PharmaShots Weekly (Mar 23 Edition)
Cover Story
Novartis Acquires Pikavation Therapeutics for $3B
Biopharma Partnerships & Collaborations
Voro & Daiichi Sankyo Partner on Tumor-Activated Biologics – PrimeBody platform drives safer, tumor-selective ADCs.
Samsung Bioepis & G2GBIO Forge Alliance for Long-Acting Therapeutics – Microsphere technology enhances patient adherence and pipeline expansion.
Samsung Bioepis & Sandoz Expand Global Biosimilars Alliance – Multi-asset licensing deal for up to five biosimilars.
M&A & Strategic Deals
Amplifon to Buy GN Store Nord Hearing Business for $2.6B – ReSound and Beltone brands transfer; amplifies global audiology leadership.
Clinical & Pipeline Updates
Eli Lilly Posts Phase III TRANSCEND‑T2D‑1 Results for Retatrutide – Triple-agonist therapy shows dual A1C and weight-loss efficacy.
Bayer Reports Positive Phase III FIND-CKD Results for Kerendia – Advances non-diabetic CKD treatment.
Sana Biotechnology Reports 14-Month Data for UP421 in Type 1 Diabetes – Hypoimmune islet cell therapy shows durable β-cell function.
Eli Lilly ADorable-1 Results for Pediatric Atopic Dermatitis – Ebglyss demonstrates efficacy in children ≥6 months.
Pfizer FOURLIGHT-1 Trial Positive for HR+/HER2− Advanced Breast Cancer – Atirmociclib combination advances post-CDK4/6 inhibitor therapy.
Ascendis Pharma New InsiGHTS Data for TransCon hGH in Turner Syndrome – Once-weekly dosing convenience confirmed.
AL-S Pharma Phase II AP-101-02 Results for ALS – IV therapy shows disease-modifying potential.
Pfizer TALAPRO-3 Phase III Positive in HRR-Mutated mHSPC – Talzenna + Xtandi improves rPFS.
Regulatory & MedTech Milestones
Celltrion Launches Avtozma SC, FDA-Approved Tocilizumab Biosimilar – Dual IV/SC dosing for patient convenience.
Merck Animal Health Expands Bravecto Quantum Label – Year-long tick protection for dogs.
Regulatory Wins Across Pharma – FDA/EC approvals highlight breakthroughs in rare diseases, oncology, dermatology, and autoimmune conditions.
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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$3B Pikavation Acquisition Propels Novartis’ Oncology Ambitions
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.
Why It Matters
Deal Value: $2B upfront + $1B milestones for $3B potential.
Lead Asset: SNV4818 in Phase I/II for high-unmet breast cancer/solid tumors.
Timeline: Targets close in H1 2026.
Strategic Focus
Novartis Oncology Boost: Expands targeted therapy pipeline in PI3Kα space.
Synnovation Monetization: Funds independence while advancing key asset.
Patient Impact: Addresses resistant cancers with novel inhibition.
Market Potential: Strengthens Novartis in precision breast cancer treatments.
This acquisition accelerates Novartis’ oncology leadership with promising PI3Kα inhibitors, signaling big pharma’s push into next-gen targeted therapies.
Voro Therapeutics and Daiichi Sankyo Partner to Advance Next-Generation Tumor-Activated Biologics
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.
Why It Matters
Tech Innovation: PrimeBody enables tumor-selective ADCs, targeting hard-to-hit antigens.
Partnership Scope: Joint research leverages Voro’s platform with Daiichi Sankyo’s oncology expertise.
Pipeline Boost: Builds on Voro’s prior CD47 program advancements.
Strategic Focus
Therapeutic Index: Enhances safety via masked activation in tumors only.
Voro Momentum: Unlocks new ADC opportunities in solid tumors.
Daiichi Expansion: Strengthens next-gen biologics portfolio.
Market Potential: Advances precision oncology beyond traditional ADCs.
This collaboration positions tumor-activated biologics as a breakthrough in safer, more selective cancer therapies.
Samsung Bioepis and G2GBIO Forge Alliance to Advance Long-Acting Therapeutics
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.
Why It Matters
Tech Platform: Microsphere delivery enables sustained-release for improved patient adherence.
Asset Pipeline: Includes long-acting semaglutide plus expansion options.
Collaboration Strength: Combines Samsung’s biosimilar expertise with G2GBIO’s innovation.
Strategic Focus
Samsung Expansion: Bolsters long-acting portfolio in high-demand areas like diabetes.
G2GBIO Validation: Accelerates microsphere tech commercialization.
Epis NexLab Role: Enhances drug-delivery development synergies.
Market Potential: Targets obesity/diabetes with differentiated, patient-friendly therapies.
This alliance accelerates innovative long-acting treatments, addressing key unmet needs in chronic disease management.
Amplifon to Acquire GN Store Nord’s Hearing Business in $2.6B Strategic Deal
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.
Why It Matters
Deal Value: $2.59B total, blending cash and equity for strategic alignment.
