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Welcome to PharmaShots Weekly
| | | Jan 26 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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GSK Supercharges Immunology with $2.2B RAPT Deal
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| | ViiV Healthcare Reshaped: Shionogi Steps In, Pfizer Exits
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| | BMS Partners with Janux on Next-Gen Tumor-Activated Therapy
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| | Pfizer Leverages Novavax’s Matrix-M to Power Future Vaccines
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Stay Curious.
| | | Stay informed!
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| | Stay ahead with PharmaShots Weekly!
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Top Stories This Week
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| • | GSK Supercharges Immunology with $2.2B RAPT Deal
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| • | ViiV Healthcare Reshaped: Shionogi Steps In, Pfizer Exits
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| • | BMS Partners with Janux on Next-Gen Tumor-Activated Therapy
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| • | Pfizer Leverages Novavax’s Matrix-M to Power Future Vaccines
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Cover Story
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GSK Strengthens Immunology Pipeline with $2.2B RAPT Acquisition
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| • | Deal details: $58/share, ~$2.2B equity, ~$1.9B upfront cash
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| • | Phase II ozureprubart (immune-mediated diseases), global rights ex-Greater China
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| • | Expected data: 2027; closing: Q1 2026
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| • | Strategic impact: Pipeline boost, global rights, long-term growth
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Key Strategic Deals
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| • | AstraZeneca & C-CAR031: Full global rights for GPC3 CAR-T therapy; up to $630M payments
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| • | GSK & Alteogen: SC dostarlimab licensing; $20M upfront + ~$265M milestones
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| • | Pfizer & Novavax: Matrix-M adjuvant license; $30M upfront + ~$500M milestones
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| • | ViiV Healthcare Restructure: Shionogi invests $2.125B; Pfizer exits
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| • | Insilico & Hygtia: Co-development of ISM8969 (AI-discovered CNS therapy)
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| • | BMS & Janux: Tumor-activated solid tumor therapy license; $50M upfront + ~$800M milestones
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Clinical Highlights
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| • | MDD: J&J Caplyta OLE & pooled Phase III data show sustained remission
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| • | r/r DLBCL: AbbVie epcoritamab improves PFS in Phase III EPCORE study
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| • | Early Prostate Cancer: Telix doses first patient in PSMA-PET pre-biopsy trial
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| • | Lichen Sclerosus: LEO Pharma DELTA CARE 1 Phase III trial of Anzupgo cream
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| • | Ataxia-Telangiectasia: IntraBio’s Aqneursa Phase III topline shows SARA improvement
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| • | Ovarian Cancer: Corcept relacorilant + nab-paclitaxel demonstrates OS benefit in PROC
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| • | GI Cancers: Mabwell 7MW4911 Phase I/II for advanced colorectal/GI tumors
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| • | Congenital Adrenal Hyperplasia: Crinetics BALANCE-CAH Phase II/III atumelnant dosing
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| • | Communicating Hydrocephalus: CereVasc ETCHES-1 enrollment complete
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Regulatory Milestones
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| • | D3 Bio: IND clearance (D3S-003, Elisrasib combo)
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| • | Daiichi Sankyo: EMA MAA acceptance (Enhertu + Perjeta)
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| • | Akeso: NMPA sNDA acceptance (Gumokimab)
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| • | iRegene: FDA RMAT designation (NouvNeu001)
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| • | Levicept: FDA IND (LEVI-04)
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| • | EC approves Ionis/Otsuka Dawnzera (HAE)
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| • | IntraBio Aqneursa: EC approval (NPC)
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| • | Celcuity: FDA NDA priority review (Gedatolisib)
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| • | BPGbio: FDA orphan designation (BPM31510)
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Medtech & Veterinary Updates
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| • | Abbott: CE Mark for TactiFlex™ Duo Ablation Catheter
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| • | SurGenTec: FDA clearance for ION-C Facet Fixation System
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| • | Boehringer Ingelheim: Vetmedin FDA-approved to delay CHF onset in dogs
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Pharma & Medtech Roundup
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| • | M&A, licensing, and regulatory milestones shaping oncology, immunology, rare disease, medtech, and veterinary care pipelines.
