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_Stockcafeteria版 - Four Drug Stocks Facing FDA Approval Decisions in July (转载)
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Re: 不要太迷信technical (转载)MNKD
张果老还弄HEB吗?几百年前mike发的贴子,我居然保存了,希望大家有用。
相关话题的讨论汇总
话题: fda话题: drug话题: july话题: qnexa话题: approval
1 (共1页)
n**********8
发帖数: 340
1
【 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
Tues. July 17. Recall, FDA was supposed to rule on Qnexa in April but
delayed the decision by three months in order to review a risk management
plan ensuring safer use of the drug.
Shares of Vivus are up 24% since the company announced the Qnexa regulatory
delay in early April, largely because investors interpreted it as a vote of
confidence in the drug's eventual approval.
Seventy-seven percent of contestants in TheStreet's Summer FDA Drug Approval
Contest predict Qnexa's full approval on July 17 against 19% predicting the
drug's rejection. [Another 5% believe FDA will delay its decision again.]
The positive sentiment towards Vivus in the contest is much higher than it
was for Arena Pharmaceuticals(ARNA_) and its weight-loss drug Belviq. [FDA
approved Belviq, of course.]
Qnexa helped patients lose more weight than Belviq (comparing across
different phase III trials) but Qnexa also causes more side effects. While
Qnexa is widely expected to receive FDA approval on July 17, what remains a
mystery still is how regulators will restrict the drug's use in order to
mitigate side effects and risks, most notably the potential for birth
defects in babies born to women who take Qnexa while pregnant.
Investors also wait to see how quickly Vivus can launch Qnexa after approval
. With Arena and its marketing partner Eisai stuck in neutral and unable to
launch Belviq until early next year, Vivus could become the first new weight
-loss drug to become available for obese Americans despite being approved
second.
Amarin(AMRN_) probably has the most highly anticipated date with FDA on
Thursday July 26, as regulators decide on the approval of the company's
prescription fish-oil pill AMR101 for the treatment of patients with very
high levels of triglycerides. As with Qnexa, investor expectations for
AMR101 are ultra-bullish: 76% of contestants in TheStreet's drug-approval
contest forecast full approval versus just 5% predicting rejection. Another
19% believe FDA will delay its decision. Confidence in AMR101's approval is
bolstered by strongly positive results from the phase III "MARINE" trial and
the decision by FDA not to bring the drug in front an outside advisory
panel.
Amarin shares have already doubled in value this year, boosted by strong
AMR101 clinical data and improved patent protection that should give the
drug sufficient market exclusivity if approved on July 26. If AMR101 is
approved, however, watch investor focus shift quickly to speculation about
the sale of the company to Big Pharma. Very few Amarin shareholders will be
happy if the company announces plans to launch AMR101 on its own.
Also on July 26, Horizon Pharmaceuticals(HZNP_) will also receive FDA's
approval decision for a proprietary, time-release formulation of the steroid
prednisone for the treatment of rheumatoid arthritis. The same drug under
the brand name Lodotra is already approved in Europe.
Lastly, Onyx Pharmaceuticals(ONXX_) is all but assured FDA approval of its
multiple myeloma drug Kyprolis on Friday, July 27 following last month's
overwhelmingly positive advisory panel vote.
Onyx share are up more than 50% since the FDA panel voted unanimously to
recommend the approval of Kyprolis for patients with advanced multiple
myeloma that no longer responds to current treatment.
--Written by Adam Feuerstein in Boston.
比较喜欢amrn and vvus.老牛和168上的general mao 都一直推荐AMRN。 但是AMRN强庄
,震的比较厉害。general mao 认为amrn 最终是buyout candidate." there is a 3-4
months window for buyout after FDA APPROVAL. quite likely it will be
takenout at $35. it may take a half year to get there."
1 (共1页)
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几百年前mike发的贴子,我居然保存了,希望大家有用。几个股票
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相关话题的讨论汇总
话题: fda话题: drug话题: july话题: qnexa话题: approval