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Welcome to PharmaShots Weekly
| May 18, 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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Fosun Expands AR1001 Global AD Rights Option
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| | BI’s €407.5M Immunitas Deal Expands Immunology Pipeline
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| | Isomorphic’s $2.1B Raise Scales AI Drug Design
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| | Zydus’ $166.4M Assertio Buyout Replaces Garda Deal
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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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| • | BMS and Hengrui’s Up to ~$15.2B Pact Builds a 13-Program Oncology, Hematology, and Immunology Portfolio
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Strategic Partnerships
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| • | GSK’s China Hepatitis B Pact with Sino Biopharm Leverages CTTQ to Launch Bepirovirsen
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| • | Rigel’s Global Veppanu License Brings First FDA-Approved PROTAC into Its Oncology Portfolio
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| • | Fosun’s Global AR1001 Option Extends Alzheimer’s Bet Beyond China and ASEAN
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| • | Boehringer’s €407.5M Immunitas License Adds First-in-Class Pathogenic Cell–Targeting Antibody to Immunology Pipeline
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Fund Secured
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| • | Isomorphic Labs’ $2.1B Series B Fuels IsoDDE and Next-Gen AI Drug Design at Global Scale
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M&A
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| • | Zydus’ $166.4M Cash Takeover of Assertio Supplants Prior Garda Deal
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Clinical Trials
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Ophthalmology
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| • | PulseSight Reports Positive Phase I PST-611 Data in Dry AMD / Geographic Atrophy
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| • | Astellas Shares Long-Term Izervay Data Showing Reduced Risk of Driving Eligibility Loss in GA Secondary to AMD
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Metabolic Disorders
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| • | Novo Nordisk Highlights Enhanced Weight Loss and Fat Reduction with Wegovy 7.2mg in STEP UP Trial
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Endocrinology
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| • | AstraZeneca’s Eneboparatide Meets Primary Endpoint in Phase III CALYPSO Trial for Hypoparathyroidism
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Oncology
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| • | AstraZeneca’s VOLGA Trial Shows Survival Benefit with Imfinzi + Enfortumab Vedotin in Muscle-Invasive Bladder Cancer
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| • | Protara Therapeutics Reports P-II (ADVANCED-2) Trial on TARA-002 in BCG-Naïve Non-Muscle Invasive Bladder Cancer (NMIBC)
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Neuroscience
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• Biogen Advances Diranersen into Registrational Development Despite Mixed Phase II CELIA Results in Early Alzheimer’s Disease
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Regenerative Medicine / Orthopedics
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• MEDIPOST’s Cartistem Demonstrates Superiority Over Hyaluronic Acid in Phase III Knee Osteoarthritis Trial
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Regulatory Watch: This Week’s Key Approvals and Milestones
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| • | BMS’ Sotyktu Gains EC Approval for Psoriatic Arthritis
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| • | argenx Secures FDA Approval for Vyvgart & Vyvgart Hytrulo in gMG
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| • | Partner Therapeutics’ Bizengri Wins FDA Approval for NRG1+ Cholangiocarcinoma
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| • | Pfizer Receives EC Approval for Hympavzi in Hemophilia A & B
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| • | BeOne Medicines Gains FDA Accelerated Approval for Beqalzi in Mantle Cell Lymphoma
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| • | Taiho Oncology’s Inqovi + Venclexta Approved by FDA for AML
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| • | Henlius Receives FDA IND Clearance for HLX05-N Biosimilar to Erbitux
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| • | AstraZeneca’s Fasenra Approved by FDA for Hypereosinophilic Syndrome
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MedTech Watch: This Week’s Key Innovations and Clearances
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| • | Roche’s Elecsys pTau217 Test Receives CE Mark for Alzheimer’s Amyloid Pathology Assessment
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| • | Tolion Health AI Launches Brain Coach App for Cognitive Health and Longevity
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| • | Cepheid Secures IVDR CE Mark for Xpert GI Panel Detecting 11 GI Pathogens
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| • | Revvity Gains FDA Clearance for Total Testosterone ChLIA Assay
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| • | Glooko Receives FDA Clearance for Cloud-Based EndoTool IV Insulin Dosing Platform
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MedTech Clinical Updates
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Surgical Monitoring
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| • | Exero Medical’s xBar Detects Anastomotic Leaks Earlier Than Standard Care in Colorectal Surgery
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Urology
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| • | Resurge Therapeutics Reports Promising Clinical Outcomes with IPDE Platform for BPH-Related LUTS
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BMS–Hengrui’s $15.2B Pact Expands Multi-Asset Portfolio
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Bristol Myers Squibb (BMS) has partnered with Hengrui Pharma in a global strategic collaboration covering 13 early-stage programs, including four Hengrui‑originated oncology/hematology assets, four BMS‑originated immunology assets, and five jointly discovered and developed candidates, with closing expected in the third quarter of 2026.
