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Welcome to PharmaShots Weekly
| | | Dec 22 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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The Oral GLP-1 Breakthrough: Lilly’s Orforglipron and the Next Era of Weight Management
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| | Sobi strengthens its gout portfolio with a $1.5B acquisition of Arthrosi Therapeutics, adding late-stage asset pozdeutinurad and positioning for Phase III readouts in 2026
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| | Sanofi doubles down on immunology with a $1.8B partnership with Dren Bio, targeting next-generation B-cell–depleting therapies across autoimmune diseases
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| | Sanofi expands its neuroscience pipeline through a $1.04B global licensing deal with ADEL, advancing ADEL-Y01, a differentiated tau-targeted antibody for Alzheimer’s disease
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Stay Curious.
| | | Stay informed!
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| | Stay ahead with PharmaShots Weekly!
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Lilly’s Orforglipron Redefines the Future of Sustained Weight Loss
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Highlights from the Phase III ATTAIN‑MAINTAIN Trial of Orforglipron by Eli Lilly
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Eli Lilly announced positive topline results from the Phase III ATTAIN‑MAINTAIN trial evaluating orforglipron, its oral non‑peptide GLP‑1 receptor agonist, for long‑term weight‑loss maintenance in adults with obesity or overweight and related comorbidities. The study enrolled 376 adults who had previously achieved weight loss with injectable GLP‑1 therapies (Wegovy or Zepbound) in the SURMOUNT‑5 trial. Importantly, Lilly has submitted a New Drug Application (NDA) for orforglipron to the FDA, which has received Complete New Drug Application Validation (CNPV).
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Key Outcome
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The trial met its primary endpoint, showing superior long‑term weight‑loss maintenance with orforglipron in patients who had reached a plateau on prior injectable GLP‑1 therapy. At 52 weeks, the efficacy estimand analysis demonstrated:
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| • | 0.9 kg greater weight maintenance vs placebo in patients switching from Wegovy.
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| • | 5.0 kg greater weight maintenance vs placebo in patients switching from Zepbound.
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Post‑hoc analyses at 24 weeks reinforced orforglipron’s benefit in preventing weight regain:
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| • | Patients switching from Wegovy saw a mean weight change of −0.1 kg, compared with a +9.4 kg gain in the placebo group.
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| • | Those transitioning from Zepbound experienced a +2.6 kg change, versus +9.1 kg with placebo.
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Across both cohorts, mean body weight declined from 113.5 kg (Wegovy) and 115.8 kg (Zepbound) at SURMOUNT‑5 initiation to 95.0 kg and 90.9 kg, respectively, at oral therapy switch—remaining stable at approximately 95.9 kg after 52 weeks. These findings underscore orforglipron’s potential as a convenient oral GLP‑1 option for sustaining weight loss after initial injectable treatment.
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Regulatory Path Ahead
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Following the successful readout from ATTAIN‑MAINTAIN, Lilly’s NDA for orforglipron is currently under accelerated FDA review, supporting potential commercialization as the first oral GLP‑1 therapy for long‑term weight maintenance.
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What’s Next
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Eli Lilly continues expanding its metabolic disease pipeline with additional Phase III trials of orforglipron across obesity, overweight, and type 2 diabetes populations. Further data from ATTAIN‑MAINTAIN are expected to be presented at upcoming scientific meetings, positioning orforglipron as a promising bridge between injectable and oral weight‑management solutions for sustained metabolic health.
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| | $1.5B Gout Play: Sobi Acquires Arthrosi Therapeutics
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Sobi Acquires Arthrosi Therapeutics in $1.5B Deal to Bolster Gout Franchise
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Strengthening Leadership in Rare and Specialty Diseases
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Sobi has entered into a definitive agreement to acquire Arthrosi Therapeutics, including its lead asset pozdeutinurad (AR882), in a move that significantly enhances Sobi’s position in progressive and tophaceous gout. The acquisition reflects Sobi’s strategic focus on expanding its rare and specialty disease portfolio, addressing areas of high unmet medical need and building long-term therapeutic depth.
