Sophiris Bio (NASDAQ.SPHS) is a Canada-based biopharmaceutical company focused on the research, development and commercialization of products for the treatment of urological diseases.
We began our coverage of the company on December 14th 2016. The stock was trading at $2.9 at the moment of our recommendation start.
The company lead drug in development is PRX302 (topsalysin). With the drug Sophiris Bio has successfully passed Phase 2а of the study in prostate cancer. Despite that the study primary endpoint was only safety of the drug - it showed the drug ability to destroy tumor cells for at least 6 months (monitoring period in the study) in 11 of 18 total participants. The drug showed good tolerability during the study
Now the company needs to do a Phase 2b trial to determine optimal dosage of the drug. The Phase 2a was completed in June 2016. In August 2016 the company did a secondary offering and raised $30M which is enough to fund the Phase2b study. The study has been initiated in Q1 2017. The resusts are dure to be published in Q1 2018.
Also Sophiris Bio has successfully completed Phase 3 study in benign prostatic hyperplasia. The company announced that a second Phase 3 study is required before submission to the FDA for Topsalysin marketing approval in the indication. The second Phase 3 estimated cost announced by Sophiris is $53M. The company announced that it will initiate the study only after a partnership or other options are concluded with a large biopharma to fund the Phase 3.
Array BioPharma Inc. (NASDAQ:ARRY) is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, hepatitis C
Recommendation is no longer valid
We began our coverage of the company on August 21th 2016. At the moment we started coverage of the company the stock was worth $3.5. Currently the stock is worth around $12.5 per share. INVESTORS PROFIT 257%
The company pipeline consists of 17 ongoing programs: 1-NDA pending , 4 - Phase 3 stage, 9- Phase 2 stage, 4- Phase 1 stage.
The company wholly owns global or key markets (incl the U.S.) rights for 6 of its drugs.
12 Array invented drugs are licensed by Array to a number of global pharmaceutical companies for future sales. All research and development costs related to those programs are financed by those companies. The collaborators names include Novartis, Roche Holding, Astra Zeneca, Pierre Fabre, Merck, Celgene, El Lilly.
Array flagship program is development of the drugs named Binimetinib and Encorafenib for melanoma treatment.
COLUMBUS - trial of the combination of binimetinib + encorafenib to treat another melanoma type - BRAF mutant melanoma. On September 26th 2016 Array Biopharma announced that its COLUMBUS Phase 3 study ended successfully.
Array Biopharma submitted the application to the FDA on July 5th 2017
If COLUMBUS program receives the FDA approval (and its highly likely now given the actual outcome figures) - Array Biopharma will cover the half whole market with treatments (BRAF type = 50% of patients). The potential sales of the drugs could amount to $ 1,5 -$2 billion annually.
Another leading Array program is BEACON - treatment for colorectal cancer. Array announced very encouraging Phase 2 results in June 2016. Phase 3 began in July 2016 and it is co funded by Merck and Pierre Fabre.