Wednesday, June 17
Gene therapy startup soars after FDA reversal on Huntington's
The agency did a rare about-face and agreed that early trial data can be the foundation for a fast-track approval path, sending uniQure's stock up nearly 80%.
Top Stories
The FDA's reversal on uniQure hands Huntington's patients their most credible treatment hope in years
uniQure announced Wednesday that the FDA agreed its Phase 1/2 trial data for AMT-130 can serve as the primary basis for accelerated approval in Huntington's disease, ending months of public dispute with the agency and clearing the path for a regulatory submission next year.
This is not just a win for one small biotech; it signals the FDA is willing to accept earlier-stage data for devastating diseases with no existing treatments, which could reshape how other gene therapy developers approach their own approval strategies.
CarMax's margin warning exposes structural pressure across the entire used-car market
CarMax beat earnings estimates in its latest quarter but the stock dropped nearly 9% after the company flagged that gross profit per vehicle fell year-over-year and consumers are increasingly trading down to cheaper cars, a warning that applies well beyond CarMax's own lot.
Carvana, which had posted strong growth numbers of its own, got caught in the same downdraft, falling more than 10%, because when the industry's largest traditional dealer says margins are structurally squeezed, no used-car seller is immune.
Fortinet's firewall breach is a credibility problem, not just a security patch
Fortinet disclosed Wednesday that an active campaign is targeting its firewall and VPN devices to harvest login credentials, while independent cybersecurity researchers separately reported that tens of thousands of Fortinet devices used by major companies globally have already been compromised.
For a company whose entire business proposition is keeping attackers out of corporate networks, being the attack surface is a reputational wound that no software update fully heals.
Also Today
- Boeing's defense unit landed $9 billion in new orders
- GSK wins FDA approval for drug-resistant UTI antibiotic
- Saudi fund files EU approval for $55 billion EA acquisition
Takeaway
Today's market conversation was really about trust breaking down in two directions at once: Fortinet struggling to convince customers its security products are secure, and CarMax's margin data undermining confidence in used-car sellers broadly.
The most concrete thing to watch next is uniQure's BLA submission timeline, since any signal that the Q3 2026 filing could slip or accelerate will move uniQure sharply.