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Why It Matters
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| • | Deal Scale: With up to ~$15.2B in potential value, this is one of the largest disclosed multi‑asset R&D collaborations of 2026, second only to a handful of mega‑pacts.
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| • | Bidirectional Access: Gives BMS access to Hengrui’s oncology/heme assets ex‑China while giving Hengrui access to BMS’s immunology assets within Greater China, creating balanced geographic strengths.
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| • | De-Risked Economics: Structures $950M as staged near‑term payments, with the bulk of the headline value tied to downstream success across multiple programs.
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Strategic Focus
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| • | Pipeline Breadth: Builds a diversified portfolio of 13 early programs spanning oncology, hematology, and immunology rather than a single‑asset bet.
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| • | China–Global Bridge: Uses a territory‑split model that leverages Hengrui’s strength in China and BMS’s global reach, with co‑development and co‑commercialization options on select assets.
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| • | Long-Term Optionality: Embeds options and tiered royalties to align incentives over the 2030s, giving both parties upside if assets succeed while controlling upfront risk.
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| | Strategic Deals & Partnerships
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GSK’s China Hepatitis B Pact with Sino Biopharm Leverages CTTQ to Launch Bepirovirsen
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GSK has entered an exclusive strategic collaboration with Sino Biopharmaceutical’s subsidiary Chia Tai Tianqing Pharmaceutical Group (CTTQ) to support the launch and commercialization of bepirovirsen in mainland China, where the antisense oligonucleotide for chronic hepatitis B is under NMPA Priority Review.
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Why It Matters
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| • | Launch Acceleration: Uses CTTQ’s extensive hepatology footprint to accelerate bepirovirsen uptake once NMPA approval is granted under Priority Review.
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| • | Focused Territorial Split: Keeps GSK in control of regulatory and global strategy while delegating local commercial execution to a China market leader.
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| • | Pipeline Optionality: Gives GSK a window into Sino Biopharm’s early hepatology assets for potential ex‑China partnerships.
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Strategic Focus
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| • | China HBV Opportunity: Positions GSK to maximize the commercial potential of a first‑in‑class chronic hepatitis B therapy in one of the world’s largest HBV markets.
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| • | Scalable Model: Creates a template for future GSK–Sino collaborations that pair GSK’s pipeline assets with CTTQ’s China commercialization engine.
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| • | Long-Term Collaboration: The 5.5‑year supply term, with potential extension, supports sustained market development and relationship building.
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Rigel’s Global Veppanu License Brings First FDA-Approved PROTAC into Its Oncology Portfolio
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Rigel has entered into an exclusive, global license agreement with Arvinas and Pfizer to develop, manufacture, and commercialize Veppanu (vepdegestrant), the first and only FDA‑approved PROTAC, for adults with ER+/HER2‑, ESR1‑mutated advanced or metastatic breast cancer.
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Why It Matters
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| • | Deal Economics: $85M near term ($70M upfront + $15M on transition) plus up to ~$320M in milestones and mid‑teens to mid‑twenties tiered royalties on global net sales.
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| • | First-in-Class PROTAC: Veppanu is the first FDA‑approved PROTAC, expanding treatment options for 2L+ ER+/HER2‑, ESR1‑mutated metastatic breast cancer with a novel protein‑degradation mechanism.
