v**********m
发帖数: 5516 | 1 来自主题: _pennystock版 - OREX Orexigen® Therapeutics Provides a Regulatory Update on Contrave® NDA
0
0
0
My news for Investors
AtLeast one of the check box should be selected You are following news about Follow the latest news about OREX
SAN DIEGO, June 3, 2011 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX) announced today that it recently met with the Food and Drug Administration (FDA) regarding the New Drug Application for Contrave® (naltrexone HCl/bupropion HCl) extended-release tablets fo... 阅读全帖 |
|
v**********m
发帖数: 5516 | 2 Orexigen Revives Obesity Drug Development With FDA Agreement
Q
By Ryan Flinn - Sep 20, 2011 4:38 PM ET
inShare1
More
Print
Email
Orexigen Therapeutics Inc. (OREX) is renewing development of the
experimental obesity drug Contrave after reaching an agreement with U.S.
regulators to further study heart risks.
Orexigen, one of three companies with rival obesity treatments competing for
approval, will start a two-year clinical trial of about 10,000 patients in
the first half of next y... 阅读全帖 |
|
v**********m
发帖数: 5516 | 3 Orexigen Revives Obesity Drug Development With FDA Agreement
Q
By Ryan Flinn - Sep 20, 2011 4:38 PM ET
inShare1
More
Print
Email
Orexigen Therapeutics Inc. (OREX) is renewing development of the
experimental obesity drug Contrave after reaching an agreement with U.S.
regulators to further study heart risks.
Orexigen, one of three companies with rival obesity treatments competing for
approval, will start a two-year clinical trial of about 10,000 patients in
the first half of next y... 阅读全帖 |
|
p********e
发帖数: 1960 | 4 周末刚刚被某娱乐周刊评为2014的潜力股
2014 Top health-care stock No. 1: Joining the pack
It's a heck of a lot easier to determine the potential value a biotech when
there's a company further ahead with nearly identical assets. Orexigen (
NASDAQ: OREX ) has two.
The biotech is developing an obesity drug Contrave, which will be reviewed
by the FDA in 2014. Further ahead, Arena Pharmaceuticals (NASDAQ: ARNA )
developed obesity drug Belviq that launched this year. VIVUS (NASDAQ: VVUS
) sells Qsymia, which has bee... 阅读全帖 |
|
f**********g
发帖数: 2252 | 5 3rd UPDATE: FDA Panel Backs Use Of Orexigen's Proposed Weight-Loss Drug
Contrave
Tuesday 12/07/2010 7:06 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ARNA 1.66 17.73%
OREX 10.82 127.31%
VVUS 9.00 15.38%
As of 9:35 AM ET 12/8/10
(Updates after-hours share movement)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--A federal advisory panel Tuesday backed the use of a
proposed weight-loss drug from Orexigen Therapeutics Inc. (OREX), saying
potential safety conce... 阅读全帖 |
|
O**I
发帖数: 776 | 6 【 以下文字转载自 pennystock 俱乐部 】
发信人: OSCI (TX), 信区: pennystock
标 题: FDA Drug Approvals in 2011
发信站: BBS 未名空间站 (Sat Jan 8 17:29:50 2011, 美东)
http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
... 阅读全帖 |
|
O**I
发帖数: 776 | 7 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
|
O**I
发帖数: 776 | 8 http://www.thestreet.com/story/10944267/1/biotech-calendar-fda-
BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
More from Adam Feuerstein
Dendreon Bringing Provenge to EuropeBiotech Stock Mailbag: Best Stocks to
Watch in '11Merck Beats Vertex to FDA Hep C Filing
Market Activity
Orexigen Therapeutics Inc.| OREX
DOWN
Dendreon Corporation| DNDN
InterMune Inc.| ITMN
For easy reference, I've organized this regulatory ... 阅读全帖 |
|
v**********m
发帖数: 5516 | 9 Orexigen Therapeutics, Inc. And FDA Identify Clear And Feasible Path to
Approval for Contrave
4:00pm EDT
Orexigen Therapeutics, Inc. announced that following a recent meeting with
senior officials in FDA's Office of New Drugs (OND), the Company received
written correspondence detailing OND's design requirements for a
cardiovascular outcomes trial (CVOT) for Contrave that would address the
Complete Response Letter (CRL) received in January 2011 . Orexigen believes
that these design requirements a... 阅读全帖 |
|
D******9
发帖数: 2665 | 10 不过好像我这把赌对了， 呵呵
Orexigen Wins Panel’s Backing for First Diet Pill in a Decade
December 07, 2010, 4:26 PM EST
Dec. 7 (Bloomberg) -- Orexigen Therapeutics Inc. won a U.S. panel’s backing
for Contrave, a new prescription diet pill.
