Trial PF1281 Friday, June 12, 6:45 – 7:45 p.m. CEST Khaled M. Musallam, M.D., Ph.D., Burjeel Medical City, Abu Dhabi, United Arab Emirates
Poster
ENERGIZEKIDS: Mitapivat in Pediatric Patients With Non-Transfusion‑Dependent Alpha‑ or Beta‑Thalassemia PB4160 N/A Kathryn Dickerson, M.D., University of Texas Southwestern Medical Center
Publication
ENERGIZEKIDS‑T: Mitapivat in Pediatric Patients With Transfusion‑Dependent Alpha‑ or Beta‑Thalassemia PB4162 N/A Janet Kwiatkowski, M.D., MSCE, Children’s Hospital of Philadelphia Publication
Other
The Patient Experience of Fatigue in Individuals With Sickle Cell Disease, Thalassemia, and Pyruvate Kinase Deficiency PB4417 N/A Biree Andemariam, M.D., University of Connecticut Health Publication
Effects of Mitapivat on Iron Burden and Spleen Size in Erythrocyte Membranopathies and Congenital Dyserythropoietic Anemia Type II: 56‑Week Follow‑Up Results From the SATISFY Study S304 Thursday, June 11, 4:45 – 6:00 p.m. CEST Thomas Doeven, M.D., University Medical Center Utrecht, Netherlands Oral
Diamond‑Blackfan Anemia Syndrome Erythroid Progenitors Display Abnormal Metabolic Profile PS1781 Saturday, June 13, 6:45 – 7:45 p.m. CEST Veronica Riccardi, M.D., University of Verona, Italy Poster

Please refer to the EHA (Free EHA Whitepaper) 2026 online program for full session details and data presentation listings, and visit the Agios booth (#A1.04) onsite.

EHA 2026 Investor Event
Agios will host a conference call and live webcast during the EHA (Free EHA Whitepaper) 2026 congress on Saturday, June 13, at 9:00 a.m. ET (3:00 p.m. CEST). The live webcast will be accessible on the Investors section of the company’s website (www.agios.com) under the "Events & Presentations" tab. A replay of the webcast will be available on the company’s website approximately two hours after the event.

(Press release, Agios Pharmaceuticals, MAY 12, 2026, View Source [SID1234665519])

Bristol Myers Squibb and Hengrui Pharma Announce Strategic Agreements to Advance Innovative Medicines Across Oncology, Hematology, and Immunology

On May 12, 2026 Bristol Myers Squibb (NYSE: BMY, "BMS") and Hengrui Pharma ("Hengrui") (600276.SH; 01276.HK) reported the companies have entered into global strategic collaboration and license agreements to advance a portfolio of 13 early stage programs in oncology, hematology and immunology, with the goal of accelerating discovery and development of innovative medicines for the benefit of patients worldwide.

The agreements include four oncology/hematology assets from Hengrui, four immunology assets from BMS, and five innovative assets to be jointly discovered and developed by both companies, leveraging Hengrui’s discovery engine and platform technologies across several innovative modalities. Hengrui has the option to co-develop select assets and the potential to conduct certain commercialization activities globally with BMS.

Under the collaboration, BMS obtains exclusive worldwide rights to the Hengrui‑originated assets outside Chinese mainland, Hong Kong SAR, and Macau SAR (the "Hengrui Territory"), while Hengrui obtains exclusive rights to the BMS‑originated assets within the Hengrui Territory, with BMS retaining rights for the rest of the world. Hengrui will be fully responsible for early clinical development to accelerate clinical proof of concept for these programs.

Aligned with the collaborative innovation strategies of both BMS and Hengrui, these agreements reflect the companies’ continued focus on advancing innovative science through partnership in areas of significant unmet medical need. The collaboration brings together BMS’s differentiated research and discovery strengths, global clinical development capabilities, regulatory expertise, and commercial scale with Hengrui Pharma’s discovery engine, platform technologies, and efficient early-stage development expertise, enabling the advancement of a broad portfolio of high-value programs.

"This strategic collaboration reflects our commitment to advancing innovative science while maintaining a disciplined approach to portfolio management," said Robert Plenge, MD, PhD, Executive Vice President and Chief Research Officer, Bristol Myers Squibb. "By leveraging complementary capabilities across geographies, we aim to accelerate early clinical learning and make informed decisions that support driving top tier growth in the next decade and, ultimately, our mission to deliver medicines that help patients prevail over serious diseases."

"This broad strategic collaboration reflects a highly synergistic collaboration between two global innovators with complementary strengths. By leveraging Hengrui’s growing R&D capabilities and proven efficiency in discovering and advancing innovative therapies, we are poised to advance the best of both pipelines," said Frank Jiang, MD, PhD, Executive Vice President and Chief Strategy Officer of Hengrui Pharma. "It also reflects Hengrui’s continued commitment to strengthen our global presence. Together, we aim to deliver meaningful benefits to patients worldwide."

Under the terms of the agreement, BMS will pay Hengrui up to $950 million, including a $600 million upfront payment, a $175 million first anniversary payment, and a second contingent anniversary payment of $175 million in 2028. The potential total value of the agreement is up to approximately $15.2 billion, including the exercise of available options for the joint discovery programs and the achievement of applicable development, regulatory, and commercial milestones for all programs. In addition, Hengrui is eligible to receive tiered royalties on net sales of products commercialized outside the Hengrui Territory.

The transaction is subject to review under the Hart‑Scott‑Rodino Antitrust Improvements Act and other customary closing conditions. The parties expect that the agreement will close in the third quarter of 2026.

(Press release, Bristol-Myers Squibb, MAY 12, 2026, View Source [SID1234665453])