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Regulatory

ALZN

Alzamend Neuro Inc (NASDAQ:ALZN) has received a 'Study May Proceed' letter from the FDA to initiate a Phase 2A clinical study of AL001 for major depressive disorder (MDD). The company's CEO, Stephan Jackman, highlighted the potential of AL001 as a next-generation lithium product that may not require routine therapeutic drug monitoring, which could be a significant improvement for MDD treatments. Alzamend's Phase IIA study of AL001 in Alzheimer's patients indicated a benign safety profile. The first patient for the MDD study is expected to be dosed in Q1 2024. ALZN shares closed at $1.69 on Friday.

Portfolio Pulse from Vandana Singh

November 20, 2023 | 12:31 pm

ALZN

Alzamend Neuro has indicated to Benzinga that the safety aspects of its AL001 development could be eligible for a 505(b)(2) New Drug Application (NDA) pathway with the FDA, which could streamline the approval process.

Portfolio Pulse from Benzinga Newsdesk

November 20, 2023 | 12:30 pm

BMY

TSVT

The FDA's Oncologic Drugs Advisory Committee (ODAC) is set to review a supplemental marketing application for Abecma, a therapy developed by Bristol Myers Squibb and 2Seventy Bio, for use in earlier lines of treatment for triple-class exposed relapsed or refractory multiple myeloma. The exact date for the ODAC meeting is not confirmed, and the FDA has indicated that a decision on the application will not be reached by the original PDUFA target date of December 16, 2023.

Portfolio Pulse from Benzinga Newsdesk

November 20, 2023 | 12:06 pm

CLDI

Calidi Biotherapeutics has been granted a new US patent for its SuperNova Technology Platform, which is a significant development for the company's proprietary technology and intellectual property portfolio.

Portfolio Pulse from Benzinga Newsdesk

November 20, 2023 | 12:05 pm

HOOK

HOOKIPA Pharma has announced that the FDA has cleared its Investigational New Drug (IND) application for HB-500, a new treatment for Human Immunodeficiency Virus (HIV). This clearance allows HOOKIPA Pharma to proceed with clinical trials for HB-500, potentially bringing a new treatment option to HIV patients.

Portfolio Pulse from Benzinga Newsdesk

November 20, 2023 | 12:04 pm

ENLT

Enlight Renewable Energy Ltd. (NASDAQ:ENLT) announced that its subsidiary Clenera's affiliate, Country Acres, has signed agreements for a solar and storage project in California. The project will have a capacity of 392 MWdc/344MWac solar energy and 688 MWh storage. A 30-year PPA for solar and 20-year for storage has been signed with SMUD. Construction is set to begin in 2024, operations in 2026, and the project will power about 80,000 homes annually with zero carbon electricity. It also includes an agrivoltaic pilot program.

Portfolio Pulse from Benzinga Newsdesk

November 20, 2023 | 11:59 am

IRON

Disc Medicine has filed for a mixed shelf offering of up to $400 million, indicating potential future financing activities that could include the sale of various types of securities.

Portfolio Pulse from Charles Gross

November 20, 2023 | 11:54 am

WBX

Wallbox N.V. (NYSE:WBX) has partnered with Atlante, a company of NHOA Group, to develop a network of EV fast-charging stations across Italy, France, Spain, and Portugal. The collaboration aims to install 5,000 charging points by 2025 and 35,000 by 2030, powered by renewable energy. Atlante will use Wallbox's Supernova chargers for the network, which will be located along major transportation routes in compliance with new EU legislation. Wallbox's stock is down 5.96% in premarket trading.

Portfolio Pulse from Vandana Singh

November 20, 2023 | 11:51 am

BABAF

Alibaba Group Holding Limited (OTC:BABAF) has canceled the spinoff of its cloud business, leading to mixed reactions from analysts and a significant drop in market value. Morgan Stanley removed Alibaba from its top pick and lowered the price target from $125 to $110. Bernstein reduced their price target from $100 to $93, while Barclays maintained a $138 price target, supporting the decision amidst regulatory uncertainties. JPMorgan kept a $150 price target but expressed concerns over the cloud business's growth. The cancellation follows U.S. chip curbs affecting Chinese companies, contributing to a $20 billion loss in Alibaba's market value.

Portfolio Pulse from Benzinga Neuro

November 20, 2023 | 10:43 am

BIDU

China's Ministry of Industry and Information Technology has announced that select vehicles with level 3 or 4 autonomous driving functions qualified for mass production will be allowed to pilot on roads in limited areas. This move is part of China's investment in upgrading its highway system to support autonomous driving, with 1.6 trillion yuan allocated in 2022 for highway upgrades. Baidu Inc (NASDAQ:BIDU) has already received approval for its robotaxi fleets in several Chinese cities.

Portfolio Pulse from Anan Ashraf

November 20, 2023 | 10:30 am