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| • | Immediate Revenue Asset: Adds a newly approved, guideline‑listed (NCCN Category 2A) breast cancer drug to Rigel’s commercial portfolio, diversifying revenue beyond its existing hematology products.
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Strategic Focus
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| • | Oncology Franchise Build: Positions Rigel as a commercial player in solid tumors and in the emerging protein‑degradation class, not just hematologic diseases.
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| • | Global Sublicensing Optionality: Gives Rigel flexibility to partner ex‑U.S. markets while retaining U.S. commercialization control and sharing upside with Arvinas and Pfizer.
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| • | Platform Entry Point: Establishes a strategic relationship with Arvinas and Pfizer that could support future PROTAC collaborations as the modality matures.
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Fosun’s Global AR1001 Option Extends Alzheimer’s Bet Beyond China and ASEAN
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Fosun Pharma and AriBio have entered into an exclusive global option agreement for the development, registration, manufacturing, and commercialization of AR1001 for Alzheimer’s disease, expanding their existing collaboration beyond Greater China and ten ASEAN countries to cover major global markets including the US, EU, and Japan.
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Why It Matters
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| • | Deal Economics: $60M option fee today with up to ~$180M in additional upfront and regulatory milestones upon option exercise, plus high sales milestones above $2.5B in annual net sales.
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| • | Global Footprint: Extends Fosun’s prior China/ASEAN rights into a near‑global position ahead of pivotal Phase III data for a once‑daily oral Alzheimer’s therapy.
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| • | Late-Stage Optionality: Structures risk around the POLARIS‑AD readout, allowing Fosun to lean in only if Phase III results support a compelling risk–benefit profile.
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Strategic Focus
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| • | Alzheimer’s Expansion: Positions Fosun to become a global player in Alzheimer’s disease with an oral PDE5 inhibitor if the Phase III program succeeds.
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| • | Capital Efficiency: Provides AriBio with meaningful non‑dilutive capital while keeping substantial upstream value tied to option exercise and sales milestones.
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| • | Data-Driven Trigger: Links the major economic step‑up to clinical proof from the 1,500+‑patient POLARIS‑AD trial, aligning both parties around high‑quality Phase III data.
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Boehringer’s €407.5M Immunitas License Adds First-in-Class Pathogenic Cell–Targeting Antibody
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Boehringer Ingelheim (BI) has entered into a global licensing agreement with Immunitas Therapeutics for a preclinical, first‑in‑class antibody program being developed for chronic inflammatory and autoimmune diseases, expanding BI’s immunology pipeline beyond traditional cytokine and receptor blockers.
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Why It Matters
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| • | Deal Value: Up to €407.5M in potential milestones, plus tiered royalties, underscores big‑pharma demand for early, differentiated immunology assets.
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| • | Novel Mechanism: Targets pathogenic cells at the source of inflammation, going beyond pathway‑specific cytokine inhibition toward more precise disease modification.
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| • | Unmet Need Focus: Designed for patients with chronic inflammatory and autoimmune diseases who have limited or waning responses to current standard‑of‑care therapies.
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Strategic Focus
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| • | Pipeline Expansion: Strengthens Boehringer’s growing immunology pipeline with a first‑in‑class biologic that can potentially be developed across multiple indications.
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| • | Translational Partnership: Leverages Immunitas’ human biology–driven discovery engine with Boehringer’s global development and commercialization capabilities.
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| • | Long-Term Disease Control: Aims to shift treatment goals from symptom management to sustained disease control by eliminating or reprogramming key pathogenic cell populations.
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| | Isomorphic’s $2.1B Raise Powers AI Drug Design
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Isomorphic Labs’ $2.1B Series B Fuels IsoDDE and Next-Gen AI Drug Design at Global Scale
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Isomorphic Labs has raised $2.1B in a Series B financing round led by Thrive Capital, with participation from existing investors Alphabet and GV and new backers MGX, Temasek, CapitalG, and the UK Sovereign AI Fund, marking one of the largest private financings in AI-enabled drug discovery.
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Why It Matters
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| • | Financing Scale: $2.1B Series B, led by Thrive Capital with blue‑chip strategic and sovereign investors, is among the largest AI‑biotech rounds to date.
