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Dyne Therapeutics

DYN Rare disease Lead: NDA Submitted 13 Biotech Distilled articles ↓ 37 filings & releases ↓ Cash $913M (Sep 30, 2026) ↓ 13 verdicts ↓ 8 timing quotes ↓
MetabolicNeurology Nucleic AcidProtein

Market cap $3.39B 187.4M shares (10-Q, Oct 30, 2026) × $18.07 close Nov 6, 2026

Most recent annual filing: 2026-03-02

Catalyst timeline

4 trackedQuarter catalyst calendar →
  1. DYNE-302 Ph1 readout2H 2026DYNE-302 Ph1 readout, 2H 2026, notable
  2. z-basivarsen pivotal topline1Q 2027z-basivarsen pivotal topline, 1Q 2027, material
  3. z-rostudirsen FDA decisionJan 21, 2027z-rostudirsen FDA decision, Jan 21, 2027, major
  4. Hercules covenant FDA approval~Oct 2027Hercules covenant FDA approval, ~Oct 2027, material

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 (10 active programs)

Technology platforms

FORCE

TfR1-targeting Fab-conjugate delivery platform that links therapeutic payloads (PMOs, ASOs, siRNAs, enzymes) to a proprietary anti-TfR1 Fab via a clinically-validated linker, enabling targeted delivery to skeletal, cardiac and smooth muscle and CNS. Disease focus: neuromuscular diseases including DMD, DM1, FSHD, Pompe disease, rare skeletal muscle diseases, and cardiac/metabolic muscle diseases.

Targets: TfR1, transferrin receptor 1

Capital (as filed)

Cash
$913M cash and cash equivalents · Sep 30, 2026 (10-Q)
Short-term investments
$221M Sep 30, 2026
Operating cash flow
−$177M quarter Jun 30, 2026 → Sep 30, 2026, year-to-date difference (10-Q)
As stated in coverage
$1.13B cash, runway into Q2 2028 per the update of Nov 5, 2026 — the company's own words as read there, not the filed figure

Offering documents (1)

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 (13)

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

Verdict history (13 calls)

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

  1. 2026-01-20 Buy core Dyne Therapeutics (DYN): Scientific Due Diligence for FORCE™ and Pipeline Products Biomarker data is undeniable, balance sheet is fortress-level, and risk/reward is heavily skewed to the upside with the biology of delivery largely de-risked.
  2. 2026-01-22 Buy core UPDATE: Dyne Secures Japan Orphan Drug Designation (ODD) Japan ODD for z-basivarsen completes a global regulatory trifecta, widening the commercial moat and reinforcing the thesis intact.
  3. 2026-03-07 Buy core UPDATE: Dyne Therapeutics (DYN) - Annual Audit Audited $1.1B cash confirmed and T. Rowe Price's 26.6M share position signals high institutional conviction ahead of BLA approval.
  4. 2026-03-14 Buy core UPDATE: Dyne Therapeutics (DYN) - Generational Moment Cardiopulmonary preservation data at 24 months solves the clinical meaningfulness question for the FDA, and Phase 3 HARMONIA initiation provides a clear path to full DM1 approval.
  5. 2026-05-26 Buy core UPDATE: Dyne Therapeutics (DYN) - The BLA is In BLA filed on schedule with Priority Review requested; execution risk resolved and fortress balance sheet intact, with late-July filing acceptance as the next inflection.
  6. 2026-06-03 Buy core UPDATE: Dyne Therapeutics (DYN) - The Second Catalyst Lands ACHIEVE registrational cohort fully enrolled at n=71 with dose locked at 6.8 mg/kg Q8W, giving DM1 hard timeline dates and confirming greenfield commercial opportunity.
  7. 2026-06-17 Buy core UPDATE: Dyne Therapeutics (DYN) - The Non-Dilutive Top-Off Hercules facility expanded to $400M non-dilutively with covenant relief pushed past the PDUFA window, widening the fortress balance sheet moat without issuing shares.
  8. 2026-07-20 Buy core UPDATE: Dyne Therapeutics (DYN) - The PDUFA Clock is Set FDA accepted the BLA with Priority Review and set a January 21, 2027 PDUFA, converting the regulatory overhang into a defined six-month window.
  9. 2026-07-21 Buy core UPDATE: Dyne Therapeutics (DYN) - The Day-After Raise The $300M equity raise is launch-prep capital that extends runway to Q2 2028 and signals management confidence in the January PDUFA, despite ~8% dilution.
  10. 2026-07-22 Buy core UPDATE: Dyne Therapeutics (DYN) - The Raise Prices Offering priced at a wider-than-expected 12.6% discount but cleared at upsized $375M, with FORZETTO Phase 3 endpoint architecture confirmed; balance sheet reinforced despite incremental dilution.
  11. 2026-07-28 Buy core UPDATE: Dyne Therapeutics (DYN) - The Third Package DYNE-302 IND cleared in FSHD, activating the preclinical call option and expanding the FORCE platform to three clinical assets across three payload chemistries.
  12. 2026-07-30 Buy core UPDATE: Dyne Therapeutics (DYN) - The Q2 Print and Two Buried Footnotes Operational execution remains flawless but Q2 burn accelerated to $178.6M and a CDMO BIOSECURE designation adds a new CMC watch item heading into the January PDUFA.
  13. 2026-09-30 Buy core UPDATE: Dyne Therapeutics (DYN) - The One-Year DM1 Receipts One-year pooled ACHIEVE data show consistent myotonia, strength, function, and PRO improvements with clean safety, supporting the DM1 thesis despite a 35% stock drawdown unexplained by filings.

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 (8 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 (37)

SEC filings from EDGAR and press releases captured from the company's investor-relations site, newest first. Releases captured from May 11, 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 →

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