J&J(JNJ) ZACKS·2025-01-09 14:35Johnson & Johnson's MedTech Unit - Johnson & Johnson's MedTech unit has temporarily paused sales of Varipulse, its pulsed field ablation (PFA) therapy for atrial fibrillation (AFib) in the United States, due to four reported cases of neurovascular events [1] - The pause on Varipulse procedures began on Jan 5, 2024, and does not impact the rollout in markets outside the United States [1][2] - Since the external rollout began until Jan 3, 2024, Johnson & Johnson completed more than 130 cases across 14 sites in the United States [2] - Globally, Johnson & Johnson has completed over 3,000 commercial cases of the Varipulse PFA system [2] Market Reaction - Johnson & Johnson's shares slipped around 2.8% on Wednesday following the announcement of the pause [2] - In the past year, Johnson & Johnson's shares have declined 12.1%, compared to the industry's 2.9% decrease [2] - Shares of rivals Boston Scientific (BSX) and Medtronic (MDT) rose 4.3% and 3.5%, respectively, as they also offer PFA systems in the United States [4] - Medtronic's PulseSelect PFA device was approved in the United States in December 2023, while Boston Scientific's Farapulse device was approved in January 2024 [4] FDA Fast Track Designation - The FDA has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb), for the treatment of early Alzheimer's disease [5] - The FDA had earlier granted Fast Track status to Johnson & Johnson's another candidate, JNJ-2056, an anti-tau active immunotherapy for treating preclinical Alzheimer's disease in July 2024 [5] - Both posdinemab and JNJ-2056 are being developed in phase IIb studies [5] Bristol-Myers Squibb (BMY) - In the past 60 days, estimates for Bristol-Myers' 2025 earnings have risen from 7.19 per share [7] - In the past year, shares of Bristol-Myers have risen 12.2% [7] - Bristol-Myers' earnings beat estimates in each of the trailing four quarters, with an average surprise of 15.54% [7]