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| • | Platform Maturation: Funding accelerates IsoDDE from a research platform to a scaled engine designed to produce clinical drug candidates across multiple modalities.
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| • | Partnership Validation: Deep collaborations with Novartis, Lilly, and J&J—totaling several billion dollars in committed deal value—validate IsoDDE’s utility across top‑tier pharma pipelines.
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Strategic Focus
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| • | Pipeline Build-Out: Pushes multiple internal programs toward IND and first‑in‑human trials, aiming to turn AI-designed molecules into clinical proof-of-concept assets.
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| • | Global Talent Expansion: Supports aggressive hiring in AI, engineering, drug design, and clinical development to build a full-stack, AI‑first drug company.
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| • | AI-Driven Precision: Positions Isomorphic to bridge frontier structure-prediction models with practical drug design, targeting faster, more precise discovery cycles.
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| | Mergers & Acquisitions (M&A)
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Zydus’ $166M Assertio Buyout Expands US Oncology
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Assertio Holdings’ Board has approved a definitive merger agreement under which Zydus Worldwide DMCC, a subsidiary of Zydus Lifesciences, will acquire all outstanding shares of Assertio and subsequently delist the company from the Nasdaq.
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Why It Matters
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| • | Deal Value: $23.50 per share in cash, valuing Assertio at ~$166.4M and representing a 30.6% premium to the prior $18 per‑share Garda deal and a ~75% premium to the unaffected March 20, 2026 close.
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| • | Superior Proposal: The Board’s “Superior Proposal” determination triggered termination of the Garda transaction, with Zydus funding the applicable Garda break‑up fee.
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| • | Strategic Fit: Strengthens Zydus’ U.S. specialty oncology and hospital presence, adding Assertio’s lead asset Rolvedon and its 170+ community oncology accounts.
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Strategic Focus
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| • | US Footprint Expansion: Provides Zydus with a direct commercial platform in the U.S. oncology and specialty market.
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| • | Clean Capital Structure: All‑cash, no‑financing‑contingency structure offers certainty of value and closing for Assertio shareholders.
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| • | Delisting and Integration: Post‑closing Nasdaq delisting allows Zydus to integrate Assertio outside the scrutiny and costs of U.S. public markets.
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| | Clinical Trials & Data Readouts
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Phase I (PST‑611‑CT1)
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Dry Age-related Macular Degeneration / Geographic Atrophy
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PulseSight has presented P‑I (PST‑611‑CT1) trial data assessing two dose levels (low and high) of PST‑611 in two successive dose groups (n=6) with late‑stage dry AMD/Geographic Atrophy and 16wk. follow‑up at ARVO 2026.
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Key Details
The trial met its 1 & 2EPs, demonstrating favorable safety and tolerability with stable BCVA, no SAEs/SUSARs or intraocular inflammation, and early efficacy signals including patient‑reported vision improvements and reduced GA lesion growth in 1 case persisting beyond follow‑up.
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Next Steps
Following these P‑I results, PulseSight has submitted a CTA to France’s ANSM for a 52wk. repeat‑dose P‑IIa (PST‑611‑CT2) trial (~20 pts, 3 sites) evaluating 3 administrations of high‑dose PST‑611, with initiation anticipated in H2’26 and results expected in 2028, subject to approval.
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Obesity – Adults without Diabetes
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Novo Nordisk has reported a sub‑analysis from the Phase 3b STEP UP trial assessing once‑weekly Wegovy (semaglutide) 7.2mg vs Wegovy 2.4mg and placebo, all with lifestyle intervention for 72wks. in >1,400 adults with obesity (BMI ≥30kg/m²) without diabetes.
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Key Details
Wegovy 7.2mg achieved 20.7% mean weight loss vs 17.5% with 2.4mg and 2.4% with placebo; among early responders (≥15% loss by Wk. 24), 26.9% of pts on 7.2mg achieved 27.7% weight loss at Wk. 72 vs 24.8% in 20.9% of pts on 2.4mg, while non‑early responders achieved 15.4% vs 13.2% loss, respectively.
