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Welcome to PharmaShots Weekly
| | | Mar 23 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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Voro & Daiichi Sankyo Partner on Tumor-Activated Biologics
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| | Amplifon to Buy GN Store Nord Hearing Business for $2.6B
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| | Lilly Reports Phase III TRANSCEND‑T2D‑1 Results for Retatrutide
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| | Celltrion Launches Avtozma SC, FDA-Approved Tocilizumab Biosimilar
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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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Novartis Acquires Pikavation Therapeutics for $3B
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Biopharma Partnerships & Collaborations
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| • | Voro & Daiichi Sankyo Partner on Tumor-Activated Biologics – PrimeBody platform drives safer, tumor-selective ADCs.
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| • | Samsung Bioepis & G2GBIO Forge Alliance for Long-Acting Therapeutics – Microsphere technology enhances patient adherence and pipeline expansion.
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| • | Samsung Bioepis & Sandoz Expand Global Biosimilars Alliance – Multi-asset licensing deal for up to five biosimilars.
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M&A & Strategic Deals
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| • | Amplifon to Buy GN Store Nord Hearing Business for $2.6B – ReSound and Beltone brands transfer; amplifies global audiology leadership.
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Clinical & Pipeline Updates
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| • | Eli Lilly Posts Phase III TRANSCEND‑T2D‑1 Results for Retatrutide – Triple-agonist therapy shows dual A1C and weight-loss efficacy.
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| • | Bayer Reports Positive Phase III FIND-CKD Results for Kerendia – Advances non-diabetic CKD treatment.
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| • | Sana Biotechnology Reports 14-Month Data for UP421 in Type 1 Diabetes – Hypoimmune islet cell therapy shows durable β-cell function.
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| • | Eli Lilly ADorable-1 Results for Pediatric Atopic Dermatitis – Ebglyss demonstrates efficacy in children ≥6 months.
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| • | Pfizer FOURLIGHT-1 Trial Positive for HR+/HER2− Advanced Breast Cancer – Atirmociclib combination advances post-CDK4/6 inhibitor therapy.
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| • | Ascendis Pharma New InsiGHTS Data for TransCon hGH in Turner Syndrome – Once-weekly dosing convenience confirmed.
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| • | AL-S Pharma Phase II AP-101-02 Results for ALS – IV therapy shows disease-modifying potential.
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| • | Pfizer TALAPRO-3 Phase III Positive in HRR-Mutated mHSPC – Talzenna + Xtandi improves rPFS.
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Regulatory & MedTech Milestones
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| • | Celltrion Launches Avtozma SC, FDA-Approved Tocilizumab Biosimilar – Dual IV/SC dosing for patient convenience.
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| • | Merck Animal Health Expands Bravecto Quantum Label – Year-long tick protection for dogs.
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| • | Regulatory Wins Across Pharma – FDA/EC approvals highlight breakthroughs in rare diseases, oncology, dermatology, and autoimmune conditions.
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| • | MedTech Approvals Drive Innovation – Diagnostics and devices, including Elecsys ApoE4 Test, Urocross Expander, MyChoice CDx, Trilogy Heart Valve, Smart Neurostimulation, and aura6000 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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$3B Pikavation Acquisition Propels Novartis’ Oncology Ambitions
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Novartis has agreed to acquire Pikavation Therapeutics (Synnovation subsidiary) and its PI3Kα inhibitor portfolio, including Phase I/II SNV4818 for HR+/HER2− metastatic breast cancer and solid tumors. Terms: $2B upfront + up to ~$1B milestones (total ~$3B). Closure expected H1 2026; Novartis takes full development/commercialization, Synnovation retains other R&D.
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Why It Matters
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| • | Deal Value: $2B upfront + $1B milestones for $3B potential.
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| • | Lead Asset: SNV4818 in Phase I/II for high-unmet breast cancer/solid tumors.
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| • | Timeline: Targets close in H1 2026.
