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HUTCHMED has completed enrolment in its P-III (SANOVO) trial to assess Orpathys + Tagrisso as a 1L treatment of pts with locally advanced or metastatic NSCLC harboring EGFR mutation & MET overexpression; last patient was enrolled in Aug 18, 2025
Trial will evaluate Orpathys + Tagrisso vs Tagrisso in NSCLC pts, assessing PFS as 1EP,…
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VantAI has entered into a strategic research collaboration with Halda Therapeutics to advance the discovery & development of selective proximity-based therapies for cancer & immunology indications
As per the deal, VantAI will receive over ~$1B incl. upfront, research support, development & commercial milestones as well as net sales-based tiered royalties
VantAI will use its…
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The EC has granted conditional approval to Rezdiffra to treat adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with mod. to adv. liver fibrosis in 30 EEA states; launch is planned throughout EU starting with Germany in Q4’25
Approval was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which…
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ONWARD Medical has received the US FDA IDE approval to initiate its Empower BP study evaluating ARC-IM System for blood pressure instability in spinal cord injury
The IDE trial will assess ARC-IM System in pts with C2–T6 spinal cord injuries, injury severities of AIS A-D & blood pressure instability, incl. chronic OH & autonomic…
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The US FDA has approved Tonmya (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia in adults; commercially available in Q4’25
Approval was based on 2 P-III (RELIEF & RESILIENT) trial assessing Tonmya vs PBO in 503 & 457 pts, respectively in the US, where pts started on Tonmya 2.8mg & increased the dose…
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RemeGen has granted Santen exclusive rights to develop, manufacture, & commercialize RC28-E in Greater China (incl. Mainland China, Hong Kong, Macau, & Taiwan), South Korea, Thailand, Vietnam, Singapore, Philippines, Indonesia, & Malaysia, while RemeGen will retain its rights in other territories
As per the deal, RemeGen will receive $38.9M (¥250M) upfront, ~$72.3M (¥520M) in…
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BI has entered into a global research collaboration and licensing agreement with Palatin Technologies to develop novel melanocortin receptor agonist for retinal diseases
As per the deal, Palatin is eligible for ~$327.6M (€280M) in upfront, development, regulatory, & commercial milestone payments, along with tiered royalties on net sales
Collaboration strengthens Boehringer’s retinal pipeline by…
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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…

