- Chinook Therapeutics Inc KDNY has voluntarily paused dosing in the Phase 1 trial of CHK-336 in healthy volunteers to allow a thorough investigation of a serious adverse event (SAE) that occurred in a single subject following the first dose in the 125 mg multiple ascending dose (MAD) group.
- The event has been reported to the FDA through a Suspected Unexpected Severe Adverse Reaction (SUSAR) report.
- The SAE had a rapid onset and rapid recovery; follow-up of the subject is ongoing.
- The underlying cause of the event is being investigated as a potential hypersensitivity reaction to the study drug or its excipients.
- Also Read: Analyst Views Multiple Opportunities For Chinook To Thrive In Emerging Renal Markets, Sees More Than 100% Upside.
- Previously, CHK-336 was generally well tolerated in 62 subjects at single doses up to 500 mg and multiple doses up to 60 mg daily for 14 days.
- William Blair says that while the prospects of CHK-336 for hyperoxaluria have been intriguing, the program has not been viewed as a value driver for Chinook.
- The analyst remains focused on key upcoming catalysts, such as the Phase 3 ALIGN trial with atrasentan, expected in Q4 2023.
- It maintains Outperform rating and says any pullback presents a buying opportunity for the shares.
- Price Action: KDNY shares are down 4.12% at $20.71 on the last check Tuesday.
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