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
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.
), 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.
Last 6 Months
BSTC's CCH Fails in Phase II Study:
BioSpecifics Technologies Corp.'s
) 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
) 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:
) 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
Priority Review for Cubist Drug:
The FDA has agreed to review
) 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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BIOSPECIFICS TE (BSTC): Get Free Report
CAN FITE BIOPHR (CANF): Get Free Report
CUBIST PHARM (CBST): Free Stock Analysis
MEDICINES CO (MDCO): Free Stock Analysis
SUPERNUS PHARMA (SUPN): Free Stock Analysis
TESARO INC (TSRO): Free Stock Analysis Report
UTD THERAPEUTIC (UTHR): Free Stock Analysis
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