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Eli lilly

Eli Lilly Reports the P-Ib (Heart-2) Trial Data on VERVE-102 as a One-Time Treatment for Hypercholesterolemia

Shots: Trial assessed Lilly's VERVE-102 (IV; 0.3, 0.45, 0.6, 0.7, 0.8 & 1mg/kg) in 35 adults with HeFH or premature coronary artery disease who required additional LDL-C lowering despite maximally tolerated oral lipid-lowering therapy Single infusion of VERVE-102 led to dose-dependent PCSK9 reductions of 51% (0.3mg/kg) to 88% (1mg/kg), with corresponding mean LDL-C reductions of…

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Astrazeneca

AstraZeneca Reports the US FDA Approval of Baxfendy (Baxdrostat) To Treat Hard-to-Control Hypertension

Shots: The US FDA has approved AstraZeneca's Baxfendy in combination with other antihypertensive medications for the treatment of pts with uncontrolled or treatment-resistant hypertension  Approval was supported by the P-III (BaxHTN) trial assessing baxdrostat (1 or 2mg, QD, PO) vs PBO on top of SoCs in 796 pts with uncontrolled or treatment-resistant hypertension  Trial met…

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Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals Receives the CHMP’s Positive Opinion for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The CHMP has recommended Arrowhead's Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS; EC’s decision is expected in Q2’26  Opinion was supported by the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts could join a…

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ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients

Shots: The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…

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Cytokinetics Reports the EC Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The EC has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic (NYHA, class II-III) oHCM, with first EU launch expected in Germany by Q2’26 Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen uptake by…

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Natera Seeks US FDA Approval for Signatera Cdx To Support MRD-Guided Treatment in Bladder Cancer

Shots: The US FDA has received a premarket approval (PMA) application of Signatera CDx for the detection of molecular residual disease (MRD) in pts with muscle-invasive bladder cancer (MIBC) who may benefit from treatment with Tecentriq (atezolizumab) Submission was supported by the P-III (IMvigor011) trial, which met its 1EP & showed that Signatera-guided therapy improved…

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Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals Receives the Health Canada Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: Health Canada has approved Redemplo as an adjunct to diet to reduce triglycerides (TGs) in adults with FCS who had an inadequate response to standard triglyceride lowering therapies Approval was based on the P-III (PALISADE) trial assessing Redemplo (25mg & 50mg, SC, Q3M) vs PBO in 75 adults with genetically confirmed/clinically diagnosed FCS. Pts…

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Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic oHCM, available in second half of Jan 2026 through a restricted program via REMS Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen…

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