pdufa.bio

TSHA-101

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

TSHA-101 is a Taysha Gene Therapies, Inc. program. Its next catalyst is a Readout in Mar 2027. Every date links its source.

TSHA catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Taysha Gene Therapies, Inc. (TSHA). We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

Readout · Mar 2027TSHA

Specialist biotech funds holding TSHA, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Avoro Capital Advisors23,888,888$162.7 millionfiled August 14, 2026
RA Capital Management23,555,648$160.4 millionfiled August 14, 2026
RTW Investments13,560,258$92.3 millionfiled August 14, 2026
Baker Bros. Advisors4,004,756$27.3 millionfiled August 14, 2026
OrbiMed Advisors2,000,000$13.6 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is TSHA-101's next FDA decision or readout?

The next tracked catalyst for TSHA-101 is a Readout in Mar 2027.

What happened at TSHA-101's most recent FDA decision?

No FDA decision for TSHA-101 is in our archive yet.

Who makes TSHA-101?

Taysha Gene Therapies, Inc. (TSHA).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.