Ultragenyx seeks FDA nod for Sanfilippo A gene therapy

Published 19/12/2024, 14:10
Ultragenyx seeks FDA nod for Sanfilippo A gene therapy

This news is based on a press release statement from Ultragenyx Pharmaceutical (NASDAQ:RARE) Inc. Wall Street analysts maintain a strong buy consensus on the stock, with price targets ranging from $48 to $140 per share. For comprehensive analysis and detailed valuation metrics, check out the full RARE Research Report, available exclusively on InvestingPro. Wall Street analysts maintain a strong buy consensus on the stock, with price targets ranging from $48 to $140 per share. For comprehensive analysis and detailed valuation metrics, check out the full RARE Research Report, available exclusively on InvestingPro.

Sanfilippo syndrome type A, also known as MPS IIIA, is a lysosomal storage disease that leads to severe neurodegeneration, with symptoms typically emerging in early childhood. The disease is estimated to affect between 3,000 and 5,000 patients in areas with market access and has a median life expectancy of 15 years. It is caused by mutations in the SGSH gene, which result in the accumulation of heparan sulfate and subsequent cell damage.

The BLA for UX111 is underpinned by data from the ongoing Transpher A study, which indicates that treatment with UX111 leads to a rapid and sustained decrease in cerebrospinal fluid heparan sulfate levels. This reduction correlates with improved cognitive development outcomes when compared to natural disease progression.

UX111 has been designed as a one-time intravenous infusion using a self-complementary AAV9 vector that delivers a functional copy of the SGSH gene to cells. The therapy aims to address the underlying enzyme deficiency responsible for the disease's progression.

The FDA's acceptance of cerebrospinal fluid heparan sulfate as a biomarker for accelerated approval was a significant milestone for Ultragenyx. This decision followed discussions and data presentations at a workshop hosted by the Reagan-Udall Foundation for the FDA in February 2024.

This news is based on a press release statement from Ultragenyx Pharmaceutical (TADAWUL:2070) Inc. Wall Street analysts maintain a strong buy consensus on the stock, with price targets ranging from $48 to $140 per share. For comprehensive analysis and detailed valuation metrics, check out the full RARE Research Report, available exclusively on InvestingPro.

The most common treatment-related adverse events reported were mild to moderate elevations in liver enzymes, all of which resolved. The company, experienced in rare disease therapeutics, emphasizes its commitment to efficient drug development and delivering effective therapies urgently.

This news is based on a press release statement from Ultragenyx Pharmaceutical Inc.

In other recent news, Ultragenyx Pharmaceutical Inc. reported a substantial 42% year-over-year increase in its Q3 2024 revenue, reaching $139 million. Despite recording a net loss of $134 million for the quarter, the company remains on track with its clinical pipeline and anticipates achieving GAAP profitability by the end of 2026. Ultragenyx is preparing for Biologics License Application (BLA) submissions for treatments targeting rare diseases, with potential for three new therapies launching in upcoming years.

The company's CEO, Emil Kakkis, underscored the significance of timely execution in rare disease programs and discussed the AURORA study for Angelman syndrome. Crysvita, one of the company's leading products, contributed $98 million to the total revenue, with projections for the year between $530 million and $550 million. Ultragenyx also plans to initiate a Phase 3 trial for GTX-102 by year-end.

These recent developments underline Ultragenyx's growth in the rare disease market. Despite the net loss in the recent quarter, the company's robust cash reserves of $825 million provide a solid foundation for continued investment in rare disease treatments. The company's strategic focus on BLA submissions and international product launches positions it for potential future successes.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

Latest comments

Risk Disclosure: Trading in financial instruments and/or cryptocurrencies involves high risks including the risk of losing some, or all, of your investment amount, and may not be suitable for all investors. Prices of cryptocurrencies are extremely volatile and may be affected by external factors such as financial, regulatory or political events. Trading on margin increases the financial risks.
Before deciding to trade in financial instrument or cryptocurrencies you should be fully informed of the risks and costs associated with trading the financial markets, carefully consider your investment objectives, level of experience, and risk appetite, and seek professional advice where needed.
Fusion Media would like to remind you that the data contained in this website is not necessarily real-time nor accurate. The data and prices on the website are not necessarily provided by any market or exchange, but may be provided by market makers, and so prices may not be accurate and may differ from the actual price at any given market, meaning prices are indicative and not appropriate for trading purposes. Fusion Media and any provider of the data contained in this website will not accept liability for any loss or damage as a result of your trading, or your reliance on the information contained within this website.
It is prohibited to use, store, reproduce, display, modify, transmit or distribute the data contained in this website without the explicit prior written permission of Fusion Media and/or the data provider. All intellectual property rights are reserved by the providers and/or the exchange providing the data contained in this website.
Fusion Media may be compensated by the advertisers that appear on the website, based on your interaction with the advertisements or advertisers
© 2007-2025 - Fusion Media Limited. All Rights Reserved.