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Regulatory

GURE

Gulf Resources, Inc. (NASDAQ:GURE) announced upcoming management changes, with Chairman Min Yang and board member Tengfei Zhang not standing for re-election at the Annual Meeting on November 30, 2023. CEO Xiaobin Liu will become the new Chairman. The company has nominated a new director candidate, details of which are in the proxy statement filed on October 3, 2023. Yang expressed pride in the team and believes it's the right time to focus on other business pursuits, while Liu thanked Yang for his mentorship.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:36 pm

APLM

Apollomics Inc. announced that its Chinese partner, Avistone Biotechnology, received approval from the NMPA to commercialize vebreltinib for MET exon 14 skipping NSCLC in China. Apollomics is in discussions with the FDA for a New Drug Application in the U.S. based on clinical data from the SPARTA trial and Avistone's KUNPENG trial. NSCLC, which accounts for 85% of lung cancer cases, has limited treatment options for patients with MET exon 14 skipping mutations. Apollomics retains rights to vebreltinib outside China, Hong Kong, and Macau.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:34 pm

ADN

Advent Technologies received a letter from the Greek State confirming continued support for the Green HiPo Project, with an updated funding plan of EUR 60 million. The Just Transition Fund will provide a grant of EUR 24 million, which is 40% of the total budget, to initiate the project.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:17 pm

CRSP

VRTX

The UK MHRA has granted conditional marketing authorization for Casgevy, a CRISPR/Cas9 gene-edited therapy for SCD and TDT, developed by Vertex Pharmaceuticals and CRISPR Therapeutics. The therapy has shown positive trial results and could replace bone marrow transplants, but it requires a complex administration process. VRTX shares closed at $349.34, and CRSP shares are up 4.93% in premarket trading.

Portfolio Pulse from Vandana Singh

November 16, 2023 | 1:17 pm

CATX

Perspective Therapeutics has completed the dosing for Cohort 1 in its Phase 1/2A trial of [212Pb]VMT-α-NET, a treatment for patients with unresectable or metastatic somatostatin receptor type 2-expressing neuroendocrine tumors.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:14 pm

NMTC

The US Patent and Trademark Office has issued a Notice of Allowance for NeuroOne Medical's innovative electrodes designed for standard neural monitoring with the added capability of delivering a treatment agent directly to a patient's brain. This development could enhance the company's product portfolio and potentially improve treatment outcomes in neurological applications.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:12 pm

WINT

Windtree Therapeutics has been granted a European patent (No. 3805243) for the composition of matter for its SERCA2a activator class of drug candidates. This patent strengthens the company's intellectual property rights in Europe for these potential therapeutic agents.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:08 pm

ALZN

Alzamend Neuro, Inc. has regained compliance with Nasdaq's minimum bid price requirement. The company's stock had previously been at risk of being delisted due to its share price falling below the $1.00 minimum threshold required by Nasdaq. However, Alzamend Neuro's share price has since recovered, satisfying the exchange's listing rule. This news is likely to be viewed positively by investors as it removes the immediate risk of delisting and may instill confidence in the company's ability to maintain its listing standards.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:05 pm

PRAX

Praxis Precision Medicines has received the Priority Medicines (PRIME) designation from the European Medical Agency (EMA) for its investigational drug Elsunersen (PRAX-222), which is being developed to treat SCN2A gain of function developmental and epileptic encephalopathy.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:04 pm

DZSI

DZS Inc. has received a notification from Nasdaq due to the late filing of its Form 10-Q. The company is required to submit a plan to regain compliance within 60 calendar days. If the plan is accepted, Nasdaq can grant an extension of up to 180 days from the Form 10-Q's due date for DZS to regain compliance.

Portfolio Pulse from Benzinga Newsdesk

November 16, 2023 | 1:02 pm