Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: 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…

ByRidhi RastogiJanuary 13, 2026

NEWS

The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: 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…

ByRidhi RastogiDecember 23, 2025

NEWS

Valo Health Inks Over $3B Partnership with Merck KGaA to Advance Novel Therapies for Neurodegenerative Disorders

Shots: 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 &…

ByRidhi RastogiNovember 21, 2025

NEWS

Biocytogen Partners with Merck KGaA to Develop Antibody-Conjugated Lipid-Based Delivery Solutions

Shots: 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…

ByRidhi RastogiSeptember 4, 2025

NEWS

Skyhawk Therapeutics Enters a ~$2B Deal with Merck KGaA to Identify RNA-Targeting Small Molecules for Neurological Disorders

Shots: 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…

ByRidhi RastogiAugust 19, 2025

NEWS

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

Shots: 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…

ByRidhi RastogiAugust 19, 2025

NEWS

NMPA Accepts Marketing Authorization for Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: 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…

ByDipanshu DixitJune 10, 2025

NEWS

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Shots: 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…

ByRidhi RastogiMay 28, 2025

NEWS

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B

Shots: 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…

ByRidhi RastogiApril 28, 2025

INSIGHTS+

PharmaShots’ Key Highlights of Second Quarter 2024

Shots: The second quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Vertex’ acquisition of Alpine Immune Sciences for ~$4.9B This quarter also showcased multiple clinical trial results including Moderna’s P-III Study Data of mRNA-1283 Vaccine to Prevent COVID-19…

BySenior EditorJuly 2, 2024

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Valo Health Inks Over $3B Partnership with Merck KGaA to Advance Novel Therapies for Neurodegenerative Disorders

Biocytogen Partners with Merck KGaA to Develop Antibody-Conjugated Lipid-Based Delivery Solutions

Skyhawk Therapeutics Enters a ~$2B Deal with Merck KGaA to Identify RNA-Targeting Small Molecules for Neurological Disorders

SpringWorks Therapeutics (Merck KGaA) Reports the EC’s Approval of Ogsiveo (Nirogacestat) for Desmoid Tumors

NMPA Accepts Marketing Authorization for Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B

PharmaShots’ Key Highlights of Second Quarter 2024

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