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AMPH

Amphastar

$16.27

0.17 (1.06%)

, AVDL

Avadel Pharmaceuticals

$9.45

-0.16 (-1.66%)

18:59
09/25/17
09/25
18:59
09/25/17
18:59

Amphastar announces FDA approval of Neostigmine Methylsulfate Injection, USP

Amphastar (AMPH) announced that the U.S. FDA granted approval of its abbreviated new drug application for Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10mL vial. Amphastar's newly approved product was determined by the FDA to be therapeutically equivalent to Bloxiverz sold in the United States by Avadel (AVDL), with the same active ingredients, route of administration, strength and dosage form. According to IMS Health data, U.S. brand and generic sales of Neostigmine Methylsulfate Injection, USP, 1mg/mL, 10mL, and 0.5mg/mL, 10 mL were approximately $185M for the 12 months ended June 30, 2017. Amphastar anticipates launching its product in the fourth quarter of 2017.

AMPH

Amphastar

$16.27

0.17 (1.06%)

AVDL

Avadel Pharmaceuticals

$9.45

-0.16 (-1.66%)

  • 25

    Sep

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    Sep

  • 04

    Oct

  • 05

    Oct

AMPH Amphastar
$16.27

0.17 (1.06%)

02/21/17
WELS
02/21/17
NO CHANGE
WELS
Outperform
Wells calls Amphastar CRL for naloxone spray 'disappointing and surprising'
Wells Fargo analyst David Maris said the fact that the FDA issued a Complete Response Letter, or CRL, to Amphastar on its nasal naloxone product was both "disappointing and surprising" given that the company currently markets the leading injectable generic naloxone. However, the stock's decline in pre-market trading "seems to more than reflect the nasal naloxone opportunity," added Maris, who keeps an Outperform rating on Amphastar shares, which are down 15% in early trading after the opening bell to $15.62.
03/14/17
RAJA
03/14/17
DOWNGRADE
Target $18
RAJA
Outperform
Amphastar downgraded to Outperform from Strong Buy at Raymond James
Raymond James analyst Elliot Wilbur downgraded Amphastar Pharmaceuticals to Outperform and lowered his price target for the shares to $18 from $21. The analyst sees an increased near-term risk profile following indications from FDA that Amphastar may have to withdraw its epinephrine product.
03/14/17
03/14/17
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Corning (GLW) downgraded to Neutral from Buy at Goldman with analyst Doug Clark citing valuation with the stock up 33% since his upgrade back in April of 2016. The analyst keeps a $29 price target for the shares. 2. Amphastar (AMPH) downgraded to Outperform from Strong Buy at Raymond James with analyst Elliot Wilbur saying he sees an increased near-term risk profile following indications from FDA that Amphastar may have to withdraw its epinephrine product. 3. Abbott (ABT) downgraded to Market Perform from Outperform at BMO Capital. 4. GGP (GGP) downgraded to Neutral from Buy at UBS with analyst Jeremy Metz saying he does not see headwinds in the sector easing in the short term and cut his price target for GGP shares to $25 from $28. 5. Harmonic (HLIT) downgraded to Hold from Buy at Drexel Hamilton. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
07/21/17
WELS
07/21/17
NO CHANGE
WELS
Outperform
Amphastar 'David-vs-Goliath' win over Momenta a major victory, says Wells Fargo
Wells Fargo analyst David Maris said a jury's ruling that a Momenta (MNTA) patent was invalid and unenforceable is a very positive outcome for Amphastar (AMPH) in its "David-vs-Goliath-type" case. While he expects Momenta and partner Novartis' (NVS) Sandoz to appeal, Maris thinks this ruling puts Amphastar in a good position for any future potential settlement talks. Maris does not think investors should "count on any windfall" for Amphastar, but he does think, if approved, this could be an over $50M opportunity and keeps an Outperform rating on the stock, which is up 2% to $18.32 in afternoon trading.
AVDL Avadel Pharmaceuticals
$9.45

-0.16 (-1.66%)

