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Welcome to PharmaShots Weekly
| June 01, 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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Merz-Kvvit Inbrija Deal Expands in Greater China
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| | Apogee’s $1.3B Blackstone Deal Backs Zumilokibart
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| | Olympus’s $270M BioProtect Deal Expands Urology
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| | Lilly’s $3.8B Vaccine Deals Boost Infectious Disease
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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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| • | Pfizer and Innovent’s ~$10.5B Oncology Pact Accelerates 12 Programs Across ADCs, Immunology, and Cell Therapy
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Strategic Deals & Partnerships
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| • | Merz’s Inbrija License with Kvvit Targets Parkinson’s OFF Episodes in Greater China
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| • | Apogee’s ~$1.3B Blackstone Financing Funds Zumilokibart’s Late-Stage Development and Commercialization
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Merger & Acquisition
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| • | Olympus’s ~$270M BioProtect Acquisition Expands GI and Urological Care Portfolio
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| • | Eli Lilly’s ~$3.8B Trio of Vaccine Acquisitions Builds Infectious Disease Pipeline
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Clinical Trials
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Oncology
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| • | OSE Immunotherapeutics Reports Positive P-II Data for Tedopi ± Keytruda in Platinum-Sensitive Recurrent Ovarian Cancer
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| • | Junshi Biosciences Reports Final P-III NEOTORCH Data for Toripalimab in Resectable Stage II–III NSCLC
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Cardiometabolic & Rare Diseases
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| • | Lilly Reports P-Ib Data on VERVE-102 for HeFH and Premature Coronary Artery Disease
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| • | Sobi Reports P-III CORE/CORE2 Data for Tryngolza in Severe Hypertriglyceridemia
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Liver & Metabolic Diseases
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| • | D&D Pharmatech Reports Positive P-II Data for Zabopegdutide in MASH
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| • | Altimmune Reports 48-Week P-IIb IMPACT Data for Pemvidutide in MASH
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Immunology & Infectious Diseases
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| • | GSK Reports Positive P-III B-Well Data for Bepirovirsen in Chronic Hepatitis B
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| • | Apogee Therapeutics Reports Positive P-II APEX Data for Zumilokibart in Atopic Dermatitis
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Regulatory Watch: This Week’s Key Approvals and Milestones
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| • | Gilead’s Hepcludex Wins FDA Accelerated Approval for HDV Infection
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| • | Pharming’s Joenja Gains EC Approval for APDS
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| • | Daiichi Sankyo and AstraZeneca’s Datroway Approved for Metastatic TNBC
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| • | Agios’ Pyrukynd Secures EC Approval for Thalassemia-Related Anemia
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| • | AstraZeneca’s Camizestrant Receives CHMP Positive Opinion in Breast Cancer
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| • | Sanofi’s Venglustat Gains FDA Priority Review for Type 3 Gaucher Disease
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| • | AbbVie’s Decnupaz Approved for BPDCN
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| • | Ironwood’s Linzess Approved for Pediatric Functional Constipation
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| • | AstraZeneca’s Imfinzi Regimen Approved for High-Risk NMIBC
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| • | Cogent Biosciences’ Bezuclastinib Combination Receives FDA Priority Review for GIST
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| • | Merck’s Calderasib Granted FDA Breakthrough Therapy Designation for KRAS G12C-Mutant NSCLC
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MedTech Watch: This Week’s Key Innovations and Clearances
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| • | Oticon Medical Launches Ponto Instant Portfolio for Non-Surgical Bone Conduction Hearing
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| • | TOBY Secures FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Test
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| • | Myriad Genetics Launches Prolaris + AI Test for Personalized Prostate Cancer Surveillance
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| • | Cardiosense Receives FDA De Novo Classification for PCWP Analysis Software
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Pfizer-Innovent $10.5B Oncology Pact Advances 12 Assets
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Innovent Biologics and Pfizer have entered into a strategic collaboration to advance 12 early-stage and de novo cancer therapies.
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Why It Matters
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| • | Deal Value: $650M upfront plus up to ~$9.85B in milestones and double-digit royalties, totaling approximately $10.5B and ranking among the largest oncology collaborations announced this year.
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| • | Program Portfolio: 12 early-stage oncology programs spanning ADCs, immunology, and cell therapy, with Pfizer assuming global development after Phase I completion across all assets.
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| • | Flexible Rights Structure: Exclusive global rights for four programs, exclusive ex-Greater China rights for four programs, and co-development/co-commercialization for four programs, with Innovent retaining Greater China rights across all assets.
