TX2100 is a Tectonic Therapeutic, Inc. program. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Sponsor: Tectonic Therapeutic, Inc. (TECX). Review status: Tectonic Therapeutic announced favorable Phase 1 safety, tolerability and PK results for TX2100 in hereditary hemorrhagic telangiectasia on September 29, 2026 (8-K exhibit 99.1). We track 1 catalyst event for this program: 0 upcoming and 1 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.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| Baker Bros. Advisors | 607,788 | $20.9 million | filed August 14, 2026 |
| OrbiMed Advisors | 226,600 | $7.8 million | filed 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.
TX2100's most recent tracked catalyst has already reported: positive data on Sep 29, 2026, per the company's own release (linked in the history below). No further catalyst is on our calendar yet.
No FDA decision for TX2100 is in our archive yet.
Tectonic Therapeutic, Inc. (TECX).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.