PALM BEACH, Florida,
November 17, 2016 /PRNewswire/ --
The biotech sector reacted positively to the election results
based on high hopes there may be fewer drug pricing issues to deal
with in the near future. The market for anti-cancer drug
solutions specifically is poised to benefit from various
advancements & factors including the commercialization of
follow-on-biologics, as well as the overall development of new
treatments and therapies. Biotech stocks with current and
recent achievements in the markets include: Moleculin
Biotech, Inc., (NASDAQ: MBRX), Exelixis, Inc. (NASDAQ: EXEL), Cara
Therapeutics (NASDAQ: CARA), Ocular Therapeutix, Inc. (NASDAQ:
OCUL) and Teva Pharmaceutical Industries Ltd., (NYSE: TEVA).
Moleculin Biotech, Inc. (NASDAQ: MBRX), a
preclinical and clinical-stage pharmaceutical company focused on
the development of anti-cancer drug candidates, some of which are
based on license agreements with The University of Texas System on behalf of the M.D.
Anderson Cancer Center, today announced it has received verbal
positive guidance from the FDA regarding its planned IND submission
indicating that the Company may incorporate by reference the IND
established by a prior developer.
Read the full Moleculin Biotech (MBRX) Press Release at:
http://marketnewsupdates.com/news/mbrx.html
Moleculin's Chairman and CEO, Walter
Klemp, commented, "this new positive guidance removes a
major question mark and allows us to create a tighter timeline for
the estimated beginning of our next clinical trial. To be
clear, we still can't rule out the possibility of a delay in the
timeline, but with the knowledge that the FDA is encouraging us to
simply incorporate by reference the prior developer's IND, we
believe we can accelerate our IND submission process. On our
current path, we expect to be able to file our IND submission
before year end. Barring a negative surprise from the FDA's
review of our submission, that should allow us to begin treating
patients in our next clinical trial several months sooner than
expected."
The Company has indicated in previous disclosures that it
expected to begin its next clinical trial by the first half of
2017, however this development may reduce that time frame by
several months. The Company has submitted a pre-IND briefing
document to the FDA along with key questions regarding its clinical
development plan and a request for a meeting, if the FDA deems it
necessary. The FDA recently indicated in writing that it
intends to provide written responses to the Company by December 6, 2016 and that it does not believe a
live meeting is necessary. Once those written responses are
received, the Company will adjust its final IND submission document
accordingly and submit for final FDA review. IND submissions
are normally reviewed within 30 days of filing.
In other Biotech developments and movement in the
sector:
Exelixis, Inc. (NASDAQ: EXEL) this month announced the
presentation of new data from clinical trials of cobimetinib in
combination with other therapies to treat forms of advanced
melanoma. Data from phase 1b trials of cobimetinib in combination
with atezolizumab, and with atezolizumab and vemurafenib,
respectively, form the basis for two Genentech-sponsored phase 3
pivotal trials anticipated to start in 2017. Additionally, data
from a pooled analysis of the combination of cobimetinib and
vemurafenib demonstrate the potential for the combination to
deliver lasting clinical benefit.
Shares of clinical-stage biopharma Cara Therapeutics
(NASDAQ: CARA) soared over 25% higher on Wednesday after analysts
at Piper Jaffray upgraded their price target to $21 per share. Analyst Charles Duncan raised the price target for Cara
Therapeutics after meeting with management and confirming his
confidence in due diligence conducted with respect to the company's
clinical programs. CARA closed up over 20% at $12.20 trading over 5.5 Million shares by the
market close.
Ocular Therapeutix, Inc. (NASDAQ: OCUL), a
biopharmaceutical company focused on the development and
commercialization of innovative therapies for diseases and
conditions of the eye, this week announced positive topline results
from its phase 3 clinical trial of DEXTENZA™ (dexamethasone insert)
0.4 mg, for the treatment of post-surgical ocular inflammation and
pain. DEXTENZA is a product candidate administered by a physician
as a bioresorbable intracanalicular insert and designed for drug
release to the ocular surface for up to 30 days.
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA)
recently announced approval of generic Tribenzor®1(olmesartan
medoxomil, amlodipine and hydrochlorothiazide) tablets in the U.S.
and is in the final stages of launch preparation. Teva also
recently received approval and launched generic Azor®2 (amlodipine
and olmesartan medoxomil) tablets in the U.S. These products
enhance Teva's antihypertensive portfolio. Olmesartan
medoxomil, amlodipine and hydrochlorothiazide tablets are a
combination of an angiotensin II - receptor blocker, a
dihydropyridine calcium channel blocker and a thiazide diuretic
indicated for the treatment of hypertension, to lower blood
pressure.
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