COLUMBIA LABORATORIES INC. REGISTERED SHARES DL -,01 (WKN 877111- Warum ist die Aktie gestern so abg - 500 Beiträge pro Seite

[Kurier-des-Zaren]

Hallo,

ich hätte eine Frage an die Experten :


Wer weiß, warum die Aktie von COLUMBIA LABORATORIES INC. REGISTERED SHARES US1977791011

gestern an der Wallstreet so abgestürzt ist.

Hat jemand eine Quelle, wo man Nachrichten über diesen starken Kursrückgang erhalten kann?

Danke im Voraus!

[Yatt]

Quelle Bloomberg:

Columbia Laboratories Inc. (CBRX) fell the most in almost five years after U.S. regulators said the company’s progesterone gel to reduce the risk of preterm birth isn’t effective.

Columbia Labs dropped 54 percent to $1.10 at the close in New York, the biggest single-day decline since Feb. 5, 2007. Watson Pharmaceuticals Inc. (WPI), a partner on the drug, fell 6.8 percent to $57.98, the greatest single-day loss in almost three years.

“The information and data in this application do not support the efficacy of progesterone gel compared with placebo in reducing the risk of preterm births before 33 completed weeks,” Food and Drug Administration staff wrote in a Dec. 22 report released today.

The product would compete with KV Pharmaceutical Co. (KV/A)’s gel Makena, approved in February 2010. KV rose 6.2 percent to $1.89.

The FDA staff based its determination on data from narrow groups in a global study, said Amy Raskopf, a spokeswoman for Livingston, New Jersey-based Columbia Labs.

“This is a global study,” she said in a telephone interview. “It was designed as a global study. FDA agreed.”

An FDA advisory panel is set to meet Jan. 20 on Columbia Lab’s gel and weigh the risks and benefits. The agency isn’t required to follow the panel recommendations.
Not Statistically Significant

Of U.S. patients, 16.8 percent using the gel experienced preterm birth at 33 weeks of pregnancy, the endpoint the company and the agency agreed on, compared with 19.2 percent using placebo, not a statistically significant difference, FDA staff said.

“It does not appear that the applicant has identified a population of U.S. women who are likely to benefit from the use of progesterone gel to reduce their risk of preterm birth,” FDA staff wrote.

Columbia Labs said its gel was associated with a statistically significant reduction in preterm birth compared with placebo of 8.9 percent versus 15.2 percent in 465 pregnant women from 10 countries, according to a document from the company.

Preterm birth affects 10 percent to 12 percent of all pregnancies in the U.S., with an economic impact of $26 billion annually, according to the company.

The safety of Columbia Lab’s gel was similar to placebo, according to the FDA staff report. There were no maternal deaths in either the group using the gel or the placebo and the rates of fetal, neonatal and infant deaths were similar.

[Mittachmahl]

Antwort auf Beitrag Nr.: 42.610.210 von Kurier-des-Zaren am 18.01.12 14:35:54

Source: http://estocksdaily.com/tuesdays-big-time-losers-and-the-rea…" target="_blank" rel="nofollow ugc noopener">http://estocksdaily.com/tuesdays-big-time-losers-and-the-rea…

Tuesday’s big time losers and the reasons why (CBRX, SAVE, KGC)
Posted on January 17, 2012 by Martin Timble

In this report: Kinross Gold (NYSE:KGC), Columbia Laboratories (NASDAQ:CBRX) and Sprint Airlines (NASDAQ:SAVE).

Columbia Laboratories (NASDAQ:CBRX) shares have sank by more than 56 percent so far today after reviewers from the Food and Drug Administration said that the company’s gel for reducing the risk of premature birth did not work. The FDA posted online that the gel did not show statistically significant result in the U.S. and have asked an advisory panel to consider whether the company should do more clinical trials. Columbia Laboratories currently trades at $1.05 per share.

Sprint Airlines (NASDAQ:SAVE) is trading over 4.3 percent lower today after the company announced its intention to conduct a secondary offering to the public of 11 million shares of common stock by selling shareholders. The company will not be selling any share in the offering but common stock will be offer and sold by existing stockholders of the company. Sprint Airlines currently trades at $14.36 per share.

Kinross Gold (NYSE:KGC) shares have plummeted by more than 16 percent today after the company said that it expects production to be flat to slightly higher his year while production costs rise by 12 to 19 percent due to higher labor and mine expenses. The company says that it expects 2011 production of around 2.6 million ounces of gold with production costs of $600 per ounce. For 2012 the company expects to produce between 2.6 million and 2.8 million ounces of gold equivalents while productions costs are expects to rise to between $670 to $715 per ounce. The company also announced that construction of its Tasiast mine in Africa is expected to be delayed by 6 to 9 months as the company determines the optimal processing mix to reduce operating costs.

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