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FDA Calendar Updates: BDSI, SVNT Deadlines Approach

Bullish Bankers — Sun, 21 Jun 2009 16:00:59 +0000

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 [...]

Updated Calendar of 12 Extreme Trades on Pending FDA Decisions

Bullish Bankers — Fri, 22 May 2009 16:00:20 +0000

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 includ

Bet on BDSI’s Onsolis Approval – Analyst Blog

Zacks Market Commentaries — Mon, 18 May 2009 16:46:26 +0000

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 advantages over existing delivery technologies, and could allow for Onsolis to be at least a $250 million peak sales drug.

A $6 price yields a market capitalization of approximately $115 million. This more fairly values the company based on the pending approval of Onsolis. Post-approval, we would not be surprised to see the shares head towards $10 per share due to the dramatically improved financial situation, and the ability it provides for management to now move two pipeline candidates, BEMA Buprenorphine and Bioral Amphotericin B, each with $500 million sales potential, forward in clinical development.
Read the full analyst report on "BDSI"
Zacks Investment Research

An Extreme FDA Trade that Paid: Vanda Pharma

Bullish Bankers — Thu, 07 May 2009 19:20:35 +0000

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 [...]

Zacks Analyst Blog Highlights: Vivus Inc, Nokia Corp, GOL, TAM and BioDelivery Sciences International – Press Releases

Zacks Market Commentaries — Fri, 17 Apr 2009 15:02:17 +0000

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).

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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 comfortable recommending the shares.

We view Qnexa as the leading phase III obesity candidate under development today. Qnexa is a fixed-dose combination of phentermine (15mg) and topiramate controlled release (92mg). Phentermine is FDA approved for use in obesity and topiramate has significant off-label use in obesity and smoking cessation.

Nokia Gains with Cheaper Phones

News from Nokia Corp (NOK) in Helsinki report that the new, lower priced smart phones are gaining market share against other smart phones, and that the smart-phone market should increase by about 20% versus a decline in total cell phones of about 10% for 2009.

Nokia's 5800, introduced late last year, is a tremendous success (as have been the cheaper Blackberry models), particularly outside North America. Nokia is the largest smart-phone maker with about 40% market share, although the company has not grown as fast as Research In Motion (RIMM) or Apple (AAPL) over the past year. It is too early to say, but the 5800 may reverse this trend.

Brazil Airline Competition Grows

The Brazilian airline sector grew 4.7% year-over-year during the first quarter 2009 according to the data released yesterday by ANAC (Brazilian Civil Airline Agency). While that was great news for the Brazilian airline sector, however, for GOL (GOL) and TAM (TAM) the news was not that great. If we only consider the two biggest companies -- GOL and TAM -- the growth was just 1.5%.

In fact, the growth was headed by smaller aggressive low fare companies, such as Oceanair, Trip, Azul and Webjet. Just as an example, Trip (a fast growing domestic airline) almost tripled its revenues during 2008!

Initiating BioDelivery as a Buy

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.

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Initiating BioDelivery as a Buy – Analyst Blog

Zacks Market Commentaries — Fri, 17 Apr 2009 14:29:49 +0000

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 a $250 million peak sales drug.

Besides Onsolis, BDSI is developing BEMA Buprenorphine and Bioral Amphotericin B, two drugs each with $500 million sales potential.

BDSI's future success is tied closely to the pending approval of Onsolis. We estimate cash at the end of the first quarter will be in the area of $3-4 million, enough to make it to the FDA decision in June. Approval will make BDSI cash-flow positive in 2009, and the $30 million milestone payment from Meda AB will be enough to fund development of the pipeline for the next several years.

The market capitalization is only $71 million, which leads us to believe the shares would be significantly undervalued based on Onsolis approval. Additional detail can be found in the report.
Read the full analyst report on "BDSI"
Zacks Investment Research

A Dozen Extreme FDA Trades on New Product Decisions

Bullish Bankers — Mon, 13 Apr 2009 15:07:16 +0000

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 [...]

BioDelivery Sciences (BDSI) to Meet with FDA to Routinely Finalize Proposed Risk Strategy

QualityStocks — Mon, 10 Nov 2008 12:59:20 +0000

BioDelivery Sciences International, inc. (NASDAQ: BDSI) remains on schedule to meet with the Food And Drug Administration, on Nov. 17 to discuss its Risk Evaluation and Mitigation Strategy for ONSOLIS, its main cancer pain treatment drug. The company said it has already sent the FDA the information it needs, in advance preparation for the meeting. ONSOLIS [...]