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Welcome to PharmaShots Weekly
| | | Mar 30 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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Gilead Acquires Ouro to Expand Inflammation Pipeline
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| | Novartis to Acquire Excellergy in ~$2B Immunology Deal
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| | Sanofi Signs $1.23B Autoimmune Deal with Kali
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| | Quotient and Merck Strike ~$2.2B IBD Discovery Deal
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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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Merck’s $6.7B Bet on Next-Generation CML Therapy
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Strategic Deals & Partnerships
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| • | Gilead Acquires Ouro to Expand Inflammation Pipeline (~$2.2B)
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| • | Cencora Acquires EyeSouth Retina Business (~$1.1B)
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| • | Novartis to Acquire Excellergy in ~$2B Immunology Deal
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| • | Sanofi Signs $1.23B+ KT501 Autoimmune Licensing Deal
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| • | Quotient Therapeutics & Merck Forge ~$2.2B IBD Discovery Partnership
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| • | Insilico Medicine & Tenacia Expand AI-Driven CNS Drug Discovery
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| • | Biogen Licenses Alteogen’s ALT-B4 for Subcutaneous Biologics (~$579M)
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Clinical Trial Highlights
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| • | Dizal Reports Positive Phase III Data for Zegfrovy in EGFR Exon20+ NSCLC
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| • | HUTCHMED Initiates Phase III Trial for HMPL-760 in r/r DLBCL
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| • | Pfizer & Valneva Report Phase III Data for Lyme Disease Vaccine
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| • | Apogee Reports Phase II Maintenance Data for Zumilokibart in Atopic Dermatitis
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| • | Karyopharm Reports Phase III SENTRY Data for Selinexor in Myelofibrosis
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| • | United Laboratories & Novo Nordisk Report Phase II Data for UBT251 in Type 2 Diabetes
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| • | Otsuka Reports Phase III Data for Voyxact in IgA Nephropathy
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| • | AstraZeneca Reports Positive Phase III Data for Tozorakimab in COPD
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| • | Abcuro Reports MUSCLE Trial Data for Ulviprubart in Inclusion Body Myositis
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| • | Novocure Reports Phase II PANOVA-4 Data in Metastatic Pancreatic Cancer
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| • | Prestige Biopharma Reports Phase III Data for HD204 Biosimilar in NSCLC
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Regulatory Highlights
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| • | Wegovy HD approved for chronic weight management
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| • | Aqneursa sNDA filed for Ataxia-Telangiectasia
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| • | Zilganersen receives FDA Priority Review
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| • | Dupixent approved in Japan for Bullous Pemphigoid
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| • | Lifyorli approved for Platinum-Resistant Ovarian Cancer
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| • | Avlayah receives Accelerated Approval for Hunter Syndrome
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| • | Awiqli approved for Type 2 Diabetes
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| • | EMA accepts MAA for Bepirovirsen in Chronic Hepatitis B
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| • | NMPA clears IND for HLX18 (Opdivo biosimilar)
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MedTech Highlights
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| • | Pixee Medical Receives CE Mark for Knee+ NexSight
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| • | Kallisio Secures CE Mark for Stentra Radiotherapy Positioning System
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Celebrating Innovation and Excellence Across the Global Pharma & Healthcare Industry
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We are thrilled to announce the PharmaShots Pharma Awards 2026, a premier virtual event dedicated to recognizing groundbreaking innovation, leadership, and excellence in the pharmaceutical and healthcare sectors worldwide.
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This prestigious initiative brings together industry leaders, innovators, and key decision-makers from around the globe, creating a unique platform to celebrate achievements and set new benchmarks for the industry.
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Why Partner with PharmaShots Pharma Awards?
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Our sponsorship opportunities allow partners to:
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| • | Showcase your brand in front of a highly engaged, global pharma audience.
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| • | Position your organization as a leader in innovation and thought leadership.
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| • | Gain exclusive networking access to decision-makers, innovators, and influencers shaping the future of healthcare.
