Tuesday, September 30, 2014

Merrimack (MACK) Reports Good News

Merrimack (MACK) provided updated clinical date on its compound MM-121.  The drug initially showed a lack of statistical benefit in Phase 2 trails but the biomarker data has been analyzed and showed that the compound increased Progression Free Survival in patients with biomarker positive metatastic breast cancer by 74%.  This is encouraging news for both the company and patients and I'd expect Merrimack to provide a strategic update on a pivotal trial in this patient subgroup in the future.

Monday, September 29, 2014

Daily Dose - News on Tonix (TNXP), Exelixis (EXEL), and Array (ARRY)

Tonix (TNXP) reported results for it's trial of its lead compound to treat Fibromyalgia.  The drug failed its two primary endpoints though it did show a 30% improvement vs. placebo on pain improvement but this would be expected as the compound is a variation of flexeril, a drug used to treat pain.  I'm getting out of my position as I believe this stock is dead in the water.
Check this out!
Exelixis (EXEL) reported results for it's trial in partnership with Roche of Cobimetinib in patients with BRAF mutation-positive advanced melanoma.  The trial met its primary endpoint of Progression Free Survival which was 9.9 months vs. 6.2 months in the control arm.  Roche has already filed to market the drug in Europe and expects to file an NDA with the FDA by the end of the year.  Exelixis has an option to co-promote the drug in the United States.  I'm holding onto my shares of Exelixis as I believe there's a chance the company could be acquired by Roche.
Check this out!
Array (ARRY) reported phase 2 results for it's trial of Binimetinib in NRAS Melanoma.  PFS was 3.6 months in a group of patients with a very poor prognosis.  The drug is currently in a phase 3 trial with results expected next year.  I'm holding onto my shares of Array as I hope for positive results in the phase 3 study and a subsequent NDA filing next year.

Thursday, September 25, 2014

Trading Opportunity - Tonix Pharmaceuticals (TNXP)

Tonix Pharmaceuticals is due to report top line results in it's pivotal, phase 3 trial of it's lead compound, TNX-102,  as a treatment of Fibromyalgia.   The compound is a reformulated delivery of cyclobenzaprine (many of us with back pain know it as flexiril) which allows the drug to be delivered directly into the blood stream by placing the pill under the tongue.

The market isn't giving it much of a chance with a market cap of only $131 million as of the time of this post but the stock appreciation upside is massive if the results come back positive.  If negative, you will see just the opposite result as there isn't much of a pipeline outside of TNX-102.

I've got 1,000 shares and I may add another 1,000 tomorrow and roll the dice for positive results.

Good luck on your biotech investments and hope everyone has a great weekend!

Rexahn (RNN) receives orphan drug status for lead compound

Rexahn announced they received orphan drug status from the FDA for it's lead compound targeting pancreatic cancer.  The stock is up over 7% in afternoon trading which is typical for such a release but the reality is orphan drug status is worthless if the drug isn't approved.  I'd sell on the uptick and buyback when reality sets back in.

Rexahn receives orphan drug status for lead compound