Fast track approval9 Apr 2026 17:24
Although this is not a place for political opinion, this is arguably the only sensible thing Trump has done:
The FDA is actively implementing initiatives to entice early-stage drug manufacturing to the United States, driven by a desire to boost domestic supply and reduce reliance on foreign manufacturing and combat the threat of China. Key initiatives launched in 2026 include the FDA PreCheck program, which offers expedited regulatory review and closer communication for new, onshored manufacturing sites. In February 2026, this program provides selected manufacturers of "critical medications" with increased regulatory predictability during facility design, construction, and pre-production. It aims to reduce regulatory uncertainty, acting as a "carrot" for onshoring.Advanced Manufacturing Technologies (AMT) Designation: This program provides a pathway for accelerated adoption of advanced technologies like continuous manufacturing, AI and 3D printing, which can increase production efficiency in the US.Faster Regulatory Reviews:
The FDA has pledged to speed up reviews of drug applications that are made in the US, with some proposals promising fast-track, rapid reviews (in a few weeks) for projects that align with national priorities, like pediatriccancer treatment. The PreCheck program includes two-phase communication, involving pre-operational reviews and early feedback on Chemistry, Manufacturing, and Controls (CMC) sections of a drug application, allowing for faster, more predictable approvals.These initiatives are specifically designed to reduce the high-risk, expensive nature of facility investment for smaller pharmaceutical companies.
This month FDA officials proposed easing the transition into clinical testing for drugs made in the US and offering exclusivity periods for US-based generic manufacturers.These initiatives are driven by a May 2025 Executive Order focused on "Regulatory Relief to Promote Domestic Production of Critical Medicines".
This is exciting news for Hemogenyx being both developed and manufactured in the USA, in particular for the imminent start of the pediatric trial as cancer treatment for children is at the top of this administrations agenda. Fast tracking of HG-CT-1 could lead to tax incentives, grants and even priority review vouchers that can be used or sold on for on excess of ,$100m. We have already seen the FDA move very quickly to approve HG-CT-01 for pediatrics after seeing the initial data from just two patients and I think this is just the start.
Personally I can't wait for the next patients to be treated which I think should start next week. Passing safety on both dose escalation and the first child will be the most important milestone in Hemogenyx's history.
Tick tock.