Frequency Therapeutics shares plummet after FX-322 Phase 2b failure

Frequency Therapeutics (Nasdaq:FREQ) shares were down more than 80% on Monday afternoon after the company announced the failure of the Phase 2b study for FX-322, its lead candidate drug for hearing loss. As a result, the Lexington, Massachusetts-based biotech company will discontinue its hearing loss program and cut its workforce by 55%.

It says its cost savings measures will extend its runway into 2025.

In late 2022, Otonomy, another neurotology biopharma once listed on Nasdaq, said it had decided to dissolve its business and liquidate its assets.

FX-322 had no statistically significant difference over placebo

Frequency Therapeutics said the Phase 2b study showed that the drug FX-322 did not improve speech perception more than placebo. The company will also discontinue its second program for sudden or noise-induced sensorineural hearing loss, FX-345.

FX-322 did not meet its primary endpoint or any of the study’s secondary endpoints. The saf…

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Decibel Therapeutics announces study on noise-related inner ear damage

Decibel Therapeutics (NSDQ:DBTX) has a working hypothesis that molecular characterization of the cell biology of the inner ear could pave the way for treatments for hearing and balance disorders. 

The Boston-based biotech company has announced that a recent study published in Cell Reports supports that hypothesis. 

“We were thrilled to leverage our data and expertise in inner ear biology to help fuel this analysis, which may help enable identification of therapeutics that counter the observed trends in gene expression that occur following noise exposure,” said Joe Burns, vice president, discovery at Decibel Therapeutics, in a statement. 

The company partnered with the University of Maryland School of Medicine and the Karolinska Institute on the research.

Decibel Therapeutics had its IPO on February 12. Its shares have since fallen from $18.03 apiece to $7.71 today.

Lexington, Massachusetts–based Frequency Therapeutics has also seen its stoc…

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Frequency Therapeutics faces growing legal challenges

Hearing loss drug developer Frequency Therapeutics (NASDAQ: FREQ) is the subject of a growing number of security fraud accusations on behalf of investors.

Earlier this year, things were looking up for the company’s lead product candidate, FX-322. But on March 23, Frequency Therapeutics announced that interim results suggested that FX-322 was not effective at improving mild to moderately severe sensorineural hearing loss in a Phase 2a study compared to placebo. Previous results from a smaller study had been more positive.

The company’s stock fell from a high of $55.01 on Feb. 19 to $9.55 in mid-day trading on June 15.

Among the law firms filing lawsuits against Frequency Therapeutics is Robbins LLP (San Diego), which recently filed a class-action lawsuit for purchasers of Frequency Therapeutics stock between Nov. 16, 2020 and March 22. That lawsuit alleges that the company misrepresented its FX-322 experimental drug in earnings calls, press releases, SEC …

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