Q2 2024 Regenxbio Inc Earnings Call Transcript
Key Points
- Regenxbio Inc (RGNX) reported positive data for RGX-202, demonstrating consistent and robust microdystrophin expression across treated patients, including older ambulatory boys.
- The company completed a successful end-of-Phase 2 meeting with the U.S. FDA for RGX-202, with plans to file a BLA using microdystrophin as the primary endpoint for accelerated approval.
- Regenxbio Inc (RGNX) is advancing RGX-314 for diabetic retinopathy and wet AMD in collaboration with AbbVie, with plans to initiate pivotal trials in the first half of 2025.
- The company reported a strong financial position with $327 million in cash, cash equivalents, and marketable securities as of June 30, 2024, providing a runway into 2026.
- Regenxbio Inc (RGNX) is expanding its RGX-314 program to include patients with diabetic macular edema, further broadening the potential market for this gene therapy.
- Regenxbio Inc (RGNX) faces uncertainties and risks associated with forward-looking statements, which may cause actual results to differ from forecasts.
- The company reported a decrease in R&D expenses to $49 million for Q2 2024 from $60 million in Q2 2023, primarily due to reduced manufacturing and clinical supply costs, which may indicate slower progress in some areas.
- Regenxbio Inc (RGNX) is still awaiting final agreement from the FDA on the proposed threshold for microdystrophin levels for RGX-202, which could impact the approval process.
- The company has not yet finalized the safety database requirements for RGX-202, which could affect the timeline for approval.
- Regenxbio Inc (RGNX) faces competition in the gene therapy space, particularly for wet AMD, where other companies are also advancing their programs.
Welcome everyone to the Q2 2024 Regenxbio earnings conference call. (Operator Instructions)
At this time, I'd like to the conference over to Patrick Christmas, Chief Legal Officer of Regenxbio. Please go ahead.
Good afternoon, and thank you for joining us today. Earlier this afternoon. Regeneron bio released financial and operating results for the second quarter ended June 30th, 2020. For the press release is available on our website at www.regenxbio.com.
Today's conference call will include forward-looking statements regarding our financial outlook in addition to regulatory and product development plans. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ from those forecasted. It can be identified by words such as expect, plan, will, may, anticipate, believe, should, intend and other words of similar meaning any such forward-looking
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