Although many biotechs have made substantial upward moves in 2012, many have fallen as much as 80% or more. Sometimes this is due to clinical trials or FDA decisions that end in disappointing results which can be difficult to predict ahead of time. After good trial data, often the risk profile declines as investors perceived a higher chance of a company ultimately getting FDA approval, sales, profits, and rewarding investors.
December 10, 2012 was a particularly interesting day in biotech land. There were many big movers including Amarin (AMRN) which fell for the second day in a row following its double dose of bad news on Thursday, and Orexigen Therapeutics (OREX) rallied 8.87% on no obvious news that I can find, which simply suggests that biotech fever continues to be strong. Below are 3 biotech stocks who made big moves Monday on positive developments that I found particularly interesting:
(1) Celldex Therapeutics (CLDX)
Celldex Therapeutics focuses on the development, manufacture, and commercialization of novel therapeutics for human health care primarily in the United States. Before the open, CLDX revealed results of a small Phase II trial using their CDX-011 drug. The study results suggest a potential breakthrough in the fight against advanced breast cancer helping to slow down the spread and extend the life expectancy of patients. CLDX is hoping the data will be sufficient enough to warrant accelerated approval from the FDA. The news received a warm welcome as investors speculated this could mean a quicker and cheaper path to sales and profits for the CDX-011 drug. The survival rate for advanced stage breast cancer is very poor, as low as 33.6%. Breast cancer is so prevalent that it is estimated 12.38% of women born today will be diagnosed with breast cancer at some point in their lifetimes. Shares of CLDX rocketed up 25.54% by close.
(2) Infinity Pharmaceuticals (INFI)
Infinity is an innovative drug discovery and development company seeking to discover, develop and deliver to patients best-in-class medicines for diseases with significant unmet need. Before the open, INFI revealed results of its Phase I trial using the drug IPI-145 that suggested potential success is treating chronic lymphocytic leukemia, indolent non-Hodgkin's lymphoma, mantle cell lymphoma, Hodgkin's lymphoma, and T-cell lymphoma which are blood cancers. These cancers kill an average of 50,000 people a year and is the most common and leading cause of death among children. As such, any progress in the fight against just terrible diseases get a very warm welcome from investors. Although the trial only consisted of 55 patients, the drug was shown to be well tolerated, allowing the company to continue with trials at higher dosing levels giving more hope for even better survival rates. Investors sent the shares of INFI soaring up 21.42% for the day.
(3) Cellceutix Corporation (CTIX.OB)
Cellceutix Corporation is focused on the development of its pipeline of compounds targeting areas of unmet medical need. Their flagship compound, Kevetrin, is an anti-cancer drug which has demonstrated the ability in pre-clinical studies to regulate the p53 pathway and attack cancers which have proven resistant to today's cancer therapies (drug-resistant cancers). In regards to the potential breakthrough Kevetrin is, CEO Leo Ehrlich claims:
Our flagship compound, Kevetrin, is a novel drug that has shown extremely promising laboratory data as a new cancer treatment. Clinical trials have already started at Harvard University's Dana-Farber Cancer Institute and partner Beth Israel Deaconess Medical Center, arguably the pinnacle of cancer research hospitals in the world, to test Kevetrin against advanced solid tumors. Additional studies are being conducted at Beth Israel Deaconess to research Kevetrin in conjunction with two Pfizer (PFE) multikinase inhibitors as potential new therapies for renal cancer and melanoma. In 2013, we expect to start a clinical trial against blood tumors, sponsored by a European university.
CTIX.OB announced Monday $10 million in funding. This funding, on very friendly terms at market rates and at the company's sole discretion as a line of credit, helps financially bridge the gap between now and Phase II trials next year. This is an important milestone because p53 has been nicknamed the "Guardian Angel of the Human Genome" which has been shown in Phase I trials to reduce tumor size and progression when other cancer-fighting drugs simply failed. CTIX.OB feels this is something the cancer industry has been in search of for decades. Investors seem to agree with CTIX.OB and it jumped up 19.01% to close at a new multi-year high.
Disclosure: I have no positions in any stocks mentioned, but may initiate a long position in CTIX.OB over the next 72 hours.