Drug Approval
Branded Legacy Advances FDA Pathway for Low-Cost Intranasal Naloxone Alternative
Branded Legacy's subsidiary BioLegacy Evaluative Group is preparing FDA submission materials for a proprietary intranasal naloxone spray that aims to replicate Narcan's performance while reducing costs and improving global accessibility to opioid overdose reversal medication.
Gyre Therapeutics Advances Hydronidone Toward China Approval and Expands Clinical Pipeline
Gyre Therapeutics has submitted Hydronidone for approval in China and initiated a U.S. Phase 2 trial, positioning the company for significant growth in liver fibrosis treatment markets.
Alpha Cognition Inc. Advances Alzheimer's Treatment with ZUNVEYL, Secures Key Regulatory Milestones
Alpha Cognition Inc. reports significant progress in the commercialization of ZUNVEYL for Alzheimer's disease, highlighting early adoption in the U.S. long-term care market and a key regulatory achievement in China.
Clene Inc. Advances Toward FDA Approval for ALS Treatment, Highlighting Market Potential
Clene Inc. is making significant progress toward FDA accelerated approval for its ALS drug CNM-Au8®, targeting a $1.3 billion market by 2034 with a novel approach to neurodegenerative diseases.
Clene Inc. Advances Regulatory Strategy for CNM-Au8 with FDA Meetings Scheduled for ALS and MS Programs
Clene Inc. progresses in its regulatory strategy for CNM-Au8, with FDA meetings set to discuss ALS and MS treatments, marking a significant step towards potential accelerated approval.
FDA Approval of Keytruda® in Head and Neck Cancer Highlights Potential for Gedeptin® Combination Therapy
The FDA's approval of Keytruda® for head and neck cancer treatment underscores the therapeutic potential of combining it with GeoVax’s Gedeptin®, aiming to enhance tumor clearance and reduce relapse rates.
Stonegate Initiates Coverage on Alpha Cognition, Projects Strong Growth for New Alzheimer's Drug
Alpha Cognition's newly approved Alzheimer's drug ZUNVEYL is positioned to address a significant market gap with a potentially safer treatment option, as Stonegate Capital Partners initiates coverage with a valuation range of $27.62 to $38.44 per share.