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IMGN

ImmunoGen

$3.15

0.055 (1.78%)

06:32
05/15/19
05/15
06:32
05/15/19
06:32

ImmunoGen: FDA recommends new Phase 3 trial of mirvetuximab soravtansine

ImunoGen announced the United States FDA has recommended that the company conduct a new Phase 3 randomized trial to evaluate the safety and efficacy of mirvetuximab soravtansine in patients with high folate receptor alpha-positive, platinum-resistant ovarian cancer as part of a Type C meeting held this week. ImmunoGen requested the meeting to discuss the results of the Phase 3 FORWARD I trial and a potential path to registration for mirvetuximab monotherapy. The agency advised that, because FORWARD I did not meet its primary endpoint under the pre-specified statistical analysis plan, the data generated assessing the secondary endpoints from the study could not be used to support an application for accelerated approval. FDA acknowledged that platinum-resistant ovarian cancer is a disease with unmet need, provided guidance regarding the design and endpoints of a potential registration study, and encouraged the company to return to discuss a proposed study design.

  • 31

    May

IMGN ImmunoGen
$3.15

0.055 (1.78%)

05/06/19
COWN
05/06/19
UPGRADE
COWN
Outperform
ImmunoGen upgraded to Outperform from Market Perform at Cowen
05/06/19
HCWC
05/06/19
UPGRADE
Target $7
HCWC
Buy
ImmunoGen upgraded to Buy from Neutral at H.C. Wainwright
H.C. Wainwright analyst Debjit Chattopadhyay upgraded ImmunoGen to Buy from Neutral and raise his price target for the shares to $7 from $3.50. The analyst sees 40% downside risk to the stock if the FDA does not consider mirvetuximab to be a clinically meaningful addition to the armametum against ovarian cancer versus a 145% upside potential, which assumes a second half of 2020 approval with a post-marketing commitment. A "potential green light for accelerated approval sets up a compelling risk reward scenario," Chattopadhyay tells investors in a research note.
05/06/19
COWN
05/06/19
UPGRADE
COWN
Outperform
ImmunoGen upgraded to Outperform from Market Perform at Cowen
Cowen analyst Boris Peaker upgraded ImmunoGen to Outperform from Market Perform, saying the company noted on its Q1 earnings conference call that all secondary endpoints continued to trend positively in FRa high patients from the FORWARD I trial. Peaker tells investors in a research note that he sees additional clarity in the second half of the year after the company meets with the FDA, and says he believes shares are undervalued. If approved, Peaker says he believes that ImmunoGen's drug could acheive peak sales of ~1.6B per year.
05/06/19
05/06/19
UPGRADE

Fly Intel: Top five analyst upgrades
Catch up on today's top five analyst upgrades with this list compiled by The Fly: 1. Sinclair Broadcast (SBGI) upgraded to Buy from Neutral at B. Riley FBR with analyst Barton Crockett saying yhe company's deal to acquire 21 regional sports networks from Disney (DIS) at valuation of $10.6B "looks like a home-run". 2. ImmunoGen (IMGN) upgraded to Buy from Neutral at H.C. Wainwright with analyst Debjit Chattopadhyay seeing 40% downside risk to the stock if the FDA does not consider mirvetuximab to be a clinically meaningful addition to the armametum against ovarian cancer versus a 145% upside potential. 3. Dish (DISH) upgraded to Neutral from Underperform at Credit Suisse with analyst Douglas Mitchelson saying he finds that risk/reward and potential catalysts across wireless and Pay TV are now in balance. 4. Post Holdings (POST) upgraded to Buy from Neutral at Goldman Sachs with analyst Jason English stating he views the recent pullback as a buying opportunity as he thinks transient headwinds were the reason results missed investor expectations in Q2. 5. Dentsply Sirona (XRAY) upgraded to Outperform from Market Perform at Barrington with analyst Michael Petusky saying the company's turnaround is "now on a firm, provable footing". This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

TODAY'S FREE FLY STORIES

LTXB

LegacyTexas Financial

$39.02

0.11 (0.28%)

18:36
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Downgrade
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UNP

Union Pacific

$165.49

0.885 (0.54%)

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MYOS

MYOS

$1.40

0.11 (8.53%)

18:12
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MYOS says fortetropin shows increase rate of muscle protein synthesis in study »

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GM

General Motors

$36.71

0.58 (1.61%)

18:06
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Periodicals
Breaking Periodicals news story on General Motors »

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BXC

BlueLinx

$22.03

0.305 (1.40%)

18:00
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BlueLinx sells two distribution facilities for $12M »

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EADSY

Airbus

$0.00

(0.00%)

, BA

Boeing

$374.21

19.31 (5.44%)

17:59
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17:59
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17:59
Periodicals
U.S. expected to be open to ending aircraft subsidy dispute, Reuters says »

The U.S. is expected to…

EADSY

Airbus

$0.00

(0.00%)

BA

Boeing

$374.21

19.31 (5.44%)

