Latest news with #AOCs
Yahoo
12-06-2025
- Business
- Yahoo
Vertical and Bristow Partner to Deliver Full Service 'Ready-to-Fly' eVTOL Operations for VX4 Customers
Strategic partnership will accelerate global eVTOL adoption by combining Vertical's category leading aircraft with Bristow's global vertical lift operational and safety track record and experience "Ready-to-fly" model provides Vertical's customers with turnkey access to aircraft, pilots, maintenance, and insurance – lowering barriers to entry Bristow places pre-order for up to 50 VX4, with option to purchase up to 50 more Companies exploring Maintenance, Repair and Overhaul (MRO) services, including battery swapping and field maintenance solutions LONDON & HOUSTON, June 12, 2025--(BUSINESS WIRE)--Vertical Aerospace (Vertical) [NYSE: EVTL], a global aerospace and technology company pioneering electric aviation, and Bristow Group Inc. [NYSE: VTOL], the leading global provider of innovative and sustainable vertical flight solutions, today announced an expansion of their strategic partnership to bring advanced air mobility (AAM) into commercial operation. The companies will develop a scalable, capital-light eVTOL operations platform, designed to reduce barriers to adopting these aircraft by providing Vertical's current and future customers with fully integrated solutions to launch services without building operational infrastructure from scratch. This "ready-to-fly" model, which mirrors existing, successful operating models adopted by regional airlines, includes access to certified aircraft, trained pilots, maintenance, and insurance – allowing VX4 customers to focus on customer experience, sales, and network integration, while Vertical and Bristow manage aircraft operations on their behalf. Under the memorandum of understanding between the companies, Bristow has also placed a pre-order for up to 50 VX4, with the option to purchase up to 50 more. This expanded pre-order builds on the strategic partnership launched in 2021 and reflects Bristow's confidence in the potential of Vertical's VX4 aircraft, including its commercial viability, certification path, and delivery roadmap. Chris Bradshaw, President and CEO of Bristow Group, said: "We are excited about expanding our relationship with Vertical and helping move the future of advanced air mobility forward. Bristow has over 75 years of providing critical safety, operational, certification, and logistics expertise, and this agreement outlines a framework to help scale these new aircraft globally, offering customers a seamless path from concept to revenue." Stuart Simpson, CEO of Vertical Aerospace, said: "This strategic partnership is about execution and mirrors what already successfully works in aviation today. It will lower barriers to market entry and accelerate the adoption of eVTOL services worldwide. Together, we're making it easy for customers to adopt electric flight, allowing them to focus on what they are best at – customer service, loyalty and sales." Bristow will leverage its global operational footprint, including multiple Air Operator Certificates (AOCs) and Bristow's global MRO network approvals, to offer fully managed operations for Vertical's current and future customers. Target customers include airlines, logistics operators and rescue services – sectors where Bristow has over seven decades of mission-critical experience across the world. As part of the strategic partnership, the companies will harmonize their respective safety management systems and utilize the VX4's cloud-connected architecture to deliver predictive maintenance, enhanced reliability, and data-driven fleet insights. The companies are also exploring Maintenance, Repair and Overhaul (MRO) services, including battery swapping and field maintenance solutions This agreement is a key enabler of Vertical's Flightpath 2030 strategy - its roadmap to delivering scalable, certified, and commercially viable eVTOL operations globally. It also builds on Vertical's recent completion of the first-ever wingborne flight of a winged eVTOL in European open airspace - a critical step toward certification and commercial launch that reflects growing regulatory confidence in the capabilities of the VX4. About Vertical Aerospace Vertical Aerospace is a global aerospace and technology company pioneering electric aviation. Vertical is creating a safer, cleaner and quieter way to travel. Vertical's VX4 is a piloted, four passenger, Electric Vertical Take-Off and Landing (eVTOL) aircraft, with zero operating emissions. Vertical will also be launching a hybrid-electric variant, offering increased range and mission flexibility to meet the evolving needs of the advanced air mobility market. Vertical combines partnering with leading aerospace companies, including GKN, Honeywell and Leonardo, with developing its own proprietary battery and propeller technology to develop the world's most advanced and safest eVTOL. Vertical has c.1,500 pre-orders