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Welcome to PharmaShots Weekly
| June 08, 2026 Edition
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| | PharmaShots Weekly is your Monday signal check: a fast, story-driven run-through of the deals, data, approvals, and platforms that actually shift the biopharma landscape.
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Haisco, Lilly Ink $3.05B Drug Discovery Pact
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| | Alnylam, Inceptive Forge $2B RNAi Pact
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| | CytomX, Regeneron Expand $4B Cancer Pact
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| | Servier Buys Edgewise DMD Assets in $2.65B
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Stay Curious.
| Stay informed!
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| | Stay ahead with PharmaShots Weekly!
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Cover Story
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A New Chapter in Pancreatic Cancer Treatment?
Daraxonrasib delivers compelling Phase III results in metastatic pancreatic cancer, demonstrating significant improvements in overall survival, progression-free survival, and quality of life.
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Strategic Deals & Partnerships
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| • | Hanmi Pharm Inks ~$1.26B Deal with Eli Lilly to Advance Sonefpeglutide
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| • | Agios Licenses Cevidoplenib from Oscotec in a ~$165M Deal
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| • | Haisco, Lilly Ink $3.05B Drug Discovery Pact
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| • | Travere Secures Civorebrutinib Rights in ~$1.14B Pact
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| • | Ascidian, Lilly Forge ~$1.9B RNA Editing Deal
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| • | Alnylam, Inceptive Ink ~$2B AI-RNAi Deal
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| • | CytomX, Regeneron Expand $4B Cancer Pact
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| • | Lundbeck, Cradle Team Up on AI-Powered Biotherapeutics Discovery
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| • | Pfizer Licenses Chai AI for Biologics R&D
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Mergers & Acquisitions
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| • | Servier Acquires Edgewise DMD Assets for $2.65B
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| • | Rallybio, Avenzo Merge to Advance Oncology Therapies
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Clinical Trial Highlights
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| • | Retevmo significantly improves event-free survival in the Phase III LIBRETTO-432 study.
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| • | Ivonescimab demonstrates overall survival superiority in the Phase III HARMONi-6 trial.
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| • | Daraxonrasib achieves landmark survival gains in the Phase III RASolute 302 study.
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| • | Camizestrant delivers strong progression-free survival benefits in SERENA-6.
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| • | Livdelzi advances treatment goals with encouraging Phase III IDEAL results.
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| • | Pelareorep combination strategies show promising preclinical anti-tumor activity.
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| • | Gedatolisib combinations demonstrate meaningful efficacy in VIKTORIA-1.
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| • | Arcotatug Tavatecan achieves positive Phase III outcomes in Claudin 18.2-positive disease.
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| • | Bocunebart delivers encouraging efficacy in patients with prior treatment failures.
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| • | Voyxact continues to demonstrate kidney function preservation in Phase III development.
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Regulatory Watch
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This Week’s Key Approvals and Milestones
Key updates from Amgen, Genentech, AbbVie, and Chiesi across oncology, neurology, migraine, and rare diseases.
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MedTech Watch
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This Week’s Key Innovations and Clearances
FDA milestones for NeuroPace’s AI-powered epilepsy solution and Signati Medical’s minimally invasive vasectomy platform.
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Biosimilars Watch
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This Week’s Key Regulatory and Commercial Milestones
Key updates from Alvotech, Xbrane Biopharma, Teva, and Kashiv BioSciences spanning regulatory submissions, BLA acceptances, market launches, and biosimilar expansion across ophthalmology, immunology, and allergy therapeutics.
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A New Chapter in Pancreatic Cancer Treatment?
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For decades, metastatic pancreatic ductal adenocarcinoma (PDAC) has stood among the most formidable challenges in oncology. Characterized by aggressive disease progression, limited therapeutic options, and poor survival outcomes, pancreatic cancer has long remained an area of urgent unmet medical need.
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At ASCO 2026, Revolution Medicines presented findings that could mark a significant turning point in the treatment landscape. Data from the pivotal Phase III RASolute 302 trial demonstrated that daraxonrasib, a first-in-class RAS(ON) multi-selective inhibitor, delivered substantial clinical benefits in previously treated patients with metastatic PDAC, irrespective of RAS mutation status.
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The study reported a 60% reduction in the risk of death compared with standard chemotherapy, while median overall survival doubled to 13.2 months versus approximately 6.6–6.7 months in the control arm. Patients receiving daraxonrasib also experienced a notable improvement in progression-free survival, reaching 7.2–7.3 months compared with 3.5–3.6 months for chemotherapy-treated patients.
