Streetbeat News

Regulatory

MIRM

Mirum Pharmaceuticals, Inc. (NASDAQ:MIRM) has received authorization from Health Canada for its medication LIVMARLI® (maralixibat oral solution) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). This approval is supported by over six years of LIVMARLI data showing improvements in pruritus and serum bile acids. LIVMARLI is also approved in the United States and Europe for the same indication. Mirum has submitted a supplemental new drug application to the FDA and EMA for approval of LIVMARLI in cholestatic pruritus associated with progressive familial intrahepatic cholestasis (PFIC).

Portfolio Pulse from Happy Mohamed

July 25, 2023 | 12:36 pm

ATXI

Avenue Therapeutics has announced an agreement with the FDA on the study design and analysis approach of the Phase 3 safety study for IV Tramadol.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 12:34 pm

LLY

The European Commission has approved Jardiance (Empagliflozin), a drug developed in partnership by Boehringer Ingelheim and Eli Lilly, for use in adults with chronic kidney disease.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 12:18 pm

NISN

Nisun International Enterprise Development Group Co., Ltd (NASDAQ:NISN) has been granted an additional 180-day period by NASDAQ to comply with the timely filing of periodic financial reports requirement. The company is required to file the Form 20-F for the year ended December 31, 2022, by November 13, 2023.

Portfolio Pulse from Happy Mohamed

July 25, 2023 | 12:18 pm

NVACF

SNDL

SNDL Inc. and Nova Cannabis Inc. have announced a further extension of the closing date for their strategic partnership due to continued review by a provincial regulator. The transaction is now expected to close on or before August 25, 2023, subject to regulatory approval and mutually satisfactory amendments to certain terms. The maturity date of Nova's revolving credit facility with SNDL has also been extended to the same date.

Portfolio Pulse from Vuk Zdinjak

July 25, 2023 | 12:14 pm

BXRX

Baudax Bio has received approval from Nasdaq for the continued listing of its common stock, subject to certain conditions.

Portfolio Pulse from Charles Gross

July 25, 2023 | 12:11 pm

ECOR

ElectroCore has announced the publication of a peer-reviewed manuscript that shows improved attention and memory in patients with Posttraumatic Stress Disorder (PTSD) using GammaCore, a non-invasive vagus nerve stimulation device.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 12:09 pm

BXRX

Baudax Bio has been granted a request for the continued listing of its common stock on the Nasdaq Stock Market, subject to the company evidencing compliance.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 12:07 pm

BFRG

BullFrog AI has announced a US patent for novel prodrugs of mebendazole, which are used in treating cancer. This news has led to an increase in the company's share price.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 11:59 am

SPY

VGK

Russia's lower house of parliament has voted to raise the upper age limit for conscription to 30. This could potentially impact the country's military manpower and geopolitical stance.

Portfolio Pulse from Charles Gross

July 25, 2023 | 11:57 am