Regenxbio (RGNX) Misses Q2 EPS by 2c, Revenues Miss
Regenxbio (NASDAQ: RGNX) reported Q2 EPS of ($0.91), $0.02 worse than the analyst estimate of ($0.89). Revenue for the quarter came in at $16.57 million versus the consensus estimate of $22.07 million.
"Now halfway through 2020 and with the backdrop of the challenging COVID-19 pandemic, I am pleased that we have made significant progress in our gene therapy programs and continue to make important decisions with respect to our pipeline and plans. We expect to initiate the RGX-314 wet AMD pivotal program later this year based on the latest data from our RGX-314 Phase I/IIa trial, which has demonstrated durable treatment effect, with stable to improved visual acuity and retinal thickness. We also look forward to dosing patients in our RGX-314 trials using the suprachoroidal delivery approach for the treatment of wet AMD and diabetic retinopathy later this year," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "Our team has also been hard at work moving our CNS-focused gene therapy programs forward. We have completed dosing of patients in the second cohort of our Phase I/II study of RGX-121 for the treatment of MPS II, which includes one patient dosed in Brazil at our first ex-U.S. gene therapy site. We look forward to providing additional updates for this program, as well as our RGX-111 program for the treatment of MPS I, later this year."
Mr. Mills continued: "We are committed to continuously evaluating our portfolio of gene therapy candidates, with innovation and patient needs in mind. Today, we have announced the expansion of our pipeline to include RGX-381 for the treatment of ocular manifestations of CLN2 disease, also known as Batten disease. This will complement our existing RGX-181 program for the treatment of CLN2 disease in the central nervous system. I look forward to providing additional details and updates for RGX-381 and RGX-181 in the coming months."
"Finally, we have made the difficult decision to discontinue the development of RGX-501 for the treatment of HoFH. This program was one of our first clinical-stage gene therapy programs, and we are grateful for the support of the HoFH patient community over the years. We will look for opportunities to support the continued advancement of this program through business development."
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