Streetbeat News

Regulatory

GCTK

Glucotrack, Inc. (NASDAQ:GCTK) has announced the completion and positive results of its feasibility study for its implantable continuous glucose monitor technology for patients with Type 1 and Type 2 insulin-dependent diabetes. The study confirmed that the CGM sensor design could reliably report glucose measurements for two years post-implant. The company is now preparing for long-term animal studies.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 1:04 pm

BLPH

Bellerophon Therapeutics has received a delisting notice, causing its shares to trade lower.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2023 | 1:01 pm

THRD

Third Harmonic Bio, Inc. (NASDAQ:THRD) has announced its next-generation product candidate, THB335, a potent oral KIT inhibitor for inflammatory diseases. The company plans to file a U.S. IND and initiate clinical trials of THB335 in the first half of 2024. The previous product, THB001, was discontinued due to observed liver transaminitis in two of five patients. However, THB335 is believed to address this risk with its differentiated metabolic profile.

Portfolio Pulse from Happy Mohamed

July 25, 2023 | 12:42 pm

ONDS

Ondas Holdings Inc. (NASDAQ:ONDS) has announced that its subsidiary, Airobotics, is partnering with Aero A2Z to expand into the Indian market. The partnership will market and support the Optimus Unmanned Aerial Systems (UAS) and Iron Drone Counter-Unmanned Aerial Systems (C-UAS) solutions for Smart Cities, Government, and Industrial entities in India. The companies will be jointly participating in the International Drone Expo in New Delhi on July 26 - 27.

Portfolio Pulse from Happy Mohamed

July 25, 2023 | 12:39 pm

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