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Axsome surges after oral depression drug gets FDA approval

(Reuters) - The U.S. Food and Drug Administration has approved Axsome Therapeutics (NASDAQ:AXSM) Inc's oral depression pill, the company said on Friday, sending its shares soaring...
Axsome surges after oral depression drug gets FDA approval © 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/File Photo

(Reuters) - The U.S. Food and Drug Administration has approved Axsome Therapeutics (NASDAQ:AXSM) Inc's oral depression pill, the company said on Friday, sending its shares soaring 38% in premarket trading.

The approval clears the way for the drugmaker to make its treatment available for more than 20 million Americans in a highly competitive market. Axsome said the treatment, Auvelity, will be commercially available in the fourth quarter.

The drug is designed to reduce symptoms of depression as early as one week and will compete with existing antidepressants, which take longer to show any effect.

Truist Securities analyst Joon Lee said the approval "represents a turning point for the company" and the drug could be a commercial success given its rapid mechanism of action.

New depression treatments have been rare, and the field of anti-depressants has been littered with trial failures. Johnson & Johnson (NYSE:JNJ)'s nasal spray Spravato was approved in 2019, making it the first new type of antidepressant in more than 30 years.

The long-awaited approval for Axsome's pill comes after the agency found deficiencies in the company's marketing application last year.

Axsome had since then been working with the FDA to resolve the agency's concerns.

Auvelity, which targets several neurotransmitters including serotonin, had succeeded in reducing symptoms of major depressive disorder (MDD) in a late-stage trial in 2019.

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01-05-2024 10:45:17 (UTC+7)

EUR/USD

1.0658

-0.0008 (-0.07%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (2)

Sell (3)

EUR/USD

1.0658

-0.0008 (-0.07%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (2)

Sell (3)

GBP/USD

1.2475

-0.0015 (-0.12%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (10)

USD/JPY

157.91

+0.12 (+0.07%)

Summary

↑ Buy

Moving Avg:

Buy (12)

Sell (0)

Indicators:

Buy (9)

Sell (0)

AUD/USD

0.6469

-0.0003 (-0.05%)

Summary

Neutral

Moving Avg:

Buy (10)

Sell (2)

Indicators:

Buy (2)

Sell (3)

USD/CAD

1.3780

+0.0003 (+0.03%)

Summary

↑ Buy

Moving Avg:

Buy (12)

Sell (0)

Indicators:

Buy (7)

Sell (0)

EUR/JPY

168.32

+0.10 (+0.06%)

Summary

↑ Buy

Moving Avg:

Buy (12)

Sell (0)

Indicators:

Buy (9)

Sell (0)

EUR/CHF

0.9808

+0.0001 (+0.01%)

Summary

Neutral

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (3)

Sell (2)

Gold Futures

2,295.80

-7.10 (-0.31%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (9)

Silver Futures

26.677

+0.023 (+0.09%)

Summary

↑ Sell

Moving Avg:

Buy (2)

Sell (10)

Indicators:

Buy (0)

Sell (9)

Copper Futures

4.5305

-0.0105 (-0.23%)

Summary

↑ Buy

Moving Avg:

Buy (10)

Sell (2)

Indicators:

Buy (8)

Sell (1)

Crude Oil WTI Futures

81.14

-0.79 (-0.96%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (1)

Sell (7)

Brent Oil Futures

85.62

-0.71 (-0.82%)

Summary

↑ Sell

Moving Avg:

Buy (1)

Sell (11)

Indicators:

Buy (1)

Sell (7)

Natural Gas Futures

1.946

-0.009 (-0.46%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (5)

US Coffee C Futures

213.73

-13.77 (-6.05%)

Summary

↑ Sell

Moving Avg:

Buy (3)

Sell (9)

Indicators:

Buy (0)

Sell (10)

Euro Stoxx 50

4,920.55

-60.54 (-1.22%)

Summary

↑ Sell

Moving Avg:

Buy (4)

Sell (8)

Indicators:

Buy (1)

Sell (7)

S&P 500

5,035.69

-80.48 (-1.57%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (7)

DAX

17,921.95

-196.37 (-1.08%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (1)

Sell (6)

FTSE 100

8,144.13

-2.90 (-0.04%)

Summary

Sell

Moving Avg:

Buy (5)

Sell (7)

Indicators:

Buy (2)

Sell (4)

Hang Seng

17,763.03

+16.12 (+0.09%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (1)

Sell (6)

US Small Cap 2000

1,973.05

-42.98 (-2.13%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (7)

IBEX 35

10,854.40

-246.40 (-2.22%)

Summary

Neutral

Moving Avg:

Buy (6)

Sell (6)

Indicators:

Buy (3)

Sell (3)

BASF SE NA O.N.