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  • 09

    Jul

FB

Facebook

$188.46

-0.43 (-0.23%)

17:56
06/18/19
06/18
17:56
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17:56
Periodicals
House Banking chair Waters calls on Facebook to halt Libra, Reuters says »

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  • 10

    Jul

OII

Oceaneering

$18.34

0.7 (3.97%)

, APC

Anadarko

$69.95

0.16 (0.23%)

17:36
06/18/19
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17:36
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17:36
Hot Stocks
Oceaneering awarded supply contract for Mozambique LNG Project »

Oceaneering (OII)…

OII

Oceaneering

$18.34

0.7 (3.97%)

APC

Anadarko

$69.95

0.16 (0.23%)

03/08/13
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  • 18

    Jun

GVA

Granite Construction

$44.64

1.335 (3.08%)

17:35
06/18/19
06/18
17:35
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17:35
Hot Stocks
Granite Construction JV awarded $275M highway construction project in Sacremento »

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APC

Anadarko

$69.95

0.16 (0.23%)

, FTI

TechnipFMC

$23.76

0.7 (3.04%)

17:33
06/18/19
06/18
17:33
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17:33
Hot Stocks
TechnipFMC awarded subsea contracts by subsidiary of Anadarko Petroleum »

TechnipFMC (FTI) has been…

APC

Anadarko

$69.95

0.16 (0.23%)

FTI

TechnipFMC

$23.76

0.7 (3.04%)

03/08/13
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  • 18

    Jun

  • 25

    Jul

MDT

Medtronic

$97.96

0.65 (0.67%)

17:33
06/18/19
06/18
17:33
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Hot Stocks
Medtronic exec Surface sells 9,000 ordinary shares »

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  • 19

    Jun

EAF

GrafTech

$10.95

0.14 (1.30%)

17:20
06/18/19
06/18
17:20
06/18/19
17:20
Syndicate
Breaking Syndicate news story on GrafTech »

GrafTech files automatic…

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APC

Anadarko

$69.95

0.16 (0.23%)

17:12
06/18/19
06/18
17:12
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17:12
Hot Stocks
Anadarko Area 1 Plan of Development now effective »

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IMASY

Inmarsat

$0.00

(0.00%)

17:11
06/18/19
06/18
17:11
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17:11
Hot Stocks
Inmarsat awarded $246M Defense Information Systems Agency BPA »

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DLX

Deluxe

$41.32

-0.505 (-1.21%)

17:03
06/18/19
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Hot Stocks
Deluxe appoints Chief Strategy Officer, Chief Human Resources Officer »

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PFIE

Profire Energy

$1.40

0.03 (2.19%)

17:02
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Hot Stocks
Profire Energy subsidiary to acquire assets of Millstream Energy Products »

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HPE

HP Enterprise

$14.59

0.29 (2.03%)

, GOOG

Alphabet

$1,104.40

12.15 (1.11%)

17:02
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HP Enterprise, Google Cloud expand strategic partnership »

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HPE

HP Enterprise

$14.59

0.29 (2.03%)

GOOG

Alphabet

$1,104.40

12.15 (1.11%)

GOOGL

Alphabet Class A

$1,105.22

12.51 (1.14%)

03/08/13
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  • 19

    Jun

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  • 25

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    Jun

  • 09

    Jul

  • 09

    Jul

  • 10

    Jul

  • 27

    Oct

HPE

HP Enterprise

$14.59

0.29 (2.03%)

17:01
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Hot Stocks
HP Enterprise to transition into an as a Service company by 2022 »

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  • 25

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MTSI

Macom

$14.40

-0.02 (-0.14%)

16:55
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Hot Stocks
Breaking Hot Stocks news story on Macom »

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MTSI

Macom

$14.40

-0.02 (-0.14%)

16:53
06/18/19
06/18
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16:53
Hot Stocks
Macom to lay off 20% of staff or 250 workers, expects $50M in savings »

MACOM announced it has…

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SRRK

Scholar Rock

$19.95

1.265 (6.77%)

16:52
06/18/19
06/18
16:52
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16:52
Syndicate
Scholar Rock files to sell 3M shares of common stock »

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MTSI

Macom

$14.40

-0.02 (-0.14%)

16:50
06/18/19
06/18
16:50
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16:50
Earnings
Macom cuts Q3 EPS view to (45c) to (41c) from (8c) to (4c), consensus (6c) »

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MTSI

Macom

$14.40

-0.02 (-0.14%)

16:48
06/18/19
06/18
16:48
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16:48
Earnings
Breaking Earnings news story on Macom »

Macom cuts Q3 EPS,…

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FTFT

Future FinTech

$1.18

0.04 (3.51%)

16:48
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Hot Stocks
Future FinTech submits compliance plan to Nasdaq »

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PKOH

Park-Ohio

$32.11

-0.08 (-0.25%)

16:45
06/18/19
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ParkOhio's Edward Crawford resigns as officer, board member »

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