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Why This Acquisition Matters
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| • | High-value transaction: Under the all-cash agreement, Sobi will pay $950 million upfront, with potential milestone payments totaling approximately $550 million, bringing the total value to around $1.5 billion.
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| • | Strategic portfolio expansion: The acquisition adds a late-stage, first-in-class oral URAT1 inhibitor, strengthening Sobi’s foothold in gout and related inflammatory conditions.
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| • | Clinical progress: Pozdeutinurad (AR882) is being assessed in two fully recruited global Phase III trials—REDUCE 1 and REDUCE 2—focused on efficacy in progressive and tophaceous gout.
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| • | Pivotal catalysts ahead: With Phase III readouts expected in 2026, the deal positions Sobi for a potential near-term commercial expansion in gout management.
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| • | Global reach: The acquisition fully integrates Arthrosi’s clinical and scientific expertise into Sobi’s global infrastructure, facilitating accelerated late-stage development and commercialization.
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A Strategic Step Forward
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For Sobi, this acquisition marks a bold step toward becoming a leader in metabolic and inflammatory rare diseases, anchoring its portfolio in high-impact, patient-centric therapies. For Arthrosi, it represents the culmination of a focused development journey for pozdeutinurad and a clear path toward global access. Together, the companies are poised to reshape the treatment landscape for severe gout—delivering targeted, oral solutions that can transform long-term outcomes for patients worldwide.
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| | Big Bets, Bold Science: The Partnerships Redefining Biopharma Innovation
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Sanofi and Dren Bio Forge $1.8B Partnership to Develop Next-Generation B-Cell Therapy
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Powering Innovation in Autoimmune Disease Treatment
Dren Bio has entered into a strategic partnership with Sanofi to discover and develop a next-generation B-cell–depleting therapy targeting a broad spectrum of autoimmune diseases.
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Why This Collaboration Matters
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| • | High-impact financials: Dren Bio will receive a $100 million upfront payment and up to $1.7 billion in potential development and commercial milestones, underscoring the high confidence in the program’s promise.
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| • | Joint early-stage leadership: Both companies will co-lead discovery and preclinical development using Dren Bio’s proprietary platform to advance novel B-cell–targeting candidates.
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| • | Global execution by Sanofi: Following early development, Sanofi will assume responsibility for worldwide development, manufacturing, regulatory, and commercialization activities.
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| • | Strategic co-development flexibility: Dren Bio retains an option for a U.S. profit-and-loss share, enabling it to co-fund 40% of global development in return for U.S. co-promotion rights and an equitable 50/50 profit split domestically.
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| • | Long-term value creation: Outside the U.S., Dren Bio remains eligible for ex-U.S. milestones and tiered royalties, providing both sustained upside and strategic optionality.
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A Strategic Step Forward
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For Dren Bio, this partnership validates the breadth and adaptability of its immune-modulation platform, positioning it at the forefront of next-generation autoimmune therapies. For Sanofi, it enhances its immunology leadership while expanding access to novel B-cell biology innovations. Together, the collaboration aims to chart a new course in autoimmune disease management—merging precision science with scalable global reach.
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Sanofi and ADEL Ink $1.04B Global Licensing Deal to Advance Next-Generation Alzheimer’s Therapy
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Pioneering Tau-Targeted Innovation in Neurodegeneration
Sanofi and ADEL have entered an exclusive worldwide licensing agreement for ADEL-Y01 and related backup compounds—marking a major milestone in Alzheimer’s disease research.
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Why This Collaboration Matters
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| • | High-value global partnership: The alliance combines Sanofi’s clinical and commercial strength with ADEL’s deep neurobiology expertise to accelerate novel Alzheimer’s disease therapies.
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| • | Differentiated mechanism: ADEL-Y01 is a humanized antibody designed to selectively bind toxic acK280 tau, blocking pathological aggregation while preserving normal tau function.
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| • | Robust financial structure: With an $80 million upfront and total potential deal value exceeding $1 billion, the collaboration represents one of the largest recent Alzheimer’s licensing deals.