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Beyond survival outcomes, daraxonrasib demonstrated meaningful improvements in objective response rates and delayed deterioration in pain, quality of life, and overall health status—factors that remain critically important for patients facing advanced disease.
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Simultaneously published in The New England Journal of Medicine, the results position daraxonrasib as a potentially transformative RAS-targeted therapy in pancreatic cancer, a field where major breakthroughs have been rare.
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With global regulatory submissions planned, including a forthcoming FDA New Drug Application, and an Expanded Access Program already authorized for eligible patients, attention is now turning toward the therapy’s path to approval and real-world impact.
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If approved, daraxonrasib could represent one of the most significant advances in metastatic pancreatic cancer treatment in recent years, offering renewed hope to patients and clinicians in a disease where meaningful progress has historically been difficult to achieve.
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2026 HLTH Europe | June 15-18 | Amsterdam
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Join PharmaShots at HLTH Europe, continent’s #1 healthcare innovation event. Following an enormously successful launch and the exponential growth of HLTH in the US, this landmark event is where global expertise meets local insight to address Europe’s unique healthcare challenges and opportunities.
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Unlock an exclusive €250 discount with PharmaShots!
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Use code HE26PHARMASHOTS at checkout to save on your registration.
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| | Strategic Deals & Partnerships
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Hanmi Pharm Inks ~$1.26B Deal with Eli Lilly to Advance Sonefpeglutide
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Hanmi Pharm has granted Eli Lilly exclusive global rights (excluding Korea) to develop, manufacture, and commercialize sonefpeglutide, a GLP-2 analog that incorporates Hanmi’s long-acting Lapscovery platform technology.
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Why It Matters
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| • | Deal Value: ~$1.26B total consideration, including a $75M upfront payment and up to $1.185B in clinical, regulatory, and commercial milestone payments, plus tiered royalties post-launch, providing Lilly with a mid-stage GLP-2 analog for short bowel syndrome.
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| • | Clinical Benefit: Sonefpeglutide is a once-monthly GLP-2 analog designed to improve intestinal absorption in short bowel syndrome patients, potentially reducing parenteral support dependence and improving quality of life.
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| • | Therapeutic Area Expansion: Strengthens Eli Lilly’s portfolio in gastrointestinal and rare disease indications by adding a differentiated GLP-2 analog that complements its existing metabolic and oncology platforms.
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Strategic Focus
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| • | GI and Rare Disease Portfolio: Expands Eli Lilly’s gastrointestinal offerings with a long-acting GLP-2 analog addressing the unmet need for effective short bowel syndrome treatments with less frequent dosing.
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| • | Global Commercial Synergy: Combines Hanmi’s Lapscovery long-acting platform technology with Eli Lilly’s established global commercial infrastructure to accelerate market penetration and expand access to short bowel syndrome treatment solutions.
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| • | Development Risk Sharing: Hanmi continues to lead and complete the ongoing global Phase II trial while Lilly evaluates additional development opportunities, allowing both companies to leverage their respective clinical and commercial expertise.
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Agios Pharmaceuticals Licenses Cevidoplenib from Oscotec in a ~$165M Deal
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Oscotec has granted Agios exclusive global rights to cevidoplenib (oral), a spleen tyrosine kinase (SYK) inhibitor, across all indications, including immune thrombocytopenia (ITP).
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Why It Matters
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| • | Deal Value: ~$165M total consideration, including a $25M upfront payment, ~$140M in development and regulatory milestones across ~3 indications in the US and EU, plus commercial milestones and tiered royalties from high single digits to mid-teens on net sales.
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| • | Clinical Benefit: Cevidoplenib is an oral SYK inhibitor targeting immune thrombocytopenia and other immune-mediated indications, offering a potential once-daily oral treatment option for patients with low platelet counts.
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| • | Therapeutic Area Expansion: Strengthens Agios’s hematology and immuno-oncology portfolio by adding a differentiated SYK inhibitor that complements its existing cancer metabolism and sickle cell disease platforms.
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Strategic Focus
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| • | Hematology Portfolio: Expands Agios’s hematology offerings with an oral SYK inhibitor addressing the unmet need for effective ITP treatments with convenient oral dosing.
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| • | Global Development Control: Agios assumes full development and commercialization costs and rights globally, enabling streamlined decision-making and faster progression through Phase III in ITP.
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| • | Korea Option Structure: Oscotec retains an option to obtain exclusive South Korea rights after Phase III results, allowing flexibility for regional commercialization while Agios drives global development.
