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Solid Biosciences Inc. (Nasdaq: SLDB) is a Cambridge, MA-based biotechnology company focused on developing treatments and cures for Duchenne muscular dystrophy (DMD), a genetic muscle-wasting disease. Solid Biosciences combines commercial acumen with top-tier science to advance promising therapies that address all aspects of DMD. The core of Solid's mission is to improve the daily lives of patients and target the roots of this debilitating condition.
The company's primary focus is on developing gene therapies and other treatments for neuromuscular and cardiac diseases. Their product pipeline includes:
- SGT-003: A next-generation gene therapy candidate for DMD, recently granted FDA clearance for an Investigational New Drug (IND) application. The therapy uses a proprietary capsid (AAV-SLB101) to deliver a microdystrophin transgene to promote muscle function and durability. The planned Phase 1/2 trial aims to evaluate the safety and tolerability of SGT-003 in pediatric patients.
- SGT-501: A treatment for catecholaminergic polymorphic ventricular tachycardia (CPVT), a fatal childhood disease.
- AVB-401: For the treatment of BAG3-mediated dilated cardiomyopathy.
- AVB-202-TT: Aimed at treating Friedreich鈥檚 ataxia.
Solid Biosciences has made significant strides in obtaining regulatory milestones. Recently, SGT-003 was granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the FDA, enhancing its potential marketability and support for clinical development.
The company has also been involved in strategic collaborations and financing activities. Notably, Solid entered a licensing agreement with Armatus Bio for the use of its AAV-SLB101 capsid, securing a non-exclusive worldwide license and upfront and milestone payments. In January 2024, they raised $108.9 million from a private placement to support ongoing pipeline development and business activities.
Financially, Solid Biosciences reported a net loss of $96.0 million for 2023 but expects its cash reserves and recent financing to fund strategic priorities into 2026. As of December 31, 2023, the company had $123.6 million in cash, cash equivalents, and available-for-sale securities.
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Solid Biosciences (SLDB), a precision genetic medicines developer focusing on neuromuscular and cardiac diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Bo Cumbo, President and CEO, will deliver a presentation on Wednesday, January 15, 2025, at 3:45 p.m. PT (6:45 p.m. ET).
The presentation will be accessible through a live webcast on the Company's website's Investors section under the Events page. A replay of the webcast will remain available for 30 days following the event. Institutional investors seeking meetings with management during the conference are advised to contact their J.P. Morgan representatives.
Solid Biosciences (NASDAQ: SLDB) has received FDA IND clearance for SGT-212, a pioneering dual-route gene therapy designed to treat Friedreich's ataxia (FA). This therapy is unique as it's the only candidate delivering full-length frataxin protein through both systemic intravenous infusion and direct intradentate nuclei infusion into the cerebellum.
The therapy aims to address both neurologic and cardiac manifestations of FA, targeting the insufficient levels of frataxin protein that cause this degenerative disease. Preclinical studies have shown safe transduction and frataxin expression in target tissues, demonstrating significant restoration of neurologic function and reversal of cardiac implications in mice.
The company plans to initiate a Phase 1b clinical trial in the second half of 2025. This first-in-human, open-label, dose-finding study will enroll both non-ambulatory and ambulatory adult FA patients across up to three cohorts, with participants being followed for five years after receiving SGT-212.
Solid Biosciences (Nasdaq: SLDB), a company focused on developing precision genetic medicines for neuromuscular and cardiac diseases, announced on January 6, 2025, the grant of 11,847 restricted stock units (RSUs) to a newly hired employee.
The RSUs will vest in four equal installments on each one-year anniversary of the grant date, provided the employee continues to serve with the company through each vesting date. This grant was made under the company's 2024 Inducement Stock Incentive Plan and complies with Nasdaq Listing Rule 5635(c)(4).
Solid Biosciences (Nasdaq: SLDB), a life sciences company focused on precision genetic medicines for neuromuscular and cardiac diseases, has been added to the Nasdaq Biotechnology Index庐 (NBI) effective December 23, 2024. The NBI tracks performance of biotechnology and pharmaceutical securities listed on Nasdaq, using a modified capitalization-weighted methodology. Companies must meet specific eligibility criteria including minimum market capitalization, daily trading volume, and public company seasoning requirements. Index constituents are selected annually in December.
Solid Biosciences (SLDB) has announced a strategic collaboration with Mayo Clinic to advance AAV gene therapy development for cardiac diseases. The partnership grants Solid exclusive worldwide licenses to Mayo Clinic's Suppression-Replacement gene therapy platform and six cardiac gene therapy programs developed by their Windland Smith Rice Sudden Death Genomics Lab.
Under the agreement, Mayo Clinic will conduct research and development up to IND-enabling studies, after which Solid will have options for continued development and commercialization. The collaboration will utilize Solid's next-generation AAV capsids, including AAV-SLB101, and advanced manufacturing capabilities to target genetic heart diseases. The company expects to submit an IND for CPVT in the first half of 2025.
Solid Biosciences (Nasdaq: SLDB), a life sciences company focused on developing precision genetic medicines for neuromuscular and cardiac diseases, has granted 11,847 restricted stock units (RSUs) to a new employee. The RSUs will vest in four equal annual installments over four years, contingent upon continued employment. The grant was made under the Company's 2024 Inducement Stock Incentive Plan and complies with Nasdaq Listing Rule 5635(c)(4) as an employment inducement.
Solid Biosciences (Nasdaq: SLDB), a precision genetic medicines company, announces participation in two major healthcare conferences. At Citi's 2024 Global Healthcare Conference in Miami, President and CEO Bo Cumbo will join a panel on Neuromuscular Disorders on December 4, 2024, at 1:00 p.m. ET. The following day at the Piper Sandler 36th Annual Healthcare Conference in New York, Cumbo and Chief Medical Officer Gabriel Brooks will participate in a fireside chat at 9:30 a.m. ET. Both events will be webcast live and available for replay on the company's website for 30 days.
Solid Biosciences (Nasdaq: SLDB), a precision genetic medicines company, has announced its participation in the upcoming Jefferies London Healthcare Conference. The company's President and CEO, Bo Combo, along with Chief Medical Officer Gabriel Brooks, M.D., will deliver a presentation on Wednesday, November 20, 2024, at 1:30 p.m. GMT (8:30 a.m. ET).
The presentation will be accessible via live webcast on the company's website's Investors section under Events, with a replay available for 30 days afterward. Institutional investors can arrange meetings with management through their Jefferies representatives.
Solid Biosciences (SLDB) reported Q3 2024 financial results and business updates. The company completed dosing for the first three patients in the INSPIRE DUCHENNE trial, with SGT-003 showing good tolerability and no serious adverse events. Cash position stands at $171.1 million, providing runway into 2026. Q3 net loss increased to $32.7 million ($0.79 per share) from $21.0 million year-over-year. R&D expenses rose to $27.3 million from $16.7 million, while G&A expenses increased to $7.9 million from $6.4 million. The company expanded its study protocol and plans to present initial three-patient data in Q1 2025.
Solid Biosciences (Nasdaq: SLDB) has granted 9,741 restricted stock units (RSUs) to a new employee as part of their inducement compensation package. The RSUs will vest in four equal annual installments, with full vesting occurring on the fourth anniversary of the grant date. The grant was issued under the Company's 2024 Inducement Stock Incentive Plan and complies with Nasdaq Listing Rule 5635(c)(4). Vesting is contingent upon the employee's continued employment with the company through each vesting date.
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