Shots:
The FDA has granted De Novo classification to Cardiosense's PCWP Analysis Software to noninvasively estimate pulmonary capillary wedge pressure (PCWP) in adults with heart failure with reduced ejection fraction (HFrEF), incl. those with LVEF ≤40% & NYHA Class II, III & IV symptoms
The Software integrates its CardioTag wearable sensor with AI to…
Shots:
The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026
NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…
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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 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…
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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D&D Pharmatech has reported the topline P-II (DD01-DN-02) trial data assessing zabopegdutide (DD01) vs PBO in 67 overweight/obese pts with MASH & significant liver fat across the US, which met its all 3 key histological EPs
Pts received a 2wk. 20mg titration followed by maintenance dosing of DD01 (40mg, QW) or PBO; the Wk.…
Shots:
Myriad Genetics to launch the Prolaris + AI Test, with the new AI metric available for all Prolaris Biopsy Tests in the US from May 29, 2026 excl. New York; approval in NY is expected soon
A validation study of 998 pts for model training & 296 pts for validation, demonstrated that AI-GUR independently…
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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…
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…
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…

