Posted on Tue, 03 Mar 2026 14:57:47 +0000

Australia Opens The Door for SKY-0515: Skyhawk Seeks Provisional Approval for Its Oral HD Drug

⏱️ 8 min read | An oral Huntington's disease drug is eligible for accelerated approval in Australia. This isn't full approval yet, but it opens a faster path to potentially getting this once-daily pill to people with HD sooner.

From: HDBuzz

Posted on Mon, 02 Mar 2026 21:54:11 +0000

The road ahead for uniQure: FDA says more data needed for AMT-130 gene therapy

⏱️ 10 min read | The FDA wants more data before approving AMT-130 for Huntington’s disease in the U.S. On March 2026, uniQure shared in an update that current Phase 1/2 data weren’t enough for the agency. A new randomized, sham-controlled trial may be required.

From: HDBuzz

Posted on Mon, 02 Mar 2026 10:00:00 +0000

Vico’s Trial Adjusts With Twice-Yearly Dosing, And The U.S. Is Next

⏱️ 6 min read | Vico Therapeutics' Huntington’s disease drug VO659 is now being tested just twice a year, and the FDA has cleared the way for US trials to begin later this year.

From: HDBuzz