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Welcome to PharmaShots Weekly
| May 25, 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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SERB Expands Idefirix Reach in Europe & MENA
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| | QIAGEN and NVIDIA Advance AI Drug Discovery
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| | LillyAcquires Engage Biologics for DNA Delivery Platform
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| | Medtronic Acquires SPR Therapeutics to Expand Pain Portfolio
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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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| • | CVC-GBL’s €10.7B Recordati Rare Disease Bid
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Strategic Deals & Partnerships
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| • | Regeneron–Parabilis $2.3B Antibody-Helicon Pact
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| • | SERB–Hansa Idefirix Expansion Across Europe & MENA
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| • | QIAGEN–NVIDIA AI Drug Discovery Partnership
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| • | Incyte–Genesis Expanded AI Discovery Pact
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| • | Polpharma–Tuteur LATAM Biosimilar Licensing Deal
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| • | Lilly Acquires Engage Biologics for Non-Viral DNA Delivery
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| • | Medtronic to Acquire SPR Therapeutics for Temporary PNS
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Clinical Trials
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Rare Diseases & Respiratory
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| • | Sanofi’s ElevAATe Trial in AATD-Related Emphysema
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Obesity & Weight Management
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| • | Vincentage Pharma’s VCT220 Phase III Data
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| • | Lilly’s Retatrutide TRIUMPH-1 Results
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Immunology & Inflammation
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| • | UCB’s BE BOLD Trial in Psoriatic Arthritis
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Vaccines & Infectious Disease
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| • | Pfizer’s 25vPnC Pediatric Pneumococcal Vaccine Data
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Oncology
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| • | Merck’s TroFuse-005 in Endometrial Cancer
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Regulatory Watch
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| • | Enhertu FDA Approval Expansion in Breast Cancer
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| • | Tecentriq/Tecentriq Hybreza Approval in Bladder Cancer
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| • | Bayer’s Sevabertinib Priority Review in NSCLC
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| • | Astellas’ Padcev + Keytruda CHMP Opinion
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| • | Boehringer’s Hernexeos China Approval
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| • | AstraZeneca’s Baxfendy FDA Approval
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| • | Bayer’s Kerendia Priority Review
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| • | GSK’s Arexvy Approval in Japan
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Biosimilars
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| • | Accord BioPharma’s Immgolis Approvals
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| • | Sandoz EC Approval for Bysumlog & Dazparda
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Aesthetics
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| • | AbbVie/Allergan’s Boey Positive CHMP Opinion
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MedTech Watch
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| • | PainTEQ Launches TRAQ SI Joint Fusion Implant
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| • | Tempus AI Launches ArteraAI Prostate Test
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| • | Sunrise Air Home Sleep Apnea Test FDA Clearance
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Cardiovascular Devices
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| • | Reflow Medical’s DEEPER CORONARY ISR Results
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Diagnostics & Oncology
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| • | Sensome INSPECT Study in Bronchoscopic Lung Biopsy Detection
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CVC-GBL’s €10.7B Recordati Rare Disease Bid
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A consortium led by CVC Capital Partners and Groupe Bruxelles Lambert (GBL) has launched a voluntary all-cash tender offer to acquire Recordati at €51.29 per share, valuing the transaction at approximately €10.7B (~$12.4B) and aiming to delist the company from Euronext Milan, with closing expected in the fourth quarter of 2026.
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Why It Matters
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| • | Deal Value: ~€10.7B (~$12.4B) total consideration at €51.29 per share, representing approximately a 13% premium to pre-deal trading levels and a major private equity take-private in the European pharma sector.
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| • | Anchor Investor Support: Rossini’s commitment to tender its 46.8% stake ensures near-certain closing once the offer is accepted by a majority of remaining shareholders.
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| • | Rare Disease Strategy: The proposed private ownership structure is designed to accelerate Recordati’s expansion in rare diseases, enable strategic acquisitions, increase R&D investment, and support long-term global development without public market pressure.
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Strategic Focus
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| • | Rare Disease Expansion: Private ownership enables Recordati to pursue more aggressive growth in orphan and specialty care, where longer development timelines and higher risk tolerance are often required.
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| • | Strategic Acquisitions: Freed from quarterly earnings scrutiny, Recordati can execute bolt-on and transformative acquisitions to strengthen its rare disease and specialty portfolios.
