Latest news with #therapies
Associated Press
6 days ago
- Business
- Associated Press
Quetzal Therapeutics Debuts with Expert Leadership, High-Impact Pipeline and $50 Million of Committed Capital
CHICAGO, July 16, 2025 (GLOBE NEWSWIRE) -- Quetzal Therapeutics, a newly formed biopharmaceutical company, announced its official launch today with $50 million of committed capital. Founded to address urgent unmet needs in rare and life-threatening diseases, Quetzal brings together a team of seasoned executives, scientific pioneers, and biotech & pharmaceutical veterans committed to delivering transformative therapies to patients around the world. At the core of Quetzal's mission is a belief that cutting-edge science, guided by proven leadership, can redefine what's possible in treatment for conditions like Acute Promyelocytic Leukemia ('APL') and invasive infections. The company has formed around a multi-asset pipeline, initially including: Built on Leadership Excellence Quetzal is led by an executive team with deep expertise in drug development, clinical strategy, and operational execution. 'Our team was brought together by a shared conviction: that patients with rare diseases deserve the same urgency and innovation as those with more common conditions,' said Usman Ahmed, CEO. 'Quetzal Therapeutics is built to deliver on that promise with the right science, the right strategy, and the right people.' Usman Ahmed, CEO & Chairman – A proven leader with over two decades of leadership in pharmaceuticals and start-up innovation. During his tenure at Nexus Pharmaceuticals, Usman led the execution of complex transactions, spearheaded operational improvements, and championed cost efficiencies in the highly specialized and challenging field of specialty and generic injectables. Dr. Sridhar Desikan, Co-Founder & Chief Scientific Officer – An industry veteran with 28 years of experience in NCE and generics development. Sridhar began his career at Novartis Pharmaceuticals and subsequently worked at DuPont Pharma, Bristol-Myers Squibb, Dr. Reddy's, and most recently at Nexus Pharmaceuticals as Chief Scientific Officer. Sridhar holds a Ph.D. in Chemical Engineering and has accreditations from Harvard Medical School's HMX Pro program. Sara Mathews, Vice President Program Leadership – With nearly 15 years of experience in the biotech industry, Sara is a seasoned asset leader with a proven track record of bringing cross-functional teams together and leading novel oncology therapeutics through global clinical programs from IND filing through late-stage development, filing preparation, and commercial launch planning. Christina Liwski, General Counsel & CHRO – With over a decade of diverse and sophisticated legal experience, Christina brings deep legal acumen to the team. Christina's experience spans multiple practice areas, including transactions and litigation. She most recently served as Assistant General Counsel at Nexus Pharmaceuticals, LLC and is admitted to practice in Illinois, Massachusetts, and the United States District Court for the District of Massachusetts. Guided by an Accomplished Board of Directors The company's Board of Directors features industry leaders with a track record of building, funding, and guiding successful companies: Aman Ahmed – With nearly a decade of experience in the pharmaceutical industry, Aman brings deep expertise in sales operations, DEA and FDA regulatory compliance, international sales, and therapeutic portfolio management. Dr. Jonathan Cheng – Dr. Jonathan Cheng is a physician-scientist and oncology drug development expert with a distinguished career across both industry and academia. As Chief Medical Officer at Systimmune, he leads the clinical development of a diverse pipeline of novel therapeutics, including innovative antibody-drug conjugates (ADCs) and the company's first-in-class EGFR-HER3 bispecific ADC currently in Phase 3 trials. Todd Chermak, Ph.D – Todd Chermak is a life sciences executive with 30 years of experience spanning the biopharmaceutical, diagnostics, and nutrition industries. He currently serves as Senior Vice President and Global Business Head of Immunology and Proteomics at CellCarta. Mike Warmuth – Mike Warmuth is currently working on various Boards: for profit, academic, and not-for-profit. From 2018 to 2023 Mr. Warmuth worked for EW Healthcare as an Operating Partner in their New York office. Prior to EW, Mr. Warmuth spent 30 years at Abbott in various senior executive capacities, where he led multiple divisions and business units. Strategic Talent Acquisition Partnership Quetzal Therapeutics proudly acknowledges the role of Heidrick & Struggles, a premier global leadership advisory firm, in identifying and recruiting Dr. Jonathan Cheng to the company's Board of Directors. Their expertise and commitment to excellence were instrumental in securing a highly respected thought leader whose insight will help shape Quetzal's long-term scientific and clinical strategy. For more information, please visit: Media Contact: [email protected]
National Post
6 days ago
- Business
- National Post
