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Regulatory

ATNF

180 Life Sciences Corp. (NASDAQ:ATNF) has submitted a request to the UK's MHRA for a follow up scientific advice meeting to seek guidance on obtaining Conditional Marketing Authorization (CMA) for the use of adalimumab in the treatment of early stage Dupuytren's disease. The company has also initiated a Type C meeting request with the U.S. FDA to seek advice on obtaining US marketing approval. Promising data from a Phase 2b Dupuytren's treatment trial was published in June 2022.

Portfolio Pulse from Happy Mohamed

August 04, 2023 | 1:16 pm

TLS

Telos Corporation's cyber risk management and compliance solution, Xacta, has been prioritized by the U.S. Federal Risk and Authorization Management Program (FedRAMP) to pursue a Provisional Authority to Operate (P-ATO) from the Joint Authorization Board (JAB). This prioritization indicates a government-wide demand for the cloud service offering. Achieving P-ATO will provide defense industry base and government agencies a validated SaaS option for cyber risk management and compliance solution.

Portfolio Pulse from Happy Mohamed

August 04, 2023 | 1:15 pm

SPY

The USA Unit Labor Costs for Q2 have been reported at 1.6%, lower than the estimated 2.6% and the prior figure of 3.3%.

Portfolio Pulse from Happy Mohamed

August 04, 2023 | 1:14 pm

VRTX

Vertex Pharmaceuticals has published preclinical data and results from its Phase 2 proof-of-concept trials of VX-548 for acute pain following abdominoplasty and bunionectomy surgeries in the New England Journal of Medicine.

Portfolio Pulse from Benzinga Newsdesk

August 04, 2023 | 1:14 pm

BIOR

Biora Therapeutics has announced the issuance of a new patent and the allowance of a patent application related to its BioJet platform. The platform uses an ingestible device designed to achieve systemic uptake through liquid jet delivery to the small intestine.

Portfolio Pulse from Benzinga Newsdesk

August 04, 2023 | 1:14 pm

EYEN

Eyenovia, Inc. (NASDAQ:EYEN) has announced the first commercial sale of Mydcombi, the first FDA approved and commercially available fixed combination of tropicamide and phenylephrine for pupil dilation. The initial sale was to Dr. Nathan M. Radcliffe, a renowned ophthalmologist. Mydcombi is designed to streamline the estimated 106 million office-based comprehensive eye exams with pupil dilation performed every year in the United States.

Portfolio Pulse from Happy Mohamed

August 04, 2023 | 1:13 pm

HUMA

Humacyte has announced the publication of a biological mechanism explaining the low rates of infection observed in a clinical study of its Human Acellular Vessel (HAV).

Portfolio Pulse from Benzinga Newsdesk

August 04, 2023 | 1:12 pm

NRBO

NeuroBo Pharmaceuticals has received the first site Institutional Review Board approval for its Phase 2a clinical trial evaluating DA-1241 for the treatment of NASH.

Portfolio Pulse from Benzinga Newsdesk

August 04, 2023 | 1:10 pm

CNSP

CNS Pharmaceuticals, Inc. (NASDAQ:CNSP) has provided an update on its ongoing clinical study of Berubicin for the treatment of recurrent GBM, a form of brain cancer. The company has enrolled 180 patients across 46 clinical trial sites globally, with full enrollment expected by the end of 2023. An interim analysis is expected before the end of the year. The FDA has granted CNS Pharmaceuticals Fast Track Designation for Berubicin, which expedites the development and review process.

Portfolio Pulse from Happy Mohamed

August 04, 2023 | 1:08 pm

VRAX

Virax Biolabs Group Limited (NASDAQ:VRAX), a diagnostics company, has been granted a 180-day extension by Nasdaq to meet the $1 minimum bid price requirement. The company was initially given until July 31, 2023, to regain compliance, but this has now been extended to January 29, 2024.

Portfolio Pulse from Happy Mohamed

August 04, 2023 | 1:05 pm