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Technical Breakout Alert Issued For CytRx (NASDAQ:CYTR)

Mon, 23 Nov 2009 13:57:08 GMT

Miv Investments Inc. has initiated an independent bullish technical trading alert for 11/23/09 on CytRx Corporation (NASDAQ:CYTR). Shares of the company finished trading during 11/20/09 at $1.35 per share, up 20.18% from the opening bell on heavy buying pressure. As of 11/18/09, the biopharmaceutical company announced plans to initiate an open-label, multinational Phase 2 clinical trial with its doxorubicin prodrug INNO-206 as a second-line treatment in patients with advanced gastric (stomach) cancer.[More...]

BioMed News Bytes: GeoVax, Cerus, Discovery Labs

Tue, 17 Nov 2009 20:23:35 GMT

On 11/17/09, GeoVax (OTC: GOVX.OB) announced that the FDA has granted its request for a pre-IND meeting to discuss the proposed Investigational New Drug (IND) application for the Company's therapeutic vaccine as a treatment for individuals already infected with HIV. The meeting will only take place if the Company is not satisfied or requires some clarification to the FDA's answers to the questions submitted in the pre-IND package.[More...]

Market Closing : Lower Finish But Markets Record 2%-3% September Gains, 15% Surge in Quarter

Wed, 30 Sep 2009 21:25:00 GMT

Stocks end in the red, but finish well off session lows. The Dow Jones Industrial Average is up 2.3% for the month of September and up around 15% for the third quarter. The S&P 500 is up 3.6% for the month, up 15% for the quarter. The Nasdaq ends September up 5.6% for the month and gains 15.7% for the quarter.[More...]

Discovery Labs – FDA Meet For Surfaxin Approval (DSCO)

Mon, 14 Sep 2009 17:31:43 GMT

After a sit-down plan with the FDA regulators over the possibility of a limited trial, shares of Discovery Laboratories suddenly saw an upwards trend. This meeting will help Discovery Laboratories to get more information and data to overcome the outstanding primary concerns related to its respiratory drug Surfaxin.[More...]

Updated Calendar Of 12 Extreme Trades On Pending FDA Decisions

Tue, 19 May 2009 17:08:30 GMT

Below are 12 extreme FDA trades of companies with market caps below $200M which have pending new drug product decisions or other meetings/milestones scheduled with the FDA that are expected to have a major impact on each of the underlying stock prices as the PDUFA decision dates approach and the decision is ultimately announced. A high risk/reward trading approach to consider for speculative traders is investing a small amount of money that you can afford to lose in a basket of stocks included i (...)[More...]

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, Clinical Trial Calendar Updates: DSCO, IPXL

Mon, 20 Apr 2009 16:32:00 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...]

Elan, NRG Energy, Boeing are big movers

Thu, 02 Jul 2009 22:06:00 GMT

Johnson & Johnson said it will take an 18.4 percent stake in the Ireland-based drug developer with a $1 billion investment.
Exelon Corp. sweetened its hostile takeover bid for the company to $8 billion in stock, citing newly identified cost savings.
Rite Aid Corp., down 19 cents at $1.35

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Discovery Labs Says More Capital is Key

Fri, 13 Mar 2009 21:46:00 GMT

Mar. 13--Discovery Laboratories Inc. today reported a loss of $8.54 million, or 8 cents a share, in the latest fourth quarter, and said if it can't raise additional capital it will likely not have sufficient cash flow and liquidity to fund business operations.
As of Dec. 31, the company had an accumulated deficit of $327.4 million.
Discovery disclosed in its annual report that its auditor, Ernst & Young LLP, has raised questions about Discovery's ability to continue as a going concern.

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PicksThatMove.Com Announces Investment Opinion: Hot Stocks That Are on the Move

Wed, 30 Sep 2009 20:48:00 GMT

PicksThatMove is pleased to bring investors special situation stocks which have a high potential for price appreciation.
The investment opinions offered below and in this press release are provided by Nick Hunter, RIA, of PicksThatMove.com
Hoku Scientific, Inc. (NASDAQ:HOKU) shares jumped over 50% and trade as high as $4.33 in morning trade as the Company announced a definitive agreement for majority investment with Tianwei Energy Holdings Co. for the construction and development of Hoku's polysilicon production facility in Pocatello, Idaho.

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PicksThatMove.Com Announces Investment Opinion: Small Cap Biopharmaceuticals and Biotechnology 101 From PicksThatMove

Tue, 15 Sep 2009 21:46:00 GMT

PicksThatMove.com opines promising trading opportunities with likely potential for gain.
Please visit us at PicksThatMove.com to view more of our profiled stocks.
Morning movers in biopharmaceutical sector include: GenovaBiotherapeutics Inc. (OTCBB:GVBP) up 84% closing at $0.80, Tenet Healthcare Corp (NYSE:THC) down 0.17% trading at $5.75, Discovery Laboratories Inc. (NASDAQ:DSCO) down 5% trading at $1.01, ARIAD Pharmaceuticals Inc. (NASDAQ: ARIA) down 7% trading at $2.54 and KERX Biopharmaceuticals Inc. (NASDAQ:KERX) up 1.30% trading at $1.55.

