With the holiday season in full swing, it’s been a slow week for the biotech sector. That being said, some companies that made headlines last week include United Therapeutics (UTHR) and TESARO, Inc. (TSRO).
Early Christmas for UTHR: The FDA played Santa for UTHR with the agency approving Orenitram (treprostinil) Extended-Release Tablets for the treatment of pulmonary arterial hypertension (:PAH) in WHO Group I patients to improve exercise capacity. It proved to be third time lucky for the company which had already received two complete response letters from the FDA earlier for the drug. Shares shot up 30.6% on the surprise approval and hit a 52-week high as well.
Supernus (SUPN), UTHR’s partner, also benefited from the news with shares soaring 8%. Supernus stands to receive a milestone payment as well as royalties on Orenitram sales.
Investors Not Impressed with TESARO Data: Even though TESARO presented phase III data on its oncology candidate, rolapitant, saying that it achieved the primary endpoints in the studies, investors were not impressed - reason being the failure to achieve the secondary endpoints. Rolapitant is being developed for the prevention of chemotherapy-induced nausea and vomiting (:CINV). Shares plunged 24.7% on the data.
A Look at the Major Players
The table below captures the price movement of the major biotech players last week and during the past 6 months. There wasn’t much of an update from these companies last week.
|Company||Last Week||Last 6 Months|
BSTC’s CCH Fails in Phase II Study: BioSpecifics Technologies Corp.’s (BSTC) collagenase clostridium histolyticum (CCH) failed to meet the primary endpoint in a phase II study that was being conducted in canines with benign subcutaneous lipomas. A human lipoma study is ongoing with results due this month. Shares were not impacted significantly by the news.
EMA Accepts Cangrelor Marketing Application: The European Medicines Agency (:EMA) has accepted The Medicines Company’s (MDCO) regulatory application for its experimental intravenous antiplatelet agent, cangrelor. Cangrelor is currently under review in the U.S. as well.
RedHill Shares Gain on Positive Data: Shares of RedHill Biopharma inched up almost 4% on positive data from a pharmacokinetic (:PK) study on RHB-105. RHB-105 is being evaluated for the eradication of Helicobacter pylori (H. pylori) infection, which is a major cause of chronic gastritis, peptic ulcer disease, gastric cancer and mucosa associated lymphoid tissue (:MALT) lymphoma.
The Week So Far:
Can-Fite Shares Plunge: Can-Fite (CANF) ended the year on a disappointing note with shares plunging 32.4% on data from a phase III study on CF101. CF101 failed to achieve the primary as well as secondary endpoints in the study that was conducted in patients with moderate-to-severe dry eye syndrome.
Priority Review for Cubist Drug: The FDA has agreed to review Cubist’s (CBST) experimental antibiotic tedizolid phosphate (TR-701) on a priority basis. This means a response should be out by Jun 20 this year. Cubist is looking to get tedizolid approved for the treatment of acute bacterial skin and skin structure infections (:ABSSSI). The EU marketing application for the antibiotic will be submitted in the first half of this year.
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