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| • | Long-Term Capital Base: Backing from ADIA, CPP Investments, PSP Investments, and other long-duration investors provides stable capital for multi-year R&D and commercial expansion initiatives.
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| | Strategic Deals & Partnerships
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Regeneron’s $2.3B Helicon Therapeutics Bet
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Regeneron has entered into a strategic research collaboration with Parabilis Medicines to discover and develop multiple therapeutics using Parabilis’ Helicon peptide platform, with a primary focus on Antibody-Helicon Conjugates (AHCs).
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Why It Matters
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| • | Deal Scale: Up to ~$2.2B in milestones plus tiered royalties across five initial targets, following a $50M upfront and $75M financing commitment, totaling ~$2.3B in near-term and potential upside.
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| • | Novel Conjugate Modality: AHCs merge the specificity of antibodies with the functional breadth of macrocyclic peptides, potentially unlocking targets beyond conventional small molecules and biologics.
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| • | Strategic Platform Bet: Signals Regeneron’s commitment to expanding beyond traditional antibodies and ADCs into hybrid peptide–antibody therapeutics with broader therapeutic reach.
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Strategic Focus
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| • | Broad Therapeutic Scope: Collaboration spans multiple therapeutic areas, giving Regeneron flexibility to prioritize AHC programs as early data emerge.
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| • | Option-Like Structure: Five initial targets plus additional option targets allow Regeneron to scale the collaboration selectively based on early proof of concept.
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| • | Long-Term Royalty Upside: Tiered low‑double‑digit royalties create sustained revenue potential if AHCs reach commercial scale in oncology, immunology, or other areas.
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SERB’s €115M Idefirix Europe Expansion Deal
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Hansa Biopharma has granted SERB Pharmaceuticals exclusive development and commercialization rights to Idefirix (imlifidase) in the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland, and the MENA region, marking a major expansion of Idefirix beyond its current markets.
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Why It Matters
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| • | Deal Value: €115M total in near-term consideration, including €110M upfront and €5M upon EMA filing acceptance, with Hansa retaining future upside through potential commercialization royalties.
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| • | Territory Expansion: Gives SERB rights across the EU, UK, Switzerland, Norway, Liechtenstein, Iceland, and the MENA region, significantly broadening Idefirix’s geographic footprint.
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| • | Regulatory Pathway: Activity hinges on topline data from the PAES study, which supports the EMA filing and full approval for Idefirix in high-risk kidney transplant patients.
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Strategic Focus
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| • | Kidney Transplant Franchise: Reinforces Idefirix as a differentiated therapy for high-risk ABO-incompatible and HLA-sensitized kidney transplant patients.
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| • | Partner-Led Development: SERB assumes long-term PAES follow-up and pediatric studies, allowing Hansa to focus on its core R&D pipeline while maintaining strategic oversight.
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| • | Capital-Efficient Growth: The €115M upfront structure provides immediate liquidity for Hansa while SERB invests in EMA filing, commercialization, and long-term clinical obligations.
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QIAGEN & NVIDIA Advance AI Drug Discovery
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QIAGEN has entered into a strategic partnership with NVIDIA to integrate its Digital Insights bioinformatics business with NVIDIA’s accelerated computing infrastructure and the NVIDIA BioNeMo platform, strengthening AI-driven applications across the drug discovery lifecycle.
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Why It Matters
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| • | AI + Knowledge Graphs: Combines QIAGEN’s curated biomedical knowledge graphs with NVIDIA’s accelerated computing and BioNeMo foundation models to move beyond simple pattern matching to reasoning and validation.
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| • | Drug Discovery Lifecycle: Supports practical applications across target identification, biomarker discovery, mechanism-of-action elucidation, and hypothesis generation, not just data visualization.
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| • | Scalable Infrastructure: GPU-accelerated GraphRAG and PyTorch Geometric integration enable handling of large, multi-modal datasets that are otherwise computationally prohibitive.
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Strategic Focus
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| • | Digital Insights Expansion: Strengthens QIAGEN’s Digital Insights portfolio by embedding NVIDIA’s AI and computing capabilities into its bioinformatics platform.
