Posts for Ticker ‘PROVENGE’

Dendreon Shares Losing House Committee Hope (DNDN)

CNBC’s Mike Huckman just announced what is going to be a disappointment for Dendreon (NASDAQ: DNDN) holders, and that may be an understatement.  The House Committee will not be forcing any action or pressing the FDA over Dendreon’s PROVENGE until FDA makes a final decision, and that could be one to three years away.  There had been hopes that the committee would uncover conflicts of interest that have been alleged by many hopeful patients and investors alike.  That doesn’t look to be in the realm of possibilities now.

As a reminder, there is still hope that the EU might actually save it when the FDA wouldn’t.

Dendreon shares are now down over 7% to $5.37, and its 52-week trading range is $3.57 to $25.25.

Jon C. Ogg
February 13, 2008

Posted on: February 13, 2008 – 3:34 pm in Biotech, FDA, , , , ,

Will The E.U. Save Dendreon If The U.S. Won’t? (DNDN)

Dendreon Corp. (NASDAQ:DNDN) shares are trading up in early trading on a patent award, and that is after the fairly large gains yesterday.   Dendreon was granted a broad European patent covering what is still its lead product candidate PROVENGE, its investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

This patent grant is in the E.U. rather than in the U.S. and has been granted European patent No. 0 870 022 B1.  The patent covers the composition of matter of PROVENGE as well as the company’s other active cellular immunotherapy product candidates, such as NEUVENGE(TM) (lapuleucel-T). The patent also covers methods of activating antigen presenting cells in vitro with certain fusion proteins developed by Dendreon, including the fusion protein that is used in PROVENGE.

As previously noted, the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application (BLA) and support the efficacy claim for PROVENGE. Interim data from the fully-enrolled IMPACT study are expected in the second half of 2008.

A patent grant is far from an approval to commence sales.  But this is good news in that the E.U. now has a chance to become a market for PROVENGE even if the FDA sticks it to the company again in late 2008.  With Congress involved and looking into potential conflicts of interest from FDA panel members that gave PROVENGE the thumbs down, this might be one more ray of hope for the company, its shareholders, and for those with prostate cancer.

Dendreon shares were up as much as 5% in early trading, but shares sit up about 3% at $6.67 at 10:00 AM EST and we’ve already seen a full average daily volume after only 30 minutes.

Jon C. Ogg
January 15, 2008

Posted on: January 15, 2008 – 10:07 am in Biotech, ,

Dendreon A Double Already? (DNDN)

If you read 24/WallSt.com’s "Ten Stocks That Could Double in 2008" from us, you saw that Dendreon (NASDAQ:DNDN) is on that list.  We weren’t expecting a 22% pop in shares this fast.  We’d like to take credit for that pop, although the real credit belongs to CNBC’s Mike Huckman who reported that Congressmen are probing the recent failed approval process in the FDA over the review and over conflicts of interest.

We have been looking for something like this to come up, although the day-after time period was not what we were thinking.

Dendreon regularly is screened for our weekly "10 Stocks Under $10" newsletter.  Shares are now up 25% at $7.03 on almost 20 million shares and options trading activity has gone through the roof today.

Jon C. Ogg
December 13, 2007

Jon Ogg can be reached at jonogg@247wallst.com; he does not own securities in the companies he covers.

Posted on: December 13, 2007 – 3:56 pm in Biotech, , ,

Dendreon Sets Stage for 2008 for PROVENGE

Dendreon (NASDAQ:DNDN) has issued a press release noting that it has completed its target enrollment of 500 patients in phase III IMPACT study of PROVENGE for advanced prostate cancer.  It also noted:

  • FDA Has Agreed That Positive Survival Data from IMPACT Study Would Support Licensure of PROVENGE;
  • Interim Survival Results Expected in Second Half of 2008.

The IMPACT study is a double-blind, randomized, placebo-controlled Phase 3 trial designed to measure overall survival in men with metastatic hormone-refractory prostate cancer receiving PROVENGE versus placebo.  Even though the company received a set back this year that may or may not allow PROVENGE onto the market, Dendreon maintains that the FDA will accept either a positive interim or positive final analysis of overall survival from the IMPACT study to amend the Biologics License Application and support the efficacy claim for PROVENGE.