of the VX4, with customers across four continents, including American Airlines, Japan Airlines, GOL and Bristow. Certain customer obligations are expected to be fulfilled via third-party agreements. Headquartered in Bristol, the epicentre of the UK's aerospace industry, Vertical's experienced leadership team comes from top tier automotive and aerospace companies such as Rolls-Royce, Airbus, GM and Leonardo. Together they have previously certified and supported over 30 different civil and military aircraft and propulsion systems. About Bristow Group Bristow Group Inc. is the leading global provider of innovative and sustainable vertical flight solutions. Bristow primarily provides aviation services to a broad base of offshore energy companies and government entities. Bristow's aviation services include personnel transportation, search and rescue ("SAR"), medevac, fixed-wing transportation, unmanned systems and ad hoc helicopter services. Bristow's business is comprised of three operating segments: Offshore Energy Services, Government Services and Other Services. Bristow's energy customers charter its helicopters primarily to transport personnel to, from and between onshore bases and offshore production platforms, drilling rigs and other installations. Bristow's government customers primarily outsource SAR activities whereby we operate specialized helicopters and provide highly trained personnel. Bristow's other services include fixed wing transportation services through a regional airline and dry-leasing aircraft to third-party operators in support of other industries and geographic markets. Bristow currently has customers in Australia, Brazil, Canada, Chile, the Dutch Caribbean, the Falkland Islands, India, Ireland, Mexico, the Netherlands, Nigeria, Norway, Spain, Suriname, Trinidad, the United Kingdom ("UK") and the United States ("U.S."). Forward-Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that relate to Vertical's current expectations and views of future events. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements as contained in Section 27A of the Securities Act and 21E of the Exchange Act. Any express or implied statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements regarding the expected benefits of the strategic partnership between Vertical and Bristow disclosed herein, Bristow's purchase of aircraft from Vertical, the design and manufacture of the VX4, the features and capabilities of the VX4 and the hybrid-electric variant, expectations surrounding pre-orders and commitments, business strategy and plans and objectives of management for future operations, including the building and testing of Vertical's prototype aircrafts on timelines projected, completion of the piloted test programme phases, selection of suppliers, certification and the commercialization of both the VX4 and the hybrid-electric VX4 variant, and Vertical's ability to achieve regulatory certification of Vertical's aircraft products on any particular timeline or at all, Vertical's ability to integrate hybrid technology into the VX4 on any particular timelines or at all, the ability of the hybrid-electric VX4 variant VX4 to be applied in defense, cargo, logistics and emergency services sectors, Vertical's ability to scale the hybrid-electric VX4 upon the VX4, the transition towards a net-zero emissions economy, Vertical's future results of operations and financial position and expected financial performance and operational performance, liquidity, growth and profitability strategies, business strategy and plans and objectives of management for future operations, Vertical's ability and plans to raise additional capital to fund Vertical's operations, Vertical's plans to mitigate the risk that we are unable to continue as a going concern, Vertical's plans for capital expenditures, as well as statements that include the words "expect," "intend," "plan," "believe," "project," "forecast," "estimate," "may," "should," "anticipate," "will," "aim," "potential," "continue," "is/are likely to" and similar statements of a future or forward-looking nature. These forward-looking statements reflect Vertical's current views with respect to future events and are not a guarantee of future performance. Actual outcomes may differ materially from the information contained in the forward-looking statements as a result of a number of factors, including, without limitation, the important factors discussed under the caption "Risk Factors" in Vertical's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the "SEC") on March 11, 2025, as such factors may be updated from time to time in Vertical's other filings with the SEC. Any forward-looking statements contained in this release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. Vertical disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this release whether as a result of new information, future events or otherwise, other than to the extent required by applicable law. This Press Release also contains "forward-looking statements" representing Bristow Group Inc.'s ("Bristow") current expectations or forecasts of future events. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may," "will," "expect," "intend," "estimate," "anticipate," "believe," "project," or "continue," or other similar words, and include statements regarding the expected benefits of the fleet support and training agreements disclosed herein. These statements are made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, reflect Bristow management's current views with respect to future events and therefore are subject to significant risks and uncertainties, both known and unknown. Without limiting the generality of the foregoing, such forward-looking statements include statements regarding the capabilities, development, certification, marketing, and future operations of Vertical's VX4 aircraft, Bristow's purchase of aircraft from Vertical, and the anticipated benefits of the collaboration between Bristow and Vertical. Bristow's actual results may vary materially from those anticipated in forward-looking statements. Bristow cautions investors not to place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of the document in which they are made. Bristow disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statement to reflect any change in Bristow's expectations or any change in events, conditions or circumstances on which the forward-looking statement is based that occur after the date hereof, except as may be required by applicable law. You should not place undue reliance on Bristow's forward-looking statements because the matters they describe are subject to known and unknown risks, uncertainties, and other unpredictable factors, many of which are beyond Bristow's control. New risks and uncertainties arise from time to time, and it is impossible for Bristow to predict these matters or how they may affect Bristow. Bristow has included important factors in the section entitled "Risk Factors" in Bristow's Annual Report on Form 10-K for the year ended December 31, 2024 (the "Annual Report") which Bristow believes over time, could cause Bristow's actual results, performance, or achievements to differ from the anticipated results, performance or achievements that are expressed or implied by Bristow's forward-looking statements. You should consider all risks and uncertainties disclosed in the Annual Report and in Bristow's filings with the SEC, all of which are accessible on the SEC's website at View source version on Contacts For more information about Vertical Aerospace: Justin Bates, Head of Communications +44 7878 357 463Samuel Emden, Head of Investor Affairs +447816 459 904 Investors Bristow Group Inc. Jennifer Media Bristow Group Inc. Adam Sign in to access your portfolio
Business Wire
12-06-2025
- Business
- Business Wire
Vertical and Bristow Partner to Deliver Full Service 'Ready-to-Fly' eVTOL Operations for VX4 Customers
LONDON & HOUSTON--(BUSINESS WIRE)--Vertical Aerospace (Vertical) [NYSE: EVTL], a global aerospace and technology company pioneering electric aviation, and Bristow Group Inc. [NYSE: VTOL], the leading global provider of innovative and sustainable vertical flight solutions, today announced an expansion of their strategic partnership to bring advanced air mobility (AAM) into commercial operation. The companies will develop a scalable, capital-light eVTOL operations platform, designed to reduce barriers to adopting these aircraft by providing Vertical's current and future customers with fully integrated solutions to launch services without building operational infrastructure from scratch. This "ready-to-fly" model, which mirrors existing, successful operating models adopted by regional airlines, includes access to certified aircraft, trained pilots, maintenance, and insurance – allowing VX4 customers to focus on customer experience, sales, and network integration, while Vertical and Bristow manage aircraft operations on their behalf. Under the memorandum of understanding between the companies, Bristow has also placed a pre-order for up to 50 VX4, with the option to purchase up to 50 more. This expanded pre-order builds on the strategic partnership launched in 2021 and reflects Bristow's confidence in the potential of Vertical's VX4 aircraft, including its commercial viability, certification path, and delivery roadmap. Chris Bradshaw, President and CEO of Bristow Group, said: 'We are excited about expanding our relationship with Vertical and helping move the future of advanced air mobility forward. Bristow has over 75 years of providing critical safety, operational, certification, and logistics expertise, and this agreement outlines a framework to help scale these new aircraft globally, offering customers a seamless path from concept to revenue.' Stuart Simpson, CEO of Vertical Aerospace, said: 'This strategic partnership is about execution and mirrors what already successfully works