Latest news with #Tecarfarin
Business Wire
5 days ago
- Business
- Business Wire
Cadrenal Therapeutics to Engage Potential Partners at BIO International Convention 2025
PONTE VEDRA, Fla.--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced that members of its executive leadership team will be attending and participating in the upcoming BIO International Convention 2025, taking place June 16-19, 2025 in Boston. Cadrenal executives will participate in one-on-one meetings with investors and potential partners to provide key updates on the Company's strategic direction and clinical development of its lead asset, tecarfarin. Those interested in meeting with Cadrenal management should request a meeting through the Conference meeting portal or contact Investor Relations at cadrenal@ The BIO International Convention is the world's largest and most comprehensive biotechnology event, convening over 20,000 industry leaders from across the global life sciences ecosystem. About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for a number of indications, extensive clinical and real-world data have shown it can have significant, serious side effects. With tecarfarin, Cadrenal is advancing an innovative solution to address the unmet needs in anticoagulation therapy, aiming to reduce the clinical complexities of warfarin and capture value in a market with high demand for safer, more manageable treatment options. Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib). Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn.
Yahoo
19-05-2025
- Business
- Yahoo
U.S. Orphan Designated Drugs Market Research 2025-2030: 500 FDA Designated Orphan Drugs, 400 Marketed Orphan Drugs Pricing & Dosage, 850 Orphan Drugs in Trials
Development of the orphan drug market has contributed to the rise in collaborations between pharmaceutical firms. Collaborations can assist in the division of the cost and the acceleration of the development of new medicines. An example is the partnership between Cadrenal Therapeutics and Abbott, established in March 2025 to aid in the development of tecarfarin, a new oral anticoagulant, in patients with HeartMate 3T Left Ventricular Assist Devices (LVADs). Dublin, May 19, 2025 (GLOBE NEWSWIRE) -- The "U.S. Orphan Designated Drugs Market Opportunity, Drugs Sales, Price, Dosage & Clinical Trials Insight 2030" report has been added to offering. U.S. market for orphan drugs will continue to grow. The regulatory environment will continue to shift to facilitate orphan drug development, with increasingly streamlined approval procedures and additional incentives to stimulate innovation. As rare diseases are increasingly well understood, and as advances in science offer new means of attacking them, the market for orphan drugs will increasingly be characterized by diversity in the types of diseases being treated. There is also increased awareness that rare diseases tend to have common molecular mechanisms, raising the possibility that treatments applicable across larger groups could be developed. Development of the orphan drug market has contributed to the rise in collaborations between pharmaceutical firms. Collaborations can assist in the division of the cost and the acceleration of the development of new medicines. An example is the partnership between Cadrenal Therapeutics and Abbott, established in March 2025 to aid in the development of tecarfarin, a new oral anticoagulant, in patients with HeartMate 3T Left Ventricular Assist Devices (LVADs). Tecarfarin, granted orphan drug status, is under investigation in a clinical trial for enhancing anticoagulation benefit in patients with advanced heart failure. This alliance reflects the increased trend of grouping together resources and expertise to make therapies for rare conditions, as the scientific and logistical hurdles associated with orphan drug development can be significant. More drugs have over the years acquired orphan drug status. To date, hundreds of drugs in development have been assigned such status with the indications ranging from rare tumors to genetic conditions, cardiovascular diseases, and neurologic conditions. The FDA orphan drug designation not only encouraged the development of novel treatments but also has resulted in some unexpected commercial success stories. Those drugs initially designed for limited patient populations now are showing to be profitable products, reversing the opinion that orphan drugs cannot exhibit good market performance. One of the best examples is Merck's Keytruda (pembrolizumab), an immune checkpoint inhibitor that originally received orphan drug designation in 2012 for malignant melanoma. Since then, Keytruda has had its indications broadened to include various cancers, such as esophageal carcinoma, lymphoma, and lung cancer, among others, many of which are orphan diseases. Although an orphan drug, Keytruda is now amongst the world's best-selling cancer medications, with 2024 revenue of almost U.S.