Satellos Appoints Dr. Wildon Farwell as Chief Medical Officer
Article content TORONTO — Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (' Satellos ' or the ' Company '), a biotech company developing new small molecule therapeutic approaches to improve the treatment of muscle diseases, today announced the appointment of Wildon Farwell, M.D., MPH, as chief medical officer ('CMO'). Dr. Farwell joins Satellos from Dyne Therapeutics (Nasdaq: DYN), where he most recently served as CMO and medical advisor. Article content 'We are thrilled to welcome Dr. Farwell as our CMO,' said Frank Gleeson, Satellos co-founder and CEO. 'He brings deep expertise in global clinical development — particularly in neuromuscular and rare diseases — and a strong track record of successfully advancing novel therapies through regulatory approval. His experience will be invaluable as we move SAT-3247 into a global, randomized, placebo-controlled Phase 2 clinical trial in children living with DMD, with the goal of delivering a transformative treatment.' Article content At Dyne, Dr. Farwell built the development organization, led the protocol development and regulatory submissions for their Duchenne muscular dystrophy (DMD) and myotonic dystrophy type 1 (DM1) programs, oversaw the conduct of multiple potentially registrational clinical studies, and contributed to several successful capital raises. Before joining Dyne, he spent a decade at Biogen in increasing leadership roles, including vice president of Late-Stage Clinical Development and global medical head of Neuromuscular Diseases. During his time at Biogen, Dr. Farwell led the development and lifecycle management of SPINRAZA®, the first approved treatment for spinal muscular atrophy. He also initiated late-stage development of QALSODY®, an investigational therapy for amyotrophic lateral sclerosis. Dr. Farwell also led biomarker development and pharmacovigilance for therapies across multiple indications. Prior to moving into industry, Dr. Farwell served as an assistant professor of medicine at Harvard Medical School and was a physician at Brigham and Women's Hospital and the VA Boston Healthcare System. He earned his medical degree from the University of Missouri School of Medicine and holds a Master of Public Health in clinical effectiveness from the Harvard T.H. Chan School of Public Health. Article content 'I'm honored to join Satellos at such a pivotal point in its growth,' said Dr. Farwell. 'Throughout my career, I've been fortunate to lead the development of several therapies that have had profound impacts on the lives of specific populations of people with serious neuromuscular diseases. Now, working to advance SAT-3247 and support Satellos' novel approach to muscle regeneration represents a natural and meaningful next chapter. I look forward to working with the team to drive clinical progress and bring forward a treatment that may have a profound impact across a broad population of people living with Duchenne and other serious muscle diseases.' Article content Dr. Farwell succeeds Jordan Dubow, MD, who has served as Satellos' part-time CMO since January 2024. Dr. Dubow will continue to serve as a consultant to Satellos and chair of its Clinical Advisory Board. Article content About Satellos Bioscience Inc. Article content Satellos is a clinical-stage drug development company focused on restoring natural muscle repair and regeneration in degenerative muscle diseases. Through its research, Satellos has developed SAT-3247, a first-of-its-kind, orally administered small molecule drug designed to address deficits in muscle repair and regeneration. SAT-3247 targets AAK1, a key protein that Satellos has identified as capable of replacing the signal normally provided by dystrophin in muscle stem cells to effect repair and regeneration. By restoring this missing dystrophin signal in DMD, SAT-3247 enables muscle stem cells to divide properly and more efficiently, promoting natural muscle repair and regeneration. SAT-3247 is currently in clinical development as a potential disease-modifying treatment initially for DMD. Satellos also is leveraging its proprietary discovery platform MyoReGenX™ to identify additional muscle diseases or injury conditions where restoring muscle repair and regeneration may have therapeutic benefit and represent future clinical development opportunities. For more information, visit Article content This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding Satellos and its business, which may include, but are not limited to, statements regarding the potential for SAT-3247 to represent a disease modifying approach to the therapeutic treatment of people living with Duchenne; anticipated benefits to patients from a small molecule treatment for Duchenne; the advancement SAT-3247 through clinical trials; the pharmacodynamic properties and mechanism-of-action of SAT-3247; the potential of our approach in other degenerative muscle diseases; its/their prospective impact on Duchenne patients, patients with other degenerative muscle disease or muscle injury or trauma, and on muscle regeneration generally; and Satellos' technologies and drug development plans. