y**w
发帖数: 516 | 1 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 |
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t******g
发帖数: 462 | 2 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 |
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w*******d
发帖数: 3714 | 4 UPDATE 1-Vivus shares fall on regulatory concerns
Tue Jun 15, 2010 3:10pm EDTStocks
* Jefferies: FDA likely to focus on cardiovascular risk
* Lazard downgrades shares to "hold" from "buy"
* Qnexa FDA panel follows Avandia panel
* Shares down 8 pct in afternoon (Adds analyst comment, company comment,
updates stock price)
By Deena Beasley
LOS ANGELES, June 15 (Reuters) - Shares of Vivus Inc (VVUS.O) fell as much
as 9 percent on Tuesday after analysts raised questions about how U.S.
regulators wil... 阅读全帖 |
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n**********8
发帖数: 340 | 5 【 以下文字转载自 Chinook 俱乐部 】
发信人: niuniuzhu168 (妞妞), 信区: Chinook
标 题: Four Drug Stocks Facing FDA Approval Decisions in July
发信站: BBS 未名空间站 (Wed Jul 4 00:08:43 2012, 美东)
BOSTON (TheStreet) -- Four FDA drug approval decisions in July -- headlined
by another weight-loss drug and a prescription fish oil pill with
blockbuster potential -- will keep biotech investors busy in what is
normally one of the sector's slower months.
Vivus(VVUS_) is expected to learn the fate of its weight-loss pill Qnexa on
Tu... 阅读全帖 |
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h*******g
发帖数: 205 | 6 刚看到这个帖子，说是Cramer把Belviq and Qunexs 完全说反了。个人觉得他是为MM低
价进ARNA做托儿，如果你的进价低，没准再hold一下。我还拿着，进点比较低，但是，
锁利很重要！！
Great post on ARNA message board by a doctor responding to Cramer's show
last night.....
REAL PHYSICIAN: CRAMER REBUTTAL 11-Jul-12 09:14 am A very important (but
never discussed) point about anti-obesity treatment is what real physicians
will prescribe for their patients in coming years. I have discussed with
many of my fellow M.D.s, and almost all of us are going with BELVIQ instead
of QNEXA, ... 阅读全帖 |
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y*****l
发帖数: 5997 | 7 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 |
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n****e
发帖数: 1677 | 8 我先写点，以后有新的东西再补充，另外还有些数据要斟酌，有保留的看吧。
obesity的药，FDA有明确的guideline http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf,里面详细列举了clinical trials的design,和要求，其中包括patient size, duration,还有safety等等，简单的说，phase III要至少4500人一年，safety对于obesity的药尤其重要，因为obesity不是life threatening,而且要长期使用。主要的safety concern是心血管疾病，还有就是精神疾病比如depression。
现在来看vvus和arna的药：
vvus的叫Qnexa，是low dose phentermine and topiramate, phentermine是1959年FDA
批准的，到现在也没有efficacy和safety的data,唯一的数据是1990年的Fen-p... 阅读全帖 |
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h*******g
发帖数: 205 | 10 看到CNBC上的这个，comment写的很professional。
http://www.cnbc.com/id/48201596?__source=yahoo%7Cheadline%7Cquo
Genesis667 | Jul 16, 2012 08:51 PM ET
Jim,
It would be nice if you would quote the correct figures for Belviq. You keep
claiming that Qnexa is more effective than Belviq. No one knows that until
the FDA makes it's ruling.
VVUS recommended the Mid dose be approved for Qnexa, not the top dose which
shows a higher weight loss percentage.
Given the fact that the FDA is concerned that 5 people had hear... 阅读全帖 |
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y*****l
发帖数: 5997 | 11 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 |
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O**I
发帖数: 776 | 12 【 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 |
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d******8
发帖数: 1972 | 13 新型伟哥，据说比伟哥效果更快，明天开盘会不会大涨？还是已经涨过了。
NEW YORK - The Food and Drug Administration on Friday approved a new
impotence drug, Vivus Inc.'s Stendra.
The pill is intended to be taken 30 minutes before sex, but Vivus said that
in clinical trials, some patients were able to have sex as little as 15
minutes after taking the drug. Pfizer Inc.'s Viagra is supposed to be taken
at least 30 minutes before sex. The FDA said an estimated 30 million men
have importance, or erectile dysfunction.