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Body Composition Analysis
In a secondary MRI sub‑analysis of 55 pts, ~84% of weight loss with Wegovy (2.4mg and 7.2mg combined) was attributable to fat mass reduction, including >30% reduction in abdominal visceral fat, whereas muscle mass declined by only ~10% from baseline with improved muscle health and preserved functional strength; data were presented at ECO’26.
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Chronic Hypoparathyroidism (HypoPT)
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AstraZeneca has reported P‑III CALYPSO (NCT05778071) data assessing eneboparatide (ENB; QD, SC) vs placebo for 24wks. in 202 adults with HypoPT receiving active vitamin D and oral Ca supplements, followed by a 28wk. OLE in which pts continued ENB (ENB/ENB) or switched from placebo to ENB (PBO/ENB).
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Key Details
The trial met its composite 1EP, with 31.1% of ENB‑treated pts achieving normalized albumin‑adjusted sCa levels and independence from supplements at Wk. 24 vs 5.9% on placebo (41/132 vs 4/68); immunogenicity was observed in most pts, but sCa remained controlled with supplements and ENB up‑titration. ENB also met all key 2EPs at Wk. 24, including normalization of uCa excretion in hypercalciuric pts in 56.6% vs 20% (43/76 vs 9/45), and improved PROs, while benefits were maintained in the ENB/ENB group through Wk. 52 with preserved bone health, balanced bone turnover markers, and no clinically significant BMD reduction.
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Geographic Atrophy (GA) Secondary to AMD
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Astellas has reported post hoc analysis results from the P‑III GATHER1 and GATHER2 trials evaluating Izervay (avacincaptad pegol, QM) vs sham in pts with GA secondary to AMD for 18 and 12mos., respectively, with GATHER2 pts subsequently re‑randomized to Izervay QM or Q2M for up to 24mos.; data were presented at ARVO’26.
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Key Details
In driving‑eligible pts at baseline (BCVA ≥70 ETDRS letters; n=403), Izervay reduced the risk of losing driving eligibility at 24mos. to 12.6% vs 20.1% with sham, reflecting a 41% relative risk reduction; similar benefits were observed after switching from QM to Q2M dosing, while QM‑only dosing showed a 35% relative risk reduction (15.1% vs 20.1%). Exploratory long‑term GATHER2 OLE data demonstrated sustained slowing of GA lesion growth, with earlier treatment yielding greater retinal tissue preservation: GA lesion growth from mos. 24–42 was reduced by 40.5% vs projected sham in pts switched to Izervay QM from prior QM or Q2M, and by 37% in prior sham‑treated pts converted to Izervay QM.
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Muscle-invasive Bladder Cancer (MIBC)
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AstraZeneca has reported P‑III VOLGA data in 695 cisplatin‑ineligible MIBC pts undergoing radical cystectomy, randomized to perioperative Imfinzi (durvalumab) + neoadj. enfortumab vedotin (EV) with or without Imjudo (tremelimumab) vs comparator surgery ± standard therapy.
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Key Details
Perioperative Imfinzi + EV significantly improved event‑free survival (EFS) and overall survival (OS) vs comparator, while Imfinzi + Imjudo in combination with neoadj. EV also improved EFS and showed a favorable OS trend; OS follow‑up is ongoing.
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Related Program (NMIBC)
Separately, Imfinzi + BCG met the 1EP of disease‑free survival in high‑risk non‑MIBC pts in the P‑III POTOMAC trial, and this regimen is under regulatory review in the US, EU, Japan and other countries.
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Alzheimer’s Disease – Early Symptomatic (MCI / Mild Dementia)
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Biogen has reported global P‑II CELIA (NCT05399888) data assessing intrathecal diranersen (BIIB080) 60mg Q24W, 115mg Q24W, or 115mg Q12W vs placebo over 76wks. in 416 pts with mild cognitive impairment due to AD or mild AD dementia.
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Key Details
CELIA did not meet its 1EP of dose‑response on CDR‑SB change from baseline at Wk. 76, but pre‑specified analyses showed slowing of clinical decline across all diranersen regimens, with the greatest effect at 60mg Q24W, alongside robust and sustained reductions in CSF tau and tau pathology on tau PET throughout the 18‑month treatment period; detailed data will be presented at AAIC’26.
