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Regulatory

AMPX

Amprius Technologies (NYSE:AMPX) has received approval from the Brighton City Council to rezone a 103-acre site for its next-generation lithium-ion battery manufacturing. The company plans to transform Colorado's largest single-story industrial building into a state-of-the-art lithium-ion battery manufacturing facility. The factory is expected to increase Amprius' manufacturing capacity, with an initial 500 MWh and the potential of up to 5 GWh. The company plans to create over 300 new local jobs and invest $190M in Phase 1.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:36 pm

NNOX

Nanox.AI, a subsidiary of NANO-X Imaging, has revealed that its HealthCCSng AI solution identified a previously undetected risk of a cardiovascular event in approximately 60% of patients in a study. The study, conducted by Beilinson Hospital in Israel, used routine chest CT scans to assess the impact of AI-based coronary artery calcium (CAC) measurements. The majority of patients needed further evaluation and treatment.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:35 pm

IINN

Inspira Technologies (NASDAQ:IINN) has announced the unveiling of its INSPIRA ART line of medical devices at the Extracorporeal Life Support Organization (ELSO) Conference. The line includes the INSPIRA ART100, a cardio-pulmonary bypass device, and the INSPIRA ART500, a device designed to provide acute respiratory support. The INSPIRA ART100 is expected to receive FDA clearance in the first half of 2024. Inspira has also entered into a collaboration with Perfusion Solution, Inc., a U.S. based company that provides advanced medical devices.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:34 pm

BMEA

Biomea Fusion, Inc. (NASDAQ:BMEA) has received clearance from the FDA and Health Canada to initiate the expansion portion of the COVALENT-111 Phase II study. The study will evaluate BMF-219, a novel covalent small molecule, in type 2 diabetes patients. The expansion will consist of approximately 300 patients and will begin to enroll three cohorts immediately. Topline results of the escalation portion are anticipated in Q4 2023.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:32 pm

IMNN

IMUNON has reported interim progression-free survival and overall survival data in its Phase 1/2 OVATION 2 study in advanced ovarian cancer. The intent-to-treat population showed a 9-month overall survival improvement over the control arm. A subgroup of patients treated with IMNN-001 + PARPi showed a meaningful progression-free survival and overall survival trend compared with the control arm. Continued follow-up is indicated to confirm initial observations.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:32 pm

SPY

The U.S. Core PCE Prices for Q2 came in at 3.70%, matching the forecast and lower than the previous 4.90%.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:32 pm

AAPL

GOOG

GOOGL

The ongoing antitrust case against Alphabet Inc's Google, involving Apple Inc, has been criticized for being conducted largely behind closed doors. The Justice Department accuses Google of using agreements with Apple and other phone manufacturers to stifle competition among search engines. The trial could potentially impact Google's future business practices or even result in a company breakup.

Portfolio Pulse from Vandana Singh

September 28, 2023 | 12:30 pm

BNOX

Bionomics Limited (NASDAQ:BNOX) announced positive results from its Phase 2b ATTUNE trial of BNC210 for post-traumatic stress disorder (PTSD). The trial met its primary endpoint and showed significant improvements in depressive symptoms and sleep. The company also held a Phase 3-enabling End-of-Phase 2 meeting with the FDA to advance BNC210 for the acute treatment of social anxiety disorder. BNOX shares are up 387.30% at $4.80 during the premarket session.

Portfolio Pulse from Vandana Singh

September 28, 2023 | 12:24 pm

DYNT

Dynatronics Corp's John Krier will continue as an executive consultant and interim CFO while the company continues its search for a permanent Chief Financial Officer, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:23 pm

DYNT

Brian Baker will assume the roles of Chief Executive Officer at Dynatronics Corp effective October 1, 2023, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:23 pm