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Stay Ahead with PharmaShots Weekly
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| • | Every Monday at 8:00 AM EST: concise, credible, decision-ready insights
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| • | Forward to R&D, CI, Strategy, BD teams; share takeaways on LinkedIn
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GSK Strengthens Immunology Pipeline with $2.2B RAPT Acquisition
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GSK is making a bold move in immunology. The pharma giant has agreed to acquire RAPT Therapeutics for $58/share (~$2.2B equity value; ~$1.9B upfront cash), securing global rights to Phase II ozureprubart (excluding Greater China), with pivotal data expected in 2027. The deal is set to close in Q1 2026, with GSK assuming partner milestone and royalty obligations.
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Why This Acquisition Matters
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Pipeline boost: Adds ozureprubart, a Phase II asset targeting immune-mediated diseases, to GSK’s growing immunology portfolio.
Strategic value: $2.2B equity investment with $1.9B upfront positions GSK for long-term growth in high-demand therapeutic areas.
Global rights: GSK now controls development and commercialization outside Greater China, streamlining future launches.
Timeline: Expected Q1 2026 closing ensures rapid integration and accelerated development.
A Strategic Step Forward
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By acquiring RAPT, GSK injects high-potential mid-stage innovation into its pipeline, enhancing its position in immunology and signaling confidence in its long-term growth strategy. The move not only strengthens GSK’s competitive edge but also underscores the company’s commitment to delivering next-generation therapies for patients with unmet immune-mediated needs.
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| | Major Moves in Biopharma: Global Partnerships, Acquisitions & Next-Gen Therapy Deals
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AstraZeneca Goes All-In on C-CAR031
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Secures Global Rights to GPC3 CAR-T Therapy
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AstraZeneca agrees to acquire AbelZeta’s remaining 50% stake in China development and commercialization rights for C-CAR031, a GPC3-targeted CAR-T therapy. AstraZeneca now holds full worldwide rights to develop, manufacture, and commercialize the asset, building on its prior ex-China agreement. AbelZeta stands to receive up to $630 million, including upfront and milestone payments plus royalties.
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Why This Acquisition Matters
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The transaction consolidates AstraZeneca’s cell therapy footprint in solid tumors:
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| • | Global control: Full rights to C-CAR031 after securing ex-China access earlier.
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| • | Economic alignment: AbelZeta eligible for up to $630M in upfront, milestones, and royalties.
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| • | Pipeline boost: Strengthens oncology portfolio with GPC3-targeted CAR-T potential.
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| • | Strategic confidence: Signals belief in C-CAR031’s worldwide prospects.
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A Strategic Step Forward
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This deal cements AstraZeneca’s leadership in next-gen cell therapies, accelerating C-CAR031 toward solid tumor breakthroughs amid rising demand for innovative CAR-T solutions.
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GSK Bets on Subcutaneous Innovation for Dostarlimab
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Exclusive License for SC Formulation via Alteogen
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Tesaro (GSK) signs exclusive license with Alteogen to develop and commercialize a subcutaneous (SC) dostarlimab using ALT-B4 hyaluronidase technology. Alteogen supplies clinical/commercial ALT-B4; Tesaro gains exclusive integration rights. Alteogen receives $20M upfront, up to ~$265M in milestones, and tiered royalties.
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Why This Deal Matters
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The agreement advances patient-friendly oncology delivery:
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| • | Tech core: ALT-B4 (Hybrozyme™ platform) enables large-volume SC biologics by degrading hyaluronan.
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| • | Financials: $20M upfront + ~$265M milestones + royalties on net sales.
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| • | Pipeline fit: Targets IV-to-SC shift for dostarlimab in immuno-oncology.
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| • | Patient impact: Promises shorter infusions and greater convenience.
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A Strategic Step Forward
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This partnership positions GSK to lead in SC innovations, enhancing dostarlimab’s competitiveness in crowded immuno-oncology while prioritizing accessibility and compliance.
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Pfizer Taps Novavax’s Matrix-M to Power Next-Gen Vaccines
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Non-Exclusive License for Adjuvant Tech
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Novavax grants Pfizer non-exclusive license to Matrix-M™ adjuvant for up to two disease areas in future vaccines. Novavax supplies adjuvant; Pfizer handles development/commercialization. Deal includes $30M upfront, up to ~$500M milestones, and high mid-single-digit royalties.
