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Regulatory

COMS

COMSovereign Holding Corp. (NASDAQ:COMS) filed its annual 10-K report for 2022 and is working to file delinquent quarterly reports for 2023. The company underwent a business transition, including cost-cutting and streamlining its corporate structure, which resulted in a 75% reduction in headcount and consolidation into a single reporting entity. COMSovereign has continued product sales, expanded its partner network, and disposed of non-core assets. The company aims to return to current-filer status and will update shareholders on developments early next year. COMSovereign received a delisting notice from Nasdaq for non-compliance with filing requirements but has been granted a hearing to present its compliance plan.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:15 pm

MBOT

Microbot Medical has completed its Good Laboratory Practice (GLP) pivotal pre-clinical study, adhering to FDA-required standards using a porcine model. This marks a significant milestone for the company as it progresses towards potential FDA approval for its medical devices.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:13 pm

FRLA

Fortune Rise Acquisition Corp has been granted an extension until January 5, 2024, by a sponsor affiliate to complete its initial business combination, according to an SEC 8K filing.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:13 pm

KRRO

Korro Bio, Inc. (KRRO) has nominated KRRO-110, its first RNA editing oligonucleotide candidate from its OPERA platform, for the treatment of Alpha-1 Antitrypsin Deficiency (AATD). KRRO-110 has shown promise in preclinical mouse models, demonstrating the ability to repair the A1AT protein misfolding and reduce liver aggregates. With over 50% editing efficiency and increased secretion of normal A1AT protein, Korro expects to make a regulatory filing in the second half of 2024. AATD is a genetic disorder with limited treatment options, and KRRO-110 could potentially transform the standard of care.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:10 pm

DGX

Quest Diagnostics (NYSE:DGX) has been awarded a multi-year contract by the CDC to assess the hepatitis C virus burden in the U.S. This marks a new phase in a decade-long collaboration, where Quest will provide research consulting, laboratory testing, and data analytics services. The project involves HCV antibody and molecular RNA testing on HIPAA-de-identified 'remnant' specimens. The collaboration aims to inform public policy and improve care for individuals with hepatitis C. Quest's extensive experience in hepatitis testing and its large database of de-identified laboratory results will support this initiative.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:06 pm

CDTX

Cidara Therapeutics, Inc. (NASDAQ:CDTX) presented new preclinical data on its novel drug-Fc conjugates at the ESMO Immuno-Oncology Congress. The data showed that its CD73/PD-1 inhibitor DFC and CD73-targeting DFC, CBO421, exhibited robust anti-tumor activity in humanized mouse models of colorectal cancer. The CD73/PD-1 DFC demonstrated superior efficacy compared to monotherapies and is expected to file an IND application in mid-2024 for CBO421.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:05 pm

SLDB

Solid Biosciences has been granted FDA Fast Track designation for SGT-003, its gene therapy candidate for Duchenne Muscular Dystrophy. This designation could expedite the development and review process for SGT-003, potentially bringing it to market more quickly if it proves to be safe and effective.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:02 pm

DARE

Daré Bioscience has received FDA clearance for its Investigational New Drug (IND) application for DARE-VVA1, a product aimed at treating vulvar and vaginal atrophy (VVA). This regulatory milestone allows Daré Bioscience to proceed with clinical trials, which is a critical step in the development and potential commercialization of DARE-VVA1. The FDA's clearance is a positive sign for the company's pipeline and could potentially lead to future revenue streams if the product successfully passes clinical trials and receives market approval.

Portfolio Pulse from Benzinga Newsdesk

December 07, 2023 | 1:02 pm

AAPL

GOOG

GOOGL

Apple Inc. (AAPL) has updated its Legal Process Guidelines to include data from push notifications in response to law enforcement requests. This change was prompted by concerns raised by Senator Ron Wyden about governments using notification data for surveillance. The guidelines now outline how Apple must provide Apple ID information associated with its notification service when legally ordered. Alphabet Inc. (GOOG, GOOGL) was also mentioned as having received similar requests from governments.

Portfolio Pulse from Benzinga Neuro

December 07, 2023 | 12:39 pm

AZN

BMY

The Biden administration is considering using 'march-in rights' to seize patents for high-cost medications developed with federal funding. A new framework by the Commerce Department will outline criteria for such actions, focusing on drug pricing and public accessibility. Pharmaceutical companies oppose this, claiming it's illegal and could hinder new drug development. AstraZeneca, Bristol Myers Squibb, and Boehringer Ingelheim, despite lawsuits against the administration's drug pricing policies, are open to Medicare price negotiations.

Portfolio Pulse from Vandana Singh

December 07, 2023 | 12:33 pm