Shots:
Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks.
Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…
NEWS
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Merck has highlighted P-III (CORALreef HeFH) trial data assessing enlicitide decanoate (20mg, PO, QD) vs PBO in 303 adults with HeFH at AHA’25
Trial showed significant LDL-C reductions (1EP), along with decreases in non-HDL-C (53%), ApoB (49.1%), & Lp(a) (27.5%) at Wk. 24 in HeFH pts on stable background lipid-lowering therapy. High adherence (97%) &…
Shots:
The US FDA has received the BLA seeking accelerated approval of atacicept for treating adults with immunoglobulin A nephropathy (IgAN), with the FDA’s decision expected in 2026
The BLA is supported by the ongoing global P-III (ORIGIN 3) trial evaluating atacicept (150mg, SC, QW) vs PBO in 431 adults with IgAN, assessing eGFR-based kidney…
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SanegeneBio has entered into a global research & licensing deal with Eli Lilly to advance RNAi candidates for metabolic diseases, leveraging SanegeneBio’s LEAD (Ligand & Enhancer Assisted Delivery) tech
Under the deal, SanegeneBio will discover & identify LEAD-based RNAi molecules for each program, while Lilly will oversee IND-enabling studies, clinical development, & commercialization; the…
Shots:
The P-III (CORE: n=617 & CORE2: n=446) trials assessed olezarsen (50 or 80mg, SC, Q4W) vs PBO for 12mos. in sHTG adults; the US FDA’s sNDA filing is expected by 2025 end
Both trials met their 1EP with ~72% PBO-adjusted fasting triglyceride (TG) reduction at 6mos., sustained to 12mos., while 89% (50mg) & 88%…
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AstraZeneca has reported P-III (NATRON) trial data assessing Fasenra (30mg, SC, Q4W) vs PBO, both in addition to background HES therapy in 133 HES pts for 24wks.
Trial met its 1EP of delayed time to first HES worsening or flare & reduced the risk of HES worsening/flare by 65%
Trial met all 2EPs, showing…
Shots:
Metsera announced entering into an amended merger agreement with Pfizer to acquire Metsera for up to $86.25 per share, including $65.60 in cash and a contingent value right of up to $20.65
Metsera’s Board of Directors noted that the U.S. Federal Trade Commission had raised potential antitrust concerns regarding Novo Nordisk’s proposed structure
After…
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Nitinotes has received CE Mark approval for its EndoZip System for endoscopic sleeve gastroplasty (ESG)
EndoZip automates suturing, transforming ESG into a single-physician, scalable, fast outpatient procedure with improved efficiency & reproducibility compared to manual systems requiring dual operators & longer procedure times
The company has planned to launch EndoZip in select EU centers &…
Shots:
The US FDA has approved Caplyta as an adjunctive therapy with antidepressants for treating adults with major depressive disorder (MDD). An sNDA for schizophrenia relapse prevention is also submitted
Approval was based on 2 P-III (Study 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant in MDD pts
Trial…
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The UK’s MHRA has approved Gobivaz (50mg/0.5mL & 100mg/mL in PFS & autoinjector), a biosimilar version of Simponi (golimumab) for the treatment of rheumatoid arthritis, PsA, axial spondylarthritis & ulcerative colitis in adult pts & juvenile idiopathic arthritis, following CHMP’s positive opinion
Additionally, Alvotech is responsible for the development & commercial supply of Gobivaz, while…