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Haisco, Lilly Ink $3.05B Multi-Therapy Drug Deal
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Haisco Pharmaceutical has entered into a licensing and research collaboration with Eli Lilly to develop novel medicines across multiple therapeutic areas.
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Why It Matters
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| • | Deal Value: ~$3.05B total consideration, including approximately $87M in upfront and near-term payments, approximately $2.967B in milestone payments across multiple programs, and tiered single-digit royalties on future sales.
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| • | Therapeutic Diversity: Collaboration spans approximately five target programs across multiple therapeutic areas, enabling portfolio diversification beyond Lilly's core metabolic and oncology franchises.
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| • | Regional Rights Structure: Flexible rights framework grants Lilly exclusive global rights to certain programs and ex-Greater China rights to others, while Haisco retains exclusive Greater China rights, enabling optimized commercialization in key markets.
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Strategic Focus
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| • | Discovery-to-Commercialization Pipeline: Haisco leads early-stage discovery and target identification while Lilly assumes later-stage development and commercialization, leveraging each company's respective expertise in drug discovery and global clinical development.
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| • | Greater China Market Access: Haisco retains exclusive Greater China rights across all programs, enabling the company to leverage its established commercial infrastructure in China while Lilly drives global development outside the region.
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| • | Multi-Therapeutic Portfolio Expansion: The collaboration enables Lilly to expand beyond its core metabolic and oncology portfolios by accessing novel medicines across multiple therapeutic areas through Haisco's discovery capabilities.
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Travere Secures Civorebrutinib Rights in ~$1.14B Pact
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Travere Therapeutics has entered into an exclusive licensing and collaboration agreement with Everest Medicines for the development and commercialization of civorebrutinib (EVER001) worldwide, excluding China and certain countries in East and Southeast Asia.
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Why It Matters
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| • | Deal Value: ~$1.14B total consideration, including a $112.5M upfront payment, approximately $1.03B in cash payments across up to five indications for development, regulatory, and commercial milestones, plus tiered royalties from high single-digit to double-digit percentages on net sales.
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| • | Clinical Benefit: Civorebrutinib demonstrated rapid and sustained reductions in anti-PLA2R autoantibodies and proteinuria, high rates of immunologic and clinical remission, and stable kidney function through 52 weeks in primary membranous nephropathy, addressing a significant unmet need in rare kidney disease.
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| • | Therapeutic Area Expansion: Strengthens Travere’s nephrology portfolio by adding an oral BTK inhibitor with potential across multiple kidney disease indications beyond primary membranous nephropathy.
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Strategic Focus
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| • | Nephrology Portfolio: Expands Travere’s kidney disease offerings with a BTK inhibitor addressing the unmet need for effective treatments in primary membranous nephropathy and other rare kidney diseases with convenient oral dosing.
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| • | Regional Rights Structure: Travere gains exclusive rights worldwide excluding China and certain East and Southeast Asian countries, while Everest retains rights in China and those markets, enabling optimized commercialization in key geographic regions.
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| • | Multi-Indication Potential: The collaboration covers up to five indications, enabling Travere to pursue broad标签 expansion for civorebrutinib across multiple kidney disease indications based on its mechanism of action targeting BTK-mediated pathways.
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Ascidian, Lilly Forge ~$1.9B RNA Editing Deal for Kidney Diseases
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Ascidian has entered into a global research and licensing agreement with Eli Lilly to discover and develop therapies for undisclosed monogenic kidney diseases, with an option to expand the collaboration to additional targets.
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Why It Matters
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| • | Deal Value: ~$1.9B total consideration, including an upfront payment, development and commercial milestone payments, and tiered royalties on global sales, representing one of the largest RNA editing deals in the kidney disease space.
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| • | Platform Technology: Gains access to Ascidian’s RNA exon editing technology, a novel modality that enables precise RNA-level modifications without permanent genomic changes, offering potential advantages for treating monogenic diseases.
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| • | Therapeutic Area Expansion: Strengthens Eli Lilly’s presence in rare diseases and nephrology by adding a pipeline of therapies targeting undisclosed monogenic kidney diseases with high unmet medical need.
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Strategic Focus
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| • | Rare Kidney Disease Portfolio: Expands Lilly’s rare disease offerings with RNA exon editing therapies targeting monogenic kidney diseases, addressing significant unmet needs where limited or no treatments currently exist.
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| • | Technology Platform Partnership: Leverages Ascidian’s proprietary RNA exon editing technology while Lilly assumes later-stage development and commercialization, enabling streamlined progression from discovery to clinic.
