DYN Dyne Therapeutics Inc.
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Dr. Dugar Brings Over 20 Years of Experience in Medical Affairs, Clinical and Commercial Development, and Real-World Evidence, Including in Rare Muscle Disease
WALTHAM, Mass., Feb. 08, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced the appointment of Ashish Dugar, Ph.D., MBA, as senior vice president, global head of medical affairs. Dr. Dugar brings over 20 years of broad experience across medical affairs, clinical and commercial development, and real-world evidence (RWE) generation.
"We are thrilled to welcome Ash to the Dyne team and he'll play an instrumental role in our efforts to develop life-transforming therapies for patients. He has deep experience across clinical, commercial, patient advocacy, RWE, and market access with leading drug development companies and proven success in building a global medical affairs organization in rare muscle disease," said Joshua Brumm, president and chief executive officer of Dyne. "Ash is representative of the exceptional talent we have been fortunate to attract to Dyne as we execute on our vision of building the world's leading muscle disease company."
Prior to joining Dyne, Dr. Dugar served as vice president and global head of medical affairs at Sarepta Therapeutics, Inc., where he built the company's medical affairs organization. Previously, he led all commercial and market access efforts for Intra-Cellular Therapies, Inc. as vice president and head of commercial development. Dr. Dugar joined Intra-Cellular Therapies following his tenure at Roche, where he was global head of clinical development science and innovation and global head of the external development group, including work in oligonucleotides. Previously, he spent 13 years at Pfizer Inc. in various roles, most recently serving as vice president, global head of clinical development and medical affairs of the biosimilars business unit. Dr. Dugar began his career at the National Institutes of Health. He completed a pharmacoeconomics and outcomes research fellowship at the University of Michigan School of Public Health. Dr. Dugar earned an MBA from The Pennsylvania State University and a Ph.D. in pharmacology from The Pennsylvania State University College of Medicine.
"Dyne is leading a novel approach to solving historical challenges in the development and delivery of modern oligonucleotide therapies for rare muscle diseases, an area I'm incredibly passionate about given the vast unmet patient need. With platform-validating preclinical data and the opportunity to deliver first- and best-in-class therapies at a company with a strong culture focused on innovation and excellence in execution, I am excited to join the team at this pivotal time. Dyne is well positioned for success as we work to advance our three programs into clinical trials," said Dr. Dugar.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company dedicated to advancing innovative life-transforming therapeutics for people living with genetically driven diseases. With its proprietary FORCE™ platform, Dyne is developing modern oligonucleotide therapeutics that are designed to overcome limitations in delivery to muscle tissue seen with other approaches. Dyne's broad portfolio of therapeutic candidates for serious muscle diseases includes programs for myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit https://www.dyne-tx.com/, and follow us on Twitter, LinkedIn and Facebook.Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne's strategy, future operations, prospects, plans, objectives of management, the expected timeline for submitting investigational new drug applications, the potential advantages of Dyne's FORCE platform and programs, expectations regarding the translation of preclinical findings to human disease and plans to conduct additional preclinical studies, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," or "would," or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne's ability to submit and obtain regulatory approval for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; Dyne's ability to obtain sufficient cash resources to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; the impact of the COVID-19 pandemic on Dyne's business and operations; as well as the risks and uncertainties identified in Dyne's filings with the Securities and Exchange Commission (SEC), including the Company's most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne's views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne's views as of any date subsequent to the date of this press release.
Contact:
Dyne Therapeutics
Amy Reilly
[email protected]
857-341-1203
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WALTHAM, Mass., Jan. 20, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced the pricing of an underwritten public offering of 6,000,000 shares of its common stock at a public offering price of $28.00 per share. In addition, Dyne has granted the underwriters a 30-day option to purchase up to 900,000 additional shares of common stock at the public offering price, less the underwriting discount and commissions. All of the shares are being offered by Dyne.
The gross proceeds of the offering, before deducting the underwriting discount and commissions and other offering expenses payable by Dyne, are expected to be approximately $168 million, excluding any exercise of the underwriters' option to purchase additional shares. The offering is expected to close on Monday, January 25, 2021, subject to customary closing conditions.
J.P. Morgan, Jefferies, Piper Sandler and Stifel are acting as joint book-running managers for the offering.
A registration statement relating to the securities being sold in this offering has been filed with, and declared effective by, the Securities and Exchange Commission. This offering is being made only by means of a prospectus. Copies of the final prospectus relating to this offering may be obtained, when available, from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at (866) 803-9204 or via email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, New York 10022, via telephone at (877) 821-7388 or via email at [email protected]; Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, Minnesota 55402, via telephone at (800) 747-3924 or via email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, via telephone at (415) 364-2720 or via email at [email protected].
This press release shall not constitute an offer to sell, or a solicitation of an offer to buy, these securities, nor shall there be any offer or sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. The Company is utilizing its proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD).