In clinical trials, ... 阅读全帖 |
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V**n
发帖数: 560 | 14 sorry, a big IF. Maybe a higher chance of REMS...
三种药中间 Lorcaserin 减肥效果比 contrave Qnexa 来的小， 但是副作用也小很多
， 如果你去读一下那些报告。
Qnexa ruled out for child bearing age females this is a red flag to me...
而且其实说白了，正好是这些爱美的女人是减肥药的主力吧！
我相信医生也会开相对谨慎的药。
当然，股票最重要的是顺势而为，science， data 较真是不智的。
现在美国成年人 1/3 超重， FDA 13年来都没有批过减肥药； Qnexa 就像老板没钱的
时候，你觉得他想不想你答辩通过呢？ 通过以后有没有锦绣前程 那他就不管了。 |
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s******r
发帖数: 21961 | 15 honeybugg, here i read:
"There is no way the FDA will approve Qnexa , and it is already dead in
Europe as the main ingrediant of Qnexa is banned ."
欧洲真的禁止了Qnexa的主成分？ |
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h*******g
发帖数: 205 | 16 看到一个5/14的帖子，没事看看吧，反正都是讲ARNA和VVUS的，个人观点，热火朝天的
，呵呵。
http://www.investorvillage.com/smbd.asp?mb=633&pt=msg&mn=%20213
Msg 21332 of 30450 at 5/14/2012 5:42:40 AM by
tarado96
I agree with this poster concerning ARNA near target prices: $20, and $35 (
with EMA approval)
Lorcaserin published in NEJM:worlds' most prestigious clinical journal
By far the most prestigious clinical publication in the world is NEJM (
impact factor 53.5) vs the distant second Lancet (impact factor 33.6). One
has to a... 阅读全帖 |
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O**I
发帖数: 776 | 17 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 | 18 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 |
|
w*******0
发帖数: 13 | 19 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 |
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w*******0
发帖数: 13 | 20 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 |
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y*****l
发帖数: 5997 | 21 http://www.thestreet.com/story/11016605/1/biotech-calendars-201
By Adam Feuerstein 02/22/11 - 07:36 AM ES
Stock quotes in this article:HGSI, OPTR, XNPT, SPPI, DRRX, PATH
BOSTON (TheStreet) -- I've updated the 2011 FDA drug approval calendar.
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 regul... 阅读全帖 |
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v**********m
发帖数: 5516 | 22 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 |
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v**********m
发帖数: 5516 | 23 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 |
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w*******d
发帖数: 3714 | 24 Arena's drug, lorcaserin, works in a similar way to fenfluramine, but
appears to be safer. One trial of lorcaserin showed that patients who took
the drug twice a day for a year lost, on average, 5.9 percent of their body
weight, compared with 2.8 percent for those taking a placebo.
Vivus' drug, Qnexa, combines relatively low doses of phentermine with the
epilepsy drug topiramate, sold under the brand name Topamax. One late-stage
trial showed that patients who took Qnexa lost an average of 14.7 p |
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s*******l
发帖数: 2445 | 25 Qnexa's safety is a big concern, see the FDA minutes:
"The committee members who voted 'YES' in question #5 noted that obesity is
a disease for which there are inadequate treatment methods and that
phentermine/topiramate (Qnexa) was shown to be effective in treating obesity
with minimal adverse effects. However, they supported the requirement for a
post-approval long-term cardiovascular (CV) safety trial which should be
conducted expeditiously. It was noted that the sponsor should be held
accoun... 阅读全帖 |
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t********t
发帖数: 5415 | 26 Cramer这流氓已经跟ARNA对着干若干次了，联合AF一起黑ARNA吹VVUS不是一天两天了..
.下次再摸到12我也想锁利了，adcom前买了点call，flash crash那天又冲动了一点
call目前中度水下，不知道是不是要加仓摊成本...
从ARNA的角度看，VVUS通过带来的最大利空可能是qnexa比belviq早上市。原因是：
vvus有现成的工厂，而arna要去瑞士的工厂生产，FDA可能会审查工厂是否符合生产条
件之类。而且qnexa说到底是两种generic，通过之后可以立即开工，也基本不用过DEA
schedule（成瘾调查），ARNA的DEA可能会需要数周到数月时间。（不过有消息说早在
FDA approve之前ARNA就在和DEA做schedule，所以有可能很快出结果） |
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t********t
发帖数: 5415 | 27 qnexa不就是VVUS的药么？ARNA的叫belviq...