in aviation today. It will lower barriers to market entry and accelerate the adoption of eVTOL services worldwide. Together, we're making it easy for customers to adopt electric flight, allowing them to focus on what they are best at – customer service, loyalty and sales.' Bristow will leverage its global operational footprint, including multiple Air Operator Certificates (AOCs) and Bristow's global MRO network approvals, to offer fully managed operations for Vertical's current and future customers. Target customers include airlines, logistics operators and rescue services – sectors where Bristow has over seven decades of mission-critical experience across the world. As part of the strategic partnership, the companies will harmonize their respective safety management systems and utilize the VX4's cloud-connected architecture to deliver predictive maintenance, enhanced reliability, and data-driven fleet insights. The companies are also exploring Maintenance, Repair and Overhaul (MRO) services, including battery swapping and field maintenance solutions This agreement is a key enabler of Vertical's Flightpath 2030 strategy - its roadmap to delivering scalable, certified, and commercially viable eVTOL operations globally. It also builds on Vertical's recent completion of the first-ever wingborne flight of a winged eVTOL in European open airspace - a critical step toward certification and commercial launch that reflects growing regulatory confidence in the capabilities of the VX4. About Vertical Aerospace Vertical Aerospace is a global aerospace and technology company pioneering electric aviation. Vertical is creating a safer, cleaner and quieter way to travel. Vertical's VX4 is a piloted, four passenger, Electric Vertical Take-Off and Landing (eVTOL) aircraft, with zero operating emissions. Vertical will also be launching a hybrid-electric variant, offering increased range and mission flexibility to meet the evolving needs of the advanced air mobility market. Vertical combines partnering with leading aerospace companies, including GKN, Honeywell and Leonardo, with developing its own proprietary battery and propeller technology to develop the world's most advanced and safest eVTOL. Vertical has c.1,500 pre-orders of the VX4, with customers across four continents, including American Airlines, Japan Airlines, GOL and Bristow. Certain customer obligations are expected to be fulfilled via third-party agreements. Headquartered in Bristol, the epicentre of the UK's aerospace industry, Vertical's experienced leadership team comes from top tier automotive and aerospace companies such as Rolls-Royce, Airbus, GM and Leonardo. Together they have previously certified and supported over 30 different civil and military aircraft and propulsion systems. About Bristow Group Bristow Group Inc. is the leading global provider of innovative and sustainable vertical flight solutions. Bristow primarily provides aviation services to a broad base of offshore energy companies and government entities. Bristow's aviation services include personnel transportation, search and rescue ('SAR'), medevac, fixed-wing transportation, unmanned systems and ad hoc helicopter services. Bristow's business is comprised of three operating segments: Offshore Energy Services, Government Services and Other Services. Bristow's energy customers charter its helicopters primarily to transport personnel to, from and between onshore bases and offshore production platforms, drilling rigs and other installations. Bristow's government customers primarily outsource SAR activities whereby we operate specialized helicopters and provide highly trained personnel. Bristow's other services include fixed wing transportation services through a regional airline and dry-leasing aircraft to third-party operators in support of other industries and geographic markets. Bristow currently has customers in Australia, Brazil, Canada, Chile, the Dutch Caribbean, the Falkland Islands, India, Ireland, Mexico, the Netherlands, Nigeria, Norway, Spain, Suriname, Trinidad, the United Kingdom ('UK') and the United States ('U.S.'). Forward-Looking Statements This Press Release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that relate to Vertical's current expectations and views of future events. