Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Shots: The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD) In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…

ByRidhi Rastogi11 hours ago

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Insilico Medicine and TaiGen Biotechnology Partner for ISM4808 to Treat Anemia of Chronic Kidney Disease (CKD)

Shots: Insilico has entered into an exclusive out-licensing collaboration with TaiGen & its subsidiary TaiGen Biopharmaceuticals for ISM4808 to treat CKD-related anemia As per the deal, TaiGen will gain exclusive rights to ISM4808 & related forms for further development, commercialization & sub-licensing in Greater China, while Insilico will receive upfront payment, development & sales milestones, &…

ByRidhi RastogiDecember 15, 2025

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Formation Bio Licenses Lynk Pharmaceuticals’ LNK01006 to Expand its Immunology Pipeline

Shots: Lynk Pharmaceuticals has entered into an exclusive development & licensing agreement with Formation Bio, granting the latter worldwide rights to LNK01006 (excl. Greater China), a highly selective TYK2 inhibitor LNK01006 will be developed by Formation’s new subsidiary, Bleecker Bio, following recent US FDA IND clearance, with a P-I trial planned to start in the…

ByRidhi RastogiDecember 11, 2025

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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 2025 The 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 inhibitor Kumquat 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 disorders The P-I trials will be initiated simultaneously in China & the US, with dosing in healthy & overweight or obese participants anticipated to start in H2’25 IBI3032, 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 H2’25 The 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 trial The 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 Q2’25 ATI-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 ALS SNUG01 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

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Insilico Medicine and TaiGen Biotechnology Partner for ISM4808 to Treat Anemia of Chronic Kidney Disease (CKD)

Formation Bio Licenses Lynk Pharmaceuticals’ LNK01006 to Expand its Immunology Pipeline

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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