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We are currently reaching out to potential sponsors to understand your engagement goals and preferred sponsorship avenues. Based on your input, our team will provide a customized sponsorship prospectus detailing benefits, opportunities, and recommended next steps.
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Date of Awards Announcement: May 1, 2026
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We invite organizations to join us in this landmark celebration. Your support will help us highlight excellence, inspire innovation, and strengthen connections across the global pharma ecosystem.
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Interested in exploring sponsorship opportunities?
Partner with us at the PharmaShots Pharma Awards, fill out your sponsorship form here
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Merck’s $6.7B Bet on Next-Generation CML Therapy
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Merck has entered into a definitive agreement to acquire Terns Pharmaceuticals, bringing its lead investigational oncology asset TERN-701 into Merck’s growing hematology and oncology portfolio. The move underscores Merck’s continued commitment to strengthening its post-immunotherapy pipeline and expanding its presence in targeted cancer therapies.
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Why It Matters
The acquisition represents an approximately $6.7B all-cash transaction (about $5.7B net of acquired cash), marking another significant investment as Merck continues a series of strategic oncology and hematology deals aimed at reinforcing long-term growth beyond its blockbuster portfolio.
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Lead Asset Profile
TERN-701 is designed as a novel allosteric inhibitor targeting BCR::ABL1, offering a differentiated mechanism compared with existing therapies. Early clinical findings suggest promising efficacy and tolerability, particularly in heavily pretreated patients with Chronic Myeloid Leukemia (CML) carrying the Philadelphia chromosome (Ph+).
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Clinical and Regulatory Progress
The therapy is currently being evaluated in the Phase I/II CARDINAL trial, which includes dose-expansion cohorts and a dedicated arm for patients harboring BCR::ABL1 resistance mutations, including T315I. The study aims to assess safety, optimal dosing, and early efficacy signals in patients who have experienced treatment failure or intolerance to prior therapies.
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Strategic Focus
The acquisition supports Merck’s post-Keytruda strategy, deepening its presence in hematologic malignancies and strengthening its portfolio of next-generation targeted oncology therapies.
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Next-Generation CML Treatment
By advancing TERN-701, Merck aims to address critical unmet needs among patients who fail or cannot tolerate existing tyrosine kinase inhibitors (TKIs)—including those with treatment-resistant mutations.
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Potential Patient Impact
If successful, the therapy could offer more durable molecular responses while maintaining the convenience of an oral treatment option for patients facing difficult-to-treat CML.
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Market Opportunity
The deal further enhances Merck’s competitive positioning in precision oncology, particularly as patents for several legacy blockbuster therapies approach expiry, reinforcing the company’s long-term innovation and growth strategy.
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| | Billion-Dollar Deals Reshape Immunology and Specialty Healthcare
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Gilead Expands Inflammation Portfolio with Strategic Acquisition of Ouro
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Gilead Sciences has announced plans to acquire Ouro Medicines in a transaction valued at $1.675B in upfront cash, with up to $500M in additional milestone payments, for a total potential value of about $2.2B. The deal adds OM336 (gamgertamig), a clinical-stage BCMAxCD3 T cell engager for autoimmune and inflammatory diseases, currently in Phase I/II with registrational studies anticipated to begin in 2027.
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Why It Matters
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| • | Deal Value: ~$2.2B total, including $1.675B upfront cash and up to $500M in milestones.
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| • | Lead Asset: OM336 (gamgertamig), a BCMAxCD3 T cell engager with early data suggesting transformative efficacy and a differentiated safety profile in antibody-mediated orphan autoimmune diseases.
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| • | Development Outlook: Phase I/II program underway, with registrational studies expected to start in 2027 under a shared development model.
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Strategic Focus
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| • | Gilead Immunology Expansion: Strengthens Gilead’s inflammation and immunology portfolio with a potentially first-in-class T cell engager platform.
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| • | Risk-Sharing Model: Proposed partnership with Galapagos spreads financial risk while accelerating development through shared expertise and cost-sharing.
