NT 10-Q Late Filing Notification - Kinetic Group Inc

Kinetic Group Inc (KNIT) filed Form 12b-25 notification with the SEC indicating it cannot file its Form 10-Q for the period ended March 31, 2026 within the prescribed deadline. The registrant states it and its auditors require additional time to review information and complete revisions. The company expects to file by end of June 2026. Multiple prior reports are also delinquent.

Late Filing Notice - Kinetic Group Inc Form 10-Q/A

Kinetic Group Inc (KNIT, SEC File 333-216047) filed Form 12b-25/A with the SEC notifying inability to timely file its Form 10-Q/A for the period ending December 31, 2025. The company cited need for additional auditor review of current and prior period information and expects to complete the filing by end of June 2026. The filing also disclosed multiple delinquent periodic reports including 10Q for Q4 2024, Q1 2025, Q2 2025, and 10K for fiscal year 2025.

All IPAY 2028 manufacturers agree to IRA negotiations

All IPAY 2028 manufacturers agree to IRA negotiations

Life Science Regulatory Update: AI IP, Biosimilar Approvals, Cell Therapy

FDA published new guidance in February-March 2026 allowing biosimilar applicants to use foreign clinical trial data to accelerate U.S. approval for rare and ultra-rare diseases. The agency also indicated increased flexibility for iterative manufacturing changes in cell and gene therapies, creating new IP strategy considerations. Knobbe Martens summarizes these regulatory developments for life science companies and their counsel.

EPA Draft CCL 6 Includes Microplastics and Pharmaceuticals for Drinking Water Regulation

The EPA announced the draft Sixth Contaminant Candidate List (CCL 6) under the Safe Drinking Water Act on April 2, 2026. For the first time, microplastics and pharmaceuticals have been designated as potential contaminants, alongside PFAS (as a class), disinfection byproducts, 75 chemicals, and 9 microbes. The draft is open for public comment until June 1, 2026. The CCL process identifies emerging contaminants for research but does not itself impose regulatory requirements.

Idaho Minor Consent Law Amendments

Idaho amended Idaho Code § 32-1015 governing minor consent for healthcare services, effective March 31, 2026 (H0860E1). The amendments maintain parental consent requirements for minors while creating new uncertainties regarding noncustodial parent rights and interaction with existing laws allowing minor self-consent for specific services including contraceptives, communicable disease treatment, and substance abuse care.

Texas HB 4224 - Patient Health Information Posting Requirements

Texas HB 4224 added Section 181.105 to the Texas Health and Safety Code, effective September 1, 2025. The law requires covered healthcare entities to prominently post on their websites and at physical facilities instructions covering three topics: how patients can request healthcare records, how to contact the licensing board, and how to file a consumer complaint. Entities performing only claims processing, billing, or data analysis backend functions are exempt.

Ninth Circuit Reverses FCA Case Against AbbVie for 340B Pricing Fraud

The Ninth Circuit reversed the district court in United States ex rel. Adventist Health System of West v. AbbVie Inc., holding that the False Claims Act provides an independent mechanism for relators to pursue claims alleging fraudulent drug pricing in violation of the 340B Program, even though Section 340B itself contains no private right of action. The court rejected manufacturers' arguments that FCA claims require a prior HRSA violation. The ruling exposes pharmaceutical manufacturers to significant FCA liability for 340B pricing practices.

FDA Updates Patient Preference Information Guidance for Medical Devices

FDA's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research issued final guidance on Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle, superseding the August 2016 guidance. The 2026 guidance clarifies scope across the device lifecycle and substantially enhances methodological specificity for PPI studies. The guidance now expressly recognizes PPI relevance to 510(k) submissions and postmarket enforcement decisions.

Colorado Conversion Therapy Ban Unconstitutional - First Amendment

The Supreme Court ruled 8-1 in Chiles v. Salazar that Colorado's 2019 law prohibiting licensed mental health counselors from performing conversion therapy on minors is unconstitutional. The Court held the statute violated a counselor's First Amendment rights by directly regulating the content and viewpoint of speech during counseling sessions. Colorado's argument that the law regulated professional conduct with only incidental speech effects was rejected.