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Solid Biosciences Inc. - SLDB STOCK NEWS

Welcome to our dedicated page for Solid Biosciences news (Ticker: SLDB), a resource for investors and traders seeking the latest updates and insights on Solid Biosciences stock.

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’s 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.

For more detailed information, visit www.solidbio.com.

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Solid Biosciences (Nasdaq: SLDB) reported positive two-year efficacy and safety data from the high dose cohort (2E14 vg/kg) of its IGNITE DMD Phase I/II clinical trial, showing sustained or improved motor and pulmonary function in patients treated with SGT-001. The company also noted positive 90-day biopsy results indicating microdystrophin expression consistent with prior patients. Financially, Solid ended 2021 with $207.8 million in cash, funding operations into Q3 2023. Collaboration revenue reached $13.6 million for 2021, up from zero in 2020.

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Solid Biosciences (Nasdaq: SLDB) announced participation in a fireside chat at the 11th Annual Global Healthcare Conference on February 17, 2022, at 4:20 pm ET. The chat will feature Joel Schneider, PhD, COO, and Carl Morris, PhD, CSO.

A live webcast will be accessible on the company's investor relations website. Solid Biosciences aims to develop transformative treatments for Duchenne muscular dystrophy, focusing on correcting the underlying mutation with gene therapy candidates SGT-001 and SGT-003.

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Solid Biosciences (Nasdaq: SLDB) has announced significant advancements in its Duchenne muscular dystrophy (DMD) programs. The company plans to dose more patients in the IGNITE DMD Phase I/II clinical trial for its gene therapy SGT-001 and aims to submit an IND for the next-generation therapy SGT-003 in early 2023. Additionally, Solid ends 2021 with approximately $210 million in cash and investments. Ian F. Smith, previously Chair of the Board, will assume the role of Executive Chair to support the company’s strategic initiatives.

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Solid Biosciences (Nasdaq: SLDB), a company dedicated to therapies for Duchenne muscular dystrophy, announced that CEO Ilan Ganot will present at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 9:00 am ET. A Q&A session will follow the presentation. Institutional investors can book meetings with management through their J.P. Morgan representatives. A live webcast will be available on the company’s Investors page, along with an archived replay for 30 days.

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Solid Biosciences (Nasdaq: SLDB) announced inducement awards for its new Senior VP of Human Resources, Allison Bogosian. The board approved the grants on November 18, 2021, to incentivize her employment under Nasdaq rules. The inducement includes an option for 131,400 shares at an exercise price of $1.78, alongside a restricted stock unit award for 65,700 shares. Both awards vest in four equal annual installments over four years, contingent on Bogosian's continued service.

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Solid Biosciences (SLDB) reported significant progress in its Duchenne muscular dystrophy (Duchenne) therapies during Q3 2021. They announced plans to dose more patients with SGT-001 in the IGNITE DMD trial starting Q4 2021. Financially, the company ended Q3 with approximately $229.8 million in cash, ensuring a runway into Q2 2023. Collaboration revenue rose to $3.5 million, compared to none last year, while R&D expenses decreased to $14.4 million. The net loss narrowed to $18 million from $21.2 million in 2020, indicating improved fiscal management.

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The Pathway Development Consortium (PDC), initiated by REGENXBIO and Solid Biosciences, released a draft white paper outlining a framework for the accelerated approval of AAV gene therapies. This initiative aims to unite stakeholders to expedite the development of effective treatments for rare diseases. The publication coincides with the PDC's formal launch, emphasizing collaboration among patients, regulators, and industry for meaningful discussions. Feedback is encouraged to refine this framework to support FDA approval of AAV gene therapies.

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Solid Biosciences Inc. (Nasdaq: SLDB) announced its participation in the Jefferies Gene Therapy/Editing Summit on October 28, 2021, at 2:00 p.m. ET. Co-Founder and CEO Ilan Ganot, along with Chief Scientific Officer Carl Morris, will engage in a fireside chat. Investors can access a live webcast on the company’s investor relations website, with a replay available afterward. The company focuses on developing therapies for Duchenne muscular dystrophy, particularly through its gene therapy candidate, SGT-001.

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Solid Biosciences (NASDAQ: SLDB) has partnered with Forge Biologics to enhance the development and manufacturing of SGT-003, a next-generation gene therapy aimed at Duchenne muscular dystrophy. The collaboration will leverage Forge's Blaze Vector™ production platform, focusing on AAV vector process and cGMP manufacturing at Forge's facility in Columbus, Ohio. This partnership is expected to accelerate clinical development and improve the production process, potentially offering new treatment avenues for patients suffering from Duchenne.

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Solid Biosciences (Nasdaq: SLDB) has reported positive results from its ongoing IGNITE DMD Phase I/II clinical trial of SGT-001, aimed at treating Duchenne muscular dystrophy. Data presented at the Child Neurology Society 50th Annual Meeting indicated improvements in pulmonary function in patients receiving SGT-001 compared to untreated controls. Specifically, patients showcased significant percentage increases in peak expiratory flow and forced expiratory volume one year post-administration. These findings suggest the potential clinical benefit of SGT-001 in enhancing patient outcomes.

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FAQ

What is the current stock price of Solid Biosciences (SLDB)?

The current stock price of Solid Biosciences (SLDB) is $3 as of January 23, 2025.

What is the market cap of Solid Biosciences (SLDB)?

The market cap of Solid Biosciences (SLDB) is approximately 120.9M.

What is Solid Biosciences Inc. focused on?

Solid Biosciences Inc. is focused on developing treatments and cures for Duchenne muscular dystrophy (DMD) and other neuromuscular and cardiac diseases.

What are the key products in Solid Biosciences' pipeline?

Key products include SGT-003 for DMD, SGT-501 for CPVT, AVB-401 for BAG3-mediated dilated cardiomyopathy, and AVB-202-TT for Friedreich’s ataxia.

What recent regulatory milestones has Solid Biosciences achieved?

SGT-003 has received FDA clearance for an Investigational New Drug (IND) application, Orphan Drug Designation (ODD), and Rare Pediatric Disease Designation.

How is Solid Biosciences advancing its gene therapy programs?

Solid Biosciences is advancing its programs through clinical trials, strategic partnerships, and leveraging proprietary technologies like the AAV-SLB101 capsid.

What is the significance of the AAV-SLB101 capsid?

AAV-SLB101 capsid is designed for enhanced muscle tropism and reduced liver uptake, improving the efficacy and safety of gene therapies for muscular disorders.

How does Solid Biosciences support its financial stability?

The company raised $108.9 million in a January 2024 private placement and has a cash reserve of $123.6 million as of December 31, 2023, expected to fund operations into 2026.

What is Duchenne muscular dystrophy (DMD)?

DMD is a genetic muscle-wasting disease primarily affecting boys, with symptoms appearing between three and five years of age. It is progressive, irreversible, and ultimately fatal.

What is the planned Phase 1/2 trial for SGT-003?

The Phase 1/2 trial, INSPIRE Duchenne, is a first-in-human, open-label, multicenter trial to determine the safety and tolerability of SGT-003 in pediatric patients with DMD.

What are the benefits of Orphan Drug Designation (ODD)?

ODD provides financial incentives and up to seven years of market exclusivity in the U.S. for drugs treating rare diseases affecting fewer than 200,000 people.

How can I learn more about Solid Biosciences?

For more detailed information, visit their official website at www.solidbio.com.
Solid Biosciences Inc.

Nasdaq:SLDB

SLDB Rankings

SLDB Stock Data

120.86M
32.67M
0.91%
90.05%
4.4%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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