Solid Biosciences(SLDB)
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Solid Biosciences to Present at the 43rd Annual J.P. Morgan Healthcare Conference
GlobeNewswire· 2025-01-08 21:05
CHARLESTOWN, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that Bo Cumbo, President and CEO, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 3:45 p.m. PT (6:45 p.m. ET). A live webcast of the presentation will be available on the Events page of the Investors section of the Compa ...
SLDB Stock Up as FDA Clears IND for SGT-212 in Friedreich's Ataxia
ZACKS· 2025-01-08 16:26
Company Update: Solid Biosciences Inc (SLDB) - The FDA has cleared the investigational new drug (IND) application for SGT-212, a novel AAV-based gene therapy candidate targeting Friedreich's ataxia (FA) [1] - SGT-212 is the only full-length frataxin replacement gene therapy candidate targeting the cardiac manifestations of FA [1] - The therapy aims to address the neurologic and systemic clinical manifestations of FA, covering the full spectrum of disease progression [2] - Shares of Solid Biosciences surged 17.4% in after-hours trading on Jan 7 and continued to rise in pre-market trading on Jan 8 [2] - Over the past year, SLDB shares have declined 51.4%, significantly underperforming the industry's 15.7% decline [2] Clinical Development of SGT-212 - The IND is supported by robust preclinical data on SGT-212 [3] - A phase Ib study for SGT-212 is planned to initiate in the second half of 2025 [3] - The study will evaluate the safety and tolerability of systemic intravenous infusion and direct intradentate nuclei (IDN) infusion in both non-ambulatory and ambulatory adult FA patients [3] - The dual route of administration enables direct delivery of SGT-212 to the heart and cerebellum, potentially addressing the most significant symptoms of FA [4] - SGT-212 represents a differentiated approach to treating the underlying disease [4] Competitive Landscape in FA Market - FA is a rare disease, with limited companies developing treatments [7] - Biogen (BIIB) markets Skyclarys, the first FDA-approved treatment for FA, approved in 2023 in the US and February 2024 in Europe [7] - Skyclarys was added to Biogen's portfolio through the acquisition of Reata Pharmaceuticals in September 2023 [7] - Biogen reports strong progress in the US and EU launch of Skyclarys, with increasing global demand [8] - Larimar Therapeutics (LRMR) is developing nomlabofusp (CTI-1601) as a potential FA treatment, with plans to file a biologics license application in the second half of 2025 [8] - Nomlabofusp has the potential to be the first frataxin protein replacement therapy for FA patients [9] Stock Performance and Industry Comparison - Solid Biosciences currently holds a Zacks Rank 3 (Hold) [10] - Puma Biotechnology (PBYI), a better-ranked stock in the biotech sector, holds a Zacks Rank 1 (Strong Buy) [10] - PBYI's 2025 earnings per share estimates have increased from 42 cents to 54 cents over the past 60 days [10] - PBYI shares have declined 21.7% over the past year [10] - Puma Biotechnology has beaten earnings estimates in three of the trailing four quarters, with an average surprise of 32.78% [11]
Solid Biosciences Announces FDA IND Clearance for First-In-Industry Dual Route of Administration Gene Therapy to Treat Both Neurologic and Cardiac Manifestations of Friedreich's Ataxia
GlobeNewswire News Room· 2025-01-07 21:15
- SGT-212 is the only full-length frataxin replacement gene therapy candidate targeting the CNS and cardiac manifestations of Friedreich’s ataxia - - Dual route of administration enables direct delivery of AAV-based gene therapy to the cerebellum and heart to potentially address the most significant symptoms of the disease - - Phase 1b clinical trial initiation expected in 2H 2025 - - Company to hold a conference call tomorrow, January 8, 2025, at 8:30 AM ET - CHARLESTOWN, Mass., Jan. 07, 2025 (GLOBE NEWSWI ...
Solid Biosciences Announces FDA IND Clearance for First-In-Industry Dual Route of Administration Gene Therapy to Treat Both Neurologic and Cardiac Manifestations of Friedreich's Ataxia
Newsfilter· 2025-01-07 21:15
- SGT-212 is the only full-length frataxin replacement gene therapy candidate targeting the CNS and cardiac manifestations of Friedreich's ataxia - - Dual route of administration enables direct delivery of AAV-based gene therapy to the cerebellum and heart to potentially address the most significant symptoms of the disease - - Phase 1b clinical trial initiation expected in 2H 2025 - - Company to hold a conference call tomorrow, January 8, 2025, at 8:30 AM ET - CHARLESTOWN, Mass., Jan. 07, 2025 (GLOBE NEWSWI ...
Solid Biosciences Added to the Nasdaq Biotechnology Index
GlobeNewswire· 2024-12-23 21:05
CHARLESTOWN, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that it was added to the Nasdaq Biotechnology Index® (Nasdaq: NBI) effective prior to the market open on Monday, December 23, 2024. The Nasdaq Biotechnology Index is designed to track the performance of a set of securities listed on The Nasdaq Stock Market® (Nasdaq®) that ...
Solid Biosciences Positioned For Next-Gen Duchenne Muscular Dystrophy Treatment Success: Analyst
Benzinga· 2024-12-13 18:52
Wedbush initiated coverage on Solid Biosciences, Inc. SLDB, a gene therapy company focused on treating Duchenne muscular dystrophy (DMD).DMD is a genetic disease that causes progressive muscle weakness and wasting.SGT-003 is the leading program in Solid Biosciences' pipeline, with plans to advance additional projects toward clinical trials in 2025.The therapy uses the AAV-SLB101 capsid and a specialized cargo (nNOS binding domain) to potentially boost dystrophin expression compared to earlier-generation tre ...
Solid Biosciences to Participate at Upcoming Investor Conferences
GlobeNewswire News Room· 2024-11-26 13:00
CHARLESTOWN, Mass., Nov. 26, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced participation in the following investor conferences: Citi’s 2024 Global Healthcare Conference – Miami, FLBo Cumbo, President and CEO, will participate in a panel discussion titled “Neuromuscular Disorders” on Wednesday, December 4, 2024, at 1:00 p.m. ET. Piper Sandler 36th ...
Solid Biosciences to Present at the Jefferies London Healthcare Conference
GlobeNewswire News Room· 2024-11-14 13:00
CHARLESTOWN, Mass., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for neuromuscular and cardiac diseases, today announced that Bo Combo, President and CEO, and Gabriel Brooks, M.D., Chief Medical Officer, will present at the Jefferies London Healthcare Conference on Wednesday, November 20, 2024, at 1:30 p.m. GMT (8:30 a.m. ET). A live webcast of the presentation will be available on the Event ...
Solid Biosciences(SLDB) - 2024 Q3 - Quarterly Report
2024-11-06 21:02
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol Name of exchange on which registered Common Stock, $0.001 par value per share SLDB The Nasdaq Global Select Market FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIE ...
Solid Biosciences Reports Second Quarter 2024 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2024-08-13 20:08
– Patients dosed in Phase 1/2 INSPIRE DUCHENNE trial of SGT-003 for the treatment of Duchenne muscular dystrophy (Duchenne); Dosing was well tolerated in all patients with initial data expected Q4 2024 – – Solid plans to expand patient dosing with additional clinical trial sites in the U.S., Canada and Europe and plans accelerated production of multiple GMP batches of SGT-003 to support trial expansion – – Targeting the submission of 3-4 INDs by the end of 2026, strategically selecting cardiac and neuromusc ...