Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

Shots: Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3 Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…

ByRidhi RastogiFebruary 3, 2026

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nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Shots: nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing Additionally, the company…

ByRidhi RastogiJanuary 29, 2026

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Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Shots: Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…

ByPrince GiriJanuary 28, 2026

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Neurocrine Biosciences Initiates P-II Study of NBI-1065890 to Treat Tardive Dyskinesia (TD) in Adults

Shots: Neurocrine Biosciences has initiated a P-II study of investigational NBI-1065890 in adults with TD P-II study of NBI-1065890 will enroll ~100 adults with TD, evaluating efficacy, safety, and tolerability, with the 1EP being change from baseline in Abnormal Involuntary Movement Scale (AIMS) total score at Wk 8 NBI-1065890 is a selective oral VMAT2 inhibitor…

ByDipanshu DixitJanuary 27, 2026

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Ascletis Reports First Participants Dosing in US P-II Study of ASC30 for Type 2 Diabetes

Shots: Ascletis Pharma reported that the first participants have been dosed in a US 13-week P-II study of ASC30, an oral small-molecule GLP-1 receptor agonist, for the treatment of type 2 diabetes mellitus, with topline data expected in Q3’26 The study will enroll ~100 pts and evaluate ASC30’s effects on HbA1c as a 1EP, and…

ByPrince GiriJanuary 27, 2026

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Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Shots: Crinetics has dosed the first patient with atumelnant in the P-II/III (BALANCE-CAH) trial for the treatment of classic congenital adrenal hyperplasia (CAH) in children & adolescents The study will evaluate atumelnant across 3 phases: a P-II semi-sequential dose-ranging Part A, followed by a P-III PBO-controlled Part B, & an OLE portion in Part C…

ByRidhi RastogiJanuary 23, 2026

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Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Shots: Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

ByRidhi RastogiJanuary 23, 2026

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Corcept Therapeutics Reports P-III (ROSELLA) Trial Data on Relacorilant for Platinum-Resistant Ovarian Cancer (PROC)

Shots: Corcept has reported P-III (ROSELLA) trial data assessing relacorilant (PO, GR antagonist) + nab-paclitaxel vs nab-paclitaxel in 381 pts with PROC Trial met its 1EP of OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.), & previously met its PFS endpoint with a 30% reduction in progression risk, as presented at…

ByRidhi RastogiJanuary 23, 2026

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IntraBio Reports Topline P-III (IB1001-303) Trial Data on Aqneursa for Ataxia-Telangiectasia

Shots: IntraBio has reported the topline P-III (IB1001-303) trial data on Aqneursa (levacetylleucine) vs PBO in pediatric & adult pts with Ataxia-Telangiectasia (A-T) Trial met the 1EP with a significant –1.88 SARA improvement vs PBO (–1.92 vs –0.14) after 12wks.& achieved 2EPs, showing meaningful gains on ICARS (–4.22 vs –1.69) & CGI-I (–0.6 vs –0.2)…

ByRidhi RastogiJanuary 22, 2026

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LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus

Shots: LEO Pharma has initiated P-III (DELTA CARE 1) trial assessing Anzupgocream vs cream vehicle for the treatment of adults with mild to sev. lichen sclerosus (LS) DELTA CARE 1 will enroll ~652 adults with LS, starting with 300 female pts for dose selection, followed by evaluation vs vehicle in ~352 additional female & male pts…

ByRidhi RastogiJanuary 21, 2026

Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Neurocrine Biosciences Initiates P-II Study of NBI-1065890 to Treat Tardive Dyskinesia (TD) in Adults

Ascletis Reports First Participants Dosing in US P-II Study of ASC30 for Type 2 Diabetes

Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Corcept Therapeutics Reports P-III (ROSELLA) Trial Data on Relacorilant for Platinum-Resistant Ovarian Cancer (PROC)

IntraBio Reports Topline P-III (IB1001-303) Trial Data on Aqneursa for Ataxia-Telangiectasia

LEO Pharma Initiates P-III (DELTA CARE 1) Trial of Anzupgo (Delgocitinib) for Lichen Sclerosus

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