Surmodics stock surges 10% on FDA feedback for drug-coated balloon filing [Seeking Alpha]
Surmodics, Inc. (SRDX)
Last surmodics, inc. earnings: 4/29 04:05 pm
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Source: Seeking Alpha
Surmodics stock surges 10% on FDA feedback for drug-coated balloon filingMar. 28, 2023 12:23 PM ETSurmodics, Inc. (SRDX)By:RavikashSA News EditorIryna DrozdSurmodics (NASDAQ:~10%In January, the FDA haddeclinedcutSurmodics had submitted a Submission Issue Request (SIR), under the FDA's Q-Submission program, to get a formal feedback from the agency.The FDA requested additional clarification related to completed biocompatibility studies and revisions to Surmodics' proposed labeling to amend the PMA application to put it into an approvable form."The feedback from the FDA provides the necessary clarity on the process and content required to successfully amend our PMA application. Importantly, we do not anticipate the need for additional biocompatibility studies, which will significantly reduce our initial assumptions of the time and cost to amend our PMA application,"saidThe company expects to file an amended PMA application in Q3 of its fiscal year 2023 and aims to get premarket approval
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News
- Surmodics (SRDX) Q2 Earnings Top Estimates, '24 View Up [Yahoo! Finance]Yahoo! Finance
- Surmodics, Inc. (NASDAQ: SRDX) had its "outperform" rating re-affirmed by analysts at Barrington Research. They now have a $71.00 price target on the stock.MarketBeat
- Surmodics, Inc. (NASDAQ: SRDX) had its price target lowered by analysts at Needham & Company LLC from $47.00 to $43.00. They now have a "buy" rating on the stock.MarketBeat
- SurModics (SRDX) Q2 Earnings: How Key Metrics Compare to Wall Street Estimates [Yahoo! Finance]Yahoo! Finance
- Surmodics Reports Second Quarter of Fiscal Year 2024 Financial Results; Updates Fiscal Year 2024 Financial Guidance [Yahoo! Finance]Yahoo! Finance
SRDX
Earnings
- 5/1/24 - Beat
SRDX
Sec Filings
- 5/1/24 - Form 10-Q
- 5/1/24 - Form 8-K
- 2/13/24 - Form SC
- SRDX's page on the SEC website