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Strategic Focus
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| • | Novartis Oncology Boost: Expands targeted therapy pipeline in PI3Kα space.
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| • | Synnovation Monetization: Funds independence while advancing key asset.
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| • | Patient Impact: Addresses resistant cancers with novel inhibition.
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| • | Market Potential: Strengthens Novartis in precision breast cancer treatments.
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This acquisition accelerates Novartis' oncology leadership with promising PI3Kα inhibitors, signaling big pharma's push into next-gen targeted therapies.
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| | Precision Oncology and Transformative Partnerships Lead the Way
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Voro Therapeutics and Daiichi Sankyo Partner to Advance Next-Generation Tumor-Activated Biologics
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Voro Therapeutics has entered a research collaboration with Daiichi Sankyo's San Diego institute to develop tumor-activated biologics via Voro's PrimeBody platform. Focus: masked antibody-drug conjugates (ADCs) with proprietary masking domains and protease-cleavable linkers for tumor-selective activation and improved therapeutic index. Voro will design/characterize ADC candidates against an oncology target, building on its CD47 blocker progress.
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Why It Matters
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| • | Tech Innovation: PrimeBody enables tumor-selective ADCs, targeting hard-to-hit antigens.
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| • | Partnership Scope: Joint research leverages Voro's platform with Daiichi Sankyo's oncology expertise.
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| • | Pipeline Boost: Builds on Voro's prior CD47 program advancements.
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Strategic Focus
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| • | Therapeutic Index: Enhances safety via masked activation in tumors only.
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| • | Voro Momentum: Unlocks new ADC opportunities in solid tumors.
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| • | Daiichi Expansion: Strengthens next-gen biologics portfolio.
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| • | Market Potential: Advances precision oncology beyond traditional ADCs.
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This collaboration positions tumor-activated biologics as a breakthrough in safer, more selective cancer therapies.
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Samsung Bioepis and G2GBIO Forge Alliance to Advance Long-Acting Therapeutics
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Samsung Bioepis and Epis NexLab have entered a research collaboration and license agreement with G2GBIO for next-generation therapeutics using G2GBIO’s proprietary microsphere-based sustained-release technology. Samsung Bioepis gains full rights to a long-acting semaglutide asset, an option on one more candidate, and first negotiation rights for three additional programs (financial terms undisclosed). Epis NexLab will advance the platform with G2GBIO.
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Why It Matters
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| • | Tech Platform: Microsphere delivery enables sustained-release for improved patient adherence.
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| • | Asset Pipeline: Includes long-acting semaglutide plus expansion options.
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| • | Collaboration Strength: Combines Samsung's biosimilar expertise with G2GBIO's innovation.
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Strategic Focus
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| • | Samsung Expansion: Bolsters long-acting portfolio in high-demand areas like diabetes.
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| • | G2GBIO Validation: Accelerates microsphere tech commercialization.
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| • | Epis NexLab Role: Enhances drug-delivery development synergies.
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| • | Market Potential: Targets obesity/diabetes with differentiated, patient-friendly therapies.
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This alliance accelerates innovative long-acting treatments, addressing key unmet needs in chronic disease management.
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Amplifon to Acquire GN Store Nord’s Hearing Business in $2.6B Strategic Deal
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GN Store Nord has agreed to sell its Hearing business to Amplifon for DKK 17B (~$2.59B), including DKK 12.6B (~$1.9B) cash and DKK 56M (~$8.5M) in Amplifon shares (giving GN ~16% stake). Deal transfers ReSound/Beltone brands, IP, R&D, manufacturing, and operations. Closure expected by end-2026 post-regulatory approvals.
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Why It Matters
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| • | Deal Value: $2.59B total, blending cash and equity for strategic alignment.
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| • | Asset Transfer: Includes premium hearing brands and full operational infrastructure.
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| • | Timeline: Targets close by end-2026 pending approvals.
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Strategic Focus
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| • | Amplifon Scale: Creates global audiology leader with enhanced R&D/manufacturing.
