FDA declines to approve pre-filled syringe version of Regeneron's Eylea [Reuters (UK)]
Regeneron Pharmaceuticals, Inc. (REGN)
Last regeneron pharmaceuticals, inc. earnings: 2/6 06:30 am
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Source: Reuters
FDA declines to approve pre-filled syringe version of Regeneron's Eylea | Reuters 2 Min Read (Reuters) - Regeneron Pharmaceuticals Inc said on Thursday the U.S. Food and Drug Administration declined to approve a pre-filled syringe version of its blockbuster eye drug Eylea, and has sought additional information regarding its manufacturing and supply processes. The drugmaker said the rejection does not affect its earlier expectation of launching the product in 2019. It plans to resubmit its application early next year. Regeneron told Reuters the regulator has also asked for the completion of a small study, involving about 30 patients, to demonstrate doctors are able to administer the product. Eylea has made Regeneron a dominant player in the eye-disease space and brought in sales of $3.70 billion in the United States last year. But with Swiss drugmaker Roche AG’s prefilled syringe rival treatment threatening market share, Regeneron has thrown marketing heft behind Eylea and pushed for i
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News
- Kirby McInerney LLP Announces Investigation of Shareholder Claims Against Regeneron Pharmaceuticals, Inc. (REGN)GlobeNewswire
- Regeneron Pharmaceuticals, Inc. (REGN) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Seek Compensation for Alleged WrongdoingsAccesswire
- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) had its price target raised by analysts at UBS Group AG from $1,090.00 to $1,099.00. They now have a "buy" rating on the stock.MarketBeat
- IMPORTANT INVESTOR ALERT: The Schall Law Firm Announces it is Investigating Claims Against Regeneron Pharmaceuticals, Inc. and Encourages Investors with Losses to Contact the FirmAccesswire
- REGENERON ALERT: Bragar Eagel & Squire, P.C. is Investigating Regeneron Pharmaceuticals, Inc. on Behalf of Regeneron Stockholders and Encourages Investors to Contact the FirmGlobeNewswire
REGN
Earnings
- 2/2/24 - Beat
REGN
Sec Filings
- 4/3/24 - Form 4
- 4/3/24 - Form 4
- 4/1/24 - Form 144
- REGN's page on the SEC website