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Strategic Focus
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| • | Oncology Pipeline Expansion: Strengthens Pfizer’s oncology portfolio with 12 diverse early-stage programs, including ADCs and novel immuno-oncology agents, while accelerating Innovent’s pipeline through global partnership.
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| • | Risk-Sharing Model: Co-development and co-commercialization for four programs in the US, EU, and UK allow both companies to share costs, risks, and profits while leveraging complementary capabilities.
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| • | China-Global Bridge: Innovent retains Greater China rights across all 12 programs, leveraging its established commercial infrastructure in China while Pfizer drives global development and commercialization outside the region.
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| | Strategic Deals & Partnerships
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Merz-Kvvit Inbrija Deal Targets Parkinson’s OFF in China
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Merz Therapeutics has granted Kvvit an exclusive license to Inbrija (levodopa inhalation powder) in mainland China, Hong Kong, and Macao for the intermittent treatment of OFF episodes in adults with Parkinson’s disease who are receiving levodopa/dopa-decarboxylase inhibitor therapy.
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Why It Matters
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| • | Deal Structure: Upfront payment plus development and commercial milestones, complemented by tiered supply and royalty revenues, aligning Merz’s economics with Inbrija’s commercial success in Greater China.
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| • | Targeted Therapy: Inbrija addresses OFF episodes in Parkinson’s disease, a significant unmet need for patients experiencing unpredictable motor fluctuations despite optimized oral levodopa therapy.
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Strategic Focus
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| • | Greater China Market Access: Expands Inbrija’s geographic footprint into mainland China, Hong Kong, and Macao, tapping into a large and growing Parkinson’s disease patient population.
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| • | Non-Invasive Rescue Option: Positions Inbrija as a rapid-onset, inhalation-based alternative to injectable or oral rescue therapies, improving patient convenience and adherence.
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| • | Asset-Light Commercialization: Merz monetizes Inbrija through supply and royalties without bearing the full cost of local clinical development and commercialization, while Kvvit assumes market risk and execution responsibilities.
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Apogee Secures $1.3B Blackstone Deal for Zumilokibart
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Apogee Therapeutics has secured up to approximately $1.3B in flexible, non-dilutive capital from Blackstone, including roughly $800M in synthetic royalty financing and up to $500M in senior debt available at the mutual consent of both parties, to support the late-stage development and potential commercialization of zumilokibart, a high-affinity IL-17A inhibitor for moderate-to-severe plaque psoriasis and other inflammatory conditions.
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Why It Matters
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| • | Financing Structure: Up to ~$1.3B in non-dilutive capital, combining ~$800M in synthetic royalty and up to $500M in senior debt, preserving Apogee’s equity while funding late-stage development and commercialization.
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| • | Royalty Terms: 15-year tiered royalties on global zumilokibart sales, declining by sales tier and capped at $8B in annual sales, with change-of-control protections and a repurchase option for Apogee.
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| • | Milestone-Driven Disbursements: Preapproval funding of $400M released across three tranches tied to signing, Phase III enrollment completion, and positive Phase III data, with $400M post-approval funding available to support commercial launch.
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Strategic Focus
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| • | Late-Stage Development: Funding supports Phase III advancement and potential commercialization of zumilokibart, positioning Apogee as a commercial-scale biotech in the IL-17 inhibitor space.
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| • | Equity Preservation: Non-dilutive financing allows Apogee to advance its asset without issuing additional equity, maintaining shareholder value and control.
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| • | Commercial Readiness: Post-approval funding and optional tranches enable Apogee to scale manufacturing, marketing, and sales infrastructure ahead of potential FDA approval and market entry.
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| | Mergers & Acquisitions (M&A)
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Olympus’s $270M BioProtect Acquisition Expands Urology Care
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Olympus has entered into a definitive agreement to acquire BioProtect, including its Balloon Spacer system designed to protect healthy tissue during prostate cancer radiotherapy, strengthening Olympus’s presence in GI and urological care.
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Why It Matters
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| • | Deal Value: ~$270M total consideration, with certain amounts held in escrow subject to uninterrupted business operations, providing Olympus with a clinically validated spacing technology for prostate cancer radiotherapy.
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| • | Clinical Benefit: The Balloon Spacer system protects healthy tissue during prostate cancer radiotherapy, potentially reducing rectal toxicity and improving patient quality of life during treatment.
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| • | Therapeutic Area Expansion: Strengthens Olympus’s portfolio in GI and urological care by adding a differentiated prostate cancer treatment solution that complements its existing endoscopic and surgical platforms.
