Spero Therapeutics, Inc. (SPRO)
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Performance Outlook
| Previous Close | 0.7872 |
| Open | 0.8000 |
| Bid | 0.8150 x 800 |
| Ask | 0.8199 x 1100 |
| Day's Range | 0.7776 - 0.8300 |
| 52 Week Range | 0.6800 - 19.8700 |
| Volume | |
| Avg. Volume | 350,266 |
| Market Cap | 26.257M |
| Beta (5Y Monthly) | 1.94 |
| PE Ratio (TTM) | N/A |
| EPS (TTM) | -3.2550 |
| Earnings Date | Aug 08, 2022 - Aug 15, 2022 |
| Forward Dividend & Yield | N/A (N/A) |
| Ex-Dividend Date | N/A |
| 1y Target Est | 10.50 |
Fair Value
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- Reuters
UPDATE 1-U.S. FDA declines to approve Spero's urinary tract infection drug
The U.S. Food and Drug Administration (FDA) declined to approve Spero Therapeutics Inc's oral antibiotic drug for the treatment of patients with complicated urinary tract infections, the company said on Monday. In the complete response letter, the health regulator concluded that Spero's late-stage study testing the drug was insufficient and an additional study would be required, the drugmaker said. Spero had sought approval for its most advanced drug candidate, tebipenem, to treat the infections, including a type of kidney inflammation called pyelonephritis in adult patients with limited oral treatment options.
- GlobeNewswire
Spero Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Tebipenem HBr New Drug Application
CAMBRIDGE, Mass., June 27, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced that it has received a Complete Response Letter (CRL) from the U.S. 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. The FDA had set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022. In th
