BIOD - Sector: Healthcare - Industry: Biotechnology & Drugs

[setravis]

Profile: 

Biodel Inc.
100 Saw Mill Road
Danbury, CT 06810
United States - Map
Phone: 203-796-5000
Fax: 203-796-5001
Website: http://www.biodel.com

Details   
Index Membership: N/A
Sector: Healthcare
Industry: Drug Manufacturers - Other
Full Time Employees: 55


Business Summary   

Biodel Inc., a development stage biopharmaceutical company, focuses on the development and commercialization of treatments for diabetes. The company develops its product candidates by utilizing its proprietary VIAdel technology that allows to study the interaction between peptide hormones and small molecules. Its product candidates include VIAject, an injectable formulation of recombinant human insulin, which has completed two pivotal Phase III clinical trials for the treatment of Type 1 and Type 2 diabetes; and VIAtab, a sublingual tablet formulation of insulin, which has completed Phase I clinical trial for Type 1 diabetes. The company was founded in 2003 and is headquartered in Danbury, Connecticut.


Business Overview

BRIEF: For the fiscal year ended 30 September 2010, Biodel Inc. reported no revenue. Net loss applicable to Common decreased 12% to $38.3M. Revenues reflect the Company is still being in the development stages. Lower loss reflects decreased research & development expenses. Biodel Inc., is a development stage specialty pharmaceutical company engaged in the development and commercialization of innovative treatments for diabetes. http://www.biodel.com/

[setravis]

Huge volume spike ! Above the 50-day on a huge volume spike.
Big move on big volume...expecting it to continue. 

Day's Range: 1.96 - 2.69
52wk Range: 1.96 - 6.25
Volume: 10,805,378
Avg Vol (3m): 994,114
Market Cap: 66.08M
P/E (ttm): N/A
EPS (ttm): -1.59
Div & Yield: N/A (N/A)

Technicals
Close Above the 50-day EMA
Most Actives
Percentage Gainer

Last Price Quote is:
32.31%above 13-day EMA
16.19%above 50-day EMA
RS Rating: 4 

[setravis]

Bloomberg
Biodel Rises Most Ever on Optimism of Deal Related to Experimental Insulin
By David Olmos - Jan 13, 2011 3:26 PM CT

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.

[setravis]

Small Caps Wave Systems, Biodel: Small-Cap Winners
01/13/11 - 12:37 PM EST

NEW YORK (TheStreet) -- Shares of biotech company Biodel(BIOD) were topping the small-cap space on Thursday, jumping 27% to $2.49.
Biodel, a development stage biopharmaceutical company is focused on the diabetes market. The company will be presenting an update at the J.P.Morgan Heatlhcare Conference at 9:30 a.m PST. The update will include information about the development of new follow-on formulations of its lead product, Linjeta including milestones and timelines, according to its press release.
Nearly 5 million shares were changing hands on Thursday afternoon against an average trading volume of 900,000.

Wave Systems(WAVX) was also riding on heavy volumes, soaring 14% to $5.03. Over 4 million shares were changing hands on Thursday. The Obama Administration is working on a cybersecurity ID program that would allow users to log onto different sites without having to remember different passwords for each one. That has led to a pop in the shares of Wave Systems, which offers software that enables hardware encryption and the ability to do away with multiple passwords

Canada'sEXFO (EXFO) which provides services for the telecommunications industry, was soaring after it reported higher-than-expected profits .
The company earned $14.1 million, or 23 cents a share, for the three months ended Nov. 30 with total sales rising almost 50% year-over-year to $67.6 million. EXFO's outlook called for
earnings of 17 to 21 cents a share and sales ranging from $61 million to $66 million. Earnings growth was helped by the sale of the Life Sciences and Industrial Division for $23 million in cash.
EXFO forecast earnings of 3 to 7 cents a share and sales of between $70 million and $75 million. Shares were gaining 21% to $9.14 on volume of over 2 million on Thursday's trading, much higher than its average trading volume of 28,000.

Other stocks rising on higher volumes include TTM Technologies(TTMI), Peregrine Pharmaceuticals(PPHM) and China Media Express(CCME).


Among the losers, SemiLEDS(LEDS) was shedding about a third of its value Thursday after it issued a weak revenue outlook for the next quarter. The LED market player went public in December and has risen 25% since its IPO.
Shares of Canadian communications equipment maker DragonWave (DRWI) tumbled 16% to $8.75 after it reported a loss for the latest quarter and forecast a steeper sequential drop on the topline.
 

[setravis]

Biodel Inc. is Today's Focus Stock on MicroStockProfit.com

Press Release Source: MicroStockProfit.com On Friday January 14, 2011, 6:50 am EST

DALLAS, Jan. 14, 2011 (GLOBE NEWSWIRE) -- MicroStockProfit.com announces an investment report featuring Biodel Inc. (Nasdaq:BIOD - News). The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision.



