Regenxbio (RGNX) Misses Q1 EPS by 3c
Regenxbio (NASDAQ: RGNX) reported Q1 EPS of ($0.89), $0.03 worse than the analyst estimate of ($0.86). Revenue for the quarter came in at $884 thousand, versus $132.39 thousand reported last year.
- Reports positive interim update from RGX-314 Phase I/IIa trial for wet AMD in Cohort 3 over one year
- Announces new IND submission for RGX-314 for a Phase II trial in diabetic retinopathy; filing planned for second half 2019
- Continuing subject recruitment for RGX-121 Phase I/II trial for MPS II, RGX-111 Phase I trial for MPS I and RGX-501 Phase I/II trial for HoFH; interim updates for all trials expected in second half 2019
- On-track to submit IND for first-in-human trial of RGX-181 for CLN2 form of Batten disease in second half 2019
- Anticipates FDA approval of NAV Technology licensee Novartis\' Zolgensma for SMA Type I
- $444 million in cash, cash equivalents and marketable securities as of March 31, 2019
"We continue to be encouraged by the data from Cohort 3 of the RGX-314 Phase I/IIa trial for wet AMD, which demonstrated sustained protein expression and clinical effect on best corrected visual acuity and central retinal thickness measures at one year," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "These results further support the potential of our NAV Technology gene therapy, and we are excited to announce that we will expand clinical development of RGX-314 later this year into diabetic retinopathy, the most common cause of vision loss in people with diabetes, affecting approximately 8 million people in the United States alone."
Mr. Mills added: "This past quarter, we worked to drive significant clinical and regulatory progress across our five internal candidate programs for the treatment of retinal, neurodegenerative and metabolic diseases. We continue to advance our capabilities as a leader in the development and manufacture of NAV product candidates and to enable our NAV Technology licensee network to develop potentially life-changing treatments. As we celebrate the 10th anniversary of REGENXBIO's founding, we remain highly motivated and deeply committed to our mission of improving the lives of patients through the curative potential of gene therapy."
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