FREQ - Frequency Therapeutics (FREQ) shares plunge 73% after FX-322's four-dose regime fails to improve hearing loss

Frequency Therapeutics (FREQ) slumps 73% premarket after announcing topline, day-90 data from its FX-322 Phase 2a study (FX-322-202).The interim results show that four weekly injections in subjects with mild to moderately severe sensorineural hearing loss ((SNHL)) did not demonstrate improvements in hearing measures versus placebo.There was no discernible hearing benefit of FX-322 over placebo.The Phase 2a interim results also showed an unexpected hearing benefit in the placebo group that did not occur in previous trials and exceeded published standards.No treatment-related serious adverse events were observed.Frequency also announced new data from single-dose study of FX-322 (FX-322-111), demonstrating hearing improvement from a single injection of FX-322. The company plans to advance further development as a single dose regimen. At day 90 following dosing, 34% of subjects achieved a 10% or greater absolute improvement in word recognition scores in treated ear, which was clinically meaningful and statistically significant compared to the untreated ear (p <0.05).The single

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Frequency Therapeutics (FREQ) shares plunge 73% after FX-322's four-dose regime fails to improve hearing loss