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Welcome to PharmaShots Weekly
| | | Apr 13, 2026 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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Neurocrine Bets $2.9B on Rare Endocrinology with Soleno Acquisition
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| | Gilead Secures First-in-Class CDK2 Molecular Glue in Kymera Deal
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| | Takeda Exits, Denali Reclaims Full Rights to DNL593
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| | PharmaShots Awards Set for May 1: Celebrating Industry Excellence
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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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Gilead’s $5B+ Tubulis Acquisition to Build a Next-Gen ADC Powerhouse
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Partnerships & Collaborations
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| • | Imagene x Daiichi Sankyo: AI-Powered Biomarker Discovery for ADCs
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| • | Gilead x Kymera: First-in-Class CDK2 Molecular Glue Deal
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| • | Alloy x Biogen: Multi-Target ASO Collaboration
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| • | Halozyme x Vertex: High-Concentration Biologics Partnership
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| • | Dyno x Astellas: AI-Engineered AAV Capsid Licensing Milestone
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| • | OBT x BMS: Next-Gen T-Cell Engagers for Solid Tumors
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| • | DeepCyte Launch: AI-Driven Toxicology Platform Debut
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Merger & Acquisition
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| • | Neurocrine Acquires Soleno in $2.9B Rare Disease Bet
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| • | Garda Takes Assertio Private in Strategic Reset
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Strategic Exit
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| • | Takeda Exits DNL593 Deal; Denali Regains Full Control
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Clinical Trials
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| • | Adagene: Muzastotug Combo Shows Promise in MSS CRC
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| • | Sanofi: Lunsekimig Delivers Multi-Indication Phase II Data
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| • | Amgen: Tepezza SC Hits Phase III Success in TED
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| • | Akeso: Triplet Therapy Shows Durable Activity in NSCLC
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| • | Vanda: Thetis Study Targets GLP-1–Induced Nausea
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Regulatory Updates
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| • | Eylea HD Approved with Extended Dosing in wAMD & DME
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| • | Ultragenyx UX111 BLA Accepted for Sanfilippo Syndrome A
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| • | GSK’s Depemokimab Approved in China for CRSwNP
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| • | Nuvalent NDA Accepted for ALK+ NSCLC Therapy
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MedTech
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| • | Allevion: FDA Clearance for Spinal Decompression System
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| • | Organogenesis: Positive DFU Data for PuraPly AM
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| • | Endospan: Nexus System Approved for Aortic Arch Disease
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| • | Anumana: FDA Clears ECG-AI for Cardiac Amyloidosis Detection
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| • | Waters: At-Home HPV Test Expands Screening Access
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Biosimilars Beat
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| • | CuraTeQ: Phase III Success for Omalizumab Biosimilar (BP11)
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| • | Biocon: U.S. Launch of Interchangeable Denosumab Biosimilars
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Innovation. Leadership. Breakthroughs.
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The global pharmaceutical and healthcare landscape is evolving at an unprecedented pace, driven by visionary leadership, cutting-edge science, and technologies that are redefining patient care.
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PharmaShots Awards 2026 is your front-row seat to this transformation—a premier virtual event honoring the organizations and leaders who are pushing the boundaries of innovation across the life sciences ecosystem.
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From drug discovery and biopharma breakthroughs to medtech, diagnostics, and digital health, these awards celebrate the pioneers shaping the future of healthcare and driving real-world impact.
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Awards Announcement: May 1, 2026
Format: Virtual Global Event, Register Here
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Join industry leaders, innovators, and decision-makers worldwide to recognize excellence, vision, and the breakthroughs that are changing lives. Every achievement that transforms healthcare deserves to be celebrated.
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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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Doubling Down on ADC Dominance: Gilead’s $5B+ Bet to Build a Next-Gen Oncology Engine
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Gilead Sciences has entered into a definitive agreement to acquire Tubulis, which will become Gilead’s dedicated ADC research organization, with its Munich site serving as a global hub for antibody-drug conjugate innovation.
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Why It Matters
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| • | Deal Value: $3.15B upfront plus up to ~$1.85B in milestones for a total consideration of ~$5B.
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| • | Clinical Assets: TUB-040 has shown >50% response rates in early data for platinum-resistant high-grade serous ovarian cancer, while TUB-030 broadens reach into other solid tumors.
