2010 has so far lacked all of the juice that drove many biotech stocks exponentially higher in 2009. For starters, the start of this year was not initiated with a deadly round of panic selling and followed by a major recovery in share prices with a hard V-bottom. We have also had what feels like fewer FDA blockbuster approvals at the same time that many key drugs expected to be approved were either denied approval outright or were given severe delays. We wanted to review the companies that are up more than 100% from their lows of the last 52-weeks to see which have prospects out into 2011 or beyond.
Some of the key bioheath stand out names for 2010 are Ariad Pharmaceuticals Inc. (NASDAQ: ARIA), Chelsea Therapeutics International Ltd. (NASDAQ: CHTP), Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC), EntreMed Inc. (NASDAQ: ENMD), Exact Sciences Corporation (NASDAQ: EXAS), Exelixis, Inc. (NASDAQ: EXEL), Amicus Therapeutics, Inc. (NASDAQ: FOLD), and Idenix Pharmaceuticals Inc. (NASDAQ: IDIX). A second list will post on Tuesday.
Ariad Pharmaceuticals Inc. (NASDAQ: ARIA) is around $3.93 and its 52-week range is $1.94 to $4.49. The market cap is almost $500 million and average volume is about 1.27 million shares per day. The company will present updated clinical data from a fully enrolled Phase 1 trial of its investigational, pan-BCR-ABL inhibitor, ponatinib, at the 52nd Annual Meeting of the American Society of Hematology (ASH) being held in Orlando, Florida, December 4-7, 2010. These Phase 1 findings in patients with resistant and refractory chronic myeloid leukemia will be featured in an oral presentation.
Chelsea Therapeutics International Ltd. (NASDAQ: CHTP) has been very volatile this year. At $5.26, it has a market cap of $258 million and its 52-week range is $1.94 to $7.00. The company has raised cash by selling equity and it is currently in a phase III hypertension study, a Phase III Parkison’s study, and a Phase II R.A. and a Phase II fibromyalgia study.
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC) has a long history of price volatility. Around $1.85, its 52-week trading range is $0.75 to $4.08, although the low close was under $3.00. The market cap is still under $85 million and average volume is close to 725,000 shares per day. It is developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious diseases, and it will show Phase II clinical trial results of sapacitabine for the treatment of myelodysplastic syndromes at a poster presentation during the 52nd Annual Meeting of the American Society of Hematology (ASH) in Orlando, on Saturday, December 4, 2010.
EntreMed Inc. (NASDAQ: ENMD) has been wildly volatile after falling from over $10 to almost $2 before its recovery of late. Around $6.25, its 52-week range is $2.26 to 13.64, its market cap is about $60 million, and its average volume is about 70,000 shares.
Exact Sciences Corporation (NASDAQ: EXAS) focuses on the early detection and prevention of colorectal cancer, and sometimes it feels more ‘exact’ than others. With shares around $5.71, its 52-week range is $2.43 to $9.24. The company has a $231 million market cap and its average volume is in excess of 1.3 million shares per day. From July to October it ran from $3.50 to $9.24 but the $9.00 level was not a closing high. The company recently raised about $64 million in cash, so the numbers on its market cap may now be different.
Exelixis, Inc. (NASDAQ: EXEL) was out of focus but came back in focus in November after data from a Phase II clinical trial testing XL184 in ovarian and prostate cancer showed that the drug appears to be a help in both tumor types. It was effectively given back rights to the drug by Bristol-Myers Squibb earlier. At $5.80, its 52-week range is $2.86 to $8.00 and the market cap is $631 million. This remains a wild card as it is still actually down in 2010 so far.
Amicus Therapeutics, Inc. (NASDAQ: FOLD) is close to new near-term highs at $4.30 versus a 52-week range of $1.88 to $4.53. The market cap is roughly $119 million and average volume is only about 30,000 shares. It was in late-October that it entered into a License and Collaboration Agreement with Glaxo Group Limited to develop and commercialize Amigal, which is currently in Phase III studies for the treatment of Fabry disease.
Idenix Pharmaceuticals Inc. (NASDAQ: IDIX) has also been one that has cut both ways in 2010. After an 8% drop, shares are down around $4.03, its 52-week range is $1.83 to $6.11, its market cap is just shy of $300 million, and its average volume is just over 400,000 shares per day. The most recent pop higher came from announcing a $20 million milestone payment from ViiV Healthcare for the initiation of Phase IIb trial of its ’761 for the treatment of HIV/AIDS.
For part two you can read: Outlook 2011, Part II: 2010 BioHealth Winners (AMRN, ILMN, INHX, JAZZ, NBIX, NPSP, THRX, VPHM)
JON C. OGG
Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) is surging this morning on solid news in the war on cancer. Any time you have a gain of 100% or more in a single day, the term “surge” is an understatement. The move is on the heels of results from a completed Phase II clinical trial of Onalta being published in the Journal of Clinical Oncology showing that the trial of 90 patients with Onalta improved symptoms associated with metastatic carcinoid tumors (neuroendocrine tumors of the GI tract and bronchus).
The test results were refractory to conventional treatment with the somatostatin analogue, octreotide; the Y-90-edotreotide therapy resulted in objective tumor response or stable disease in 67 of 90 patients with metastatic carcinoid refractory to octreotide therapy. That comes to 74.4% response rate.
The median progression-free survival and overall survival were 16.3 and 26.9 months, respectively; and the company noted that there appeared to be a correlation with prolongation of the period of progression free survival in those patients who had durable diarrhea improvement. Key improvements in patient symptoms and quality of life related to carcinoid tumors were also noted, and treatment was well-tolerated and had an acceptable adverse event profile.
Where this is interesting is that the patients involved in the study had incurable, progressive disease refractory to octreotide with severe symptoms which could themselves be life-threatening and the results support Onalta’s potential to improve outcomes among a refractory, metastatic patient population lacking treatment options. The article is available here.
This move in Molecular Insight is up 160% at $3.90, and the stock has traded even higher this morning. The move is strong enough that it seems to be adding a boost to other biotech shares with positive cancer news this morning.
EntreMed, Inc. (NASDAQ: ENMD) is up big this morning on reports that it has initiated a Phase II study for its ENMD-2076 in ovarian cancer. This is one of the stocks that has been around since the late 1990′s and has been in the $20′s, $40′s, $60′s and even higher in the distant past.
JON C. OGG