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| • | Patient Impact: Targets severe, treatment-resistant autoimmune diseases with the potential for deep, durable responses from limited-course therapy.
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| • | Market Potential: Positions OM336 to compete with or displace traditional chronic immunosuppressive regimens if clinical benefits are confirmed.
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Cencora Strengthens Retina Care Network with Strategic $1.1B Acquisition
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Cencora has entered into a definitive agreement to acquire the retina business of EyeSouth Partners in a transaction valued at approximately $1.1B, significantly expanding its footprint in specialty eye care and retina services.
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Why It Matters
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| • | Deal Value: ~$1.1B acquisition of EyeSouth’s retina business via RCA, reinforcing Cencora’s commitment to specialty care.
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| • | Network Expansion: Adds a strong regional retina group, enhancing RCA’s scale and presence in a fragmented retina market.
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| • | Operational Synergies: Expected to be slightly accretive to adjusted diluted EPS within twelve months post-close.
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Strategic Focus
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| • | Integrated Retina Platform: Physicians gain access to RCA’s clinical, research, and operational infrastructure, supporting innovation in sight-saving treatments and clinical trial participation.
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| • | Physician Empowerment: Model supports independent ophthalmologists with centralized resources while preserving local practice strengths.
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| • | Patient Impact: Aims to improve access to high-quality retina care and advanced therapies amid rising demand for ophthalmology services.
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| • | Market Positioning: Advances Cencora’s strategy to grow beyond distribution into high-value specialty healthcare segments like ophthalmology
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Novartis Strengthens Immunology Portfolio with ~$2B Acquisition of Excellergy
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Novartis has entered into an agreement to acquire Excellergy Therapeutics, a biotech developing next-generation anti-IgE therapies for food allergies and other IgE-driven diseases. The transaction is valued at up to approximately $2B in upfront and milestone-based payments and is expected to close in the second half of 2026, subject to customary conditions.
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Why It Matters
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| • | Deal Value: Up to ~$2B in upfront and milestone payments, underscoring strong confidence in next-generation anti-IgE biology.
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| • | Mechanism Edge: EXL-111 goes beyond conventional anti-IgE by directly dissociating receptor-bound IgE to enable faster and deeper FcεRIα suppression.
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| • | Clinical Trajectory: Early Phase I PK and pharmacodynamic data support sustained exposure and robust target engagement, consistent with its half-life–extended design.
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Strategic Focus
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| • | Allergy Leadership: Strengthens Novartis’ immunology portfolio and builds on its existing presence in allergic diseases with a differentiated anti-IgE asset.
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| • | Pipeline Synergy: Positions EXL-111 to complement current and future Novartis therapies across food allergy, CSU, CIndU, allergic asthma, and other IgE-driven conditions.
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| • | Patient Impact: If clinical benefits are confirmed, EXL-111 could offer earlier symptom relief, stronger disease control, more convenient dosing, and broader use, including potential pediatric applications.
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| • | Market Potential: Validates Excellergy’s ECRI/anti-IgE platform and gives Novartis a next-wave anchor asset in the evolving landscape of IgE-mediated allergy treatments.
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| | Strategic Collaborations Reshaping Drug Discovery and Biologic Delivery
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Sanofi Bolsters Autoimmune Portfolio with Up to $1.23B+ KT501 Licensing Deal from Kali Therapeutics
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Kali Therapeutics has entered a strategic licensing agreement with Sanofi for KT501, a novel tri-specific T-cell engager designed to treat a broad range of B-cell–mediated autoimmune diseases.
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Why It Matters
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| • | Deal Value: $180M upfront/near term + up to $1.05B in milestones, for more than $1.23B in total deal potential.
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| • | Mechanism & Modality: KT501 is an IgG-like tri-specific T-cell engager targeting CD3, CD19, and BCMA to deplete a broad range of B cells while aiming to minimize cytokine release.