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| • | Clinical progress: The candidate is currently being assessed in a global, FDA-approved Phase I trial, supporting early clinical validation.
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| • | Co-development foundation: Initially co-developed with Oscotec since 2020, ADEL-Y01 reflects years of focused innovation in precision-driven neurodegenerative therapy.
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A Strategic Step Forward
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For ADEL, this agreement showcases its discovery engine’s ability to generate globally competitive biologics in the neurodegenerative space. For Sanofi, it expands its neuroscience pipeline with a cutting-edge tau-targeted antibody that could reshape Alzheimer’s treatment paradigms. Together, the two companies aim to unlock a new chapter in disease-modifying therapies—where precision meets global reach to address one of medicine’s toughest challenges.
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Bristol Myers Squibb and Harbour BioMed Launch $1.12B Global Collaboration to Advance Multi-Specific Antibody Therapeutics
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Engineering the Next Wave of Antibody Innovation
Harbour BioMed has entered into a multi-year, global strategic collaboration and license agreement with Bristol Myers Squibb (BMS) to discover and develop next-generation multi-specific antibodies using Harbour BioMed’s proprietary Harbour Mice platform.
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Why This Collaboration Matters
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| • | Global multi-program alliance: The partnership enables joint discovery and early development of multiple multi-specific antibody programs designed to tackle complex disease mechanisms.
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| • | High-value financial framework: Harbour BioMed is eligible to receive up to $90 million in total payments, plus approximately $1.03 billion in development and commercial milestones, along with tiered royalties on future net sales if BMS advances all programs.
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| • | Cutting-edge discovery platform: The Harbour Mice® platform supports the generation of fully human monoclonal antibodies in both H2L2 and heavy chain–only antibody (HCAb) formats, offering unique versatility in biologic engineering.
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| • | Expanding therapeutic options: The technology’s ability to create complex, multi-specific antibodies has the potential to enhance efficacy, selectivity, and safety across a wide range of therapeutic areas.
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| • | Strategic validation: The collaboration reinforces global confidence in Harbour BioMed’s antibody discovery engine as a partner of choice for next-generation biologic design.
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A Strategic Step Forward
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For Harbour BioMed, the agreement represents both scientific validation and commercial acceleration, highlighting the scalability of its proprietary antibody platforms. For Bristol Myers Squibb, it provides access to powerful tools for discovering multi-specific biologics that could redefine standards across oncology, immunology, and beyond. Together, the companies aim to usher in a new era of precision antibody therapeutics—where modular design meets transformative medical potential.
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Insilico Medicine and TaiGen Partner on AI-Discovered Therapy for CKD-Related Anemia
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Expanding AI Innovation into Kidney Health
Insilico Medicine has entered an exclusive out-licensing collaboration with TaiGen and its subsidiary, TaiGen Biopharmaceuticals, for ISM4808, a novel therapy targeting anemia associated with chronic kidney disease (CKD).
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Why This Collaboration Matters
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| • | Exclusive regional rights: TaiGen gains full development and commercialization control over ISM4808 in Greater China, expanding its nephrology portfolio.
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| • | Milestone-rich structure: Insilico receives an upfront payment, development and sales milestones, and tiered royalties tied to regional success.
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| • | AI-discovered innovation: The compound was discovered using Insilico’s Chemistry42 platform, highlighting the power of generative AI in uncovering novel small molecules.
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| • | Clinical readiness: ISM4808 has shown strong preclinical results—demonstrating potent activity, favorable oral pharmacokinetics, and solid safety—backed by China IND clearance in 2023.
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| • | Pathway precision: By inhibiting prolyl hydroxylase domain (PHD) enzymes and stabilizing the HIF-α pathway, the therapy aims to restore erythropoiesis and tackle anemia at its biological root.
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A Strategic Step Forward
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For Insilico, the collaboration reinforces the commercial potential of its AI-discovered pipeline, translating digital innovation into tangible partnerships. For TaiGen, it builds a differentiated entry point into a high-prevalence disease area with pressing unmet need. Together, the companies aim to accelerate development of next-generation oral therapies for CKD-related anemia—advancing patient access while validating the global reach of AI-powered discovery.
