SLDB Solid Biosciences Inc.

2.44
-0.13  -5%
Previous Close 2.57
Open 2.6
52 Week Low 1.96
52 Week High 13.58
Market Cap $112,488,377
Shares 46,101,794
Float 24,513,483
Enterprise Value $84,182,610
Volume 466,401
Av. Daily Volume 195,625
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Drug Pipeline

Drug Stage Notes
SGT-001
Duchenne Muscular Dystrophy
Phase 1/2
Phase 1/2
Phase 1/2 trial remains on clinical hold - noted July 24, 2020.

Latest News

  1. CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the Company's IGNITE DMD Phase I/II clinical trial remains on clinical hold.

    In November 2019, the FDA placed IGNITE DMD on clinical hold as the result of a serious adverse event (SAE) that occurred in the sixth patient dosed in the trial; as previously reported the SAE has fully resolved. In April 2020, Solid provided the FDA with information and measures intended to improve patient safety and in May 2020, Solid received written communication from…

    CAMBRIDGE, Mass., July 24, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, today announced that it received written communication from the U.S. Food and Drug Administration (FDA) that the Company's IGNITE DMD Phase I/II clinical trial remains on clinical hold.

    In November 2019, the FDA placed IGNITE DMD on clinical hold as the result of a serious adverse event (SAE) that occurred in the sixth patient dosed in the trial; as previously reported the SAE has fully resolved. In April 2020, Solid provided the FDA with information and measures intended to improve patient safety and in May 2020, Solid received written communication from the FDA that the trial remained on hold. In June 2020, the Company submitted a response to the FDA that provided data related to manufacturing process improvements. Today, the FDA responded by maintaining the clinical hold and requesting further manufacturing information, updated safety and efficacy data for all patients dosed, and providing direction on total viral load to be administered per patient. Solid is evaluating next steps and will provide an update as appropriate.

    "Patient safety is our highest priority and we plan to continue our dialogue with the FDA to determine the appropriate path for SGT-001," said Ilan Ganot, Co-Founder, President and Chief Executive Officer of Solid Biosciences. "We are disappointed with the outcome today, however, we will continue to work with the FDA as we believe the clinical development of SGT-001 could offer meaningful benefits to patients with this devastating disease."

    About SGT-001

    Solid's SGT-001 is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy (Duchenne). Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin gene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including neuronal nitric oxide synthase (nNOS). Data from Solid's preclinical program suggests that SGT-001 has the potential to slow or stop the progression of Duchenne, regardless of genetic mutation or disease stage.

    SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, in the United States and Orphan Drug Designations in both the United States and European Union.

    About Solid Biosciences

    Solid Biosciences is a life sciences company focused on developing transformative treatments to improve the lives of patients living with Duchenne muscular dystrophy (Duchenne). Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.

    Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's IGNITE DMD clinical trial, the Company's expected dialogue with the FDA regarding the clinical hold, the potential lifting of the clinical hold and the safety or potential efficacy of SGT-001 and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," "working" and similar expressions. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company's ability to satisfactorily respond to requests from the FDA for further information and data regarding IGNITE DMD; successfully resolve the clinical hold with regard to IGNITE DMD on the timeline expected or at all; obtain and maintain necessary approvals from the FDA and other regulatory authorities and investigational review boards at clinical trial sites; enroll patients in IGNITE DMD; continue to advance SGT-001 in clinical trials; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop DMD/Duchenne treatments and gene therapies; manage expenses; and raise the substantial additional capital needed to achieve its business objectives.  For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Investor Contact:

    David Carey

    FINN Partners

    212-867-1768

    Media Contact:

    Erich Sandoval

    FINN Partners

    917-497-2867

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  2. CAMBRIDGE, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced today the appointment of board member Ian F. Smith as Chairman of the Board. Mr. Smith succeeds Andrey Zarur, Ph.D., who served as Chairman of the Board since 2013 and is one of the co-founders of Solid Biosciences. The appointment is effective June 16, 2020.

