Last mentioned: 3d ago
Type B FDA Meeting Target
Planned follow-up to define Phase III and regulatory path for AMT-130.
AMT-260 Data Readout
Expected clinical data from Phase I/IIa epilepsy study in H1 2026.
DOJ Missouri Filing
DOJ quietly asks the Missouri court to pause proceedings pending FDA review.
Legislative Action
Sen. Josh Hawley introduces a Senate bill to outright ban the abortion pill.
Earnings Call
Management confirms CMS reimbursement rate of $897 and 2025 assay expansion.
Type A FDA Meeting
Discussed AMT-130 approval pathway; alignment not yet reached.
Louisiana Precedent
DOJ unsuccessfully asks Louisiana to pause its separate anti-abortion lawsuit.
FDA Submission
510(k) premarket notification submitted for Lucent AD Complete.
Q4 2025 Close
Quanterix reports $43.9M in revenue with 25% YoY growth.
Fiscal Year End
Closed 2025 with $622.5 million in liquidity.
Amended Complaint
AG Catherine Hanaway adds claims that mail-order drugs are dangerous without in-person visits.
Lawsuit Filed
Missouri, Kansas, and Idaho file suit against the FDA over mifepristone regulations.
The U.S. Department of Justice has requested a federal court in Missouri to pause or dismiss a lawsuit targeting the FDA's approval of mifepristone, citing an ongoing internal agency review. This move reflects a strategic effort by the administration to manage high-stakes litigation over medication abortion and telehealth access ahead of the 2026 midterms.
Senator Ron Johnson (R-Wis.) has initiated a formal investigation into the FDA's handling of biologic therapy applications for rare diseases, specifically targeting Duchenne muscular dystrophy. The probe follows a direct consultation with FDA Commissioner Marty Makary regarding perceived regulatory barriers for life-saving treatments.
A high-ranking FDA official is reportedly attempting to recruit Dr. Tracy Beth Hoeg, a vocal advocate for stricter antidepressant warnings, to a key agency role. The move signals a potential shift in how the FDA evaluates long-term psychiatric drug risks and has raised internal concerns regarding hiring protocols.
Quanterix reported a 25% year-over-year revenue increase to $43.9 million in Q4 2025, driven by a surge in diagnostics partner revenue and critical regulatory milestones. The company achieved a commercial breakthrough with a $897 CMS reimbursement rate for its Lucent AD Complete test, positioning it for large-scale clinical adoption.
uniQure reported a strong cash position of $622.5 million, extending its operational runway into 2029. While the company continues to seek regulatory alignment with the FDA for its Huntington’s disease candidate AMT-130, it is advancing clinical trials for epilepsy and Fabry disease with key data readouts expected in 2026.
A series of recent clinical studies have directly challenged the public health assertions made by Robert F. Kennedy Jr. regarding vaccines, Tylenol, and antidepressants. These findings underscore a growing tension between evidence-based medicine and the policy platform of the potential future leadership at the Department of Health and Human Services.