Contrave’s benefits in helping obese people lose weight are greater than
the drug’s potential long-term risks, outside advisers to the Food and Drug
Administration said today in a 13- 7 vote at the agency’s headquarters in
Silver Spring, Maryland. The panel earlier said a... 阅读全帖 |
|
N**********p
发帖数: 408 | 11 February 25th is the day that Vivus (VVUS) will offer its Q4 quarterly
conference call. There will be a lot of ears listening to the call, but many
of them will not even have an investment in Vivus. Others that will be
paying close attention are investors in Arena (ARNA) and Orexigen (OREX).
Vivus, Arena and Orexigen all are vying for a position in the prescription
anti-obesity market, and while the three companies are at different stages,
the results offered by Vivus could be telling in what to... 阅读全帖 |
|
c********n
发帖数: 1793 | 12 谁能讲解分析下面的新闻：
Orexigen Therapeutics, Inc. Announces the Closing of its Offering of $115
Million of Convertible Senior Notes
SAN DIEGO, Dec. 6, 2013 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (
Nasdaq: OREX) (the "Company"), a biopharmaceutical company focused on the
treatment of obesity, today announced the closing of its offering of $115
million aggregate principal amount of convertible senior notes due 2020 (the
"Notes"), which includes $15 million aggregate principal amount of the
Notes ... 阅读全帖 |
|
p**********e
发帖数: 703 | 13 Concerning obesity drug, I trust Spencer Osborne who always give fair
analysis
More info. here:
http://seekingalpha.com/article/1871711-orexigen-announces-100-
esp. the last paragraph
In my opinion, Orexigen is still a "wait and see" play. For the sector, I
see January and February of 2014 as a key time period. Arena and its partner
Eisai should be ramping up a more aggressive ad campaign that should bring
consumer awareness, and insurance companies should be adjusting formularies
on obesity tre... 阅读全帖 |
|
p***o
发帖数: 714 | 14 Unlike U.S. Food and Drug Administration drug approvals, which are more
precisely timed, the release dates for data from clinical trials is bit
fuzzier, so the timelines here are culled from company guidance when
possible.
The working list of clinical trials expected to complete in 2009 is fairly
long, so expect more information on clinical trials to watch in the coming
weeks.
Company: GTx(GTXI)
Drug/indication: Acapodene for precancerous prostate lesions (high-grade PIN)
Clinical trial event: p... 阅读全帖 |
|
w*******1
发帖数: 1075 | 15
orex 跳水了，新闻UPDATE 2-Orexigen revises obesity drug data; shares fall
Tue Apr 13, 2010 11:48am EDT
Stocks
Orexigen Therapeutics, Inc.
OREX.O
$5.06
-0.67-11.69%
11:02am CDT
Vivus Inc
VVUS.O
$8.82
+0.11+1.26%
11:01am CDT
Arena Pharmaceuticals Inc
ARNA.O
$3.10
-0.05-1.59%
10:37am CDT
* Fewer patients lost key weight amounts than reported
* Says primary and secondary trial goals still met
* Shares fall 10 percent in midday trading. |
|
|
w****r
发帖数: 245 | 17 大侠，分类都分好了，求神签
# Basic Materials, Agricultural Chemicals
AGU Agrium Inc.
AVD American Vanguard Corp.
CAGC China Agritech Inc.
CF CF Industries Holdings, Inc.
CGA China Green Agriculture, Inc.
CMP Compass Minerals International
COIN Converted Organics Inc.
IPI Intrepid Potash, Inc.
MON Monsanto Co.
MOS Mosaic Co.
NOEC New Oriental Energy & Chemical
POT Potas... 阅读全帖 |
|
s**********9
发帖数: 846 | 18 The regulatory package for Contrave is extensive, and we believe, compelling
. It contains the interim analysis data and all the previously submitted
data from the core Phase 3 program in a broad and generalizable patient
population. As Mike noted, we will resubmit the Contrave NDA in the next few
weeks.
http://seekingalpha.com/article/1861981-orexigen-therapeutics-m |
|
A**X
发帖数: 1825 | 19 Orexigen shares hit by FDA delay in obesity drug |
|
y**w
发帖数: 516 | 20 Vivus Inc.'s weight-loss pill Qnexa won the backing of a U.S. advisory panel
as the company seeks to gain approval for the first new obesity drug in 13
years. The shares doubled in late trading.