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| • | Platform Boost: Adds Tubulis’ Tubutecan linker-payload and next-gen ADC engineering platforms to Gilead’s toolkit.
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Strategic Focus
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| • | ADC Leadership: Positions Gilead as a major ADC player alongside its existing Trodelvy franchise.
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| • | Solid Tumor Focus: Targets difficult-to-treat solid tumors, including platinum-resistant ovarian cancer and NSCLC, with potentially best-in-class ADCs.
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| • | R&D Footprint: Establishes Munich as a central ADC innovation hub, integrating Tubulis’ team and capabilities into Gilead’s global oncology network.
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| • | Long-Term Growth: Supports Gilead’s strategy to build a diversified, durable oncology revenue base beyond virology.
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| | AI, ADCs & RNA: Rewiring Biopharma Innovation
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Decoding Tumor Biology with AI: Imagene & Daiichi Sankyo Team Up to Transform Precision Oncology
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Imagene AI has entered a strategic collaboration with Daiichi Sankyo to accelerate biomarker discovery and response prediction across select oncology programs.
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Why It Matters
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Strategic Focus
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Doubling Down on Targeted Degradation: Gilead Advances First-in-Class CDK2 Molecular Glue
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Gilead Sciences has exercised its option to exclusively license KT-200 from Kymera Therapeutics, securing a first-in-class oral CDK2 molecular glue degrader under their strategic collaboration.
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Why It Matters
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Strategic Focus
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Rewriting the Rules of RNA Therapeutics: Alloy & Biogen Unite to Unlock Next-Gen ASOs
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Alloy Therapeutics has entered a multi-target collaboration and license agreement with Biogen to advance antisense oligonucleotide (ASO) therapeutics against several undisclosed targets using Alloy’s AntiClastic ASO platform.
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Why It Matters
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Strategic Focus
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Powering the Next Wave of Biologics: Halozyme & Vertex Join Forces to Unlock High-Concentration Therapies
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Halozyme Therapeutics, via its subsidiary Halozyme Hypercon, has entered a global exclusive collaboration and license agreement with Vertex Pharmaceuticals to apply its Hypercon technology to up to three drug targets.
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Why It Matters
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Strategic Focus
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AI Meets Gene Therapy Milestone: Dyno & Astellas Advance Next-Gen Muscle Targeting
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Dyno Therapeutics has announced that Astellas Pharma has exercised its option to license an AI-designed AAV capsid for skeletal muscle–targeted gene delivery, marking the first capsid licensed from their 2021 collaboration and Dyno’s first licensed muscle capsid.
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Why It Matters
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Strategic Focus
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Igniting the Next Wave of Immuno-Oncology: OBT & BMS Team Up to Crack Solid Tumors
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Oxford BioTherapeutics (OBT) has entered a multi-year strategic collaboration with Bristol Myers Squibb (BMS) to discover and develop next-generation T-cell engager (TCE) therapies for solid tumors, one of oncology’s most challenging frontiers.
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Why It Matters
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Strategic Focus
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Reinventing Toxicology with AI Precision: DeepCyte Emerges to Decode Drug Safety at the Cellular Level
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DeepCyte has officially launched as a next-generation techbio company with $1.5M in seed funding to bring AI-driven toxicology into drug development, enabling detection, prediction, and explanation of drug toxicity in human cells at single-cell resolution.
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Why It Matters
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Strategic Focus
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| | Breaking Boundaries, Redrawing Partnerships
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Takeda Exits, Denali Doubles Down on DNL593
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Denali Therapeutics has regained full global rights to DNL593 after Takeda terminated their collaboration agreement for strategic reasons unrelated to safety or efficacy.
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Why It Matters
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| • | Strategic Exit, Not Safety-Driven: Takeda’s decision to end the partnership was based on portfolio strategy and restructuring, not on DNL593’s efficacy or safety.
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| • | Full Ownership: Denali regains full control of DNL593 and its IP, preserving future partnering and commercialization flexibility.
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| • | Data Momentum: Phase I/II enrollment is complete, with dose‑dependent CSF progranulin increases and clean safety data supporting continued development.
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Strategic Focus
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| • | Blood–Brain Barrier Innovation: DNL593 leverages Denali’s PTV platform to restore progranulin in the brain, targeting lysosomal dysfunction in FTD‑GRN.
