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The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU
NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…
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Merck has reported topline P-III (CORALreef Lipids) trial data assessing enlicitide decanoate vs PBO for the treatment of adults with hypercholesterolemia receiving mod. to high-intensity statins or are intolerant to statins
Trial met its 1EP with significant LDL-C reduction at Wk. 24 & achieved 2EPs, showing reduced non-HDL-C, apolipoprotein B, & lipoprotein(a) levels; data…
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Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer
As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…
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Enlaza & Vertex’s muti-target collaboration will leverage Enlaza’s War-Lock platform to develop small format drug conjugates & T-cell engagers for autoimmune diseases & improved conditioning in sickle cell disease & β thalassemia
Enlaza will receive $45M in upfront & equity investment & is eligible for >$2B in research, development, regulatory, & commercial milestones plus…
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Arrowhead has granted Novartis exclusive global rights to develop, manufacture, & commercialize ARO-SNCA, which leverages the TRiM platform for SC dosing & targeted gene delivery to treat synucleinopathies, incl. Parkinson’s disease
As per the deal, Arrowhead will receive $200M upfront & ~$2B in development, regulatory, and sales milestones, with tiered royalties on sales up…
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The US FDA has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product
Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable quality, efficacy & safety of Bildyos & Bilprevda to reference denosumab
In 2022,…
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IDEAYA has entered an exclusive licensing agreement granting Servier global regulatory and commercial rights to darovasertib, while retaining all the US rights
IDEAYA & Servier will co-develop darovasertib & share costs, with Servier leading regulatory & commercial efforts worldwide excl. the US, in exchange for $210M upfront, ~$100M on approval, ~$220M in commercial milestones,…
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Polpharma has entered into licensing deals with MS Pharma to commercialize PB016 (vedolizumab), PB018 (ocrelizumab), & PB019 (guselkumab) biosimilars across the Middle East & North Africa (MENA) region
As per the deal, MS Pharma will be responsible for registration, marketing, & distribution of the 3 biosimilars in MENA, while Polpharma will handle development, manufacturing,…
OMass has entered into an exclusive collaboration & license deal with Genentech to develop & commercialize its preclinical oral small molecule program for inflammatory bowel disease
As per the deal, OMass will receive $20M upfront & over $400M in preclinical, development, commercial, & sales milestones, with tiered royalties based on net sales
Collaboration leverages OMass’…
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Novartis has reported P-IV (V-DIFFERENCE) trial results evaluating Leqvio (n=898) vs PBO (n=872), both added to personalized lipid-lowering therapy (LLT), in 1,770 hypercholesterolemia pts not at guideline-recommended LDL-C goals
Trial showed 85% vs 31% achieved their guideline-recommended LDL-C target after 90 days of treatment, with benefits seen as early as day 30 (81% on…

