Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

Shots: Nurix reported updated P-Ia/I b data for bexobrutideg in which P-Ia (n=48) showed an ORR of 83% incl. 2 CRs & a median PFS of 22.1mos. across all doses (50 mg to 600 mg OD) in heavily pretreated relapsed/refractory CLL/SLL pts.; P-Ib data (n=42) indicated higher ORR i.e. 83.3% & longer PFS at the 600mg…

ByPrince GiriDecember 8, 2025

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CARsgen Therapeutics Presents Trial Data of CT0596 for Relapsed/Refractory Multiple Myeloma (R/R MM) at ASH’25

Shots: CARsgen reported that early clinical results of CT0596, in Pts with R/R MM, were shared in ASH’25. The company plans a P-Ib registrational study in 2026, following an IND submission expected in H2'25 The P-I trial enrolled 8 pts with R/R MM who received CT0596, with a median of 4.5 prior therapy lines. Enrollment…

ByDipanshu DixitDecember 8, 2025

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Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Shots: Capricor Therapeutics has reported the topline P-III (HOPE-3) trial data assessing Deramiocel (IV, Q3M) vs PBO in boys & young men (n=106) with DMD for 12mos. across the US Trial met its 1EP with a 54% slowing of upper-limb functional decline (PUL v2.0) among 105 evaluable pts at 12mos. & achieved its 2EP with…

ByRidhi RastogiDecember 4, 2025

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Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Shots: Imvax has reported the topline data from the P-IIb trial assessing IGV-001 vs PBO in 99 pts with newly diagnosed glioblastoma (ndGBM) Trial showed an mOS of 20.3 vs 14mos., with an mFU of 22mos. for all pts, plus IGV-001 demonstrated measurable patient benefit across various metrics; safety was consistent with previous studies Additionally,…

ByRidhi RastogiDecember 3, 2025

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Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

Shots: Trial assessed tinlarebant (5mg, QD, PO; n=69) vs PBO (n=35) in 104 STGD1 pts (12-20yrs.), meeting its 1EP of 36% reduction in lesion growth per retinal imaging, quantified as 35.7% using the pre-specified MMRM model & confirmed at 35.4% with a post-hoc autoregressive-MMRM analysis Trial also showed reduced lesion growth rate by 33.6% in fellow…

ByRidhi RastogiDecember 2, 2025

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AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Shots: AbbVie has reported the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (atogepant, 60mg, PO, QD) vs PBO as an acute treatment of migraine in 1,223 adults (with or without aura) Trial met its 1EP, showing atogepant was superior to PBO for pain freedom at 2hrs. in the first treated migraine attack (with or without aura; 24.3%…

ByRidhi RastogiDecember 1, 2025

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Gan & Lee Pharmaceuticals Initiates P-III (GRADUAL-3) Trial of Bofanglutide for Weight Management

Shots: Gan & Lee Pharmaceuticals has initiated a P-III (GRADUAL-3) study of bofanglutide (GZR18) in adults with obesity or overweight The trial will assess the safety & efficacy of bofanglutide (SC, Q4W) in obese or overweight pts for 24wks., while evaluating the change and the percentage change from baseline in body weight at 24wk. as…

ByRidhi RastogiNovember 28, 2025

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Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Shots: Innocare has dosed the first patient in the global P-II trial of Soficitinib (ICP-332) for the treatment of pts with prurigo nodularis in China Soficitinib was also evaluated in the P-II trial for mod. to sev. atopic dermatitis, which showed superior efficacy & favorable safety, with data presented at the AAD’25 Soficitinib, a selective…

ByRidhi RastogiNovember 28, 2025

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Celltrion Reports Post-Hoc Analysis of P-III (LIBERTY-CD) Trial of Zymfentra (Infliximab-dyyb) in Crohn’s Disease Across Disease Locations

Shots: Celltrion has reported post-hoc analysis of the P-III (LIBERTY-CD) study of Zymfentra (infliximab-dyyb; SC) vs PBO in pts with mod. to sev. Crohn's disease, which has been published in the Clinical Gastroenterology and Hepatology Among 329 pts, 52.6% had colon-dominant (n=173) & 47.4% ileum-dominant CD (n=105); at Wk. 54, infliximab SC showed superior efficacy…

ByRidhi RastogiNovember 27, 2025

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Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Shots: Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026 Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety Additionally,…

ByRidhi RastogiNovember 26, 2025

Nurix Therapeutics Presents New Data from P-I of Bexobrutideg (NX-5948) in Relapsed/Refractory CLL at ASH’25

CARsgen Therapeutics Presents Trial Data of CT0596 for Relapsed/Refractory Multiple Myeloma (R/R MM) at ASH’25

Capricor Therapeutics Reports the Topline P-III (HOPE-3) Trial Data on Deramiocel for Duchenne Muscular Dystrophy

Imvax Reports P-IIb Trial Findings on IGV-001 to Treat Newly Diagnosed Glioblastoma

Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Gan & Lee Pharmaceuticals Initiates P-III (GRADUAL-3) Trial of Bofanglutide for Weight Management

Innocare Doses First Patient in P-II Trial of Soficitinib for Prurigo Nodularis in China

Celltrion Reports Post-Hoc Analysis of P-III (LIBERTY-CD) Trial of Zymfentra (Infliximab-dyyb) in Crohn’s Disease Across Disease Locations

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

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