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NEWS

IntraBio Reports Topline P-III (IB1001-303) Trial Data on Aqneursa for Ataxia-Telangiectasia

Shots: IntraBio has reported the topline P-III (IB1001-303) trial data on Aqneursa (levacetylleucine) vs PBO in pediatric & adult pts with Ataxia-Telangiectasia (A-T) Trial met the 1EP with a significant –1.88 SARA improvement vs PBO (–1.92 vs –0.14) after 12wks.& achieved 2EPs, showing meaningful gains on ICARS (–4.22 vs –1.69) & CGI-I (–0.6 vs –0.2)…
January 22, 2026

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Telix Pharmaceuticals
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Telix Reports First US Patient Dosing in the P-III Trial of Illuccix and Gozellix, for the Diagnosis of Prostate Cancer

Shots: The company has reported dosing of the first patient in the US  P-III (BiPASS) trial evaluating its PSMA-PET imaging agents, Illuccix and Gozellix, for use in the initial diagnosis of prostate cancer BiPASSa P-III study enrolling 250 pts in the US and Australia to support marketing authorization of 68Ga-PSMA-PET in the pre-biopsy setting Building…
January 19, 2026

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J&J
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Johnson & Johnson Highlights Clinical Data on Caplyta (Lumateperone) for Major Depressive Disorder (MDD) at ACNP 2026

Shots: Data from the OLE 503 study of Caplyta & pooled results from P-III (Studies 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant, in adults with MDD presented at ANCP’26 Pooled data showed higher remission (MADRS ≤10) with treatment at 6wks. (25.5% vs 13.6%), with complete remission (MADRS ≤5) in 10.6%…
January 19, 2026

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Abbvie
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AbbVie Reports Topline P-III (EPCORE DLBCL-1) Trial Data on Epcoritamab for R/R Diffuse Large B-cell Lymphoma (DLBCL)

Shots: AbbVie has reported topline P-III (EPCORE DLBCL-1) trial results assessing epcoritamab vs chemoimmunotherapy (R-GemOx or BR) in 483 adults with r/r DLBCL, who had received ≥1L of therapy (73% had received ≥2L) & were ineligible for HDT-ASCT Trial showed improved PFS, with improvements across CRR, DoR, & time to next treatment, plus the study did not…
January 19, 2026

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NEWS

ImmunityBio Reports Positive Clinical Results of ANKTIVA Plus Checkpoint Inhibitors in NSCLC

Shots: ImmunityBio announced positive results from two clinical studies evaluating ANKTIVA (nogapendekin alfa inbakicept) in combination with checkpoint inhibitors (CPI) in non-small cell lung cancer (NSCLC), demonstrating statistically significant immune restoration across 151 pts In 1L NSCLC, the randomized QUILT-2.023 study showed a significant and sustained increase in absolute lymphocyte count (ALC) with ANKTIVA +…
January 15, 2026

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NEWS

J&J Reports P-III Trial Outcomes Showing Tecvayli Monotherapy Extends PFS and OS in R/R Multiple Myeloma

Shots: J&J has reported positive topline Phase III (MajesTEC-9) results demonstrating that Tecvayli (teclistamab) monotx. significantly outperformed SoC in r/r multiple myeloma The study included patients with 1–3 prior therapies, all previously treated with anti-CD38 antibodies and lenalidomide. Most patients were refractory to anti-CD38 mAbs (85%), lenalidomide (79%), and their last therapy (>90%). Tecvayli achieved…
January 15, 2026

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NEWS

Genethon Signs Worldwide Licensing Agreement with AskBio (Bayer AG) to Advance Gene Therapy for Pompe Disease

Shots: Genethon has entered into an exclusive, worldwide licensing agreement with AskBio for the use of a patented component of AskBio’s investigational gene therapy AB-1009 for the treatment of Pompe disease The licensed component is based on a transgene encoding a truncated form of GAA, developed by Genethon, which demonstrated preclinical efficacy in correcting glycogen…
January 14, 2026

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