InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Shots: InnoCare has dosed the first patient with soficitinib (ICP-332) in the P-II/III trial for the treatment of chronic spontaneous urticaria Additionally, the company has completed enrolment in soficitinib’s P-III trial for mod. to sev. atopic dermatitis & P-II trial for vitiligo Soficitinib (ICP-332) is a selective TYK2 inhibitor in development for T-cell–mediated autoimmune diseases,…

ByRidhi RastogiFebruary 16, 2026

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Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Shots: Genentech has reported the P-III (MAJESTY) trial results assessing Gazyva vs tacrolimus in 142 pts with primary membranous nephropathy Trial met its 1EP, showing higher CR at Wk. 104 & achieved its key 2EPs, incl. improved overall remission & CR at Wks. 104 & 76, respectively; data to be presented in the future &…

ByRidhi RastogiFebruary 16, 2026

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Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

Shots: The US FDA has granted IND Clearance to initiate P-II PoC trial of AK3280 in the US for the treatment of idiopathic pulmonary fibrosis (IPF) The P-II PoC trial will evaluate AK3280 (PO) vs PBO & an active comparator in IPF pts, aiming to generate key clinical data to support future regulatory filings &…

ByRidhi RastogiFebruary 12, 2026

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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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Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

Shots: The Chinese NMPA has approved the initiation of P-II trials of AK139 across seven indications, incl. COPD, severe bronchial asthma, chronic spontaneous urticaria, allergic rhinitis, CRSwNP, mod. to sev. atopic dermatitis, & prurigo nodularis AK139 is an IL-4Rα/ST2 bispecific antibody that blocks both the IL-4/IL-13 pathway via binding to IL-4Rα subunit & the IL-33/ST2…

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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Eisai and Henlius Partner to Commercialize Serplulimab in Japan

Shots: Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties…

ByRidhi RastogiFebruary 6, 2026

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Evogene and Shanghai Lishan Biopharmaceuticals Partner for BMC128

Shots: Biomica (Evogene’s subsidiary) & Shanghai Lishan Biopharmaceuticals have entered into an exclusive worldwide licensing agreement for BMC128, currently in P-I trial As per the deal, Lishan Biotech will receive exclusive rights to develop, manufacture, & commercialize BMC128, with Biomica receiving development milestone payments & royalties on future commercial sales Lishan Biotech is planning to…

ByRidhi RastogiFebruary 5, 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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Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

Shots: The US FDA has granted BTD to zovegalisib + fulvestrant for the treatment of adults with PIK3CA mutant, HR+/HER2- locally advanced or metastatic breast cancer following recurrence or progression on or after treatment with a CDK4/6 inhibitor Designation was supported by P-I/II (ReDiscover) trial data of zovegalisib + fulvestrant ± CDK inhibitors, showing activity…

ByRidhi RastogiFebruary 4, 2026

InnoCare Pharma Reports First Patient Dosing in P-II/III Trial of Soficitinib for Chronic Spontaneous Urticaria

Genentech Reports P-III (MAJESTY) Trial Results for Gazyva in Primary Membranous Nephropathy

Ark Biopharmaceutical Receives the FDA IND Clearance to Initiate P-II Trial of AK3280 in Idiopathic Pulmonary Fibrosis

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

Akeso Receives NMPA Approval to Initiate P-II Trials of AK139 Across Seven Indications

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

Eisai and Henlius Partner to Commercialize Serplulimab in Japan

Evogene and Shanghai Lishan Biopharmaceuticals Partner for BMC128

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

Relay Therapeutics’ Zovegalisib Receives the US FDA Breakthrough Therapy Designation for PIK3CA-Mutant Advanced Breast Cancer

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