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements as contained in Section 27A of the Securities Act and 21E of the Exchange Act. Any express or implied statements contained in this release that are not statements of historical fact may be deemed to be forward-looking statements, including, without limitation, statements regarding the expected benefits of the strategic partnership between Vertical and Bristow disclosed herein, Bristow's purchase of aircraft from Vertical, the design and manufacture of the VX4, the features and capabilities of the VX4 and the hybrid-electric variant, expectations surrounding pre-orders and commitments, business strategy and plans and objectives of management for future operations, including the building and testing of Vertical's prototype aircrafts on timelines projected, completion of the piloted test programme phases, selection of suppliers, certification and the commercialization of both the VX4 and the hybrid-electric VX4 variant, and Vertical's ability to achieve regulatory certification of Vertical's aircraft products on any particular timeline or at all, Vertical's ability to integrate hybrid technology into the VX4 on any particular timelines or at all, the ability of the hybrid-electric VX4 variant VX4 to be applied in defense, cargo, logistics and emergency services sectors, Vertical's ability to scale the hybrid-electric VX4 upon the VX4, the transition towards a net-zero emissions economy, Vertical's future results of operations and financial position and expected financial performance and operational performance, liquidity, growth and profitability strategies, business strategy and plans and objectives of management for future operations, Vertical's ability and plans to raise additional capital to fund Vertical's operations, Vertical's plans to mitigate the risk that we are unable to continue as a going concern, Vertical's plans for capital expenditures, as well as statements that include the words 'expect,' 'intend,' 'plan,' 'believe,' 'project,' 'forecast,' 'estimate,' 'may,' 'should,' 'anticipate,' 'will,' 'aim,' 'potential,' 'continue,' 'is/are likely to' and similar statements of a future or forward-looking nature. These forward-looking statements reflect Vertical's current views with respect to future events and are not a guarantee of future performance. Actual outcomes may differ materially from the information contained in the forward-looking statements as a result of a number of factors, including, without limitation, the important factors discussed under the caption 'Risk Factors' in Vertical's Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the 'SEC') on March 11, 2025, as such factors may be updated from time to time in Vertical's other filings with the SEC. Any forward-looking statements contained in this release speak only as of the date hereof and accordingly undue reliance should not be placed on such statements. Vertical disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this release whether as a result of new information, future events or otherwise, other than to the extent required by applicable law. This Press Release also contains "forward-looking statements" representing Bristow Group Inc.'s ("Bristow") current expectations or forecasts of future events. Forward-looking statements generally can be identified by the use of forward-looking terminology such as "may," "will," "expect," "intend," "estimate," "anticipate," "believe," "project," or "continue," or other similar words, and include statements regarding the expected benefits of the fleet support and training agreements disclosed herein. These statements are made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, reflect Bristow management's current views with respect to future events and therefore are subject to significant risks and uncertainties, both known and unknown. Without limiting the generality of the foregoing, such forward-looking statements include statements regarding the capabilities, development, certification, marketing, and future operations of Vertical's VX4 aircraft, Bristow's purchase of aircraft from Vertical, and the anticipated benefits of the collaboration between Bristow and Vertical. Bristow's actual results may vary materially from those anticipated in forward-looking statements. Bristow cautions investors not to place undue reliance on any forward-looking statements. Forward-looking statements speak only as of the date of the document in which they are made. Bristow disclaims any obligation or undertaking to provide any updates or revisions to any forward-looking statement to reflect any change in Bristow's expectations or any change in events, conditions or circumstances on which the forward-looking statement is based that occur after the date hereof, except as may be required by applicable law. You should not place undue reliance on Bristow's forward-looking statements because the matters they describe are subject to known and unknown risks, uncertainties, and other unpredictable factors, many of which are beyond Bristow's control. New risks and uncertainties arise from time to time, and it is impossible for Bristow to predict these matters or how they may affect Bristow. Bristow has included important factors in the section entitled "Risk Factors" in Bristow's Annual Report on Form 10-K for the year ended December 31, 2024 (the "Annual Report") which Bristow believes over time, could cause Bristow's actual results, performance, or achievements to differ from the anticipated results, performance or achievements that are expressed or implied by Bristow's forward-looking statements. You should consider all risks and uncertainties disclosed in the Annual Report and in Bristow's filings with the SEC, all of which are accessible on the SEC's website at
