Taysha shares jumped after analysts at Baird, H.C. Wainwright, and Needham turned bullish, citing FDA alignment and an expedited approval path for its Rett syndrome therapy.
Shares of Taysha Gene Therapies ended at their highest level in over three years on Thursday after a wave of bullish analyst upgrades followed the U.S. Food and Drug Administration’s (FDA) Breakthrough Therapy designation for its Rett syndrome gene therapy candidate, TSHA-102.
The stock soared 53.5% on Thursday, extending gains by another 2% in after-hours trading.
Baird raised its price target on Taysha to $12 from $7 and reiterated an ‘Outperform’ rating. Analyst Jack Allen said the firm is “encouraged” that Taysha reached alignment with the FDA on the 15-patient pivotal study for TSHA-102, calling the breakthrough therapy designation “another encouraging sign” for the company’s regulatory and clinical progress.
H.C. Wainwright said Taysha has added roughly $1.2 billion to its valuation since receiving Breakthrough Therapy designation and aligning with the FDA on a six-month interim Biologics License Application (BLA) filing plan.
The firm noted that while the accelerated pathway appears faster “on paper,” Rett specialists it surveyed said the six-month interim analysis was “directionally useful but insufficient on its own to be considered definitive for projecting patient outcomes.”
The analysts added that Taysha’s pathway “looks faster on paper, but may not translate into a true lead.” In comparison, the firm said Neurogene, whose FDA-cleared 12-month design “mitigates the risk of approvability,” looks “deeply undervalued.” H.C. Wainwright reiterated its Buy rating and $45 price target on Neurogene, citing its durability focus and caregiver appeal.
Needham analyst Gil Blum also raised the price target on Taysha to $10 from $8, keeping a ‘Buy’ rating. Blum told investors that the FDA’s feedback on Taysha’s registrational study design “checked off a wishlist of features,” including the agency’s willingness to allow for a six-month interim filing. The analyst said these developments “derisk” the TSHA-102 program and position it “well ahead of NGNE-401.”
The FDA’s Breakthrough Therapy designation was based on data from 12 patients in an early-to mid-stage trial of TSHA-102 and allows for an expedited review process.
Taysha has finalized alignment with the agency on the design of its registrational study, which will test a single intrathecal administration of high-dose TSHA-102 in 15 female patients aged 6 to under 22 years. The company plans to begin enrollment in the fourth quarter of 2025.
On Stocktwits, retail sentiment for Taysha was ‘extremely bullish’ amid a 34,800% surge in 24-hour message volume.
One retail trader said they expect institutional investors to accumulate Taysha shares around the $5 mark, predicting a quick move toward $6.
Another user said they had exited their position at $4.85, citing the company’s high debt levels and booking an 8% profit.
Taysha’s stock has nearly tripled so far in 2025.
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