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Discovery Labs Announces Resignation of CEO Robert J. Capetola, Ph.D.; W. Thomas Amick, Chairman of the Board, Appointed Interim CEO

Thu, 13 Aug 2009 22:37:00 GMT

Discovery Laboratories, Inc. , a biotechnology company developing its proprietary KL4 surfactant technology to improve respiratory critical care medicine, today announced the resignation of President and Chief Executive Officer Robert J. Capetola, Ph.D. Dr. Capetola has also resigned as a Director of Discovery Labs' Board of Directors. W. Thomas Amick, Chairman of the Board of Discovery Labs, has been appointed interim Chief Executive Officer.[More...]

Discovery Labs Provides Second Quarter 2009 Financial Results and Business Strategy Update

Wed, 29 Jul 2009 10:56:00 GMT

Discovery Laboratories, Inc. today is announcing financial results for the second quarter ended June 30, 2009 and is providing an update on its strategic business activities. The Company will host a conference call today at 10:00 AM EDT. The call-in number is 866-332-5218.[More...]

Discovery Labs Schedules Conference Call and Webcast

Thu, 23 Jul 2009 11:57:00 GMT

Discovery Laboratories, Inc. will be hosting a conference call on Wednesday, July 29, 2009 at 10:00 AM EDT. Management will provide an update on business activities as well as financial results for the second quarter of 2009.[More...]

Discovery Labs Reports On Surfaxin End of Review Meeting With FDA

Wed, 01 Jul 2009 20:58:00 GMT

Discovery Laboratories, Inc. announces today, after receipt of written minutes from the United States Food and Drug Administration, the results of its June 2, 2009 meeting with the FDA. This meeting followed the FDA's April 17 Complete Response Letter for Surfaxin for the prevention of Respiratory Distress Syndrome in premature infants and was convened to discuss resolution of the remaining primary issue necessary for marketing approval of Surfaxin. The meeting focused on the Surfaxin fetal rabbit biological activity test , specifically whether data that had been previously submitted to the FDA and generated using both the BAT and a well-established preterm lamb model of RDS adequately supports the comparability of Surfaxin clinical drug product to commercial drug product, and whether the BAT can adequately distinguish change in Surfaxin biological activity over time.[More...]

Discovery Labs Announces Completion of $11.3 Million Registered Direct Offering

Wed, 13 May 2009 20:02:00 GMT

Discovery Laboratories, Inc. today announced that it has completed its previously announced registered direct offering of 14 million shares of its common stock and warrants for 7 million shares of common stock. The shares were issued and sold to select institutional investors at a price of $0.81 for each share of common stock, together with a related warrant to purchase 0.5 shares of common stock. The warrants are exercisable for a period of five years at an exercise price of $1.15 per share of common stock. As a result of the offering, Discovery Labs has received gross proceeds of approximately $11.3 million, before deducting placement agent's fees and other offering expenses. Lazard Capital Markets LLC acted as the exclusive placement agent for the transaction.[More...]

Discovery Labs and FDA to Meet On June 2, 2009 to Discuss SURFAXIN Complete Response Letter

Mon, 11 May 2009 20:26:00 GMT

Discovery Laboratories, Inc. has received written notification from the U.S. Food and Drug Administration that an end-of-review meeting has been scheduled for June 2, 2009 at the FDA offices in Rockville, Maryland. The purpose of this meeting is to determine the resolution of the remaining primary issue necessary for Discovery Labs to gain U.S. marketing approval of Surfaxin for the prevention of Respiratory Distress Syndrome in premature infants.[More...]

Discovery Labs to Raise $11.3 Million in Registered Direct Offering

Fri, 08 May 2009 19:02:00 GMT

Discovery Laboratories, Inc. today announced that it has entered into definitive agreements with select institutional investors to raise gross proceeds of approximately $11.3 million, before deducting placement agent's fees and other offering expenses, in a registered direct offering. Under the terms of the transaction, Discovery Labs will sell 14 million shares of its common stock at a purchase price of $0.81 per share. Investors will also receive warrants to purchase one half share of common stock for each share of common stock purchased. The warrants will be exercisable at any time on or after the date of issuance for a period of five years at an exercise price of $1.15 per share of common stock. The closing of the offering is expected to take place on May 13, 2009, subject to the satisfaction of customary closing conditions. Lazard Capital Markets LLC acted as the exclusive placement agent for the transaction.[More...]

Discovery Labs' Surfaxin(r) Significantly Improves Lung Surfactant Distribution in Preclinical RDS Model

Tue, 05 May 2009 10:55:00 GMT

Discovery Laboratories, Inc. , announced that data from a preclinical study using Surfaxin in a well-established preterm lamb model of Respiratory Distress Syndrome , demonstrated improved lung surfactant distribution as compared with Curosurf, the global market-leading animal-derived surfactant available today. The data were presented at the Pediatric Academic Societies Annual Meeting, which is internationally recognized as the largest, most relevant medical congress dedicated to pediatric research.[More...]