Latest news with #Precision
Business Wire
10 hours ago
- Business
- Business Wire
Precision BioSciences Receives FDA Orphan Drug Designation for PBGENE-DMD for the Treatment of Duchenne Muscular Dystrophy
BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for PBGENE-DMD for the treatment of Duchenne muscular dystrophy (DMD). 'Receipt of Orphan Drug Designation from the FDA for PBGENE-DMD underscores the tremendous unmet need and urgency to deliver safe treatments that significantly improve muscle function over time for boys living with Duchenne muscular dystrophy,' said Cindy Atwell, Chief Development and Business Officer at Precision BioSciences. 'This regulatory milestone builds on our recent receipt of Rare Pediatric Disease designation and, together with our preclinical body of evidence, gives us tremendous confidence as we move this program towards the clinic. Looking ahead, we remain in active dialogue with the FDA as we advance PBGENE-DMD toward regulatory milestones, with clinical data anticipated in 2026.' The FDA grants Orphan Drug Designation to drugs and biologics intended for the treatment, diagnosis, or prevention of rare diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides sponsors certain benefits, including financial incentives to support clinical development and the potential for up to seven years of market exclusivity for the drug for the designated orphan indication in the U.S. if the drug is ultimately approved for that use. About PBGENE-DMD PBGENE-DMD is Precision's development program for the treatment of DMD. The approach uses two complementary ARCUS nucleases delivered via a one-time administration in a single AAV to excise exons 45-55 of the dystrophin gene with the aim of restoring near full-length dystrophin protein within the body to improve functional outcomes. PBGENE-DMD is intended to address up to 60% of the DMD patient population. In preclinical studies, PBGENE-DMD demonstrated the ability to target key muscle types involved in the progression of DMD and produced significant, durable functional improvements in a humanized DMD mouse model. PBGENE-DMD restored the body's ability to produce a near full-length functional dystrophin protein across multiple muscles, including cardiac tissue and various key skeletal muscle groups. In addition, PBGENE-DMD edited satellite muscle stem cells, believed to be critical for long-term durability and sustained functional improvement. PBGENE-DMD was recently granted FDA Rare Pediatric Disease (RPD) designation for the treatment of DMD. The Company is advancing the final IND-enabling toxicology studies and is working closely with leading DMD clinicians to design a first in human trial optimized for safety and efficacy. Clinical grade material is in preparation, with initial clinical data expected in 2026. About Precision BioSciences, Inc. Precision's two lead programs, PBGENE-HBV, for chronic Hepatitis B, and PBGENE-DMD, for Duchenne muscular dystrophy, are focused on areas with large patient populations with high unmet need. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company's pipeline prioritizes in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected safety, efficacy and benefit of our and our partners' and licensees' product candidates and gene editing approaches; the potential of PBGENE-DMD to safely drive meaningful improvement in functional and durable benefit over time for up to 60% of patients with DMD; the design on PBGENE-DMD to permanently edit a patient's own DNA sequence, resulting in naturally-produced, near full-length dystrophin protein proven known to be functional in humans; the benefits of an Orphan Drug Designation including financial incentives and regulatory exclusivity; the potential value of a Priority Review Voucher(if awarded) including priority review for a different product or sale to another sponsor; the expected timing of regulatory processes and clinical operations (including IND and/or CTA filings, studies, enrollment and clinical data for PBGENE-DMD; and anticipated timing of clinical data. In some cases, you can identify forward-looking statements by terms such as 'aim,' 'anticipate,' 'appear,' 'approach,' 'believe,' , 'confidence', 'contemplate,' 'could,' 'design' 'designed,' 'estimate,' 'expect,' 'goal,' 'intend,' 'look,' 'may,' 'mission,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'pursue,' 'should,' 'strive,' 'suggest,' 'target,' 'will,' 'would,' or the negative thereof and similar words and expressions. Forward-looking statements are based on management's current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators' or other licensees' ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators' or other licensees' development of product candidates; our or our collaborators' or other licensees' ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators' and other licensees' ability to enroll patients; changes in interim 'top-line' and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees' ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators' or other licensees' ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at and the Investors page of our website under SEC Filings at All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
