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MannKind Reports Initiation of P-II (INHALE-1st) Trial of Afrezza in Pediatric Patients with Newly-Diagnosed Type 1 Diabetes

Shots: MannKind has enrolled the first patient in the P-II (INHALE-1st) trial assessing initiation of Afrezza(insulin human) Inhalation Powder in pediatric pts shortly after their type 1 diabetes diagnosis Trial will evaluate Afrezza over 13wks., followed by an optional extension phase for pts continuing to use Afrezza with basal insulin up to 26wks., assessing the proportion…
February 9, 2026

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NEWS

Genentech Presents the P-III (FENtrepid) Trial Data on Fenebrutinib for Primary Progressive Multiple Sclerosis (PPMS) at ACTRIMS Forum 2026

Shots: Genentech has reported the P-III (FENtrepid) trial data assessing fenebrutinib (QD, PO) with IV Ocrevus-matching PBO vs Ocrevus & oral fenebrutinib-matching PBO in 985 adults with PPMS Trial met its 1EP, showing a 12% reduction in disability progression (cCDP12) with curves separating by wk. 24 & consistent benefit across subgroups & duration. The strongest effect was…
February 9, 2026

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Bayer
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Bayer Reports P-III (OCEANIC-STROKE) Trial Data on Asundexian for Secondary Stroke Prevention

Shots: The P-III (OCEANIC-STROKE) trial assessed asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,327) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack Trial showed a 26% reduction in recurrent ischemic stroke without increased ISTH major bleeding across all subgroups, met key…
February 6, 2026

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NEWS

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…
January 29, 2026

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Roche
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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…
January 28, 2026

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NEWS

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…
January 27, 2026

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