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Regulatory

TM

Toyota Motor Corp (NYSE:TM) is recalling 280,663 trucks and SUVs in the U.S. due to a software glitch causing unexpected vehicle movement. The recall affects Tundra, Tundra hybrids, Lexus LX600 models, and Sequoia SUVs. Toyota will provide a free software update to fix the issue. This marks Toyota's third major recall in the past year, following a 'Do Not Drive' advisory for exploding Takata airbags and a recall for airbag deployment issues.

Portfolio Pulse from Benzinga Neuro

February 27, 2024 | 1:20 pm

COMM

CommScope (NASDAQ:COMM) announced its Comsearch AFC system received FCC certification for commercial deployment, enabling the use of 850 MHz of 6 GHz spectrum for unlicensed devices. This development supports a broad range of deployments including Wi-Fi 6E and Wi-Fi 7, enhancing signal strength and quality of service for various applications. The certification positions CommScope as a key player in providing comprehensive 6 GHz solutions, including its RUCKUS portfolio, for next-generation commercial networks.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:18 pm

CPRX

Catalyst Pharmaceuticals announced its participation in the 2024 MDA Clinical & Scientific Conference, presenting a poster on a registry for studying the long-term safety and quality of life in Duchenne muscular dystrophy patients treated with AGAMREE (vamorolone). The registry aims to track the progress of 250 male patients across 25 U.S. sites, with the first interim analysis expected in May 2025. AGAMREE, a novel corticosteroid with a unique mode of action, has shown promise in the VISION-DMD study and received U.S. FDA approval on October 26, 2023, with Orphan Drug and Rare Pediatric Disease designation.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:17 pm

LTBR

Lightbridge CEO Seth Grae provided an update to shareholders, highlighting 2023 achievements and future milestones. Key developments include strengthening the leadership team, agreements with Centrus Energy for a pilot fuel fabrication facility in Ohio, and an engineering study for CANDU reactors with RATEN ICN. Lightbridge also announced a research study with Texas A&M University, NuScale Power, and Structural Integrity Associates, and a significant finding on plutonium disposition. The company is adopting the Technology Readiness Level (TRL) system, currently at TRL 4-5, indicating progress towards commercialization. Upcoming milestones include expanding the fuel development team, ongoing work at Idaho National Laboratory, completing the CANDU reactor study, the FEED study with Centrus, and commencing manufacturing efforts for irradiation testing. COP28 recognized nuclear energy's role in decarbonization, with a commitment to triple nuclear capacity by 2050, highlighting the demand for Lightbridge's nuclear fuel technology.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:13 pm

ENSC

Ensysce Biosciences, Inc. (ENSC) has received an extension until May 13, 2024, to continue its listing on The Nasdaq Capital Market tier. This extension allows the company to demonstrate compliance with the equity requirement in Listing Rule 5550(b)(1).

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:11 pm

BCTX

BriaCell Therapeutics Corp. (NASDAQ:BCTX, TSX:BCT) has provided an update on its investigation into alleged illegal trading of its securities. The company reported significant settlement share imbalances after forensic analysis and discussions with prime brokers, leading to formal complaints with FINRA and CIRO. BriaCell is committed to combating these manipulative trading activities and will provide further updates.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:10 pm

NERV

Minerva Neurosciences received a Complete Response Letter (CRL) from the FDA for its New Drug Application (NDA) for Roluperidone, intended for treating negative symptoms in schizophrenia patients. The FDA cited clinical deficiencies including insufficient evidence from a single study, lack of data on concomitant antipsychotic administration, and inadequate long-term safety data at the proposed dose.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:10 pm

TNXP

Tonix Pharmaceuticals plans to expand the development and partnering of Tonmya in Japan and China for the management of fibromyalgia. The company will file a CTN in Japan and an IND in China, leveraging U.S. Phase 3 data without dosage adjustment. Tonmya's market exclusivity in Asia is supported by issued patents, and a U.S. FDA NDA submission is planned for the second half of 2024.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:07 pm

AMRX

Amneal Pharmaceuticals, Inc. (NASDAQ:AMRX) has entered into an exclusive licensing agreement with Zambon Biotech SA for the commercialization of IPX203, a novel Parkinson's disease treatment, in Europe. IPX203 is under review by the U.S. FDA and aims to improve the lives of over 10 million people worldwide with Parkinson's. This agreement is part of Amneal's strategy to make IPX203 available globally, following a similar agreement for Canada and Latin America with Knight Therapeutics Inc.

Portfolio Pulse from Benzinga Newsdesk

February 27, 2024 | 1:06 pm

SPY

VGK

Treasury Secretary Yellen is advocating for world leaders to release frozen Russian Central Bank assets to aid Ukraine. This move could have significant implications for global financial markets and geopolitical relations.

Portfolio Pulse from Charles Gross

February 27, 2024 | 12:52 pm