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, occurrences or developments, are 'forward-looking information or statements.' Often but not always, forward-looking information or statements can be identified by the use of words such as 'shall', 'intends', 'believe', 'plan', 'expect', 'intend', 'estimate', 'anticipate', 'potential', 'prospective' , 'assert' or any variations (including negative or plural variations) of such words and phrases, or state that certain actions, events or results 'may', 'might', 'can', 'could', 'would' or 'will' be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, risks relating to the pharmaceutical and bioscience industry (including the risks associated with preclinical and clinical trials and regulatory approvals), and the research and development of therapeutics, the results of preclinical and clinical trials, general market conditions and equity markets, economic factors and management's ability to manage and to operate the business of the Company generally, including inflation and the costs of operating a biopharma business, and those risks listed in the 'Risk Factors' section of Satellos' Annual Information Form dated March 26, 2025 (which is located on Satellos' profile at Although Satellos has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Satellos does not undertake any obligation to publicly update or revise any forward-looking statement, whether resulting from new information, future events, or otherwise. Article content Article content Article content Article content Article content Contacts Article content Investors: Article content Liz Williams, CFO, Article content Article content
Business Upturn
7 days ago
- Business
- Business Upturn
Endometrial Cancer Clinical Trial Pipeline Insights: 50+ Companies Shaping Future Treatment Paradigms
By GlobeNewswire Published on July 15, 2025, 22:00 IST New York, USA, July 15, 2025 (GLOBE NEWSWIRE) — Endometrial Cancer Clinical Trial Pipeline Insights: 50+ Companies Shaping Future Treatment Paradigms | DelveInsight Endometrial Cancer is a type of cancer that begins in the lining of the uterus, most commonly affecting postmenopausal women. Rising prevalence due to increasing obesity rates and aging population, along with advancements in targeted therapies and early diagnostic tools, are key factors driving market growth. DelveInsight's 'Endometrial Cancer Pipeline Insight 2025' report provides comprehensive global coverage of pipeline endometrial cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the endometrial cancer pipeline domain. Key Takeaways from the Endometrial Cancer Pipeline Report DelveInsight's endometrial cancer pipeline report depicts a robust space with 50+ active players working to develop 55+ pipeline endometrial cancer drugs. active players working to develop pipeline endometrial cancer drugs. Key endometrial cancer companies such as Eli Lilly and Company, Karyopharm Therapeutics, NETRIS Pharma, TORL Biotherapeutics, Compugen, 3D Medicines, Evergreen Therapeutics, Acrivon Therapeutics, Eisai, Xadcera Biopharmaceutical (Suzhou) Co., Ltd., Huabo Biopharm Co., Ltd., Multitude Therapeutics, Context Therapeutics , Leap Therapeutics , Mersana Therapeutics, MacroGenics, Accent Therapeutics, Shanghai Henlius Biotech, Imvax, and others are evaluating new endometrial cancer drugs to improve the treatment landscape. and others are evaluating new endometrial cancer drugs to improve the treatment landscape. Promising pipeline endometrial cancer therapies, such as Selinexor, Abemaciclib, NP137, TORL-1-23, COM 701, Envafolimab, EG-007, Prexasertib, E7386, DM002, HB0025, AMT-151, CTIM-76, Sirexatamab (DKN-01), XMT-1660, MGC026, DHX9 (ATX-559), HLX17, IEC-001, and others, are in different phases of endometrial cancer clinical trials. and others, are in different phases of endometrial cancer clinical trials. In June 2025, Daiichi Sankyo announced the first patient had been dosed in the DESTINY-Endometrial01 clinical trial evaluating Enhertu (trastuzumab deruxtecan) in combination with rilvegostomig or Merck's Keytruda (pembrolizumab) as a first-line treatment for patients with HER2-expressing (IHC 3+/ 2+), mismatch repair proficient (pMMR) primary advanced or recurrent endometrial cancer. In May 2025, Kaida BioPharma announced it had entered into a manufacturing agreement with Northway Biotech, Inc., an end-to-end biologics Contract Development and Manufacturing Organization (CDMO), for the manufacturing of lead product candidate, a novel biologic prolactin receptor antagonist, is being initially developed for the treatment of platinum-resistant ovarian cancer (PROC) with expansion opportunities into endometrial, uterine, and breast cancers. In May 2025, PRISM BioLab, Co. Ltd. announced that the analysis of a combination study of E7386 created through collaboration research with Eisai Co., Ltd., and Lenvatinib mesylate will be presented by Eisai at the American Society of Clinical Oncology (ASCO) Congress 2025, held in Chicago, USA from May 30 to June 3, 2025. To