Nyrada Discloses No Safety Concerns in Phase I Trial Cohort Six
Nyrada Inc has responded to ASX inquiries confirming the timely and compliant disclosure of positive safety data from its Phase I clinical trial of Xolatryp. The company detailed the timeline of its awareness and release of information, affirming adherence to continuous disclosure rules.
- Nyrada confirms positive safety review of Xolatryp Phase I trial cohort six
- Safety Review Committee found no safety concerns or serious adverse events
- Company clarified timeline of awareness and immediate disclosure on 6 August 2025
- Nyrada affirmed compliance with ASX Listing Rule 3.1 and continuous disclosure obligations
- Limited control over Safety Review Committee’s data interpretation emphasized
Background on Disclosure
On 6 August 2025, Nyrada Inc (ASX – NYR), a clinical-stage biotech focused on small-molecule therapies, released a market-sensitive announcement confirming the positive safety profile of its lead drug candidate, Xolatryp, in its Phase I clinical trial. This followed a detailed inquiry from the Australian Securities Exchange (ASX) regarding the timing and content of the disclosure.
Safety Review Committee Findings
The trial’s independent Safety Review Committee (SRC), composed of three external medical doctors, reviewed data from the sixth cohort of 48 participants. Their conclusion was clear – no safety signals, dose-limiting toxicities, or unexpected side effects were observed. All adverse events were mild or moderate, with no serious adverse events reported. This reinforced the tolerability and safety of Xolatryp in this early human study.
Clarifying the Timeline and Compliance
Nyrada outlined that while it had access to final data provided to the SRC, it does not control or influence the committee’s interpretation. The company only became aware of the SRC’s official conclusion on the morning of 6 August 2025, when the committee communicated their findings. Nyrada promptly released the announcement within the same morning before market open, demonstrating adherence to ASX continuous disclosure rules.
The company also confirmed that earlier announcements in July 2025 had noted dosing completion and absence of adverse safety signals, but the SRC’s formal review and conclusion were awaited before full disclosure. Nyrada emphasized that it complied fully with Listing Rule 3.1 and related provisions, and that its responses to ASX were authorized by its Chair, John Moore.
Implications for Investors and Market
This clarification provides investors with confidence that Nyrada is transparent and timely in its reporting of critical clinical trial data, a key factor in assessing the company’s prospects. The positive safety profile of Xolatryp supports its advancement in clinical development, potentially enhancing shareholder value. However, the company’s limited control over the SRC’s data interpretation introduces a layer of complexity in the timing of disclosures.
Looking Ahead
As Nyrada progresses to subsequent trial phases, the market will watch closely for further data releases and regulatory updates. The company’s handling of disclosure compliance sets a precedent for future communications, balancing transparency with regulatory obligations.
Bottom Line?
Nyrada’s clear compliance and positive safety data set the stage for critical next steps in Xolatryp’s clinical journey.
Questions in the middle?
- When will Nyrada announce results from Phase IIa trials for Xolatryp?
- How might the SRC’s independent role affect timing of future disclosures?
- What market reaction will follow as more clinical data emerges?
