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U.S. FDA declines to approve Revance's frown-line treatment

(Reuters) - Revance Therapeutics (NASDAQ:RVNC) Inc said on Friday the U.S. Food and Drug Administration had declined to approve its long-acting injectable drug to treat moderate...
U.S. FDA declines to approve Revance's frown-line treatment © Reuters. FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo

(Reuters) - Revance Therapeutics (NASDAQ:RVNC) Inc said on Friday the U.S. Food and Drug Administration had declined to approve its long-acting injectable drug to treat moderate to severe frown lines, sending its shares plunging 29%.

The company said the FDA pointed to "deficiencies" related to the regulator's inspection of Revance's manufacturing site.

No other concerns were raised in the agency's "complete response letter", the drug developer said.

Revance's DaxibotulinumtoxinA for Injection, a potential rival for AbbVie Inc (NYSE:ABBV)'s Botox anti-wrinkle injection, was successful in reducing moderate to severe frown lines in a late-stage study in December 2018.

In November last year, the U.S. FDA delayed its decision on the drug, as it was unable to conduct required inspection of the company's manufacturing facility due to COVID-19 travel restrictions. Revance later said it was expecting approval in 2021.

"We are very disappointed by this unanticipated response from the FDA and are seeking further clarity from the agency," Mark Foley, the chief executive officer of Revance, said in a statement on Friday.

Revance said it plans to request a meeting with the FDA as soon as possible to address the agency's concerns.

The company's shares, which closed at $22.71 on Friday, were at $16.20 in extended trade.

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29-03-2024 14:39:02 (UTC+7)

EUR/USD

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EUR/USD

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5,082.85

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Adidas AG

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 EUR/USD1.0777↑ Buy
 GBP/USD1.2623↑ Buy
 USD/JPY151.37Neutral
 AUD/USD0.6509↑ Sell
 USD/CAD1.3549Sell
 EUR/JPY163.12Neutral
 EUR/CHF0.9716↑ Sell
 Gold2,254.80Buy
 Silver25.100↑ Buy
 Copper4.0115↑ Buy
 Crude Oil WTI83.11↑ Buy
 Brent Oil86.99Neutral
 Natural Gas1.752↑ Sell
 US Coffee C188.53↑ Sell
 Euro Stoxx 505,082.85↑ Sell
 S&P 5005,254.35↑ Sell
 DAX18,504.51↑ Buy
 FTSE 1007,952.62↑ Sell
 Hang Seng16,541.42Neutral
 Small Cap 20002,120.15Neutral
 IBEX 3511,074.60↑ Sell
 BASF52.930↑ Buy
 Bayer28.43Buy
 Allianz277.80↑ Buy
 Adidas207.00↑ Buy
 Lufthansa7.281↑ Sell
 Siemens AG176.96↑ Buy
 Deutsche Bank AG14.582↑ Buy
Mua/Bán 1 chỉ SJC
# So hôm qua # Chênh TG
SJC Eximbank7,910/ 8,080
(30/ 30) # 1,361
SJC HCM7,900/ 8,100
(0/ 0) # 1,381
SJC Hanoi7,900/ 8,102
(0/ 0) # 1,383
SJC Danang7,900/ 8,102
(0/ 0) # 1,383
SJC Nhatrang7,900/ 8,102
(0/ 0) # 1,383
SJC Cantho7,900/ 8,102
(0/ 0) # 1,383
Cập nhật 29-03-2024 14:39:04
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Cập nhật lúc 14:32:13 29/03/2024
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