TXMD All Set For D-day, IMMU Soars On Strategic Plan, CTSO On Watch

(RTTNews) - 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.

Read on.

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 Global Licensing Agreement with Seattle Genetics (SGEN), returning full rights of Sacituzumab Govitecan to Immunomedics.

Sacituzumab Govitecan is under phase II study in heavily pretreated patients with metastatic triple-negative breast cancer.

Immunomedics also announced that it has raised $125 million in gross proceeds in a private placement of its Series A-1 Convertible Preferred Stock with institutional investors, and has taken a series of steps to drive positive organizational and operational changes.

IMMU closed Friday's trading at $6.36, up 17.56%.

Teva Pharmaceutical Industries Ltd. (TEVA) and Active Biotech's phase III trial of oral Laquinimod for the treatment of relapsing remitting multiple sclerosis, dubbed CONCERTO, has failed to meet the primary endpoint.

The trial's primary endpoint was the time to Confirmed Disability Progression after at least 3 months, which was not met.

The Companies have decided not to pursue Laquinimod in relapsing remitting multiple sclerosis.

Teva continues to evaluate the potential of Laquinimod in primary progressive MS (PPMS) and Huntington disease (HD) with two other clinical trials unaffected by the results of the CONCERTO trial.

TEVA closed Friday's trading at $31.14, up 0.87%.

Investors of TherapeuticsMD Inc. (TXMD) are eagerly waiting to know what the future holds for the Company's drug candidate TX-004HR.

TX-004HR, also known as Yuvvexy, is an applicator-free vaginal estradiol softgel for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar vaginal atrophy (VVA) in postmenopausal women. The FDA was supposed to have announced the decision of whether or not to approve Yuvvexy on May 7, 2017.

On April 10, 2017, the Company was informed that the FDA had identified deficiencies in the NDA for Yuvvexy. The deficiencies identified were not specified.

The company is scheduled to host a conference call and live audio webcast to provide a TX-004HR regulatory update on May 8, 2017.

TXMD closed Friday's trading at $4.67, up 3.55%.