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| • | Flexible Target Expansion: The collaboration includes an option to expand to additional targets, while Ascidian retains rights to pursue other kidney targets independently or with other partners, maximizing platform value across multiple disease indications.
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Alnylam, Inceptive Team Up in ~$2B AI-RNAi Collaboration
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Alnylam Pharmaceuticals and Inceptive Nucleics have entered into a strategic collaboration to accelerate the discovery of novel RNAi therapeutics.
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Why It Matters
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| • | Deal Value: Up to ~$2B total consideration, including a $30M upfront payment (cash plus equity investment in Inceptive) and additional preclinical, regulatory, and commercial milestone payments across multiple RNAi therapeutic programs.
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| • | Platform Technology: Combines Alnylam’s 20+ years of RNAi expertise and extensive siRNA dataset with Inceptive’s AI-powered foundation models for sequence-based medicine design, enabling accelerated discovery of novel RNAi therapeutics.
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| • | Therapeutic Area Expansion: Strengthens Alnylam’s RNAi pipeline by leveraging AI to identify and optimize novel targets across multiple disease indications, potentially expanding beyond its current focus on rare genetic diseases.
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Strategic Focus
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| • | RNAi Pipeline Acceleration: Uses AI-powered discovery to speed identification and optimization of novel RNAi therapeutics, reducing traditional timelines for nucleic acid therapeutic discovery and enabling faster progression to preclinical development.
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| • | Data-Driven AI Integration: Leverages Alnylam’s extensive 20+ year siRNA dataset as training material for Inceptive’s AI foundation models, creating a feedback loop that continuously improves target prediction and sequence optimization.
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Equity Partnership Alignment: The equity investment component aligns long-term interests between Alnylam and Inceptive, ensuring continued collaboration support and shared success across the multiple programs in the pipeline.
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CytomX, Regeneron Expand Cancer Therapy Alliance in ~$4B Deal
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CytomX has expanded its collaboration and licensing agreement with Regeneron to develop conditionally-activated bispecific cancer therapies using CytomX’s Probody platform and Regeneron’s Veloci-B BsAb development platform.
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Why It Matters
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| • | Deal Value: ~$4B total potential consideration, including $37M for nomination of two additional targets, approximately $4B in nomination, development, regulatory, and commercial milestone payments across up to eight total targets, plus tiered royalties on net sales.
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| • | Platform Technology: Combines CytomX’s Probody platform for conditionally-activated therapeutics with Regeneron’s Veloci-B BsAb development platform to create tumor-activated bispecific antibodies that remain inactive in healthy tissue while becoming active in the tumor microenvironment.
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| • | Therapeutic Area Expansion: Strengthens both companies’ oncology portfolios by advancing conditionally active bispecific therapies that potentially improve the therapeutic index and reduce off-tumor toxicity compared to traditional bispecific antibodies.
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Strategic Focus
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| • | Oncology Pipeline Expansion: Expands the collaboration to up to eight total targets (two additional nominated plus approximately six future targets), enabling Regeneron to build a broad pipeline of tumor-activated bispecific cancer therapies.
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| • | Development Risk Transfer: Regeneron assumes all preclinical and clinical development, commercialization, and associated funding responsibilities, allowing CytomX to monetize its Probody platform technology while limiting its development risk.
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| • | Tumor-Activated Therapy Differentiation: The Probody platform creates conditionally-activated therapeutics that remain inactive in healthy tissue while becoming active in the tumor microenvironment, potentially addressing the safety challenges that have limited bispecific antibody development in oncology.
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Lundbeck, Cradle Team Up on AI-Powered Biotherapeutics Discovery
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Lundbeck and Cradle have entered into a partnership to leverage AI-powered protein engineering for the discovery and optimization of biotherapeutics, with an initial focus on two antibody programs targeting central nervous system (CNS) diseases.
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Why It Matters
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| • | Deal Value: Partnership focuses on AI-driven protein engineering without disclosed upfront or milestone payments, representing a strategic technology licensing agreement rather than a traditional licensing deal with financial terms.
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| • | Platform Technology: Lundbeck deploys Cradle’s generative AI platform in its first end-to-end AI-guided protein engineering workflow, using iterative feedback from experimental data to discover and optimize higher-quality antibody candidates while reducing wet-lab testing cycles.
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| • | Therapeutic Area Focus: Initial focus on two antibody programs targeting CNS diseases, addressing Lundbeck’s core neuroscience portfolio and the significant unmet medical need for effective treatments in brain disorders.