National Post
2 days ago
- Business
- National Post
Invest in Precision: Mitutoyo America Corporation Announces Limited-Time Savings on MiSTAR 555 and 575 Coordinate Measuring Machines
Article content Sorry, your browser doesn't support embedded videos. Article content AURORA, Ill. — In today's unpredictable economy, one investment still delivers lasting certainty: Precision is the smartest investment. For a limited time, Mitutoyo America Corporation, the trusted leader in advanced metrology solutions, is offering a rare opportunity to invest in the future success of your inspection capabilities with exclusive promotional pricing of up to 26 percent off the MiSTAR 555 and 575 CMM through September 30, 2025. Article content Article content 'The MiSTAR CMM is built to thrive on the shop floor. It is rugged, reliable and fully adaptable to your machining process. With this exclusive promotion, you're not just getting precision, you're getting value with savings of up to 26 percent.' Article content Mitutoyo's MCOSMOS software scales to meet your inspection needs, from basic measurement and reporting with MCOSMOS-1, to CAD model part programming with free-form surface evaluation MCOSMOS-2 and MCOSMOS-3 adds scanning of 2D line and 3D surface profiles with CAD model analysis. Article content Three configurations offered: Article content BASIC model type- PH6 TP20 probing and MCOSMOS-1 software for small shops with essential digital routines Advanced model type- PH6M SP25 probe and MCOSMOS-2 software for growing operations who require CAD model part programming with free-form surface evaluation. Ultimate model type- PH10 SP25 MCOSMOS-3 software for high-throughput environments Article content The Mitutoyo MiSTAR CMM delivers reliable performance across a broad range of operating environments with guaranteed accuracy from 10 °C to 40 °C, and enhanced capability within narrower ranges of 10 °C to 30 °C and 18 °C to 22 °C. Article content Each MiSTAR configuration is delivered ready for immediate operation and includes: Article content When accuracy matters, manufacturers turn to Mitutoyo for proven performance that drives quality forward. Contact your local Mitutoyo representative or distributor to schedule a demo, consultation, or get a quote. Article content At Article content , precision is our profession. We are the leader in metrology instruments, solutions and support, offering more than 5,500 products, the largest and most comprehensive product portfolio of any commercial metrology provider. Mitutoyo also has the highest-performing A2LA-accredited calibration laboratories (A2LA Certificate No. 0750.01) in the nation. For more information, contact the Mitutoyo inside sales team at Article content Article content Article content Article content Article content Contacts
Business Wire
16-07-2025
- Business
- Business Wire
Precision BioSciences Highlights New Preclinical Data for PBGENE-DMD Further Supporting Advancement of Novel Gene Editing Approach for the Treatment of Duchenne Muscular Dystrophy Towards Clinic
DURHAM, N.C.--(BUSINESS WIRE)--Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for diseases with high unmet need, today announced updated additional preclinical data further validating the scientific rationale supporting the rapid development of PBGENE-DMD, the Company's first-in-class in vivo gene editing approach for Duchenne muscular dystrophy (DMD), towards first-in-human clinical investigation. 'In a long-term durability study in a DMD diseased mouse model, we have observed up to a three-fold increase in dystrophin-positive muscle cells between three and nine months in the quadricep, gastrocnemius (calf), heart, and diaphragm. In the gastrocnemius, up to 85% of cells were dystrophin-positive,' said Cassie Gorsuch, PhD., Chief Scientific Officer at Precision BioSciences. 'These new data build upon the preclinical data shared at ASGCT in May 2025, demonstrating that PBGENE-DMD treatment resulted in significant and sustained improvement of maximum force output at the same three- and nine-month timepoints. This broad increase in dystrophin-positive cells, along with the increased dystrophin protein detected in tissues, further validates the improved muscle function that was observed over time and may be attributable to edited satellite cells, which were also observed in this study. We believe these results demonstrate the unique potential of the PBGENE-DMD gene editing approach to produce a sustained functional benefit without the need for AAV persistence, which is required of microdystrophin approaches. We look forward to presenting the complete dataset at a future scientific conference. Given the totality of preclinical evidence, we remain excited and steadfast in advancing this program towards clinic.' Currently, there are no approved treatments or treatments in development