RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Shots:The US FDA has granted IND clearance to initiate P-IIb (prestIgE) trial of RPT904 for the treatment of pts with IgE-mediated food allergy by the end of 2025The P-IIb (prestIgE) trial will assess RPT904 (SC; loading at Wk. 2, then Q8W or Q12W) vs PBO in 2 parts: In Part 1, ~100 pts with ≥1 food…

ByRidhi RastogiSeptember 30, 2025

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Novatim Immune Therapeutics (Keyi Pharmaceutical) Inks a ~$1.16B Licensing Deal with RADIANCE Biopharma for KY-0301 to Treat Cancer

Shots:Novatim has entered into an exclusive global licensing agreement (excl. China) with RADIANCE Biopharma for KY-0301 to treat cancer As per the deal, RADIANCE Biopharma will receive rights to develop, register, & commercialize KY-0301 globally (excl. China) in exchange for $15M upfront, ~$150M in R&D & registration milestones & ~$1B in commercial milestone, with progressive…

ByRidhi RastogiSeptember 3, 2025

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Bayer Enters a ~$1.3B Deal with Kumquat Biosciences to Develop and Commercialize a KRAS G12D Inhibitor

Shots:Bayer has entered into an exclusive global license agreement & collaboration with Kumquat Biosciences to develop and commercialize its KRAS G12D inhibitorKumquat will initiate & complete the P-Ia study following FDA’s IND clearance in Jul 2025, while Bayer handles further development & commercialization, with Kumquat holding an exclusive option to negotiate US profit-loss…

ByRidhi RastogiAugust 13, 2025

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Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

Shots:The US FDA has approved IND application of IBI3032 to initiate P-I trial for cardiometabolic disordersThe P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25IBI3032, an oral GLP-1 receptor agonist biased toward the cAMP pathway, showed…

ByRidhi RastogiAugust 5, 2025

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MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Shots:The US FDA has approved IND application of MVX-220 for the treatment of Angelman Syndrome (AS) to initiate P-I/II (ASCEND-AS) trial, with first pts dosing expected in H2’25The P-I/II trial will evaluate the safety, tolerability, & effectiveness of MVX-220 in both adult & pediatric pts with multiple AS genotypes, incl. rare types like uniparental…

ByRidhi RastogiMay 13, 2025

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Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

Shots:The US FDA has granted IND clearance to ATI-052 for the initiation of P-Ia/Ib trialThe P-Ia/Ib trial assessing single & multiple ascending doses of ATI-052 followed by PoC portion in an undisclosed indication, is expected to begin in Q2’25ATI-052 blocks upstream TSLP receptor signaling & downstream IL-4/IL-13 activation to inhibit a central…

ByRidhi RastogiApril 24, 2025

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SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis

Shots:The US FDA has granted IND clearance to SNUG01 for ALSSNUG01 will be evaluated in a P-I/IIa dose-escalation & expansion trial to assess its safety, tolerability, & preliminary efficacy in ALS adults; SineuGene to partner with academics & institutions to lead clinical development of SNUG01 SNUG01, a TRIM72-targeted gene therapy, counteracts ALS through…

ByRidhi RastogiApril 3, 2025

RAPT Therapeutics Receives the US FDA’s IND Clearance to Evaluate RPT904 for Food Allergy

Novatim Immune Therapeutics (Keyi Pharmaceutical) Inks a ~$1.16B Licensing Deal with RADIANCE Biopharma for KY-0301 to Treat Cancer

Bayer Enters a ~$1.3B Deal with Kumquat Biosciences to Develop and Commercialize a KRAS G12D Inhibitor

Innovent Reports the US FDA’s IND Clearance of IBI3032 for Cardiometabolic Disorders

MavriX Bio Reports the US FDA’s IND Clearance of MVX-220 for Angelman Syndrome

Aclaris Therapeutics Reports the US FDA’s IND Clearance of ATI-052 for Immuno-Inflammatory Diseases

SineuGene Therapeutics Reports the US FDA’s IND Clearance of SNUG01 for Amyotrophic Lateral Sclerosis

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