determine the optimal dose of E7386 in combination with Lenvatinib in the open-label Phase Ib study (NCT04008797), expansion cohort of advanced endometrial cancer patients who progressed following platinum-based chemotherapy and anti-PD (L)1 immunotherapy have been implemented by Eisai, and the enrollment of 30 patients was completed. In March 2025, Faeth Therapeutics and The GOG Foundation, Inc. (GOG-F) announced that the first patient has been dosed in its Phase II combination trial of PIKTOR, which is FTH-001 (serabelisib) and FTH-003 (sapanisertib) with paclitaxel. The trial is the most advanced of its kind to investigate a novel approach of dual PI3Kɑ-mTORC1/2 inhibition targeting cancer metabolism in patients with endometrial cancer. In February 2025, Acrivon Therapeutics announced that the FDA had granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Endometrial Cancer. In December 2024, Repare Therapeutics Inc. reported positive data from its MYTHIC Phase I gynecologic expansion clinical trial evaluating the combination of lunresertib and camonsertib (Lunre+Camo) at the recommended Phase II dose (RP2D) in patients with endometrial cancer and platinum-resistant ovarian cancer (PROC) harboring lunre-sensitizing biomarkers. In December 2024, IDEAYA Biosciences, Inc. announced that it has dosed the first patient in the IDEAYA-sponsored Phase I trial evaluating the combination of IDE161, the company's investigational, potential first-in-class, small molecule poly (ADP-ribose) glycohydrolase, or PARG, inhibitor, in combination with Merck's (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in endometrial cancer patients with high microsatellite instability (MSI-high) and microsatellite stable(MSS). Request a sample and discover the recent advances in endometrial cancer drugs @ Endometrial Cancer Pipeline Report The endometrial cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage endometrial cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the endometrial cancer clinical trial landscape. Endometrial Cancer Overview Endometrial cancer, which arises from the uterus's inner lining (the endometrium), is the most common gynecologic cancer in developed countries, with its occurrence steadily increasing. This rise is linked to factors like aging populations and growing obesity rates. Most diagnoses occur in postmenopausal women, with abnormal uterine bleeding being the most frequent symptom. Because this symptom often prompts early medical evaluation, many cases are detected at an initial stage, improving treatment success. Several risk factors play a role in the development of endometrial cancer. Obesity, metabolic syndrome, and diabetes are key contributors, with obesity responsible for about 40% of cases. Reproductive history, such as early onset of menstruation, delayed menopause, never having given birth, and infertility, also raises risk. Genetic factors, especially Lynch syndrome, increase susceptibility. In contrast, combined oral contraceptives have been linked to a decreased risk. Diagnosis usually involves an endometrial biopsy, often following a transvaginal ultrasound to measure endometrial thickness. However, research suggests transvaginal ultrasound can produce false-negative results, particularly in Black women, indicating that biopsy remains the definitive diagnostic method. Surgical staging, based on the International Federation of Gynecology and Obstetrics (FIGO) criteria, is essential for assessing disease extent and planning treatment. Treatment varies by stage. Early-stage disease is generally treated with a total hysterectomy and removal of both ovaries and fallopian tubes. Additional therapies such as radiation or chemotherapy may be recommended depending on risk factors. For advanced or recurrent disease, newer treatments like immunotherapy show promise. In particular, the combination of dostarlimab (JEMPERLI) with chemotherapy has improved survival in advanced or recurrent cases. Research continues to evolve to optimize these treatment approaches and improve patient outcomes. Find out more about endometrial cancer drugs @ Endometrial Cancer Treatment A snapshot of the Pipeline Endometrial Cancer Drugs mentioned in the report: Drugs Company Phase MoA RoA Selinexor Karyopharm Therapeutics III Exportin 1 protein inhibitors Oral EG-007 Evergreen Therapeutics III Epidermal growth factor receptor antagonists Injectable Abemaciclib Eli Lilly and Company II Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 inhibitors Oral Envafolimab Alphamab Oncology/Ascletis/3D Medicine II Antibody-dependent cell cytotoxicity; Programmed cell death-1 ligand-1 inhibitors; T lymphocyte stimulants Subcutaneous Sirexatamab (DKN-01) Leap Therapeutics II DKK1 protein inhibitors Intravenous NP137 NETRIS Pharma II Antibody-dependent cell cytotoxicity; T lymphocyte stimulants Intravenous COM 701 Compugen I/II Antibody-dependent cell cytotoxicity; CD112 receptor antagonists; T lymphocyte stimulants Intravenous XMT-1660 Mersana Therapeutics I Tubulin inhibitors Intravenous Learn more about the emerging endometrial cancer therapies @ Endometrial Cancer Clinical Trials Endometrial Cancer Therapeutics Assessment The endometrial cancer pipeline report proffers an integral view of the emerging endometrial cancer therapies segmented by stage, product type, molecule type, route of administration, and mechanism of action. Scope of the Endometrial Cancer Pipeline Report Coverage : Global : Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type : Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy : Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action : Exportin 1 protein inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, T lymphocyte stimulants, Programmed cell death-1 ligand-1 inhibitors, Endopeptidase Clp stimulants, TNF-related apoptosis-inducing ligand receptor agonists, DKK1 protein inhibitors, Tubulin inhibitors, Epidermal growth factor receptor antagonists : Exportin 1 protein inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Antibody-dependent cell cytotoxicity, T lymphocyte stimulants, Programmed cell death-1 ligand-1 inhibitors, Endopeptidase Clp stimulants, TNF-related apoptosis-inducing ligand receptor agonists, DKK1 protein inhibitors, Tubulin inhibitors, Epidermal growth factor receptor antagonists Key Endometrial Cancer Companies : Eli Lilly and Company, Karyopharm Therapeutics, NETRIS Pharma, TORL Biotherapeutics, Compugen, 3D Medicines, Evergreen Therapeutics, Acrivon Therapeutics, Eisai, Xadcera Biopharmaceutical (Suzhou) Co., Ltd., Huabo Biopharm Co., Ltd., Multitude Therapeutics, Context Therapeutics, Leap Therapeutics, Mersana Therapeutics, MacroGenics, Accent Therapeutics, Shanghai Henlius Biotech, Imva,x and others. : Eli Lilly and Company, Karyopharm Therapeutics, NETRIS Pharma, TORL Biotherapeutics, Compugen, 3D Medicines, Evergreen Therapeutics, Acrivon Therapeutics, Eisai, Xadcera Biopharmaceutical (Suzhou) Co., Ltd., Huabo Biopharm Co., Ltd., Multitude Therapeutics, Context Therapeutics, Leap Therapeutics, Mersana Therapeutics, MacroGenics, Accent Therapeutics, Shanghai Henlius Biotech, Imva,x and others. Key Endometrial Cancer Pipeline Therapies: Selinexor, Abemaciclib, NP137, TORL-1-23, COM 701, Envafolimab, EG-007, Prexasertib, E7386, DM002, HB0025, AMT-151, CTIM-76, Sirexatamab (DKN-01), XMT-1660, MGC026, DHX9 (ATX-559), HLX17, IEC-001, and others. Dive deep into rich insights for new endometrial cancer treatments, visit @ Endometrial Cancer Drugs Table of Contents 1. Endometrial Cancer Pipeline Report Introduction 2. Endometrial Cancer Pipeline Report Executive Summary 3. Endometrial Cancer Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Endometrial Cancer Clinical Trial Therapeutics 6. Endometrial Cancer Pipeline: Late-Stage Products (Pre-registration) 7. Endometrial Cancer Pipeline: Late-Stage Products (Phase III) 8. Endometrial Cancer Pipeline: Mid-Stage Products (Phase II) 9. Endometrial Cancer Pipeline: Early-Stage Products (Phase I) 10. Endometrial Cancer Pipeline Therapeutics Assessment 11. Inactive Products in the Endometrial Cancer Pipeline 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products in the Endometrial Cancer Pipeline 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix For further information on the endometrial cancer pipeline therapeutics, reach out @ Endometrial Cancer Therapeutics Related Reports Endometrial Cancer Epidemiology Forecast Endometrial Cancer Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted endometrial cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Endometrial Cancer Market Endometrial Cancer Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometrial cancer companies, including GlaxoSmithKline, Merck & Co, AstraZeneca, Karyopharm Therapeutics, Evergreen Therapeutics, Incyte Corporation, among others. Advanced Endometrial Cancer Pipeline Advanced Endometrial Cancer Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key advanced endometrial cancer companies, including Incyte Corporation, Byondis B.V., Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Ability Pharmaceuticals SL, Zymeworks Inc., AstraZeneca, Eli Lilly and Company, Pfizer, Karyopharm Therapeutics, Genentech, Eli Lilly and Company, Genentech, Inc., NETRIS Pharma, Five Prime Therapeutics, Inc., Millennium Pharmaceuticals, Inc., Novartis Oncology, Takeda, Mundipharma-EDO GmbH, Zai Lab (Shanghai) Co., Ltd., Haihe Biopharma Co., Ltd., Xencor, Compugen Ltd, Checkpoint Therapeutics, Inc., Celon Pharma SA, Dragonfly Therapeutics, among others. Endometriosis Pipeline Endometriosis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis companies, including Enteris BioPharma, Bayer, Hope Medicine, Tiumbio, Organon, among others. Endometriosis Pain Market Endometriosis Pain Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. Endometriosis Pain Pipeline Endometriosis Pain Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key endometriosis pain companies, including Ferring Pharmaceuticals, ObsEva SA, Myovant Sciences, Hope Medicine (Nanjing) Co., Ltd, among others. DelveInsight's Pharma Competitive Intelligence Service: Through its CI solutions, DelveInsight provides its clients with