Last week turned out to be pretty eventful with
Epizyme (EPZM) and Pharmacyclics
(PCYC) shares soaring. But, the clear winner was Intercept
Pharmaceuticals (ICPT) which saw its shares gaining an
impressive 281%.
Intercept Shares Skyrocket on Data: Intercept
stood out last week with its shares skyrocketing 281% when a Data
Safety Monitoring Board halted a mid-stage study being conducted
with obeticholic acid (OCA). OCA is being evaluated in the FLINT
study for the treatment of nonalcoholic steatohepatitis (NASH) - a
serious chronic liver disease caused by excessive fat accumulation
in the liver.
The study was stopped as the primary endpoint was met. Usually,
studies are stopped prematurely due to safety signals or some other
negative event. So the halting of a study due to positive data is
always welcome news and a major positive. With no drugs currently
approved for NASH, Intercept is well placed to rule the market once
OCA is approved.
About 12% of adults in the U.S. are estimated to have NASH with
2.7% (more than 6 million) having progressed to advanced liver
disease or cirrhosis due to NASH. Not just that, the number of
liver transplants due to NASH has also gone up significantly in the
last few years. So, we could very well be looking at a candidate
with blockbuster potential.
Epizyme Shares Shoot Up: Epizyme shares shot up
75.6% with the company achieving a proof-of-concept milestone
related to the development of EPZ-5676. This means that Epizyme
will get 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.
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 its lead pipeline candidate,
bavituximab, for second-line non-small cell lung cancer.
Bavituximab was recently moved into a phase III study (SUNRISE -
Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung
Cancer).
Fast-track designation means the development and review process
could be speedier with more frequent and timely communication and
meetings with the FDA. The candidate could also be granted priority
review.
PCYC’s Imbruvica Continues to Impress:
Intercept was not the only company to receive a favorable
recommendation from a data monitoring committee last week. An
Independent Data Monitoring Committee unanimously recommended 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. Imbruvica is another drug
with blockbuster potential.
Sangamo Soars on Biogen Deal: Sangamo shares
shot up 38.3% on the company’s collaboration with Biogen for the
development of treatments for hemoglobinopathies, which are genetic
disorders resulting from the abnormal structure or underproduction
of hemoglobin. This deal not only provides Sangamo with a strong
partner in the form of Biogen, Sangamo also stands to receive an
upfront payment of $20 million and more than $300 million on the
achievement of milestones.
Biogen will also reimburse Sangamo for its internal and external
R&D costs. All in all, a good deal for Sangamo.
Company |
Last Week |
Last 6 Months |
AMGN |
3.08% |
16.60% |
BIIB |
7.90% |
36.24% |
GILD |
0.74% |
35.32% |
CELG |
0.00% |
35.76% |
REGN |
0.97% |
15.92% |
ALXN |
2.65% |
35.05% |
^BTK |
6.49% |
20.07% |
Other Developments:
Will it be Third Time Lucky for OREX Drug? The FDA
issued an action date for Orexigen’s (OREX)
obesity candidate, Contrave. The agency will act on the company’s
regulatory submission by Jun 10. Will it prove to be third time
lucky for Contrave? Considering the encouraging LIGHT study data,
chances of approval look good. If approved, Orexigen and partner
Takeda will launch the drug in the second half of the year.
ITMN Prelim Results Look Good:
InterMune’s (ITMN) shares shot up 9.5% with the
company saying that Esbriet revenues should come in at $70.2
million in 2013, up 168%. Increased penetration in existing markets
and launch in additional countries drove performance. The strong
performance should continue in 2014.
DoJ Subpeona Overshadows AEGR Prelim Results:
Aegerion (AEGR) was another company that announced
preliminary results last week. Although the company reported that
sales of its cholesterol management drug, Juxtapid, will be in-line
with the recently provided guidance of $45 million - $50 million,
this news was overshadowed by the disclosure that the Department of
Justice (DoJ) has issued a subpoena asking the company to provide
documents related to the marketing and sale of the drug. Even the
company’s 2014 guidance of global net product sales of $190 million
- $210 million could not prevent the shares from declining more
than 10% on the DoJ investigation news.
NPS End the Week Up 12.3%: NPS
Pharma (NPSP) exited last week 12% higher with the company
announcing an FDA action date for Natpara for the treatment of
hypoparathyroidism. The FDA will issue a response by Oct 24. The
company also reported preliminary results and said it expects 2013
revenues in-line with the guidance of $28 million - $32 million.
NPS also provided an encouraging outlook for Gattex sales in
2014.
MannKind Shares Slip: MannKind’s
(MNKD) shares slipped 16.4% on news that its diabetes candidate,
Afrezza, will be reviewed by an FDA advisory panel on Apr 1. But is
this really bad news? The setting up of an advisory panel actually
gives the company a chance to address any concerns that may be
associated with the candidate.
The problem in this case is that the advisory panel meeting will
be held a mere fortnight before the FDA is expected to deliver a
response on the approval status of Afrezza. So, the short gap
between the panel date and the FDA action date may make investors
jittery as the FDA may very well push out the PDUFA date in order
to discuss the panel’s recommendation.
The Week So Far:
This week, most biotech companies have been attending the
ongoing J.P. Morgan Annual Healthcare Conference where pipeline
updates, strategic goals and guidance for 2014 have been
presented.
Many companies have also been presenting preliminary results.
Celgene expects to deliver 2013 earnings of $5.96 per share, well
above current expectations. The company’s long-term outlook also
looks good.
Dendreon (DNDN) also reported a sequential
improvement in Provenge sales and saw its shares jump 9%. But will
this be enough to regain confidence in the product’s prospects?
Remember, the prostate cancer market has several strong treatments
like Zytiga and Xtandi which have been doing very well.
Alnylam Shoots Up on Sanofi Deal: Big pharma companies
continue to show a lot of interest in Alnylam
(ALNY) – Sanofi (SNY) expanded its agreement with
the company for the development of rare genetic diseases. Genzyme,
Sanofi’s subsidiary, will acquire a 12% stake in Alnylam through a
$700 million investment. Alnylam gained 40% on the news.
Lexicon to Reduce Headcount: Lexicon
Pharma (LXRX) will be cutting its headcount by about 45%
as the company has decided to focus only on late-stage programs.
The company’s CEO will also be leaving.
ICPT Loses Some Ground: Intercept, which saw its shares
shoot up a whopping 281% last week, gave back some of the gains
this week on news that its CEO said that the company may need
support from a bigger player for its experimental liver disease
drug.
Regeneron’s Eylea Keeps Impressing:
Regeneron (REGN) said that it expects Eylea’s
fourth quarter sales to be about $400 million and $1.4 billion in
2013. Importantly, Eylea continues to represent significant growth
potential in the form of additional indications and continued
uptake for approved indications. Shares were up 11.8%.
Chelsea’s Northera on Approval Track? Chelsea
Therapeutics (CHTP) should see a huge boost in its share
price as the FDA’s advisory panel has voted (16-1) in favor of
approving Northera for the treatment of symptomatic neurogenic
orthostatic hypotension in patients with primary autonomic failure
(Parkinson's disease, multiple system atrophy and pure autonomic
failure), dopamine beta hydroxylase deficiency and non-diabetic
autonomic neuropathy.
For the remainder of this week, we expect more updates at the
J.P. Morgan conference as well as a few preliminary results.
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