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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 Inc. (Nasdaq: SLDB) announced that CEO Bo Cumbo will present at the SVB Securities Global Biopharma Conference on February 15, 2023, at 1:40 pm ET. The event will be accessible via a live webcast on the company’s website, with a replay available afterward. Solid Biosciences focuses on genetic medicines for neuromuscular and cardiac diseases, highlighting candidates like SGT-003 for Duchenne and AVB-202 for Friedreich’s Ataxia. The company aims to improve patient lives and is committed to advancing its innovative therapies.

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The Pathway Development Consortium, co-founded by Solid Biosciences (SLDB), published a peer-reviewed manuscript in Human Gene Therapy, proposing microdystrophin expression levels as a surrogate endpoint for AAV gene therapy in Duchenne muscular dystrophy. This approach could expedite patient access to effective therapies under the FDA's accelerated approval pathway. A white paper submitted to the FDA further supports this initiative, advocating the use of muscle fat fraction and microdystrophin levels as predictive endpoints. These collaborative efforts aim to enhance therapeutic options for patients.

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Solid Biosciences (Nasdaq: SLDB) has announced a strategic collaboration with Phlox Therapeutics aimed at addressing severe genetic dilated cardiomyopathy (DCM). This partnership will leverage Solid's vector biology and manufacturing expertise alongside Phlox's RNA therapeutic capabilities to develop innovative gene therapies. The collaboration seeks to meet the significant unmet needs in treating DCM, enhancing both companies' scientific and commercial potential in cardiac therapy.

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Solid Biosciences (Nasdaq: SLDB) plans to file an Investigational New Drug (IND) application for SGT-003, a gene therapy for Duchenne muscular dystrophy, in the second half of 2023. The company is also transitioning manufacturing processes for its candidates targeting Friedrich's Ataxia and dilated cardiomyopathy. Kevin Tan has been appointed as Chief Financial Officer. Solid reports approximately $214 million in cash, which is expected to fund strategic priorities into 2025. The company aims to advance its gene therapies, focusing on high unmet needs in neuromuscular and cardiac diseases.

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On January 6, 2023, Solid Biosciences Inc. (Nasdaq: SLDB) approved inducement awards for new CFO Kevin Tan. The grant includes an option to purchase 90,000 shares and a restricted stock unit for 45,000 shares, aligning with Nasdaq rules. The options have a ten-year term with an exercise price set at $6.00, the closing stock price on January 9, 2023. The vesting schedule is structured to promote retention, with 25% vested after one year and monthly vesting thereafter for the option, while the restricted stock units will vest over four years.

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Solid Biosciences Inc. (Nasdaq: SLDB) has appointed Kevin Tan as Chief Financial Officer. With over 20 years of financial experience, Tan's expertise in capital markets and gene therapy is expected to support the company’s growth and pipeline advancement. CEO Bo Cumbo expressed confidence in Tan’s leadership at this pivotal time for the company. Solid continues to focus on developing genetic medicines for neuromuscular and cardiac diseases, aiming to enhance patient outcomes through innovative treatments.

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Solid Biosciences Inc. (Nasdaq: SLDB) announced that CEO Bo Cumbo will present at the 41st Annual J.P. Morgan Healthcare Conference on January 12, 2023, at 9:00 am PT / 12:00 pm ET. Interested institutional investors can schedule meetings with management through their J.P. Morgan representatives. A live webcast of the presentation will be available on the company's website's Events page, with a replay accessible for 30 days. Solid Biosciences focuses on developing genetic medicines for neuromuscular and cardiac diseases, including programs for Duchenne and Friedreich’s Ataxia.

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Solid Biosciences (Nasdaq: SLDB) announced inducement awards for its newly appointed executive team, including President and CEO Bo Cumbo and other key officers. The grants were approved by the board under Nasdaq rules, totaling stock options for 192,833 shares and RSUs for 85,514 shares to 22 new hires. Each award vests over four years, with a ten-year term and an exercise price of $6.77 per share, aligned with the company’s stock price at the time of the awards. This announcement coincided with Solid's acquisition of AavantiBio, emphasizing its commitment to advancing therapies for neuromuscular and cardiac diseases.

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Solid Biosciences (Nasdaq: SLDB) has completed its acquisition of AavantiBio, a gene therapy company specializing in neuromuscular and cardiac diseases. The merger creates a new precision genetic medicine entity focused on therapies for Duchenne muscular dystrophy, Friedreich’s ataxia, and other cardiac conditions. The combined company holds approximately $215 million in cash and investments, sufficient to fund operations until 2025. Bo Cumbo will lead the merged company as President and CEO, with a focus on advancing key gene therapy programs.

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On December 1, 2022, Solid Biosciences (Nasdaq: SLDB) announced that stockholders approved all proposals at a special meeting. This includes issuing shares of common stock to AavantiBio shareholders as part of a merger agreement dated September 29, 2022, along with a concurrent $75 million private placement. The merger aims to create a focused genetic medicine company targeting neuromuscular and cardiac rare diseases, particularly Duchenne muscular dystrophy. The combined company is expected to advance several key gene therapy programs, including SGT-003 for Duchenne and AVB-202 for Friedreich’s ataxia.

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FAQ

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

The current stock price of Solid Biosciences (SLDB) is $4.16 as of December 20, 2024.

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

The market cap of Solid Biosciences (SLDB) is approximately 160.2M.

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

160.22M
32.71M
0.91%
90.08%
3.81%
Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
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