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Updated FDA Calendar of 75 Decision Dates FRX

76%

+2.98% in 14 hours Updated FDA Calendar of 75 Decision Dates 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 upc ... Continue reading »

By  Mike Havrilla   (-6.40%  risk: moderate)  11/21/08

Comment

A Backlog of Decisions is Building at the FDA FRX

76%

-17.04% in 14 days (closed on 11/21/08) A Backlog of Decisions is Building at the FDA The accompanying table presents 70 FDA product approval decision dates along with the market caps and one year stock price change for the underlying companies. A note of caution for investors and traders is that the most common outcome from the FDA in the past year has been a delay in decisions due to understaffed conditions at the agency. However, several companies have pending decisions which are likely to occur either before year-end or early next year and will have a major impact on their stock prices. Disco ... Continue reading »

By  Mike Havrilla   (-6.40%  risk: moderate)  11/07/08

Comment

FDA Action Heats Up Before Year-End FRX

76%

-5.04% in 17 days (closed on 11/07/08) FDA Action Heats Up Before Year-End The accompanying table presents an updated calendar of expected FDA decision dates and advisory committee [FDAC] meetings expected to impact the price of underlying biotech and pharma stocks. Genzyme (GENZ) faces a FDAC tomorrow (10/21) for its pending BLA for Myozyme manufactured at the 2,000L bioreactor scale. Also, Discovery Labs (DSCO) submitted its complete response to the FDA last Friday to address an approvable ruling for Surfaxin back in May and insiders continue to buy the stock. DSCO expects the FDA to rule on Surfaxin ... Continue reading »

By  Mike Havrilla   (-6.40%  risk: moderate)  10/21/08

Comment

FDA Decision Date Calendar Through January 2009 FRX

76%

-15.07% in 30 days (closed on 10/21/08) FDA Decision Date Calendar Through January 2009 The accompanying table includes a calendar of expected FDA decision dates through the end of January 2009, including nine decisions due by the end of September. Some likely near-term movers on the calendar include Cypress Bioscience (CYPB) + partner Forest Labs (FRX) with a pending decision on milnacipran in the treatment of fibromyalgia slated for the end of October in addition to results from a Phase 3 trial for the drug some time before year end. Also, Discovery Labs (DSCO) is not listed on the calendar, b ... Continue reading »

By  Mike Havrilla   (-6.40%  risk: moderate)  09/21/08

Comment

Milnacipran Phase 3 Results and FDA Decision Should Move Forest Labs Off Lows FRX

76%

+1.60% in 8 days (closed on 09/21/08) Cypress Bioscience: Poised for Major Move on Pending Phase 3 Results and FDA Decision Since I last wrote about Cypress Bioscience (CYPB) two months ago , the stock has moved lower with the Company now trading even closer to its net cash position of $4 per share with a closing price on Friday of $6.43 per share. The level of short interest has remained steady this year and is still high at 6.6 million shares compared to a float of about 32 million shares and average volume that is just over 300,000 shares per day. Most of the options action in Cypress Bio is ... Continue reading »

By  Mike Havrilla   (-6.40%  risk: moderate)  09/13/08

Comment

Generics Embarking on Forest FRX

-38.90% in 163 days Research and development expense is also expected to dramatically increase to support the pipeline, and as a result higher milestone payments. Continue reading »

By  Zacks.com   (-29.25%  risk: conservative)  06/12/08

Comment

strong third quarter results FRX

19%

-50.05% in 271 days Forest Labs ( FRX ) Forest Labs ( FRX ) shares have put on quite a performance in 2008, as strong third quarte results have propelled the company's stock price sharply higher in a very challenging market environment. On Jan 15, Forest Labs reported that its third quarter revenue grew 12% to $998.2, while net income jumped 20% to $301.8 million, from the same period last year. Investors obviously liked the results, sending its share price rocketing higher. Since the great report, shares have been pressuring a key area of resistance just above $41. Shares have broke... Continue reading »

By  Armin Stuk   (-44.02%  risk: conservative)  02/25/08

Comment

Buy Forest Labs (FRX) and get 16% compounded annual return FRX

14%

-47.79% in 445 days Forest Labs (FRX) develops and makes branded and generic ethical drug products. It products include Lexapro, a single isomer version of Celexa for the treatment of major depression and generalized anxiety disorder; Namenda, N-methyl-D-aspartate antagonist for the treatment of moderate to severe Alzheimer's disease; Benicar, an angiotensin receptor blocker for the treatment of hypertension, and Continue reading »

By  retirerichblog   (-26.76%  risk: conservative)  09/04/07

Comment

People Bullish on FRX

Mike Havrilla Principal 76% about 15 hours ago	bargainstocks Analyst 77% 8 days ago	Art Klivinsky Analyst 73% 29 days ago
kentucky Analyst 60% 3 mos ago	stocktr0n Analyst 53% 8 mos ago

People Bearish on FRX

mlgeorge Analyst N/A 6 mos ago

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