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ONWARD Medical Receives FDA IDE Approval for ARC-IM System to Treat Blood pressure Instability in Spinal Cord Injury

Shots: 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…
August 19, 2025

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RemeGen Enters a Licensing Agreement with Santen Pharmaceutical for RC28-E to Treat Eye Diseases

Shots: 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…
August 19, 2025

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Boehringer Ingelheim Joins Forces with Palatin to Develop Novel Therapies for Retinal Diseases

Shots: 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…
August 19, 2025

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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…
August 19, 2025

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SpringWorks Therapeutics
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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…
August 19, 2025

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SystImmune and BMS’ Izalontamab Brengitecan Secures the US FDA’s Breakthrough Therapy Designation to Treat EGFRm NSCLC

Shots: The US FDA has granted BTD to izalontamab brengitecan (iza-bren) for LA/M NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations progressing on or after EGFR TKI & Pt-based CT Designation was backed by data from 3 ongoing trials: BL-B01D1-101 & BL-B01D1-203 in China led by Sichuan Biokin, & the global BL-B01D1-LUNG-101…
August 18, 2025

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Galvanize Therapeutics Enrolls First Patient in PROPEL Registry Trial of Aliya Pulsed Electric Field Ablation for Soft Tissue Lesions

Shots: Galvanize Therapeutics has enrolled the first patient in the PROPEL registry trial evaluating the Aliya Pulsed Electric Field ablation system for soft tissue lesions, including primary and metastatic lung, liver, & other organ tumors Trial will evaluate clinical application, safety, perioperative outcomes, & radiographic response of the Aliya PEF system in ~1000 pts over…
August 18, 2025

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