Contact:
Dyne Therapeutics
Amy Reilly
[email protected]
857-341-1203 -
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- In Vivo Model Developed by Dyne Sets New Standard for Evaluating Pharmacodynamics in DM1 -
- Preclinical Data Further Validate FORCE™ Platform; IND Submissions Planned for DM1, DMD and FSHD Programs Between Q4'21 and Q4'22 -
WALTHAM, Mass., Jan. 10, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced new preclinical data from its myotonic dystrophy type 1 (DM1) program demonstrating robust RNA knockdown of toxic human nuclear DMPK, the genetic basis of the disease.
Dyne's FORCE™ platform leverages the importance of transferrin 1 receptor, TfR1, in muscle biology as the foundation for its novel approach. TfR1, which is highly expressed on the surface of muscle cells, is required for iron transport into muscle cells. Dyne links therapeutic payloads to its TfR1-binding fragment antibody (Fab) to develop targeted therapeutics for muscle diseases. Dyne's DM1 lead candidate consists of a Fab conjugated to an antisense oligonucleotide (ASO) to enable targeted delivery to muscle tissue to reduce accumulation of toxic DMPK RNA in the nucleus, release splicing proteins, allow normal mRNA processing and translation of normal proteins, and potentially stop or reverse the disease.
These new preclinical data build on previous results showing significant reduction in cytoplasmic wild type DMPK RNA in a mouse model that expresses human TfR1(hTfR1). To assess the ability of its lead DM1 candidate to reduce toxic human nuclear DMPK RNA, Dyne developed an innovative hTfR1/DMSXL mouse model that expresses the human TfR1 and carries a human DMPK gene that represents a severe DM1 phenotype with more than 1,000 CTG repeats. In this model, two doses (2 x 10 mg/kg) of Dyne's candidate resulted in significant toxic human nuclear DMPK knockdown at 14 days: 60 percent in the heart; 56 percent in the diaphragm; 54 percent in the tibialis anterior and 39 percent in the gastrocnemius. In the study, Dyne's candidate was well tolerated. Dyne expects to share data from the hTfR1/DMSXL model at a scientific meeting during 2021.
"At Dyne we are focused on developing therapies designed to target the genetic basis of the disease with the goal of delivering disease modification for patients," said Romesh Subramanian, Ph.D., chief scientific officer of Dyne. "Multiple genetic studies in DM1 have suggested that a 30 to 50 percent knockdown of toxic human DMPK has the potential to be disease modifying. We are very pleased with the robust toxic human DMPK reduction observed in the hTfR1/DMSXL model, which, along with our previous preclinical data showing correction of splicing and reversal of myotonia, indicates the potential to have an impact for patients living with a disease with no approved therapies. We intend to utilize this novel model to conduct IND-enabling work as we progress toward the clinic."
"In DM1, it is critical to target the nucleus where the disease-causing toxic DMPK resides and forms foci," said Valeria Sansone, M.D., Ph.D., Clinical and Scientific Director, Clinical Center NeMO, Milan; Associate Professor of Neurology, University of Milan. "The innovative preclinical model used in this study has the potential for translation into human disease. The data demonstrate compelling reduction in levels of DMPK RNA and suggest this approach may be effective in targeting nuclear DMPK and delivering a therapeutic to muscle for diseases such as DM1."
The new preclinical data from the hTfR1/DMSXL model are included in an updated corporate presentation available in the Investors & Media section of the Company's website and add to the robust in vitro and in vivo findings generated previously in Dyne's DM1 program:
- Reduction in nuclear foci and correction of splicing in DM1 patient cells
- Correction of splicing and reversal of myotonia in well-validated HSALR model
- Enhanced muscle distribution as evidenced by reduced levels of cytoplasmic wild type DMPK RNA in non-human primates (NHPs)
- Durability of response of up to 12 weeks after a single dose in a wild type mouse model
- Favorable tolerability observed in multiple NHP studies
"Today's exciting data further validate our FORCE platform which drives our efforts to deliver targeted, modern oligonucleotide therapies with the potential to be life-transforming for patients with serious muscle diseases," said Joshua Brumm, president and chief executive officer of Dyne. "We remain on track to submit INDs for our three programs between the fourth quarter of 2021 and the fourth quarter of 2022, with DM1 and DMD submissions anticipated in the earlier part of that window, followed later by FSHD."