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Why This Deal Matters
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Matrix-M enhances vaccine potency and scalability:
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| • | Tech edge: Proven to boost immune response and enable dose-sparing.
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| • | Financials: $30M upfront + ~$500M milestones + tiered royalties.
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| • | Scope: Covers up to two disease areas for Pfizer’s pipeline.
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| • | Strategic role: Positions Novavax as key adjuvant partner.
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A Strategic Step Forward
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This alliance equips Pfizer to accelerate superior vaccines across indications, leveraging Matrix-M’s efficacy to meet demands for faster, more robust immunization solutions.
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ViiV Healthcare Reshaped: Shionogi Steps In, Pfizer Steps Out
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$2.125B Deal Reshuffles Ownership Stakes
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GSK, Shionogi & Pfizer restructure ViiV Healthcare: Shionogi buys in with $2.125B for new shares; Pfizer’s 11.7% stake cancels after receiving $1.875B plus $250M special dividend to GSK. Closure expected Q1 2026. Post-deal: Shionogi at 21.7%, GSK at 78.3%.
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Why This Deal Matters
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The transaction streamlines ViiV’s structure for HIV focus:
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| • | Ownership shift: Pfizer exits; Shionogi rises to 21.7% economic interest.
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| • | Financials: $2.125B to Shionogi; $1.875B + dividend to Pfizer/GSK.
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| • | Timeline: Q1 2026 close.
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| • | Strategic alignment: Bolsters GSK-Shionogi HIV partnership.
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A Strategic Step Forward
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This reshuffle fortifies ViiV’s agility, channeling resources into HIV innovation and cementing a unified front for sustained leadership in a vital therapeutic area.
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Insilico & Hygtia Join Forces on AI-Discovered CNS Therapy
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Global Co-Development for ISM8969 in Parkinson’s
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Insilico Medicine partners with Hygtia Therapeutics for ISM8969, an AI-discovered CNS candidate. Hygtia gains 50% worldwide rights for ~$66M ($10M upfront + milestones). Insilico leads early dev/Phase I in Parkinson’s; Hygtia handles late-stage trials, regs, and commercialization.
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Why This Deal Matters
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The collaboration merges AI discovery with execution scale:
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| • | Rights split: Hygtia 50% global; Insilico early-stage lead.
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| • | Financials: ~$66M total ($10M upfront + dev milestones).
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| • | Ops division: Insilico IND/Phase I; Hygtia late-stage/commercial.
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| • | CNS focus: Targets Parkinson’s with de-risked AI asset.
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A Strategic Step Forward
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This alliance harnesses Insilico’s generative AI with Hygtia’s late-stage prowess, positioning ISM8969 to redefine CNS therapy development speed and success.
BMS Taps Janux for Next-Gen Tumor-Activated Cancer Therapy
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Global License for Undisclosed Solid Tumor Asset
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Janux Therapeutics grants BMS exclusive global license for novel tumor-activated therapy targeting validated solid-tumor antigen. Janux leads preclinical/IND; BMS drives post-IND clinicals/commercialization (Janux supports Phase I). Financials: ~$50M upfront/near-term + up to ~$800M milestones + tiered royalties.
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Why This Deal Matters
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The partnership advances precision oncology:
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| • | Program handoff: Janux preclinical/IND; BMS global dev/commercial post-IND.
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| • | Financials: ~$50M upfront/near-term; ~$800M milestones; royalties.
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| • | Target: Undisclosed antigen across solid tumors.
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| • | Tech edge: Tumor-activated design for efficacy/toxicity balance.
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A Strategic Step Forward
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This alliance leverages Janux’s innovation with BMS’s execution scale, priming the asset for multi-indication breakthroughs in solid tumor therapy.
