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 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
Solid Biosciences Reports Q3 2025 Financial Results and Clinical Trial Updates
SLDB
Earnings
Guidance Update
New Projects/Investments
- Solid Biosciences reported a net loss of $45.8 million for the third quarter of 2025 and ended the period with $236.1 million in cash, cash equivalents, and available-for-sale securities as of September 30, 2025, providing an anticipated cash runway into H1 2027.
- In the INSPIRE DUCHENNE clinical trial for SGT-003, 23 participants have been dosed as of October 31, 2025, with the company expecting to dose a total of 30 participants by early 2026.
- Day 90 biopsy data from 10 participants (ages 5-10) showed mean microdystrophin expression of 58% by western blot and mass spectrometry, and mean microdystrophin positive fibers of 51% by immunofluorescence.
- SGT-003 has been generally well tolerated, with early signals of cardiac function normalization and mean reductions in serum cTnI of 31% at Day 90 and 70% at Day 360 observed.
- The company plans to meet with the FDA in H1 2026 to discuss potential registrational pathways for SGT-003.
Nov 3, 2025, 10:15 PM
Solid Biosciences Reports Q3 2025 Financial Results and SGT-003 Clinical Progress
SLDB
Earnings
Guidance Update
New Projects/Investments
- Solid Biosciences reported a net loss of $45.8 million for Q3 2025 and held $236.1 million in cash, cash equivalents, and available-for-sale securities as of September 30, 2025, providing a cash runway into H1 2027.
- Positive interim data from the INSPIRE DUCHENNE trial for SGT-003 showed mean microdystrophin expression of 58% by western blot and mass spectrometry, and 51% positive fibers by immunofluorescence in treated participants, with the therapy generally well tolerated.
- The company plans to meet with the FDA in H1 2026 to discuss potential registrational pathways for SGT-003, a decision made to generate a more comprehensive data set.
- Solid Biosciences has activated the first clinical trial sites for the Phase 3 IMPACT DUCHENNE (SGT-003) and Phase 1b FALCON (SGT-212) trials, and expects to activate the ARTEMIS trial site (SGT-501) in Q4 2025.
Nov 3, 2025, 9:05 PM
SLDB Provides Q3 2025 Clinical Progress Update for SGT-003
SLDB
New Projects/Investments
Guidance Update
- SLDB's SGT-003 gene therapy for Duchenne Muscular Dystrophy has dosed 23 participants as of October 31, 2025, with an anticipated total of 30 participants by early 2026.
- All 10 evaluated participants responded to SGT-003 treatment, demonstrating mean microdystrophin protein at consistent levels and compelling microdystrophin positive fibers (mean 51% at Day 90).
- Early data indicates potential cardiac benefits, with troponin I reductions of 31% at Day 90 and 70% at Day 360, and mean absolute LVEF improving from 63% at baseline to 66% at Day 90.
- SGT-003 treatment resulted in comprehensive reductions in muscle injury signals at Day 90, including CK (34%), ALT (41%), AST (25%), LDH (42%), Titin (22%), and eMHC (49%).
- The interim safety summary for 23 participants reported one serious adverse event (4.3%) and stable liver enzymes post-administration. Additionally, the Phase 3 IMPACT DUCHENNE trial initiated participant screening in October 2025, and an FDA meeting to discuss registrational pathways is anticipated in 1H 2026.
Nov 3, 2025, 9:00 PM
Solid Biosciences Provides Updates on Gene Therapy Programs and Regulatory Timelines
SLDB
New Projects/Investments
Guidance Update
- Solid Biosciences, a precision genetic medicine company, is advancing three main gene therapy programs for Duchenne muscular dystrophy (DMD), Friedreich's ataxia (FA), and CPVT (catecholaminergic polymorphic ventricular tachycardia).
- For its DMD program (SLB-101), 15 boys have been dosed with a positive safety profile. The company anticipates an FDA meeting in Q4 2025 to discuss accelerated approval, with a potential Biologics License Application (BLA) filing by end of 2026.
- Initial patient dosing for both the Friedreich's ataxia and CPVT programs is expected in Q4 2025, with first results for FA anticipated in the first half of 2026.
Sep 2, 2025, 7:04 PM
Quarterly earnings call transcripts for Solid Biosciences.
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