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Adaptive Biotechnologies and Pfizer Form $890M Agreements to Advance TCR-Driven Drug Discovery
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Harnessing Immunomics and AI for Next-Generation Therapies
Adaptive Biotechnologies has entered into two non-exclusive agreements with Pfizer, combining Adaptive’s T-cell receptor (TCR) discovery expertise and immune receptor–antigen mapping technology to accelerate Pfizer’s research in autoimmune and other complex diseases.
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Why This Collaboration Matters
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| • | Targeted discovery alliance: Under one agreement, Adaptive will identify disease-specific TCR targets in rheumatoid arthritis using Pfizer’s clinical samples, directly informing therapeutic development.
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| • | High-value structure: Adaptive stands to receive upfront and milestone-based payments totaling up to $890 million, reflecting the strategic value of its platform in immune medicine.
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| • | Pfizer-led development: Pfizer will oversee the development and commercialization of any resulting therapies derived from Adaptive’s discoveries.
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| • | Data-driven expansion: In a parallel data licensing agreement, Pfizer gains access to Adaptive’s comprehensive TCR–antigen dataset to train and refine its AI/ML models across multiple disease indications.
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| • | Sustained collaboration: Adaptive will receive upfront and annual licensing fees through this multi-year, non-exclusive arrangement, with undisclosed financial specifics signaling long-term scientific engagement.
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A Strategic Step Forward
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For Adaptive Biotechnologies, these collaborations validate the translational power of its immunomics platform across both therapeutic discovery and data-driven modeling. For Pfizer, the partnerships strengthen its AI-enabled R&D infrastructure while deepening its reach into immune-mediated diseases. Together, they represent a pivotal fusion of biological insight and computational innovation—unlocking new pathways for precision-targeted, immune-based therapies.
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GeneScience and Yarrow Therapeutics Ink $1.36B Global Licensing Deal for Graves’ and Thyroid Eye Disease Therapy
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Advancing Innovation in Immuno-Endocrinology
GeneScience has entered into an exclusive global ex-China licensing agreement with Yarrow Therapeutics, backed by RTW Investments, for GS-098 (known as YB-101 outside China)—a differentiated therapy designed to treat Graves’ disease (GD) and thyroid eye disease (TED).
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Why This Collaboration Matters
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| • | Exclusive territorial split: Yarrow secures global rights outside China to develop, manufacture, and commercialize GS-098 for GD and TED, while GeneScience retains full control within China.
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| • | High-value partnership: The deal includes a $70 million upfront payment, a $50 million near-term milestone, and additional development, regulatory, and commercial milestones—bringing the total potential value to approximately $1.365 billion.
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| • | Strong royalty terms: GeneScience will receive tiered double-digit royalties on future net sales, ensuring sustained revenue participation.
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| • | Targeting key autoimmune diseases: GS-098/YB-101 offers a differentiated approach to GD and TED, both of which represent chronic, debilitating conditions with limited targeted treatment options.
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| • | Strategic investor validation: Backing from RTW Investments reinforces institutional confidence in Yarrow’s platform and GeneScience’s asset pipeline.
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A Strategic Step Forward
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For GeneScience, the deal extends its global reach while retaining strategic autonomy in China’s fast-growing biotech market. For Yarrow Therapeutics, it provides access to a late-stage, high-potential immuno-endocrinology asset poised to address two significant autoimmune indications. Together, the alliance sets the stage for a new era in thyroid-related disease therapy—anchored by scientific differentiation, commercial synergy, and patient-focused innovation.
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Vir Biotechnology and Norgine Pharma Forge $645M Partnership to Advance Chronic Hepatitis Delta Therapy
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Expanding Global Access to Innovative Liver Disease Treatments
Vir Biotechnology has granted Norgine Pharma, an affiliate of Norgine, exclusive commercial rights to its combination therapy of tobevibart and elebsiran for the treatment of chronic hepatitis delta (CHD) across the EU, Australia, and New Zealand.