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| • | GN Refocus: Frees resources for audio/video peripherals growth.
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| • | Market Consolidation: Merges retail and tech strengths in hearing care.
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| • | Patient Impact: Boosts innovation in hearing aids amid aging populations.
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This deal reshapes audiology, positioning Amplifon as a dominant player while streamlining GN's portfolio.
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| | Breaking Ground: Key Clinical Milestones
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Phase III FIND-CKD trial
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Non-Diabetic Chronic Kidney Disease (CKD)
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Bayer announced positive topline data from the Phase III FIND-CKD trial evaluating Kerendia (finerenone; 10 or 20 mg) versus placebo, both added to standard of care, in over 1,500 adults with non-diabetic chronic kidney disease.
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Key Details
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Next Steps
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Asset Snapshot
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Non-steroidal MRA advances CKD management beyond diabetic populations.
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Type 1 Diabetes (T1D)
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Sana Biotechnology announced 14-month follow-up data from a first-in-human study of UP421, a hypoimmune-engineered allogeneic islet cell therapy transplanted into a Type 1 diabetes patient without immunosuppression.
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Key Details
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Next Steps
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Asset Snapshot
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Hypoimmune platform pioneers immunosuppression-free islet cell therapy for T1D.
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Pediatric Atopic Dermatitis (AD)
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Eli Lilly announced positive topline data from the Phase III ADorable-1 trial evaluating Ebglyss (lebrikizumab-lbkz) versus placebo in 363 pediatric patients aged ≥6 months with moderate-to-severe atopic dermatitis, on background topical corticosteroids (with tapering allowed post-IGA ≤2).
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Key Details
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Next Steps
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Asset Snapshot
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IL-13 inhibitor expands moderate-to-severe AD treatment to pediatrics ≥6 months.
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HR+/HER2− Advanced Breast Cancer
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Pfizer announced positive topline data from the Phase II FOURLIGHT-1 trial evaluating atirmociclib + fulvestrant versus fulvestrant alone or everolimus + exemestane in 264 patients with HR+/HER2− advanced/metastatic breast cancer post-CDK4/6 inhibitor.
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Key Details
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Next Steps
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Asset Snapshot
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Next-gen CDK4 inhibitor addresses post-CDK4/6 resistance in HR+/HER2− mBC.
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Turner Syndrome
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Ascendis Pharma announced topline data from the Phase II New InsiGHTS trial evaluating TransCon hGH (lonapegsomatropin; once-weekly) versus daily somatropin in 49 prepubertal children aged 1–10 years with Turner syndrome.
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Key Details
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Next Steps
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Asset Snapshot
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Once-weekly hGH prodrug offers dosing convenience in pediatric growth disorders.
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Amyotrophic Lateral Disease (ALS)
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AL-S Pharma announced topline data from the global Phase II AP-101-02 trial evaluating AP-101 (IV, every 3 weeks) versus placebo in 73 patients with sporadic ALS (n=52) or SOD1-mutated ALS (n=21) over 24 weeks, plus 24-week open-label extension and 16-week safety follow-up.
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Key Details
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Next Steps
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Asset Snapshot
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IV disease-modifying therapy targets ALS progression and biomarkers.
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HRR-Mutated mHSPC
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Pfizer announced positive topline data from the Phase III TALAPRO-3 trial evaluating Talzenna (talazoparib; 0.5 mg/day) + Xtandi (160 mg/day) versus placebo + Xtandi in 599 patients with HRR gene-mutated metastatic hormone-sensitive prostate cancer (mHSPC).
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Key Details
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Next Steps
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Asset Snapshot
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PARP inhibitor + ARPI combination advances frontline HRR-mutated mHSPC.
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Type 2 Diabetes (T2D)
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Eli Lilly announced positive topline data from the Phase III TRANSCEND‑T2D‑1 trial evaluating retatrutide versus placebo, added to lifestyle intervention, in 537 adults with inadequately controlled type 2 diabetes (mean disease duration 2.5 years). Patients started at 2 mg weekly, titrating every four weeks to 4 mg, 9 mg, or 12 mg.