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| | Clinical Breakthroughs: From Psychiatry to Rare Diseases, Oncology, and Beyond
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New OLE Study 503 & Pooled P-III Data at ANCP’26 by J&J
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Major Depressive Disorder
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New OLE Study 503 & Pooled P-III Data at ANCP’26 by J&J
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Johnson & Johnson unveils Caplyta (lumateperone) data from OLE Study 503 (n=809) and pooled Phase III (Studies 501/502) at ANCP 2026, as adjunctive MDD therapy vs placebo + antidepressant.
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Key Findings
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Pooled Phase III (Week 6): Remission (MADRS ≤10) 25.5% vs 13.6%; complete remission (MADRS ≤5) 10.6% vs 5.6%.
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OLE Study 503 (study end): Remission 65.4%; complete 44.1%; sustained 42.8%. Steady gains: 28.6% (Week 8), 37.2% (Week 16), 40.8% (Week 24)—consistent across subgroups.
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| • | Bonus: sNDA submitted to FDA for schizophrenia relapse prevention.
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These results position Caplyta for deep, lasting remission in MDD and beyond, with consistent efficacy signaling broad psychiatric utility.
r/r DLBCL
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PFS Win in Phase III EPCORE DLBCL-1 vs Chemoimmunotherapy
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AbbVie reports topline Phase III EPCORE DLBCL-1: subcutaneous epcoritamab vs R-GemOx/BR in 483 r/r DLBCL patients (≥1 prior line; 73% ≥2L; HDT-ASCT ineligible).
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Key Findings
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| • | Primary endpoint met: Superior PFS.
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| • | Secondary wins: CRR, DoR, time to next treatment.
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| • | OS: Not statistically significant at this analysis.
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| • | Next: Regulator discussions underway with Genmab.
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Epcoritamab (DuoBody® CD3xCD20 bispecific) redirects T cells to CD20+ malignant B cells.
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This PFS benefit in transplant-ineligible r/r DLBCL underscores epcoritamab’s SC convenience and potential, paving the way for label expansion.
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Early Prostate Cancer Diagnosis
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First Patient Dosed: Illuccix/Gozellix PSMA-PET Pre-Biopsy
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Telix Pharmaceuticals doses first patient in US/Australia Phase III BiPASS trial (n=250) of Illuccix/Gozellix ⁶⁸Ga-PSMA-11 PET + MRI vs standard paths for initial prostate cancer diagnosis.
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Key Findings
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| • | Objective: Improve accuracy, cut unnecessary biopsies in pre-biopsy setting.
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| • | Builds on: PRIMARY/PRIMARY2 evidence for early detection.
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| • | Goal: Support marketing auth for frontline PSMA-PET use.
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BiPASS aims to elevate PSMA-PET from staging to diagnostic frontline, refining early detection and sparing invasive procedures.
Lichen Sclerosus
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Anzupgo Cream vs Vehicle in DELTA CARE 1 Trial
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LEO Pharma starts global Phase III DELTA CARE 1: Anzupgo (topical pan-JAK inhibitor) vs vehicle in ~652 adults with mild-severe lichen sclerosus (LS).
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Key Details
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| • | Enrollment: ~300 females first (dose selection); +~352 females/males.
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| • | Sites: ~80–90 across US, Canada, UK, EU (DE, FR, IT, ES, PL).
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| • | Asset: Global rights ex-Japan (Shionogi); targets all JAK pathways topically.
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This trial targets major unmet need in LS, positioning Anzupgo as potential first-in-class non-systemic therapy.
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Ataxia-Telangiectasia
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IB1001-303 Topline: SARA Benefit vs Placebo
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IntraBio reports Phase III IB1001-303 topline: Aqneursa (levacetylleucine) vs placebo in pediatric/adult Ataxia-Telangiectasia (A-T).
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Key Findings
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| • | Primary (SARA, 12w): –1.92 vs –0.14 (Δ–1.88; p<0.05).
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| • | Secondaries: ICARS –4.22 vs –1.69; CGI-I –0.6 vs –0.2.
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| • | Next: FDA/EMA/global filings planned.
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First potential disease-modifier for A-T positions Aqneursa for approvals in rare progressive neurodegeneration.
Ovarian Cancer
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ROSELLA OS Win + PDUFA July 2026
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Corcept Therapeutics reports Phase III ROSELLA topline: oral relacorilant + nab-paclitaxel vs nab-paclitaxel alone (n=381 platinum-resistant ovarian cancer).
