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Fractyl Health

GUTS Lead: Phase 3 ★ Read the deep dive → 12 Biotech Distilled articles ↓ 33 filings & releases ↓ Cash $47.1M (Jun 30, 2026) ↓ 12 verdicts ↓ 3 timing quotes ↓
Metabolic

Most recent annual filing: 2026-01-15

Catalyst timeline

4 trackedQuarter catalyst calendar →
  1. Fractyl corporate financing4Q 2026/1Q 2027Fractyl corporate financing, 4Q 2026/1Q 2027, routine
  2. Revita filinglate 4Q 2026Revita filing, late 4Q 2026, notable
  3. Revita pivotal topline1Q 2027Revita pivotal topline, 1Q 2027, major
  4. Company-wide corporate update2Q 2027Company-wide corporate update, 2Q 2027, routine

Bar width shows how precise the guidance is — a pin is a stated date, a wide band a six-month window. Deeper blue means more of the thesis rides on the event; it is not a view on the stock.

Pipeline (1 active programs)

Technology platforms

Rejuva

AAV-delivered pancreatic gene therapy platform designed to enable long-term remission of T2D and obesity by durably reprogramming pancreatic islet cells to endogenously produce metabolic hormones (GLP-1, GIP, PYY, amylin, glucagon). Modular platform using AAV9 vectors with tissue-restricted insulin promoter-driven transgene expression, delivered via proprietary endoscopic device directly to the pancreas.

Targets: GLP-1, GIP, PYY, amylin

Discontinued (3)

Capital (as filed)

Cash
$47.1M cash and cash equivalents · Jun 30, 2026 (10-Q)
Operating cash flow
−$15.9M quarter Mar 31, 2026 → Jun 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$47.1M cash, runway early 2027 per the update of Oct 16, 2026 — the company's own words as read there, not the filed figure

Cash, investments and operating cash flow are the company's own XBRL facts as filed with the SEC, each shown with its period end and tag. As-stated figures come from the company's own words as read in Biotech Distilled coverage, dated, and routinely count securities and planned financing that a balance sheet does not. Offering rows are the SEC cover pages as filed. Not investment advice. Figures as of Nov 7, 2026.

Biotech Distilled coverage (12)

Articles open on Substack. Some are subscriber-only; those marked ★ Distilled Pro are for Distilled Pro members.

Verdict history (12 calls)

Every verdict Biotech Distilled has published on Fractyl Health, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-01-07 Speculative buy speculative Fractyl Health (GUTS): Scientific Deep Dive for Revita® and Rejuva® Strong mechanistic proof-of-concept and cleared financing overhang create favorable risk/reward for the January 2026 randomized data readout, but binary risk warrants speculative sizing.
  2. 2026-01-30 Buy speculative UPDATE: Fractyl Health (GUTS) - The Mixed Data Crash (6-Mo Readout) The 70% stock drop appears to be an overreaction to small-n statistical noise; the underlying biology in the high-responder target population remains intact (p=0.004), and the larger powered pivotal trial should wash out the noise.
  3. 2026-02-28 Buy core UPDATE: Fractyl Health (GUTS) - The Clock is Set Completion of REMAIN-1 pivotal randomization removes trial execution risk, runway is confirmed through the early Q4 2026 readout, and real-world physician/patient demand reinforces the Ozempic off-ramp thesis.
  4. 2026-03-29 Buy core UPDATES: Fractyl Health (GUTS) - Insiders Buys CEO and CFO combined open-market purchase of 350,000 shares at $0.55–$0.57 immediately after earnings reinforces that the January sell-off was a structural overreaction, not a fundamental failure of the science.
  5. 2026-05-12 Buy core UPDATE: Fractyl Health (GUTS) - The Moonshot Gets a Clinic Dutch CTA clearance for RJVA-001 gene therapy adds a second H2 2026 catalyst, re-rates pipeline optionality the market was pricing at zero, and validates the insider buys; Revita pivotal remains the base case.
  6. 2026-06-04 Buy core UPDATE: Fractyl Health (GUTS) - The Durability Question, Answered REVEAL-1 12-month open-label data shows 100% of patients cleared the pivotal's co-primary responder threshold and ~78% of GLP-1 weight loss was retained, directly answering the durability bear case from January.
  7. 2026-07-15 Buy core UPDATE: Fractyl Health (GUTS) - The Durability Question, Answered (Randomized Edition) Randomized 12-month REMAIN-1 Midpoint data confirms durable ~40–70% reduction in weight regain vs sham with a dose-response gradient, and favorable FDA De Novo feedback materially de-risks the regulatory pathway ahead of the Q4 pivotal readout.
  8. 2026-08-11 Speculative buy speculative UPDATE: Fractyl Health (GUTS) - The Going Concern Arrives A formal going-concern qualification and $47.1M cash against a $10M covenant floor shift the downgrade from conviction buy to speculative; the clinical thesis is intact but the balance sheet now makes this a genuine lottery ticket requiring lottery-ticket position sizes.
  9. 2026-09-11 Speculative buy speculative UPDATE: Fractyl Health (GUTS) - The September 9 Deadline Came and Went Nasdaq delisting letter arrived as expected, Panel hearing stay keeps shares trading through the Q4 pivotal readout, and a reverse split is the near-certain cure; science is unchanged but the listing and financing risks compound the consequence of a pivotal miss.
  10. 2026-10-01 Speculative buy speculative UPDATE: Fractyl Health (GUTS) - The Split Is Locked 1-for-12 reverse split is confirmed and mechanically cures the Nasdaq bid-price rule; science and De Novo timeline are unchanged, but the 30% price slide since September means the Tranche B warrant financing now requires a clearly strong pivotal result to reach.
  11. 2026-10-16 Hold UPDATE: Fractyl Health (GUTS) - The Pivotal Hit. The Stock Imploded. REMAIN-1 pivotal met its co-primary endpoint (p=0.0023) validating the mechanism, but the effect size came in at roughly half of what Midpoint implied and the balance sheet now outranks the biology — existing holders should wait to see who writes the financing check and on what terms before acting.
  12. 2026-10-22 Hold UPDATE: Fractyl Health (GUTS) - The Moonshot Gets Cut Dropping Rejuva and cutting 45% of staff halves the burn rate and extends runway into Q2 2027, funding both the De Novo filing and 12-month readout, but a raise before launch still looks unavoidable and new money may be better served waiting for the financing to set the dilution.

Every verdict Biotech Distilled has published on this company, in order, with the post it came from — the full history, never a selection. Position figures are the same ones shown on /track-record, computed by the same method. Editorial opinion, not investment advice.

Timing, in the company's words (3 quotes from 2 filings)

Sentences quoted verbatim from the company's SEC filings, newest filing first. Each sits under the filing it appeared in; the "matched to" tag names the calendar row it was read for.

Timing sentences quoted from the company's own SEC filings, each under the filing it appeared in. The 'matched to' tag is the calendar row the sentence was read for; the filing is the source. Not investment advice.

Filings & releases (33)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Jun 1, 2026; filings from March 2026. Summaries come from the BD update that read the document; "BD extracted" counts point at the pipeline table above. All companies →

6 more filings (13G holder notices, S-8, proxy material, SEC correspondence …)