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Why This Collaboration Matters
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| • | Regional exclusivity: The agreement provides Norgine with exclusive commercial rights in Europe and select international regions, facilitating broader patient access.
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| • | Strong financial structure: Vir will receive an initial $64.5 million (€55 million) reimbursement payment and up to $581.3 million (€495 million) in clinical, regulatory, and commercial milestone payments.
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| • | Attractive royalty terms: The deal includes tiered royalties from the mid-teens to high-twenties on net sales across Norgine’s licensed territories.
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| • | Cost-sharing model: Both companies will share clinical development costs for the ECLIPSE program, with Norgine contributing approximately 25% of future external expenses, reinforcing a balanced partnership.
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| • | Territorial balance: Vir retains commercialization rights in the U.S. and other markets outside Greater China, ensuring strategic global flexibility.
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A Strategic Step Forward
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For Vir Biotechnology, this collaboration strengthens its position as a leader in antiviral innovation while expanding the reach of its hepatitis delta program to key global markets. For Norgine, it builds on a long-standing heritage in hepatology and adds a transformative combination therapy to its portfolio. Together, the partnership paves the way for new treatment options in chronic hepatitis delta, combining scientific innovation with global outreach to meet an urgent medical need.
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| | Clinical Frontiers: Breakthrough Data Redefining Autoimmune, Neurologic, and Oncologic Care
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Orelabrutinib Shows Phase IIb Promise in Systemic Lupus Erythematosus
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Systemic Lupus Erythematosus (SLE)
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Highlights from the Phase IIb Study of Orelabrutinib by InnoCare
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InnoCare Pharma reported positive Phase IIb data for its oral BTK inhibitor orelabrutinib (50 mg or 75 mg once daily) in patients with systemic lupus erythematosus (SLE), while also receiving NMPA approval to initiate a Phase III trial in China. The 48‑week, placebo‑controlled study enrolled 187 patients, marking a major milestone in the continued development of orelabrutinib as a potential treatment for SLE.
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Key Outcome
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The trial met its primary endpoint, with the 75 mg dose achieving a statistically significant improvement in SRI‑4 response at Week 48 versus placebo (57.1% vs. 34.4%). Results also showed dose‑dependent efficacy, as the 75 mg dose outperformed the 50 mg cohort.
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The 75 mg arm additionally met key secondary endpoints, including higher SRI‑6 and BICLA response rates at 48 weeks, further validating its robust clinical profile. Enhanced efficacy was particularly notable in patients with more active disease:
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| • | A 35% higher SRI‑4 response in patients with BILAG ≥ 1A or ≥ 2B.
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| • | A 43% higher SRI‑4 response in those meeting both BILAG ≥ 1A or ≥ 2B and SLEDAI‑2K ≥ 4 criteria.
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Collectively, the results highlight orelabrutinib’s potential as a differentiated BTK inhibitor with strong activity across disease subgroups.
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Regulatory Path Ahead
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Building on these Phase IIb outcomes, InnoCare Pharma has received NMPA clearance to initiate a Phase III trial, which will further evaluate orelabrutinib’s efficacy and safety in a broader SLE population.
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What’s Next
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Comprehensive results from the Phase IIb study will be presented at upcoming scientific congresses and submitted for publication, positioning orelabrutinib as a next‑generation oral therapy with the potential to redefine treatment for patients with systemic lupus erythematosus.
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Stiff Person Syndrome (SPS)
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Highlights from the Phase II (KYSA‑8) Study of Mivocabtagene Autoleucel by Kyverna Therapeutics
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Kyverna Therapeutics reported encouraging Phase II (KYSA‑8) data for its autologous CAR T‑cell therapy mivocabtagene autoleucel (miv‑cel; KYV‑101) in patients with stiff person syndrome (SPS) who showed inadequate response to non‑approved treatment options. The single‑arm study evaluated a single dose of miv‑cel in 26 patients, underscoring the potential of this cell therapy in a rare, severe neurological disorder with limited therapeutic alternatives.