Advisers to the Food and Drug Administration voted 20-2 today that Qnexa's
benefits outweigh its risks at a meeting at agency headquarters in Silver
Spring, Maryland. The FDA isn't required to follow the panel's
recommendation. The agency is due to decide on the drug, which it rejected
in 2010, by April ... 阅读全帖 |
|
|
|
h***e
发帖数: 7320 | 23 我们开个主题，肥猪和哈密我每天更新，希望大家能找到好匹克
如果大家发现新的event, 也请及时跟帖update，非常感谢 :)
Event Thread 不是推荐股票，欢迎讨论。
先给大家总结10月份的，以后每月开一贴哈
====================================
发信人: justsing (飞天的猪), 信区: pennystock
标 题: Re: 【Biotech Event Thread】
发信站: BBS 未名空间站 (Thu Oct 15 22:23:05 2009, 美东)
potentially stock-moving biotech events for October:
Oct. 5-6
JMP Securities Healthcare Focus conference
Oct. 7-8
Cowen & Co. 12 th Annual Therapeutics Conference
Oct. 8
FDA approval decision date for Spectrum Pharmaceuticals'(SPPI Quo... 阅读全帖 |
|
|
h*****8
发帖数: 4754 | 25 根据今天的收盘价，它们给的TARGET的涨幅
OREX>ARNA>VVUS
Davenport & Co. Starts Three in the Obesity Therapeutics Sector (ARNA, OREX,
VVUS)
May 7, 2010 10:07 AM EDT
Davenport & Co. starts three Obesity Therapeutics companies today:
* Arena Pharmaceuticals (Nasdaq: ARNA) with a Buy rating and price
target range of $5 - $6. The firm cites confidence in Lorcaserin weight
management agent, whose phase III have achieved solid results. The NDA filed
with the U.S. SEC was accepted, and they expected review in Q310.
S... 阅读全帖 |
|
w***y
发帖数: 2537 | 26 【 以下文字转载自 Stock 讨论区 】
发信人: ll111 (Stealth), 信区: Stock
标 题: Events and ER for week August 2-6
发信站: BBS 未名空间站 (Sun Aug 1 22:47:17 2010, 美东)
Monday, Aug. 2
10 a.m.: ISM Manufacturing index on business activity in July, released by
the Institute for Supply Management.
10:15 a.m. Federal Reserve Chairman Ben Bernanke speaking on "challenges for
the economy and state governments."
4 p.m. Treasury Secretary Timothy Geithner speaking on the next steps for
financial reform.
Tuesday, Aug. 3
8:30 a.m.: P... 阅读全帖 |
|
f**********g
发帖数: 2252 | 27 3rd UPDATE: Abbott Halts Meridia Sales In US, Canada, Australia
Friday 10/08/2010 1:35 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ABT 52.80 -0.02%
ARNA 1.82 3.43%
GSK 41.34 -0.24%
OREX 6.32 1.77%
RHHBY 35.24 -2.11%
As of 10:11 AM ET 10/12/10
(Adds detail, background.)
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--Abbott Laboratories (ABT) said Friday it was pulling
Meridia off the U.S., Canadian and Australian markets at the request of
health regulators... 阅读全帖 |
|
y*****l
发帖数: 5997 | 28 盘前到8块了？！
FDA Rejects Vivus Inc.'s Obesity Drug Qnexa
Thursday 10/28/2010 9:18 PM ET - Dow Jones News
Related Companies
Symbol Last %Chg
ARNA 1.59 0.00%
VVUS 6.13 0.00%
As of 4:00 PM ET 10/28/10
By Jennifer Corbett Dooren
Of DOW JONES NEWSWIRES
WASHINGTON (Dow Jones)--The Food and Drug Administration rejected Vivus Inc.
's (VVUS) obesity drug Qnexa, the company said Thursday.
The rejection marks the second time in less than a week that the agency has
refused to sign off on... 阅读全帖 |
|
|
y*****l
发帖数: 5997 | 30 谁中彩票了？
Orexigen Therapeutics, Inc.