49.155

+0.100 (+0.20%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (1)

Sell (7)

Bayer AG NA

27.35

-0.24 (-0.87%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (8)

Allianz SE VNA O.N.

266.60

+0.30 (+0.11%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (3)

Sell (5)

Adidas AG

226.40

-5.90 (-2.54%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (2)

Sell (7)

Deutsche Lufthansa AG

6.714

-0.028 (-0.42%)

Summary

Neutral

Moving Avg:

Buy (3)

Sell (9)

Indicators:

Buy (9)

Sell (1)

Siemens AG Class N

175.90

-1.74 (-0.98%)

Summary

↑ Sell

Moving Avg:

Buy (0)

Sell (12)

Indicators:

Buy (0)

Sell (9)

Deutsche Bank AG

15.010

-0.094 (-0.62%)

Summary

Neutral

Moving Avg:

Buy (4)

Sell (8)

Indicators:

Buy (6)

Sell (2)

    EUR/USD 1.0658 ↑ Sell  
    GBP/USD 1.2475 ↑ Sell  
    USD/JPY 157.91 ↑ Buy  
    AUD/USD 0.6469 Neutral  
    USD/CAD 1.3780 ↑ Buy  
    EUR/JPY 168.32 ↑ Buy  
    EUR/CHF 0.9808 Neutral  
    Gold 2,295.80 ↑ Sell  
    Silver 26.677 ↑ Sell  
    Copper 4.5305 ↑ Buy  
    Crude Oil WTI 81.14 ↑ Sell  
    Brent Oil 85.62 ↑ Sell  
    Natural Gas 1.946 ↑ Sell  
    US Coffee C 213.73 ↑ Sell  
    Euro Stoxx 50 4,920.55 ↑ Sell  
    S&P 500 5,035.69 ↑ Sell  
    DAX 17,921.95 ↑ Sell  
    FTSE 100 8,144.13 Sell  
    Hang Seng 17,763.03 ↑ Sell  
    Small Cap 2000 1,973.05 ↑ Sell  
    IBEX 35 10,854.40 Neutral  
    BASF 49.155 ↑ Sell  
    Bayer 27.35 ↑ Sell  
    Allianz 266.60 ↑ Sell  
    Adidas 226.40 ↑ Sell  
    Lufthansa 6.714 Neutral  
    Siemens AG 175.90 ↑ Sell  
    Deutsche Bank AG 15.010 Neutral  
Mua/Bán 1 chỉ SJC
# So hôm qua # Chênh TG
SJC Eximbank8,300/ 8,500
(8,300/ 8,500) # 1,298
SJC 1L, 10L, 1KG8,300/ 8,520
(0/ 0) # 1,510
SJC 1c, 2c, 5c7,380/ 7,550
(0/ 0) # 540
SJC 0,5c7,380/ 7,560
(0/ 0) # 550
SJC 99,99%7,370/ 7,470
(0/ 0) # 460
SJC 99%7,196/ 7,396
(0/ 0) # 386
Cập nhật 01-05-2024 10:45:19
Xem lịch sử giá vàng SJC: nhấn đây!
ↀ Giá vàng thế giới
$2,285.72 -47.5 -2.04%
Live 24 hour Gold Chart
ʘ Giá bán lẻ xăng dầu
Sản phẩm Vùng 1 Vùng 2
RON 95-V25.44025.940
RON 95-III24.91025.400
E5 RON 92-II23.91024.380
DO 0.05S20.71021.120
DO 0,001S-V21.32021.740
Dầu hỏa 2-K20.68021.090
ↂ Giá dầu thô thế giới
WTI $80.83 +3.39 0.04%
Brent $85.50 +3.86 0.05%
$ Tỷ giá Vietcombank
Ngoại tệMua vàoBán ra
USD25.088,0025.458,00
EUR26.475,3627.949,19
GBP30.873,5232.211,36
JPY156,74166,02
KRW15,9219,31
Cập nhật lúc 10:45:15 01/05/2024
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