The full report is available at: www.microstockprofit.com/lp/BIOD



Biodel Inc. (BIOD) is a development-stage biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes. It develops its product candidates by applying its proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. BIOD's most advanced product candidate is Linjeta (formerly known as VIAject). The Company has formulated Linjeta as a rapid-acting mealtime insulin for the treatment of patients with type I and type II diabetes. Earlier stage product candidates include follow-on and second generation rapid-acting mealtime insulins or insulin analogs, VIAtab, a sublingual tablet formulation of insulin, a line of basal insulins, and a stabilized formulation of glucagon.



For only $19 a month, you can sign up for our real-time stock alert service. Click here to join now: http://www.pennystocklive.com/premium-membership/



In the report, the analyst notes:



"Shares of BIOD soared ahead of the biotech company's presentation at JPMorgan's annual healthcare conference in San Francisco Thursday. The Company was expected to provide a corporate update, which includes information about the development of new follow-on formulations of its lead product, Linjeta, including milestones and timelines.



"BIOD is trading above its 20-day moving average. This is considered to be the sign of a bullish trend. There is added weight to this indication because the moving average is rising and suggests that there has been buying interest in this stock."



To read the entire report visit: www.microstockprofit.com/lp/BIOD



See what investors are saying about BIOD at http://www.stockhideout.com



Get breaking news on BIOD at http://thestockmarketwatch.com/



MicroStockProfit.com is a small-cap research and investment commentary provider. MicroStockProfit.com strives to provide a balanced view of many promising small-cap companies that would otherwise fall under the radar of the typical Wall Street investor. We provide investors with an excellent first step in their research and due diligence by providing daily trading ideas, and consolidating the public information available on them. For more information on MicroStockProfit please visit: http://www.microstockprofit.com



MicroStockProfit.com Disclosure



MicroStockProfit.com is not a registered investment advisor and nothing contained in any materials should be construed as a recommendation to buy or sell any securities. MicroStockProfit.com is a Web site wholly owned by BlueWave Advisors, LLC. Neither MicroStockProfit.com nor its affiliates have a beneficial interest in the mentioned company; nor have they received compensation of any kind for any of the companies listed in this communication. Please read our report and visit our Web site, MicroStockProfit.com, for complete risks and disclosures.


Contact:
Brian [email protected]

[setravis]

Biodel Inc. (BIOD US) rose 10 percent to $2.75, the highest price since Oct. 29. The company announced a new strategy for the insulin formulation Linjeta that "may ultimately improve chances of partnering," JPMorgan Chase & Co. said in a note.

Shares of Biodel(BIOD) were soaring for the second consecutive day, rising 12% to $2.80 on investor optimism about the prospects for the company's insulin drug, Linjeta. The stock gained 28% on Thursday, as the company made a presentation at the JPMorgan Healthcare Conference. Volumes were higher than average at 3.5 million shares.

Biodel Inc.'s(BIOD 2.75, +0.25, +10.00%)  shares closed up 10% with investors hopeful about prospects for its insulin drug.

[setravis]

BIOD Still Running!
This pup has gone from 1.95 to 2.75 IN TWO DAYS!
Still looking real good. Expect it to keep going a little while longer.
Expecting more upside on Tuesday...after that we'll see...

Day's Range: 2.52 - 2.97
52wk Range: 1.50 - 6.25
Volume: 6,611,071
Avg Vol (3m): 1,232,320
Market Cap: 72.69M
P/E (ttm): N/A
EPS (ttm): -1.59
Div & Yield: N/A (N/A)

Technicals
Most Actives
Percentage Gainer

Last Price Quote is:
31.76%above 13-day EMA
25.67%above 50-day EMA
RS Rating: 5 

[setravis]

Loss at BIOD Narrower than Expected...

BIOD  Biodel Reports First Quarter Fiscal Year 2011 Financial...  by PR Newswire  Feb 3 2011 4:00PM

DANBURY, Conn., Feb. 3, 2011 /PRNewswire via COMTEX/ -- Biodel Inc. (BIOD) today reported financial results for the quarter ended December 31, 2010.

First Quarter Fiscal Year 2011 Financial Results

Biodel reported a net loss for the three months ended December 31, 2010 of $5.3 million, or $0.20 per share, compared to a net loss of $11.1 million, or $0.47 per share, for the same period in the prior year.

Research and development expenses were $5.5 million for the three months ended December 31, 2010, compared to $8.8 million for the same period in the prior year. The decrease in research and development expenses was primarily due to reductions in clinical and regulatory expenses following the submission of the new drug application (NDA) for Linjeta(TM) in December 2009 and the awards from the Internal Revenue Service totaling $1.2 million in research grants under the Internal Revenue Service's therapeutic discovery tax credit program in October 2010. These awards were recorded as a credit against research and development efforts. The reductions in clinical and regulatory expenses and the research credit were partially offset by a $1.3 million charge related to severance benefit obligations incurred pursuant to the company's employment agreement with Dr. Steiner, our former chief scientific officer, following his retirement in December 2010. General and administrative expenses totaled $2.6 million for the three months ended December 31, 2010, compared to $2.4 million for the same period in the prior year. The increase in general and administrative expenses was attributable to personnel expenses.