real-time and actionable intelligence on their competitors and markets of interest to keep them stay ahead of the competition by providing insights into the latest therapeutic area-specific/indication-specific market trends, in emerging drugs, and competitive strategies. These services are tailored to the specific needs of each client and are delivered through a combination of reports, dashboards, and interactive presentations, enabling clients to make informed decisions, mitigate risks, and identify opportunities for growth and expansion. Other Business Pharmaceutical Consulting Services Healthcare Conference Coverage Pipeline Assessment Healthcare Licensing Services Discover how a mid-pharma client gained a level of confidence in their soon-to-be partner for manufacturing their therapeutics by downloading our Due Diligence Case Study About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
Business Wire
15-07-2025
- Business
- Business Wire
EyeDura's Sustained-Release Eye Drop Technology Wins Double Industry Honors
NEW YORK--(BUSINESS WIRE)--EyeDura Therapeutics Inc. ( a developer of preservative-free sustained release ophthalmic therapies, announced that it received top recognition at two major industry forums among a field of innovative ophthalmic startup companies. EyeDura won The Winning Pitch challenge at SightLine during the American Society of Cataract and Refractive Surgery (ASCRS) conference and earned both the Judge's Choice and People's Choice awards at the Octane Ophthalmology Technology Forum. EyeDura's Topical Sustained Release technology is designed to address two significant challenges in ophthalmic care, which are suboptimal patient compliance and high treatment cost. Conventional eye drop treatments often require multiple daily doses, contributing to compliance rates as low as 60 percent and increasing healthcare expenses. The EyeDura platform utilizes a lipid-based, high-viscosity formulation that integrates into the tear film's lipid layer. During blinking, the aqueous layer is selectively removed while the lipid layer and medication remain, creating a stable depot that delivers therapeutic levels for seven days or longer from a single drop. "These awards reflect the strength of our platform technology and the progress of our development efforts," said Srini Venkatesh, CEO of EyeDura. "The endorsement from both expert judges and industry peers reinforces that we're addressing pressing challenges in ophthalmic drug delivery, especially as we advance our lead program, EYED-002 for neurotrophic keratitis, toward IND submission in Q3 2026." Neurotrophic keratitis is a rare but serious ocular disease affecting approximately 71,000 diagnosed patients in the U.S. Current treatments are limited in availability and difficult to administer, creating significant patient burden. In a recent preliminary study, EyeDura demonstrated complete healing of epithelial defects in all 10 patients enrolled in the study using insulin delivered via the platform — requiring only two drops per week over a four-week period. "Our experienced team has developed a platform that represents a true breakthrough in ocular drug delivery," said William Link, chairman of EyeDura's Board of Directors. "This technology doesn't just improve dosing convenience. It has the potential to reduce the healthcare burden by improving patient compliance and enabling better therapeutic outcomes. Our guiding philosophy is that patients shouldn't have to suffer, and advanced therapeutics should integrate seamlessly into their lives." In addition to neurotrophic keratitis, EyeDura's platform has shown promise across other anterior and posterior ophthalmic applications. The company has demonstrated proof-of-concept for dry eye disease and has successfully delivered insulin and axitinib to treat posterior eye tissues, pointing to future applications for neuroprotection and age-related macular degeneration. EyeDura is pursuing strategic collaborations with ophthalmic pharmaceutical partners interested in leveraging the platform for pipeline products and life cycle management. The company is also preparing for a $25 million Series A fundraise in 2026 to support advancement of its lead neurotrophic keratitis program. About EyeDura EyeDura Therapeutics Inc. ( is a seed-funded ophthalmic pharmaceutical company developing preservative-free topical sustained-release eye drops that target both anterior and posterior segment diseases. Cofounded by Dr. John Vukich and Dr. Kevin Waltz, the company developed its Topical Sustained Release technology to deliver therapeutic levels of active pharmaceutical ingredients for seven days or longer from a single dose. The platform is compatible with most active pharmaceutical ingredients currently used in ophthalmic products, including both small molecules and biologics. EyeDura's lead program, EYED-002, is developing insulin for neurotrophic keratitis, with IND submission planned for Q3 2026. The technology is protected by a global patent portfolio through 2044, with coverage across the U.S., Europe, China, Japan, and other key markets.
