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CRMD

CorMedix Inc. (NASDAQ:CRMD) has announced updates on the commercial launch of DefenCath, including a submitted HCPCS application for a J-Code to CMS, ongoing discussions for Medicare Part B reimbursement, and interest from health systems. The inpatient launch is expected by April 15, 2024, and outpatient availability is anticipated no sooner than July 1, 2024, pending CMS decisions. CorMedix may set an initial list price for DefenCath before CMS's final determination, with plans to adjust it based on the outcome. The company has sufficient funds for the launch and is expanding its staff in preparation.

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January 08, 2024 | 1:54 pm

LQR

Trading on the stock LQR has been halted at 8:45 a.m. ET due to pending news. The halt is in place to ensure a fair and orderly market until the news is released and investors have had time to digest the information.

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January 08, 2024 | 1:45 pm

IRTC

iRhythm Technologies, Inc. (NASDAQ:IRTC) reported preliminary Q4 2023 results at the J.P. Morgan Healthcare Conference, showing over 22% YoY growth in patient registrations. The company expects FY24 revenue to be between $575M-$585M, aligning with estimates. iRhythm published the CAMELOT study, submitted a 510(k) to the FDA, received CE marks for Zio Monitor and ZEUS systems, and closed a $150M term loan credit facility with Braidwell LP. The company is focusing on expanding its cardiology and primary care channels and international markets, while investing in technology and growth.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 1:41 pm

LQDA

UTHR

Liquidia Corporation has responded to a patent infringement lawsuit by United Therapeutics, seeking dismissal of all claims related to the '793 patent due to prior invalidity findings affirmed by the Federal Circuit. Liquidia also filed counterclaims asserting the '327 patent is not infringed, invalid, and unenforceable, alleging United Therapeutics failed to disclose prior art during patent prosecution. The dispute centers around Liquidia's NDA for YUTREPIA, an inhalation powder for treating pulmonary hypertension. Liquidia argues against a 30-month regulatory stay, as the patents were not issued before the original NDA filing.

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January 08, 2024 | 1:38 pm

VERU

Veru Inc. has submitted an Investigational New Drug (IND) application to the FDA for the development of Enobosarm, a drug aimed at preventing muscle loss and promoting fat loss in combination with GLP-1 drugs for weight loss. This submission marks a step forward in the company's efforts to address the needs of individuals seeking weight loss solutions that also preserve muscle mass.

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January 08, 2024 | 1:38 pm

CDIO

Cardio Diagnostics Holdings has been granted a patent in India, numbered 484488, for a kit that determines the methylation status of a CpG dinucleotide and a genotype of a single nucleotide polymorphism. The company now holds patents in multiple regions globally, including the United States, Europe, Australia, China, and Hong Kong, with additional patents pending worldwide.

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January 08, 2024 | 1:36 pm

YTEN

Yield10 Bioscience has submitted a request to the USDA-APHIS for a regulatory status review of its genetically designed Camelina plants, which are engineered to produce EPA and DHA, key components of Omega-3 oil. The review is a step towards commercializing the product, which could have implications for the agriculture and health industries.

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January 08, 2024 | 1:32 pm

SPR

Spirit AeroSystems has issued a statement regarding Alaska Airlines Flight 1282, indicating that they are following the protocols set by regulatory authorities guiding communication.

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January 08, 2024 | 1:30 pm

AFMD

Affimed N.V. has reaffirmed its guidance for the release of data readouts for two of its clinical trials, AFM24-102 and LuminICE-203, which are expected in the first half of 2024. This confirmation may indicate progress in the company's clinical programs and could be a positive signal to investors looking forward to these milestones.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 1:29 pm

ADTX

Trading on ADTX has been halted at 8:25:00 a.m. ET due to pending news. The halt is in place to manage market orderliness and investor protection pending the release of material news.

Portfolio Pulse from Benzinga Newsdesk

January 08, 2024 | 1:25 pm