$ 29.4 billion, an astonishing 18% increase over last year. Importantly, more than 60% of this originated from the U.S. alone. This business success demonstrates how orphan drugs, in the long run, can discover larger markets and generate sizeable returns. Likewise, Gilead's Biktarvy, an HIV drug, was given orphan drug designation and is now one of the company's best-selling drugs. In 2024, it recorded U.S.$ 13.4 billion in sales, up 13% from the previous year. Both drugs underscore how treatments for rare diseases can evolve from specialty therapies into big moneymakers. The success of these drugs in the market shows that orphan drug development can be both clinically effective and profitable. With appropriate incentives, companies are more likely to invest in the treatment of rare diseases, even if the number of patients is small. The incentives created by the FDA and other regulatory authorities, including the potential for market exclusivity and fast-track review, enable firms to break even on their investment and reap huge profits in the long term. These advantages have motivated numerous firms to enter the orphan drug area, particularly since rare diseases are increasingly being understood as a result of advances in genomics and biotechnology. Report Offering & Highlights: U.S. Orphan Designated Drugs Market Opportunity: > U.S.$ 190 Billion by 2030 Insight on FDA Designated Orphan Drugs in Clinical Trials: > 850 Orphan Drugs Clinical Trials Insight by Company, Indication, Phase & Priority Status Insight on FDA Designated Marketed Orphan Drugs: > 500 Orphan Drugs Pricing & Dosage Insight: > 400 Marketed Orphan Drugs U.S., Global, Regional, Annual Sales Insight (2019 - Q1'2025): >150 Orphan Drugs Sales, Price & Dosage Data Represented in More Than 1000 Charts & Tables Orphan Designation Insight by Indication, Company, Trial Phase, Marketed Drugs Represented in 1000 Tables Key Topics Covered: 1. FDA Orphan Designation Criteria & Market Exclusivity 2. US Orphan Designated Drugs Market Insight2.1 Current Market Overview2.2 Future Market Opportunity Assessment 3. US Orphan Designated Drugs Market Trends by Indication3.1 Cancer3.2 Neurological Disorders3.3 Cardiovascular Disorders3.4 Ophthalmic Diseases3.5 Rare Genetic Disorders & Metabolic Disorders3.6 Autoimmune & Inflammatory Diseases 4. US Orphan Designated Drugs Reimbursement Scenario4.1 Medicare4.2 Medicaid4.3 Private Insurers4.4 Pharmaceutical Companies 5. US Orphan Designated Drugs Clinical Trials Insight5.1 by Patient Segment5.2 by Phase5.3 by Priority Status 6. US Orphan Designated Drugs Clinical Trials by Company, Indication & Phase6.1 Research6.2 Preclinical6.3 Phase-I6.4 Phase-I/II6.5 Phase-II6.6 Phase-II/III6.7 Phase-III6.8 Preregistration6.9 Registered 7. Marketed Orphan Designated Drugs Clinical Insight by Company & Indication 8. US Orphan Designated Drugs Dosage, Price & Treatment Cost Insight8.1 Lynparza8.2 Nplate8.3 Tafinlar8.4 Halaven8.5 Jadenu8.6 Xpovio8.427 Ojemda8.428 Ojjaara8.429 Piasky8.430 Rezurock8.431 Pombiliti8.432 Ogsiveo8.433 Qfitlia8.434 Zevaskyn 9. US Orphan Designated Drugs Sales Insight (2019 - Q1'2025)9.1 Amvuttra9.2 Krazati9.3 Tecvayli9.4 Imjudo9.5 Rezurock9.6 Elrexfio9.7 Fabhalta9.154 Xospata9.155 Defitelio9.156 ReFacto9.157 Praluent9.158 Mozobil9.159 Yescarta9.160 Lunsumio9.161 Keytruda9.162 Pemazyre9.163 Camzyos 10. Competitive Landscape10.1 AbbVie10.2 Alexion AstraZeneca Rare Disease10.3 Alnylam Pharmaceuticals10.4 Amgen10.5 Amicus Therapeutics10.6 Array BioPharma10.7 Astellas Pharma10.8 AstraZeneca10.9 Bayer HealthCare10.10 BioMarin Pharmaceutical10.11 Bioverativ10.12 Boehringer Ingelheim10.13 Bristol-Myers Squibb10.14 Chiesi10.15 Chugai Pharmaceutical10.16 Collaborations Pharmaceuticals10.17 CSL10.18 Daiichi Sankyo Company10.19 Eisai Co Ltd10.20 Eli Lilly & Company10.21 Emergent BioSolutions10.22 Ferring Pharmaceuticals10.23 Flavocure Biotech10.24 Genentech10.25 Genmab10.26 Gilead Sciences10.27 GSK10.28 Hanmi Pharmaceutical10.29 Horizon Therapeutics plc10.30 Incyte Corporation10.31 Ionis Pharmaceuticals10.32 Ipsen10.33 Janssen Biotech10.34 Jazz Pharmaceuticals plc10.35 Johnson & Johnson10.36 Kamada10.37 Krystal Biotech10.38 Kyowa Kirin10.39 Leadiant Biosciences10.40 Ligand Pharmaceuticals10.41 Lundbeck A/S10.42 MeiraGTx10.43 Merck10.44 Moderna Therapeutics10.45 Novartis10.46 Novo Nordisk10.47 Omeros Corporation10.48 Onyx Pharmaceuticals (Amgen)10.49 Otsuka Pharmaceutical10.50 Pfizer10.51 PTC Therapeutics10.52 Recordati10.53 Regeneron Pharmaceuticals10.54 Roche10.55 Sanofi10.56 Servier10.57 Shionogi10.58 Spark Therapeutics10.59 Sumitomo Pharma10.60 Sutro Biopharma10.61 Swedish Orphan Biovitrum10.62 Takeda10.63 Teva Pharmaceutical Industries10.64 UCB10.65 UniQure10.66 Vertex Pharmaceuticals10.67 XOMA10.68 ZymoGenetics (BMS) For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. CONTACT: CONTACT: Laura Wood,Senior Press Manager press@ For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900Sign in to access your portfolio
Associated Press
15-05-2025
- Business
- Associated Press
