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Curanex Provides Business Update in Connection with 2025 Annual Report as Phyto-N Advances Toward Planned IND Submission
Globenewswire· 2026-03-30 21:35
Core Insights - Curanex Pharmaceuticals is advancing its lead asset, Phyto-N, towards an Investigational New Drug (IND) submission for ulcerative colitis planned for Q4 2026, while also exploring additional therapeutic opportunities [2][6][12] Operational Highlights - The company has made significant progress in manufacturing and chemistry, manufacturing, and controls (CMC) activities, including the completion of a pilot-scale GMP batch of Phyto-N to support GLP toxicology studies [4] - A dose-range finding toxicology study in rats and dogs has been completed, identifying the maximum feasible dose with no significant adverse findings, which is crucial for the design of the pivotal GLP toxicology program [5] Regulatory Pathway - Curanex is on track to submit its first IND application for ulcerative colitis in Q4 2026, contingent on the completion of required studies and regulatory review, with plans to initiate Phase 1 clinical development in Australia [6] Intellectual Property - The company has expanded its intellectual property position by filing a Patent Cooperation Treaty (PCT) application in March 2025, covering various therapeutic areas including autoimmune diseases and viral infections [7] Pipeline Development - Beyond ulcerative colitis, Curanex is evaluating additional therapeutic opportunities across a multi-indication pipeline, which includes atopic dermatitis, COVID-19, diabetes, NAFLD, and gout [8][9] Funding Position - Following its IPO, Curanex believes it has sufficient funding to support its near-term development objectives for at least the next twelve months, allowing continued advancement of IND-enabling activities and regulatory preparations [10] Strategic Vision - The CEO emphasized the company's commitment to building a robust operational foundation and pursuing regulatory approvals for differentiated therapeutic assets to address significant unmet medical needs [3][11]
SWK Holdings(SWKH) - Prospectus(update)
2023-09-28 13:29
As filed with the Securities and Exchange Commission on September 28, 2023 Registration No. 333-274511 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT No. 2 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 SWK HOLDINGS CORPORATION (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 6159 77-0435679 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identificat ...