Stuttering Spero further weakened by CRL
Shares in Spero Therapeutics (Nasdaq: SPRO) were down by nearly 9% in pre-market trading on Tuesday.
The company had just announced that it has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for its New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment of adult patients with complicated urinary tract infection (cUTI), including pyelonephritis.
"We continue to believe that tebipenem HBr offers patients and their providers an important new treatment option"Spero had expected the CRL after the FDA earlier expressed concerns about potential deficiencies in its NDA, meaning the impact of the news on the company’s share price, which was already struggling at below $1, was not as great as it could have been.
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