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Dyne Therapeutics (DYN) pipeline and stated timing

Pipeline at a glance

ProgramEventStageStated timingFiling
zeleciment rostudirsen (DYNE-251) target date (company stated)PDUFAJanuary 21, 2027SEC filing ·
z-basivarsen/data readoutOther 2027EX-99.1 ·

Source: ORION, orionbiotechai.com/company/DYN, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/DYN

Nearest upcoming stated timing: zeleciment rostudirsen (DYNE-251) · PDUFA target date (company stated) · January 21, 2027

SEC sources last checked .

Programs and stated timing

○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.

zeleciment rostudirsen (DYNE-251)

Duchenne muscular dystrophy amenable to exon 51 skipping

Matched

PDUFA target date (company stated)January 21, 2027

Stage: PDUFASEC filing · “PDUFA target action date”

Public float: $948,000,000 · as of · SEC filing

PDUFA target action date set for January 21, 2027

SEC filing · Filed · Last checked

Source details

Accession 0001193125-26-323940

How this date was described over time

Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .

Program / eventStated period and SEC wordingDisclosure in stated period
z-basivarsenClinical resultsQ1 2027
“Dyne continues to expect topline data in Q1 2027 from the ACHIEVE registrational expansion cohort (REC)”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

z-basivarsenClinical resultsQ1 2027
“Topline data from the ACHIEVE REC are planned for Q1 2027”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

zeleciment rostudirsen (DYNE-251)FDA decisionJanuary 21, 2027
“PDUFA target action date set for January 21, 2027”

Filed · SEC original

Period not started

The stated period has not started yet, so there is nothing to compare.

zeleciment rostudirsen (DYNE-251)FDA decisionJanuary 21, 2027
“Prescription Drug User Fee Act (PDUFA) target action date set for January 21, 2027”

Filed · SEC original

Period not started

The stated period has not started yet, so there is nothing to compare.

zeleciment rostudirsen (DYNE-251)FDA decisionJanuary 21, 2027
“Prescription Drug User Fee Act, or PDUFA, target action date of January 21, 2027”

Filed · SEC original

Period not started

The stated period has not started yet, so there is nothing to compare.

zeleciment rostudirsen (DYNE-251)FDA decisionJanuary 21, 2027
“Prescription Drug User Fee Act target action date of January 21, 2027”

Filed · SEC original

Period not started

The stated period has not started yet, so there is nothing to compare.

z-basivarsenClinical resultsQ1 2027
“topline data planned for Q1 2027”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

z-basivarsenClinical resultsQ1 2027
“data from the ACHIEVE REC are planned for Q1 2027”

Filed · EX-99.1

Period not started

The stated period has not started yet, so there is nothing to compare.

“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.

Retained company announcements

Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.

Historical catalog checked .

No historical announcement trail is retained for this company in this catalog.

Selected registry record

zeleciment basivarsen (DYNE-101) · NCT07486934

Condition in the selected registry record
Myotonic Dystrophy Type 1 (DM1)
Phase in the selected registry record
Phase 3
Identity checked

Original ClinicalTrials.gov record · Open the selected study

Retained company–study identity sources

Scope of retained company and registry evidence

These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.

Coverage and identity checks

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Reading these records

First stated window
The timing wording in the earliest company statement located within the sources checked, quoted as written (for example “2H 2026”). An earlier statement may exist outside those sources.
Disclosure date
The date of the filing or company release that disclosed the readout. “None found” means no such disclosure was located in the sources checked. SEC filings were searched through the “SEC filings searched through” date shown.
1H, 2H, 1Q–4Q
First or second half, or first to fourth quarter, of the year named, as the company wrote it. Equivalent notations are compared together; the original wording stays visible.
SEC original
The filing as published on the SEC EDGAR system. “Company original” is the release on the company's own investor site.
Status
One of seven labels set by founder review of the original filings. Definitions: Methodology.

See DYN in the calendar · Review labels and methodology

A PDUFA date is the target date by which the FDA aims to decide on a drug or biologic application.Topline results are the main summary results of a clinical trial, released before the full data.Q1–Q4 (also written 1Q–4Q) are quarters of the year: Q1 is January–March, Q2 April–June, Q3 July–September and Q4 October–December, unless the company uses a different fiscal year.