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Strategic Focus
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| • | Urological Care Portfolio: Expands Olympus’s urological offerings with a prostate cancer radiotherapy adjunct that addresses a key unmet need in minimizing radiation damage to surrounding healthy tissue.
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| • | Global Commercial Synergy: Combines BioProtect’s spacing technology with Olympus’s established global commercial infrastructure to accelerate market penetration and expand access to prostate cancer treatment solutions.
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| • | GI and Oncology Integration: Positions Olympus at the intersection of GI endoscopy and oncology care, leveraging its minimally invasive technology expertise to support cancer treatment workflows.
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Lilly’s $3.8B Vaccine Deals Expand Infectious Disease
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Eli Lilly has entered into agreements to acquire three companies—Curevo, LimmaTech Biologics, and Vaccine Company—to build its infectious disease portfolio through differentiated vaccine assets and proprietary platform technologies.
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Why It Matters
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| • | Deal Value: ~$3.8B total across three acquisitions—Curevo (~$1.5B), LimmaTech (~$780M), and Vaccine Company (~$1.55B)—including upfront payments and milestone-based considerations tied to clinical, regulatory, and commercial achievements.
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| • | Pipeline Diversity: Adds three distinct vaccine assets spanning Phase II shingles (amezosvatein), Phase I S. aureus (LTB-SA7), and preclinical EBV, covering viral and bacterial infectious disease indications.
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| • | Platform Technology: Gains access to Vaccine Company's proprietary in vivo nanoparticle technology, enabling Lilly to develop next-generation vaccine platforms with potential applicability across multiple infectious disease targets.
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Strategic Focus
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| • | Infectious Disease Expansion: Establishes Lilly's dedicated infectious disease franchise by acquiring differentiated vaccine candidates and platform technologies rather than relying solely on internal R&D.
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| • | Shingles Market Opportunity: The Phase II amezosvatein candidate targets the large shingles vaccine market, competing with established players while offering a differentiated mechanism of action.
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| • | Unmet Bacterial Need: LimmaTech's LTB-SA7 addresses S. aureus infections, a significant unmet medical need with limited vaccine options currently available in the market.
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| • | EBV Platform Bet: The preclinical EBV vaccine platform leverages novel in vivo nanoparticle technology, positioning Lilly to potentially address Epstein-Barr virus, which is linked to multiple cancers and autoimmune diseases.
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| | Clinical Trials & Data Readouts
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P‑II TEDOVA/GINECO‑OV244b/ENGOT‑ov58
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Ovarian Cancer – Platinum-sensitive Recurrent Disease
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OSE Immunotherapeutics has reported topline P‑II TEDOVA/GINECO‑OV244b/ENGOT‑ov58 (NCT04713514) trial results evaluating Tedopi (OSE2101) ± Keytruda as maintenance treatment in pts with platinum‑sensitive recurrent ovarian cancer who progressed after or were ineligible for PARP inhibitors and Avastin.
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Key Details
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The study enrolled 185 pts; those achieving CR, PR, or stable disease after platinum‑based therapy were randomized to best supportive care, Tedopi monotherapy, or Tedopi + Keytruda. The trial met its 1EP, with Tedopi + Keytruda improving PFS vs best supportive care, reducing the risk of progression or death by 28% (mPFS: 4.1 vs 2.8mos.); data are slated for presentation at ASCO’26.
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Hypercholesterolemia – HeFH / Premature CAD
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Lilly has reported P‑Ib Heart‑2 trial data on VERVE‑102 as a one‑time treatment in 35 adults with HeFH or premature coronary artery disease who required additional LDL‑C lowering despite maximally tolerated oral lipid‑lowering therapy.
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Key Details
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A single infusion of VERVE‑102 produced dose‑dependent PCSK9 reductions of 51% to 88% across the tested dose range, with corresponding mean LDL‑C reductions ranging from 9% to 62%; effects were sustained for about 18 mos. after treatment.
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Next Steps
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Data on VERVE‑102 were presented at EAS’26 and published in The NEJM, and Lilly plans to initiate the Phase II study by year-end.
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Severe Hypertriglyceridemia (sHTG)
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Sobi has reported pooled subgroup analysis data from the P‑III CORE and CORE2 trials evaluating Tryngolza (olezarsen; 50 or 80 mg, SC, Q4W) vs placebo in adults with severe hypertriglyceridemia and triglyceride levels ≥500 mg/dL.
