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This Fall Will Be Crazy For These Biotech Stocks

Fri, 16 Oct 2009 18:50:27 GMT

Most speculators have it all wrong when it comes to biotech trading... They'll buy biotech stocks ahead of FDA decisions, hoping an approval will bring 100% overnight gains. But more often than not, the market is one step ahead. The stock price will creep up as everyone anticipates good news.[More...]

Be Prepared For These Huge Biotech Catalysts In September

Fri, 21 Aug 2009 15:16:00 GMT

Biotech stocks are the most volatile in the world. One-day jumps of 200% and overnight crashes of 90% are commonplace. The biggest culprit behind biotech volatility? The United States Food and Drug Administration, the FDA. Before ending up on pharmacy shelves, every new drug needs to pass through a series of regulatory hurdles dictated by the FDA. Without the FDA's blessing, a drug – no matter how great it may be – cannot make it to market. So an FDA approval can help propel the stock 30% or more. A rejection could send the stock tumbling as much as 90%. Because of this, biotech traders love taking a position ahead of FDA rulings... Which means next month is shaping up to be one of the most event-packed months for biotech traders. I've highlighted six major FDA decisions in the next month below: Date Company FDA Action Drug –[More...]

BioMedReports FDA Calendar: 19 Hot Summer Trades

Wed, 17 Jun 2009 12:13:04 GMT

Below is a sample of entries from the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The companies outlined below have expected FDA new drug product decisions or clinical trial results expected over the next three months of summer. The list also includes some Extreme Trades of companies with market caps below $250 million that have pending clinical trial results or FDA decisions that could have a major stock price impact. Rigel Pharma (NASDAQ:RIGL): On 5/5/09, (...)[More...]

FDA, Clinical Trial Updates: Pro-Pharma (OTC:PRWP) Looks Promising

Thu, 30 Apr 2009 14:02:26 GMT

Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted. Theravance (THRX:[More...]

Theravance Nears Commercialization

Tue, 17 Feb 2009 14:27:00 GMT

Highlights include Theravance (THRX), ViroPharma (VPHM), Cubist (CBST), Pfizer (PFE), Wyeth (WYE) and Johnson & Johnson (JNJ). Theravance Close to Commercialization; Competition a Concern [More...]

Earnings Preview for Feb 9-13 - Earnings Preview

Fri, 06 Feb 2009 18:52:00 GMT

Activision Blizzard Inc. (ATVI) could top expectations. IntercontinentalExchange, Inc. (ICE) and Terex Corporation (TEX) could miss. Though nearly 400 companies are scheduled to report, traders are going to keep a close eye on Washington. Treasury Secretary Timothy Geithner will announce a revised bank bailout plan on Monday. This plan could include the creation of a bad bank to absorb distressed debts (what TARP was[More...]

Emerging Biotech & Pharma Index: 36 More Cos.

Mon, 24 Nov 2008 05:35:00 GMT

The accompanying table (click to enlarge or download) includes the 36 remaining companies in the ETF Innovators (ETFI) Emerging Bio-Pharma Index with market caps between $150M-$1.5B, which were not included in the previous two articles I wrote about the group – featuring the Top 40 Rated Companies and companies below the $150M market cap cutoff. However, several of the companies included in the remaining group of 36 have been in the news recently due to [More...]

Updated FDA Calendar Of 73 Decision Dates

Sat, 22 Nov 2008 16:52:00 GMT

The accompanying table (click to enlarge or download) includes an updated calendar of 75 expected FDA decision dates as part of the ETF Innovators (ETFI) New Drug Regulatory Catalyst Index, which includes a full slate of expected action before year-end outlined in my previous article. The last few days have been busy for antibiotics at the agency, resulting in sharply lower stock prices for Targanta Therapeutics (TARG) and Theravance (THRX). An FDA panel voted against Targanta's oritavancin, which has an upcoming decision in early December and sent shares crashing from 8 bucks before[More...]