that significantly improve muscle function over time to beneficially alter the long-term prognosis of DMD. PBGENE-DMD is the first in vivo gene editing program that has the potential to transform the treatment paradigm and deliver durable functional improvement for most patients, as up to 60% of those afflicted carry mutations in the 'hot spot' region between exons 45-55. Precision's approach is designed to permanently edit a patient's own DNA sequence, resulting in naturally produced, near full-length dystrophin protein known to be functional in humans. The final IND-enabling toxicology studies are currently underway with IND and/or CTA filing targeted in 2025 and initial clinical data expected in 2026. The Company believes that its current cash runway will be sufficient to progress both PBGENE-HBV, its current Phase 1 asset, and PBGENE-DMD through Phase 1 clinical readouts. About PBGENE-DMD PBGENE-DMD is Precision's development program for the treatment of DMD. The approach uses two complementary ARCUS nucleases delivered via a one-time administration in a single AAV to excise exons 45-55 of the dystrophin gene with the aim of restoring near full-length dystrophin protein within the body to improve functional outcomes. PBGENE-DMD is intended to address up to 60% of the DMD patient population. In preclinical studies, PBGENE-DMD demonstrated the ability to target key muscle types involved in the progression of DMD and produced significant, durable functional improvements in a humanized DMD mouse model. PBGENE-DMD restored the body's ability to produce a near full-length functional dystrophin protein across multiple muscles, including cardiac tissue and various key skeletal muscle groups. In addition, PBGENE-DMD edited satellite muscle stem cells, believed to be critical for long-term durability and sustained functional improvement. About Precision BioSciences, Inc. Precision's two lead programs, PBGENE-HBV, for chronic Hepatitis B, and PBGENE-DMD, for Duchenne Muscular Dystrophy, are focused on areas with large patient populations with high unmet need. Precision BioSciences, Inc. is a clinical stage gene editing company dedicated to improving life (DTIL) with its novel and proprietary ARCUS® genome editing platform that differs from other technologies in the way it cuts, its smaller size, and its simpler structure. Key capabilities and differentiating characteristics enable ARCUS nucleases to drive more intended, defined therapeutic outcomes. Using ARCUS, the Company's pipeline prioritizes in vivo gene editing candidates designed to deliver lasting cures for the broadest range of genetic and infectious diseases where no adequate treatments exist. For more information about Precision BioSciences, please visit Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the clinical development and expected safety, efficacy and benefit of our and our partners' and licensees' product candidates and gene editing approaches including PBGENE-DMD; the potential of PBGENE-DMD to drive meaningful improvement in functional and durable benefit over time for up to 60% of patients with DMD; the design on PBGENE-DMD to permanently edit a patient's own DNA sequence, resulting in naturally-produced, near full-length dystrophin protein proven known to be functional in humans; the approach of using a single AAV to deliver PBGENE-DMD to excise exons 45-55 of the dystrophin gene with the aim of restoring a near-full length dystrophin protein within the body to improve functional outcomes; the increased dystrophin protein detected in the tissues and improved muscle function that was observed over time in the DMD mouse model may be attributable to edited satellite cells could be driving sustained replenishment of edited myocytes, resulting in increased dystrophin protein expression, dystrophin -positive cells, and improved muscle function over time; the expected timing of regulatory processes and clinical operations (including IND and/or CTA filings, studies, enrollment and clinical data for PBGENE-DMD; and anticipated timing of clinical data. In some cases, you can identify forward-looking statements by terms such as 'aim,' 'anticipate,' 'appear,' 'approach,' 'believe,' , 'confidence', 'contemplate,' 'could,' 'design' 'designed,' 'estimate,' 'expect,' 'goal,' 'intend,' 'look,' 'may,' 'mission,' 'plan,' 'possible,' 'potential,' 'predict,' 'project,' 'pursue,' 'should,' 'strive,' 'suggest,' 'target,' 'will,' 'would,' or the negative thereof and similar words and expressions. Forward-looking statements are based on management's current expectations, beliefs, and assumptions and on information currently available to us. These statements are neither promises nor guarantees, and involve a number of known and unknown risks, uncertainties and assumptions, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various important factors, including, but not limited to, our ability to become profitable; our ability to procure sufficient funding to advance our programs; risks associated with our capital requirements, anticipated