NEWS

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…

February 11, 2026

Madrigal Pharmaceutical Forges ~$4.46B siRNA Deal with Ribo Life Science to Expand Genetically Targeted MASH Pipeline

Shots: Madrigal has entered into an exclusive global license agreement with Suzhou Ribo Life Science & its subsidiary Ribocure Pharmaceuticals for 6 preclinical siRNA programs in metabolic dysfunction-associated steatohepatitis (MASH) The deal allows Madrigal to pair a targeted gene-silencing siRNA approach with Rezdiffra to assess whether genetically reducing disease drivers can enhance its therapeutic impact,…

February 11, 2026

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…

February 11, 2026

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…

February 11, 2026

THX Pharma Grants Biocodex Licenses for Batten-1 and TX01 in Rare Diseases

Shots: THX has granted Biocodex an exclusive global license to develop & commercialize Batten-1 for juvenile Batten disease (CLN3), along with exclusive US & Canada rights to develop & commercialize TX01 for Gaucher & Niemann-Pick type C disease As per the deal, THX will lead clinical development with financial & scientific support from Biocodex, which will…

February 11, 2026

Insilico Medicine and CMS Enter Multiple Collaborations to Advance Therapeutics in CNS and Autoimmune Indications

Shots: Insilico Medicine has entered into multiple AI-powered drug discovery collaborations with CMS, focusing on advancing therapeutic programs across CNS & autoimmune disease indications As per the deal, Insilico will leverage its Pharma.AI platform for target discovery & small-molecule design & optimization, while CMS will lead clinical development, regulatory strategy, trials, & commercialization Under the…

February 11, 2026

Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

Shots: The US FDA has granted RMAT Designation to KB707 for the treatment of advanced or metastatic NSCLC Designation was supported by the ongoing P-I/II (KYANITE-1) trial assessing KB707 (administered via nebulization) across 7 cohorts: Arms 1-4 as monotx., Arm 5 with Keytruda, Arm 6 with Keytruda & CT & Arm 7 with CT alone…

February 10, 2026

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…

February 10, 2026

Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Shots: The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26 NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…

February 10, 2026

NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

Shots: The Chinese NMPA has accepted the application of Arexvy RSV vaccine for the prevention of LRTD caused by respiratory syncytial virus (RSV) in adults aged ≥60yrs.; regulatory decision is expected by 2027 Submission was based on extensive clinical data, incl. results from the P-III trial assessing safety & immunogenicity of Arexvy in adults (≥60yrs.)…

February 10, 2026

NEWS

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

Madrigal Pharmaceutical Forges ~$4.46B siRNA Deal with Ribo Life Science to Expand Genetically Targeted MASH Pipeline

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

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

THX Pharma Grants Biocodex Licenses for Batten-1 and TX01 in Rare Diseases

Insilico Medicine and CMS Enter Multiple Collaborations to Advance Therapeutics in CNS and Autoimmune Indications

Krystal Biotech’s KB707 Receives the US FDA RMAT Designation to Treat Advanced or Metastatic NSCLC

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

Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

NMPA Accepts GSK’s Arexvy Submission to Prevent Lower Respiratory Tract Disease in Adults

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