Breaking News Instant updates and real-time market news.

AVEO

Aveo Pharmaceuticals

$0.89

-0.0119 (-1.31%)

07:13
11/04/19
11/04
07:13
11/04/19
07:13

Aveo Pharmaceuticals provides update after FDA meeting discussing TIVO-3 results

Aveo Pharmaceuticals provided a regulatory update following a meeting with the FDA to discuss results from the August overall survival, or OS, analysis of the TIVO-3 trial and the company's proposal to proceed with a new drug application, or NDA, for tivozanib. TIVO-3 is the company's Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the company's vascular endothelial growth factor receptor tyrosine kinase inhibitor, or VEGFR-TKI, to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma, or RCC. The TIVO-3 trial was designed to address the FDA's concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the company's initial RCC pivotal trial, the FDA found that the inconsistent progression free survival, or PFS, and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval. The company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate. The August analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio, or HR, of 0.99 at two years from the last patient enrolled in the study. In the FDA's preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the company not submit an NDA at this time. The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the company's current interim OS results do not abrogate the FDA's concerns over detriment and that those results may worsen with final analysis at 263 events and that the median OS for tivozanib is worse than that of sorafenib. In view of the changing first-line treatment landscape as well as the FDA's continued concerns, the company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC. At the meeting, the FDA acknowledged AVEO's responses and reiterated its concerns about the survival information and the totality of data. The FDA noted that the choice to submit the data is the company's, and that a discussion with the Oncologic Drug Advisory Committee will likely be required. The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan, or SAP, with a planned OS update based on the projected number of events at that time. AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in Q1 of 2020. AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA. The FDA and the company agreed that if the final analysis yields an OS HR above 1.00, the company will withdraw its NDA application.

AVEO Aveo Pharmaceuticals
$0.89

-0.0119 (-1.31%)

03/28/19
NATL
03/28/19
INITIATION
NATL
Sell
Aveo Pharma initiated with a Sell, $0 price target at National Securities
National Securities initiated Aveo Pharmaceuticals with a Sell and $0 price target saying recent share appreciation is "totally unwarranted." The firm's analyst expects interim and final Phase 3 overall survival data updates to fail to support a Tivozanib NDA filing.
04/04/19
PIPR
04/04/19
NO CHANGE
Target $3
PIPR
Overweight
Piper maintains Overweight rating, $3 target on Aveo after stock sale
Piper Jaffray analyst Edward Tenthoff maintains his Overweight rating and $3 price target on Aveo Pharmaceuticals after the company "opportunistically" raised $25M by issuing 21.7M shares at $1.15 per share and 21.7M in warrants with a $1.25 strike price. The analyst, who estimates that Aveo now holds pro forma cash of about $57M, said the primary driver for the stock remains the OS analysis for TIVO-3 that is scheduled to be reported in Q4. If the hazard ratio does not drop to less than 1.0 for tivozanib, Tenthoff does not believe the FDA will accept a new NDA filing, he noted.
09/10/19
PIPR
09/10/19
NO CHANGE
Target $4
PIPR
Overweight
Aveo Pharmaceuticals price target raised to $4 from $3 at Piper Jaffray
Piper Jaffray analyst Edward Tenthoff raised his price target for Aveo Pharmaceuticals to $4 from $3 after the company announced that tivozanib's overall survival hazard ratio was 0.99 as of a planned analysis on August 15. The analyst continues to anticipate launch in the 3rd and 4th-line renal cell carcinoma setting in 2021. The analyst reduced his tivozanib discount rate and keeps an Overweight rating on shares of Aveo Pharmaceuticals.
09/11/19
HCWC
09/11/19
UPGRADE
Target $1.75
HCWC
Buy
Aveo Pharmaceuticals upgraded to Buy from Neutral at H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth upgraded Aveo Pharmaceuticals to Buy from Neutral and raised his price target for the shares to $1.75 from $1.00. The company yesterday provided an update from the ongoing Phase 3 Tivo-3 study of tivozanib for the treatment of advanced renal cell carcinoma that showed an improved overall survival hazard ratio of 0.99 compared to 1.12 reported back in February, Ramakanth tells investors in a research note. The analyst is encouraged and believes tivozanib could back on track for U.S. regulatory approval in 2021.

TODAY'S FREE FLY STORIES

UDR

UDR, Inc.

$47.78

-0.11 (-0.23%)

13:56
12/10/19
12/10
13:56
12/10/19
13:56
Conference/Events
UDR, Inc. management to meet with JPMorgan »

Meeting to be held in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 12

    Dec

XOM

Exxon Mobil

$68.73

-0.93 (-1.34%)

13:54
12/10/19
12/10
13:54
12/10/19
13:54
Hot Stocks
Exxon: Ruling affirms position company has held throughout 'baseless' probe »

ExxonMobil issued the…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 12

    Dec

ADPT

Adaptive Biotechnologies

$29.09

-0.21 (-0.72%)

13:54
12/10/19
12/10
13:54
12/10/19
13:54
Conference/Events
Adaptive Biotechnologies management to meet with JPMorgan »

Meeting to be held in New…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

LVGO

Livongo Health

$25.83

-1.57 (-5.73%)

13:52
12/10/19
12/10
13:52
12/10/19
13:52
Recommendations
Livongo Health analyst commentary  »

Livongo Health valuation…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 12

    Dec

WDFC

WD-40

$194.62

-1.12 (-0.57%)

