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Eton Pharmaceuticals

ETON Rare disease Lead: Approved ★ Read the deep dive → 12 Biotech Distilled articles ↓ 39 filings & releases ↓ Cash $55.6M (Sep 30, 2026) ↓ 12 verdicts ↓ 7 timing quotes ↓
GI/HepatologyInfectious DiseaseMetabolicNeurologyRenal PeptideProteinSmall Molecule

Market cap $1.63B 28.8M shares (10-Q, Nov 2, 2026) × $56.46 close Nov 6, 2026

Most recent annual filing: 2026-03-15

Catalyst timeline

9 trackedQuarter catalyst calendar →
  1. INCRELEX trial start2H 2026INCRELEX trial start, 2H 2026, routine
  2. Amglidia NDA filingnear the end of 2026 or early 2027Amglidia NDA filing, near the end of 2026 or early 2027, notable
  3. ZENEO hydrocortisone autoinjector NDA filing2027ZENEO hydrocortisone autoinjector NDA filing, 2027, notable
  4. ET-700 extended-release zinc NDA filing2027ET-700 extended-release zinc NDA filing, 2027, notable
  5. ASN-001 NDA filingJan 2027ASN-001 NDA filing, Jan 2027, notable
  6. VALTOCO / LIBERVANT 12+ FDAJan 10, 2027VALTOCO / LIBERVANT 12+ FDA, Jan 10, 2027, material
  7. LIBERVANT PDUFA dateMar 29, 2027LIBERVANT PDUFA date, Mar 29, 2027, thesis-defining
  8. KHINDIVI FDA approvalMay 28, 2027KHINDIVI FDA approval, May 28, 2027, major
  9. ET-700 extended-release zinc trial start~2028ET-700 extended-release zinc trial start, ~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 (17 active programs)

hydrocortisone

ET-800
Small Molecule
  • Undisclosed indication intravenous

timolol topical gel

ASN-001
  • Infantile Hemangioma Phase 2 topical Auson

Capital (as filed)

Cash
$55.6M cash and cash equivalents · Sep 30, 2026 (10-Q)
Operating cash flow
$35.2M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$55.6M 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 (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 Eton Pharmaceuticals, oldest first — the full history, never a selection. How calls are scored: the track record.

  1. 2026-02-19 Buy core Eton Pharmaceuticals (ETON): Scientific Deep Dive for ALKINDI SPRINKLE and Pipeline Products De-risked, cash-flowing commercial execution play in niche orphan markets with 19 consecutive quarters of revenue growth and imminent catalysts including ET-600 PDUFA, giving investors pipeline upside as a free call option.
  2. 2026-03-01 Buy core UPDATE: Eton Pharmaceuticals (ETON) Executes on Cue DESMODA approved on its PDUFA date with regulatory risk removed; binary traders have exited and cash-flow investors take over, making the stock more attractive post-sell-the-news flush.
  3. 2026-03-08 Buy core UPDATE: Eton Pharmaceuticals (ETON) - Bags Its 10th Commercial Asset (HEMANGEOL)... HEMANGEOL acquisition at ~1.2x sales multiple with zero external financing bolts on $11.7M annual revenue and plugs into existing pediatric rare disease infrastructure, continuing the compounding commercial execution.
  4. 2026-03-21 Buy core UPDATE: Eton Pharmaceuticals (ETON) - Delivers the Receipts, Margins Rebound, and the Market Finally Pays Up. Q4 margins rebounded to ~70% as guided, validating the one-time compression thesis, and the stock broke out above $22 as the market reprices Eton as a profitable growing specialty pharma.
  5. 2026-04-28 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The Wilson Disease Shot Clock Starts ET-700 pilot first patient dosed with management anchoring >$100M peak sales, converting the asset from a 'someday' pipeline item to a dated H2 2026 catalyst on top of an already cash-flowing base business.
  6. 2026-05-15 Buy core UPDATE: Eton Pharmaceuticals (ETON) - Guidance Goes Up, Stock Goes Up, Thesis Goes Up Q1 product sales +73% YoY, full-year guidance raised to >$120M, INCRELEX label harmonization FDA-cleared, and EBITDA margin floor set at >30%, confirming the compounder thesis with every catalyst tracking or beating.
  7. 2026-05-19 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The Boring Machine Bolts On Asset #11 IMPAVIDO licensed for effectively zero upfront cash adds another capital-efficient revenue line on a fixed SG&A base, demonstrating the mechanical cadence of the biological arbitrage playbook.
  8. 2026-07-30 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The July Catalyst Lands, and It Lands Clean KHINDIVI bioequivalence achieved and PAS filed for under-5 label expansion, completing an unbroken execution record, though valuation at ~11x forward revenue now embeds the pipeline.
  9. 2026-08-06 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The Boring Machine Buys the Other Half of the Hemangioma Market ASN-001 licensed for $3M upfront with completed Phase II/III showing 56% vs 15% placebo response and patents to 2044, giving Eton both systemic and topical ends of the infantile hemangioma market.
  10. 2026-08-14 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The Boring Machine Raises Guidance Twice in Three Months Q2 product sales +99% YoY, first profitable quarter at $11.6M GAAP net income, guidance raised to >$145M revenue and >35% EBITDA margin, with the multiple compressing to ~8x making the setup closer to fair value.
  11. 2026-08-20 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The Stock Goes Vertical, and the CEO Files to Sell CEO Form 144 on nine-year-old founder shares is portfolio management not a signal, but the 46.8% five-day move has re-expanded the multiple to ~11.8x forward revenue, reopening the valuation debate.
  12. 2026-10-15 Buy core UPDATE: Eton Pharmaceuticals (ETON) - The Boring Machine Walks Into Neurology LIBERVANT licensed with near-zero science risk and a dated regulatory path, but marks the first deal requiring a new dedicated neurology sales team in a competitive market, testing the operating-leverage thesis.

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 (7 quotes from 5 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 (39)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 12, 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 →

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