话说回来，如果VVUS通过FDA然后抢先上市，短期看对ARNA各种利空，但是长期看ARNA
还是会回来的，因为phen/top(qnexa的两种成分)不能久吃，3个月之后无论如何都要停
药，否则副作用危害太大。而ARNA可以吃一年，极端情况是统计意义不显著但是可能会
发生的肿瘤问题。（这还是在老鼠身上发现的，人身上会不会出问题另说）。虽然ARNA
的标签上会说3个月减不掉5%就不要吃了，但是对于减掉了5%的人来说就是一年的sales。 |
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p***o
发帖数: 714 | 29 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 |
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w*******d
发帖数: 3714 | 30 Meanwhile, Arena's lorcaserin seems to have the
best safety profile, but lacks efficacy. It's unlikely that the FDA will
approve a drug that is only mildly effective for a disease that has had a
history of unsuccessful drug candidates, even if the drug proves to be safe.
这个就是作者胡扯了。上次Fen-Phen为什么最后偷鸡不成蚀把米？不是因为减肥效果不
够强大，而是太强大足以把人减死了。
如果减肥药历史上出过丑闻，因为副作用太强导致药厂赔了上百亿，那FDA现在考虑批
准减肥药，是宁可错杀一百呢，还是宁可放过一个？
从这个角度来说，作者的逻辑就很搞笑了：FDA曾经据过很多减肥药，因为他们副作用
太强大。现在有了一个副作用极小的药，但是FDA还是很可能据？
我觉得呢，lorcaserin很可能因为药效不够杯具；但是qne... 阅读全帖 |
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t*******o
发帖数: 1464 | 31 The FDA has scheduled an advisory committee meeting on July 15 to review
Qnexa's safety and efficacy as a weight-loss drug. The FDA's review of Qnexa
will be posted to the agency's web site on July 13 or July 14.
========
我有一个疑问，advisory committee meeting的pump作用有这么大吗？Approval
decision date is October 28。看两个竞争者下个月option的premium都很便宜，是不
是从侧面证明advisory committee meeting的作用不大。我的 assumption是 从竞争角
度来讲，VVUS panel meeting 同意过了，对OREX/ARNA都是大利空（不管他们两最后
FDA有没有过），VVUS没过，对OREX/ARNA都是大利多（不管他们两最后FDA有没有过）
，我这个讲法... 阅读全帖 |
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S***a
发帖数: 1072 | 32 September's BioPharma Catalyst Calendar
By Lisa LaMotta Sep 01, 2010 2:40 pm
This month could be full of opportunities for biotech and pharmaceutical
investors who know where to look.
•More by Lisa LaMotta
•Forest Faces a Positive-Leaning PanelOrexigen Fattens Its Coffers
With Takeda CashSeptember's BioPharma Catalyst CalendarWhat's the Buzz?
30 top traders on these stocks and more
VVUS 6.33 +0.61 (+10.75%)
FRX 29.20 +1.55 (+5.61%)
CBST 22.52 -0.09 (-0.40%)
... 阅读全帖 |
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v**********m
发帖数: 5516 | 33 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 |
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j****e
发帖数: 624 | 34
VIVUS drug's CV profile viewed positively by FDA, says Rodman & Renshaw
After attending an FDA panel hearing focused on the effects of anti-obesity
drugs on cardiovascular systems, Rodman & Renshaw believes that the FDA and
the panel are comfortable with the cardiovascular profile of VIVUS' drug,
Qnexa. The firm indicates that it doesn't expect the agency to require
additional cardiovascular tests before Qnexa is approved, and it reiterates
an Outperform rating on VIVUS. :theflyonthewall.com
no... 阅读全帖 |
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b*****h
发帖数: 783 | 35 肥胖不像癌症，所以对药物的安全性更看重，vvus的药物有比较大的副作用，如果能过
，market的对象也会是那些特别肥的人。而且，Qnexa的两个有效成分都是generic
drug。可能现在已经有doctor在off label使用。
arna的是新药，副作用很小，虽然减肥效果不是特别好，不过也好过目前市面上的药，
新药估计可以卖贵点，如果通过的话。
body
stage
of
a
lorcaserin |
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w*******d
发帖数: 3714 | 36 52周只能减5%，这个感觉效果非常有限啊，跟Qnexa一比就小儿科了哈哈。。。
不过Arena价钱还蛮便宜的，好像没人吵啊，按照那个专家的说法，ARNA应该也爆发了
才对。。。难道MM知道啥不可告人的秘密？ |
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w*******d
发帖数: 3714 | 37 So is Qnexa by Vivus, you know what happened |
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j******e
发帖数: 294 | 38 I am not an expert. I see some articles mentioned it can $40-$50 with either
a full approval or buyout. obesity drugs are a huge market. Qnexa may
generate billion dollars sales for VVUS.
