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Regulatory

RVNC

Revance Therapeutics Inc has estimated total non-cash impairment charges from goodwill and other assets to be between $80M-$100M. The company anticipates completion of activities, including workforce reduction, by March 31, 2024, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:15 pm

DATS

Trading of DatChat shares has been halted due to pending news.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:14 pm

RVNC

Revance Therapeutics Inc. anticipates recording a restructuring charge of up to $7M in connection with certain activities, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:14 pm

RVNC

Revance Therapeutics Inc. plans to continue processing payments for current OPUL customers through January 31, 2024. The company expects to record a restructuring charge of up to $7M in connection with these activities, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:13 pm

ILMN

MYGN

Myriad Genetics and Illumina have achieved two key milestones in their strategic partnership aimed at advancing genomic profiling and homologous recombination deficiency (HRD) testing. The first milestone qualifies Myriad to conduct prospective clinical trial testing with an investigational use only test based off of Illumina's in-development IVD solution. The second milestone involves Myriad's initiation of its first reproducibility test project to support future regulatory filings.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:08 pm

NRSN

NeuroSense Therapeutics Ltd. (NASDAQ:NRSN) has been granted patents in Europe, Japan, and Israel for its ALS drug PrimeC. The patents relate to NeuroSense's unique fixed-dose combination of ciprofloxacin and celecoxib, the active ingredients in PrimeC. Corresponding patents have been issued in the U.S., Canada, and Australia and are valid through 2038. Clinical topline results from Phase 2b ALS trial are expected in H2 2023.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:08 pm

PULM

Pulmatrix has received FDA approval for its Investigational New Drug (IND) application for PUR3100, a treatment for acute migraine. The company has also received a 'study may proceed' letter for a Phase 2 study of the drug.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:06 pm

SRFM

Surf Air Mobility Inc has filed for the resale of up to approximately 2.0 million shares of common stock by the selling stockholders, according to an SEC filing.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:05 pm

SXTP

60 Degrees Pharmaceuticals Inc's subsidiary, 60P Australia Pty Ltd, has withdrawn its investigational new drug application for ACLR8-LR, a Phase 2B study of the use of tafenoquine in treating COVID-19, in response to FDA comments. The company plans to submit a new application in Q4, pending a feasibility assessment of revising the trial design. Meanwhile, 60P has paused further start-up activities for its Phase 2B trial, improving its short-term cash position. The company's shares are down 28.1% in premarket trading.

Portfolio Pulse from Vandana Singh

September 19, 2023 | 1:04 pm

TTOO

T2 Biosystems has received FDA 510(k) clearance for the T2Biothreat Panel, a direct-from-blood molecular diagnostic test that detects six biothreat pathogens. These pathogens have been identified as threats by the U.S. Centers for Disease Control and Prevention.

Portfolio Pulse from Benzinga Newsdesk

September 19, 2023 | 1:01 pm