Globe and Mail
15-07-2025
- Health
- Globe and Mail
Attention Deficit Hyperactivity Disorder Clinical Trials 2025: EMA, PDMA, FDA Approvals, Medication, Therapies, Treatment Market, Mechanism of Action, ROA, and Companies by DelveInsight
The attention deficit hyperactivity disorder market is rapidly advancing and is fueled by groundbreaking research and innovative therapies from companies such as 3Z Pharmaceuticals, Shire, Takeda, and New River Pharmaceuticals. These industry pioneers are transforming treatment strategies and redefining the future of Attention Deficit Hyperactivity Disorder care, bringing new hope to patients worldwide. (Albany, USA) DelveInsight's " Attention Deficit Hyperactivity Disorder Pipeline Insight, 2025" comprehensively analyzes the current clinical landscape and growth prospects in the Attention Deficit Hyperactivity Disorder market. The report covers disease insights, treatment guidelines, and a detailed pipeline assessment from preclinical to marketed stages. It includes drug mechanisms, clinical studies, regulatory progress, and key developments such as collaborations, mergers, funding, and designations. For emerging Attention Deficit Hyperactivity Disorder drugs, the Attention Deficit Hyperactivity Disorder pipeline analysis report provides a 360° view of the therapeutics landscape by development point, product type, route of administration, molecule type, and MOA. The pipeline research covers business opportunities, challenges, future partnerships, strong competitors, and growth strategies. Download DelveInsight's comprehensive report to uncover breakthrough therapies, clinical progress, and future market opportunities @ Attention Deficit Hyperactivity Disorder Pipeline Outlook Key Takeaways from the Attention Deficit Hyperactivity Disorder Pipeline Report DelveInsight's Attention Deficit Hyperactivity Disorder Pipeline analysis depicts a robust space with 20+ active players working to develop 22+ pipeline drugs for Attention Deficit Hyperactivity Disorder treatment. The leading Attention Deficit Hyperactivity Disorder companies include Cingulate Therapeutics, Otsuka Pharmaceutical, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals, KemPharm, Arbor Pharmaceuticals, Ensysce Biosciences, 3Z Pharmaceuticals, Shire, Takeda, New River Pharmaceuticals, Aevi Genomic Medicine LLC, Sumitomo Pharma America Inc., Orient Pharma Co. Ltd., Durect, Rhodes Pharmaceuticals L.P., Purdue Pharma LP, CoMentis, Johnson & Johnson Ltd., Xian-Janssen Pharmaceutical Ltd., Shionogi Inc., Pfizer, Novartis, Neos Therapeutics Inc., Janssen Pharmaceuticals, and others are evaluating their lead assets to improve the Attention Deficit Hyperactivity Disorder treatment landscape. Key Attention Deficit Hyperactivity Disorder pipeline therapies in various stages of development include CTx-1301, Centanafadine, PDC-1421, and others. In January 2025, generic drugmaker Granules received final approval from the U.S. Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate Capsules, a medication for Attention Deficit Hyperactivity Disorder (ADHD), available in multiple strengths. In December 2024, Granules India received FDA approval for Lisdexamfetamine Dimesylate chewable tablets, its generic version of Takeda Pharmaceuticals' Vyvanse. The product is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and moderate to severe binge eating disorder (BED). Request a sample and discover the recent breakthroughs happening in the Attention Deficit Hyperactivity Disorder pipeline landscape @ Attention Deficit Hyperactivity Disorder Treatment Drugs Attention Deficit Hyperactivity Disorder Overview ADHD is a neurodevelopmental disorder that significantly impacts a child's ability to function, characterized by persistent patterns of inattention, hyperactivity, and impulsivity. Previously classified as separate conditions-Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder-the DSM-IV merged them into a single diagnosis with three subtypes: predominantly inattentive, predominantly hyperactive, and combined type. Symptoms typically emerge in early childhood and include difficulty focusing, disorganization, forgetfulness, and trouble completing tasks. For a diagnosis, these symptoms must appear before age 12, persist for at least six months, and disrupt daily life across multiple settings, such as home and school. ADHD can affect social interactions, academic performance, and even increase the likelihood of risky behaviors and job instability. As a disorder linked to executive dysfunction, ADHD primarily affects the frontal lobe, impairing