On Monday, in the course of Morning trade, Shares of Keryx Biopharmaceuticals Inc. (NASDAQ:KERX), dropped -1.65%, and is now trading at $10.72, hitting its lowest level.
Today, Keryx Biopharmaceuticals declared its financial results for the first quarter ended March 31, 2015.
First Quarter 2015 Business Highlights
- For the quarter ended March 31, 2015, Keryx stated total revenue of about $1.2 million, counting net U.S. Auryxia product revenue and license revenue associated with royalties received on sales of Riona(R) (ferric citrate) in Japan. The Company recognized U.S. product sales based on 1,218 prescriptions filled for Auryxia during the quarter, based on data received from IMS Health and specialty pharmacies that don’t report data to IMS, counting Davita Rx and Fresenius Rx.
- In January 2015, Keryx accomplished an underwritten public offering of common stock, which offered proceeds to the Company of about $118.3 million, net of underwriting discounts and offering expenses. Keryx ended the first quarter with $168.8 million in cash and cash equivalents. Additionally, the Company ended the first quarter with about $27.2 million of inventory on its merged balance sheet, primarily comprising of Auryxia active pharmaceutical ingredient.
- The Company is seeking to expand the indication for Auryxia to comprise the treatment of iron deficiency anemia in patients with stages 3 — 5 non-dialysis dependent chronic kidney disease (CKD), who have formerly not responded to oral iron therapy. Keryx initiated a phase 3 study for this target indication in September 2014 and this study is now more than 70% enrolled. This placebo controlled study is predictable to enroll 230 patients and will evaluate changes in hemoglobin as the primary endpoint. The Company is on track to complete the study by the end of 2015. If this study is successful, Keryx intends to file a supplemental new drug application with the FDA seeking label expansion of Auryxia.
- The European review of the marketing authorization application (MAA), seeking regulatory approval of Auryxia as a treatment for hyperphosphatemia in patients with CKD, counting dialysis- and non-dialysis-dependent CKD, is ongoing. In January, the Company responded to the European Medicine Agency’s (EMA) 120-day questions. In April, Keryx requested a 2-month extension to provide adequate time to respond to the final questions from the EMA and anticipates a mid-2015 opinion from the Committee for Medicinal Products for Human Use (CHMP) and subsequent regulatory approval from the EMA.
Keryx Biopharmaceuticals, Inc., a biopharmaceutical company, focuses on providing therapies for patients with renal disease in the United States. Its lead product Auryxia (ferric citrate), an oral, ferric iron-based compound that has the capacity to bind to phosphate in the gastrointestinal tract and form non-absorbable complexes, in addition to treats iron deficiency anemia.
On the other hand, Spark Therapeutics, Inc. (NASDAQ:ONCE), lost -12% Monday.
Spark Therapeutics, declared that it will have several presentations during the Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO), taking place in Denver, Colorado, from May 3rd through May 7th in addition to at the Retina Gene Therapy conference in Denver on May 8th. ARVO is the largest gathering of eye and vision researchers in the world, attracting over 11,000 attendees from more than 75 countries.
In its development of SPK-RPE65 as a potential gene therapy treatment for RPE65-mediated inherited retinal degenerations (IRDs), Spark is utilizing a proprietary mobility test of functional vision as the primary endpoint in its current Phase 3 clinical trial. While traditional vision tests, such as visual acuity or visual fields, measure discrete aspects of visual function, there is a growing need for a validated ability to measure functional vision in subjects with IRDs. The mobility test was designed to assess a subject’s ability to function in a particular visual environment and to carry out typical activities of daily living, assessing light sensitivity, visual fields, visual acuity and navigational ability in one measure. Subjects in a Phase 1 clinical trial of SPK-RPE65 have been followed from two to four years after injection of the second eye and the levels of improvement from baseline generally have been maintained. These observations of durability are further supported by retinal sensitivity testing.
On Wednesday, May 6th, Sarah McCague of The Children’s Hospital of Philadelphia and Dr. Daniel Chung, Spark’s Medical Affairs Ophthalmic Lead, will present a poster entitled “Mobility Testing Validation Study — Using a Novel, Standardized Mobility Test to Evaluate Functional Vision in Patients with Inherited Retinal Degeneration” detailing an evaluation of the construct and content validity, reliability and the ability of the mobility test to detect changes in functional vision over time. The study enrolled 60 subjects, counting individuals with normal vision and with IRDs, and tracked changes in performance over a 12-month time period. The reliability and reproducibility of 12 different courses, in addition to the change in performance in test subjects, will be presented.
Spark Therapeutics, Inc. focuses on the development of gene therapy products for patients suffering from debilitating genetic diseases. The company is developing SPK-RPE65, which is in Phase III clinical trial for the treatment of inherited retinal dystrophies, a group of rare blinding conditions caused by non-sex linked, or autosomal recessive, mutations in the RPE65 gene.
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