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Key Outcome
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The trial met its primary endpoint, achieving a median 46% improvement in the Timed 25‑Foot Walk (T25FW), with 81% of patients attaining a clinically meaningful ≥20% gain.
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| • | Robust improvements were observed across all key secondary endpoints, including the modified Rankin Scale (mRS), Disability Status Index (DSI), Health Assessment Index (HAI), and Hammersmith Scale Score (HSS).
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| • | Among 12 patients requiring a walking aid at baseline, 67% no longer needed assistance following treatment.
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| • | All treated patients remained immunotherapy‑free, with no need for rescue therapy, indicating durable, sustained responses.
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Regulatory Path Ahead
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Building on these positive findings, Kyverna Therapeutics plans to submit a Biologics License Application (BLA) to the FDA in H1 2026 for miv‑cel (KYV‑101) as a potential first‑in‑class therapy for SPS.
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What’s Next
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Comprehensive safety and efficacy results from KYSA‑8 will be presented at a medical meeting in 2026. These data support mivocabtagene autoleucel as an emerging cell‑based therapy capable of transforming outcomes in patients with stiff person syndrome, addressing a critical gap in neurological care.
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Muscle‑Invasive Bladder Cancer (MIBC)
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Highlights from the Phase III KEYNOTE‑B15/EV‑304 Trial of Keytruda (pembrolizumab) Plus Padcev (enfortumab vedotin) by Merck
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Merck announced positive results from the Phase III KEYNOTE‑B15/EV‑304 trial, which evaluated a perioperative regimen of Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin) in cisplatin‑eligible patients with muscle‑invasive bladder cancer (MIBC). The global study enrolled 808 patients, comparing four cycles of neoadjuvant Keytruda + Padcev followed by surgery and adjuvant Keytruda (13 cycles) + Padcev (five cycles) against standard‑of‑care neoadjuvant chemotherapy followed by surgery.
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Key Outcome
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The perioperative Keytruda–Padcev combination delivered statistically significant improvements across all major efficacy endpoints compared with chemotherapy and surgery, including:
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| • | Event‑free survival (EFS).
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| • | Pathologic complete response (pCR) rates.
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These findings highlight superior clinical outcomes with the immunotherapy + ADC combination and signal a potential paradigm shift in the management of muscle‑invasive bladder cancer.
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Regulatory Path Ahead
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Based on these compelling Phase III outcomes, Merck is expected to pursue global regulatory submissions for the Keytruda + Padcev perioperative regimen in MIBC, aiming to establish a new standard of care for cisplatin‑eligible patients.
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What’s Next
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Merck continues to expand Keytruda’s footprint in bladder cancer through ongoing Phase III trials, including:
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| • | KEYNOTE‑866 and KEYNOTE‑992 in MIBC.
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| • | KEYNOTE‑676 evaluating Keytruda + BCG in non‑muscle‑invasive bladder cancer (NMIBC).
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Together, these programs strengthen Keytruda’s role across the spectrum of bladder cancer, from early‑stage to advanced disease, reinforcing its position as a cornerstone in urologic oncology.
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Psoriasis (PsO)
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Highlights from the Global Phase III Trials of Zasocitinib (TAK‑279) by Takeda
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Takeda reported positive top‑line results from two global Phase III studies (NCT06088043 and NCT06108544) evaluating its oral TYK2 inhibitor zasocitinib (TAK‑279) in adults with moderate‑to‑severe psoriasis (PsO). The trials enrolled 693 and 1,108 patients, respectively, and compared zasocitinib with apremilast and placebo, marking a major milestone in Takeda’s expanding immunology pipeline.
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Key Outcome
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Zasocitinib demonstrated clear superiority over placebo across both co‑primary endpoints—sPGA 0/1 and PASI 75—at Week 16, alongside rapid onset of action with PASI 75 responses observed by Week 4 and durable efficacy maintained through Week 24.
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The therapy also achieved broad improvements across all 44 secondary endpoints versus both placebo and apremilast:
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| • | Over 50% of patients achieved PASI 90.