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| • | Pharma-First Pilots: Prioritizes validation with leading pharma and biotech partners to demonstrate real-world impact before broader commercialization.
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| • | Long-Term AI Platform: Positions QIAGEN as a key enabler of next-generation, AI-first drug discovery workflows that integrate data, models, and expert reasoning.
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Incyte Expands Genesis AI Drug Discovery Pact
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Incyte and Genesis Biopharma have expanded their AI-driven collaboration to accelerate the discovery of novel small molecules for Incyte-selected targets by deploying Genesis’ GEMS molecular AI platform across a broader range of challenging targets in Incyte’s portfolio.
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Why It Matters
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| • | Deal Scale: Up to $120M upfront ($80M cash + $40M equity), ~$232M per program in milestones across five initial targets, and potential total value exceeding $1B, with multi-billion-dollar upside from future targets and royalties.
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| • | AI Platform Expansion: Broadens GEMS application beyond the initial set of targets to more challenging, Incyte-selected areas, leveraging Incyte’s experimental data to improve model performance.
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| • | Exclusive Rights for Incyte: Incyte secures exclusive development and commercialization rights to all newly discovered molecules, while Genesis monetizes its AI platform through upfront, milestones, and royalties.
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Strategic Focus
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| • | Target Portfolio Depth: Adds at least five new targets with options for more, allowing Incyte to scale AI-driven discovery across its oncology and immunology pipeline.
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| • | Data-Driven AI Improvement: Incyte’s experimental data feed into GEMS to enhance predictive accuracy and success rates for novel small-molecule discovery.
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| • | Long-Term Royalty Upside: Genesis’ revenue model includes royalties on approved products, aligning incentives for successful clinical and commercial outcomes.
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Polpharma-Tuteur LATAM Biosimilar Pact
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Polpharma Biologics has entered into a licensing agreement with Tuteur to commercialize a biosimilar candidate for autoimmune diseases across Latin America, excluding Brazil, expanding Polpharma’s biosimilar footprint in the region under a partner-led model.
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Why It Matters
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| • | Territory Strategy: Covers Latin America minus Brazil, allowing Polpharma to focus its own commercial efforts on Brazil while using Tuteur to access the rest of the region efficiently.
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| • | Partner-Led Commercialization: Offloads LATAM go-to-market activities to Tuteur, reducing Polpharma’s near-term commercial investment while maintaining control over development and manufacturing.
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| • | Regulatory Timeline: Regulatory submission within three years positions the biosimilar for potential market entry in the mid-to-late 2020s, coinciding with continued growth in autoimmune biologics in LATAM.
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Strategic Focus
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| • | Biosimilar Portfolio Expansion: Reinforces Polpharma Biologics’ position as a global player in biosimilars for autoimmune diseases, complementing its existing portfolio.
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| • | LATAM Market Access: Leverages Tuteur’s regional expertise and distribution network to accelerate market penetration across Latin America.
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| • | Manufacturing Leverage: Uses Polpharma’s biologics manufacturing infrastructure to support development and supply for the biosimilar across multiple markets.
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| | Mergers & Acquisitions (M&A)
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Lilly’s $202M Engage Deal Boosts Gene Tech
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Eli Lilly has acquired Engage Biologics, combining Engage’s Tethosome platform with Lilly’s genetic medicines capabilities and portfolio to strengthen its capabilities in non-viral gene delivery and targeted DNA therapeutics.
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Why It Matters
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| • | Deal Value: ~$202M in cash, including upfront and development milestone payments, provides Lilly with a differentiated non-viral DNA delivery platform at an efficient price point.
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| • | Non-Viral Gene Delivery: Tethosome offers an alternative to viral vectors, addressing limitations such as immunogenicity, re-dosing challenges, and payload size constraints.
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| • | Genetic Medicines Expansion: Strengthens Lilly’s genetic medicines portfolio by adding a programmable, lipid nanoparticle-based DNA delivery system that can be tailored to multiple targets and indications.
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Strategic Focus
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| • | In Vivo Gene Therapy: Supports Lilly’s long-term goal of developing in vivo gene therapies that can be administered systemically and reach target tissues with high specificity.
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| • | Platform Synergy: Integrates Tethosome’s delivery capabilities with Lilly’s existing genetic medicine expertise to accelerate discovery and clinical development.
