Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. 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 BioMedReports.com, 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 late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

Before reviewing the latest updates, below are two companies from the FDA Calendar with pending catalysts expected within the next week.

Savient Phama [SVNT: 12.06, -0.40 (-3.21%)] announced on 5/7/09 that its pending BLA for Krystexxa (pegloticase), a novel biological drug for

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This morning, BioDelivery Sciences International (BDSI) announced that it has reached an agreement with the U.S. Food and Drug Administration's (FDA) Division of Anesthesia, Analgesia and Rheumatology Product on all aspects of the company's New Drug Application (NDA) on Onsolis.The agreement includes the Risk Evaluation and Mitigation Strategy (REMS), which was the previous hurdle to approval and the key reason for the complete response letter received in August 2008. BDSI refilled the NDA in December 2008 with the updated REMS requirement.We expect final FDA action in the next few weeks. Coming to an agreement with the reviewing division and the review team on all aspects of the NDA, including the REMS, clearly bodes well for final approval of the drug.Approval will be a transformational event for BDSI. Not only will it bring about a $30 million milestone payment from worldwide commercialization partner, ...

BioDelivery Sciences International

(NASDAQ:BDSI)

Continuing with the trend of pre-FDA decision BioPharma companies, StocksHaven Investments takes a closer look at BDSI which hopes it’s product Onsolis will strive past approval and make its way onto shelves world-wide.

About BDSI: BioDelivery Sciences International, Inc. is a specialty pharmaceutical company that is utilizing licensed and owned drug delivery technologies to develop and commercialize, either on its own or in partnerships with third parties, significant new formulations of proven therapeutics. Utilizing its drug delivery technologies, the Company is developing formulations of pharmaceuticals aimed at acute (short term) conditions occurring in patients, mostly notably in the areas of pain and fungal infections.

Onsolis: BDSI®’s first application of the lead BEMA™ technology is Onsolis™ (fentanyl buccal soluble film). Onsolis™ utilizes the BioErodible MucoAdhesive (BEMA®) drug delivery technology, which consists of a small, bioerodible polymer

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Below are 12 extreme FDA trades for 11 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 in extreme FDA and Clinical Trial Calendar trades, which are highlighted in periodic articles at BioMedReports.com.

Hemispherx Biopharma [HEB: 1.36, -0.10 (-6.85%)]: Ampligen (Poly I: Poly C12U) NDA (three month PDUFA decision date delay was announced on 2/18/09 as additional data was submitted by HEB within three months of original decision date). Ampligen is an experimental treatment for chronic fatigue syndrome (which has no

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In April 2009, we are initiated coverage of BioDelivery Sciences International, Inc. (BDSI) with a Buy rating and a $6 price target. Since that time, the shares are up 35% on investors gaining confidence in the pending approval of Onsolis, a transmucosal fentanyl patch for breakthrough cancer pain. The FDA decision is expected on or before June 12, 2009.We view the event as a high likelihood of approval (>80% chance). Approval would be a transformational event for BDSI. Not only would it bring about a $30 million milestone payment from worldwide commercialization partner, Meda AB, but BDSI would also receive double-digit royalties (we estimate 20%) on sales of Onsolis upon launch.The breakthrough cancer pain market is highly competitive, and there are several formulations of fentanyl already on the market, with several more in late-stage development. But we believe that BDSI's BEMA technology offers significant ...

Shares of Vanda Pharma [VNDA: 7.87, +6.79 (+628.70%)] soared by nearly nine-fold in after-hours trading Wednesday evening as Fanapt (iloperidone) was approved by the FDA for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase 3 clinical studies comparing Fanapt to placebo and active control in patients with schizophrenia, as well as safety data in more than 3,000 patients.

Below are the nine remaining companies from my article last month on a dozen extreme FDA trades of companies with market caps below $200M which have pending new drug product decisions at 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.

1.) Vion Pharma [VION: 0.00, N/A (N/A)]: Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA requesting approval as

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For Immediate Release

Chicago, IL - April 17, 2009 - Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Vivus Inc (VVUS), Nokia Corp (NOK), GOL (GOL), TAM (TAM) and BioDelivery Sciences International (BDSI).

Get the most recent insight from Zacks Equity Research with the free Profit from the Pros newsletter: http://at.zacks.com/?id=4579.

Here are highlights from Thursday's Analyst Blog:

Vivus: Big Hopes for Qnexa

We are initiating coverage of Vivus Inc (VVUS) with a `Hold' rating and $6 price target. We are optimistic with respect to the pipeline and feel the valuation is below fair; however, we are waiting for additional data from both Qnexa and avanafil before we are

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We are initiating coverage of BioDelivery Sciences International (BDSI) with a Buy rating and a $6 price target. Paramount to our recommendation is the pending approval of Onsolis, a transmucosal fentanyl patch for breakthrough cancer pain. The FDA decision is expected on or before June 12, 2009.We view the event as a high likelihood of approval (>80% chance). Approval will be a transformational event for BDSI. Not only will it bring about a $30 million milestone payment from worldwide commercialization partner Meda AB, but BDSI will also receive double-digit royalties (we estimate 20%) on sales of Onsolis upon launch.The breakthrough cancer pain market is highly competitive, and there are several formulations of fentanyl already on the market, with several more in late-stage development, but we believe that BDSI's BEMA technology offers significant advantages over existing delivery technologies and could allow for Onsolis to be ...

Below are 12 companies with market caps below $200M which have pending new drug product decisions at 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.

BioMedReports.com FDA Calendar

1.) Vion Pharma (VION.OB): Onrigin (laromustine) Injection (formerly known as Cloretazine or VNP40101M) NDA (filed with the FDA on 2/17/09) with priority review request as a single agent for remission induction treatment for patients age 60 and older with de novo poor-risk acute myeloid leukemia (AML). 4/17/09 is date for FDA to accept the filing and rule on priority review request - if granted the PDUFA would be 8/17/09 instead of 12/17/09 for standard 10-month review.

2.) Discovery Labs (DSCO): Surfaxin (lucinactant) NDA for prevention of respiratory distress syndrome (RDS) in premature infants. DSCO received its third approvable letter for Surfaxin last

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