Yahoo
12-06-2025
- Automotive
- Yahoo
Avidity Biosciences, Inc. (RNA) Initiated with a Strong Buy at Raymond James
Avidity Biosciences, Inc. (NASDAQ:RNA) is one of the 13 Biotech Stocks with Huge Upside Potential. Raymond James has started coverage of Avidity Biosciences, Inc. (NASDAQ:RNA), with a Strong Buy rating and a price objective of $65. A scientist holding a vial of a promising product candidate for therapeutic development. The rating is part of a larger biotech sector note, in which the firm sees favorable risk/reward across the board. Raymond James points out that less de-risked platforms can produce the most outsized returns, even if companies with de-risked, high probability-of-success assets are frequently viewed with greater certainty. The firm stresses its confidence in del-zota, which is anticipated to be the first medicine from Avidity Biosciences, Inc. (NASDAQ:RNA)'s antibody oligonucleotide conjugate (AOC) platform to be approved. Avidity Biosciences, Inc. (NASDAQ:RNA) is becoming more well-known for its AOC platform, which targets muscle disorders by combining oligonucleotides and antibodies. According to Raymond James, one of the platform's top candidates, Del-Zota, has a strong chance of being approved. The $65 objective is in line with the firm's opinion that early-stage, less-risked assets can yield higher returns and points out faith in the platform's revolutionary potential. Avidity Biosciences, Inc. (NASDAQ:RNA) is a biopharmaceutical firm dedicated to developing a novel type of RNA treatment known as Antibody Oligonucleotide Conjugates, or AOCs. While we acknowledge the potential of RNA as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 10 High-Growth EV Stocks to Invest In and 13 Best Car Stocks to Buy in 2025. Disclosure. None.
Associated Press
11-06-2025
- Business
- Associated Press
Avidity Biosciences to Present Topline Data from Phase 1/2 FORTITUDE™ Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress
-- FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD) -- -- Jeffrey M. Statland, M.D., Professor of Neurology, University of Kansas Medical Center, and FORTITUDE trial investigator, will present topline del-brax data from dose escalation cohorts in oral presentation -- -- Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, will highlight results on the characterization of a novel DUX4-regulated circulating biomarker in oral and poster presentations -- SAN DIEGO, June 11, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today announced that the company will be presenting two oral and one poster presentations at the 32nd Annual FSHD Society International Research Congress, being held June 12-13, 2025, in Amsterdam, the Netherlands. Earlier this week, Avidity announced FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD). 32nd Annual FSHD Society International Research Congress Presentations The presentations and poster are available on the publications page of Avidity's website at About Avidity Avidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare neuromuscular diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is also advancing two wholly-owned precision cardiology development candidates addressing rare genetic cardiomyopathies. In addition, Avidity is broadening the reach of AOCs with its advancing and expanding pipeline including programs in cardiology and immunology through key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline and people, please visit and engage with us on LinkedIn and X. Forward-Looking Statements Avidity cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Avidity's plans to present topline data from the dose escalation cohorts of the Phase 1/2 FORTITUDE™ trial; the status and availability of accelerated and full approval pathways for del-brax and Avidity's planned participation at the 32nd Annual FSHD Society International Research Congress and the contents of its scheduled presentations. The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Avidity's business and beyond its control, including, without limitation, the data and results produced from the clinical study of del-brax may not support BLA submission or accelerated or full approval, and may not be satisfactory to the FDA and other regulators; later developments with the FDA and other regulators may be inconsistent with the feedback received as of the date hereof; and the risks described in Avidity's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and subsequent filings with the SEC. Avidity cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that arise after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor Contact: Kat Lange (619) 837-5014 [email protected] Media Contact: Kristina Coppola (619) 837-5016 [email protected] View original content to download multimedia: SOURCE Avidity Biosciences, Inc.
