Core Viewpoint - REGENXBIO Inc. is under investigation for potential violations of federal securities laws following the FDA's clinical holds on its RGX-111 and RGX-121 programs, which resulted in a significant decline in the company's share price by 30-35% [1]. Regulatory Compliance - SEC disclosure rules mandate that public companies must provide material information for informed investment decisions, with Form 8-K allowing disclosure of material events not covered by other items [2]. - Rule 10b-5 prohibits material misstatements and omissions in securities transactions, covering both false statements and the omission of necessary facts [2]. Earnings Call Insights - During the Q3 2025 earnings call, CEO Curran Simpson highlighted positive regulatory interactions, noting that the FDA completed inspections with no observations, which may have created an asymmetric presentation of the company's regulatory standing [3]. - The Q3 2025 earnings call did not address the RGX-111 program for MPS I, despite it being a material pipeline asset later subjected to the FDA clinical hold, raising concerns about the completeness of information provided to shareholders [4].

Core Insights - Holzer & Holzer, LLC is investigating whether REGENXBIO Inc. complied with federal securities laws following the announcement of a clinical hold on its Investigational New Drug applications by the FDA [1] - The clinical hold affects two trials: RGX-111 for Mucopolysaccharidosis type I and RGX-121 for Mucopolysaccharidosis type II [1] - Following the announcement, REGENXBIO's stock price experienced a decline [1] Company Information - REGENXBIO Inc. is publicly traded on NASDAQ under the ticker RGNX [1] - The company is focused on developing gene therapies for various diseases, including Mucopolysaccharidosis [1] Legal Context - Holzer & Holzer, LLC is a law firm that specializes in representing shareholders and investors in securities litigation [3] - The firm has a history of recovering significant amounts for shareholders affected by corporate misconduct [3]

Core Points - VYNE Therapeutics Inc. announced a clinical hold on its Phase 1b study of VYN202 for moderate-to-severe plaque psoriasis due to observed testicular toxicity in dogs from a non-clinical toxicology study [1][2] - The company has suspended all screening, enrollment, and patient dosing in the Phase 1b trial and aims to resolve the clinical hold with the FDA as soon as possible [2] - The clinical hold does not affect VYNE's ongoing Phase 2b trial of repibresib gel for nonsegmental vitiligo, with top-line results expected mid-year [3] - The CEO of VYNE expressed disappointment over the clinical hold but emphasized the priority of patient safety and the intention to work closely with the FDA [4] - VYNE is focused on developing differentiated therapies for chronic inflammatory and immune-mediated conditions, utilizing its proprietary BET inhibitors [4]