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.
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.
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.
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.
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.
Solid Biosciences (Nasdaq: SLDB) reports positive findings from the ongoing IGNITE DMD Phase I/II trial of SGT-001, a gene therapy for Duchenne muscular dystrophy. The data, presented at the World Muscle Society 2021 Virtual Congress, shows sustained functional benefits and patient-reported outcomes 1.5 years post-treatment. Key metrics include a mean decrease of 1.7 points in North Star Ambulatory Assessment (NSAA) compared to a projected decline of 4.5 points, and a 15.3-meter increase in the 6-Minute Walk Test (6MWT). No new safety concerns were reported over 3.5 years.
Solid Biosciences Inc. (Nasdaq: SLDB) announced the upcoming presentation of long-term data from patients 4-6 in the IGNITE DMD Phase I/II clinical trial of SGT-001 for Duchenne muscular dystrophy. The data will be presented by Dr. Vamshi Rao at the World Muscle Society 2021 Virtual Congress on September 23, 2021. SGT-001 aims to address the genetic cause of Duchenne by delivering a synthetic dystrophin gene via an adeno-associated viral vector. The therapy has received multiple designations from regulatory authorities, reflecting its potential in treating Duchenne.
Solid Biosciences (Nasdaq: SLDB) announces participation of Dr. Joel Schneider and Dr. Carl Morris at the SVB Leerink CybeRx Series and Chardan's 5th Annual Genetic Medicines Conference. The fireside chat from the Chardan conference will be available via live webcast on October 5, 2021, at 2:30 p.m. ET on the company's investor relations website. Solid Biosciences is committed to developing transformative therapies for Duchenne muscular dystrophy and is advancing its lead gene therapy candidate, SGT-001.
Solid Biosciences (Nasdaq: SLDB) will showcase its advanced AAV gene therapy manufacturing capabilities at the 11th Annual World Orphan Drug Congress USA 2021 on August 27 at 11:15 AM ET. Chief Operating Officer Joel Schneider, PhD, will discuss the scalable approach to producing AAV gene therapies targeting Duchenne muscular dystrophy (Duchenne). Following his talk, he will join a panel discussion on manufacturing strategies at 11:55 AM ET. Solid’s gene therapy candidate, SGT-001, aims to address the genetic cause of Duchenne and has received several designations to expedite development.
Solid Biosciences Inc. (Nasdaq: SLDB) has announced the grant of inducement awards to its new Senior Vice President of Finance, Michael Inbar. This decision was approved by independent directors on July 27, 2021. The inducement grant includes options to purchase 118,000 shares of common stock and restricted stock units for 59,000 shares, both vesting over four years. The options have a ten-year term with an exercise price set at $2.51 per share, reflecting the closing price on August 16, 2021.
Solid Biosciences Inc. (Nasdaq: SLDB) announced that Michael Inbar, CPA, MBA, has joined as Senior Vice President, Finance, effective August 16, 2021. Inbar brings extensive expertise in public accounting and finance team management from his previous roles at Syros Pharmaceuticals and Acronis. CEO Ilan Ganot emphasized the importance of Inbar's experience for the company's growth and commitment to improving patients' lives through transformative therapies for Duchenne muscular dystrophy. Inbar expressed excitement about being part of a team focused on significant patient outcomes.
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