The Telix Pharmaceuticals Ltd (ASX: TLX) share price is racing higher today.
Shares in the S&P/ASX 200 Index (ASX: XJO) diagnostic and therapeutic product developer closed yesterday trading for $13.60. In earlier trade shares were up more than 10%. At the time of writing in late morning trade on Tuesday, shares are changing hands for $14.29 apiece, up 5.1%.
For some context, the ASX 200 is down 0.5% at this same time.
This outperformance of the Telix share price follows a promising development with the United States Food and Drug Administration (FDA).
Here's what is grabbing ASX investor interest.
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Telix share price soars on FDA agreement
The Telix share price is enjoying a boost after the company announced that it has reached agreement with the FDA regarding resubmission of its New Drug Application (NDA) for its TLX101-CDx product.
TLX101-CDx is an investigational agent for the imaging of glioma, a rare brain cancer.
Telix said that after engaging with the FDA, including a successful Type A meeting, it has received detailed feedback regarding a resubmission package. This will include an additional confirmatory efficacy study analysis of existing data.
The company believes that, based on this feedback, the new study will meet the FDA's request for additional confirmatory evidence to supplement the NDA as well as addressing the review matters cited in the agency's Complete Response Letter (CRL).
The ASX 200 healthcare stock reconfirmed its plan to resubmit the NDA during the fourth quarter of calendar year 2025.
What did management say?
Commenting on the agreement with the FDA that's helping lift the Telix share price today, chief medical officer David N. Cade said, "As previously advised, Telix had multiple options for delivering additional data requested by the FDA in the CRL response."
Cade added:
This flexibility has enabled us to work with relative speed to reach a mutually agreed path forward for resubmission of the NDA. We remain steadfastly focused on our goal of bringing this important imaging agent to patients in the US to support improved diagnosis and management of glioma.
Cade said the FDA will advise Telix of a new Prescription Drug User Fee Act goal date following a successful resubmission.
He noted that the FDA has acknowledged the unmet medical need TLX101-CDx is intended to help address. The FDA also indicated that it's likely to grant the company an expedited review on this basis, subject to submission review.
The ASX 200 healthcare stock said that TLX101-CDx is not included in its 2025 revenue guidance, as guidance excludes revenue forecasts from unapproved products.
With today's intraday rebound factored in, the Telix share price remains down 18% since this time last year.
