Regenxbio (NASDAQ: RGNX) reported Q4 EPS of $0.11, $0.45 better than the analyst estimate of ($0.34). Revenue for the quarter came in at $40.78 million versus the consensus estimate of $17.33 million.

• Announces updates from recently expanded RGX-314 Phase I/IIa trial for wet AMD
  • Completed dosing of six additional subjects in the fourth cohort for a total of 12 subjects; 30 subjects dosed across four cohorts in the trial
  • On-track to initiate Phase IIb trial for wet AMD in late 2019
  • Continues to advance development of RGX-314 for other chronic retinal diseases; new IND submission for a Phase II trial in an additional retinal condition planned in second half 2019
  • Hosted an Analyst and Investor Day on February 21, 2019, with leading retina specialists who provided their perspectives on the potential advantages of one-time gene therapy as a foundational anti-VEGF treatment for wet AMD and other retinal diseases
• Continuing additional site activation and subject recruitment in RGX-121 Phase I/II trial for MPS II; recruitment continues in RGX-111 Phase I trial for MPS I
• Resumed recruitment in the RGX-501 Phase I/II trial for HoFH
• IND-enabling studies progressing for RGX-181 for CLN2 form of Batten disease; on-track to submit IND for first-in-human trial in second half 2019
• First anticipated commercial launch for a proprietary NAV® Technology-based treatment, Novartis\' ZOLGENSMA® for the treatment of SMA Type I, expected in first half 2019 in United States and Japan; European launch expected in second half 2019
• $471 million in cash, cash equivalents and marketable securities as of December 31, 2018

"2018 was a pivotal year for REGENXBIO. Significant clinical and regulatory progress was made in advancing our NAV Technology Platform across 18 diverse clinical stage programs, four of which are in our own expanding pipeline of gene therapy product candidates for the treatment of retinal, neurodegenerative and metabolic diseases," said Kenneth T. Mills, President and Chief Executive Officer of REGENXBIO. "In 2019, we are focused on advancing and expanding our ophthalmology franchise with RGX-314, our lead product candidate for subjects with wet AMD, by extending development of this asset as a one-time anti-VEGF treatment in another chronic retinal condition. In addition, we anticipate the launch of the first NAV Technology-based treatment, Novartis' ZOLGENSMA for the treatment of SMA Type I, in the United States, Japan and Europe in 2019. This would be a major commercial milestone for our NAV Technology Platform and represent a post-launch commercial revenue stream for REGENXBIO.\"

Mr. Mills added: \"Our mission is to improve lives through the curative potential of gene therapy. We continue to execute on our strategic priorities including the expansion of RGX-314 development into additional retinal conditions, advancing our current clinical programs with RGX-314, RGX-121, RGX-111 and RGX-501 and enabling our NAV Technology licensee network to develop potentially life-changing treatments. We believe we are well-positioned for a transformative 2019 as we build on last year\'s pivotal achievements and broaden our NAV Technology footprint."

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