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Strategic Focus
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| • | AI-Driven Discovery Integration: Establishes Lundbeck’s first end-to-end AI-guided protein engineering workflow, enabling faster identification and optimization of biotherapeutic candidates while reducing traditional drug discovery timelines.
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| • | CNS Pipeline Enhancement: Focuses initial antibody programs on central nervous system diseases, leveraging AI to overcome the challenges of developing biotherapeutics that can cross the blood-brain barrier for brain disorders.
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| • | Computational Infrastructure Expansion: Complements Lundbeck’s recent agreement with the Danish Centre for AI Innovation by providing access to the Gefion AI supercomputer, enabling large-scale scientific modeling and drug discovery efforts to support the AI-driven discovery workflow.
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Pfizer, Chai Partner on AI-Driven Biologics Research
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Pfizer and Chai Discovery have entered into a licensing agreement, allowing Pfizer to integrate Chai’s AI-driven drug discovery platform into its biologics research workflows.
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Why It Matters
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| • | Deal Structure: Licensing agreement without disclosed upfront or milestone payments, representing a strategic technology licensing partnership rather than a traditional licensing deal with financial terms.
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| • | Platform Technology: Pfizer gains early access to Chai-3, an AI-driven antibody discovery model designed to improve therapeutic antibody development, multispecific molecule design, and candidates against hard-to-drug targets while enhancing design success rates and generalizability.
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| • | Therapeutic Area Focus: Supports biologics research across therapeutic antibodies and multispecific molecules, addressing Pfizer’s need for improved antibody discovery capabilities and potential advantages in targeting difficult disease mechanisms.
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Strategic Focus
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| • | AI-Driven Discovery Integration: Integrates Chai’s AI platform into Pfizer’s drug discovery engine, enabling faster identification and optimization of antibody candidates while reducing traditional wet-lab screening timelines for biologics development.
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| • | Customized Model Development: Pfizer gains access to a customized AI model built using its proprietary data and tailored to its research workflows, creating a feedback loop that continuously improves model performance for Pfizer-specific discovery needs.
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| • | Hard-to-Drug Target Access: Chai-3’s enhanced generalizability and design success rates enable Pfizer to pursue candidates against hard-to-drug targets that have been challenging with traditional antibody discovery approaches, potentially opening new therapeutic opportunities.
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| | Mergers & Acquisitions (M&A)
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Servier Buys Edgewise Muscular Dystrophy Assets in ~$2.65B Deal
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Servier has entered into an agreement with Edgewise Therapeutics to acquire its muscular dystrophy business, supporting Servier’s strategic ambition in rare neurology.
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Why It Matters
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| • | Deal Value: ~$2.65B total consideration, including a $1.55B upfront payment and approximately $1.1B in regulatory and commercial milestone payments, marking one of the largest acquisitions in the rare neurology space this year.
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| • | Clinical Benefit: Sevasemten is a fast skeletal myosin inhibitor being evaluated in a pivotal trial for Becker muscular dystrophy and a Phase II study for Duchenne muscular dystrophy, offering a potential first-in-class treatment targeting skeletal myosin to improve muscle function in these rare genetic disorders.
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| • | Therapeutic Area Expansion: Strengthens Servier’s pipeline in rare neurology and muscular dystrophies by adding a differentiated fast skeletal myosin inhibitor with potential across Becker and Duchenne muscular dystrophy indications.
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Strategic Focus
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| • | Rare Neurology Portfolio: Expands Servier’s rare disease offerings with sevasemten, addressing the significant unmet need for effective treatments in Becker and Duchenne muscular dystrophy where limited or no therapies currently exist.
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| • | Mechanism of Action Differentiation: Adds a fast skeletal myosin inhibitor with a novel mechanism targeting skeletal myosin to improve muscle function, complementing Servier’s existing rare disease portfolio and offering potential advantages over current treatment approaches.
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| • | Pivotal Trial Positioning: Sevasemten’s ongoing pivotal trial for Becker muscular dystrophy and Phase II study for Duchenne muscular dystrophy provide near-term development milestones and potential regulatory approval pathways for both indications.
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Rallybio to Combine with Avenzo in Strategic Oncology Merger
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Rallybio has entered into a definitive agreement to acquire Avenzo through a merger transaction, after which the combined company will operate under the name Avenzo Therapeutics and is expected to trade on Nasdaq under the ticker symbol "AVZO."
