BioSpace News Archive

Today, the U.S. Food and Drug Administration cleared the Beta Bionics iLet ACE Pump and the iLet Dosing Decision Software for people six years of age and older with type 1 diabetes.

Tempest Therapeutics, Inc. announced that the Compensation Committee of the company’s Board of Directors granted one employee a nonqualified stock option to purchase 12,600 shares of its common stock with an exercise price equal to the closing price of Tempest’s common stock on May 15, 2023, the grant date of the award.

Exicure, Inc., announced it received a notice of non-compliance from Nasdaq Stock Market LLC on May 17, 2023 notifying the Company that, as a result of the Company’s failure to timely file its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2023, the Company is not in compliance with Nasdaq Listing Rule 5250, which requires listed companies to timely file all periodic financial reports with the U.S. Securities and Exchange Commission.

Celularity Inc. (Nasdaq: CELU) (“Celularity”) announced results from an exploratory analysis of Phase 1 data evaluating alterations in gene and protein signatures associated with reduced inflammation and fistula formation resulting from therapy with mesenchymal‐like adherent stromal cells (MLASCs) in adult patients with Crohn’s disease (CD).

Dyno Therapeutics, Inc. today announced the launch of its Dyno bCap 1™ capsid product, a breakthrough CNS-targeted AAV gene delivery vector with best-in-class potential, in a keynote address at the company’s Scientific Symposium at the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting.

Alpine Immune Sciences, Inc. (NASDAQ: ALPN) announced the Company will present data from RUBY-1, a phase 1 study of povetacicept in healthy adult volunteers, at multiple upcoming scientific congresses, including participation in a poster tour at the European Congress of Rheumatology (EULAR) and an oral presentation at the European Hematology Association (EHA).

DAXOR CORPORATION, the global leader in blood volume measurement technology, announces that it has commenced an underwritten public offering of shares of its common stock.

Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) today announced the outcome of the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) Meeting to review the Company’s New Drug Application (NDA) for obeticholic acid (OCA) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH).

CorFlow Therapeutics AG has announced the interim positive results of its MOCA I study at EuroPCR in Paris, France.

Sobi announced that the European Medicines Agency has accepted and validated a marketing authorisation application for efanesoctocog alfa, a new class of high-sustained FVIII developed for the treatment of people with haemophilia A of all age groups.