ClearPoint Neuro CEO Sees Possible Huntington's Gene Therapy Approval By Mid-To-Late 2027
CEO Joe Burnett said an FDA acceptance decision on partner uniQure's application could come in about a month, and 2027 growth stays near mid-teens.
ClearPoint Neuro, which makes systems for minimally invasive brain surgery, expects the FDA to decide within about a month whether to accept partner uniQure's Huntington's disease gene therapy application, CEO Joe Burnett said on the company's third-quarter earnings call on Wednesday. Approval could follow in the middle to second half of next year, he said, "if everything went according to plan."
The Huntington's timeline
Burnett said the FDA should formally accept, reject or delay the uniQure application "here in the next month or so." If it accepts, ClearPoint would file a companion 510(k), the FDA clearance filing for its delivery device. He said the company followed the same path for Kebilidy, the only other neuro gene therapy approved for delivery directly to the brain.
Based on the FDA's limited experience with these therapies, he said a final decision would typically come six to eight months after acceptance, if everything went perfectly. That points to approval in the middle to second half of next year.
uniQure reported on September 29 that its treatment did not reach statistical significance on a primary clinical measure at 48 months, according to a law firm's release. The release says ClearPoint shares fell 23.12% that day.
Mid-teens growth, no guidance
An analyst at Stifel asked for an early read on 2027 growth, noting past talk of high-teens growth. Burnett said the company still feels good about mid-teens base growth but has given no official guidance. He said the next couple of months, including phase three trial starts, the FDA's response and progress on its own products, will teach the company a lot.
The analyst also asked about the fourth-quarter step-up implied by the $49 million midpoint of 2026 revenue guidance. Burnett said capital equipment, disposables and lab services could all contribute, and called the capital funnel the healthiest the company has had.
Third-quarter revenue was $12.1 million, up 36% from $8.9 million a year earlier. Operating expenses rose 23% to $13.4 million, and cash stood at $46.2 million after the company tapped its at-the-market stock program for the first time, raising net proceeds of $22 million.
Bigger trials, more sites
Burnett said early studies can involve fewer than 15 patients at a handful of sites, while phase three and confirmatory trials may reach up to 200 patients and around 20 sites. He said uniQure has announced a parallel confirmatory study that could reach up to 200 patients.
ClearPoint's market value was $296 million as of Wednesday's report.
Burnett said he expects the company to be in a position to say more about 2027 after the next two months of trial starts and FDA feedback.
Sources
- ClearPoint Neuro, Inc. GAAP EPS of -$0.24 beats by $0.08, revenue of $12.1M misses by $0.2M (CLPT:NASDAQ) | Seeking Alpha — seekingalpha.com
- ClearPoint Neuro to Announce Third Quarter 2026 Results October 28, 2026 - The Globe and Mail — theglobeandmail.com
- INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On — globenewswire.com