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| • | Approximately 30% achieved complete skin clearance (PASI 100) at Week 16.
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This strong and consistent efficacy profile underscores zasocitinib’s potential as a differentiated oral therapy for psoriasis.
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Regulatory Path Ahead
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Building on the success of these pivotal trials, Takeda plans to submit a New Drug Application (NDA) to the FDA and other regulators in 2026 seeking approval for zasocitinib in moderate‑to‑severe PsO.
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What’s Next
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Zasocitinib continues to advance across multiple indications in Takeda’s immunology portfolio, including:
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| • | A head‑to‑head study versus Sotyktu (deucravacitinib) in psoriasis.
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| • | A Phase III trial in psoriatic arthritis (PsA).
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| • | Phase II studies in Crohn’s disease and ulcerative colitis.
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Together, these programs highlight zasocitinib’s multi‑indication potential as a novel, best‑in‑class TYK2 inhibitor, positioned to transform immune‑mediated inflammatory disease therapy across dermatology and gastroenterology.
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| | Inside the Regulatory Arena: Key FDA & EMA Moves This Week
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Regulatory Radar: Breakthrough Approvals to Watch This Week
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This week’s regulatory landscape underscores continued momentum across respiratory, oncology, immunology, and rare diseases, with multiple approvals and positive opinions from the FDA, and European Commission. From first-in-class therapies to label expansions, these milestones reflect steady progress in translating innovation into patient access worldwide.
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| • | GSK announced a positive opinion from the EMA’s CHMP for depemokimab in the treatment of asthma with type 2 inflammation and chronic rhinosinusitis with nasal polyps (CRSwNP), reinforcing its potential as a differentiated biologic in respiratory care.
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| • | Johnson & Johnson secured U.S. FDA approval for Akeega to treat metastatic hormone-sensitive prostate cancer (mHSPC), expanding treatment options in an earlier-stage prostate cancer setting.
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| • | Cytokinetics reported a CHMP positive opinion for Myqorzo (aficamten) for patients with obstructive hypertrophic cardiomyopathy (oHCM), marking a key regulatory milestone for this cardiac myosin inhibitor.
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| • | Sobi received a CHMP positive opinion for Aspaveli in C3 glomerulopathy and primary immune complex–mediated membranoproliferative glomerulonephritis (IC-MPGN), addressing a significant unmet need in rare kidney diseases.
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| • | Vanda Pharmaceuticals announced its plans to seek U.S. FDA approval for imsidolimab for the treatment of generalized pustular psoriasis (GPP), a rare and potentially life-threatening dermatologic condition.
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| • | AstraZeneca gained European Commission (EC) approval for Saphnelo in systemic lupus erythematosus (SLE), strengthening its immunology portfolio in autoimmune disease.
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| • | GSK also reported U.S. FDA approval of Exdensur (depemokimab-ulaa) for asthma with an eosinophilic phenotype, marking a significant expansion of depemokimab’s regulatory footprint.
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| • | Incyte achieved EC approval for Minjuvi (tafasitamab) in combination therapy for relapsed/refractory follicular lymphoma (FL), extending its use beyond diffuse large B-cell lymphoma.
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| • | Johnson & Johnson further expanded its oncology portfolio with U.S. FDA approval of Rybrevant Faspro for patients with EGFR-mutated non–small cell lung cancer (NSCLC).
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| • | Daiichi Sankyo has achieved a key regulatory milestone with the EMA’s validation of its Marketing Authorization Application (MAA) for Datroway (datopotamab deruxtecan) for the treatment of metastatic triple-negative breast cancer (TNBC).
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| • | Novo Nordisk has submitted an NDA to the US FDA for CagriSema, marking a major regulatory milestone in its pursuit of next-generation weight management therapies.
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| | MedTech Momentum: Innovations Shaping Tomorrow’s Care
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MedTech Momentum: Breakthrough Device Approvals This Week
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This week’s MedTech updates showcase meaningful regulatory progress across women’s health, sleep medicine, and neonatal cardiac care, with innovative devices gaining key approvals that expand access to safer, more effective treatment options worldwide.
