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Regulatory

BXRX

Baudax Bio has been granted orphan drug designation by the FDA for TI-168, a treatment for Hemophilia A with inhibitors. This news has led to a rise in the company's share prices.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:48 pm

VCEL

Vericel Corporation has announced the publication of results from the Phase 3 DETECT study assessing the safety and efficacy of NexoBrid in the Journal of Burn Care & Research. The study showed that treatment with NexoBrid resulted in early complete eschar removal in more than 90% of treated patients, reduced surgery, and was safe and well-tolerated without deleterious effects on wound closure and scarring. These results served as the foundation for the FDA approval of NexoBrid for commercial use in the U.S.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:38 pm

OP

Sphinx Investment Corp. has increased its stake in OceanPal Inc. to 9.1%, according to a 13G filing with the SEC.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:36 pm

AYRWF

VRNOF

Cannabis industry leaders shared their strategies for success without relying on the SAFE Banking Act at the 2024 Benzinga Cannabis Capital Conference. Darren Weiss, president of Verano Holdings Corp (OTCQX:VRNOF), emphasized building a sustainable business without assuming cash availability. Jamie Mendola from Ayr Wellness (OTCQX:AYRWF) noted a slight improvement in risk appetite in the sector. Alex Gray from Good Day Farm suggested that capital will be more readily available once either SAFER or rescheduling happens. The leaders advised focusing on core markets, staying lean, and building a business that can stand on its own.

Portfolio Pulse from Nina Zdinjak

September 28, 2023 | 12:36 pm

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