is expecting to hear soon on the status of its Orphan Drug application submitted to The Food and Drug Administration (FDA) in November of last year for its drug KRN5500, which is being studied for the treatment of chronic chemotherapy-induced peripheral neuropathy (CCIPN).
KRN5500 is a novel, spicamycin-derived, non-opioid-non-narcotic intravenous pain therapeutic with promising clinical trial results in patients with chemotherapy-induced peripheral neuropathy (CIPN)
More than 70% of patients treated with taxane-class or platinum-class chemotherapeutic agents; at least 25% of those treated with vinca-class agents; and significant numbers of those treated with Thalomid®, Revlimid®, Velcade®, and a variety of other cancer drugs experience CIPN, which can be disabling and adversely affect quality of life
There is presently no FDA-approved drug for CIPN.
In October, 2011, the U.S. FDA granted KRN-5500 Fast Track designation for CIPN, an indication with a market potential estimated at $2.5B.
Summary of Phase 2a clinical trial results:
- "A Spicamycin Derivative (KRN5500) Provides Neuropathic Pain Relief in Patients with Advanced Cancer: A Placebo-Controlled, Proof-of-Concept Trial"; Journal of Pain and Symptom Management
- Patients had failed on at least two previous pain therapeutics
- KRN5500 met primary endpoints: reduction of pain and safety
- Significantly more effective than placebo (p=0.03)
- Transient and manageable GI side effects
The stock is trading in a manner where it appears positive news concerning Orphan status may be very close to come.
The above chart shows us an extended cup and handle pattern with nice continuation -- DARA is about to break out. The red line is the Relative Strength Index (RSI), the purple one is the accumulation/distribution (AD) indicator. Accumulation is super strong, and the RSI is just starting to catch up.
I predicted a move to $0.98 on my live online show as a good entry point before beginning to break out -- The price hit $0.97, then began to move back upwards. I am setting a price target opinion of $1.35 to $1.45 for the short term.
Disclosure: Long DARA