GSK Boosts Theravance, Near-Term

Thu, 26 Jun 2008 14:27:46 GMT

We expect the U.S. launch of Theravance, Inc.'s (THRX) Telavancin, for the treatment of complicated skin infections, to occur by August, provided the company satisfactorily deals with the manufacturing issues and site monitoring and conduct concerns raise[More...]

Analyst Comments: MCG Capital, TELUS, Smith International, Theravance, Omnicom, China Mobile

Wed, 23 Apr 2008 14:12:01 GMT

MCG Capital Corporation's (MCGC) fourth quarter 2007 distributable net operating income per share (DNOI) was ahead of estimates but GAAP EPS fell substantially short of the expectation. We anticipate the ongoing disruptions in the capital markets to conti[More...]

Big Deals to Reshape Bay Area Biotech

Fri, 13 Mar 2009 00:46:00 GMT

Mar. 12--A wave of multibillion-dollar deals this week signals the acceleration of a deal-making frenzy that will likely reshape the life-sciences industry.
Failing in large measure to develop their own new medicines and facing a slew of generic competitors as their drug patents expire, companies like Roche -- often dubbed Big Pharma -- increasingly are bolstering their product lines by swallowing up biotech and other drug companies with hot products.
And Bay Area biotech companies are especially attractive take-over targets.

[More...]

Big Deals Reshape Bay Area Biotech Industry

Thu, 12 Mar 2009 15:46:00 GMT

Mar. 12--A wave of multibillion-dollar deals this week signals the acceleration of a deal-making frenzy that will likely reshape the life-sciences industry.
Failing in large measure to develop their own new medicines and facing a slew of generic competitors as their drug patents expire, companies like Roche -- often dubbed Big Pharma -- increasingly are bolstering their product lines by swallowing up biotech and other drug companies with hot products.
And Bay Area biotech companies are especially attractive takeover targets.

[More...]

Theravance Announces New Employment Inducement Awards

Mon, 03 Aug 2009 23:10:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 08/03/09 -- Theravance, Inc. today reported that equity awards were made to one new employee. Pursuant to Nasdaq Marketplace Rule 5635, the equity awards were granted under the Theravance, Inc. 2008 New Employee Equity Incentive Plan, which the Board of Directors of Theravance adopted to facilitate the granting of equity awards to new employees. In accordance with Nasdaq rules, these grants were made under an equity incentive plan without stockholder approval. Nasdaq rules require a public announcement of equity awards to be made under this type of plan. One employee was granted an option to purchase 75,000 shares of the Company's common stock and 8,000 restricted stock units. These equity awards vest over approximately four years, and the option expires in 10 years, in each case assuming continued employment. No executive officers received any award under this plan. The exercise price for the option shares granted is $14.73, which was the closing price of Theravance common stock on the Nasdaq Global Market as such price was reported by NASDAQ on the date of grant.[More...]

Theravance Reports Second Quarter 2009 Financial Results

Thu, 23 Jul 2009 20:56:00 GMT

Theravance, Inc. (NASDAQ: THRX) reported today its financial results for the quarter ended June 30, 2009.
Net loss for the second quarter of 2009 was $21.7 million compared with $27.0 million for the same period of 2008, a decrease of $5.3 million.
Net loss per share was $0.35 for the second quarter of 2009 compared with a net loss per share of $0.44 for the same period of 2008.

[More...]

Theravance to Report Second Quarter 2009 Financial Results on July 23, 2009

Thu, 09 Jul 2009 20:00:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 07/09/09 -- Theravance, Inc. announced today that it will release financial results for the period ended June 30, 2009 after market close on Thursday, July 23, 2009.[More...]

Theravance Announces New Employment Inducement Awards

Thu, 02 Jul 2009 00:26:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 07/01/09 -- Theravance, Inc. today reported that equity awards were made to three new employees. Pursuant to Nasdaq Marketplace Rule 4350, the equity awards were granted under the Theravance, Inc. 2008 New Employee Equity Incentive Plan, which the Board of Directors of Theravance adopted to facilitate the granting of equity awards to new employees. In accordance with Nasdaq rules, these grants were made under an equity incentive plan without stockholder approval. Nasdaq rules require a public announcement of equity awards to be made under this type of plan. Three employees were granted options to purchase an aggregate of 90,000 shares of the Company's common stock, which options vest over four years and expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the option shares granted is $15.19, which was the closing price of Theravance common stock on the Nasdaq Global Market as such price was reported by NASDAQ on the date of grant.[More...]