(NasdaqGM: OREX )
After Hours: 12.42 Up 7.55 (155.03%) 7:59PM EST |
|
f**********g
发帖数: 2252 | 31 http://www.thestreet.com/_yahoo/story/10989791/1/biotech-calend
By Adam Feuerstein 01/31/11 - 09:10 AM EST
ALIM, AEN, EXEL, PLX, GENZ, IDIX, AVNR
BOSTON, Mass. (TheStreet) -- A calendar of important, potentially stock-
moving biotech events for February:
More from Adam Feuerstein
NPS Pharma: Gattex Bowel Study SucceedsArena Pharma: Weight-Loss Drug
WoesBiotech Stock Mailbag: Orexigen TherapeuticsMarket Activity
AVANIR Pharmaceuticals| AVNR DOWNAlimera Sciences Inc.| ALIM DOWNProtalix
BioThera... 阅读全帖 |
|
f**********g
发帖数: 2252 | 32 http://www.thestreet.com/_yahoo/story/10989791/1/biotech-calend
By Adam Feuerstein 01/31/11 - 09:10 AM EST
ALIM, AEN, EXEL, PLX, GENZ, IDIX, AVNR
BOSTON, Mass. (TheStreet) -- A calendar of important, potentially stock-
moving biotech events for February:
More from Adam Feuerstein
NPS Pharma: Gattex Bowel Study SucceedsArena Pharma: Weight-Loss Drug
WoesBiotech Stock Mailbag: Orexigen TherapeuticsMarket Activity
AVANIR Pharmaceuticals| AVNR DOWNAlimera Sciences Inc.| ALIM DOWNProtalix
BioThera... 阅读全帖 |
|
w*******0
发帖数: 13 | 33 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
|
w*******0
发帖数: 13 | 34 BOSTON (TheStreet) -- An early Christmas present for biotech investors: The
first (overstuffed) FDA drug approval calendar of 2011.
For easy reference, I've organized this regulatory calendar in chronological
order based on the drug approval decision date. I've also included
information on pending FDA advisory panels. At the end of the calendar is a
list of companies with potential regulatory milestones in 2011 based on
expected but not yet completed drug approval filings.
In all, this calendar ... 阅读全帖 |
|
v**********m
发帖数: 5516 | 35 Arna pump新文。
http://seekingalpha.com/article/292994-is-arena-s-lorcaserin-on
Is Arena's Lorcaserin On Track For Approval In 2012?
28 comments | by: KLLJ Investments September 12, 2011 | about: ARNA
Arena Pharmaceuticals (ARNA) investors have had a tough road over the last
12 months since a negative vote by an Advisory Committee called to review
Arena’s lead drug candidate for the treatment of obesity – lorcaserin. The
stock was trading close to $7.00 a year ago heading into that fateful
Advis... 阅读全帖 |
|
y*****l
发帖数: 5997 | 36 22 Hot Drugs Facing FDA Approval in 2012
By Adam Feuerstein 11/29/11 - 08:55 AM EST
BOSTON (TheStreet) -- Here's your first look at the biotech and
pharmaceutical companies with pending FDA drug approval decisions in 2012.
The calendar on the following pages captures nearly two-dozen U.S.
regulatory events -- FDA drug approvals and advisory panels -- expected
between December 2011 and July 2012. As every savvy biotech investor and
trader knows, the volatility in biotech and drug stocks ramps sig... 阅读全帖 |
|
y****o
发帖数: 329 | 37 医药里面的股，我只炒过sppi.确实没注意过减肥方面的。我是搞pharmaceutical的，
但是我自己都不炒这些股，因为觉得太多都是luck了。
我仔细看了文章，减肥药里面就三家，Vivus’ (VVUS) qnexa, Orexigen’s (OREX)
contrave and Arena’s (ARNA) lorcaserin。 前面被否的那两家，都不是新药，是把
已经有的药combine起来。只有这个arna的药，是novel target到蛋白质的receptor上
的新药。
看了FDA之前对他们rat的data的疑问，觉得很正常。因为现在是脑子里面的target,研
究脑子的pk数据，都是用plasma数据估算的。而且还有问题，就是肿瘤模型很复杂，就
算control rat里面，各种肿瘤模型也很复杂。这些确实都是问题，因为FDA审批的时候
，特别按部就班，他们很不容易接受regulation方面新的挑战。
但我现在是觉得这个药还是比较promising的。至少好像efficacy和toxicity都没问题
。我会hold到resubmission.如果这个他们能被接受... 阅读全帖 |
|
m*****t
发帖数: 1987 | 38 大概是因为这个吧
Orexigen® Announces Agreement From the FDA on a Special Protocol
Assessment for the Contrave® Outcomes Trial
大牛说说这个药有希望么？记得你以前说不要碰，考虑要不要把手里得出了。谢谢 |
|
t******g
发帖数: 462 | 39 A lot of options will be dead
http://www.businessweek.com/news/2012-04-09/vivus-weight-loss-d
Vivus Inc. (VVUS) (VVUS) said U.S. regulators delayed their decision date on
whether to approve the obesity pill Qnexa by three months to July 17.
The date was extended after Vivus submitted, at the Food and Drug
Administration’s request, a risk evaluation and mitigation strategy, the
company said today in a statement. The strategy is based on discussions with
the agency after advisers voted Feb. 22 in ... 阅读全帖 |
|
