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Agios Pharmaceuticals

AGIO Rare disease Lead: Approved 3 Biotech Distilled articles ↓ 12 filings & releases ↓ Cash $129M (Sep 30, 2026) ↓ 3 verdicts ↓
HematologyMetabolic Nucleic AcidSmall Molecule

Market cap $1.76B 59.8M shares (10-Q, Oct 30, 2026) × $29.41 close Nov 6, 2026

Most recent annual filing: 2026-02-12

Catalyst timeline

9 trackedQuarter catalyst calendar →
  1. HIBISCUS Etavopivat Ph3 readout2026HIBISCUS Etavopivat Ph3 readout, 2026, notable
  2. AG-181 Ph2 readout2H 2026AG-181 Ph2 readout, 2H 2026, notable
  3. Etavopivat Novo Nordisk filing2H 2026Etavopivat Novo Nordisk filing, 2H 2026, notable
  4. AG-236 Ph2 start2H 2026AG-236 Ph2 start, 2H 2026, routine
  5. Mitapivat Ex-US SCD FDA approval2027Mitapivat Ex-US SCD FDA approval, 2027, major
  6. Mitapivat sNDA SCD FDA approvalFeb 1, 2027Mitapivat sNDA SCD FDA approval, Feb 1, 2027, thesis-defining
  7. PYRUKYND corporate updateFeb 17, 2027PYRUKYND corporate update, Feb 17, 2027, routine
  8. Etavopivat Novo Nordisk FDA decision~Mid-2027 to early 2028 (estimate)Etavopivat Novo Nordisk FDA decision, ~Mid-2027 to early 2028 (estimate), major
  9. Cevidoplenib Ph3 start1H 2028Cevidoplenib Ph3 start, 1H 2028, 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 (7 active programs)

Discontinued (2)

Capital (as filed)

Cash
$129M cash and cash equivalents · Sep 30, 2026 (10-Q)
Short-term investments
$501M Sep 30, 2026
Long-term investments
$277M Sep 30, 2026
Operating cash flow
−$59.2M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$907M cash per the update of Nov 5, 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 (3)

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

Verdict history (3 calls)

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

  1. 2026-10-16 Watch Agios Pharmaceuticals (AGIO) - Scientific Deep Dive for Mitapivat (PYRUKYND / AQVESME) and Pipeline Products Mitapivat is a real franchise with cash backing and likely SCD approval, but the surrogate-based filing, missed crisis endpoint, and superior once-daily rival (etavopivat) make the risk/reward roughly fair at current prices; wait for the label and HIBISCUS data.
  2. 2026-10-31 Watch UPDATE: Agios Pharmaceuticals (AGIO) - The REMS Rerun FDA extended the PDUFA to February 1, 2027 over REMS concerns, shortening the first-mover window over etavopivat and placing full HIBISCUS data before the SCD label; no CRL or compound-patent challenge has occurred, so PASS triggers are not met, but upgrade requires a REMS-free label.
  3. 2026-11-06 Watch UPDATE: Agios Pharmaceuticals (AGIO) - The Record Quarter the Market Sold Record Q3 thalassemia revenue of $48.7M and 75% six-month persistence strengthen the launch floor, but the SCD leg is unchanged — a REMS still looks likely, HIBISCUS reports before the February 1 label, and the voxelotor precedent remains; waiting for ASH and February 1 is still the sensible course.

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.

Filings & releases (12)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from Oct 30, 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 →

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