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Regulatory

MEIP

MEI Pharma has been granted U.S. Patent #11723893 for isoflavonoid compositions and methods for the treatment of cancer. This could potentially strengthen the company's intellectual property portfolio and provide a competitive edge in the oncology market.

Portfolio Pulse from Charles Gross

August 15, 2023 | 1:40 pm

GLTO

Galecto Inc (NASDAQ:GLTO) announced that its Phase 2b GALACTIC-1 trial for inhaled GB0139 for idiopathic pulmonary fibrosis (IPF) did not meet its primary endpoint. The company plans to discontinue the development of GB0139 and will focus on severe liver diseases. Galecto plans to initiate Phase 2a GULLIVER-3 trial evaluating GB1211 in patients with decompensated NASH cirrhosis in early 2024. GLTO shares are down 57.30% at $1.00.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:39 pm

AULT

Ault Alliance, Inc. (NYSE:AULT) has reached a settlement with the U.S. Securities and Exchange Commission (SEC) over an investigation into the company's public disclosures and accounting for certain transactions. The company will pay a civil penalty of $700,000, which was fully accrued in Q4 2022. Additionally, the company will retain an independent consultant to review its internal control over financial reporting and disclosure controls and procedures.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:17 pm

EDBL

Edible Garden AG Incorporated (NASDAQ:EDBL) has received a grant from the United States Department of Agriculture Organic Certification Program. The funds are intended to help reduce the cost of organic certification. The grant will be used for the organic processing/handling certification for the Edible Garden Heartland facility in Grand Rapids, Michigan.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:16 pm

WAVE

Eco Wave Power has officially connected to the Israeli electrical grid, supplying the country's power supply with its first wave energy. The news was confirmed through an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:10 pm

SHPH

Shuttle Pharmaceuticals has provided a Q2 2023 corporate update, highlighting its progress in the development of Ropidoxuridine, a drug candidate for brain cancer treatment. The company is on track to commence Phase II clinical study in Q4 2023. It has completed the initial manufacturing campaign for the active pharmaceutical ingredient (API) of Ropidoxuridine and received approval for a Type B pre-IND meeting with the FDA. The company's Q2 2023 operating expenses totaled $1.5 million and its cash balance was $8.4 million as of June 30, 2023.

Portfolio Pulse from Happy Mohamed

August 15, 2023 | 1:07 pm

TLSA

Tiziana Life Sciences announced that the FDA has cleared its Investigational New Drug (IND) application for intranasal foralumab to be studied in Alzheimer's disease. This news has led to an increase in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:06 pm

ACLX

The FDA has lifted the partial clinical hold on Arcellx Inc's iMMagine-1 Phase 2 Clinical Program. The decision comes after modifications were made to the trial protocol to better manage the risk of adverse events. Arcellx has retrained clinical sites and expanded treatment options for therapies that patients can receive. Preliminary data from the study is expected in the second half of 2024. Arcellx's shares are down 0.09% at $33.66 premarket.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:05 pm

DSGN

Design Therapeutics Inc (NASDAQ:DSGN) reported initial results from its Phase 1 clinical trial of DT-216 in patients with Friedrich ataxia (FA). The results showed that DT-216 was generally well-tolerated and achieved a significant increase in frataxin (FXN) mRNA levels. However, injection site reactions were observed, leading the company to plan a reformulation of the drug. A new Phase 1 study is planned for the second half of 2024. DSGN shares are down 45.7% in premarket trading.

Portfolio Pulse from Vandana Singh

August 15, 2023 | 1:05 pm

FXLV

F45 announced its intention to voluntarily delist and deregister its securities, leading to a drop in its share price.

Portfolio Pulse from Benzinga Newsdesk

August 15, 2023 | 1:03 pm