With this being one of the only hopes for late-stage prostate cancer patients, this ‘completed enrollment’ would have been easy to expect.  There have not yet been any trades in the pre-market, but first indications are $7.62X$8.05 versus the $7.58 close.  If there was much new data or anything that pointed to positive data there would be significant pre-market trading.

Jon C. Ogg
October 23, 2007

Posted on: October 23, 2007 – 6:55 am in Biotech, , , ,

Institutional Buyer Sheds Light on Dendreon (DNDN)

An interesting event happened yesterday in the form of an SEC Filing on Dendreon (NASDAQ:DNDN) that ran the stock.  In a fed-filing from yesterday it was disclosed that BNP Paribas Arbitrage SA held 6,961,101 shares of Dendreon stock.  That equates to an 8.18% stake.  If you review the June 30, 2007 holders, this will put BNP Paribas at roughly double the holdings held by Barclays (largest holder previously).

This filing actually lists the transaction date as JULY 25, 2007, so there is a full six weeks of look back here. If that form is accurate on the ownership date, shares are higher now than on the trade date.  Also last night the company filed its form 424B3, which allows holders of the 4.75% convertible senior subordinated notes that were placed on June 11 and July 11, 2007 to resell notes and common shares.  This is actually a common event and does not necessarily mean any such sale is pending.

Other than its breast cancer Phase I data from last month, this one has been fairly quiet on the news front of late.

Yesterday there were some 13.68 million shares that traded hands and shares rose 5.6% from Friday’s close.  Shares are up another 1.5% today at $8.25 and it has already traded over 6 million shares in less than two hours of being open.  The stock did briefly put in a near-term high of $8.48 today, but have come back in.  The $8.30 to $8.35 had been the prior intra-day levels that acted as intraday highs in both July and August.

Jon C. Ogg
September 11, 2007

Jon Ogg produces the 24/7 Wall St. SPECIAL SITUATION INVESTING NEWSLETTER; he does not own securities in the companies he covers.

Posted on: September 11, 2007 – 10:24 am in Biotech, , ,

Looking Beyond Dendreon’s Upcoming Earnings Release (DNDN)

Dendreon Corp. (NASDAQ:DNDN) will release earnings next Tuesday, August 7, after the close.  The volatility in shares has dried up considerably as shares have only traded above $8.00 or below $7.00 for part of three trading days in July.  The company’s only expected revenues here will be from interest and the loss expected looks like it is -$0.30 on an EPS basis.  That number may change before the report.

There can always be some activist group activity here, or at least that is what incoming emails received have stated.  Some sent in to us listed "the first of many" and "Many more to come."  We’ll see if that creates some movement or not. Options are still fairly active in the open interest with over 154,000 contracts in the August $7.50 Calls and over 129,000 contracts in the $7.50 puts.  That huge open interest drops off a cliff in the near-months after this as no new FDA data is really expected.  An at-the-money straddle right now only looks like it costs $0.70, lower than in any recent month.   

All of these following issues are already known and already in the news, but on top of earnings the company is going to address the following:

  • The Company received confirmation that the U.S. Food and Drug Administration will accept either a positive interim or final analysis of survival from its ongoing IMPACT study to amend the Biologics License Application for Provenge® (sipuleucel-T), its investigational active cellular immunotherapy for metastatic, androgen-independent prostate cancer.
  • The Company continues to have strong patient enrollment in its Phase 3 IMPACT study, which is on track for completion of enrollment this year.
  • The Company completed a financing that resulted in gross proceeds of approximately $85 million from a convertible senior subordinated notes offering.
  • Presented data from an analysis of Phase 3 Studies (D9901 and D9902A) that showed a prolonged survival benefit for patients who were initially treated with PROVENGE who then went on to receive docetaxel chemotherapy after disease progression.

Obviously if there is any new development out of the FDA or if the company decides it wants a partner that will be key to watch over anything else.  We previously noted how shares may face a news vacuum through much of summer and that looks like it has been the case as trading volume has dropped and volatility in the stock has disappeared.  What we will be looking at the closest is the company’s current and projected cash burn rates since it secured the recent financing package and announced its reduced cost structure. 

This one has been eerily quiet of late as far as any real news out of the company.  We’ll follow up if there are any substantial changes ahead of the release. 

Jon C. Ogg
August 3, 2007

Jon Ogg can be reached at jonogg@247wallst.com; he does not own securities in the companies he covers.

Posted on: August 3, 2007 – 11:44 am in Biotech, Earnings, FDA, , , ,