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Why It Matters
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| • | Deal Structure: Merger transaction with Avenzo shareholders receiving newly issued Rallybio shares based on relative valuations, combined with $215M in committed financing from a syndicate of investors and mutual funds expected to close before the merger.
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| • | Ownership Structure: Rallybio shareholders will own approximately 2.8% of the combined company while Avenzo shareholders, including financing investors, will own approximately 97.2%, with Rallybio shareholders receiving CVRs tied to REV102 asset sale proceeds and potential monetization of other legacy assets.
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| • | Therapeutic Area Focus: Combined company advances next-generation oncology therapies, leveraging Rallybio’s clinical-stage oncology pipeline and Avenzo’s development capabilities to build a focused oncology biopharma company.
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Strategic Focus
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| • | Oncology Pipeline Integration: Combines Rallybio’s clinical-stage oncology assets with Avenzo’s development capabilities to create a unified platform for advancing next-generation oncology therapies with multiple programs in development.
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| • | Public Market Positioning: The combined company will trade on Nasdaq under the ticker symbol "AVZO," providing public market access and liquidity for shareholders while positioning the company for future growth through oncology pipeline progression.
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| • | Legacy Asset Monetization: Rallybio shareholders receive CVRs tied to proceeds from the REV102 asset sale and potential monetization of other legacy assets, providing additional upside from non-core assets while the combined company focuses on oncology development.
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| | Clinical Trials & Data Readouts
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P‑III LIBRETTO‑432
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Early-Stage RET Fusion–Positive NSCLC
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Lilly has reported global P‑III LIBRETTO‑432 (NCT04819100) trial data assessing Retevmo (selpercatinib; 160 mg, BID) vs placebo in 151 pts with early-stage (IB–IIIA) RET fusion–positive NSCLC following definitive radiotherapy or surgery with curative intent, with or without other adjuvant therapy. The trial met its 1EP, improving EFS by 83% in stage II–IIIA RET-positive NSCLC (n=109), with 24mos. EFS rates of 92% vs 61%; median EFS was not reached with selpercatinib vs 31.8mos. for placebo.
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Key Details
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In the overall population, the trial showed 24mos. EFS rates of 94% vs 70%. Benefits were consistent across BICR and key subgroups, while OS showed a favorable trend but remained immature because of few events.
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Next Steps
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The data will be submitted to global health authorities and were published in The NEJM.
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1L Squamous NSCLC
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Akeso has reported global P‑III HARMONi‑6/AK112‑306 trial data assessing ivonescimab + chemotherapy vs Tevimbra + chemotherapy in 532 pts with 1L sqNSCLC. The trial met its 2EP of improved OS; as of Feb. 27, 2026 (median follow‑up: 21.36mos.), ivonescimab + chemotherapy reduced the risk of death by 34% (mOS: 27.9 vs 23.7mos.), with 12‑ and 24‑mos. OS rates of 78.9% vs 72.2% and 64.7% vs 48.6%, respectively.
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Key Details
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At interim analysis, the trial also showed improved PFS, with median PFS of 11.1 vs 6.9mos. OS benefit was consistent regardless of PD‑L1 status and metastatic burden, while subsequent therapies were less common in the ivonescimab arm, including immunotherapy (13.9% vs 19.2%), targeted therapy (12.4% vs 17.3%), ADCs (4.5% vs 5.6%), and participation in other trials (0.8% vs 2.3%).
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Metastatic Pancreatic Cancer
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Revolution Medicines has highlighted P‑III RASolute 302 (NCT06625320) trial results on daraxonrasib (300 mg, QD, PO) vs chemotherapy in previously treated metastatic PDAC, regardless of RAS mutation, in 500 pts. As of Feb. 10, 2026 (median follow‑up: 8.5mos.), the trial met all 1 and key 2EPs, with benefits seen in both the RAS G12 mutant and overall populations.
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Key Details
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Daraxonrasib improved OS by 60% in both the RAS G12 and ITT populations, with median OS of 13.2 vs 6.6mos. and 13.2 vs 6.7mos., respectively; it also significantly improved mPFS (7.3 vs 3.5mos. in RAS G12; 7.2 vs 3.6mos. in ITT) and ORR by BICR (33.2% vs 11.8% and 31.6% vs 11.2%).
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Additional Findings
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Daraxonrasib delayed time to deterioration in pain, global health status, and QoL, and the data were published in The NEJM.
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Next Steps
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Revolution Medicines plans to submit the data to global regulators, including the FDA, through an NDA under a CNPV, and has received FDA authorization to initiate an EAP for eligible pts.
