March 20th. Array Biopharma today announced it had withdrawn its NDA for the drug named binimetinib in NRAS Mutant melanoma (known as NEMO program). The company did not provide any insight on the matter by now. We believe the decision was made after the planned meeting with the FDA officials which Array announced several months ago to be held in March 2017. We also believe the FDA suggested that the NDA would likely face a negative decision by the FDA most probably due to not long PFS (period of life extention) the drug showed in the Phase 3 (2.8months vs 1.5 months) and showed no statistically significant improvement in OS (Overall Survival) vs current treatments.
However we find this FDA decision very disappointing and not fair because
1. there are NO existing treatments for the disease on the market
2. Binimetinib showed almost 100% PFS improvement.
3. The NDA was submitted June 30th 2016 and it is only 3 months left till the planned decision date. Not clear why the FDA has not indicated its position much earlier instead of waiting 9 months.
But the most interesting was the market response to the news. On Monday March 20th the stock plunged over 30% (to the $7.5 range) during the pre market hours but then quickly recovered and was down only 5% to trade at the $10 level mid day.
The company has a very high rate of institutional ownership (96%). And what happened during the trading session was -- a large number of retail holders began panic selling and taking profits and institutions just kept adding cheap shares from the retail. After the Monday session the institututional ownership got very close to 100%.
The point for institutions is that the failed NEMO program was going to generate much less revenue than other Array programs at the Phase 3 stages (COLUMBUS and BEACON). Since those 2 are intact - the company is still on the right track. And talking buyout - its shape got more clear now - until today potential acquirers were uncertain of the BO price (whether to include the NEMO program value or not). Now with the program gone - the price can be determined easier and the possible BO became closer.
We are noting that the investors who have been following Array with us are still enjoing over 200% profit in just 6 months.
At this point however we would not discourage investors to sell some more of their positions to take profits.
March 9th. We are pleased to announce that since we began recommending Array Biopharma (August 21st 2016) the stock gained 230% during 6 months. The PPS was 3.45$ on August 21st and these days the stock is trading at 11.5$-12$ level. Congratulations to the investors who have followed Array Biopharma with us. Nevertheless, we are not encouraging investors to cash out just yet, however it could be wise to sell some portion of the investment. We reiterate our buy signal on Array Biopharma and believe the stock has more upside potential as Q2 catalysts start rolling in.
February 23rd. 2017. Transenterix announced that the Company has launched commercial operations and completed its first sale of the Senhance Surgical System in Germany.
St. Marien-Krankenhaus Siegen, a large multi-specialty hospital, has purchased the Senhance Surgical System to establish a robotic surgical program that will initially be focused on general and gynecologic surgery.
January 5th 2017 TransEnterix, Inc. (NYSE MKT:TRXC), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced today that the Company has received an increased equity investment from SOFAR S.p.A("SOFAR"), valued at €5 million, or approximately $5.2 million.