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| • | Long-Term Pipeline Optionality: Positions Lilly to pursue a broader range of DNA-based therapies across multiple therapeutic areas, leveraging Tethosome’s programmability and scalability.
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Medtronic’s $650M SPR Deal Expands Pain Tech
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Medtronic has announced its intent to acquire SPR Therapeutics for an upfront payment of approximately $650M, aiming to expand its neuromodulation portfolio with SPR’s temporary peripheral nerve stimulation (PNS) technology for chronic pain management.
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Why It Matters
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| • | Deal Value: ~$650M upfront for a commercially validated, FDA-cleared temporary PNS system with strong real-world evidence.
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| • | Complementary Pain Tech: Adds a minimally invasive, 60-day temporary nerve stimulation option to Medtronic’s permanent implantable neuromodulation portfolio, broadening treatment options across the pain continuum.
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| • | Real-World Evidence: Over 71% of patients achieving significant pain relief or quality-of-life improvement in a large retrospective cohort (n > 6,100) strengthens the clinical and commercial case for SPRINT.
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Strategic Focus
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| • | Pain Portfolio Expansion: Reinforces Medtronic’s leadership in pain management by combining temporary and permanent neuromodulation solutions under one portfolio.
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| • | Market Differentiation: Temporary PNS offers a lower-risk, reversible alternative to permanent implants, appealing to patients and providers seeking less invasive options.
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| • | Fiscal Year Timeline: Closing expected in H1 FY27 aligns with Medtronic’s strategic planning cycle and allows for integration ahead of key market expansion initiatives.
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| | Clinical Trials & Data Readouts
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P‑II ElevAATe
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Alpha-1 Antitrypsin Deficiency (AATD)-Related Emphysema
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Sanofi has reported P‑II ElevAATe (NCT05856331) data assessing efdoralprin alfa (Q3W or Q4W) vs standard plasma-derived augmentation therapy (pdAAT; QW) in 97 pts with AATD-related emphysema.
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Key Details
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Efdoralprin alfa achieved a mean increase in functional AAT trough levels of 24.1 μM (Q3W) and 16.8 μM (Q4W) vs 7.6 μM at Wk. 32, with Q3W meeting the 1EP, and all key 2EPs also met. In the key secondary endpoints, mean serum fAAT average concentrations increased by 32.9 μM (Q3W) and 26 μM (Q4W) vs 17.9 μM at Wk. 32, with Q3W maintaining fAAT levels above the normal threshold for 100% of days and Q4W for 89.3% of days vs 40.8% over 32wks.; data were presented at ATS’26.
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Weight Management – Obesity / Overweight
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Vincentage Pharma has reported topline P‑III NCT06939296 data assessing VCT220 (120 or 160 mg, QD, PO) vs placebo for 52wks. in 840 Chinese adults with obesity or overweight and at least one weight-related comorbidity.
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Key Details
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The trial met its 1EP, with mean body weight reductions of -12.2% and -12.4% in the 120 mg and 160 mg groups, respectively, vs -1.3% with placebo at 52wks., and showed a safety profile consistent with existing GLP-1 therapeutics.
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Next Steps
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Vincentage plans to submit an NDA to the NMPA for VCT220 for weight management in China in the near term.
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Active Psoriatic Arthritis (PsA)
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UCB has reported P‑III BE BOLD (NCT06624228) trial data assessing Bimzelx (bimekizumab‑bkzx) vs Skyrizi (risankizumab‑rzaa) in 553 adults with active PsA.
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Key Details
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The trial met its 1EP, with 49.1% of patients achieving ACR50 at Week 16 vs 38.4% with Skyrizi. The first ranked 2EP, MDA, was numerically higher with Bimzelx at Week 16 (43% vs 39.9%) but did not reach statistical significance, halting sequential testing, while subsequent 2EPs descriptively favored Bimzelx.
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Additional Data
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Patients achieved simultaneous ACR50+PASI100 at Week 16 (33.5% vs 24.4%) and ACR50 at Week 4 (19.9% vs 7.2%). Among exploratory endpoints, PASI100 at Week 16 was reached by 53.4% vs 46.6%, while DAPSA LDA+REM was achieved by 65.3% vs 54.7%; data are slated for presentation at EULAR’26
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Pneumococcal Disease Prevention – Infants
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Pfizer has reported P‑II data for PF‑07872412 (25vPnC), assessing the safety, tolerability and immunogenicity of a 4‑dose series vs Prevnar 20 at months 2, 4, 6 and 12–15 in infants.
