Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041

Shots: 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…

ByDipanshu DixitJuly 11, 2025

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Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

Shots: 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…

ByPrince GiriJune 11, 2025

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UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

Shots: 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…

ByRidhi RastogiMay 9, 2025

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HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Shots: 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…

ByRidhi RastogiApril 21, 2025

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Makana Therapeutics Collaborates with Tonix Pharmaceuticals for TNX-1500

Shots: 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…

ByRidhi RastogiApril 10, 2025

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Lexicon Enters a Global Licensing Agreement with Novo Nordisk for LX9851

Shots: 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…

ByRidhi RastogiApril 2, 2025

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BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Shots: 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…

ByRidhi RastogiMarch 17, 2025

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Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Shots: The US FDA approved Bioheng’s IND application for CTD402 to treat pediatric and adult patients with relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (R/R T-ALL/LBL) CTD402 will be evaluated in a P-Ib/II single-arm, open-label, dose-finding study to optimize dosing and accelerate clinical development CTD402 is a CD7-targeted universal CAR-T (UCAR-T) cell therapy that is genetically…

ByRidhi RastogiMarch 5, 2025

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Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

Shots: The company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization FP008 is an anti-PD-1×IL-10M fusion protein with a…

ByRidhi RastogiFebruary 28, 2025

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The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

Shots: The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity…

ByDipanshu DixitSeptember 2, 2024

Eolas Therapeutics Joins Forces with AstraZeneca to Develop AZD4041

Nuevocor Reports the US FDA’s IND Clearance of NVC-001 for LMNA DCM

UTR Therapeutics Seeks the US FDA’s IND Clearance of UTRxM1-18 to Target c-MYC-Driven Cancers

HighField Biopharmaceuticals Seeks NMPA’s IND Clearance for HF158K1 & HFK2 to Treat Solid Tumors

Makana Therapeutics Collaborates with Tonix Pharmaceuticals for TNX-1500

Lexicon Enters a Global Licensing Agreement with Novo Nordisk for LX9851

BMS Reports the EC’s Approval of Breyanzi to Treat R/R Follicular Lymphoma

Bioheng Therapeutics Secures the FDA Clearance of IND Application for CTD402 in T-ALL/LBL

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors

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