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2025 pharma M&A was defined by fewer but more transformational deals, with companies prioritizing commercial-stage assets, late-stage pipelines, and platform technologies capable of reshaping long-term growth and strengthening core therapeutic franchisesÂ
The year’s momentum was led by three standout transactions, J&J’s $14.6B acquisition of Intra-Cellular Therapies, Novartis’ $12B deal for Avidity Biosciences, and Merck’s…
Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)
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The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval
NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…
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The NMPA has approved Merck KGaA's Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity
Approval was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which…
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Valo Health has entered into a strategic collaboration with Merck KGaA to accelerate therapeutic discovery for Parkinson’s disease & related neurodegenerative disorders
As per the deal, Valo Health will receive an upfront & milestone payment totaling over $3B, with royalties & R&D funding
Collaboration will use Valo’s AI-enabled human causal biology platform to discover &…
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Biocytogen has entered into an evaluation & option agreement with Merck KGaA to develop antibody-conjugated lipid-based delivery solutions for nucleic acid payloads, incl. antibody-conjugated lipid nanoparticles
As per the deal, Biocytogen will provide fully human antibodies from its RenMice platform for evaluation to Merck KGaA’s antibody-conjugated LNP services, with Merck KGaA holding an exclusive…
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Skyhawk Therapeutics has entered into a strategic research collaboration with Merck KGaA to discover novel RNA-targeting small molecules for neurological diseases with limited treatment options
Skyhawk will receive ~$2B incl. upfront, milestones, & potential tiered royalties, leading discovery & preclinical development, while Merck KGaA gains exclusive global rights & handles further development & commercialization upon…
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The EC has approved Ogsiveo as a monotx. for adults with progressing desmoid tumors needing systemic treatment
Approval was based on global P-III (DeFi) trial (N=142) assessing Ogsiveo (150mg, BID, n=70) vs PBO (n=72) in adults with progressing desmoid tumors
Trial met its 1EP with 71% reduction in risk of disease progression & showed…
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The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapy
The application was based on Part 1 of the P-III (MANEUVER) global study, trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment, the trial also…
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Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)
Trial met its 1EP of improved ORR (54.0% vs…
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Merck KGaA has entered into a definitive agreement to acquire SpringWorks Therapeutics to strengthen its rare disease portfolio & expand SpringWorks’ reach to markets beyond the US
As per the agreement, Merck KGaA will acquire SpringWorks for $47/share (~26% premium), with an equity value of ~$3.9B or an enterprise value of ~$3.4B, funded by…

