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Regulatory

COCP

Cocrystal Pharma has begun dosing subjects in a Phase 1 study of CDI-988, a potential treatment for pandemic Norovirus and Coronavirus.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:07 pm

CLNN

Clene Inc. (NASDAQ:CLNN) announced the publication of a scientific paper describing the catalytic mechanism of action of its investigational drug CNM-Au8. The study demonstrates that the neuroprotective properties of CNM-Au8 can be attributed to its therapeutic catalytic activity. The drug is being investigated as a potential treatment for multiple neurodegenerative diseases, including ALS, MS, and Parkinson's disease.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:07 pm

JVA

Coffee Holding Co., Inc. (NASDAQ:JVA) and Delta Corp Holdings Limited have jointly announced the filing with the U.S. Securities and Exchange Commission of a registration statement on Form F-4 by Delta Corp Holdings Limited, a newly created holding company. This is in line with the previously announced merger and share exchange agreement, where both companies will become wholly owned subsidiaries of the new holding company. The closing of the transactions is subject to certain conditions, including the approval of the stockholders of Coffee Holding and the listing of the ordinary shares of the new holding company on the Nasdaq Stock Market.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:06 pm

ARDX

Ardelyx has announced the publication of results from the T3MPO-3 long-term open-label safety trial of Ibsrela (Tenapanor) for Irritable Bowel Syndrome with constipation in the Journal of Neurogastroenterology and Motility. The results could potentially impact the company's stock.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:04 pm

BXRX

Baudax Bio has received FDA Orphan Drug Designation for TI-168, a drug aimed at treating Hemophilia A with inhibitors. This designation could provide various benefits including tax credits, market exclusivity, and FDA assistance in clinical trial design.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:02 pm

AKBA

Akebia Therapeutics has resubmitted its New Drug Application (NDA) to the FDA for Vadadustat, a treatment for anemia due to chronic kidney disease.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 12:01 pm

QGEN

QIAGEN's QuantiFERON immune response blood tests have been recommended for use by kidney specialists in Tunisia. This is the first-ever guidance of this type by a professional body in kidney medicine.

Portfolio Pulse from Charles Gross

September 28, 2023 | 11:55 am

JNJ

Johnson & Johnson's unit, Janssen Pharmaceutical, announced positive topline results from the Phase 3 MARIPOSA study. The study evaluated the combination of RYBREVANT and lazertinib versus osimertinib as a first-line treatment in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer. The study met its primary endpoint and showed a trend favoring the combination of RYBREVANT and lazertinib.

Portfolio Pulse from Charles Gross

September 28, 2023 | 11:38 am

COTY

Coty Inc. has announced the pricing of its global offering of 33 million shares of its outstanding Class A common stock at $10.80 per share. The offering is made pursuant to an effective shelf registration statement filed with the SEC.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 11:17 am

BOLT

The FDA has granted Orphan Drug Designation to Bolt Biotherapeutics' BDC-1001 for the treatment of gastric cancer, including gastroesophageal junction cancer.

Portfolio Pulse from Benzinga Newsdesk

September 28, 2023 | 11:04 am