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Next Steps
Based on the strength of the convergent biomarker and clinical efficacy signals, Biogen plans to advance diranersen into registrational‑stage development for early AD.
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Knee Osteoarthritis
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MEDIPOST has reported P‑III trial data from Japan assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over 52wks. across 13 sites.
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Key Details
The trial met both co‑1EPs of WOMAC knee pain and function scores and ICRS cartilage repair grading, with statistically significant superiority vs active control; improvements were also seen across all 2EPs, including 100 mm VAS pain, IKDC and KOOS knee function assessments, and WOMAC subscales for pain, function and stiffness.
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Next Steps
WOMAC and 100 mm VAS endpoints, aligned with the ongoing US P‑III Cartistem trial, showed superiority over hyaluronic acid, and MEDIPOST plans to file a BLA in Japan in H2’26, targeting approval by end‑2027 and commercial launch thereafter.
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Non-muscle Invasive Bladder Cancer (NMIBC) – BCG-naïve
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Protara Therapeutics has reported 12mos. P‑II ADVANCED‑2 (NCT05951179) cohort A data assessing intravesical TARA‑002 in adults with high‑grade carcinoma in situ (CIS ± Ta/T1) NMIBC who are BCG‑unresponsive or BCG‑naïve; a P‑III ADVANCED‑3 trial in BCG‑naïve pts is planned to initiate in H2’26.
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Key Details
In the BCG‑naïve subgroup (n=31; 29 evaluable for efficacy, 27 evaluable at 6mos. and 20 at 12mos. as of Apr 5, 2026), TARA‑002 achieved a 72.4% overall CR rate, with 66.7% CR at 6mos. and 55% CR at 12mos. Among responders, the Kaplan–Meier estimated probability of maintaining CR for 6mos. was 73.1%, with 91.7% maintaining CR from 9–12mos., and 66.7% of re‑induced pts achieving CR at 6mos.; updated interim data were presented at AUA’26.
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| | Global Regulatory Momentum in Pharma
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Regulatory Watch: This Week’s Key Approvals and Milestones
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From immunology and hematology to oncology and rare diseases, this week’s regulatory activity reflects continued momentum in expanding treatment options and accelerating innovative therapies across global markets. Here’s a snapshot of the latest approvals, clearances, and regulatory milestones shaping the healthcare landscape:
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| • | Bristol Myers Squibb’s Sotyktu (deucravacitinib) received European Commission approval to treat adults with active psoriatic arthritis (PsA).
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| • | argenx reported FDA approval of Vyvgart and Vyvgart Hytrulo for generalized myasthenia gravis, expanding treatment options in autoimmune disease.
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| • | Partner Therapeutics announced FDA approval of Bizengri for NRG1 fusion–positive cholangiocarcinoma, advancing precision oncology care.
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| • | Pfizer secured European Commission approval for Hympavzi to treat hemophilia A and B.
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| • | BeOne Medicines received FDA accelerated approval for Beqalzi (sonrotoclax) to treat relapsed/refractory mantle cell lymphoma.
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| • | Taiho Oncology, part of Taiho Pharmaceutical, reported FDA approval of Inqovi in combination with Venclexta (venetoclax) for newly diagnosed acute myeloid leukemia (AML).
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| • | Henlius received FDA IND clearance for HLX05-N, a biosimilar to Erbitux, supporting continued growth in the biosimilars space.
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| • | AstraZeneca’s Fasenra received FDA approval for hypereosinophilic syndrome, expanding its immunology portfolio.
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| | MedTech Watch: AI, Diagnostics & Surgical Advances
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Colorectal Resection Surgery – Anastomotic Leak Detection
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Exero Medical has reported pivotal clinical trial data in 222 colorectal resection surgery pts assessing the xBar post‑surgical tissue monitoring system for early detection of post‑operative anastomotic leaks.
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Key Details
The study showed that xBar detected post‑operative anastomotic leaks earlier than standard clinical practice, achieving 100% sensitivity and 88% specificity by post‑operative day 3 and identifying leaks on average >3 days sooner; results were presented at ASCRS’26.
