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FDA Watchlist - (AMEX: HEB)

Fri, 08 May 2009 15:45:00 GMT

Due to the explosive demand for BioPharma companies pending Food and Drug Approval on new and innovative drugs, I will begin focusing on companies which are a few weeks away from their reviews. Taking notice of the recent 3000%, and 1000% over night gains respectively of TTNP and VNDA, the risk versus rewards leans well towards the positive end on these[More...]

FDA Calendar Updates: AMAG Pharma (Nasdaq: AMAG), Northfield Labs (NASDAQ:NFLD)

Fri, 01 May 2009 04:29:49 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 (...)[More...]

FDA Calendar Stocks On The Move: DSCO, VION, NFLD

Thu, 16 Apr 2009 20:05:12 GMT

Below is a summary of updates to the BioMedReports.com database of 241 entries included in the FDA and Clinical Trial Calendars. 1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). The NDA was filed 2/17/09, accepted by FDA for standard, 10-month review on 4/17/09 with a PDUFA decision (...)[More...]

Trading FDA Decisions: 14 Extreme Trades

Wed, 11 Mar 2009 16:25:00 GMT

Below is a summary of companies from the BioMedReports.com FDA Decision Date Calendar which have market caps below $200M, making them ideal candidates for extreme stock price volatility trades as their decision dates become imminent. Dyax Corp. (DYAX) secured a narrow approval from a FDA Advisory Panel in early February (with a 6-5-2 vote) for its Kalbitor (ecallantide or DX-88) BLA with a PDUFA date of 3/23/09, which is designated for priority review in the treatment of acute attacks of hereditary angioedema (HAE is a rare disorder marked by severe swelling which can be fatal if the throat area is involved). The panel debated the need for an effective treatment for this rare, potentially dangerous condition against the 3% higher incidence of allergic reactions (13% versus 10%) in patients taking[More...]

FDA Decision Calendar: 16 Extreme Trades

Wed, 04 Feb 2009 18:49:00 GMT

Click here for a link to my previous FDA calendars and the list below highlights 16 companies with pending new product decisions at the agency + market caps below $150M, making them ideal candidates for extreme stock price volatility trades. BioDelivery Sciences (BDSI) – Onsolis approval is possible by mid-2009 and the Company raised $6M in cash from partner Meda AB, representing a $3M expanded licensing agreement + a $3M advance of the $30M milestone payment upon FDA approval. The remaining $27M cash milestone payment on FDA approval for Onsolis represents nearly one-half of the Company's current market cap, in addition to royalties that will be received on product sales once the breakthrough cancer pain drug is on the market. Discovery Labs (DSCO) has a 4/17/09 PDUFA[More...]

FDA Decision Calendar: Extreme Trades

Sun, 18 Jan 2009 03:45:00 GMT

The accompanying table (click to enlarge) includes an updated calendar of 78 expected FDA new product decisions with more detailed comments for each entry. Click here for a link to my previous FDA calendars and the list below highlights companies with pending decisions + market caps below $100M, making them ideal candidates for extreme trading opportunities. [More...]

Buyout Binge Begins for Bio-Pharma, Diagnostics

Sat, 10 Jan 2009 18:09:00 GMT

With news late Friday that Roche (RHHBY) is prepared to up its bid for complete control of Genentech (DNA) to $95 from a previous offer of $89 per share and a $41M ($1.50 per share) all-stock takeover offer by Sequenom (SQNM) for EXACT Sciences (EXAS); 2009 is off to a strong start for M&A activity in the bio-pharma and diagnostic[More...]

Morning Brief: Pre Market Stock News and ETF Update

Tue, 30 Dec 2008 13:50:00 GMT

: iStockAnalyst.com Symbols Feed

FDA Watchlist - (AMEX: HEB)

FDA Calendar Updates: AMAG Pharma (Nasdaq: AMAG), Northfield Labs (NASDAQ:NFLD)

FDA Calendar Stocks On The Move: DSCO, VION, NFLD

Trading FDA Decisions: 14 Extreme Trades

FDA Decision Calendar: 16 Extreme Trades

FDA Decision Calendar: Extreme Trades

Buyout Binge Begins for Bio-Pharma, Diagnostics

Morning Brief: Pre Market Stock News and ETF Update

FDA Calendar: Allergan's New Rx for Eyelashes

Pre-Market - Thursday September 6th

Northfield Laboratories Files for Bankruptcy

Northfield Laboratories Announces Receipt of Delisting Notification From the Nasdaq Stock Market

Northfield Laboratories Inc. Reports Fiscal 2009 Third Quarter Financial Results

RedChip Visibility Initiates Research Coverage On Northfield Laboratories Inc.

Northfield Announces Closing of Financing

Northfield Announces Financing

Northfield Implements Measures to Preserve Cash

New Study Demonstrates Use of Northfield’s PolyHeme® Mitigates Tumor Progression in Pancreatic Cancer Model

Northfield Laboratories Inc. Reports Fiscal 2009 Second Quarter Financial Results

Northfield Laboratories Inc. Announces Second Quarter 2009 Financial Results Webcast

BenchmarkJournal.Com (Complimentary) Analyst Review for CVH, CI, LOGI and NFLD

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