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Key Details
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Next Steps
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Asset Snapshot
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Triple‑agonist retatrutide sets a high benchmark for dual A1C and weight‑loss efficacy in early‑stage T2D
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| | Industry Momentum Fueled by FDA & EC Wins
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FDA & EC Approvals Power Industry Surge
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The regulatory landscape is buzzing with major approvals and designations this week:
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| • | Rhythm secures FDA approval of Imcivree for Acquired Hypothalamic Obesity
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| • | Novartis secures FDA approval of Cosentyx for pediatric patients with hidradenitis suppurativa, expanding treatment options for young patients.
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| • | AstraZeneca earns EC approval of Imfinzi as a perioperative therapy for gastric and gastroesophageal junction cancers, marking a new standard in surgical oncology.
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| • | Sun Pharma reports FDA acceptance of Ilumya sBLA for active psoriatic arthritis, paving the way for broader patient access.
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| • | Cogent Biosciences achieves FDA NDA acceptance for Bezuclastinib in non-advanced systemic mastocytosis (NonAdvSM), offering hope for rare disease patients.
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| • | Sanofi’s Venglustat receives FDA Breakthrough Therapy designation for Type 3 Gaucher Disease, accelerating development timelines for this unmet need.
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| • | Johnson & Johnson announces FDA approval of Icotyde (Icotrokinra) for plaque psoriasis, expanding its dermatology portfolio.
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| • | GSK wins FDA approval of Lynavoy for primary biliary cholangitis patients with cholestatic pruritus, addressing a critical symptom for PBC sufferers.
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These moves underscore a dynamic period in pharma, with regulatory agencies unlocking new therapies across rare diseases, dermatology, oncology, and autoimmune conditions bringing transformative treatments closer to patients worldwide.
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| | MedTech Milestones: Approvals Power Innovation
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MedTech Innovation Hits Key Milestones
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The medtech sector is making waves with a series of regulatory milestones:
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| • | Roche earns CE mark for its Elecsys ApoE4 Test, enabling blood-based biomarker testing for Alzheimer’s disease.
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| • | Prodeon Medical secures FDA clearance for the Urocross Expander System, offering new relief for urinary symptoms associated with BPH.
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| • | Myriad Genetics receives FDA approval for MyChoice CDx as a companion diagnostic for GSK’s Zejula, advancing precision oncology.
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| • | JenaValve’s Trilogy Transcatheter Heart Valve System gains FDA approval to treat symptomatic, severe aortic regurgitation, expanding structural heart therapy options.
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| • | Nia Therapeutics’ Smart Neurostimulation System earns FDA Breakthrough Device designation for memory loss treatment, opening doors to innovative neurotherapies.
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| • | LivaNova’s aura6000 System secures FDA premarket approval to treat obstructive sleep apnea, enhancing options for patients with OSA.
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These approvals highlight a surge in medtech innovation, from cutting-edge diagnostics to transformative devices, reflecting the industry’s commitment to improving patient care across neurology, cardiology, sleep, and urology.
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| | Biosimilars Go Big: Dual Formats & Global Deals
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Celltrion Makes a Bold Move: Avtozma SC Brings Dual-Formulation Tocilizumab to US Patients
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Celltrion has launched Avtozma SC in the US, offering one of the first FDA-approved IV and SC tocilizumab biosimilars. Approved by FDA/EC in early 2025, Avtozma matched Actemra in Phase III efficacy/safety/immunogenicity; IV cleared for CRS in patients ≥2 years. SC version (162 mg/0.9 mL prefilled syringe/autoinjector) targets IL-6 receptor for flexible, patient-friendly dosing.
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Why It Matters
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| • | Dual Format Launch: First-mover with both IV and SC tocilizumab options in US.
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| • | Clinical Validation: Phase III equivalence to Actemra across efficacy/safety.