Asset Transfer: Includes premium hearing brands and full operational infrastructure.
Timeline: Targets close by end-2026 pending approvals.
Strategic Focus
Amplifon Scale: Creates global audiology leader with enhanced R&D/manufacturing.
GN Refocus: Frees resources for audio/video peripherals growth.
Market Consolidation: Merges retail and tech strengths in hearing care.
Patient Impact: Boosts innovation in hearing aids amid aging populations.
This deal reshapes audiology, positioning Amplifon as a dominant player while streamlining GN’s portfolio.
Phase III FIND-CKD trial
Non-Diabetic Chronic Kidney Disease (CKD)
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.
Key Details
Primary endpoint: Met with statistically significant improvement in eGFR slope (mean annual change from baseline to Month 32).
Safety: Consistent with known profile (details not specified in topline).
Additional: Kerendia (Firialta in select regions) under review in China and EU for heart failure (LVEF ≥40%).
Next Steps
Full data presentation at upcoming scientific conference.
Submission to global health authorities for potential approval in non-diabetic CKD.
Asset Snapshot Non-steroidal MRA advances CKD management beyond diabetic populations.
Type 1 Diabetes (T1D).
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.
Key Details
Efficacy: Sustained β-cell survival and function; fasting/MMTT C-peptide levels stable from months 1–6 through 14, surpassing months 9–12; improved glycemic control at months 12–14.
Imaging: PET-MRI confirmed transplanted cell persistence at 52 weeks.
Platform: Hypoimmune technology enables immune evasion.
Pipeline: SC451 (stem cell-derived HIP-modified islets) IND filing planned for 2026, advancing to Phase I.
Next Steps
Continued follow-up and development of SC451 into clinical trials.
Asset Snapshot Hypoimmune platform pioneers immunosuppression-free islet cell therapy for T1D.
Pediatric Atopic Dermatitis (AD)
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).
Key Details
Primary/secondary endpoints (Week 16): 63% vs 22% EASI-75; 44% vs 15% IGA 0/1 (≥2-point improvement); 39% vs 11% EASI-90.
Pruritus (patients ≥6 years): 35% vs 6% ≥4-point NRS improvement.
Ongoing: ADorable-2 (52-week extension); additional data expected later this year.
Next Steps
Data to support regulatory submissions for pediatric label expansion.
Asset Snapshot IL-13 inhibitor expands moderate-to-severe AD treatment to pediatrics ≥6 months.
HR+/HER2− Advanced Breast Cancer
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.
Key Details
Primary endpoint: Met with improved investigator-assessed PFS, consistent across subgroups.
Secondary (OS): Immature; ~20% events at analysis.
Pipeline: Phase III first-line metastatic trial advancing; Phase II neoadjuvant early breast cancer data pending at future meeting.
Next Steps
Advancement of Phase III registrational trial in first-line setting.
Asset Snapshot Next-gen CDK4 inhibitor addresses post-CDK4/6 resistance in HR+/HER2− mBC.
Turner Syndrome
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.
Key Details
Primary efficacy (Week 52): Comparable annualized height velocity (AHV) of 9.05 cm/year (TransCon hGH) vs 9.04 cm/year (somatropin), at lower mean weekly dose (0.22 mg/kg/week vs 0.29 mg/kg/week).
Safety: Favorable profile through ~143 weeks follow-up.
Ongoing: Phase III HighLiGHts basket trial for label expansion.
Next Steps
Phase III data to support regulatory submissions for Turner syndrome.
Asset Snapshot Once-weekly hGH prodrug offers dosing convenience in pediatric growth disorders.
Amyotrophic Lateral Disease (ALS)
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.
Key Details
Primary endpoint: Met for safety/tolerability.
Efficacy: Disease-modifying effects with prolonged survival (AP-101 vs placebo switchers); NfL/pNfH biomarker reductions at 6 months; benefits in sporadic and SOD1 cohorts (stabilization, reduced functional decline).
Next Steps
Data presentation at AD/PD 2026.
Phase III ALS trial initiation by end-2026.
Asset Snapshot IV disease-modifying therapy targets ALS progression and biomarkers.
HRR-Mutated mHSPC
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).
Key Details
Primary endpoint: Met with improved rPFS (HR better than pre-specified 0.63 target); majority progression-free.
Consistency: Across BRCA and non-BRCA HRR mutations.
Secondary: Interim OS trend favorable; gains in ORR, DoR, time to PSA progression.
Next Steps
Data presentation at upcoming scientific conference.
Discussions with global regulators for potential submissions.
Asset Snapshot PARP inhibitor + ARPI combination advances frontline HRR-mutated mHSPC.
Type 2 Diabetes (T2D)
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.
Key Details
Primary endpoint (A1C at 40 weeks): Superior reductions of 1.7%, 2.0%, and 1.9% at 4 mg, 9 mg, and 12 mg versus 0.8% with placebo.
