SRPT · Company research

Sarepta Therapeutics, Inc.

4 upcoming catalysts · 0 phase 2+ trials on file

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Upcoming catalysts

Trial resultsSRPTSareptaH2 2026

Sarepta expects to report results from its Phase 1/2 study of siRNA candidates (DM1 and FSHD programs) for Myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy in the second half of 2026 (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.

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Entry

Phase 1/2 MAD-cohort readouts for siRNA programs in DM1 and FSHD · Clinical trial results (readout / topline data)

Drug

siRNA candidates (DM1 and FSHD programs)

For

Myotonic dystrophy type 1; facioscapulohumeral muscular dystrophy

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

H2 2026 · the company gave a window, not a day

Source note

Per Q2 2026 earnings release (Aug 5, 2026): readouts from the multiple-ascending-dose cohorts of ongoing Phase 1/2 studies in DM1 and FSHD remain on track for 2H 2026.

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Source: businesswire.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

MilestoneSRPTSareptaQ4 2026

ELEVIDYS ENDEAVOR Cohort 8 full enrollment expected by year-end 2026, expected in Q4 2026 (Oct–Dec) (no exact date yet). A company milestone for Sarepta (ELEVIDYS (delandistrogene moxeparvovec) for Duchenne muscular dystrophy): a step in the program rather than a decision or a data readout.

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Entry

ELEVIDYS ENDEAVOR Cohort 8 full enrollment expected by year-end 2026 · Company milestone

Drug

ELEVIDYS (delandistrogene moxeparvovec)

For

Duchenne muscular dystrophy

Stage

Phase 1b (ENDEAVOR Cohort 8)

When

Q4 2026 · the company gave a window, not a day

Source note

Q2 2026 earnings PR (Aug 5, 2026) guides to completing enrollment of ENDEAVOR Cohort 8 by year-end 2026, ahead of the already-tracked Q1 2027 12-week data readout.

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Source: biospace.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsSRPTSareptaQ1 2027

Sarepta expects to report results from its Phase 1b (ENDEAVOR Cohort 8) study of ELEVIDYS (delandistrogene moxeparvovec) + immunosuppressant regimen for Duchenne muscular dystrophy (gene therapy safety/immunosuppression cohort) in Q1 2027 (Jan–Mar) (no exact date yet). This is the first look at whether the drug did what the company hoped.

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Entry

ENDEAVOR Cohort 8 12-week data for ELEVIDYS with immunosuppression · Clinical trial results (readout / topline data)

Drug

ELEVIDYS (delandistrogene moxeparvovec) + immunosuppressant regimen

For

Duchenne muscular dystrophy (gene therapy safety/immunosuppression cohort)

Stage

Phase 1b (ENDEAVOR Cohort 8)

When

Q1 2027 · the company gave a window, not a day

Source note

Q2 2026 earnings release guides full enrollment of ENDEAVOR Cohort 8 by year-end 2026 and 12-week data from the full cohort in Q1 2027 — key to ELEVIDYS's path back to broader use after 2026 safety events and label restriction to ambulatory patients.

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Source: businesswire.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

FDA decisionSRPTSareptaFeb 28, 2027

The FDA is due to decide by Feb 28, 2027 whether to approve Sarepta’s AMONDYS 45 (casimersen) / VYONDYS 53 (golodirsen) for Duchenne muscular dystrophy (exon 45 / exon 53 skipping). Approval clears it for sale in the US; a rejection usually arrives as a letter listing what has to be fixed first.

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Entry

PDUFA date for AMONDYS 45 and VYONDYS 53 sNDAs (conversion to full approval) in DMD · FDA decision due (PDUFA date)

Drug

AMONDYS 45 (casimersen) / VYONDYS 53 (golodirsen)

For

Duchenne muscular dystrophy (exon 45 / exon 53 skipping)

Stage

sNDA under FDA review

When

Feb 28, 2027

Source note

FDA accepted sNDAs (announced July 1, 2026) seeking conversion of accelerated approvals to traditional approval, supported by ESSENCE confirmatory data and real-world evidence; PDUFA target action date Feb 28, 2027.

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Source: investorrelations.sarepta.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Past catalysts

MilestoneSRPTSareptaJun 30, 2026

FDA accepts AMONDYS 45 and VYONDYS 53 sNDAs; PDUFA date Feb 28, 2027, on Jun 30, 2026. A company milestone for Sarepta (AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) for Duchenne muscular dystrophy): a step in the program rather than a decision or a data readout.

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Entry

FDA accepts AMONDYS 45 and VYONDYS 53 sNDAs; PDUFA date Feb 28, 2027 · Company milestone

Drug

AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen)

For

Duchenne muscular dystrophy

Stage

Regulatory (sNDA filing acceptance)

When

Jun 30, 2026

Source note

FDA accepted for filing supplemental NDAs seeking conversion of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) from accelerated to traditional approval in Duchenne muscular dystrophy, supported by the ESSENCE confirmatory study and real-world evidence. FDA assigned a PDUFA target action date of February 28, 2027.

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Source: investorrelations.sarepta.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

Trial resultsSRPTSareptaMar 25, 2026

Sarepta reported results from its Phase 1/2 study of SRP-1001 and SRP-1003 for Facioscapulohumeral muscular dystrophy type 1 (FSHD1) and myotonic dystrophy type 1 (DM1) on Mar 25, 2026. The study met its main goal.

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Entry

First siRNA clinical data in FSHD1 and DM1 show knockdown, favorable tolerability · Clinical trial results (readout / topline data)

Drug

SRP-1001 and SRP-1003

For

Facioscapulohumeral muscular dystrophy type 1 (FSHD1) and myotonic dystrophy type 1 (DM1)

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Mar 25, 2026

Source note

Sarepta released the first clinical results from Phase 1/2 ascending-dose studies of SRP-1001 (FSHD1) and SRP-1003 (DM1), reporting dose-dependent muscle exposure, early biomarker effects and proof-of-concept target knockdown after a single dose. Most adverse events were mild to moderate with no dose-limiting safety signals, validating the avb6 integrin-targeted delivery platform.

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Source: investorrelations.sarepta.com ↗ — where this entry was taken from
SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalSRPTSareptaJun 22, 2023

The FDA approved Sarepta’s Elevidys (SRP-9001) for DMD on Jun 22, 2023. The company can now sell it in that market.

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Entry

FDA accelerated approval of Elevidys · Regulatory approval

Drug

Elevidys (SRP-9001)

For

DMD

When

Jun 22, 2023

Source note

First gene therapy approved for Duchenne muscular dystrophy (ages 4-5).

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SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

ApprovalSRPTSareptaSep 19, 2016

The FDA approved Sarepta’s Exondys 51 (eteplirsen) for DMD on Sep 19, 2016. The company can now sell it in that market.

More details

Entry

FDA accelerated approval of Exondys 51 · Regulatory approval

Drug

Exondys 51 (eteplirsen)

For

DMD

When

Sep 19, 2016

Source note

First approved exon-skipping therapy for Duchenne muscular dystrophy.

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SEC filings (8-K) ↗ — press releases are attached to 8-K filings
ClinicalTrials.gov ↗ — trials of this drug
Drugs@FDA ↗ — search the drug name for approval letters
SRPT headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page

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Pipeline trials

ClinicalTrials.gov · phase 2 and later

No phase 2+ trials cached for this company.

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