Biotech Stock Roundup: Amgen Data Looks Good, CANF Tumbles - Industry Outlook
January 08 2014 - 10:17AM
Zacks
It was yet another slow week for the biotech sector with very
few updates making an impact. Newsmakers included
Can-Fite (CANF), Amgen (AMGN) and
Cubist (CBST).
Disappointing Data Pulls Down Can-Fite:
Can-Fite ended 2013 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.
Amgen’s Romosozumab Fares Well in Mid-Stage
Study: Amgen's shares were up 1.5% on positive data from a
mid-stage study on romosozumab. The study was conducted in
postmenopausal women with low bone mineral density (BMD). Treatment
with romosozumab for 12 months resulted in a significant increase
in BMD at the lumbar spine, total hip and femoral neck compared to
placebo.
Moreover, exploratory analyses showed that BMD increased
significantly at the lumbar spine and hip compared to Fosamax and
Forteo (currently approved treatments). The data looks good but it
remains to be seen how romosozumab performs in ongoing phase III
studies.
Priority Review for Cubist Drug: The FDA agreed
to review Cubist’s experimental antibiotic tedizolid phosphate
(TR-701) on a priority basis. This means a response should be out
by Jun 20. Cubist is looking to get tedizolid approved for the
treatment of acute bacterial skin and skin structure infections.
The EU marketing application for the antibiotic will be submitted
in the first half of this year. Cubist shares gained 1.3% on the
news. Tedizolid became a part of Cubist’s pipeline following its
Sep 2013 acquisition of Trius.
Patent Protection for Immunomedics (IMMU): IMMU
shares have been gaining steadily ever since the company received
additional patent protection for its antibody-drug conjugates. This
is good news for the company as the patents will cover IMMU-132 and
IMMU-130, both phase II oncology candidates.
Orphan Drug Status for NPS’ Natpara: NPS
Pharmaceuticals’ (NPSP) shares inched up 2.1% with the
company gaining orphan drug status in Europe for Natpara for the
treatment of hypoparathyroidism. Natpara already has orphan drug
status for this indication in the U.S. where it is currently under
FDA review. Orphan drug status brings several incentives like
protocol assistance, scientific advice, and exclusivity once the
drug is on the market.
Company |
Last Week |
Last 6 Months |
AMGN |
-0.57% |
20.49% |
BIIB |
0.08% |
27.54% |
GILD |
-0.17% |
42.98% |
CELG |
0.52% |
40.42% |
REGN |
-1.91% |
16.67% |
ALXN |
0.11% |
37.15% |
^BTK |
-0.57% |
16.50% |
The Week So Far:
This week has turned out to be pretty eventful so far with
Epizyme (EPZM) and Pharmacyclics
(PCYC) shares soaring significantly.
Epizyme Shares Shoot Up: Epizyme shares shot up a
whopping 75.6% on the achievement of a proof-of-concept milestone
related to the development of EPZ-5676. This triggered a $25
million milestone payment from partner Celgene
(CELG). The company will also get a $4 million milestone payment
under its agreement with Glaxo regarding small molecule HMT
inhibitors. Epizyme now expects to exit 2013 with a cash balance of
$145 million, significantly above the earlier forecast of $115
million.
Pharmacyclics Gains on Imbruvica News: With an
Independent Data Monitoring Committee unanimously recommending that
the phase III RESONATE study, being conducted on Pharmacyclic’s
leukemia drug, Imbruvica should be stopped early, the company saw
its shares gaining 19.8%. This is a very positive development for
the company as the study met its primary and a key secondary
goal.
Fast Track Status for Peregrine’s Bavituximab:
Peregrine Pharma’s shares gained 14.5% on news that the FDA has
granted fast track status to the company’s lead pipeline candidate,
bavituximab, for second-line non-small cell lung cancer.
EU Nod for Abraxane Label Expansion: Celgene’s Abraxane
gained EU approval for use as a first-line treatment in patients
suffering from metastatic pancreatic cancer. It is to be used in
combination with Gemzar. Approval was expected as last year the
Committee for Medicinal Products for Human Use (CHMP) had issued a
positive opinion regarding the same.
Synageva Wraps Up Patient Enrolment: Synageva has
finished enrolling patients far above its original target in its
phase III study (Acid Lipase Replacement Investigating Safety and
Efficacy - ARISE) on sebelipase alfa. The study is being conducted
in children and adults suffering from lysosomal acid lipase
deficiency. Top-line results from this study will be out the second
half of the year. Shares were up 1.4%.
FDA Action Date for Orexigen Drug: The FDA issued an
action date for Orexigen’s obesity candidate, Contrave. The agency
will act on the company’s regulatory submission by Jun 10.
Coming Up:
Pipeline Update from Intercept: Intercept will be
providing an update on its pipeline on Jan 9. Information to look
out for: updates on the completion of the double-blind phase of the
POISE study, top line data from the OBADIAH and PESTO studies and
milestones expected this year. Intercept focuses on the development
of novel bile acid therapeutics for the treatment of chronic liver
diseases.
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