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Key Findings
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| • | Primary OS: 35% risk reduction; mOS 16.0 vs 11.9 months.
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| • | PFS (prior): 30% risk reduction (ASCO 2025/The Lancet).
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| • | Regulatory: FDA PDUFA July 11, 2026; EMA MAA submitted.
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OS success in tough PROC setting advances relacorilant toward global approval as potential SOC backbone.
Gastrointestinal (GI) Cancers
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7MW4911 Phase I/II: CDH17-Targeted for Resistant CRC/GI Tumors
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Mabwell doses first US patient in Phase I/II of 7MW4911 (CDH17 ADC) for advanced colorectal cancer and GI tumors.
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Key Details
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| • | Preclinical: Outperforms MMAE/DXd ADCs in CDX/PDX; reverses prior ADC progression (AACR 2025/Cell Reports Med).
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| • | Platform: IDDC™ (internalizing mAb + stable linker + MF-6 topoisomerase I payload).
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| • | Design: Engineered for multidrug resistance in GI oncology.
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7MW4911 heralds resistance-overcoming ADCs, poised to extend options in pretreated GI cancers.
Congenital Adrenal Hyperplasia
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Phase II/III BALANCE-CAH: Oral Atumelnant for Pediatrics
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Crinetics doses first patient in Phase II/III BALANCE-CAH of atumelnant for classic congenital adrenal hyperplasia (CAH) in children/adolescents.
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Key Details
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| • | Design: Part A (Phase II dose-ranging); Part B (Phase III vs placebo); Part C (OLE).
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| • | Mechanism: Once-daily oral ACTH antagonist (MC2R-selective).
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| • | Goal: Normalize hormones, cut supraphysiologic steroids.
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Atumelnant eyes pediatric CAH transformation with targeted control and reduced steroid risks.
Communicating Hydrocephalus
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ETCHES-1: Post-SAH ICP Management Milestone
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CereVasc completes enrollment in ETCHES-1 study of eShunt™ System for adults with post-aneurysmal SAH communicating hydrocephalus.
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Key Details
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| • | Endpoints: ICP changes, device performance, safety (24-month follow-up).
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| • | Procedure: Minimally invasive CSF drainage (subarachnoid to venous).
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| • | Innovation: Dedicated delivery + permanent implant vs traditional shunts.
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eShunt eyes safer ICP control post-SAH, redefining hydrocephalus care with endovascular precision.
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| | Global Regulatory Milestones: Multiple Therapies Advance Across FDA, EMA, NMPA, and EC
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Regulatory Surge: Major Approvals and Designations Driving Global Patient Access
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The regulatory landscape is heating up as companies achieve key approvals, clearances, and designations across rare and oncology indications:
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| • | D3 Bio secures US FDA IND clearance to initiate a Phase I trial of D3S-003 and a Phase II combination study of Elisrasib (D3S-001) with D3S-002.
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| • | Daiichi Sankyo reports the EMA’s MAA acceptance for Enhertu + Perjeta in HER2-positive metastatic breast cancer.
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| • | Akeso announces NMPA sNDA acceptance of Gumokimab for active ankylosing spondylitis.
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| • | Levicept obtains US FDA IND acceptance for LEVI-04 in osteoarthritis.
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| • | European Commission approves Ionis & Otsuka’s Dawnzera (Donidalorsen) as a prophylactic therapy for hereditary angioedema (HAE).
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| • | IntraBio’s Aqneursa receives EC approval for Niemann-Pick Disease Type C (NPC).
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| • | US FDA accepts Celcuity’s Gedatolisib NDA under priority review for HR+/HER2- breast cancer.
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| • | BPGbio’s BPM31510 receives US FDA orphan drug designation for primary CoQ10 deficiency.
This wave of regulatory milestones spans rare diseases, oncology, and immunology, highlighting accelerated development paths and expanded patient access across multiple regions worldwide.
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| | Medtech Moves Forward: CE Mark and FDA Clearances
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Regulatory Green Lights: Medtech Innovations Advance in Cardiac and Spine Care
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The medical device landscape is advancing as companies secure key regulatory milestones:
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| • | Abbott receives the European CE Mark for its TactiFlex™ Duo Ablation Catheter, designed to treat atrial fibrillation with precision and efficiency.