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla.--(BUSINESS WIRE)--May 15, 2025-- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. 'We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,' said Quang X. Pham, Chairman & CEO. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib). Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements.' The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potentially,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. View source version on CONTACT: Corporate and Investor Relations Paul Sagan LaVoieHealthScience (617) 865-0041 [email protected] Andrew Korda LaVoieHealthScience (617) 865-0043 [email protected] KEYWORD: UNITED STATES NORTH AMERICA FLORIDA INDUSTRY KEYWORD: HEALTH OTHER HEALTH GENERAL HEALTH CLINICAL TRIALS PHARMACEUTICAL CARDIOLOGY BIOTECHNOLOGY SOURCE: Cadrenal Therapeutics, Inc. Copyright Business Wire 2025. PUB: 05/15/2025 07:30 AM/DISC: 05/15/2025 07:29 AM
Yahoo
15-05-2025
- Business
- Yahoo
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla., May 15, 2025--(BUSINESS WIRE)--Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. "We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin," said Quang X. Pham, Chairman & CEO. "This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation." About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib). Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements." The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potentially," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise. View source version on Contacts Corporate and Investor Relations Paul SaganLaVoieHealthScience(617) 865-0041psagan@ Media Andrew KordaLaVoieHealthScience(617) 865-0043akorda@ 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
Business Wire
15-05-2025
- Business
- Business Wire
Cadrenal Therapeutics Announces Tecarfarin Manufacturing Progress in Support of Clinical Trial Readiness
PONTE VEDRA, Fla.--(BUSINESS WIRE)-- Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing therapeutics for patients with cardiovascular disease, today announced manufacturing and supply chain milestones for its lead drug candidate, tecarfarin, a novel oral vitamin K antagonist (VKA) anticoagulant that is designed to address unmet needs in anticoagulation therapy. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' Cadrenal completed the technical transfer and manufacturing of its tecarfarin drug substance in accordance with current good manufacturing practices (cGMP) earlier this year at a U.S. site of a leading global Contract Development and Manufacturing Organization (CDMO). Manufacturing of the tecarfarin drug product candidate is currently underway. 'We are pleased with the important progress we have made with the supply chain and cGMP manufacturing process for tecafarin,' said Quang X. Pham, Chairman & CEO. 'This is a key milestone as we support our clinical development strategy and tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation.' About Cadrenal Therapeutics, Inc. Cadrenal Therapeutics, Inc. is a biopharmaceutical company developing therapeutics for patients with cardiovascular disease. Cadrenal's lead investigational product is tecarfarin, a novel oral vitamin K antagonist anticoagulant that addresses unmet needs in anticoagulation therapy. Tecarfarin is a reversible anticoagulant (blood thinner) designed to prevent heart attacks, strokes, and deaths due to blood clots in patients requiring chronic anticoagulation. Although warfarin is widely used off-label for several indications, extensive clinical and real-world data have shown it can have significant, serious side effects. Cadrenal is pursuing a pipeline-in-a-product approach with tecarfarin. Tecarfarin received Orphan Drug designation (ODD) for advanced heart failure patients with implanted mechanical circulatory support devices, including Left Ventricular Assisted Devices (LVADs). The Company also received ODD and fast-track status for tecarfarin in end-stage kidney disease and atrial fibrillation (ESKD+AFib). Cadrenal is opportunistically pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. For more information, visit and connect with us on LinkedIn. Safe Harbor Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute 'forward-looking statements.' The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'intend,' 'may,' 'plan,' 'potentially,' 'predict,' 'project,' 'should,' 'target,' 'will,' 'would' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include statements regarding tecarfarin's potential to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation and pursuing business development initiatives with a longer-term focus on creating a pipeline of cardiovascular therapeutics. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability of tecarfarin to provide clinical benefits for patients with cardiovascular disease who require chronic VKA anticoagulation, the ability of Cadrenal to build a pipeline of specialized cardiovascular therapeutics and other assets and the other risk factors described in the Company's Annual Report on Form 10-K for the year ended December 31, 2024, and the Company's subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