attention, decision-making, and emotional regulation. Children with ADHD may struggle with frustration, impulsivity, and social interactions, often being misperceived as troublemakers. Brain abnormalities, including reduced size in the anterior cingulate gyrus and dorsolateral prefrontal cortex (DLPFC), contribute to deficits in goal-directed behavior, with decreased activity in the frontostriatal region observed through fMRI scans. The exact cause of ADHD remains unclear but involves both genetic and environmental influences. It is one of the most heritable psychiatric disorders, with higher concordance in identical twins and an increased risk among siblings. Environmental factors such as prenatal exposure to smoking, alcohol, nutritional deficiencies, and viral infections have also been linked to its development. Research suggests that lower dopamine receptor availability in the frontal lobes and noradrenergic system involvement may play a role in the disorder's pathology. Find out more about Attention Deficit Hyperactivity Disorder medication @ ADHD Medication and Companies Attention Deficit Hyperactivity Disorder Treatment Analysis: Drug Profile CTx-1301: Cingulate Therapeutics CTx-1301 leverages Cingulate's Precision Timed Release (PTR) technology to develop an advanced multi-core dexmethylphenidate formulation for ADHD treatment. This innovative tablet integrates immediate and sustained release layers, ensuring precise drug delivery throughout the day. Designed for rapid onset, full-day efficacy, and a controlled decline in plasma levels, CTx-1301 aims to optimize symptom management. Currently, the drug is in Phase III clinical trials for ADHD. Centanafadine: Otsuka Pharmaceutical Centanafadine, a triple-reuptake inhibitor targeting serotonin, norepinephrine, and dopamine, was initially developed by Neurovance before Otsuka Pharmaceutical acquired its rights in 2017. Two Phase III trials, involving approximately 900 adults (ages 18-55) with ADHD, assessed its efficacy through randomized, double-blind, placebo-controlled studies. Participants received either 100 mg or 200 mg doses twice daily, or a placebo. Centanafadine demonstrated significant symptom improvements compared to placebo across primary and key secondary endpoints. Safety data from both studies indicated no adverse events affecting more than 7% of participants. Key Attention Deficit Hyperactivity Disorder Therapies and Companies Attention Deficit Hyperactivity Disorder Therapeutics Assessment By Product Type Mono Combination Mono/Combination. By Stage Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates By Route of Administration Oral Intravenous Subcutaneous Parenteral Topical By Molecule Type Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Scope of the Attention Deficit Hyperactivity Disorder Pipeline Report Coverage: Global Key Attention Deficit Hyperactivity Disorder Companies: Cingulate Therapeutics, Otsuka Pharmaceutical, BioLite, Mind Medicine, Tris Pharma, RespireRx Pharmaceuticals, KemPharm, Arbor Pharmaceuticals, Ensysce Biosciences, 3Z Pharmaceuticals, Shire, Takeda, New River Pharmaceuticals, Aevi Genomic Medicine LLC, Sumitomo Pharma America Inc., Orient Pharma Co. Ltd., Durect, Rhodes Pharmaceuticals L.P., Purdue Pharma LP, CoMentis, Johnson & Johnson Ltd., Xian-Janssen Pharmaceutical Ltd., Shionogi Inc., Pfizer, Novartis, Neos Therapeutics Inc., Janssen Pharmaceuticals, and others. Key Attention Deficit Hyperactivity Disorder Pipeline Therapies: CTx-1301, Centanafadine, PDC-1421, and others. Dive deep into rich insights for drugs used for Attention Deficit Hyperactivity Disorder treatment; visit @ Attention Deficit Hyperactivity Disorder FDA Approvals and Recent Development Table of Contents 1. Introduction 2. Executive Summary 3. Attention Deficit Hyperactivity Disorder Pipeline: Overview 4. Analytical Perspective In-depth Commercial Assessment 5. Attention Deficit Hyperactivity Disorder Pipeline Therapeutics 6. Attention Deficit Hyperactivity Disorder Pipeline: Late-Stage Products (Phase III) 7. Attention Deficit Hyperactivity Disorder Pipeline: Late-Stage Products (Phase III) 8. Attention Deficit Hyperactivity Disorder Pipeline: Mid-Stage Products (Phase II) 9. Attention Deficit Hyperactivity Disorder Pipeline: Early Stage Products (Phase I) 10. Therapeutic Assessment 11. Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Key Companies 14. Key Products 15. Unmet Needs 16. Market Drivers and Barriers 17. Future Perspectives and Conclusion 18. Analyst Views 19. Appendix About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.