    "I want to thank Andrey for putting Duchenne patients and their families first. His contributions enabled the advancement of Solid from an idea to a clinical stage company that is developing a potentially meaningful therapy for patients with Duchenne," said Ilan Ganot, Chief Executive Officer…

    CAMBRIDGE, Mass., June 18, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced today the appointment of board member Ian F. Smith as Chairman of the Board. Mr. Smith succeeds Andrey Zarur, Ph.D., who served as Chairman of the Board since 2013 and is one of the co-founders of Solid Biosciences. The appointment is effective June 16, 2020.

    "I want to thank Andrey for putting Duchenne patients and their families first. His contributions enabled the advancement of Solid from an idea to a clinical stage company that is developing a potentially meaningful therapy for patients with Duchenne," said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. He added, "We are honored to have Ian lead the board in this next phase for Solid Biosciences. His extensive operational leadership experience in the biopharmaceutical industry will be instrumental as we progress our company and clinical program for the benefit of patients with Duchenne."  

    Mr. Smith has held multiple roles in biotechnology companies, most recently serving as Executive Vice President and Chief Operating Officer of Vertex Pharmaceuticals. Prior to that, Mr. Smith served as Chief Financial Officer of Vertex. Mr. Smith currently serves as Executive Chairman of ViaCyte, Inc. Mr. Smith previously has served on the Board of Directors of Acorda Therapeutics and Infinity Pharmaceuticals, both public biotechnology companies, as well as other private biotechnology companies.

    About Solid Biosciences

    Solid Biosciences is a life sciences company focused on developing transformative treatments to improve the lives of patients living with Duchenne muscular dystrophy (Duchenne). Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.

    Investor Contact:

    David Carey

    FINN Partners

    212-867-1768

    Media Contact:

    Erich Sandoval

    FINN Partners

    917-497-2867

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  3. CAMBRIDGE, Mass., May 22, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, its 2020 Annual Meeting of Stockholders (the "Annual Meeting"), to be held on Tuesday, June 16, 2020 at 8:00 a.m. Eastern Time, has been changed to a virtual-only meeting. The virtual-only Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    Stockholders are entitled to participate in and vote at the Annual Meeting if they were a stockholder at the close of business on April 20…

    CAMBRIDGE, Mass., May 22, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) today announced that, due to the public health impact of the novel coronavirus (COVID-19) outbreak and governmental restrictions limiting the number of people who may gather together, its 2020 Annual Meeting of Stockholders (the "Annual Meeting"), to be held on Tuesday, June 16, 2020 at 8:00 a.m. Eastern Time, has been changed to a virtual-only meeting. The virtual-only Annual Meeting is expected to provide stockholders with the same rights and opportunities to participate as they would have at an in-person meeting.

    Stockholders are entitled to participate in and vote at the Annual Meeting if they were a stockholder at the close of business on April 20, 2020, the record date, or hold a legal proxy for the meeting provided by the stockholder's bank, broker or nominee as of such record date. To access, participate in, and vote at the Annual Meeting at www.virtualshareholdermeeting.com/sldb2020 (the "Annual Meeting Website"), you must enter the control number found on your proxy card, voting instruction form or notice you previously received.  Stockholders may submit questions for the Annual Meeting through the virtual meeting platform. Those without a control number may attend as guests of the meeting, but will not have the option to vote or ask questions during the virtual meeting. Additional information regarding the virtual meeting, such as technical support, are included in a proxy supplement that the company has filed today with the Securities and Exchange Commission.

    Please note that the proxy card included with the proxy materials previously distributed will not be updated to reflect the change in location and may continue to be used to vote your shares in connection with the Annual Meeting.

    All stockholders – whether attending the Annual Meeting or not – are encouraged to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials. Stockholders may also vote online during the Annual Meeting by following the instructions available on the Annual Meeting Website.

    About Solid Biosciences
    Solid Biosciences is a life sciences company focused on developing transformative treatments to improve the lives of patients living with Duchenne muscular dystrophy (Duchenne). Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.