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| • | Clinical Status: Currently in a first-in-human trial in adults with Rheumatoid Arthritis, assessing safety, tolerability, PK, and PD.
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Strategic Focus
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| • | Sanofi Immunology Push: Strengthens Sanofi’s autoimmune and immune-reset pipeline with a next-generation T-cell engager platform.
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| • | Kali Value Creation: Provides non-dilutive capital and validates Kali’s discovery engine while retaining its remaining R&D subsidiaries.
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| • | Patient Impact: Targets complex B-cell–driven autoimmune diseases with the potential for deeper, safer immune modulation than legacy B-cell depleters.
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| • | Market Potential: Positions KT501 as a first-in-class, scalable off-the-shelf alternative to cell therapies across multiple autoimmune indications.
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This collaboration underscores growing big-pharma interest in immune-reset strategies and next-generation T-cell engagers in autoimmunity.
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Unlocking New Frontiers in IBD Research Through Somatic Genomics
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Quotient Therapeutics has entered a multi-year research collaboration with Merck & Co. (MSD outside the US and Canada) to discover novel drug targets for Inflammatory Bowel Disease using Quotient’s somatic genomics platform.
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Why It Matters
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| • | Deal Value: $20M upfront, with a potential total deal value of approximately $2.2B tied to development, regulatory, and commercial milestones.
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| • | Platform Approach: Somatic genomics leverages naturally occurring mutations in patient tissues to pinpoint causal disease genes beyond traditional germline GWAS.
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| • | Disease Focus: Targets IBD, including Crohn’s disease and ulcerative colitis, where disease-modifying therapies remain a significant unmet need.
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Strategic Focus
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| • | Merck Immunology Push: Enhances Merck’s immunology and inflammation pipeline with a next-generation, modality-agnostic target discovery engine.
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| • | Quotient Validation: Provides meaningful non-dilutive funding and validates the somatic genomics platform for broader use beyond IBD.
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| • | Patient Impact: Aims to enable truly disease-modifying, precision therapies for complex inflammatory diseases.
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| • | Market Potential: Positions somatic genomics as a cornerstone technology for next-wave drug discovery in immune-mediated conditions.
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Insilico Medicine and Tenacia Expand AI-Powered CNS Drug Discovery Collaboration
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Insilico Medicine and Tenacia Biotechnology have expanded their AI-driven R&D collaboration to advance an additional central nervous system (CNS) drug candidate with defined molecular properties, aiming to progress the program to the preclinical candidate stage for neurological disorders.
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Why It Matters
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| • | Deal Value: The expanded collaboration carries a total potential value of up to approximately $94.75M, including near-term and milestone-based payments to Insilico.
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| • | AI-Enabled Design: Uses generative AI to create novel CNS candidates with precisely defined physicochemical and pharmacokinetic properties tailored for challenging neurological diseases.
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| • | Platform Progress: Builds on a first AI-designed BBB-permeable program already advancing toward development, underscoring the promise of AI in de-risking CNS pipelines.
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Strategic Focus
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| • | Risk Mitigation: Dual-program strategy aims to reduce late-stage attrition and improve clinical success rates in CNS, an area historically marked by high failure rates.
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| • | Partner Synergy: Marries Insilico’s Pharma.AI engine with Tenacia’s deep CNS biology and development experience to accelerate candidate selection and optimization.
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| • | Patient Impact: Targets hard-to-treat neurological disorders by generating BBB-penetrant small molecules with differentiated mechanisms and safety profiles.
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| • | Market Potential: Positions the collaboration to deliver best-in-class CNS assets in an area with significant unmet need and limited effective therapeutic options.
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Advancing Subcutaneous Biologics Delivery Through Strategic Innovation
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Alteogen has entered into an exclusive license agreement with Biogen, granting Biogen rights to use ALT-B4 (berahyaluronidase alfa) to develop and commercialize subcutaneous (SC) formulations of two biologic therapies, with an option to extend the collaboration to a third product.
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Why It Matters
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| • | Deal Value: Up to ~$579M in total economics, including $30M in early payments plus ~$549M in milestones, alongside royalties.
