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Abbvie

AbbVie Reports the US FDA Approval for Decnupaz to Treat Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

Shots: The US FDA has approved AbbVie's Decnupaz (pivekimab sunirine-pvzy) for the treatment of adults with BPDCN Approval was supported by the global P-I/II (CADENZA) trial in 84 pts with CD123+ hematologic malignancies, incl. BPDCN, where pts received Decnupaz in both frontline (n=33) & relapsed/refractory (R/R) settings (n=51) without active CNS disease  Trial reported a 69.7% composite…

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Apogee Therapeutics Secures Up to $1.3B Financing from Blackstone to Advance Zumilokibart

Shot: Apogee will receive ~$1.3B in flexible, non-dilutive capital from Blackstone, incl. ~$800M of synthetic royalty & ~$500M in senior debt available at the mutual consent of both parties, to support the late-stage development & potential commercialization of zumilokibart Blackstone will provide ~$800M in synthetic royalty funding to Apogee in exchange for 15-year tiered royalties…

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Junshi Biosciences Reports P-III (NEOTORCH) Trial Results on Toripalimab + CT for Resectable Stage II-III NSCLC

Shots: Junshi Biosciences has reported the final analysis from the P-III (NEOTORCH) trial assessing toripalimab + Pt-containing doublet CT vs PBO + CT as perioperative treatment in 501 pts with resectable stage II-III NSCLC pts Trial improved EFS, with mEFS not reached vs 15.1mos. for CT alone, reducing risk of recurrence, progression, or death by 60%,…

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TOBY Secures US FDA Breakthrough Device Designation for Urine-Based Alzheimer’s Disease Test

Shots: The US FDA has granted BDD to the TOBY Test for diagnosing Alzheimer’s disease in adults (≥50yrs.) with signs and symptoms of cognitive impairment undergoing evaluation for Alzheimer’s disease The TOBY Test is a non-invasive urine-based diagnostic designed to aid Alzheimer’s disease diagnosis by analyzing urinary volatile organic compound patterns using mass spectrometry and…

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Sobi Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at EAS 2026

Shots: Sobi has reported pooled subgroup analysis (n=455) from P-III (CORE: n=617 & CORE2: n=446) trials assessing Tryngolza (olezarsen; 50 or 80mg, SC, Q4W) vs PBO in adults with severe hypertriglyceridemia (sHTG) & triglyceride (TG) levels ≥500 mg/dL Trial showed PBO-adjusted TG reductions of 66% (80mg) & 59% (50mg) at 6mos. in pts with TGs…

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Eli Lilly Builds Infectious Disease Pipeline With 3 Acquisitions Valued ~$3.8B

Shots: Eli Lilly will acquire 3 companies, Curevo, LimmaTech Biologics, & Vaccine Company, to build its infectious disease portfolio through differentiated vaccine & platform technologies The deals incl. Curevo’s P-II shingles vaccine candidate amezosvatein, LimmaTech’s P-I vaccine LTB-SA7 targeting S. aureus infections, & Vaccine Company’s preclinical EBV vaccine platform leveraging proprietary in vivo nanoparticle technology As…

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