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NEWS

Ionis and Roche Report Interim P-III (IMAgINATION) Trial Data on Sefaxersen in IgA Nephropathy (IgAN)

Shots: Ionis & Roche have reported interim P-III (IMAgINATION) trial results assessing sefaxersen (QM, SC) in 459 adults with IgAN for 105wks., after which eligible pts may switch to open-label treatment IMAgINATION met its 1EP, showing improvements in proteinuria reduction at 37wks., as measured by 24hr. UPCR; data to be presented in future & shared with…
September 23, 2026

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Amgen
NEWS

Amgen Reports Topline P-III (OASIZ 301) Trial Data on Dazodalibep for Systemic Sjögren’s Disease

Shots: Amgen has reported topline P-III (OASIZ 301) trial results evaluating dazodalibep vs PBO in adults (n=~621) with Sjögren's disease with mod. to sev. systemic disease activity (ESSDAI ≥ 5) Trial met its 1EP, showing statistically significant & clinically meaningful improvement at Wk. 48, as measured by the ESSDAI, with benefits seen as early as…
September 23, 2026

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NEWS

Envisagenics and Boehringer Ingelheim Sign >$1B Cancer Drug Development Deal

Shots: Envisagenics has entered a multi-year research collaboration & option agreement with BI to validate tumor-specific targets for developing first-in-class precision therapies for solid tumors, using Envisagenics’ AI-powered SpliceCore platform  Collaboration builds on targets identified through SpliceCore to validate their potential across ADCs, TCEs & multispecific Abs, with BI having an option to exclusively license…
September 23, 2026

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Roche
NEWS

Roche Reports EC Approval of Susvimo to Treat nAMD

Shots: The EC has approved Susvimo (ranibizumab 100mg/mL solution for injection) for the treatment of neovascular age-related macular degeneration (nAMD), based on the 3 studies, P-III (Archway), P-II (LADDER) & open-label LTE study (Portal) Archway showed Susvimo (refilled in Q6M) maintained vision improvements equivalent to ranibizumab (QM, IVT), with Portal showing maintenance of vision up…
September 22, 2026

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NEWS

BoomRay Inks a ~$900M Deal with Novartis for a Novel RLT Asset

Shots: Boomray Pharmaceuticals has entered into an exclusive global license agreement with Novartis for an undisclosed preclinical radioligand therapy (RLT) asset As per the deal, BoomRay will receive ~$900M, incl. an upfront payment as well as development, regulatory, & sales milestone payments, with royalties on future global net sales Agreement combines BoomRay’s discovery & development capabilities…
September 22, 2026

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NEWS

Johnson & Johnson Reports the EC Approval of Icotyde (Icotrokinra) to Treat Plaque Psoriasis (PsO)

Shots: The EC has approved Icotyde for the treatment of pts (≥12yrs., ≥40kg) with mod. to sev. plaque PsO who are candidates for systemic therapy Approval was backed by P-III (ICONIC-TOTAL, ICONIC LEAD, ICONIC-ADVANCE 1 & 2) trials, where Icotyde met all 1EP across all 4 trials (n=2,500). In the head-to-head studies, ~70% pts achieved IGA 0/1 & 55%…
September 22, 2026

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NEWS

Corcept Therapeutics Reports the CHMP Positive Opinion of Lifyorli (Relacorilant) to Treat Platinum-Resistant Ovarian Cancer

Shots: The CHMP has recommended Lifyorli (relacorilant) + nab-paclitaxel for the treatment of patients with platinum-resistant ovarian cancer; EC decision is expected in Q4’26 Approval was backed by the P-II trial and P-III (ROSELLA) study assessing Lifyorli + nab-paclitaxel vs nab-paclitaxel alone in the above-mentioned pts (n=381) across the US, EU, South Korea, Brazil, Argentina, Canada…
September 21, 2026

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