The company marks-to-market each reporting period the change in fair value of 2.4 million warrants which were issued as part of an August 2010 financing. For the three months ended December 31, 2010, Biodel reported $2.8 million in other income as a result of the revaluation.

Expenses for the three months ended December 31, 2010 and 2009 include $1.5 and $1.3 million, respectively in stock-based compensation expense related to options granted to employees and non-employees.

Biodel did not recognize any revenue during the three months ended December 31, 2010 or 2009.

At December 31, 2010, Biodel had cash and cash equivalents of $22.3 million and 26.4 million shares outstanding.

Business Review

Biodel recently met with staff from the U.S. Food and Drug Administration (FDA) on January 28, 2011 to discuss the agency's October 29, 2010 complete response letter regarding the NDA for Linjeta(TM) and to explore appropriate next steps for the ultra-rapid-acting prandial insulin program. The End of Review Meeting addressed questions posed by Biodel in response to the FDA's complete response letter. During the meeting the FDA considered questions posed by Biodel to help define paths forward regarding clinical trial design, injection site tolerability, toxicology and chemistry, manufacturing and controls.

Since the Linjeta(TM) NDA was submitted in December 2009, Biodel has developed and tested new formulations of Linjeta(TM) that maintain its favorable pharmacokinetic profile for speed of activity and stability and may improve injection site tolerability. Based upon encouraging early results from these studies, Biodel has decided to fund clinical development of several alternative formulations of Linjeta(TM) with the goal of determining the preferred formulation and advancing it into Phase 2 clinical testing in 2012.

The company has decided to focus most of its resources on the ultra-rapid-acting prandial insulin program and to limit funding of its earlier-stage development programs, which include a glucose-sensing basal insulin formulation, a glargine formulation with improved basal characteristics, a stable liquid formulation of glucagon for convenient rescue therapy and pump use, and a sublingual insulin formulation known as VIAtab(TM). In a related action, the company has reduced certain expenses and cut staff by 25 percent in order to maintain funding for the ultra-rapid-acting prandial insulin program.

Conference Call and Webcast Information

Biodel's senior management will host a conference call on February 3, 2011, beginning at 4:30 pm Eastern Standard Time, to discuss these results and provide a company update. Live audio of the conference call will be available to investors, members of the news media and the general public by dialing 1-877-303-8028 (United States) or 1-760-536-5167 (international). To access the call by live audio webcast, please log on to the investor section of the company's website at www.biodel.com . An archived version of the audio webcast will be available at Biodel's website.

About Biodel Inc.

Biodel Inc. is a specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that may be safer, more effective and more convenient for patients. We develop our product candidates by applying our proprietary formulation technologies to existing drugs in order to improve their therapeutic profiles. For further information regarding Biodel, please visit the company's website at www.biodel.com .

Safe-Harbor Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements about future activities related to the complete response letter regarding the company's new drug application for Linjeta(TM); the company's response to the complete response letter; the importance of the complete response letter; and the company's focus, goals, strategy, research and development programs, and ability to develop and commercialize product candidates. Forward-looking statements represent our management's judgment regarding future events. All statements, other than statements of historical facts, including statements regarding our strategy, future operations, future clinical trial results, future financial position, future revenues, projected costs, prospects, plans and objectives of management are forward-looking statements. The words "anticipates," "believes," "could," "estimates," "expects," "intends," "may," "plans," "potential," "predicts," "projects," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The company's forward-looking statements are subject to a number of known and unknown risks and uncertainties that could cause actual results, performance or achievements to differ materially from those described or implied in the forward-looking statements, including, but not limited to, our ability to respond to the complete response letter regarding our new drug application for Linjeta(TM) in a timely manner and the possibility that information we provide in response to the letter may not be accepted by the FDA; our ability to secure FDA approval for Linjeta(TM) and our other product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act; our ability to market, commercialize and achieve market acceptance for product candidates developed using our VIAdel(TM) technology; the progress or success of our research, development and clinical programs and the initiation and completion of our clinical trials; the possibility that patients taking Linjeta(TM) may experience more injection site discomfort than they experience with competing products; unexpected data that may result from our clinical trials and our research and development activities; our ability to protect our intellectual property and operate our business without infringing upon the intellectual property rights of others; our estimates of future performance; our ability to enter into collaboration arrangements for the commercialization of our product candidates and the success or failure of those collaborations after consummation, if consummated; the rate and degree of market acceptance and clinical utility of our products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; and other factors identified in our most recent annual report on Form 10-K for the year ended September 30, 2010. The company disclaims any obligation to update any forward-looking statements as a result of events occurring after the date of this press release.

SOURCE Biodel Inc.
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Development and commercialization of treatments for diabetes.
Pulled back into buy range.