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| • | High-Unmet-Need Indication: There are currently no approved disease‑modifying therapies for FTD‑GRN, underscoring the potential impact if DNL593 succeeds.
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| • | Denali’s Pipeline Autonomy: Full rights enable Denali to shape future trial design, partnering options, and potential commercialization strategies once pivotal data emerge.
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| | M&A Power Plays: Billion-Dollar Bets & Strategic Reinventions
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Betting Big on Rare Endocrinology: Neurocrine’s $2.9B Move to Capture a High-Value Niche
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Neurocrine Biosciences has entered into a definitive agreement to acquire Soleno Therapeutics, expanding its endocrinology and rare disease portfolio.
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Why It Matters
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| • | Deal Value: ~$2.9B all‑cash acquisition at $53 per share, representing a substantial premium to Soleno’s recent trading levels.
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| • | First-in-Class Asset: VYKAT XR is the first FDA‑approved therapy targeting hyperphagia in PWS, addressing a core, life‑limiting symptom.
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| • | IP Durability: Robust patent protection projected into the mid‑2040s supports long-term revenue potential.
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Strategic Focus
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| • | Endocrinology Leadership: Expands Neurocrine’s rare disease and endocrine franchise alongside INGREZZA and CRENESSITY as first‑in‑class offerings.
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| • | Revenue Diversification: Adds a growing commercial rare disease asset, reducing reliance on a single blockbuster.
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| • | Patient Impact: Offers meaningful relief from uncontrolled hunger in PWS, with potential downstream benefits in weight, behavior, and quality of life.
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Strategic Reset in Motion: Garda’s Takeover Reshapes Assertio’s Future
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Garda Therapeutics has entered into a definitive agreement to acquire Assertio Holdings, taking the company private and delisting it from Nasdaq.
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Why It Matters
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| • | Deal Value: $18 per share in cash (~$125.1M) plus a Sprix-linked CVR for additional upside.
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| • | Ownership Shift: Assertio transitions from a Nasdaq-listed specialty pharma to a privately held Garda platform company.
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| • | Conditionality: Closing targeted for Q2 2026, subject to tendering a majority of shares and other customary conditions.
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Strategic Focus
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| • | Portfolio Realignment: Divestiture of legacy brands to Cosette sharpens the focus of the combined Garda–Assertio business.
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| • | Value Unlock: CVR structure ties additional consideration to future Sprix performance, aligning incentives for legacy shareholders.
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| • | Private Equity-Style Rebuild: Move creates room for Garda to re-shape Assertio’s strategy, capital structure, and future pipeline away from public market pressures.
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| | Clinical Breakthroughs: High-Impact Data Across Oncology & Immunology
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Phase Ib/II data for muzastotug (ADG126) + Keytruda (pembrolizumab)
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MSS Colorectal Cancer
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Adagene reports Phase Ib/II data for muzastotug (ADG126) + Keytruda (pembrolizumab) in late-line MSS CRC patients without liver metastases (n=67; 65 evaluable), with Phase II readout expected in H1 2027.
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Key Details
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| • | 10 mg/kg cohorts (N=39): ORR 13% (17% Q3W; 0% Q6W), DCR 74%, median PFS 4.8 months, median OS 19.8 months; 12- and 24-month OS rates 70.1% and 48%.
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| • | 20 mg/kg cohorts (N=26): confirmed ORR 31% (36% with loading dose), including 4% CR and DCR 85%; median PFS 6.7 months overall and 15.4 months in the loading-dose arm, with 1-year OS 80.8% and median OS not yet reached.
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Next Steps
Dose-optimization insights from 10 vs. 20 mg/kg support the ongoing randomized Phase II expansion, with Fast Track–enabled planning toward a potential registration path.
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Asset Snapshot
Masked anti–CTLA-4 SAFEbody engineered for tumor-selective activation, enabling potent checkpoint blockade in historically immunotherapy-resistant MSS CRC.
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These results suggest a potential breakthrough for checkpoint inhibitor combinations in MSS CRC.
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Asthma / CRSwNP / Atopic Dermatitis
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Sanofi reports Phase IIb AIRCULES (asthma), Phase IIa DUET (CRSwNP), and Phase IIb VELVET (atopic dermatitis) data for lunsekimig (SC).