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| • | Delivery Innovation: Supports transition of IV biologics to SC administration, aligning with growing demand for more convenient, outpatient-friendly treatment options.
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| • | Program Scope: Covers two defined biologic products with an option for a third, giving Biogen flexibility to broaden SC strategies across its portfolio.
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Strategic Focus
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| • | Biogen Portfolio Shift: Advances Biogen’s strategy to modernize biologic delivery in neurology and immunology with patient-centric SC formats.
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| • | Alteogen Platform Validation: Further validates ALT-B4 and the Hybrozyme technology as key enablers for high-volume SC biologics.
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| • | Patient Impact: SC delivery can reduce infusion burden, increase treatment accessibility, and improve overall care experience versus clinic-based IV infusions.
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| • | Market Potential: Positions ALT-B4 at the center of the broader industry shift toward SC reformulations of existing and next-generation biologics.
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| | Clinical Frontiers: Advancing the Next Generation of Treatments
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Phase III WU-KONG28 Study by Dizal
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EGFR Exon 20+ NSCLC
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Dizal Pharmaceutical reports positive Phase III WU-KONG28 topline data for Zegfrovy (sunvozertinib; oral QD) vs. platinum chemo as 1L therapy (global study across Asia/Europe/N.America/S.America).
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Key Details
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| • | Primary endpoint met: Significant PFS improvement by BICR.
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| • | Superiority across key secondaries: cORR, DOR, DCR.
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Next Steps
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Detailed data at upcoming conference; global NDA discussions planned.
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Asset Snapshot
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Chemo-free targeted oral therapy for high-unmet-need exon20ins population.
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These results position Zegfrovy as potential 1L standard in EGFR exon20-mutant NSCLC.
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r/r DLBCL (China)
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HUTCHMED initiates a registrational Phase III trial of HMPL-760 + R-GemOx vs. placebo + R-GemOx in Chinese patients with r/r DLBCL; first patient dosed on March 20, 2026.
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Key Details
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| • | Randomized, double-blind Phase III study in ~240 transplant-ineligible patients relapsed/refractory after first-line systemic therapy.
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| • | Builds on Phase II combo data showing improved ORR, CRR, PFS, and OS vs. R-GemOx alone, with a favorable safety profile.
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Next Steps
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Phase III readout to support potential registration in China and broader hematology strategy.
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Asset Snapshot
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Oral non-covalent BTK inhibitor advancing in aggressive B-cell malignancies.
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This milestone underscores HUTCHMED’s commitment to expanding options for patients with r/r DLBCL.
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Lyme disease
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Pfizer and Valneva report Phase III VALOR data for Lyme vaccine candidate PF-07307405 in individuals ≥5 years at high risk of Lyme disease, dosed at months 0, 2, 5–9 with a booster one year later.
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Key Details
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| • | Vaccine efficacy: 73.2% at 28 days post–dose 4 and 74.8% at 1 day post–dose 4 vs. placebo in reducing confirmed Lyme disease cases.
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| • | Primary endpoint not met in first analysis as the 95% CI lower bound did not exceed 20 amid fewer-than-expected cases; second pre-specified analysis met this threshold, supporting clinical benefit.
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Next Steps
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Data support planned regulatory submissions for PF-07307405 in Lyme disease prevention.
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Asset Snapshot
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Quadrivalent Lyme vaccine candidate offering >70% efficacy in a high-risk, broad age population.
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These findings highlight the potential of PF-07307405 to address a significant unmet need in Lyme disease prevention.
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Atopic Dermatitis
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Apogee Therapeutics reports Phase II APEX Part A maintenance data for zumilokibart (APG777; 360 mg Q3M or Q6M) in moderate-to-severe atopic dermatitis.
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Key Details
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| • | Week 16 responders maintaining EASI-75: 75% (Q3M) and 85% (Q6M); vIGA 0/1 sustained in 86% (Q3M) and 78% (Q6M), with continued deepening of lesional and itch responses through maintenance.