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| • | SurGenTec obtains US FDA clearance for the ION-C Facet Fixation System, expanding options for minimally invasive spinal stabilization.
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These approvals highlight the ongoing innovation in cardiac and spine care, providing clinicians with next-generation tools to enhance patient outcomes and procedural efficiency globally.
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| | A Win for Canine Hearts: FDA Clears Vetmedin to Delay Early Heart Failure in Dogs
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Boehringer Ingelheim’s Vetmedin Gets FDA Nod to Protect Dogs from Early Heart Failure
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Good news for dog lovers and veterinarians alike: Boehringer Ingelheim’s Vetmedin available as chewable tablets and oral solution has received full FDA approval to delay the onset of congestive heart failure (CHF) in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD).
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The decision is grounded in robust multi-site research, including the landmark EPIC trial, where Vetmedin delayed CHF or cardiac-related death by an impressive 15.6 months compared with placebo. A second study confirmed that nearly 8 in 10 dogs remained CHF-free after one year.
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This new approval expands Vetmedin’s role beyond managing mild-to-severe CHF in dogs with MMVD or dilated cardiomyopathy, complementing its proven track record in improving survival and quality of life.
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Why it matters:
With Vetmedin, veterinarians can now intervene earlier, helping dogs stay active, healthy, and happy for longer—turning a life-threatening condition into a manageable one before symptoms even appear.
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| | ViVE 2026: Where Healthcare Leadership Meets Technology
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ViVE 2026 is returning to Los Angeles, bringing together over 9,000 executives from across the healthcare ecosystem to explore the future of digital health and innovation. Co-created by HLTH Inc. and CHIME, the event is the premier forum where health system and payer leaders connect with innovators, investors, and solution providers driving measurable transformation in healthcare delivery.
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This is where CIOs, CTOs, CMIOs, and digital health executives come to accelerate strategy, evaluate what truly works, and build collaborations beyond the noise. In just a few days, ViVE delivers insights and connections that would otherwise take months to achieve.
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Attendees can expect thought-provoking sessions, hands-on demonstrations, and peer-to-peer networking with leaders shaping the next era of healthcare technology. From breakthrough solutions in telehealth, AI, and patient engagement to strategic discussions on digital transformation and operational efficiency, ViVE 2026 provides an immersive environment for actionable insights.
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Whether you’re looking to discover new technologies, foster partnerships, or gain executive-level insights, ViVE is the destination for those shaping what’s next in healthcare.
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Exclusive for the PharmaShots community:
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| • | Get $250 off ViVE General Attendee passes
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| • | Use discount code: V26PHARMASHOTS
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Los Angeles | 2026 – don’t miss your chance to be part of the future of digital health.
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| | That’s a Wrap for This Week
We will see you next week
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Pharma & Medtech Roundup: Deals, Trials, and Approvals
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GSK acquires RAPT Therapeutics ($2.2B) for Phase II ozureprubart; ViiV reshuffled with Shionogi investment.
AstraZeneca secures full rights to C-CAR031 CAR-T; GSK/Tesaro partner with Alteogen for SC dostarlimab.
Pfizer licenses Novavax Matrix-M; BMS taps Janux for tumor-activated therapy; Insilico & Hygtia co-develop CNS asset.
Clinical highlights: J&J Caplyta MDD remission; AbbVie epcoritamab PFS win in r/r DLBCL; Telix PSMA-PET trial starts; Crinetics, Mabwell, CereVasc, LEO Pharma, IntraBio, Corcept advancing key programs.
Regulatory wins: FDA/EMA/NMPA approvals and IND/MAA acceptances across rare and oncology therapies.
Medtech & veterinary: Abbott TactiFlex CE-marked; SurGenTec ION-C cleared; Boehringer Ingelheim Vetmedin FDA-approved to delay CHF in dogs.
Why it matters: Strategic acquisitions, next-gen therapies, and regulatory milestones are reshaping global healthcare pipelines across oncology, immunology, rare diseases, medtech, and veterinary care.
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