Yahoo
11-06-2025
- Business
- Yahoo
Avidity Biosciences to Present Topline Data from Phase 1/2 FORTITUDE™ Trial of Del-brax in People Living with Facioscapulohumeral Muscular Dystrophy at 32nd Annual FSHD Society International Research Congress
-- FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD) -- -- Jeffrey M. Statland, M.D., Professor of Neurology, University of Kansas Medical Center, and FORTITUDE trial investigator, will present topline del-brax data from dose escalation cohorts in oral presentation -- -- Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, will highlight results on the characterization of a novel DUX4-regulated circulating biomarker in oral and poster presentations -- SAN DIEGO, June 11, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today announced that the company will be presenting two oral and one poster presentations at the 32nd Annual FSHD Society International Research Congress, being held June 12-13, 2025, in Amsterdam, the Netherlands. Earlier this week, Avidity announced FDA alignment on accelerated and full approval pathways for delpacibart braxlosiran (del-brax) in facioscapulohumeral muscular dystrophy (FSHD). 32nd Annual FSHD Society International Research Congress Presentations Topline Data from Dose Escalation Cohorts A and B in FORTITUDE™, a Phase 1/2 Trial Evaluating Del-brax (delpacibart braxlosiran) in Adults with Facioscapulohumeral Muscular Dystrophy (FSHD) Oral presentation: Jeffrey M. Statland, M.D., to present June 13, 2025, from 5:20 - 5:40 p.m. Central European Summer Time (CEST) / 11:20 - 11:40 a.m. ET Characterization of a promising DUX4-regulated circulating biomarker for facioscapulohumeral dystrophy (FSHD) Oral presentation: Stephen Tapscott, M.D., Ph.D., Professor of Human Biology and Clinical Research, Fred Hutchinson Cancer Center, to present on June 12, 2025, from 6:25 - 6:30 p.m. CEST / 12:25 - 12:30 p.m. ET Poster presentation (#7.08): June 12, 2025, from 7:15 - 8:00 p.m. CEST / 1:15 - 2:00 p.m. ET The presentations and poster are available on the publications page of Avidity's website at About AvidityAvidity Biosciences, Inc.'s mission is to profoundly improve people's lives by delivering a new class of RNA therapeutics - Antibody Oligonucleotide Conjugates (AOCs™). Avidity is revolutionizing the field of RNA with its proprietary AOCs, which are designed to combine the specificity of monoclonal antibodies with the precision of oligonucleotide therapies to address targets and diseases previously unreachable with existing RNA therapies. Utilizing its proprietary AOC platform, Avidity demonstrated the first-ever successful targeted delivery of RNA into muscle and is leading the field with clinical development programs for three rare neuromuscular diseases: myotonic dystrophy type 1 (DM1), Duchenne muscular dystrophy (DMD) and facioscapulohumeral muscular dystrophy (FSHD). Avidity is also advancing two wholly-owned precision cardiology development candidates addressing rare genetic cardiomyopathies. In addition, Avidity is broadening the reach of AOCs with its advancing and expanding pipeline including programs in cardiology and immunology through key partnerships. Avidity is headquartered in San Diego, CA. For more information about our AOC platform, clinical development pipeline and people, please visit and engage with us on LinkedIn and X. Forward-Looking StatementsAvidity cautions readers that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: Avidity's plans to present topline data from the dose escalation cohorts of the Phase 1/2 FORTITUDE™ trial; the status and availability of accelerated and full approval pathways for del-brax and Avidity's planned participation at the 32nd Annual FSHD Society International Research Congress and the contents of its scheduled presentations. The inclusion of forward-looking statements should not be regarded as a representation by Avidity that any of these plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Avidity's business and beyond its control, including, without limitation, the data and results produced from the clinical study of del-brax may not support BLA submission or accelerated or full approval, and may not be satisfactory to the FDA and other regulators; later developments with the FDA and other regulators may be inconsistent with the feedback received as of the date hereof; and the risks described in Avidity's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and subsequent filings with the SEC. Avidity cautions readers not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the company undertakes no obligation to update such statements to reflect events that occur or circumstances that arise after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Investor Contact:Kat Lange(619) 837-5014investors@ Media Contact:Kristina Coppola (619) 837-5016media@ View original content to download multimedia: SOURCE Avidity Biosciences, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