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| • | Data presented at AAD 2026 Annual Meeting.
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Next Steps
APEX Part B (high/medium/low dose vs. placebo; n=347) 16-week readout expected in Q2 2026; Phase III initiation planned in 2H 2026, targeting potential launch around 2029.
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Asset Snapshot
Extended half-life IL-13 mAb enabling Q3–6M dosing with durable disease control.
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These findings support zumilokibart’s potential as an infrequent-dosing biologic for long-term AD management.
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Myelofibrosis (Frontline)
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Karyopharm Therapeutics reports topline Phase III SENTRY data for selinexor (60 mg QW) + ruxolitinib vs. placebo + ruxolitinib in 353 frontline myelofibrosis patients, with ongoing FDA discussions and potential compendia inclusion in 2H 2026.
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Key Details
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| • | SVR35 at Week 24: 50% with selinexor combo vs. 28% control; rapid responses at Week 12 (49% vs. 20%) sustained to Week 36 (47% vs. 23%).
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| • | Mean Abs-TSS change at Week 24: −9.89 vs. −10.86; >50% OS improvement signal with ongoing follow-up, SVR35 correlated with OS in post-hoc analyses; ≥20% VAF reduction more frequent with selinexor (32% vs. 24%), with no meaningful differences in PFS, hemoglobin stabilization, or bone marrow fibrosis.
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Next Steps
Engagement with FDA on sNDA pathway and labeling, with further maturation of OS and disease-modification data.
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Asset Snapshot
First-in-class XPO1 inhibitor plus JAKi delivering deeper spleen responses and encouraging OS signal in MF, with a manageable safety profile.
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These results support selinexor + ruxolitinib as a potentially differentiated frontline option in myelofibrosis.
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Type 2 Diabetes
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The United Laboratories & Novo Nordisk report Phase II data for weekly UBT251 (2/4/6 mg SC) vs. placebo and semaglutide 1 mg in 211 Chinese patients with Type 2 Diabetes.
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Key Details
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| • | At Week 24, mean HbA1c reduction: 2.16% with UBT251 vs. 1.77% with semaglutide and 0.66% with placebo (baseline 8.12%).
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| • | Mean weight loss up to 9.8% with UBT251 vs. 4.8% with semaglutide and 1.4% with placebo (baseline 80.1 kg), with additional benefits on waist circumference, blood pressure, and lipids vs. placebo.
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Next Steps
Two Phase III trials planned in Chinese T2D patients; Novo Nordisk running a global Phase Ib/IIa study in ~330 overweight/obese participants (28 weeks; topline 2027) and preparing a global Phase II T2D trial starting 2H 2026.
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Asset Snapshot
Triple agonist (GLP-1/GIP/glucagon) showing robust glucose lowering and weight loss with broad cardiometabolic improvements.
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These results support UBT251 as a promising next-generation metabolic therapy in diabetes and obesity.
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IgA Nephropathy (IgAN)
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Otsuka Pharmaceutical reports Phase III VISIONARY data for Voyxact (sibeprenlimab-szsi; 400 mg SC Q4W) vs. placebo in IgAN patients at risk of progression.
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Key Details
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| • | At Week 48, 82.5% on Voyxact achieved negative microscopic hematuria (0–5/HPF) vs. 52.6% with placebo; median time to 0–5/HPF: 9 vs. 24 weeks.
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| • | Data presented at ISN World Congress of Nephrology 2026; trial continues to assess long-term eGFR slope over 24 months to evaluate kidney function preservation.
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Next Steps
Ongoing VISIONARY follow-up to confirm long-term renal benefit and support full approval beyond proteinuria reduction.
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Asset Snapshot
First-in-class APRIL inhibitor with complementary effects on proteinuria and hematuria in progressive IgAN.
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These findings further support Voyxact’s potential to address a key unmet need in IgAN.
