Today’s Daily Dose brings you news about the much awaited regulatory event of TherapeuticsMD; strategic plan devised by Immunomedics; the next business milestone of Agile and news about Teva’s CONCERTO trial.
Agile Therapeutics Inc. (AGRX) on Saturday reported additional results from SECURE, its phase III trial of investigational low-dose combined hormonal contraceptive patch Twirla.
The efficacy and safety results from the SECURE clinical trial were previously reported in January 2017. The newly reported bleeding profile shows a reduction in unscheduled bleeding/spotting days, noted the Company.
The SECURE study was conducted to address issues raised by the FDA in its 2013 Complete Response Letter to the company.
The Company will be re-submitting its NDA for Twirla by the end of the second quarter of 2017.
AGRX closed Friday’s trading at $3.37, down 2.88%.
CytoSorbents Corp. (CTSO) on Friday announced that the results of REFRESH 1 trial, which demonstrated safety and feasibility of CytoSorb, a blood purification technology, were presented on May 1, 2017 at the American Association for Thoracic Surgery Centennial Conference in Boston.
According to the trial results, CytoSorb treatment resulted in significant reduction of toxic inflammatory mediators during complex open heart surgery.
The Company plans to initiate a pivotal REFRESH 2 trial intended to support U.S. FDA approval of CytoSorb this year.
CytoSorb has been used safely in more than 20,000 human treatments to date. A companion product, VetResQ, based on similar underlying technology to CytoSorb, is now commercially available in the United States for the treatment of hyper-inflammatory conditions in animal health, noted the Company.
CTSO closed Friday’s trading at $4.85, up 1.04%.
Shares of Immunomedics Inc. (IMMU) were up over 17% on Friday on announcement of a new strategic plan to drive long-term value for stockholders.
The strategic plan includes the termination of the previously announced Exclusive…