Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

Shots: The global P-II (VALIANT) trial data assessed Verekitug vs PBO in 478 pts with severe asthma for ~60wks., with a minimum of 24wks. of treatment. Eligible pts could then enroll in the VALOUR LTE trial Trial met its 1EP, reducing annualized asthma exacerbation rates by 56% (100mg; Q12W) & 39% (400mg, Q24W), with FEV1…

ByRidhi RastogiFebruary 11, 2026

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OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Shots: OrsoBio has reported topline P-IIa PoC trial data assessing TLC-2716 (6 or 12mg, QD, PO) vs PBO in 30 overweight pts with severe hypertriglyceridemia & metabolic dysfunction–associated steatotic liver disease (MASLD) The study met its 1EP, showing statistically significant reductions in fasting triglycerides & remnant cholesterol, plus improved liver fat by MRI-PDFF, with stronger lipid…

ByRidhi RastogiFebruary 11, 2026

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Zenas BioPharma Presents P-II (MoonStone) Trial Data on Obexelimab in Relapsing Multiple Sclerosis (RMS) at ACTRIMS Forum 2026

Shots: The P-II trial of obexelimab (250mg, SC, QW) vs PBO in RMS, met its 1EP with a 95% relative reduction in cumulative new Gd-enhancing T1 lesions over wks. 8 & 12, with near-complete suppression by wk. 8 sustained through wk. 12. Adjusted mean new lesions was 0.01 vs 0.23, only 2 vs 19 total…

ByRidhi RastogiFebruary 10, 2026

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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…

ByRidhi RastogiFebruary 9, 2026

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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…

ByRidhi RastogiFebruary 9, 2026

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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…

ByRidhi RastogiFebruary 6, 2026

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Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma

Shots: Daiichi Sankyo has dosed the first patient with DS3790 in the P-I/II trial for pts with r/r B-cell non-Hodgkin lymphoma The trial will assess DS3790 in ~420 pts with r/r B-cell NHL, evaluating safety endpoints as well as efficacy endpoints incl. overall response, DCR, DoR, time to response, PFS, & OS DS3790 is a…

ByRidhi RastogiFebruary 5, 2026

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Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

Shots: Assessing PF’3944 (QW titration to QM) in obese/overweight pts without T2D, the trial randomized pts to Arm 1 (0.4mg QW/ 0.8mg QW/ 3.2mg QM), Arm 2 (0.8mg QW/ 3.2mg QM), Arm 3 (0.4mg QW/ 0.8mg QW/ 1.2mg QW/ 4.8mg QM), Arm 4 (0.6mg QW/ 1.2mg QW/ 4.8mg QM), or Arm 5 (PBO) Trial met…

ByRidhi RastogiFebruary 4, 2026

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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

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…

ByRidhi RastogiJanuary 29, 2026

Upstream Bio Reports Topline P-II (VALIANT) Trial Data on Verekitug in Severe Asthma

OrsoBio Reports P-IIa Trial Data on TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease

Zenas BioPharma Presents P-II (MoonStone) Trial Data on Obexelimab in Relapsing Multiple Sclerosis (RMS) at ACTRIMS Forum 2026

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

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

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

Daiichi Sankyo Reports First Patient Dosing in P-I/II Trial of DS3790 for R/R B-Cell Non-Hodgkin Lymphoma

Pfizer Reports P-IIb (VESPER-3) Trial Results on PF’3944 in Weight Management

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

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