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| • | May Health secured the European CE Mark for its Anavi System, a novel solution designed to support women facing infertility associated with polycystic ovary syndrome (PCOS), marking an important step toward expanding reproductive health technologies in Europe.
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| • | SleepRes received U.S. FDA 510(k) clearance for its Kricket PAP device for the treatment of obstructive sleep apnea (OSA), strengthening the company’s presence in the sleep medicine space with a patient-friendly therapeutic option.
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| • | Abbott announced U.S. FDA clearance and European CE Mark approval for its Amplatzer Piccolo Delivery System, enabling a minimally invasive treatment option for premature infants born with patent ductus arteriosus (a hole in the heart), and advancing neonatal cardiac care across global markets.
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| • | Pulse Biosciences has secured U.S. FDA Investigational Device Exemption (IDE) approval to begin clinical studies of its nsPFA system in patients with paroxysmal atrial fibrillation (PAF).
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| | CHMP Greenlights Steqeyma, Turning Up the Heat in the Ustekinumab Biosimilar Race
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Biosimilar Alert: Steqeyma Gains CHMP Nod This Week
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CHMP Backs Celltrion’s Steqeyma® Autoinjector for Multiple Autoimmune Indications
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The Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Celltrion’s Steqeyma® autoinjector (45 mg/0.5 mL and 90 mg/1 mL)—a biosimilar of Stelara® (ustekinumab)—for the treatment of plaque psoriasis, psoriatic arthritis (PsA), and Crohn’s disease (CD).
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| | A New Line of Defense: Credelio® Quattro-CA1 Secures FDA Clearance for Canine Screwworm
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VetCare Alert: Credelio Quattro-CA1 Gains FDA Nod for Screwworm in Dogs
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Elanco’s Credelio® Quattro-CA1 Secures FDA Conditional Approval for the treatment of New World screwworm infestations in dogs, marking a significant advancement in veterinary parasitic care and providing veterinarians with a targeted solution for this severe and potentially life-threatening condition.
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| | Warm Wishes for a Healthy, Bright Holiday Season
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As the year comes to a close, we extend our warmest holiday wishes to our readers, partners, and the global healthcare community. Thank you for being part of the PharmaShots journey, here’s to a joyful holiday season and a healthier, brighter year ahead.
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| | That’s a Wrap for This Week
We will see you next week
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Inside Biopharma’s Fast Lane: Innovation, Capital, and Catalysts
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This week’s PharmaShots Weekly captures the accelerating pace of biopharma innovation across AI-driven discovery, high-value partnerships, late-stage clinical breakthroughs, and global regulatory momentum.
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From multi-billion-dollar licensing and M&A deals spanning AI, immunology, neuroscience, and rare diseases, to pivotal Phase III readouts in oncology, immunology, metabolic disease, and neurology, the edition highlights how science is rapidly translating into strategic and commercial impact. Regulatory wins across the FDA, EMA, and EC—alongside MedTech and biosimilar milestones—underscore continued progress toward patient access worldwide. Together, these developments offer a sharp snapshot of where pipelines are advancing, capital is flowing, and the next standards of care are taking shape.
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Stay curious. Stay informed. Stay ahead—with PharmaShots Weekly.
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We’ll be back next Monday at 8 AM EST with the updates that truly matter—pipeline shifts, competitive intelligence, regulatory wins, and strategic moves—delivered in minutes, not hours.
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If this edition sparked new ideas or sharpened your insights, make it a ritual. Subscribe to PharmaShots Weekly and receive a concise, credible, leader-ready intelligence brief delivered like clockwork.
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Know someone in R&D, CI, strategy, or BD who thrives on clear signals, not scattered noise? Forward this issue. And if a takeaway stood out, share it on LinkedIn and tag us—we love amplifying your voice.
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The industry moves fast. Your intelligence should move faster. Let PharmaShots keep you one step ahead, every week.
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| | Questions?
Reach out to us [email protected] for any comments, questions, partnership and media inquiry.
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