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Key Details
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In patients with TGs ≥880 mg/dL, placebo-adjusted TG reductions at 6mos. were 66% with 80 mg and 59% with 50 mg, while remnant cholesterol fell by 64% and 53% and non‑HDL‑C by 35% and 27%, respectively; overall, 85% of treated pts reached TGs <10 mmol/L.
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Regulatory Status
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In Mar 2026, the EMA validated an indication extension application for olezarsen in adults with sHTG and TGs ≥880 mg/dL, and in Feb 2026 the US FDA granted priority review to its sNDA for sHTG (TGs ≥500 mg/dL), with a PDUFA date of Jun 30, 2026.
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Resectable Stage II–III NSCLC
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Junshi Biosciences has reported the final analysis from the P‑III NEOTORCH (NCT04158440) trial assessing toripalimab + platinum-containing doublet chemotherapy vs placebo + chemotherapy as perioperative treatment in 501 pts with resectable stage II–III NSCLC.
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Key Details
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The trial improved EFS, with median EFS not reached vs 15.1mos. with chemotherapy alone, reducing the risk of recurrence, progression, or death by 60%; it also increased pCR rates about 25-fold (24.8% vs 1%) and MPR rates about 6-fold (48.5% vs 8.4%), with a favorable OS trend observed.
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Next Steps
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Junshi Biosciences plans to submit an sNDA for toripalimab to regulatory authorities in the near future.
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Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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D&D Pharmatech has reported topline P‑II DD01‑DN‑02 trial data assessing zabopegdutide (DD01) vs placebo in 67 overweight/obese pts with MASH and significant liver fat across the US.
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Key Details
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The study met all 3 key histological endpoints. At Wk. 48, fibrosis improvement (≥1 stage) without MASH worsening was achieved in 50% vs 15.8%, MASH resolution without fibrosis worsening in 62.5% vs 5.3%, and both fibrosis improvement and MASH resolution in 37.5% vs 5.3%; treatment also reduced liver fat, stiffness, and fibrosis biomarkers.
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Additional Context
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Pts received a 2wk. 20 mg titration followed by maintenance DD01 40 mg QW or placebo, and the Wk. 48 per-protocol population included 35 pts with biopsy-confirmed MASH and F1–F3 fibrosis who completed paired liver biopsies with high treatment adherence; data were presented at EASL’26.
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Chronic Hepatitis B
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GSK has reported data from the P‑III B‑Well 1 and B‑Well 2 trials assessing bepirovirsen vs placebo in nucleos(t)ide analogue‑treated pts with chronic hepatitis B and baseline HBsAg ≤3000 IU/mL. Bepirovirsen is currently under regulatory review in the US, EU, China and Japan.
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Key Details
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Pooled data showed a 19% functional cure rate in the overall population (233/1,220 vs 0/614; B‑Well 1: 20% vs 0%; B‑Well 2: 19% vs 0%) and 26% in pts with HBsAg ≤1000 IU/mL (200/768 vs 0/393; B‑Well 1: 25% vs 0%; B‑Well 2: 28% vs 0%). In an exploratory analysis, 49% of bepirovirsen recipients achieved qHBsAg ≤100 IU/mL 1yr. post‑treatment, while sustained HBV DNA <LLOQ at Wk. 72 was seen in 23% of all recipients and 31% of those with HBsAg ≤1000 IU/mL after treatment stopped at Wk. 48.
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Atopic Dermatitis (AD)
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Apogee Therapeutics has reported Part B P‑II APEX trial data assessing zumilokibart vs placebo in 346 pts with AD. Mid‑ and high‑dose zumilokibart met the 1EP at Wk. 16, with EASI‑75 achieved by 65.9% of mid‑dose pts and 61.6% of high‑dose pts vs 23.4% on placebo; the low dose achieved EASI‑75 in 50.5% of pts.
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Key Details
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At Wk. 16, the mid dose also met key 2EPs, including IGA 0/1 response in 46% vs 10.9%, EASI‑90 in 47.4% vs 9.3%, I‑NRS ≥4 reduction in 50.5% vs 13.9%, EASI‑100 in 16.5% vs 3.4%, and vLDA response in 20.6% vs 4.5% of pts.
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Next Steps
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Apogee plans to advance the mid‑dose zumilokibart into P‑III Adventure 1 and Adventure 2 trials for moderate to severe AD in H2’26, pending regulatory interactions, while also initiating a P‑II asthma study in H1’27 and an eosinophilic esophagitis trial in H2’26.