01/31/17
JEFF
01/31/17
NO CHANGE
Target $24
JEFF
Buy
Jefferies says new approvals now even more critical for Akorn
After Endo (ENDP) received approval for Corphedra, the second FDA approved formulation of ephedrine after Avadel Pharmaceuticals' (AVDL), Jefferies analyst David Steinberg says new product approvals are now even more critical to Akorn's (AKRX) 2017 outlook and share price. Both Endo and Avadel will compete with Akorn's largest product, Steinberg tells investors in a research note. His model assumes Akorn's ephedrine sales will decline to $80M in FY17 from $230M in FY16. The analyst keeps a Buy rating on Akorn, however, saying the shares look "very inexpensive" on "multiple valuation metrics."
02/24/17
RHCO
02/24/17
NO CHANGE
RHCO
Avadel Pharmaceuticals price target lowered to $13 from $17 at SunTrust
SunTrust analyst John Boris reduced his price target on Avadel (AVDL) after Endo (ENDP) launched an injectable drug that will compete, at a similar price point, with Avadel's Akovaz. The analyst adds that Avadel's Bloxiverz is also being challenged by Merck's (MRK) Bridion which is taking share in the neostigmine market. He lowered his estimates for Avadel below consensus levels but keeps a Buy rating on the name.
09/07/17
LTCO
09/07/17
NO CHANGE
Target $30
LTCO
Buy
Avadel Pharmaceuticals price target raised to $30 from $27 at Ladenburg
09/08/17
ROTH
09/08/17
NO CHANGE
Target $13.25
ROTH
Buy
Roth Capital 'cautiously optimistic' on Avadel's deal for Noctiva
Roth Capital analyst Scott Henry said he is "cautiously optimistic" on Avadel's (AVDL) deal to acquire U.S./Canadian rights for Noctiva, though he notes concerns, such as this drug needing an expensive, market-creating type of promotion and the fact that Allergan (AGN) walked away from a prior deal for Noctiva after its approval. He lowered his price target on Avadel to $13.25 from $15 to reflect lower cash post this acquisition, but keeps a Buy rating, citing his positive view on the sodium oxybate program.

TODAY'S FREE FLY STORIES

NCI

Navigant Consulting

$21.68

2.94 (15.69%)

13:40
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13:40
Downgrade
Navigant Consulting rating change  »

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TWTR

Twitter

$33.74

0.9 (2.74%)

13:38
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Hot Stocks
Twitter: TweetDeck to no longer allow concurrent actions from multiple accounts »

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MO

Altria Group

$64.06

-0.13 (-0.20%)

13:37
02/21/18
02/21
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13:37
Hot Stocks
Altria Group plans to reinvest one-third of tax reform benefit in 2018 »

CFO Billy Gifford says…

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  • 21

    Feb

SO

Southern Company

$43.25

-0.225 (-0.52%)

13:35
02/21/18
02/21
13:35
02/21/18
13:35
Hot Stocks
Breaking Hot Stocks news story on Southern Company »

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  • 21

    Feb

QCOM

Qualcomm

$63.99

-0.86 (-1.33%)

, AVGO

Broadcom

$249.62

0.73 (0.29%)

13:35
02/21/18
02/21
13:35
02/21/18
13:35
Recommendations
Qualcomm, Broadcom analyst commentary  »

Stifel sees Broadcom…

QCOM

Qualcomm

$63.99

-0.86 (-1.33%)

AVGO

Broadcom

$249.62

0.73 (0.29%)

03/08/13
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03/08/13
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03/06/13
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03/06/13
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  • 26

    Feb

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MO

Altria Group

$64.11

-0.08 (-0.12%)

13:25
02/21/18
02/21
13:25
02/21/18
13:25
Hot Stocks
Altria Group says focused on stabilizing Marlboro share »

COO Howard Willard says…

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  • 21

    Feb

BA

Boeing

$358.54

5.19 (1.47%)

13:25
02/21/18
02/21
13:25
02/21/18
13:25
Hot Stocks
Breaking Hot Stocks news story on Boeing »

Boeing says additive and…

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UNIT

Uniti Group

$15.44

-0.69 (-4.28%)

13:25
02/21/18
02/21
13:25
02/21/18
13:25
Options
Uniti Group call volume above normal and directionally bullish »

