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Regulatory

MIRM

Mirum Pharmaceuticals (NASDAQ:MIRM) received FDA approval for a label expansion of LIVMARLI® (maralixibat) oral solution, now approved for treating cholestatic pruritus in PFIC patients aged 12 months and older. The approval also includes a higher concentration formulation evaluated in the MARCH Phase 3 study.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 12:33 pm

SCPH

scPharmaceuticals Inc. (NASDAQ:SCPH) announced that the FDA has accepted its Supplemental New Drug Application (sNDA) to expand the indication of FUROSCIX to include treatment of edema in patients with chronic kidney disease (CKD). The FDA has set a target action date of March 6, 2025, and no additional clinical studies are required.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 12:16 pm

PEGA

Pega Cloud for Government has achieved FedRAMP High Ready compliance and is in process status with the Department of Veterans Affairs, making it suitable for the U.S. federal government's most sensitive IT projects.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 12:15 pm

COFS

ChoiceOne Financial Services, Inc. (NASDAQ:COFS) has announced a $30 million common stock offering. The proceeds will be used for general corporate purposes, including supplementing regulatory capital ratios and supporting its merger with Fentura Financial, Inc.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 12:08 pm

AQST

Aquestive Therapeutics has released topline pharmacokinetic (PK) data from its self-administration study of Anaphylm, showing comparable results whether administered by subjects or healthcare providers. The final Oral Allergy Syndrome (OAS) challenge study is currently enrolling, and a pre-New Drug Application (NDA) meeting is anticipated by the end of Q3 2024.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 12:05 pm

TNXP

Tonix Pharmaceuticals has received FDA Fast Track designation for its drug Tonmya, aimed at treating fibromyalgia. The company plans to submit a New Drug Application (NDA) in the second half of 2024. If approved, Tonmya could be the first new fibromyalgia drug in over 15 years.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 12:03 pm

ENVB

Enveric Biosciences (NASDAQ:ENVB) announced positive preclinical results for its non-hallucinogenic psychedelic drug candidate EB-003, which can be administered orally. The company plans to advance EB-003 to clinical trials by the end of 2025. Enveric also recently obtained a US patent for another drug candidate, EB-002, aimed at treating neurological disorders.

Portfolio Pulse from Nina Zdinjak

July 25, 2024 | 12:00 pm

PPBT

Purple Biotech has received an extension from the Nasdaq Listing Qualifications Department to regain compliance with the minimum $1.00 bid price requirement.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 11:39 am

CKPT

Checkpoint Therapeutics announced that the FDA has accepted for review its resubmission of the Biologics License Application for Cosibelimab, an anti-PD-L1 antibody for treating metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA has set a PDUFA goal date of December 28, 2024.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 11:33 am

ACB

Aurora Cannabis has been granted two licenses by Germany's Federal Institute for Drugs and Medical Devices under the new Medical Cannabis Act. These licenses allow for continued domestic cultivation and the trial of additional novel cultivars at their EU GMP facility in Leuna, Germany.

Portfolio Pulse from Benzinga Newsdesk

July 25, 2024 | 11:26 am