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COPD (Exacerbation Risk)
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AstraZeneca reports replicate Phase III OBERON and TITANIA data for tozorakimab (300 mg Q4W, 52 weeks) vs. placebo on top of standard inhaled therapy in 2,306 adults with symptomatic COPD and prior exacerbations.
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Key Details
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| • | Both trials met their primary endpoint, reducing the annualized rate of moderate-to-severe COPD exacerbations in former smokers and in the overall population.
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| • | Benefit observed across broad subgroups, including by eosinophil level, smoking status, and baseline lung function severity; detailed results to follow at a future scientific meeting.
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Next Steps
Tozorakimab is also being evaluated in Phase III PROSPERO and MIRANDA COPD trials, the Phase III TILIA study in severe viral lower respiratory tract disease, and the Phase II UMBRIEL trial in asthma.
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Asset Snapshot
Anti–IL-33 mAb with dual mechanism under late-stage development across COPD and other respiratory indications.
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These findings support tozorakimab’s potential as an add-on biologic to reduce COPD exacerbations across a wide patient population.
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Inclusion Body Myositis (IBM)
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Abcuro reports Phase II/III MUSCLE data for ulviprubart (ABC008; Q8W) in 272 IBM patients randomized to 0.5 mg/kg, 2 mg/kg, or placebo.
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Key Details
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| • | Overall population: trend toward slower functional decline at Week 76 on IBMFRS, with mean declines of 1.7 points (low dose) and 2.1 points (high dose) vs. 2.4 points on placebo.
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| • | In a prespecified subgroup with baseline IBMFRS ≥29, both doses showed a 1.3-point decline vs. 2.6 points on placebo at Week 76 (~50% reduction in functional deterioration), suggesting greater disease-modifying potential in less severe patients.
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Next Steps
Abcuro plans to meet with the U.S. FDA to discuss regulatory path and future development of ulviprubart in IBM.
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Asset Snapshot
First-in-class KLRG1-targeting antibody aiming to slow functional decline in a rare, progressive neuromuscular disease with high unmet need.
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These findings support continued evaluation of ulviprubart, particularly in patients with earlier-stage IBM.
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Metastatic Pancreatic Cancer (mPDAC)
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Novocure reports Phase II PANOVA-4 data for TTFields plus atezolizumab + gemcitabine/nab-paclitaxel as first-line therapy in mPDAC, with median TTFields duration of 25.6 weeks and six cycles of systemic therapy.
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Key Details
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| • | Primary endpoint met: DCR 74.4% with TTFields combo (N=78) vs. 48% with gemcitabine/nab-paclitaxel alone in historical MPACT control (N=431).
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| • | Secondary signals: ORR 34.6% and median OS 9.7 months, with additional endpoints including PFS, 1-year survival, 6-month PFS, DoR, and TRAEs under further analysis.
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Next Steps
Full PANOVA-4 data will be presented at an upcoming scientific conference to further define TTFields’ role in mPDAC treatment.
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Asset Snapshot
Non-invasive TTFields platform combined with chemo-immunotherapy showing encouraging disease control and survival signals vs. historical standard.
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These findings support continued development of TTFields-based regimens in metastatic pancreatic cancer.
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Advanced Non-Sq NSCLC
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Prestige Biopharma reports Phase III SAMSON-II topline data for HD204 (bevacizumab biosimilar) vs. Avastin in 625 adults with advanced non-squamous NSCLC.
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Key Details
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| • | ORR at Week 18: 48.7% with HD204 vs. 46.5% with Avastin, meeting the primary endpoint and confirming clinical equivalence; similar ORR at Week 12 and no significant differences in PFS or OS.
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Next Steps
SAMSON-II outcomes, together with strong analytical and PK similarity data, support ongoing global regulatory submissions for HD204.
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Asset Snapshot
Proposed bevacizumab biosimilar designed to offer comparable efficacy and safety with potential cost advantages in advanced NSCLC and other Avastin indications.
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These results reinforce HD204’s potential as a clinically equivalent alternative to Avastin.