13:51
12/10/19
12/10
13:51
12/10/19
13:51
Hot Stocks
WD-40 increases quarterly dividend nearly 10% »

WD-40 Company announced…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 10

    Dec

13:50
12/10/19
12/10
13:50
12/10/19
13:50
General news
Treasury Action: the Treasury market is unmoved »

Treasury Action: the…

13:49
12/10/19
12/10
13:49
12/10/19
13:49
Conference/Events
JPMorgan consumer finance analyst to hold analyst/industry conference call »

Specialty & Consumer…

EVH

Evolent Health

$8.27

0.375 (4.75%)

13:49
12/10/19
12/10
13:49
12/10/19
13:49
Hot Stocks
Evolent Health jumps $1.55, or 20%, to $9.42 »

Contacts tell The Fly…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

13:45
12/10/19
12/10
13:45
12/10/19
13:45
Conference/Events
JPMorgan semiconductors anayst to hold an analyst/industry conference call »

Semiconductors,…

NFLX

Netflix

$297.38

-5.1 (-1.69%)

13:45
12/10/19
12/10
13:45
12/10/19
13:45
Hot Stocks
Netflix says 'really proud' of animation work, cadence of films picking up »

Speaking at the UBS…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 10

    Dec

  • 10

    Dec

13:41
12/10/19
12/10
13:41
12/10/19
13:41
Conference/Events
JPMorgan restaurants analyst to hold an analyst/industry conference call »

Restaurants Analyst…

VALE

Vale

$12.35

-0.035 (-0.28%)

13:33
12/10/19
12/10
13:33
12/10/19
13:33
Conference/Events
Morgan Stanley materials analyst holds an analyst/industry conference call »

Head of Australia…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CTL

CenturyLink

$14.24

0.075 (0.53%)

13:33
12/10/19
12/10
13:33
12/10/19
13:33
Hot Stocks
CenturyLink pays Washington $6.1M to settle hidden fees lawsuit »

Washington Attorney…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 10

    Dec

CI

Cigna

$190.30

-5.59 (-2.85%)

, MET

MetLife

$49.25

-0.315 (-0.64%)

13:31
12/10/19
12/10
13:31
12/10/19
13:31
Periodicals
New York Life in talks to buy nonmedical insurance unit from Cigna, WSJ reports »

New York Life Insurance…

CI

Cigna

$190.30

-5.59 (-2.85%)

MET

MetLife

$49.25

-0.315 (-0.64%)

SLF

Sun Life Financial

$44.95

0.465 (1.05%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 12

    Dec

  • 06

    Feb

  • 13

    Feb

UPWK

Upwork

$10.60

-0.55 (-4.93%)

13:25
12/10/19
12/10
13:25
12/10/19
13:25
Options
Upwork call volume above normal and directionally bullish »

Bullish option flow…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 10

    Dec

VIAC

ViacomCBS

$38.13

-0.52 (-1.35%)

, VIACA

ViacomCBS

$41.51

-0.27 (-0.65%)

13:23
12/10/19
12/10
13:23
12/10/19
13:23
Periodicals
ViacomCBS, Paramount resume talks to buy Miramax stake, Variety reports »

ViacomCBS and Paramount…

VIAC

ViacomCBS

$38.13

-0.52 (-1.35%)

VIACA

ViacomCBS

$41.51

-0.27 (-0.65%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

$NSD

NASDAQ Market Internals

$0.00

(0.00%)

13:17
12/10/19
12/10
13:17
12/10/19
13:17
Technical Analysis
NASDAQ market internals summary »

Volume is average for…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

$NYE

NYSE Market Internals

$0.00

(0.00%)

13:16
12/10/19
12/10
13:16
12/10/19
13:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

DBI

Designer Brands

$14.06

-2.95 (-17.34%)

13:16
12/10/19
12/10
13:16
12/10/19
13:16
Downgrade
Designer Brands rating change  »

Designer Brands…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 10

    Dec

13:15
12/10/19
12/10
13:15
12/10/19
13:15
General news
Treasury's $24 B 10-year reopening was ok, fractionally better than average »

Treasury's $24 B…

SPY

SPDR S&P 500 ETF Trust

$313.70

-0.17 (-0.05%)

, SPX

S&P 500

$0.00

(0.00%)

13:11
12/10/19
12/10
13:11
12/10/19
13:11
Periodicals
Pelosi says new USMCA deal improves on initial Trump version, Reuters says »

U.S. House Speaker Nancy…

SPY

SPDR S&P 500 ETF Trust

$313.70

-0.17 (-0.05%)

SPX

S&P 500

$0.00

(0.00%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

13:08
12/10/19
12/10
13:08
12/10/19
13:08
General news
10-Yr Note Auction Coupon Rate data reported »

10-Yr Note Auction Coupon…

13:08
12/10/19
12/10
13:08
12/10/19
13:08
General news
10-Yr Note Auction Total Amount data reported »

10-Yr Note Auction Total…

EVH

Evolent Health

$8.15

0.255 (3.23%)

13:05
12/10/19
12/10
13:05
12/10/19
13:05
Options
Evolent Health call volume above normal and directionally bullish »

Bullish option flow…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

13:04
12/10/19
12/10
13:04
12/10/19
13:04
Conference/Events
UBS services analysts to hold an analyst/industry conference call »

Services Analysts Geiger…

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.