TVTX - Chinook falls after adverse event in early-stage trial

2023-04-11 08:32:18 ET

• Chinook Therapeutics ( NASDAQ: KDNY ) lost ~8% pre-market Tuesday after the biotech announced that dosing in its Phase 1 study for oral therapy CHK-336 was on hold following a serious adverse event (SAE) in a single trial subject.
• An LDHA inhibitor targeted at rare renal disease hyperoxaluria, CHK-336, was undergoing a Phase 1 trial in healthy volunteers.
• The company said it voluntarily paused dosing in the study after a trial participant in the 125 mg multiple ascending dose (MAD) group, developed an SAE following the first dose. The event is currently under investigation as a potential hypersensitivity reaction to CHK-336 or its components.
• Chinook ( KDNY ) notified the FDA of the incident through a Suspected Unexpected Severe Adverse Reaction (SUSAR) report. The company intends to evaluate the next steps following a review of full safety data from the study by the trial’s Safety Monitoring Committee .
• Read: Seeking Alpha contributor, BiotechValley Insights issued a Buy rating on Chinook in February after Travere Therapeutics ( TVTX ) won FDA approval for rival IgAN therapy Filspari, which has a similar mechanism of action to its lead asset atrasentan.

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