cash runway, requirements under our current debt instruments and effects of restrictions thereunder, including our ability to raise additional capital due to market conditions and/or our market capitalization; our operating expenses and our ability to predict what those expenses will be; our limited operating history; the progression and success of our programs and product candidates in which we expend our resources; our limited ability or inability to assess the safety and efficacy of our product candidates; the risk that other genome-editing technologies may provide significant advantages over our ARCUS technology; our dependence on our ARCUS technology; the initiation, cost, timing, progress, achievement of milestones and results of research and development activities and preclinical and clinical studies, including clinical trial and investigational new drug applications; public perception about genome editing technology and its applications; competition in the genome editing, biopharmaceutical, and biotechnology fields; our or our collaborators' or other licensees' ability to identify, develop and commercialize product candidates; pending and potential product liability lawsuits and penalties against us or our collaborators or other licensees related to our technology and our product candidates; the U.S. and foreign regulatory landscape applicable to our and our collaborators' or other licensees' development of product candidates; our or our collaborators' or other licensees' ability to advance product candidates into, and successfully design, implement and complete, clinical trials; potential manufacturing problems associated with the development or commercialization of any of our product candidates; delays or difficulties in our and our collaborators' and other licensees' ability to enroll patients; changes in interim 'top-line' and initial data that we announce or publish; if our product candidates do not work as intended or cause undesirable side effects; risks associated with applicable healthcare, data protection, privacy and security regulations and our compliance therewith; our or our licensees' ability to obtain orphan drug designation or fast track designation for our product candidates or to realize the expected benefits of these designations; our or our collaborators' or other licensees' ability to obtain and maintain regulatory approval of our product candidates, and any related restrictions, limitations and/or warnings in the label of an approved product candidate; the rate and degree of market acceptance of any of our product candidates; our ability to effectively manage the growth of our operations; our ability to attract, retain, and motivate executives and personnel; effects of system failures and security breaches; insurance expenses and exposure to uninsured liabilities; effects of tax rules; effects of any pandemic, epidemic, or outbreak of an infectious disease; the success of our existing collaboration and other license agreements, and our ability to enter into new collaboration arrangements; our current and future relationships with and reliance on third parties including suppliers and manufacturers; our ability to obtain and maintain intellectual property protection for our technology and any of our product candidates; potential litigation relating to infringement or misappropriation of intellectual property rights; effects of natural and manmade disasters, public health emergencies and other natural catastrophic events; effects of sustained inflation, supply chain disruptions and major central bank policy actions; market and economic conditions; risks related to ownership of our common stock, including fluctuations in our stock price; our ability to meet the requirements of and maintain listing of our common stock on Nasdaq or other public stock exchanges; and other important factors discussed under the caption 'Risk Factors' in our Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2025, as any such factors may be updated from time to time in our other filings with the SEC, which are accessible on the SEC's website at and the Investors page of our website under SEC Filings at All forward-looking statements speak only as of the date of this press release and, except as required by applicable law, we have no obligation to update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Hamilton Spectator
02-07-2025
- Business
- Hamilton Spectator
Precision Drilling Corporation 2025 Second Quarter Results Conference Call and Webcast
