am 30.10.2010 entscheidet hier die FDA
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Biodel Inc. (Biodel) ist ein Entwicklungs-Stadium Unternehmens. Die Gesellschaft ist ein spezialisiertes biopharmazeutisches Unternehmen auf die Entwicklung und Vermarktung von Behandlungsmethoden für Diabetes konzentriert. Das Unternehmen entwickelt seine Produkte Kandidaten durch die Anwendung seiner proprietären Rezeptur Technologien mit bestehenden Medikamenten, um ihre therapeutischen Profilen zu verbessern. Die Gesellschaft ursprünglichen Entwicklungsanstrengungen sind auf Peptidhormone konzentriert. Das Produktportfolio von Kandidaten, VIAject, wurde in zwei klinischen Phase-III-Studien für die Behandlung von Patienten mit Typ 1 und Typ 2-Diabetes untersucht. Neben VIAject, entwickelt das Unternehmen VIAtab, eine sublinguale oder unter der Zunge Tabletten-Formulierung von Insulin. Das Unternehmen entwickelt seine Produkte Kandidaten unter Anwendung seiner proprietären VIAdel Technologie, die es um die Interaktion zwischen Peptid-Hormone und kleine Moleküle untersucht werden können.
www.finanznachrichten.de
www.prnewswire.com/news-releases/...cation-for-linjeta-106432728.html
war wohl nix, das gibt ein Blutbad, da die FDA auch 2 neue Phase III Trials verlangt. :-(
dann halt mit Avanir Geld verdienen.
BRIEF-Biodel says to cut jobs, to record charge in Q2
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Jan 10 (Reuters) - Biodel Inc:
* Says on January 4, co committed to a restructuring plan resulting in a
reduction in force affecting 16 employees
* Says none of affected employees are executives of Biodel - SEC filing
* Says estimates it will record restructuring charge of approximately $0.4
million in Q2 of FY 2011
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Konferenz macht Biodel-Kurse
San Francisco (BoerseGo.de) - Die Aktien der US-amerikanischen Biodel, einem Pharmahersteller, der sich auf den Diabetes-Markt fokussiert hat, steigen am Donnerstag im frühen Handel an der Nasdaq deutlich an. CEO Errol De Souza präsentiert im Verlauf der JP Morgan Healthcare Conference neue Daten zum Hauptprodukt des Unternehmen, Linjeta. Dabei wird er auch über erreichte Meilensteine und die weitere Planung berichten. Die Anleger setzen im Vorfeld auf Optimismus und hieven den Kurs bei deutlich höheren Umsätzen als normal um mehr als 20 Prozent nach oben.
(© BörseGo AG 2011 - Autor: Thomas Godt, Redakteur)
© 2011 BörseGo
By David Olmos - Jan 13, 2011 10:26 PM GMT+0100
inShare.1More
Business ExchangeBuzz up!DiggPrint Email .Biodel Inc. rose the most since it began selling public shares in May 2007 on an analyst’s note expressing optimism about the company’s insulin product.
Biodel gained 54 cents, or 28 percent, to $2.50 at 4 p.m. New York time in Nasdaq Stock Market composite trading for the biggest one-day gain since the company’s initial public offering more than 3 1/2 years ago.
Prospects for a partnership for the fast-acting insulin, known as Linjeta, or an acquisition may have driven up the Danbury, Connecticut-based company’s shares, Liana Moussatos, an analyst at Wedbush Securities in San Francisco, said today in a note to investors. Biodel made a presentation today to investors at the J.P. Morgan Healthcare Conference in San Francisco.
“We believe value-oriented investors may be interested in Biodel’s approximately $60 million market capitalization contrasted to the blockbuster revenue potential” of Linjeta, Moussatos wrote in the note.
In November, Biodel lost almost half its value after U.S. regulators declined to approve the company’s product without new clinical studies. The agency asked for two clinical trials in patients with Type 1 and Type 2 diabetes to prove that Linjeta, works and is safe.
Erik Steiner, the company’s vice president for operations, declined to comment in an e-mail on the shares gain.
To contact the reporter on this story: David Olmos in San Francisco at dolmos@bloomberg.net
To contact the editor responsible for this story: Reg Gale at Rgale5@bloomberg.net
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Bin gespannt was da auf uns zu kommt....
Jul 30 2013, 10:05 by: Sam Quirke | about: BIOD (Biodel Inc) 23:35Disclosure: I am long BIOD. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)
Just over a month ago I wrote an article on the biotech company Bidoel (BIOD), examining the company's summer prospects of a run-up into the release of Phase II data of their lead investigational candidate BIOD-123, an ultra-rapid acting insulin for the treatment of diabetes Type-1 & 2. The company announced on July 11th that it expects to release top-line results by the ''end of this quarter''.
The stock was at $4.01 at the time of my article's publication and after popping yesterday is over $5 now, giving people who invested on my advice a return so far of 25%. I am just as bullish as I was a month ago, and would go as far as to say that not only will BIOD run into its Phase II data but I believe it will announce positive results and will briefly outline why in this article.
BIOD-123 has a long history. Originally it was developed as VIAject before management saw fit to rename it Linjecta. In its Phase III trial, Linjecta (at the time VIAject was examined to see if it was non-inferior to RHI -- regular human insulin) in the management of blood glucose levels as measured by the mean change in patients HbA1c levels from baseline. How well diabetics can control their blood glucose level is reflected in their HbA1c.
(Almost) Positive Linjecta Phase III Results
Preliminary results of the Phase III trials (both Type 1 & 2 were tested) showed that the trials met their primary endpoint of non-inferior mean change in HbA1c when compared to RHI. The Type 1 & 2 trials were conducted in centers in the USA, Germany and India. Type 2 patients who received Linjecta experienced fewer non-severe hypoglycemic events than RHI receiving patients. Type 1 & 2 patients who received Linjecta also gained less weight than patients on RHI. Over the 26 week trial, Linjecta patients gained an average of 0.3kg while RHI patients gained 1.7kg. At the release of the final Phase III results in June 2010 Dr. Rodbard commented
Wenn man denkt, dass BIODEL eine schnell wirkende Insuline entwickelt und die momentane Marketwert nur 107 Million ist (zum Vergleich MNKD 2.3 Millard), ist klar, wohin die Reise geht!!!
August 16th, 2013 - 0 comments - Filed Under - by admin
Filed Under: Analyst Articles - US - Markets
Investment analysts at JMP Securities increased their price objective on shares of Biodel (NASDAQ:BIOD) from $6.00 to $9.00 in a note issued to investors on Thursday, Analyst Ratings Network.com reports. JMP Securities’ price objective would suggest a potential upside of 94.38% from the company’s current price.
Shares of Biodel (NASDAQ:BIOD) traded up 0.22% on Thursday, hitting $4.64. 194,506 shares of the company’s stock traded hands. Biodel has a 1-year low of $2.13 and a 1-year high of $6.08. The stock’s 50-day moving average is $4.54 and its 200-day moving average is $3.50. The company’s market cap is $66.1 million.
Biodel (NASDAQ:BIOD) last announced its earnings results on Monday, August 12th. The company reported ($0.66) EPS for the quarter, missing the Thomson Reuters consensus estimate of ($0.37) by $0.29. During the same quarter last year, the company posted ($0.52) earnings per share. On average, analysts predict that Biodel will post $-1.42 earnings per share for the current fiscal year.
Biodel Inc (NASDAQ:BIOD) is a development-stage company.
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