Bullish option flow…

03/08/13
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03/06/13
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03/06/13
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  • 01

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TROW

T. Rowe Price

$109.91

-0.58 (-0.52%)

13:25
02/21/18
02/21
13:25
02/21/18
13:25
Conference/Events
T. Rowe Price to host investor day »

Investor Day to be held…

03/08/13
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BA

Boeing

$358.70

5.3515 (1.51%)

13:22
02/21/18
02/21
13:22
02/21/18
13:22
Hot Stocks
Boeing says737 MAX production line ramping up to 47 per month »

The company will get up…

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SO

Southern Company

$43.39

-0.08 (-0.18%)

13:22
02/21/18
02/21
13:22
02/21/18
13:22
Hot Stocks
Breaking Hot Stocks news story on Southern Company »

Southern Company sees 8c…

03/08/13
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03/08/13
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03/06/13
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  • 21

    Feb

SO

Southern Company

$43.43

-0.04 (-0.09%)

13:21
02/21/18
02/21
13:21
02/21/18
13:21
Hot Stocks
Breaking Hot Stocks news story on Southern Company »

Southern Company says…

03/08/13
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  • 21

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13:20
02/21/18
02/21
13:20
02/21/18
13:20
General news
Treasury Action: yields remained relatively inert »

Treasury Action: yields…

WMT

Walmart

$92.00

-2.11 (-2.24%)

13:17
02/21/18
02/21
13:17
02/21/18
13:17
Technical Analysis
Technical Take: Walmart moves up off lows of the day »

The shares are down over…

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$NSD

NASDAQ Market Internals

13:17
02/21/18
02/21
13:17
02/21/18
13:17
Technical Analysis
NASDAQ market internals summary »

Volume is average for…

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BHGE

Baker Hughes

$27.68

1.24 (4.69%)

, GE

General Electric

$14.53

-0.21 (-1.42%)

13:16
02/21/18
02/21
13:16
02/21/18
13:16
Hot Stocks
Baker Hughes rises after GE CFO signals plans to stand pat until lockup expires »

Shares of Baker Hughes…

BHGE

Baker Hughes

$27.68

1.24 (4.69%)

GE

General Electric

$14.53

-0.21 (-1.42%)

03/08/13
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$NYE

NYSE Market Internals

13:16
02/21/18
02/21
13:16
02/21/18
13:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

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13:15
02/21/18
02/21
13:15
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13:15
General news
Treasury's upsized $35 B 5-year auction was ok, as expected »

Treasury's upsized…

SO

Southern Company

$43.29

-0.18 (-0.41%)

13:14
02/21/18
02/21
13:14
02/21/18
13:14
Hot Stocks
Southern Company sees productivity improvement at Vogtle »

Says will look to reduce…

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  • 21

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MO

Altria Group

$64.04

-0.15 (-0.23%)

13:11
02/21/18
02/21
13:11
02/21/18
13:11
Hot Stocks
Altria Group aspires to be U.S. leader in non-combustible, reduced-risk products »

CEO Marty Barrington says…

03/08/13
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  • 21

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13:07
02/21/18
02/21
13:07
02/21/18
13:07
General news
5-Yr Note Auction Coupon Rate data reported »

5-Yr Note Auction Coupon…

13:06
02/21/18
02/21
13:06
02/21/18
13:06
General news
5-Yr Note Auction Total Amount data reported »

5-Yr Note Auction Total…

CBRL

Cracker Barrel

$161.88

-11.86 (-6.83%)

13:04
02/21/18
02/21
13:04
02/21/18
13:04
Periodicals
Telsey tells Bloomberg Cracker Barrel canceled from consumer conference »

Telsey Advisory…

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  • 06

    Jun

ILG

ILG

$32.19

-0.01 (-0.03%)

13:00
02/21/18
02/21
13:00
02/21/18
13:00
Options
Bullish option play in ILG ahead of earnings »

Bullish option play in…

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  • 13

    Mar

SO

Southern Company

$43.27

-0.2 (-0.46%)

12:57
02/21/18
02/21
12:57
02/21/18
12:57
Earnings
Breaking Earnings news story on Southern Company »

Southern Company sees Q1…

03/08/13
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  • 21

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