Nov. 10, 2014, 9:31 AM
- Dendreon (NASDAQ:DNDN) reaches agreement with certain holders of its 2.875% Convertible Senior Notes due 2016 on the terms of a financial restructuring pursuant to its Chapter 11 filing. The holders' stakes represent 84% of the $620M aggregate principal amount of the notes.
- Under the terms of the agreements, the financial restructuring may be a stand-alone recapitalization or a sale of the company or its assets. All of the Senior Notes will convert to common equity of the reorganized Dendreon. For a sale of the firm or substantially all of its assets, the minimum bid must be at least $275M. If more than one qualified offer is received, an auction will take place to determine the winning bid.
- The company expect its quick assets of $100M to be sufficient to fund operations during the restructuring process.
- The availability of Provenge will be unaffected.
Nov. 10, 2014, 9:01 AM
Nov. 10, 2014, 7:05 AM
- Former highflier Dendreon (NASDAQ:DNDN) files for Chapter 11 bankruptcy protection. The Provenge maker plans to continue operations while it restructures its debt.
- When the prostate cancer therapy was approved in 2010, analysts forecasted peak sales of over $4B. Last year's top line was ~$284M.
- DNDN is off 65% premarket on light volume but the turnover will increase dramatically as the open approaches. Shares will trade today in the $0.30 range which represents a 99.5% loss of value from the late April 2010 peak of $57.67.
Nov. 10, 2014, 3:02 AM
- Filing for Chapter 11 bankruptcy protection, Dendreon (NASDAQ:DNDN) says it has reached agreements on the terms of a financial restructuring with certain bond holders and has significant liquidity to support all of its operations during the restructuring process.
- "Whether the restructuring takes the form of a stand-alone recapitalization or a sale of the company or its assets, we are confident that this process will allow Provenge to remain commercially available to the patients and providers," says CEO Thomas Amick.
- Provenge, the company's sole product in the market, is designed to reprogram the body's immune cells to attack advanced prostate cancer cells.
Oct. 3, 2014, 1:53 PM
- The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee voted against recommending regulatory approval of SonaCare Medical's Sonablate 450 for the treatment of recurrent prostate cancer in patients previously treated with external beam radiation therapy. The device utilizes high intensity focused ultrasound (HIFU) to ablate tissue.
- The panel's rejection was due to the fact that Sonacare's clinical trial data were based on an interim analysis of the first 100 patients in a planned 200-patient study. The company obviously believed the data were compelling enough to proceed with its submission prior to the conclusion of the study but the reviewers felt otherwise.
- The panel voted 7-3 against (1 abstention) recommending that the treatment was safe if used as intended; 9-2 against recommending that the treatment was effective if used as intended and 10-0 against recommending that the benefits outweigh the risks.
- Briefing docs
- Prostate cancer therapy-related tickers:(TKAI -2.1%)(MDVN +1.2%)(NYMX +4.8%)(EXEL -0.3%)(PGNX +2.8%)(MRK +1.8%)(ADXS +2.7%)(EBS +1.8%)(EDAP +3%)(ISIS +2.1%)(NVGN)(DNDN +0.7%)(ISR +1.4%)(OGXI +0.4%)
Aug. 13, 2014, 9:15 AM
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Jun. 9, 2014, 4:27 PM
- Dendreon (DNDN) chairman/CEO John H. Johnson plans to step down for "personal reasons."
- Johnson has already resigned as chairman, and lead independent director Douglas G. Watson has been appointed his replacement.
- A search firm has been hired to find a new CEO; Johnson will keep the job until Aug. 15.
- Investors seem pleased with the news, which comes with shares down 60% from a 52-week high of $5.38, and trading at a small fraction of their 2010/2011 highs.
May. 23, 2014, 5:36 PM
May. 20, 2014, 10:52 AM
- Shares of Dendreon (DNDN +8.4%) are up in heavy volume in response to the company's presentation of data from two Provenge clinical studies at the American Urological Association meeting in Orlando. Interim data from the ProACT and IMPACT studies suggest that Provenge elicits an immune response associated with an overall survival benefit.
- The firm will also present data from the PROCEED registry suggesting similar treatment patterns for urologists and oncologists in Provenge-treated patients with metastatic castration-resistant prostate cancer.
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