Recently, Taysha Gene Therapies announced it has regained full rights to its lead gene therapy candidate TSHA-102 for Rett syndrome after the expiration of an option agreement with Astellas, following the submission of clinical trial data and receipt of Breakthrough Therapy designation from the FDA.
This development leaves Taysha in a position to independently advance TSHA-102, a one-time treatment for Rett syndrome utilizing miRARE technology, with multiple regulatory designations highlighting its clinical and regulatory significance.
We’ll examine how Taysha’s regained autonomy over its FDA-designated gene therapy could influence the company’s investment outlook and growth prospects.
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To own shares in Taysha Gene Therapies, investors must believe in the potential of TSHA-102 to achieve regulatory approval and transition to commercialization for Rett syndrome, overcoming the inherent risks of long clinical timelines and financial losses. The recent regaining of full rights to TSHA-102 boosts Taysha’s ability to independently steer its pivotal trial; however, this news does not materially alter the short-term catalyst, which remains the progress and outcome of upcoming regulatory milestones. The most important risk continues to be the timing and outcome of regulatory review processes.
Among recent announcements, the FDA’s Breakthrough Therapy designation for TSHA-102 stands out, underscoring the therapy’s clinical significance and helping clarify the regulatory path. This designation could accelerate Taysha’s route to potential approval, which directly supports the company’s most critical near-term catalyst, successful progression within the REVEAL pivotal trial framework.
In contrast, investors should be aware that even with positive clinical momentum, regulatory requirements and timelines could …
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Taysha Gene Therapies’ outlook anticipates $88.9 million in revenue and $14.1 million in earnings by 2028. This scenario depends on a 120.1% annual revenue growth rate and a $103.4 million increase in earnings from the current level of -$89.3 million.
Uncover how Taysha Gene Therapies’ forecasts yield a $9.50 fair value, a 101% upside to its current price.
TSHA Community Fair Values as at Oct 2025
Three separate fair value estimates from the Simply Wall St Community range from US$9.50 to US$27.86 per share. While some see substantial upside, the company’s dependence on FDA approvals means outcomes could differ widely, explore how these perspectives could impact your own view.
Explore 3 other fair value estimates on Taysha Gene Therapies – why the stock might be worth just $9.50!
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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.
Companies discussed in this article include TSHA.
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