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Key Details
25vPnC generated higher immune responses against serotype 3 than Prevnar 20, with geometric mean titers 8.8‑fold higher 1 month after Dose 3 (4.22 vs 0.48) and about 15‑fold higher 1 month after Dose 4 (13.85 vs 0.92); the candidate is expected to cover about 90% of disease‑causing serotypes in children under 5 years, including about 15% from serotype 3.
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Next Steps
Based on the Phase II data and regulatory discussions, Pfizer initiated a pediatric Phase III program in May 2026 evaluating 25vPnC vs PCV20 in about 2,400 healthy children receiving vaccines at 2, 4, 6 and 12–15 months of age, and expects to advance the adult 25vPnC candidate into clinical development by the end of 2026.
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Weight Management – Obesity / Overweight
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Lilly has reported P‑III TRIUMPH‑1 (NCT05929066) data assessing retatrutide (4, 9 and 12 mg; dose escalation) vs placebo in adults with obesity or overweight and at least one weight‑related comorbidity, without diabetes.
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Key Details
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The trial met its 1EP, with mean weight loss at 80wks. of 19.0% for 4 mg, 25.9% for 9 mg, and 28.3% for 12 mg vs placebo. In key 2EPs, retatrutide reduced waist circumference by 16.3 cm, 21.8 cm and 24.1 cm vs 3.6 cm, respectively, and rates of ≥25% weight loss were 27.8%, 52.9% and 62.5% vs 2.2%; ≥30% weight loss were 15.3%, 37.9% and 45.3% vs 0.5%; and ≥35% weight loss were 5.9%, 20.8% and 27.2% vs 0.3%.
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Longer-term Data
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At 104wks., mean weight reductions reached 27.9%, 29.5% and 30.3%, while placebo pts switched to retatrutide achieved a 19.2% reduction. Under the treatment-regimen estimand, weight loss at 80wks. was 17.6%, 23.7% and 25.0% vs 3.9%, and at 104wks. it was 25.7%, 28.7% and 29.9% across the respective dose-to-MTD groups, while placebo-to-MTD pts achieved an 18.9% reduction; cardiovascular risk factors also improved.
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Advanced or Recurrent Endometrial Cancer
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Merck has reported global P‑III TroFuse‑005 (NCT06132958) trial data assessing sacituzumab tirumotecan (sac‑TMT; 4 mg/kg, Q2W) vs doxorubicin/paclitaxel in 776 pts with endometrial carcinoma and carcinosarcoma who had received prior platinum‑based chemotherapy and anti‑PD‑1/anti‑PD‑L1 immunotherapy either together or separately.
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Key Details
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The trial met its 1EP of improved OS and PFS in this patient population, and also achieved its key 2EP of ORR; data will be presented at a future meeting and discussed with global regulatory authorities.
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Program Context
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Sac‑TMT is being evaluated as both monotherapy and in combination with immunotherapies across Merck’s TroFuse clinical program, which includes 17 ongoing global P‑III trials across multiple tumor types, including 10 P‑III trials in women’s cancers.
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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 cardiovascular disease to vaccines and biosimilars, this week’s regulatory activity highlights strong momentum in advancing innovative therapies and expanding treatment access across global markets. Here’s a snapshot of the latest approvals, priority reviews, and regulatory milestones shaping the healthcare landscape:
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| • | AstraZeneca and Daiichi Sankyo’s Enhertu received FDA approval in early breast cancer for two indications, further expanding its oncology footprint.
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| • | Genentech reported FDA approval of Tecentriq and Tecentriq Hybreza for adjuvant muscle-invasive bladder cancer with ctDNA-guided treatment.
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| • | AstraZeneca announced FDA approval of Baxfendy (baxdrostat) for hard-to-control hypertension, strengthening its cardiovascular portfolio.
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| • | Bayer’s Hyrnuo (sevabertinib) received FDA Priority Review for first-line treatment of HER2-mutated non-small cell lung cancer (NSCLC).
