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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…

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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…

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SpringWorks Therapeutics

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…

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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…

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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…

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Eli Lilly Collaborates with Superluminal Medicines to Develop Small Molecule for Cardiometabolic Diseases and Obesity

Shots: Superluminal Medicines & Eli Lilly have partnered to develop small molecule therapeutics for undisclosed GPCR targets in cardiometabolic diseases & obesity, leveraging Superluminal’s drug discovery platform As per the deal, Superluminal will use its platform to discover & optimize small molecules, while Lilly will obtain exclusive rights to develop & commercialize the candidates in…

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Precigen’s Papzimeos Receives the US FDA’s Full Approval for Recurrent Respiratory Papillomatosis

Shots: The US FDA has granted full approval to Papzimeos (zopapogene imadenovec-drba) for adults with recurrent respiratory papillomatosis (RRP), even though its BLA was originally submitted under the accelerated approval pathway Approval was based on a P-I/II trial meeting its 1EP of safety as well as efficacy & showed 51% pts (18/35) achieving CR with…

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