Theravance Announces New Employment Inducement Awards

Thu, 04 Jun 2009 21:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/04/09 -- Theravance, Inc. today reported that equity awards were made to two new employees. Pursuant to Nasdaq Marketplace Rule 4350, the equity awards were granted under the Theravance, Inc. 2008 New Employee Equity Incentive Plan, which the Board of Directors of Theravance adopted to facilitate the granting of equity awards to new employees. In accordance with Nasdaq rules, these grants were made under an equity incentive plan without stockholder approval. Nasdaq rules require a public announcement of equity awards to be made under this type of plan. Two employees were granted options to purchase an aggregate of 3,500 shares of the Company's common stock, which options vest over four years and expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the option shares granted is $14.48, which was the closing price of Theravance common stock on the Nasdaq Global Market as such price was reported by NASDAQ on the date of grant.[More...]

Theravance to Present at Investor Conferences in June 2009

Tue, 02 Jun 2009 20:00:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 06/02/09 -- Theravance, Inc. announced today that Michael W. Aguiar, Senior Vice President and Chief Financial Officer, is scheduled to present at the following investor conferences in June 2009:[More...]

Theravance Announces New Employment Inducement Awards

Mon, 04 May 2009 23:55:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 05/04/09 -- Theravance, Inc. today reported that equity awards were made to three new employees. Pursuant to Nasdaq Marketplace Rule 4350, the equity awards were granted under the Theravance, Inc. 2008 New Employee Equity Incentive Plan, which the Board of Directors of Theravance adopted to facilitate the granting of equity awards to new employees. In accordance with Nasdaq rules, these grants were made under an equity incentive plan without stockholder approval. Nasdaq rules require a public announcement of equity awards to be made under this type of plan. Three employees were granted options to purchase an aggregate of 12,000 shares of the Company's common stock, which options vest over four years and expire in 10 years assuming continued employment. No officers received any award under this plan. The exercise price for the option shares granted is $14.54, which was the closing price of Theravance common stock on the Nasdaq Global Market as such price was reported by NASDAQ on the date of grant.[More...]

Theravance to Present at the Bank of America and Merrill Lynch 2009 Health Care Conference

Thu, 30 Apr 2009 20:00:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 04/30/09 -- Theravance, Inc. announced today that Rick E Winningham, Theravance's Chief Executive Officer, is scheduled to present at the Bank of America and Merrill Lynch 2009 Health Care Conference on Wednesday, May 13, 2009, at 10:00 a.m. EDT. The conference will be held from March 12-14, 2009 at The Palace Hotel in New York City.[More...]

FDA Accepts for Review Theravance's Complete Response Submission for Telavancin for the Treatment of Complicated Skin and Skin Structure Infections

Fri, 24 Apr 2009 20:00:00 GMT

SOUTH SAN FRANCISCO, CA -- -- 04/24/09 -- Theravance, Inc. announced today that the U.S. Food and Drug Administration accepted as complete for review Theravance's response to the February 2009 Complete Response letter, which outlined requirements for approval of telavancin for the treatment of complicated skin and skin structure infections . Telavancin is a novel, bactericidal, once-daily injectable investigational antibiotic studied in the treatment of cSSSI and hospital-acquired pneumonia caused by Gram-positive bacteria, including resistant pathogens such as methicillin-resistant Staphylococcus aureus . The FDA assigned a Prescription Drug User Fee Act goal date of September 16, 2009.[More...]

Theravance to Webcast 2009 Annual Meeting of Stockholders on April 24, 2009

Thu, 16 Apr 2009 20:00:00 GMT

Theravance, Inc. announced today that it will webcast its 2009 Annual Meeting of Stockholders at 1:00 p.m. Pacific Daylight Time on Friday, April 24, 2009.[More...]