Earnings summaries and quarterly performance for Solid Biosciences.
Executive leadership at Solid Biosciences.
Alexander Cumbo
Detailed
President and Chief Executive Officer
CEO
GB
Gabriel Brooks
Detailed
Chief Medical Officer
JH
Jessie Hanrahan
Detailed
Chief Regulatory Officer
KT
Kevin Tan
Detailed
Chief Financial Officer and Treasurer
PH
Paul Herzich
Detailed
Chief Technology Officer
TH
Ty Howton
Detailed
Chief Operating Officer and Secretary
Board of directors at Solid Biosciences.
Research analysts who have asked questions during Solid Biosciences earnings calls.
JS
Joseph Schwartz
Oppenheimer
4 questions for SLDB
Also covers: ASND, AUPH, BMRN +14 more
AR
Anupam Rama
JPMorgan Chase & Co.
2 questions for SLDB
Also covers: APLS, BBIO, BOLD +16 more
Gena Wang
Barclays
2 questions for SLDB
Also covers: ALNY, BCRX, BLUE +12 more
MC
Mark Connolly
Credit Suisse
2 questions for SLDB
Allison Bratzel
Piper Sandler Companies
1 question for SLDB
Also covers: ABCL, AKBA, ALXO +5 more
GA
Gbola Amusa
Chardan
1 question for SLDB
MM
Maneka Mirchandaney
Evercore ISI
1 question for SLDB
MR
Maury Raycroft
Jefferies
1 question for SLDB
Also covers: ABEO, ALNY, ARWR +11 more
Recent press releases and 8-K filings for SLDB.
Solid Biosciences Provides Update on Clinical Programs and Regulatory Strategy at J.P. Morgan Healthcare Conference
SLDB
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
- Solid Biosciences has dosed 33 patients in its phase 1/2 Duchenne trial (Inspire), reporting a strong safety profile with no drug-induced liver injury, myocarditis, or AHUS, and 58% mean microdystrophin expression. The Inspire trial is now fully enrolled.
- The company plans three meetings with the FDA by mid-year to discuss a phase 3 placebo-controlled trial and the accelerated approval pathway for its Duchenne program (003), aiming to start a rolling BLA by year-end.
- Solid Biosciences has initiated dosing for its Friedreich's ataxia program and expects to dose the first patient in its CPVT program this quarter.
- The company has secured over 50 partnerships for its capsid platform technology, indicating broader application and potential revenue streams.
4 days ago
Solid Biosciences Outlines Pivotal 2026 Clinical Milestones
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences anticipates a transformational 2026 with multiple key clinical catalysts across its four lead programs, building on consistent execution in 2025.
- For SGT-003 (Duchenne Muscular Dystrophy), the company expects to dose the first participant in the Phase 3 IMPACT DUCHENNE trial in Q1 2026 and plans interactions with the U.S. FDA in H1 2026 for potential alignment on an accelerated approval pathway. Interim data from the Phase 1/2 INSPIRE DUCHENNE trial showed compelling microdystrophin expression (Mean 58%) and a promising safety profile in 33 participants as of January 9, 2026.
- The SGT-212 (Friedreich's ataxia) program dosed its first participant in the Phase 1b FALCON trial in January 2026, with initial data expected in H2 2026.
- For SGT-501 (CPVT), the first participant is expected to be dosed in the Phase 1b ARTEMIS trial in Q1 2026, with initial safety data anticipated in H2 2026.
4 days ago
Solid Biosciences Provides Clinical and Regulatory Updates at J.P. Morgan Healthcare Conference
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences has dosed 33 patients in its Phase 1/2 Inspire trial for Duchenne Muscular Dystrophy (DMD) and has fully enrolled the study, reporting a safety profile with 0% drug-induced liver injury, TMA, aHUS, or myocarditis.
- The company is initiating a double-blind placebo-controlled trial (IMPACT Duchenne) for DMD, which will serve as a confirmatory study for accelerated approval in the United States, with a rolling BLA submission planned for late 2026.
- In the Inspire trial, Solid Biosciences reported mean microdystrophin expression of 58% in 9 out of 10 patients at the lowest dose (1E14), and observed 70% declines in troponin and increases in ejection fraction in cardiac data.
- Beyond DMD, the company has dosed its first patient in Friedreich's Ataxia (FA) using a dual-route administration and expects to begin dosing for its CPVT program in Q1 2026.
- Solid Biosciences has established over 50 partnerships for its next-generation capsid platform, positioning itself as a broader gene therapy technology provider.
4 days ago
Solid Biosciences Provides Update on Clinical Progress and Regulatory Strategy at J.P. Morgan Healthcare Conference
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences reported significant clinical progress, including dosing 33 patients in its Phase 1/2 Duchenne trial (Inspire), initiating the first patient in its Friedreich's ataxia (FA) program with a dual-route administration, and preparing to dose the first patient in the double-blind placebo control Duchenne trial.
- The Duchenne therapy, SGT-003, demonstrated a 58% mean microdystrophin expression in 9 out of 10 patients at the lowest dose (1E14), coupled with a favorable safety profile showing 0% drug-induced liver injury, TMA, AHUS, or myocarditis.
- The company plans three meetings with the FDA by mid-year to discuss the Phase 3 placebo control and an accelerated approval pathway, with a goal to initiate a rolling BLA by the end of the year. Solid Biosciences also received the ILAP (Innovation Passport) in the UK, highlighting a significant market opportunity.