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Next Steps
Exero has submitted these pivotal data to the US FDA as part of a De Novo application seeking clearance of xBar, with a US launch targeted for 2027, while additional studies are underway to extend the system’s use and form factors across broader GI indications and patient populations.
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Benign Prostatic Hyperplasia (BPH) – LUTS
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Resurge Therapeutics has reported clinical results from two studies evaluating its intraprostatic drug elution (IPDE) platform delivering paclitaxel‑eluting bioabsorbable implants via transperineal and transrectal approaches for LUTS secondary to BPH; data were presented at AUA 2026.
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Key Details
In the transperineal study (n=20), IPDE improved IPSS by 15 points and Qmax by ~4 mL/s at 1yr., with clinical benefit observed in ~80% of pts, while in the transrectal study (n=11), IPSS improved by 15 points as early as 1mo. and was sustained through ≥6mos., with a 4.1 mL/s increase in Qmax and a 23% reduction in prostate volume at 6mos.
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Next Steps / Platform Context
The IPDE platform enables one‑time, localized drug delivery to the enlarged prostate, designed to provide durable symptom relief while minimizing systemic exposure, and Resurge plans larger global randomized, placebo‑controlled studies in collaboration with regulators and other stakeholders to support further development across broader BPH and GI urology populations.
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MedTech Watch: This Week’s Key Innovations and Clearances
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From AI-powered brain health tools and advanced diagnostics to precision testing in neurology and infectious diseases, this week’s MedTech developments highlight continued innovation in personalized and preventive healthcare. Here’s a snapshot of the latest launches, approvals, and clearances shaping the MedTech landscape:
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| • | Roche’s Elecsys pTau217 Test received European CE Mark approval to help rule in or rule out Alzheimer’s-related amyloid pathology, advancing early diagnostic capabilities in neurology.
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| • | Tolion Health AI launched the AI-powered Tolion Brain Coach app focused on brain health, longevity, and prevention of Alzheimer’s Disease.
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| • | Cepheid received IVDR CE Mark approval for the Xpert GI Panel designed to detect 11 gastrointestinal pathogens, strengthening rapid infectious disease diagnostics.
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| • | Revvity secured FDA clearance for its Total Testosterone ChLIA Assay, supporting expanded hormone testing capabilities in clinical diagnostics.
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| • | Glooko secured FDA clearance for its cloud-based EndoTool IV Insulin Dosing Platform, advancing digital insulin management and inpatient diabetes care.
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Dealmaking, AI, and Clinical Momentum Define This Week in Biopharma
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This week’s newsletter spotlights blockbuster cross-border partnerships, AI-driven drug discovery expansion, high-impact M&A, and pivotal clinical milestones shaping the future of healthcare. From Bristol Myers Squibb and Hengrui Pharma’s potential $15.2B multi-program alliance to Isomorphic Labs’ $2.1B AI financing, the industry continues accelerating innovation across oncology, immunology, neurology, and metabolic disease. Major regulatory approvals, MedTech breakthroughs, and late-stage trial readouts further underscore a rapidly evolving healthcare ecosystem focused on precision medicine, global expansion, and next-generation therapeutics.
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Stay Ahead with PharmaShots Weekly
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The biopharma world never slows—breakthrough data drops overnight, billion-dollar deals shift competitive landscapes, and regulatory decisions can reshape entire markets in real time. In a sector moving at this speed, timely intelligence isn’t optional—it’s mission-critical.
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PharmaShots Weekly cuts through the noise, delivering only what matters: pivotal pipeline updates, regulatory milestones, clinical breakthroughs, strategic partnerships, and emerging competitive dynamics—distilled into a crisp, executive-ready briefing you can absorb in minutes.
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Every Monday at 8:00 AM EST, get a decision-focused snapshot of the forces shaping global pharma and biotech—curated for leaders who act on insight, not overload.
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If this edition sparked ideas, make it a habit. Subscribe to PharmaShots Weekly for intelligence that is concise, credible, and crafted for decision-makers across R&D, competitive intelligence, strategy, and business development.
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Your intelligence should move faster.
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