    Investor Contact:
    David Carey
    FINN Partners
    212-867-1768

    Media Contact:
    Erich Sandoval
    FINN Partners
    917-497-2867

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  4. Virtual oral presentation reviews interim clinical biomarker data for SGT-001 and provides data on expression and co-localization of microdystrophin and dystrophin associated proteins in patients in the IGNITE DMD trial

    Virtual poster presentation provides data characterizing novel adeno-associated virus (AAV) vectors engineered for muscle gene delivery

    CAMBRIDGE, Mass., May 14, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) today announced the presentation of clinical biomarker data from its SGT-001 microdystrophin gene therapy clinical trial for the treatment of Duchenne muscular dystrophy (Duchenne) on May 13 at the American Society of Gene and Cell Therapy (ASGCT) 23rd Annual Meeting, which is being held virtually. In addition…

    Virtual oral presentation reviews interim clinical biomarker data for SGT-001 and provides data on expression and co-localization of microdystrophin and dystrophin associated proteins in patients in the IGNITE DMD trial

    Virtual poster presentation provides data characterizing novel adeno-associated virus (AAV) vectors engineered for muscle gene delivery

    CAMBRIDGE, Mass., May 14, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB) today announced the presentation of clinical biomarker data from its SGT-001 microdystrophin gene therapy clinical trial for the treatment of Duchenne muscular dystrophy (Duchenne) on May 13 at the American Society of Gene and Cell Therapy (ASGCT) 23rd Annual Meeting, which is being held virtually. In addition, data from studies characterizing novel adeno-associated virus (AAV) vectors engineered for muscle gene delivery were presented in a poster session.

    Presentation Information

    Abstract Number: 500
    SGT-001 Microdystrophin Gene Therapy for Duchenne Muscular Dystrophy. Oral presentation delivered by Patrick Gonzalez, PhD, Associate Director, R&D, Solid Biosciences.

    Data presented from the ongoing IGNITE DMD clinical trial studying SGT-001 at a dose of 2E14 vg/kg were:

    • SGT-001 administration results in dose-dependent, muscle wide microdystrophin expression in muscle biopsies collected 90 days post-SGT-001 administration.
    • SGT-001-driven microdystrophin expression results in stabilization of dystrophin associated proteins.
    • SGT-001-driven microdystrophin expression results in restored enzymatically active neuronal nitric oxide synthase (nNOS) at the sarcolemma.

    Abstract Number: 558
    Characterization of Novel AAV Vectors Engineered for Muscle Gene Delivery. Poster presentation and online Q&A delivered by Jennifer Green, PhD, Senior Scientist, R&D, Solid Biosciences.

    This study utilized a rational design approach to generate a set of novel capsids predicted to have increased muscle tropism and transduction efficiency for the development of treatment for Duchenne. Key findings are:

    • AAV-SLB101, a novel capsid, showed superior transduction efficiency in comparison to AAV9 in in vitro assays in both mouse and Duchenne human skeletal muscle cells.
    • These in vitro results translated to increased biodistribution and microdystrophin protein expression in vivo in both quadriceps and heart, and decreased biodistribution to liver, in comparison to AAV9.
    • An expanded panel of novel capsids identified two more candidates of interest, AAV-SLB102 and AAV-SLB111, that look similar to AAV-SLB101 in in vitro assays for binding, uptake and microdystrophin protein expression in C2C12 cells.

    The presentation and poster are available on the Scientific Publications & Presentations page of the Solid Biosciences corporate website.

    About SGT-001
    Solid's SGT-001 is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy (Duchenne). Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin gene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including neuronal nitric oxide synthase (nNOS). Data from Solid's preclinical program suggests that SGT-001 has the potential to slow or stop the progression of Duchenne, regardless of genetic mutation or disease stage.

    SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, in the United States and Orphan Drug Designations in both the United States and European Union.

    About Solid Biosciences
    Solid Biosciences is a life sciences company focused on developing transformative treatments to improve the lives of patients living with Duchenne muscular dystrophy (Duchenne). Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.

    Forward-Looking Statements
    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's IGNITE DMD clinical trial, the safety or potential efficacy of SGT-001 and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," "working" and similar expressions. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Investor Contact:
    David Carey
    FINN Partners
    212-867-1768

    Media Contact:
    Erich Sandoval
    FINN Partners
    917-497-2867

    Primary Logo

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  5. CAMBRIDGE, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced that it received written communication from the U.S. Food and Drug Administration (FDA) regarding the clinical hold placed on the Company's IGNITE DMD Phase I/II clinical trial. The program remains on clinical hold and the Company will continue to work with the FDA to address their requests. 