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| | Regulatory Watch: Major Global Decisions
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Regulatory Highlights: Key Global Approvals, Reviews, and Filings Shaping the Biopharma Landscape
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The regulatory landscape continues to evolve with significant approvals, priority reviews, and regulatory submissions across major global agencies, including the U.S. FDA, EMA, Japan’s MHLW, and China’s NMPA. These milestones reflect continued momentum in innovative therapeutics, biosimilars, and treatments addressing rare and high-unmet-need diseases.
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| • | Novo Nordisk reports the U.S. FDA approval of Wegovy HD for chronic weight management, further expanding treatment options in the growing obesity care landscape.
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| • | IntraBio announces the U.S. FDA submission of a supplemental NDA for Aqneursa to treat Ataxia-Telangiectasia.
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| • | Ionis Pharmaceuticals reports that Zilganersen has received U.S. FDA Priority Review for the treatment of Alexander Disease.
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| • | Corcept Therapeutics reports the U.S. FDA approval of Lifyorli (relacorilant) for patients with Platinum-Resistant Ovarian Cancer.
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| • | The U.S. FDA grants Accelerated Approval to Denali Therapeutics for Avlayah (tividenofusp alfa-eknm) to treat Hunter Syndrome (MPS II).
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| • | Novo Nordisk also receives U.S. FDA approval for Awiqli for the treatment of Type 2 Diabetes.
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| • | GSK reports the EMA’s acceptance of the Marketing Authorization Application (MAA) for Bepirovirsen to treat Chronic Hepatitis B.
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| • | Shanghai Henlius Biotech receives NMPA IND clearance for HLX18, a biosimilar candidate to Opdivo (nivolumab), advancing its development program in oncology.
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Together, these regulatory developments highlight continued progress across therapeutic areas ranging from metabolic and infectious diseases to oncology and rare disorders, reinforcing the global commitment to bringing innovative therapies to patients faster.
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| | Advancing Precision and Innovation in Medical Devices
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MedTech Pulse: Precision Innovations in Medical Devices
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The MedTech sector continues to witness important regulatory milestones in Europe, with new device approvals focused on enhancing surgical precision, improving treatment planning, and advancing patient care across orthopedics and oncology.
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These approvals underscore the growing role of advanced MedTech solutions in enabling more precise interventions, optimizing treatment workflows, and improving patient outcomes across complex medical procedures.
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The Next Wave of Biopharma Innovation: Mega Deals, Breakthrough Trials, and Strategic Pipeline Expansion
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This week’s PharmaShots Weekly highlights a wave of strategic biopharma deals reshaping immunology and oncology. Merck & Co. leads with a $6.7B acquisition of Terns Pharmaceuticals to advance next-generation CML therapy. Meanwhile, Gilead Sciences, Novartis, and Sanofi expand immunology portfolios through major acquisitions and licensing deals. A ~$2.2B partnership between Quotient Therapeutics and Merck & Co. further accelerates novel target discovery in Inflammatory Bowel Disease, underscoring growing investment in next-generation immune therapies.
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Stay Ahead with PharmaShots Weekly
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The biopharma industry never pauses—breakthrough clinical data emerges overnight, billion-dollar deals redefine competitive landscapes, and regulatory decisions can reshape entire markets in real time. In a sector moving at this speed, timely intelligence isn’t optional—it’s essential.
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PharmaShots Weekly cuts through the noise to deliver what truly matters: pivotal pipeline updates, regulatory inflection points, clinical milestones, strategic partnerships, and emerging competitive dynamics—distilled into a concise, executive-ready briefing you can absorb in minutes.
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Every Monday at 8:00 AM EST, receive a decision-focused snapshot of the forces shaping global pharma and biotech, carefully curated for leaders who act on insight—not information overload.
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If this edition sparked new ideas, make it part of your weekly routine. Subscribe to PharmaShots Weekly for intelligence that is concise, credible, and crafted for decision-makers across R&D, competitive intelligence, strategy, and business development.
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