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ESR1-mutated Advanced Breast Cancer
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AstraZeneca has reported P‑III SERENA‑6 data assessing camizestrant (n=157) vs anastrozole/letrozole (n=158), each combined with a CDK4/6 inhibitor, in 315 pts with locally advanced/metastatic HR+/HER2‑ advanced breast cancer harboring an ESR1 mutation; filings supported by the trial are under review in the US, EU and Japan.
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Key Details
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The trial showed a 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs 9.2mos.) and a 24mos. PFS2 rate of 50.8% vs 36.3% (mPFS2: 25.7 vs 19.1mos.), while OS remained immature at 30% maturity, with an OS rate of 29.3% vs 31% and ongoing evaluation.
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Additional Findings
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Pts switched to camizestrant showed a 99% median reduction in total ctDNA by Wk. 8, with 51% achieving total ctDNA clearance vs a 64% increase and 1.9% clearance in the AI arm; ctDNA clearance was associated with improved OS. The regimen also delayed the need for chemotherapy or ADCs (22.6 vs 18.7mos.) and improved PROs.
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Primary Biliary Cholangitis (PBC)
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Gilead has reported P‑III IDEAL (NCT06060665) data assessing Livdelzi (seladelpar) vs placebo in 96 adults aged 18–75 years with PBC whose disease was inadequately controlled on ursodeoxycholic acid or who were intolerant to it.
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Key Details
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The trial showed that a higher proportion of pts treated with Livdelzi achieved normalization of ALP after 52wks.; data will be presented at a future conference and discussed with global regulatory authorities.
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Asset Snapshot
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Livdelzi is an oral PPAR‑delta agonist approved for PBC, with preclinical and clinical data supporting anticholestatic, anti-inflammatory, antipruritic, and antifibrotic effects across key metabolic and liver disease pathways.
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Solid Tumors
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Oncolytics Biotech has reported initial preclinical data on pelareorep in combination with RAS inhibitor modalities, showing greater anti-tumor activity in a solid tumor model than either therapy alone.
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Key Details
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The findings suggest the combination may enhance immune activation and improve tumor control beyond single-agent activity. Oncolytics plans additional studies in pancreatic ductal adenocarcinoma and colorectal cancer models to further assess immune activation, durability of response, and time-to-resistance.
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Next Steps
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Pelareorep is also being evaluated with KRAS G12C inhibitors, pan-RAS inhibitors, and other next-generation RAS pathway-targeting agents in RAS-mutated tumor models, with the full dataset expected later in 2026.
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HR+/HER2- Advanced Breast Cancer – PIK3CA Mutant
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Celcuity has reported P‑III VIKTORIA‑1 PIK3CA mutant cohort data for gedatolisib + fulvestrant ± palbociclib vs standard of care in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor.
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Key Details
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In the cohort, the gedatolisib triplet achieved median PFS of 11.1 vs 5.6mos., ORR of 48.9% vs 26%, and median DOR of 15.7 vs 7.5mos. The gedatolisib doublet showed median PFS of 11.3 vs 5.6mos., with an ORR of 35.7% and median DOR of 24.2mos.; early OS data showed promising trends for both combinations.
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Next Steps
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Celcuity plans to submit the VIKTORIA‑1 data to the FDA as an sNDA and to other authorities thereafter. Separately, the FDA is reviewing its NDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer, with a PDUFA date of Jul. 17, 2026.
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G/GEJ Adenocarcinoma
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Innovent has reported P-III G-HOPE-001 trial results for arcotatug tavatecan (IBI343/TAK-921) vs investigator-selected therapy in pts with Claudin 18.2-positive, locally advanced unresectable or metastatic G/GEJA who had received at least 2 prior therapies.
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Key Details
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The trial met its primary endpoint of improved PFS in the interim analysis and showed a favorable safety profile. The data are expected to be presented at future academic conferences or published in journals.
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Next Steps
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Based on the clinical data, Innovent has submitted the NDA for arcotatug tavatecan to the NMPA for this indication, and the application has been accepted with priority review.
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Migraine Prevention
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Lundbeck has reported primary P-IIb PROCEED trial data for bocunebart (Lu AG09222, given subcutaneously or intravenously) vs placebo as a preventive treatment in pts with 1-4 prior preventive migraine treatment failures.
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Key Details
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In the IV group (n=429), bocunebart met its primary endpoint by reducing monthly migraine days over weeks 1-12, with a mean reduction of 4.24 vs 2.86 days. In pooled P-II data, pts with prior treatment failures achieved a mean reduction of 5.94 vs 3.63 monthly migraine days.