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| • | Regulatory Wins: FDA/EC approvals in 2025, including pediatric CRS indication.
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Strategic Focus
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| • | Patient Convenience: SC enables at-home dosing via syringe/autoinjector.
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| • | Celltrion Expansion: Strengthens US biosimilars footprint in immunology.
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| • | Access Impact: Lowers barriers for rheumatoid arthritis, CRS treatments.
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| • | Market Potential: Differentiates in crowded tocilizumab biosimilar space.
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Avtozma SC empowers US patients with convenient biosimilar access, advancing Celltrion's immunology leadership.
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Samsung Bioepis and Sandoz Expand Global Biosimilars Alliance with Multi-Asset Licensing Deal
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Samsung Bioepis has signed a global license, development, and commercialization deal with Sandoz for up to five biosimilars, including preclinical SB36 (vedolizumab/Entyvio biosimilar). Samsung leads development/manufacturing/regulatory filings; Sandoz handles commercialization outside China, Hong Kong, Taiwan, Macau, and South Korea. Builds on prior deals: Pyzchiva (ustekinumab, EU 2024/US 2025) and Epysqli (eculizumab, MEA 2025).
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Why It Matters
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| • | Portfolio Scope: Up to five assets, led by vedolizumab biosimilar SB36 (preclinical).
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| • | Division of Labor: Samsung on tech/regs; Sandoz on global sales (ex-Asia regions).
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| • | Partnership Momentum: Extends 2023–2025 collaborations with proven launches.
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Strategic Focus
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| • | Samsung Scale: Leverages manufacturing for broader biosimilar pipeline.
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| • | Sandoz Growth: Expands access to immunology/inflammatory disease markets.
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| • | Cost Savings: Biosimilars target high-price biologics like Entyvio.
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| • | Market Potential: Accelerates affordable therapies in GI/autoimmune areas.
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This expanded alliance reinforces biosimilar leadership, driving global access to cost-effective alternatives.
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| | Merck Powers Up Tick Defense for Dogs
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One Shot, 12 Months: Bravecto Quantum
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Merck Animal Health has secured US FDA approval to expand Bravecto Quantum (fluralaner extended-release injectable) labeling, adding 12-month protection against Asian longhorned ticks (H. longicornis) and Gulf Coast ticks (A. maculatum) in dogs. This once-yearly vet-administered option boosts compliance; previously approved July 2025 for fleas/multiple ticks in dogs ≥6 months.
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Why It Matters
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| • | Label Expansion: Now covers two additional tick species for full-year protection.
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| • | FDA Clearance: Builds on 2025 approval for broad flea/tick control.
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| • | Compliance Edge: Single annual dose simplifies long-term parasite management.
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Strategic Focus
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| • | Patient (Pet) Convenience: Injectable extended-release reduces dosing frequency.
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| • | Merck Leadership: Enhances Bravecto franchise in veterinary parasitology.
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| • | Disease Prevention: Targets emerging ticks linked to vector-borne risks.
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| • | Market Potential: Exclusive vet channel positions for premium uptake.
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This expansion cements Bravecto Quantum as a cornerstone in proactive tick prevention for dogs.
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Big Pharma & Biotech Drive Innovation Across Oncology, Rare Diseases, and MedTech
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Novartis’ $3B acquisition of Pikavation strengthens its PI3Kα oncology pipeline, while Voro-Daiichi and Samsung Bioepis-G2GBIO collaborations advance tumor-activated biologics and long-acting therapeutics. Amplifon acquires GN Hearing for $2.6B, expanding audiology leadership. Positive trial readouts span Eli Lilly, Bayer, Pfizer, Sana, Ascendis, and AL-S Pharma. Regulatory and medtech approvals—from FDA/EC clearances to dual-formulation biosimilars—highlight accelerating innovation, patient access, and transformative treatments across multiple therapeutic areas worldwide.
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Stay Ahead with PharmaShots Weekly
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