- Solid Biosciences has secured over 50 partnerships for its capsid program, positioning itself as a platform technology company that leverages its SLB101 capsid for enhanced distribution and liver de-targeting in next-generation therapies.
4 days ago
Solid Biosciences Receives FDA Orphan Drug Designation for SGT-212 and Doses First Participant in FALCON Trial
SLDB
New Projects/Investments
Regulatory Approval
- Solid Biosciences (SLDB) announced that its investigational gene therapy, SGT-212, has received FDA Orphan Drug designation for the treatment of Friedreich's ataxia (FA).
- SGT-212 had previously been granted FDA Fast Track and Rare Pediatric Disease designations.
- The company also reported the dosing of the first participant in the Phase 1b FALCON clinical trial, which is evaluating SGT-212 for FA.
- Initial data from the FALCON trial is anticipated in H2 2026, subject to participant enrollment.
5 days ago
Solid Biosciences Doses First Participant in FALCON Trial for Friedreich’s Ataxia
SLDB
New Projects/Investments
- Solid Biosciences dosed the first participant in its Phase 1b FALCON clinical trial for Friedreich’s ataxia (FA) with investigational gene therapy SGT-212 on January 12, 2026.
- SGT-212 is a first-in-class investigational gene therapy utilizing a dual-route administration to target neurologic, cardiac, and systemic manifestations of FA.
- The company expects to share preliminary safety insights in the coming months and an initial data update in the second half of 2026.
- Friedreich's ataxia is a rare, degenerative disease impacting approximately 5,000 people in the United States and 15,000 in Europe, with no current treatments to cure or halt disease progression.
6 days ago
Solid Biosciences Updates on Gene Therapy Pipeline and FDA Discussions
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences' lead gene therapy program, SGT-003 for Duchenne muscular dystrophy (DMD), has dosed 23 patients and expects to reach 28-30 patients by early December 2025, with 72 patients in the queue.
- The company plans three meetings with the FDA starting early Q1 2026 to discuss its registrational trial, external control strategy, and data requirements, aiming for a potential filing in late 2026.
- Solid Biosciences has begun dosing in the 0-3 age cohort for DMD, safely treating two boys (18 and 20 months old), targeting a significant unmet need.
- Patient dosing for Friedreich's ataxia (FA) is anticipated in early January 2026, and for CPVT in January-February 2026, with initial FA data potentially available by H2 2026.
- Safety data for SGT-003 indicates no drug-induced liver injury to date, and the company has adapted its dosing protocol based on the SLB101 capsid's rapid clearance from the bloodstream.
Dec 2, 2025, 4:30 PM
Solid Biosciences Discusses SGT-003 Progress and Upcoming Milestones
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences is advancing its lead gene therapy program, SGT-003, for Duchenne muscular dystrophy (DMD), utilizing a novel SLB101 capsid designed to target skeletal and cardiac muscle and recruit beneficial proteins like nNOS and cavin-4.
- The company has dosed 23 patients in the DMD program and anticipates reaching 28-30 patients by the end of 2025.
- Solid Biosciences plans to hold three meetings with the FDA starting early Q1 2026 to discuss its double-blind placebo control trial, external control strategy, and data requirements, with a goal to file for submission in late 2026.
- The company has observed no drug-induced liver injury to date and has addressed a grade three myositis case by excluding a specific mutation.
- Initial patient dosing for the Friedreich's ataxia (FA) program is expected in early January 2026, followed by the CPVT program in January/February 2026.
Dec 2, 2025, 4:30 PM
Solid Biosciences Provides Update on Gene Therapy Pipeline and Regulatory Strategy
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences is advancing its gene therapy pipeline, with its lead Duchenne muscular dystrophy (DMD) program, SGT-003, utilizing a novel SLB101 capsid.
- The company has dosed 23 patients in its DMD program and anticipates reaching 28-30 patients by the end of the week of December 2, 2025.
- Solid Biosciences plans three meetings with the FDA starting early Q1 2026 to discuss its clinical trial strategy and data requirements, with a goal for rolling submission late 2026.
- Safety data for the DMD program indicates no drug-induced liver injury to date, and the company has adjusted its dosing strategy to use steroids only.
- Clinical expansion includes the first patient for Friedreich's ataxia (FA) expected in early January 2026 and the CPVT program initiating in Q1 2026, bringing the total to three drugs in the clinic within two months.
Dec 2, 2025, 4:30 PM
Solid Biosciences' SGT-003 Receives UK Innovation Passport Designation
SLDB
New Projects/Investments
Product Launch
- Solid Biosciences' investigational gene therapy, SGT-003, for Duchenne muscular dystrophy, was granted an Innovation Passport under the UK's new Innovative Licensing and Access Pathway (ILAP) on November 6, 2025.
- This designation is designed to accelerate time to market and facilitate patient access to new medicines in the UK, providing early and enhanced interactions with regulators.
- SGT-003 is one of the first three investigational medicinal products to join the relaunched ILAP, which focuses on transformative products addressing unmet clinical needs.
- The therapy is currently being evaluated in the Phase 1/2 INSPIRE DUCHENNE clinical trial and has activated the first clinical trial site for the Phase 3 IMPACT DUCHENNE clinical trial outside the US.
Nov 6, 2025, 1:00 PM
Quarterly earnings call transcripts for Solid Biosciences.
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