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CSL Reports P-IIIb Trial Data on Andembry for HAE
Shots: CSL has reported topline P-IIIb results evaluating Andembry (garadacimab-gxii) in children aged 2 to 11yrs. with hereditary angioedema (HAE) Pts aged 6–11 years received 100mg (QM, n=16), while those aged 2–5yrs. received 100mg (Q2M, n=6). Andembry showed a favorable safety profile & treatment response, with most pts remaining attack-free over 12mos. Full results will be…
July 28, 2026
Innocare Pharma
InnoCare Reports P-III Trial Findings on Fadeucravacitinib in Plaque Psoriasis
Shots: InnoCare has reported a P-III trial assessing the efficacy, safety & tolerability of fadeucravacitinib (ICP-488) vs PBO in pts with moderate-to-severe plaque psoriasis Trial met its 1EP with statistically significant & clinically meaningful improvement, while also achieving multiple 2EPs, demonstrating consistent efficacy across measures; data to be presented & published in the future Fadeucravacitinib…
July 28, 2026
ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV
Shots: ViiV has reported P-IIIb (VOGUE) study data assessing Dovato (DTG/3TC; n=254) vs Biktarvy (BIC/FTC/TAF; n=255) in 509 treatment-naïve adults living with HIV-1, where treatment was initiated before the availability of baseline resistance testing results At baseline, 47% pts had HIV-1 RNA ≥100,000 copies/mL, 16% had ≥500,000 copies/mL, & 16% had CD4+ counts <200 cells/mm³. At Wk.…
July 28, 2026
Roche
Roche Reports CHMP Positive Opinion for Susvimo to Treat nAMD
Shots: The CHMP has recommended Susvimo (100mg/mL) for the treatment of neovascular age-related macular degeneration (nAMD) The opinion was based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal), where Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to Lucentis (QM, IVT), with Portal showing maintenance of vision up…
July 27, 2026
argenx to Acquire Forte Biosciences for $2.2B
Shots: argenx has entered into a definitive agreement to acquire Forte Biosciences, strengthening argenx’s innovative immunology portfolio with FB102 As per the deal, argenx will acquire Forte Biosciences for $77/share in cash, representing a total equity value of ~$2.2B; closing is expected in Q3’26 FB102 is an anti-CD122 antibody showing clinical PoC in vitiligo & celiac disease, with…
July 27, 2026
NewAmsterdam and Menarini Report the CHMP Positive Opinion for Ubeslo and Evlarco for Primary Hypercholesterolemia
Shots: The CHMP has recommended Ubeslo (obicetrapib 10mg) & Evlarco (10mg obicetrapib + 10mg ezetimibe FDC) for pts with primary hypercholesterolemia, both HeFH & non-familial or mixed dyslipidemia; EC decision expected in H2’26 & will be valid across 30 EEA states Opinion was supported by extensive clinical data assessing obicetrapib, incl. the P-III (BROADWAY, BROOKLYN…
July 27, 2026
Otsuka Reports the US FDA Approval for Simtriyo to Treat ADHD
Shots: The US FDA has approved Simtriyo (centanafadine) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pts (≥6yrs.; ≥20kg), with availability expected later this year following scheduling by the US DEA Approval was supported by 4 P-III trials assessing Simtriyo vs PBO in children, adolescents, & adults with ADHD In two adult studies, both Simtriyo dose groups…
July 27, 2026
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