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Next Steps
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Based on the data, Lundbeck is advancing plans for further clinical development of bocunebart in migraine prevention. Lundbeck also presented P-I data showing safety and tolerability of bocunebart when administered with ubrogepant.
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IgA Nephropathy
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Otsuka Pharmaceutical has reported ongoing P-III VISIONARY trial data for Voyxact (sibeprenlimab) vs placebo in IgA nephropathy pts, assessing preservation of kidney function over a 24-month treatment period.
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Key Details
At 12 months, Voyxact improved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², meeting the KDIGO treatment goal of limiting annual kidney function decline to the normal physiological rate of less than 1 mL/min/1.73 m²/year.
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Next Steps
Voyxact also showed a slower annualized eGFR decline over 12 months, with an annualized slope of -3.0 vs -7.6 mL/min/1.73 m²/year, and the data were presented at ERA 2026.
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| | Global Regulatory Momentum in Pharma
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Regulatory Watch: This Week’s Key Approvals and Milestones
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From oncology and neurology to biosimilars, this week’s regulatory activity highlights continued momentum in expanding treatment options and advancing access to innovative and cost-effective therapies across global markets. Here’s a snapshot of the latest approvals, priority reviews, and regulatory milestones shaping the healthcare landscape:
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| • | Amgen reported European Commission approval of Imdylltra for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
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| • | Genentech received FDA Priority Review for Giredestrant as an adjuvant treatment for ER-positive early-stage breast cancer, advancing endocrine therapy options in oncology.
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| • | AbbVie’s Aquipta secured European Commission approval for the acute treatment of migraine.
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| • | Chiesi reported European Commission approval of Lojuxta for pediatric patients with homozygous familial hypercholesterolaemia (HoFH), expanding treatment options for this rare inherited lipid disorder.
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| | MedTech Watch: This Week’s Key Innovations and Clearances
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From AI-enabled neurology solutions to next-generation minimally invasive procedures, this week’s MedTech developments highlight continued innovation in patient care and clinical decision support. Here’s a snapshot of the latest approvals and regulatory milestones shaping the MedTech landscape:
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| • | NeuroPace received FDA approval for the ECoG Assistant, an AI-driven tool designed to enhance epilepsy care through advanced electroencephalography analysis and clinical decision support.
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| • | Signati Medical secured FDA IDE approval to initiate a pivotal trial of the Separo Vasectomy System, supporting the development of a minimally invasive approach to vasectomy procedures.
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| | Biosimilars Watch: This Week’s Key Regulatory Milestones
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From ophthalmology and immunology to allergy therapeutics, this week’s biosimilars landscape continued to gain momentum through regulatory submissions, approvals, and commercial launches aimed at expanding patient access and market competition. Here’s a snapshot of the latest developments shaping the global biosimilars market:
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| • | Alvotech reported FDA BLA resubmissions for AVT05, a biosimilar to Simponi and Simponi Aria, and AVT06, a biosimilar to Eylea, advancing its late-stage biosimilars portfolio.
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| • | Xbrane Biopharma announced FDA acceptance of the resubmitted BLA for Lucamzi, a biosimilar to Lucentis, supporting increased competition in the retinal disease market.
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| • | Teva Pharmaceutical Industries launched Ahzantive, a biosimilar to Eylea, across key European markets, expanding access to anti-VEGF therapies for ophthalmic conditions.
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| • | Kashiv BioSciences announced validation and acceptance of its Health Canada market authorization application for ADL-018, a proposed biosimilar to Xolair (omalizumab), marking progress toward entry into the Canadian allergy and immunology market.
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AI, RNA, and Oncology: Biopharma’s Next Growth Wave
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This week’s biopharma landscape highlights a powerful convergence of artificial intelligence, precision medicine, and strategic dealmaking. From Alnylam’s ~$2B AI-powered RNAi collaboration with Inceptive and Pfizer’s adoption of Chai Discovery’s biologics platform to Lilly’s multi-billion-dollar partnerships with Haisco and Ascidian, companies are accelerating innovation through technology-enabled drug discovery. Major oncology developments, including CytomX-Regeneron’s expanded ~$4B alliance and promising late-stage clinical data across lung, breast, and pancreatic cancers, underscore continued momentum in precision therapeutics. Meanwhile, Servier’s ~$2.65B acquisition of Edgewise’s muscular dystrophy assets signals sustained investment in rare disease innovation and portfolio expansion.
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