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HUMA

The FDA has announced a delay in the review of Humacyte Inc.'s Biologic License Application for its acellular tissue-engineered vessel (ATEV) for vascular trauma injuries. The original PDUFA date was August 10, 2024, but the new action date is currently undisclosed. This delay has caused Humacyte's stock to drop by 8.98% in premarket trading.

Portfolio Pulse from Vandana Singh

August 12, 2024 | 1:21 pm

WVE

Wave Life Sciences shares are trading higher after the company announced that the FDA has granted Rare Pediatric Disease Designation to WVE-N531 for the treatment of Duchenne muscular dystrophy.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:19 pm

SXTP

60 Degrees Pharma has granted the University of Kentucky the right of reference to its New Drug Application (NDA) for ARAKODA. This will facilitate a Phase IIb clinical study of SJ733 for Vivax malaria, combining SJ733 with a single dose of Tafenoquine.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:14 pm

SDST

Stardust Power Inc. (NASDAQ:SDST) has selected Primero USA to complete a definitive engineering study for its lithium refinery in Muskogee, Oklahoma. This study is crucial for the development of battery-grade lithium products.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:14 pm

WLDS

Wearable Devices Ltd. (NASDAQ: WLDS) has partnered with a leading European automaker to showcase its AI-powered touchless sensing technology, Mudra, in a demonstration car. This marks the company's entry into the automotive sector.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:13 pm

GOOGL

TRI

Thomson Reuters has announced CoCounsel 2.0, a next-gen GenAI assistant that combines the capabilities of Google Cloud AI and OpenAI. This new version is three times faster, more intuitive, and delivers more nuanced results, marking a significant milestone in the company's vision for a single GenAI assistant to streamline workflows across industries.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:10 pm

MULN

Mullen Automotive has delivered a Class 1 EV cargo van to the University of Virginia's Sustainable Fleet Department. This follows a previous purchase by UVA and a recent $7.7 million order from Eco Auto, indicating growing demand for Mullen's electric commercial vehicles.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:10 pm

NEWT

PALT

Paltalk, Inc. (NASDAQ:PALT) has entered into a definitive agreement to acquire Newtek Technology Solutions, Inc. from NewtekOne, Inc. (NASDAQ:NEWT) for $4 million in cash and 4 million shares of a newly created series of Paltalk's preferred stock. The acquisition will enhance Paltalk's offerings in server hosting, cloud hosting, data storage, and managed security services.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:08 pm

AMLX

Amylyx Pharmaceuticals announced the publication of data from the Phase 2 PEGASUS trial, showing that their drug AMX0035 affects cerebrospinal fluid biomarkers related to Alzheimer's disease and neurodegeneration. The findings were published in the journal Alzheimer's & Dementia: Translational Research & Clinical Interventions.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:06 pm

TDC

Teradata (NYSE:TDC) has been named the official cloud analytics partner for the Los Angeles Clippers and their new arena, Intuit Dome. The partnership includes leveraging Teradata VantageCloud Lake and AI technologies. Teradata is also a Founding Partner of Intuit Dome with special entitlement of the arena's Halo Loft Level.

Portfolio Pulse from Benzinga Newsdesk

August 12, 2024 | 1:05 pm