CALGARY, Alberta, July 02, 2025 (GLOBE NEWSWIRE) — Precision Drilling Corporation (Precision) intends to release its 2025 second quarter results after the market closes on Tuesday, July 29, 2025, and has scheduled a conference call to begin at 11:00 a.m. MT (1:00 p.m. ET) on the next day, Wednesday, July 30, 2025. To participate in the conference call please register at the URL link below. Once registered, you will receive a dial-in number and a unique PIN, which will allow you to ask questions. The call will also be webcast and can be accessed through the link below. A replay of the webcast call will be available on Precision's website for 12 months. About Precision Precision is a leading provider of safe and environmentally responsible High Performance, High Value services to the energy industry, offering customers access to an extensive fleet of Super Series drilling rigs. Precision has commercialized an industry-leading digital technology portfolio known as Alpha™ that utilizes advanced automation software and analytics to generate efficient, predictable, and repeatable results for energy customers. Our drilling services are enhanced by our EverGreen™ suite of environmental solutions, which bolsters our commitment to reducing the environmental impact of our operations. Additionally, Precision offers well service rigs, camps and rental equipment all backed by a comprehensive mix of technical support services and skilled, experienced personnel. Precision is headquartered in Calgary, Alberta, Canada and is listed on the Toronto Stock Exchange under the trading symbol 'PD' and on the New York Stock Exchange under the trading symbol 'PDS'. Additional Information For more information about Precision, please visit our website at or contact: Lavonne Zdunich, CPA, CA Vice President, Investor Relations 403.716.4500 800, 525 - 8th Avenue S.W. Calgary, Alberta, Canada T2P 1G1 Website:
Mid East Info
01-07-2025
- Business
- Mid East Info
Precision Football Celebrates Three Years as UAE's Ministry of Sports Taps Platform for National Talent Pipeline
Dubai United Arab Emirates, June 2025: Precision Football, the high-performance platform backed by Agon Capital and founded by former professional footballer and UEFA-qualified coach Sonny Cobbs, is celebrating three years of operations. This milestone coincides with a strategic new partnership with the UAE Ministry of Sports, cementing its role as a key player in the country's long-term sports infrastructure and youth development strategy. The collaboration, signed earlier this year with Playermaker and the Ministry, formally integrates Precision Football into the UAE's national scouting, performance tracking, and player development ecosystem. The agreement also includes the rollout of a region-first diploma programme that blends elite athletic training with accredited academic pathways, a model designed to align with global benchmarks for professional sport. In just three years, Precision has trained more than 7,000 athletes, including Premier League talent and four players now competing with the UAE national women's team. Its 165,000 sq ft Dubai flagship houses FIFA-grade hybrid turf, smart recovery facilities, and one of the most advanced data-driven football analysis centres in the region. Private investment in the venture has exceeded USD $10 million to date. 'This is more than a training centre, it's a national asset,' said Ryan Hattingh, Group CEO of Agon Capital. 'Precision Football represents the kind of investment we believe defines the future of our region: purpose-led, performance-driven, and deeply integrated with national priorities. As the Gulf continues to diversify its economy, there's a growing appetite for platforms that sit at the intersection of lifestyle, infrastructure, and long-term value. Precision is proof that sports can deliver not just social capital, but real economic return, and that private investment has a critical role to play in building the region's next generation of talent and opportunity.' Precision's proprietary tech stack integrates biometric analytics, cognitive tracking, heat mapping, and decision-tree modelling, capabilities typically only seen at top-tier European clubs. Every pass, sprint, and movement is translated into performance intelligence, giving athletes and scouts unprecedented visibility into real-time progress. 'Coaching today has moved far beyond the ball-and-whistle era. The modern game demands more – more insight, more precision, more accountability, said Sonny Cobbs, Founder and Creator of Precision Football. 'At Precision, we combine instinct and experience with data and analysis to develop players in ways that were never possible before. It's no longer just about what you see on the pitch – it's about what the data reveals beneath it. That's where real progress happens.' Beyond talent, the platform is helping reposition sport as a cornerstone of national development, bridging education, health, and entertainment. While Precision's technology is elite in standard, it's fully embedded into its academy and youth development programmes – ensuring that the same tools used to train professionals are also shaping the next generation. It also reflects Agon Capital's broader strategy of investing in scalable, future-forward lifestyle assets with fast ROI and cultural significance. With expansion into Saudi Arabia in planning, and additional UAE activations expected in 2026, Precision Football is positioning itself not just as a player development platform, but as a catalyst for the region's next-generation sports economy.