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Metabolic Dysfunction-Associated Steatohepatitis (MASH)
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Altimmune has reported 48wk. P‑IIb IMPACT (NCT05989711) trial data assessing pemvidutide (1.2 or 1.8 mg, SC, QW) vs placebo in 212 pts with MASH and fibrosis stages F2 or F3, with and without diabetes. Pemvidutide 1.8 mg showed reductions in triglycerides by 23.7%, total cholesterol by 15.4%, BMI by 3 kg/m², waist circumference by 5.3 cm, and systolic/diastolic BP by 4/2.2 mmHg, while delivering sustained 7.5% weight loss with no plateau observed; data were presented at EASL’26.
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Next Steps
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Pemvidutide is being evaluated in the P‑II RECLAIM trial for alcohol use disorder, with topline data expected in Q3’26, and the RESTORE trial in alcohol-associated liver disease, with enrollment completion anticipated in Q3’26, while the P‑III PERFORMA trial in MASH is planned to begin in H2’26.
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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 oncology and rare diseases to gastroenterology and infectious diseases, this week’s regulatory activity highlights continued momentum in advancing innovative therapies and expanding patient access across global markets. Here’s a snapshot of the latest approvals, priority reviews, and regulatory milestones shaping the healthcare landscape:
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| • | Gilead Sciences reported FDA accelerated approval of Hepcludex to treat chronic hepatitis delta virus (HDV) infection, addressing a major unmet need in liver disease.
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| • | Pharming Group received European Commission approval for Joenja (leniolisib) to treat activated phosphoinositide 3-kinase delta syndrome (APDS).
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| • | Daiichi Sankyo and AstraZeneca secured FDA approval for Datroway to treat metastatic triple-negative breast cancer, further expanding targeted oncology options.
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| • | Agios Pharmaceuticals reported European Commission approval of Pyrukynd for anemia in alpha or beta thalassemia.
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| • | AstraZeneca received a positive CHMP opinion for Camizestrant to treat advanced breast cancer.
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| • | Sanofi’s Venglustat secured FDA Priority Review for Type 3 Gaucher disease.
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| • | AbbVie announced FDA approval for Decnupaz to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN).
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| • | Ironwood Pharmaceuticals reported FDA approval of Linzess for pediatric patients aged ≥2 years with functional constipation.
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| • | AstraZeneca received FDA approval for an Imfinzi-based regimen to treat high-risk non-muscle-invasive bladder cancer (NMIBC).
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| • | Cogent Biosciences received FDA Priority Review for its bezuclastinib combination therapy to treat gastrointestinal stromal tumors (GIST).
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| • | Merck & Co. secured FDA Breakthrough Therapy Designation for calderasib to treat newly diagnosed metastatic KRAS G12C-mutant NSCLC.
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| | MedTech Watch: This Week’s Key Innovations and Clearances
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From AI-powered diagnostics and precision oncology tools to digital cardiology and hearing technologies, this week’s MedTech developments highlight continued innovation in personalized and patient-centered healthcare. Here’s a snapshot of the latest launches, designations, and regulatory milestones shaping the MedTech landscape:
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| • | Oticon Medical launched the Ponto Instant Portfolio to expand non-surgical bone conduction hearing options for patients with hearing loss.
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| • | TOBY secured FDA Breakthrough Device Designation for its urine-based Alzheimer’s Disease Test, supporting advancements in non-invasive neurodegenerative disease diagnostics.
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| • | Myriad Genetics launched the Prolaris + AI Test for personalized prostate cancer active surveillance, integrating AI into precision oncology decision-making.
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| • | Cardiosense received FDA De Novo classification for its PCWP Analysis Software, advancing digital cardiovascular monitoring and hemodynamic assessment.
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Mega Deals, Precision Oncology & Next-Gen Innovation Drive Biopharma Forward
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This week’s healthcare landscape was shaped by high-value collaborations, strategic acquisitions, breakthrough clinical data, and major regulatory milestones across oncology, immunology, infectious diseases, and metabolic disorders. Pfizer and Innovent Biologics led headlines with a ~$10.5B oncology alliance spanning ADCs, immunology, and cell therapy, while Eli Lilly and Company expanded its infectious disease footprint through three vaccine acquisitions worth ~$3.8B. Clinical updates from companies including Apogee Therapeutics, GSK, and Altimmune highlighted strong momentum in MASH, atopic dermatitis, and chronic hepatitis B. Meanwhile, regulatory and MedTech advances continued accelerating innovation in precision medicine, AI-powered diagnostics, and targeted therapeutics.
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Stay Ahead with PharmaShots Weekly
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