Recent 8-K filings for TSHA
Highest-materiality recent filing
Taysha Gene Therapies Announces FDA Alignment on Pivotal Part B Trial Design for TSHA-102 in Rett Syndrome
- 100% of 10 patients in Part A gained/regained ≥1 developmental milestone post-TSHA-102, with ~0% likelihood from natural history data.
- FDA supports single-arm open-label pivotal trial (N=15) with primary endpoint of developmental milestone gain/regain in patients ≥6 years.
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Taysha Q1 net loss $42.4M; FDA aligns on TSHA-102 BLA submission pathway
Net loss $42.4M ($0.12/sh) vs $21.5M ($0.08/sh) Q1 2025; R&D expense doubled to $33.8M on PPQ and clinical costs.
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Taysha reports FY2025 net loss $109M; TSHA-102 pivotal trial dosing on track to complete Q2 2026
Net loss $109.0M ($0.34/share) vs $89.3M ($0.36) in 2024; R&D expenses rose to $86.4M.
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Taysha Gene Therapies: TSHA-102 gets FDA Breakthrough Therapy, Q3 net loss $32.7M
FDA granted Breakthrough Therapy designation for TSHA-102 in Rett syndrome; FDA alignment finalized on REVEAL pivotal trial protocol with 6-month interim analysis to expedite BLA.
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Taysha regains full rights to TSHA-102 for Rett syndrome after Astellas option expires
Regained full rights to lead TSHA-102 program after 2022 Option Agreement with Astellas expired.
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All 10 patients (Part A) achieved ≥1 natural-history-defined developmental milestone post-TSHA-102, 0% to <6.7% likelihood without treatment.
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FDA Breakthrough Therapy designation for TSHA-102 based on Part A data from 12 patients showing 100% response rate on milestone gain.
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Taysha Q2 net loss $26.9M; TSHA-102 pivotal trial site activation begun, enrollment Q4 2025
Cash $312.8M after $230M follow-on offering; runway extended into 2028.
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Taysha reports FDA-aligned pivotal trial for TSHA-102; 100% of Part A patients gained milestones
FDA aligned on single-arm pivotal Part B trial (N=15) for TSHA-102 in Rett syndrome patients ≥6 years; primary endpoint: developmental milestone gain/regain.
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Issued 46.9M shares at $2.75/sh and 25.9M pre-funded warrants at $2.749; net proceeds ~$187.4M.
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100% of 10 patients in Part A gained/regained ≥1 developmental milestone post-TSHA-102, with ~0% likelihood from natural history data.
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Taysha secures FDA alignment on TSHA-102 pivotal trial design; Q1 net loss $21.5M
FDA alignment on pivotal Part B trial design; IND amendment with protocol/SAP expected Q2 2025, potentially expediting registration.
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Net loss $89.3M ($0.36/sh) vs $111.6M ($0.96/sh) in FY2023; cash $139.0M, runway into Q4 2026.
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Taysha Q3 net loss $25.5M; TSHA-102 high dose safe; FDA aligns on pivotal trial design
Net loss $25.5M ($0.10/sh) vs $117.1M loss in Q3 2023; cash $157.7M into Q4 2026.
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Taysha launches $75M public offering; reports positive clinical data in Rett syndrome
Commenced underwritten public offering of up to $75M in common stock and pre-funded warrants; underwriters have 30-day option for additional 15%.
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Taysha Gene Therapies prices $75M public offering of common stock and pre-funded warrants
Gross proceeds ~$75M; 14,361,113 shares at $2.25 each and 18,972,221 pre-funded warrants at $2.249 each.
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Longer-term adult data (up to 52 weeks) show durable improvements in motor, communication, autonomic, and seizure domains.
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Taysha Q1 net loss $24.1M; TSHA-102 advances to high-dose cohort, gets RMAT designation
Q1 net loss of $24.1M ($0.10/share) vs $17.6M loss a year ago; R&D expenses $20.7M.
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Taysha reports 2023 net loss of $111.6M; TSHA-102 shows sustained improvements in Rett patients
Revenue of $15.5M for full-year 2023 (up from $2.5M in 2022) from Astellas option agreement.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.75 · Most common event other_material