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| • | GSK secured approval from Japan’s Ministry of Health, Labour and Welfare for Arexvy to prevent respiratory syncytial virus (RSV) disease.
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| • | The FDA granted Priority Review to Bayer’s Kerendia for chronic kidney disease associated with Type 1 Diabetes.
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| • | Accord BioPharma reported FDA approval of Immgolis and Immgolis Intri, biosimilars to Simponi and Simponi Aria.
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| • | Sandoz received European Commission approval for Bysumlog and Dazparda, biosimilars to Humalog and NovoRapid.
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| • | Allergan Aesthetics, part of AbbVie, received a positive CHMP opinion for Boey to temporarily improve glabellar lines in adults.
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| • | Astellas Pharma received a positive CHMP opinion for perioperative Padcev in combination with Keytruda for muscle-invasive bladder cancer (MIBC).
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| • | Boehringer Ingelheim’s Hernexeos received conditional approval from China’s National Medical Products Administration for first-line HER2-mutant NSCLC.
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| | MedTech Watch: This Week’s Key Innovations and Clinical Advances
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Coronary In-Stent Restenosis (ISR)
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Reflow Medical has reported DEEPER CORONARY study results evaluating the short-term safety of the coronary Spur Elute Sirolimus-Eluting Retrievable Stent System for coronary ISR at EuroPCR 2026.
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Key Details
At 6mos., the study showed 100% freedom from MACE and all-cause mortality in nine treated pts, while all pts demonstrated improved CCS angina class with a median improvement of three classes.
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Asset Snapshot
Spur Elute Stent System is the first retrievable self-expanding stent with drug-coated expandable spikes and an integrated balloon delivering sirolimus-based Retrievable Scaffold Therapy (RST) to enhance drug uptake, support the artery, maximize luminal diameter, and reduce restenosis without leaving a permanent implant.
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Lung Cancer – Bronchoscopic Biopsy Detection
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Sensome has reported results from its INSPECT study assessing its microsensor technology integrated into a smart stylet for bronchoscopic lung biopsy in 27 pts across Australia and France.
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Key Details
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The smart stylet was inserted into the biopsy needle to capture tissue readings immediately before biopsy, with histopathology confirming measurement accuracy and cross-validating the results. It differentiated cancer from healthy and necrotic tissue, achieving 80.9% accuracy in distinguishing healthy from abnormal lung tissue (88.5% sensitivity; 71.4% specificity) and 78.7% accuracy in differentiating cancer from all other tissues (78.3% sensitivity; 79.2% specificity); data were presented at ATS’26.
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MedTech Watch: This Week’s Key Innovations and Launches
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From AI-powered oncology tools and sleep diagnostics to cardiovascular technologies and minimally invasive implants, this week’s MedTech developments highlight continued innovation in precision medicine and patient-centered care. Here’s a snapshot of the latest launches, clearances, and clinical milestones shaping the MedTech landscape:
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| • | PainTEQ launched the TRAQ SI Joint Fusion Implant in the U.S., expanding minimally invasive treatment options for sacroiliac joint dysfunction.
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| • | Tempus AI launched the ArteraAI Prostate Test for metastatic prostate cancer, supporting AI-driven precision oncology and treatment decision-making.
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| • | Sunrise Group secured FDA clearance for the Sunrise Air Home Sleep Apnea Test, advancing at-home diagnostics for sleep disorders.
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AI, M&A & Clinical Momentum Reshape Biopharma
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This week’s biopharma landscape was defined by billion-dollar AI alliances, strategic acquisitions, and major late-stage clinical breakthroughs. Regeneron expanded into next-generation Antibody-Helicon Conjugates through a ~$2.3B Parabilis pact, while QIAGEN and NVIDIA advanced AI-driven drug discovery with graph-based reasoning platforms. Incyte deepened its AI collaboration with Genesis, and Lilly strengthened its genetic medicines franchise through the Engage Biologics acquisition. Medtronic expanded its pain portfolio with SPR Therapeutics’ temporary PNS technology. Meanwhile, Phase II/III data from Sanofi, Lilly, Pfizer, UCB, and Merck highlighted continued momentum across obesity, oncology, vaccines, immunology, and rare disease innovation worldwide.
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