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The US FDA has approved Keytruda/Keytruda Qlex + paclitaxel ± Avastin for the treatment of adults with PD-L1+ (CPS ≥1) Pt-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma, who have received 1 or 2 prior systemic therapy
Approval was based on the P-III (KEYNOTE-B96/ENGOT-ov65) trial data assessing Keytruda (400mg, IV, Q6W) with CT…
NEWS
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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…
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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,…
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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…
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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…
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…
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…
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…
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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…
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,…