About Myotonic Dystrophy Type 1 (DM1)
DM1 is a rare, progressive, genetic disease that affects skeletal, cardiac and smooth muscles. It is a monogenic, autosomal dominant disease caused by an abnormal expansion in a region of the DMPK gene. The expansion in the number of CTG triplet repeats causes toxic RNA to cluster in the nucleus, forming nuclear foci and altering the splicing of multiple proteins essential for normal cellular function. This altered splicing results in a wide range of symptoms. People living with DM1 typically experience progressive weakness of major muscle groups, which can affect mobility, breathing, heart function, speech, digestion and vision as well as cognition. DM1 is estimated to affect more than 40,000 people in the United States and over 74,000 people in Europe, but there are currently no approved disease-modifying therapies.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. The Company is utilizing its proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, including statements regarding Dyne's strategy, future operations, prospects, plans, objectives of management, the expected timeline for submitting investigational new drug applications, the potential advantages of Dyne's FORCE platform and programs, expectations regarding the translation of preclinical findings to human disease and plans to conduct additional preclinical studies, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "might," "objective," "ongoing," "plan," "predict," "project," "potential," "should," or "would," or the negative of these terms, or other comparable terminology are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Dyne may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the conduct of research activities, the initiation and completion of preclinical studies and clinical trials; uncertainties as to the availability and timing of results from preclinical studies; the timing of and Dyne's ability to submit and obtain regulatory approval for investigational new drug applications; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; Dyne's ability to obtain sufficient cash resources to fund the Company's foreseeable and unforeseeable operating expenses and capital expenditure requirements; the impact of the COVID-19 pandemic on Dyne's business and operations; as well as the risks and uncertainties identified in Dyne's filings with the Securities and Exchange Commission (SEC), including the Company's most recent Form 10-Q and in subsequent filings Dyne may make with the SEC. In addition, the forward-looking statements included in this press release represent Dyne's views as of the date of this press release. Dyne anticipates that subsequent events and developments will cause its views to change. However, while Dyne may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Dyne's views as of any date subsequent to the date of this press release.
Contact:
Dyne Therapeutics
Amy Reilly
[email protected]
857-341-1203 -
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WALTHAM, Mass., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that Joshua Brumm, president and chief executive officer, and Romesh Subramanian, Ph.D., chief scientific officer, are scheduled to present at the virtual 39th Annual J.P. Morgan Healthcare Conference on Wednesday, January 13, 2021 at 10:00 a.m. ET.
A live webcast will be available in the Investors & Media section of Dyne's website at https://investors.dyne-tx.com/investors-and-media and a replay will be accessible for 90 days following the presentation.
About Dyne Therapeutics
Dyne Therapeutics is building a leading muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. The Company utilizes its proprietary FORCE™ platform to overcome the current limitations of muscle tissue delivery with modern oligonucleotide therapeutic candidates. Dyne is developing a broad portfolio of therapeutics for muscle diseases, including programs in myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). For more information, please visit www.dyne-tx.com, and follow us on Twitter, LinkedIn and Facebook.
Contact:
Dyne Therapeutics
Amy Reilly
[email protected]
857-341-1203 -
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BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) -- Cerevance, a private drug discovery and development company focused on brain diseases, today announced the appointment of David Lubner, a senior finance executive with more than 25 years of experience in the life sciences industry, to Cerevance's Board of Directors.
Mr. Lubner most recently served as executive vice president and chief financial officer of Ra Pharma, which was acquired by UCB in April of this year. Before joining Ra Pharma, he served as a member of the senior management team of Tetraphase Pharmaceuticals, Inc. and PharMetrics Inc., a leading patient-based pharmacy and medical claims data informatics company, and at ProScript, where Velcade® (bortezomib), a therapy widely used for the treatment of multiple myeloma, was discovered.
Mr. Lubner currently serves on the Board of Directors of Dyne Therapeutics (NASDAQ:DYN), a company developing life-transforming therapies for patients with serious muscle diseases, Therapeutics Acquisition Corporation (NASDAQ:RACA), a blank check company focused on the healthcare industry sponsored by RA Capital and several other private biotechnology companies. He previously served on the Board of Directors of Nightstar Therapeutics plc (NASDAQ:NITE), a company focused on the development of one-time retinal gene therapies for patients suffering from rare inherited retinal diseases, which was acquired by Biogen in June 2019. Mr. Lubner is a Certified Public Accountant. He received his B.S. in business administration from Northeastern University and an M.S. in taxation from Bentley University.
"David's expertise across a wide range of financial, operational and corporate strategic areas, in both senior management and Board roles, will be a valuable complement to Cerevance's Board," said Brad Margus, chief executive officer, co-founder and board member of Cerevance. "We're thrilled to gain his counsel as our company's powerful target discovery platform and rapidly expanding therapeutic pipeline open new opportunities with partners and in the capital markets."
Mr. Lubner, stated, "I am pleased to be joining Cerevance's Board as the company works to advance novel treatments for a range of neurodegenerative and psychiatric diseases for which effective treatments are desperately needed. The company has assembled a strong team of managers, advisors and investors, and I look forward to contributing my expertise as we explore and execute on strategic opportunities."
About Cerevance
Cerevance, a private, clinical-stage pharmaceutical company focused on brain diseases, is applying a new technology, called NETSseq, to reveal transcriptional and epigenetic differences between specific cell types in mature human brains. NETSseq profiles neuronal and glial cell populations at depths not possible with other approaches, generating unprecedented data sets and insights. The company has thus far partnered with 19 brain banks around the world to assemble a growing collection of more than 8,000 clinically annotated, human brain tissue samples from healthy and diseased donors spanning nine decades in age. By applying NETSseq to specific cell types critical to circuits disrupted by disease and comparing vulnerable and resilient cell populations, Cerevance's scientists have begun identifying targets and advancing a pipeline of novel therapeutics that modulate them for CNS diseases.
Contacts
Cerevance:
Robert Middlebrook, +1-408-220-5722Media:
Andrew Mielach, [email protected], +1-646-876-5868