    In April 2020, the Company submitted a response to the FDA that included changes to the clinical protocol designed to enhance patient safety, as well as information related to improvements to its manufacturing process. The FDA has responded by maintaining the…

    CAMBRIDGE, Mass., May 07, 2020 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (NASDAQ:SLDB), a life sciences company focused on advancing meaningful therapies for Duchenne muscular dystrophy, announced that it received written communication from the U.S. Food and Drug Administration (FDA) regarding the clinical hold placed on the Company's IGNITE DMD Phase I/II clinical trial. The program remains on clinical hold and the Company will continue to work with the FDA to address their requests. 

    In April 2020, the Company submitted a response to the FDA that included changes to the clinical protocol designed to enhance patient safety, as well as information related to improvements to its manufacturing process. The FDA has responded by maintaining the clinical hold and requesting further data and analyses relating to this manufacturing process.  The Company is in the process of generating these data and expects to submit this information to the FDA before the end of the third quarter of 2020. 

    "We share the FDA's commitment to patient safety and are working collaboratively with the agency to resolve the clinical hold," said Ilan Ganot, Chief Executive Officer, President and Co-Founder of Solid Biosciences. "We consider patient safety the utmost priority and believe the clinical development of SGT-001 could offer meaningful benefits to patients with this devastating disease."

    In addition, Solid Biosciences today filed its Quarterly Report on Form 10-Q for the quarter ended March 31, 2020 with the Securities and Exchange Commission.

    About SGT-001
    Solid's SGT-001 is a novel adeno-associated viral (AAV) vector-mediated gene transfer therapy designed to address the underlying genetic cause of Duchenne muscular dystrophy (Duchenne). Duchenne is caused by mutations in the dystrophin gene that result in the absence or near absence of dystrophin protein. SGT-001 is a systemically administered candidate that delivers a synthetic dystrophin gene, called microdystrophin, to the body. This microdystrophin encodes for a functional protein surrogate that is expressed in muscles and stabilizes essential associated proteins, including neuronal nitric oxide synthase (nNOS). Data from Solid's preclinical program suggests that SGT-001 has the potential to slow or stop the progression of Duchenne, regardless of genetic mutation or disease stage.

    SGT-001 is based on pioneering research in dystrophin biology by Dr. Jeffrey Chamberlain of the University of Washington and Dr. Dongsheng Duan of the University of Missouri. SGT-001 has been granted Rare Pediatric Disease Designation, or RPDD, in the United States and Orphan Drug Designations in both the United States and European Union.

    About Solid Biosciences
    Solid Biosciences is a life sciences company focused on developing transformative treatments to improve the lives of patients living with Duchenne muscular dystrophy (Duchenne). Disease-focused and founded by a family directly impacted by Duchenne, our mandate is simple yet comprehensive – work to address the disease at its core by correcting the underlying mutation that causes Duchenne with our lead gene therapy candidate, SGT-001. For more information, please visit www.solidbio.com.

    Forward-Looking Statements
    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company's IGNITE DMD clinical trial, the Company's expected response to the FDA with respect to the clinical hold on the IGNITE DMD clinical trial, the potential lifting of the clinical hold on the Company's IGNITE DMD clinical trial, and the safety or potential efficacy of SGT-001 and other statements containing the words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "would," "working" and similar expressions. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company's ability to satisfactorily respond to requests from the FDA for further information and data regarding IGNITE DMD on the timeline expected or at all; successfully resolve the clinical hold with regard to IGNITE DMD; obtain and maintain necessary approvals from the FDA and other regulatory authorities and investigational review boards at clinical trial sites; enroll patients in its clinical trials; continue to advance SGT-001 in clinical trials; replicate in clinical trials positive results found in preclinical studies and earlier stages of clinical development; advance the development of its product candidates under the timelines it anticipates in current and future clinical trials; successfully scale its manufacturing process; obtain, maintain or protect intellectual property rights related to its product candidates; compete successfully with other companies that are seeking to develop DMD/Duchenne treatments and gene therapies; manage expenses; and raise the substantial additional capital needed to achieve its business objectives. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company's actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in the Company's most recent filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date hereof and should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

    Investor Contact:
    David Carey
    FINN Partners
    212-867-1768

    Media Contact:
    Erich Sandoval
    FINN Partners
    917-497-2867


     

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