已收盘 11-13 16:00:00 美东时间
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Celcuity Inc. announced that the FDA has accepted its supplemental New Drug Application (sNDA) for REVTORPYK™ (gedatolisib) to treat HR+/HER2- locally advanced or metastatic breast cancer (ABC) with a <em>PIK3CA</em> mutation. The FDA assigned a PDUFA goal date of June 25, 2027. The submission is based on clinical data from the <em>PIK3CA</em> mutant cohort of the Phase 3 VIKTORIA-1 trial. If approved, REVTORPYK would become available as a second...
11-09 13:30
Nuwellis, Inc. (Nasdaq: NUWE) will report financial results for the third and first nine months of 2026 before U.S. markets open on November 12, 2026. A conference call will follow at 9:00 a.m. Eastern time. The call can be accessed via phone or webcast, with details provided. Nuwellis focuses on medical technology solutions for cardiorenal conditions.
11-04 13:30
<p>MINNEAPOLIS, Nov. 03, 2026 -- Inspire Medical Systems, Inc. announced that its management team will present at the Stifel 2026 Healthcare Conference on November 10, 2026, at 2:40 p.m. Eastern Time. The presentation will be available via live webcast and a replay will be accessible for two weeks post-event on Inspire’s Investor website. Inspire, a medical technology company, focuses on developing innovative solutions for obstructive sleep apnea...
11-03 21:05
OneMedNet Corporation announced a high six-figure add-on order under its September 2026 agreement, increasing data volume by 150% to support a customer's derivative data offering. The customer, leveraging OneMedNet's de-identified, multimodal clinical data, aims to train AI models and develop a licensable dataset. The order reflects the customer's need for additional data within weeks of the initial agreement. OneMedNet's data, sourced from over ...
11-03 13:40
CVRx, Inc. announced that its management team will participate in two investor conferences: the Canaccord Genuity Medtech, Diagnostics & Digital Health Services Forum in New York on Nov. 11, 2026, and the Jefferies Global Healthcare Conference in London on Nov. 19, 2026. Both events will be available via webcast. CVRx, a medical device company, focuses on developing neuromodulation solutions for cardiovascular diseases, including Barostim, an FDA...
11-02 21:01
Nuwellis, Inc. announced the publication of a study in *Pediatric Nephrology* highlighting the effectiveness of its Aquadex SmartFlow® System in pediatric patients, including infants weighing less than 10 kg. The ULTRA-Peds Registry evaluated 91 pediatric patients across seven hospitals, demonstrating 87% survival and 86.5% uninterrupted procedures. The study provides clinical evidence to support expanding Aquadex's FDA-cleared labeling for patie...
10-27 12:00
Park Dental Partners, Inc. announced it will release its Q3 2026 financial results after market close on November 12, 2026. A conference call to discuss the results will be held the next day at 8:30 a.m. ET (7:30 a.m. CT). The call can be accessed via webcast or phone, with replay available on the company's website. Park Dental Partners, based in Roseville, MN, provides comprehensive support services to its affiliated dental practices, with 222 d...
10-26 20:13
Clearfield, Inc. announced that CEO Cheri Beranek will retire effective March 31, 2027, and will transition to an emeritus role. The Board of Directors will begin the search for her successor, considering both internal and external candidates. Beranek has led Clearfield for two decades, driving growth and innovation. The company remains on track for its financial targets and expects to report Q4 and full-year 2026 results on November 10, 2026.
10-20 11:00
Anteris Technologies Global Corp. has received regulatory clearance from the German Federal Institute for Drugs and Medical Devices (BfArM) for its DurAVR® Transcatheter Heart Valve global pivotal trial (PARADIGM Trial) for patients with severe calcific aortic stenosis. This approval allows the company to begin patient recruitment in leading German centers, enhancing the trial's European presence. Germany, with its extensive TAVR infrastructure a...
10-20 01:12