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Key Details
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| • | AIRCULES (moderate-to-severe asthma): Met primary and key secondary endpoints, significantly reducing exacerbations and improving pre-bronchodilator FEV1 vs. placebo.
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| • | DUET (CRSwNP): Met primary endpoint on nasal polyp score and a key secondary endpoint, with meaningful improvements in nasal congestion and LMK-CT at Week 24.
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| • | VELVET (AD): Missed primary endpoint (EASI change) but showed encouraging gains on key secondary skin-clearance endpoints, including EASI-75 and vIGA-AD 0/1.
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Next Steps
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Ongoing development positions lunsekimig as a multi-indication immunology asset across high-burden respiratory and dermatologic diseases.
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Asset Snapshot
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Bispecific immunology candidate with differentiated efficacy signals spanning asthma, CRSwNP, and atopic dermatitis.
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Thyroid Eye Disease (TED)
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Amgen reports positive Phase III data for Tepezza (teprotumumab) given subcutaneously Q2W via on-body injector (OBI) in adults with moderate-to-severe active TED.
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Key Details
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| • | Primary endpoint met: proptosis response rate 76.7% with Tepezza SC vs. 19.6% with placebo at Week 24; mean proptosis reduction −3.17 mm vs. −0.80 mm.
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| • | Significant improvements across key secondary endpoints, including overall responder rate, CAS 0/1, diplopia outcomes, and GO-QoL appearance scores.
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Next Steps
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Full results will be presented at an upcoming medical congress to further inform integration into TED treatment algorithms.
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Asset Snapshot
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SC Tepezza delivered via OBI offers robust efficacy with a more convenient, potentially at-home administration option for TED.
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Advanced NSCLC (Post–PD-(L)1)
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Akeso reports Phase Ib/II data for cadonilimab + anlotinib + docetaxel in locally advanced or metastatic NSCLC after progression on prior PD-(L)1–based therapy, with updated results presented at ELCC 2026.
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Key Details
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| • | Median follow-up 21.45 months: 6-month PFS rate 55.7%; median PFS 7.0 months overall, 7.5 months in squamous NSCLC and 7.4 months in PD-L1 TPS ≥1%.
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| • | DCR 95.2%, ORR 26.2%, median DoR 6.0 months; patients with ctDNA clearance achieved median PFS 9.1 months, with ctDNA detection dropping from 1.5% to 0.5% after the first cycle.
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Next Steps
Data support further development of cadonilimab-based combinations as potential second-line options in immunotherapy-resistant NSCLC.
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Asset Snapshot
First-in-class PD-1/CTLA-4 bispecific antibody showing durable disease control and molecular response signals when combined with anlotinib and docetaxel.
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GLP-1–Induced Nausea/Vomiting
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Vanda Pharmaceuticals initiates the Thetis study of Nereus (tradipitant) vs. placebo to prevent vomiting in patients starting GLP-1 receptor agonist therapies, with topline data expected by Q4 2026.
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Key Details
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| • | Primary endpoint: proportion of patients remaining free from vomiting episodes during treatment; Vanda notes additional data may be needed ahead of a potential NDA.
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| • | Prior Phase II study with 1 mg Wegovy showed vomiting in 29.3% on tradipitant vs. 58.6% on placebo, and vomiting with severe nausea in 22.4% vs. 48.3%, respectively.
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Next Steps
Thetis aims to confirm tradipitant’s antiemetic benefit directly in GLP-1–treated patients and support a future regulatory strategy.
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Asset Snapshot
Oral NK-1 receptor antagonist positioned to improve GLP-1 tolerability, adherence, and long-term therapeutic value.
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| | Regulatory Surge: Approvals & Filings Accelerate Biopharma
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Regulatory Tailwinds: Approvals Drive the Next Wave
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Regulatory momentum is accelerating across biopharma, with a wave of approvals and filings signaling faster paths to market. From extended-duration therapies to first-in-class treatments for rare diseases and precision oncology, these milestones highlight a shifting landscape where innovation is translating into real-world impact at speed.
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| • | Regeneron secures U.S. FDA approval for Eylea HD, introducing extended dosing intervals of up to five months for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME)—a major leap in treatment durability and patient convenience.
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| • | The U.S. FDA has accepted Ultragenyx’s resubmitted BLA for UX111, advancing a potential therapy for Sanfilippo Syndrome Type A, a rare and devastating genetic disorder with high unmet need.
