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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. grants inducement awards to two new employees as part of its 2024 Inducement Stock Incentive Plan. The awards consist of 17,090 shares of common stock, vesting in four equal installments annually over four years.
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Solid Biosciences Inc. (SLDB) receives Rare Pediatric Disease Designation from the FDA for SGT-003, a gene therapy candidate for Duchenne muscular dystrophy. The company plans to initiate site activations in April 2024 and start patient dosing in Q2 2024. The Phase 1/2 trial, INSPIRE Duchenne, aims to assess the safety and tolerability of SGT-003 in pediatric patients with DMD.
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Solid Biosciences Inc. to present at Cantor's Virtual Muscular Dystrophy Symposium. Bo Cumbo, CEO, and Gabriel Brooks, CMO, will discuss precision genetic medicines for neuromuscular and cardiac diseases on April 2, 2024.
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Solid Biosciences Inc. ends 2023 with $123.6 million in cash and investments, with a cash runway anticipated into 2026. The company obtained FDA clearance, Fast Track Designation, and Orphan Drug Designation for Duchenne gene therapy candidate SGT-003. Solid also entered a licensing agreement for AAV-SLB101 capsid use.
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Solid Biosciences (SLDB) collaborates with Armatus Bio for FSHD treatment using AAV-SLB101 capsid. The agreement includes upfront payment, milestone payments, and royalties. AAV-SLB101 shows enhanced biodistribution and muscle cell expression in preclinical studies. Armatus will develop and commercialize ARM-201, a potential FSHD therapeutic, utilizing AAV-SLB101.
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Solid Biosciences Inc. (SLDB) will be participating in the Leerink Partners Global Biopharma Conference and Barclays 26th Annual Global Healthcare Conference in Miami, FL. Bo Cumbo, the President and CEO, will present on March 13, 2024, at 1:35 pm ET. Institutional investors can arrange meetings with management through Leerink or Barclays representatives.
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Solid Biosciences Inc. has been granted orphan drug designation (ODD) from the U.S. Food and Drug Administration for SGT-003, their next-generation Duchenne muscular dystrophy gene therapy candidate. The company is preparing for a Phase 1/2 clinical trial and expects patient dosing to begin in mid-to-late Q1 2024. The therapy has unique attributes that may yield more potent transduction and a microdystrophin capable of addressing muscle resiliency.
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Solid Biosciences Inc. (SLDB) announced a $108.9 million private placement with institutional accredited investors for developing precision genetic medicines for neuromuscular and cardiac diseases.
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Solid Biosciences Inc. (Nasdaq: SLDB) announced that Bo Cumbo, President and CEO, will present at the J.P Morgan Healthcare Conference on January 11, 2024. The company is developing precision genetic medicines for neuromuscular and cardiac diseases. A live webcast of the presentation will be available on the Company website. Institutional investors interested in meeting management during the conference may reach out to their J.P. Morgan representatives.
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Solid Biosciences Inc. (Nasdaq: SLDB) has received FDA Fast Track Designation for SGT-003, its next-generation Duchenne muscular dystrophy gene therapy candidate. The company aims to rapidly develop this potentially life-changing therapy to address the unmet needs of the Duchenne community. IND clearance for SGT-003 was received in November 2023, with a planned Phase 1/2 trial to determine safety and tolerability in pediatric patients. Solid Biosciences looks forward to continuing its partnership with the FDA to ensure the collection of data needed to support future marketing authorization.
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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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