yesterday's close was a good opportunity to get in. missed it. |
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V**n
发帖数: 560 | 39 Retail investor 占了70%, 机构才 ~20%
当然是之前 $2 买的投机客都take gain 啦。
反正一个月内也不会变太多，直到Qnexa 被拒 才会再涨。
|
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h*******g
发帖数: 205 | 41 Just googled it and found this here. Also ARNA's drug is a drug of novelty.
http://www.mnn.com/health/fitness-well-being/stories/5-banned-o
"5 banned or discontinued appetite suppressants"
"Fen-Phen: To be clear, although the “fen” in Fen-Phen, fenfluramine, was
outlawed by the FDA way back in 1997 due to adverse side effects including
heart valve disease and pulmonary hypertension, the “phen,” phentermine,
found in the controversial, once-insanely popular appetite suppressant combo
drug is stil... 阅读全帖 |
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p********e
发帖数: 1960 | 42 Cramer said that when it comes to biotech companies, he looks for small,
undiscovered names -- the exact opposite of Arena, which took center stage
when its weight loss drug Belviq received U.S. Food and Drug Administration
approval earlier this year. While the markets are expecting Belviq to be a $
1 billion to 3 billion opportunity for the company, it may not be able to
live up to the hype.
What could go wrong? Well, for starters Belviq its not the panacea for
obesity. The drug only produces a... 阅读全帖 |
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o**y
发帖数: 1466 | 43 qnexa最快要明年1月才会面市
VVUS一旦通过马上就会面市
..
DEA |
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t********t
发帖数: 5415 | 44 如果12周减掉了超过5%那么这些人就会坚持吃一整年。Qnexa的问题在于12周就算你减
掉25%也不能再吃，因为对心血管系统压力太大。phen/top一个促进新陈代谢一个抑制
食欲，停药之后食欲++代谢--，体重反弹的可能性...通俗点说就是belviq挑人，不是
所有肥胖都能治，毕竟肥胖成因不同（基因，懒，食物...），而且是个减肥药都说自
己不是仙丹，要配合饮食和运动... |
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V**n
发帖数: 560 | 45 其实今天是 allowed to trade window 最后一天,
for some big retail investor before the 17th the D day of Qnexa |
|
h*******g
发帖数: 205 | 46 同意“如果能够通过，ARNA可能会掉一些，但肯定不会出现恐慌性大跌。”
VVUS如果通过，有可能
“A severely restrictive label, such as a patient registry, would be
devastating to the outlook for Qnexa (and consequently Vivus shares)” |
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k**********4
发帖数: 16092 | 47 here is the reason, wonder how true it is.
the USA Today appears to have jumped the gun with an article suggesting the
FDA has ok'd VIVUS's (Nasdaq: VVUS) Qnexa, which will be marketed under
Qsymia.
A new prescription diet drug OK'd today by the government is expected to
help heavy patients drop about 10% of their weight — more than any other
approved obesity medication.
The article appears to have been inadvertent posted early, as the FDA
decision has yet been announced. It was taken down at th... 阅读全帖 |
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h*******g
发帖数: 205 | 48 Another interesting thing is that some attorneys have started to advertise
litigation against Qnexa for its side effects - hilarious!!! |
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h*******g
发帖数: 205 | 49 http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm312468.htm
FDA approves weight-management drug Qsymia
The U.S. Food and Drug Administration today approved Qsymia (phentermine and
topiramate extended-release) as an addition to a reduced-calorie diet and
exercise for chronic weight management.
The drug is approved for use in adults with a body mass index (BMI) of 30 or
greater (obese) or adults with a BMI of 27 or greater (overweight) who have
at least one weight-related condition suc... 阅读全帖 |
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T*C
发帖数: 5492 | 50 OREX win?
and
or
have
is |
|
