On Monday, Shares of Omeros Corporation (NASDAQ:OMER), added 3.54% and closed at $7.60 in the last trading session. OMER stock opened its last trade at $8.63 and after floating in a range of $7.45 to $8.70. The company’s Market capitalization is $306.56 million with the total Outstanding Shares of 42.76 million. During the 52-week trading session the minimum price at which share price traded, registered at $7.26 and reached to max level of $16.80. Omeros Corporation (OMER) recently declared positive data from the company’s Phase 2 clinical trial of OMS721 for the treatment of kidney disorders, none of which presently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. Statistical significance (p ≤ 0.017) was achieved on key endpoints of improvement in renal function. Omeros also stated the outcome of a recent FDA meeting regarding breakthrough therapy designation for OMS721 in immunoglobulin A (IgA) nephropathy (also known as Berger’s disease). Based on that meeting, Omeros is pursuing FDA breakthrough therapy designation. In addition to the Phase 2 program in renal diseases, OMS721 is being evaluated in a Phase 3 program for patients with atypical hemolytic uremic syndrome (aHUS) and in a Phase 2 program for patients with thrombotic microangiopathies (TMAs), counting hematopoietic stem cell transplant-associated TMAs and thrombotic thrombocytopenic purpura. OMS721 is Omeros’ lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.
The Phase 2 open-label renal trial is evaluating OMS721 across four different types of complement-associated kidney diseases: IgA nephropathy (i.e., Berger’s disease), membranous nephropathy, lupus nephritis, and complement component 3 (C3) glomerulopathy. Each of the four renal-disease cohorts was planned to enroll four patients. All patients in the trial must have high levels of urinary protein (a marker used by nephrologists to assess disease activity) despite ongoing treatment with a stable corticosteroid dose; these inclusion criteria ensure that study patients are unlikely to improve spontaneously. Patients are treated with OMS721 for a total of 12 weeks: four weeks maintaining their entry corticosteroid dose; four weeks of corticosteroid tapering, if tolerated; and four weeks of resultant corticosteroid dose maintenance. Patients are then followed post-treatment for six weeks. The key efficacy measures are urine albumin-to-creatinine ratios (uACRs) throughout the trial and change in 24-hour urine protein levels from baseline to the end of treatment. To date, two patients with IgA nephropathy, two patients with membranous nephropathy, and two patients with lupus nephritis have accomplished the trial. Additional patients have been enrolled and are being dosed.
EXACT Sciences Corporation (NASDAQ:EXAS), jumped 7.64% and closed at $19.73 in the last trading session. EXAS stock opened its last trade at $18.72 and after floating in a range of $18.58 to $22.80. The company’s Market capitalization is $2.08 Billion with the total Outstanding Shares of 106.77 million. During the 52-week trading session the minimum price at which share price traded, registered at $4.67 and reached to max level of $22.80. Exact Sciences Corp. (EXAS) recently declared that Cologuard® is now covered under TRICARE’s preventive services policies for use every three years without patient coinsurance, copayments or deductibles. The update was made after TRICARE’s review of its screening coverage policies to align them with the preventive services coverage mandate of the Affordable Care Act. TRICARE is the health care program of the U.S. Department of Defense, providing benefits to 9.4 million active-duty, reserve and National Guard personnel, veterans and their dependents.
“Cologuard is the ideal patient-friendly colon cancer screening option for America’s active military and veterans to use at-home, ensuring they can efficiently be screened for the most preventable form of cancer,” said Kevin Conroy, chairman and CEO of Exact Sciences. “Ensuring Cologuard is available to those who serve our country and their families with no out-of-pocket cost through TRICARE is a critical step toward increasing colon cancer screening.”
TRICARE’s advisory to Congress stated, “TRICARE will add coverage for additional preventive services in alignment with the United States Preventive Services Task Force (USPSTF) recommendations…. Collectively these changes also will revise TRICARE colon cancer screening provisions to allow coverage of stool DNA testing (e.g., Cologuard) once every 3 years starting at the age of 50 for individuals at average risk of colon cancer based on the USPSTF’s most recent recommendations. Coverage is effective June 21, 2016 for all beneficiaries.”