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| • | GSK achieves a key regulatory milestone as Exdensur (depemokimab) receives NMPA approval in China for chronic rhinosinusitis with nasal polyps (CRSwNP), expanding its global immunology footprint.
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| • | Nuvalent announces the U.S. FDA acceptance of its NDA for neladalkib, targeting patients with ALK-positive NSCLC, marking another step forward in precision oncology innovation.
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| | MedTech Momentum: Breakthroughs Transform Patient Care
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MedTech Surge: Next-Gen Innovations Redefine Care
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MedTech innovation is hitting an inflection point, with new approvals and technologies rapidly reshaping how care is delivered. From AI-powered diagnostics to minimally invasive devices and at-home testing, these breakthroughs are driving earlier detection, better outcomes, and more patient-centric healthcare.
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| • | Allevion secures U.S. FDA clearance for its Vantage Spinal Decompression System, advancing minimally invasive solutions for spine care and improving outcomes for patients with chronic back conditions.
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| • | Organogenesis reports promising clinical trial results for PuraPly AM, demonstrating its potential to enhance wound healing in patients with diabetic foot ulcers—a critical area of unmet need in regenerative medicine.
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| • | Endospan achieves a major milestone with U.S. FDA approval for its Nexus System, offering a novel solution for the treatment of complex aortic arch disease.
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| • | Anumana receives U.S. FDA 510(k) clearance for its ECG-AI algorithm, enabling earlier detection of cardiac amyloidosis risk and showcasing the growing impact of AI in cardiovascular diagnostics.
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| • | Waters expands access to cervical cancer screening with approval of its at-home HPV test, marking a significant step toward more accessible, patient-centric preventive care.
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| | Biosimilars Momentum: From Validation to Market Transformation
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Phase III data for BP11
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Chronic Spontaneous Urticaria (CSU)
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CuraTeQ reports topline Phase III data for BP11 (omalizumab biosimilar) vs. Xolair in CSU patients at the 300 mg dose (n=608; ~80 sites in Europe and India).
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Key Details
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| • | Primary endpoint met: change from baseline in ISS7 at Week 12, demonstrating equivalence between BP11 and Xolair with CIs within predefined margins (−2.5 to 2.0); co-primary relative-potency endpoint also met, showing parallelism across doses.
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Next Steps
Regulatory filings with EMA and FDA for BP11 are planned to be completed by the end of Q2 2026.
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Asset Snapshot
Investigational omalizumab biosimilar designed to offer comparable efficacy and safety to Xolair with potential cost advantages across CSU and other IgE-mediated indications.
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Breaking Bone Health Barriers: Biocon Unleashes U.S. Launch of Game-Changing Denosumab Biosimilars
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In a bold move shaking up the $10B+ U.S. bone health market, Biocon just dropped Bosaya and Aukelso—the first interchangeable biosimilars to Prolia and Xgeva (denosumab)—hot on the heels of FDA approval in September 2025.
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| • | Bosaya: 60 mg/mL prefilled syringe for osteoporosis warriors.
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| • | Aukelso: 120 mg/1.7 mL (70 mg/mL) single-dose vial targeting oncology bone mets.
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This RANKL-blocking powerhouse duo promises to slash costs, smash access barriers, and turbocharge treatments for millions battling osteoporosis and cancer-related bone loss. Biocon's milestone isn't just a launch—it's a revolution in affordable biologics.
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Biopharma in Overdrive: AI, Deals, and Breakthrough Science Reshape the Future
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This week’s landscape signals a decisive shift in biopharma strategy and innovation. From Denali reclaiming DNL593 to a surge in AI-driven partnerships (Imagene, Dyno, DeepCyte), the industry is doubling down on precision and platform technologies. M&A heats up with Gilead and Neurocrine making bold bets, while clinical data across oncology and immunology shows renewed promise. Regulatory wins, MedTech advances, and biosimilar momentum further highlight one theme: faster innovation, broader access, and intensifying competition.
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Stay Ahead with PharmaShots Weekly
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PharmaShots Weekly cuts through the noise to deliver what truly matters: pivotal pipeline updates, regulatory milestones, clinical inflection points, strategic deals, and shifting competitive dynamics—distilled into a sharp, executive-ready briefing you can absorb in minutes.
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