Secondary endpoint (weight): 11.5%, 15.5%, and 16.8% weight loss versus 2.5% with placebo, with no plateau and improvements in cardiovascular risk factors.
Next Steps
Full data presentation at ADA 2026.
Additional retatrutide results expected next year across T2D and obesity indications.
Asset Snapshot Triple‑agonist retatrutide sets a high benchmark for dual A1C and weight‑loss efficacy in early‑stage T2D
FDA & EC Approvals Power Industry Surge
The regulatory landscape is buzzing with major approvals and designations this week:
Rhythm secures FDA approval of Imcivree for Acquired Hypothalamic Obesity
Novartis secures FDA approval of Cosentyx for pediatric patients with hidradenitis suppurativa, expanding treatment options for young patients.
AstraZeneca earns EC approval of Imfinzi as a perioperative therapy for gastric and gastroesophageal junction cancers, marking a new standard in surgical oncology.
Sun Pharma reports FDA acceptance of Ilumya sBLA for active psoriatic arthritis, paving the way for broader patient access.
Cogent Biosciences achieves FDA NDA acceptance for Bezuclastinib in non-advanced systemic mastocytosis (NonAdvSM), offering hope for rare disease patients.
Sanofi’s Venglustat receives FDA Breakthrough Therapy designation for Type 3 Gaucher Disease, accelerating development timelines for this unmet need.
Johnson & Johnson announces FDA approval of Icotyde (Icotrokinra) for plaque psoriasis, expanding its dermatology portfolio.
GSK wins FDA approval of Lynavoy for primary biliary cholangitis patients with cholestatic pruritus, addressing a critical symptom for PBC sufferers.
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.
The medtech sector is making waves with a series of regulatory milestones:
Roche earns CE mark for its Elecsys ApoE4 Test, enabling blood-based biomarker testing for Alzheimer’s disease.
Prodeon Medical secures FDA clearance for the Urocross Expander System, offering new relief for urinary symptoms associated with BPH.
Myriad Genetics receives FDA approval for MyChoice CDx as a companion diagnostic for GSK’s Zejula, advancing precision oncology.
JenaValve’s Trilogy Transcatheter Heart Valve System gains FDA approval to treat symptomatic, severe aortic regurgitation, expanding structural heart therapy options.
Nia Therapeutics’ Smart Neurostimulation System earns FDA Breakthrough Device designation for memory loss treatment, opening doors to innovative neurotherapies.
LivaNova’s aura6000 System secures FDA premarket approval to treat obstructive sleep apnea, enhancing options for patients with OSA.
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.
Celltrion Makes a Bold Move: Avtozma SC Brings Dual-Formulation Tocilizumab to US Patients
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.
Why It Matters
Dual Format Launch: First-mover with both IV and SC tocilizumab options in US.
Clinical Validation: Phase III equivalence to Actemra across efficacy/safety.
Regulatory Wins: FDA/EC approvals in 2025, including pediatric CRS indication.
Strategic Focus
Patient Convenience: SC enables at-home dosing via syringe/autoinjector.
Celltrion Expansion: Strengthens US biosimilars footprint in immunology.
Access Impact: Lowers barriers for rheumatoid arthritis, CRS treatments.
Market Potential: Differentiates in crowded tocilizumab biosimilar space.
Avtozma SC empowers US patients with convenient biosimilar access, advancing Celltrion’s immunology leadership.
Samsung Bioepis and Sandoz Expand Global Biosimilars Alliance with Multi-Asset Licensing Deal
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).
Why It Matters
Portfolio Scope: Up to five assets, led by vedolizumab biosimilar SB36 (preclinical).
Division of Labor: Samsung on tech/regs; Sandoz on global sales (ex-Asia regions).
Partnership Momentum: Extends 2023–2025 collaborations with proven launches.
Strategic Focus
Samsung Scale: Leverages manufacturing for broader biosimilar pipeline.
Sandoz Growth: Expands access to immunology/inflammatory disease markets.
Cost Savings: Biosimilars target high-price biologics like Entyvio.
Market Potential: Accelerates affordable therapies in GI/autoimmune areas.
This expanded alliance reinforces biosimilar leadership, driving global access to cost-effective alternatives.
One Shot, 12 Months: Bravecto Quantum
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.
Why It Matters
Label Expansion: Now covers two additional tick species for full-year protection.
FDA Clearance: Builds on 2025 approval for broad flea/tick control.
Compliance Edge: Single annual dose simplifies long-term parasite management.
Strategic Focus
Patient (Pet) Convenience: Injectable extended-release reduces dosing frequency.
Merck Leadership: Enhances Bravecto franchise in veterinary parasitology.
Disease Prevention: Targets emerging ticks linked to vector-borne risks.
Market Potential: Exclusive vet channel positions for premium uptake.
This expansion cements Bravecto Quantum as a cornerstone in proactive tick prevention for dogs.
Big Pharma & Biotech Drive Innovation Across Oncology, Rare Diseases, and MedTech
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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