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FDA Calendar Updates: KG, PTIE, DRRX, ALTH, TRIB, CBST, DYAX ALTH

73%

-19.15% in 151 days <> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 243 entries as of 7/7/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending... Continue reading »

Lixte Biotech (OTC:LIXT): Key 2H09 Catalysts Await ALTH

73%

+9.00% in 14 days (closed on 07/07/09) <> Since I first wrote about Lixte Biotech (OTC:LIXT) at <font> BioMedReports.com in early April </font> , the Company has provided an update on its development-stage cancer drug discovery operations as part of a SEC 10Q filing in mid-May for 1Q09. LIXT.OB was originally founded as a diagnostics company in 2005 evaluating biomarkers (indicators of disease at the molecular level), but has shifted its focus to cancer drug discovery research that is primarily focused on the development of compounds for malignancies with few effective treatment options – such as certain types of brain cancer<><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><><>... Continue reading »

FDA, Clinical Trial Calendars: Cancer Drug Updates from ASCO ALTH

73%

+0.69% in 23 days (closed on 06/23/09) <> Below is a summary of updates to the BioMedReports.com database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . 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 respon... Continue reading »

Clinical Trial Updates: Cancer Drugs in Focus as ASCO Approaches ALTH

73%

+13.75% in 14 days (closed on 05/31/09) <> Below is a summary of updates to the <font> BioMedReports.com </font> database of over 200 entries included in the <font> FDA and Clinical Trial Calendars </font> . 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 fo... Continue reading »

Allos Therapeutics: Small-Cap Cancer Biotech with FDA Catalyst ALTH

73%

+13.27% in 20 days (closed on 05/17/09)  Allos Therapeutics (ALTH) is small-cap cancer biotech which filed a NDA on 3/25/09 for pralatrexate (PDX) in the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (PTCL). ALTH requested priority (six-month) review for the application, with an expected 60-day period for the FDA to accept the filing and rule on priority review status.   <> The priority review PDUFA date would be 9/25/09 (versus 1/25/10 for standard, 10-month review). PTCL comprises a biologically diverse group of blood-based cancers that typically have a worse progno... Continue reading »

From the Blogosphere

Allos Reports in Line – Analyst Blog

38%

Allos Therapeutics’ (ALTH) third quarter loss per share came in at 21 cents, in line with the Zacks Consensus Estimate. However, the loss increased compared to the net loss of 16 cents reported in the year ago period. Loss increased primarily due to a 41% rise in operating expense. The huge increase in general and administrative expenses by 113% led to a rise in operating expenses.  The quarter has been quite significant for Allos. In September, the company received accelerated approval from the US Food and Drug Administration (FDA) for pralatrexate (Folotyn) for the treatment of patients... Continue reading »

Analyst upgrades, downgrades and initiations: WDC, NSTX, UBS, TIF, BA ...

Filed under: Analyst reports, Analyst upgrades and downgrades, Boeing Co (BA), Tiffany and Co (TIF), Analyst initiations Analyst upgrades: <> Baird upgraded Western Digital (NYSE: WDC) and Seagate (NASDAQ: NSTX) to Outperform from Neutral citing better than expected industry conditions. The firm believes supply has tightened, resulting in price increases in certain market segments. RBC Capital upgraded XTO Energy (NYSE: XTO) to Outperform from Sector Perform citing free cash flow and stable growth. <>Goldman upgraded Manpower (NYSE: MAN) to Neutral from Sell and raised its target to $2... Continue reading »

Morning Movers 12/08: Chesapeake Energy (CHK) Higher on Capex Cut; GM (GM) Up On Likely Short-Term Gov Aid

StreetInsider.com Morning Movers: <>Chesapeake Energy Corp. (NYSE: CHK) 28% HIGHER; Updates Financial and Operational Plans Through 2010. Cutting capex, common shares to be offered. General Motors (NYSE: GM) 22% HIGHER; US Considering $15B short-term loan package for automakers Allos Therapeutics, Inc. (NASDAQ: ALTH) 21% LOWER; announced preliminary top line results from PROPEL, the Company's pivotal Phase 2 trial of pralatrexate (PDX) in patients with relapsed or refractory peripheral T-cell lymphoma. 29 of 109 evaluable patients (27%) achieved either a complete or partial response. Human Gen... Continue reading »

Analyst initiations: FSC and HD

Filed under: Home Depot (HD), Analyst initiations MOST NOTEWORTHY: Fifth Street Finance and Home Depot were today's noteworthy initiations: <> Wachovia believes Fifth Street Finance (NYSE: FSC) is better positioned than many of its peers, especially in the areas of capital and growth. The firm, which started shares with an Outperform rating, believes the company's reduced competition and liquidity should allow it to pick the best investment opportunities. <>Home Depot (NYSE: HD) was initiated with a Buy rating and $30 target at Rochdale, citing Home Depot's valuation and shift towards maxi... Continue reading »

Analyst initiations: RIO, ALTH and TMK

Filed under: Analyst reports, Analyst initiations MOST NOTEWORTHY: Vale, Allos Therapeutics and Torchmark were today's noteworthy initiations: <> Lehman believes Vale (NYSE:RIO) is well-positioned to benefit from rising steel demand in emerging economies. The firm started shares with an Overweight rating and $45 target. Citigroup initiated Allos Therapeutics (NASDAQ:ALTH) with a Buy rating and $11 target and believes the company's lead drug PDX is likely to be the first FDA approved agent for peripheral T cell lymphoma. <>Friedman Billings expects Torchmark's (NYSE:TMK) sales to get b... Continue reading »

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