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Regeneron has entered into a global collaboration with Tessera Therapeutics to develop & commercialize TSRA-196 as a one-time gene editing treatment of AATD
As per the deal, Tessera & Regeneron will equally share global development costs & potential future profits for TSRA-196. Tessera will receive $150M in upfront & equity investment plus $125M in near…
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Ascletis Pharma has selected ASC37 tablets (PO), a GLP-1R/GIPR/GCGR triple peptide agonist, as a clinical development candidate
ASC37, utilizing Ascletis’ POTENT tech, showed an average of 4.2% absolute oral bioavailability, higher than semaglutide, tirzepatide, & retatrutide in oral SNAC formulations, & ~57-fold greater AUC vs retatrutide (PO) in NHP studies, with an observed t½ of…
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VectorY has entered into an option & license deal with Shape to assess Shape’s SHP-DB1 (AAV capsid) for vectorized Abs payloads against 3 targets & may secure an exclusive license for their delivery if evaluation succeeds
As per the deal, VectorY will handle development & commercialization of resulting therapies in exchange for an upfront…
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Eolas Therapeutics has secured full development rights from AstraZeneca for AZD4041 to treat opioid use disorder (OUD) and other substance use disorders; terms remain confidential
As per the agreement, Eolas will take full responsibility for AZD4041 under the existing IND and advance it to P-II trials with NIDA UG3 support, focusing on a patient-centered…
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The US FDA has approved the IND application of NVC-001 to treat LMNA-related dilated cardiomyopathy (LMNA DCM), enabling a P-I/II trial to start in early 2026
Preclinical studies showed that NVC-001 significantly improved survival and cardiac function. They planned a P-I/II trial, a 52-week, open-label, multicenter ascending-dose study to assess the safety, tolerability, and…
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The US FDA has received the IND application for UTRxM1-18, a novel therapy targeting c-MYC-driven cancers, to initiate P-I trial in 2026 pending approval, focusing on c-MYC driven tumors incl. triple-negative breast, pancreatic, colorectal, & ovarian cancer
UTRxM1-18 has demonstrated strong, dose-dependent efficacy against human-derived tumors from multiple cancer subtypes, with no dose-limiting toxicities…
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China’s NMPA has received 2 IND applications for HF158K1 (K1) & HFK2 (K2) to initiate P-I dose escalation trial in China to evaluate safety & PK of K1 alone & its preliminary efficacy with K2 to treat pts with solid tumors refractory to prior therapies
Preclinical studies of K1, K2, & their combination showed…
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Makana Therapeutics has collaborated with Tonix Pharmaceuticals for TNX-1500 (anti-CD40L mAb) to reduce rejection of Makana’s genetically engineered (GE) pig organs in xenotransplantation
Preclinical R&D collaboration may extend across Makana’s kidney, heart, & islet cell transplant programs, with an aim to support the US FDA’s IND submission for compassionate use in xenotransplantation pts
Makana’s…
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Lexicon has granted Novo Nordisk exclusive global rights to develop, manufacture & commercialize LX9851 (oral ACSL5 inhibitor) in all indications
As per the deal, Lexicon will receive $45M upfront, ~$485M in regulatory & launch milestones, ~$475M in sales milestones, & tiered royalties from single to low-double-digit % of annual net sales. Lexicon will complete…
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The EC has approved Breyanzi for r/r follicular lymphoma adults treated with ≥2 previous lines of systemic therapy in 30 EEA states
Approval was based on global P-II (TRANSCEND FL) study, assessing Breyanzi’s safety & efficacy to treat r/r indolent B-cell NHL incl. FL
In pts treated in 3L+ setting, study met…

