Zynerba Pharmaceuticals, Inc.
ZYNE announced issuance of a new U.S. patent covering cannabidiol,
a key compound of its lead pipeline candidate, Zygel, for treating
autism spectrum disorder. The U.S. Patent and Trademark Office
issued US Patent No. 10,314,792, which includes claims directed to
methods of treating autism spectrum disorder through administration
of a therapeutically effective amount of synthetic cannabidiol. The
patent will expire in 2038.
Last month, the company initiated a phase II
study to evaluate Zygel in pediatric patients with autism spectrum
We remind investors that Zynerba was awarded
another methods of treating patent in February, covering synthetic
or purified cannabidiol for the treatment of Fragile X syndrome, a
genetic disorder causing certain developmental problems in
patients. With the issuance of the new patent, the company owns 11
patents covering its pipeline products.
Shares of the company rallied 16.6% on Jun 11 as
the new patent issuance strengthens its intellectual property
portfolio covering Zygel. Zynerbaâs shares have surged 354.5% so
far this year against the industryâs decrease of 14.3%.
Please note that the company is evaluating Zygel
for Fragile X syndrome, autism spectrum disorder in pediatric
patients, 22q11.2 deletion syndrome, and developmental and
epileptic encephalopathies in multiple clinical studies in
different stages of development. With the issuance of two patents
this year, the candidate will be shielded from competition till
2038 upon successful development in Fragile X syndrome and autism
spectrum disorder indications.
The legalization of medical marijuana in multiple
states in the United States suggests that the availability of
cannabis-based products like cannabidiol is likely to increase.
Several companies focused on developing similar products will
likely have sufficient supply of cannabis, which will likely make
the segment competitive. Patents will help Zynerba to offset
competition for its products in approved indications.
Zynerba initiated a pivotal phase II/III study
evaluating Zygel in pediatric patients with Fragile X syndrome last
year. Top-line results from the study are expected in the second
half of 2019 with potential new drug application submission in the
first half of 2020. Previously presented data from an open-label
phase II study showed improvement in core emotional and behavioral
symptoms of statistical significance in patients with Fragile X
syndrome. In May, the FDA granted Fast Track designation to the
Zygel for this indication.
A phase II study is evaluating the candidate in
developmental and epileptic encephalopathies. Top-line data is
expected in the third quarter. In addition to autism spectrum
disorder, the company initiated another phase II study last month
to evaluate Zygel as a treatment for 22q11.2 deletion syndrome, a
genetic disorder which may lead to mental illness.
We note that a few companies have cannabidiol
drugs in their portfolio. The market is expected to reach $22
billion by 2022 per a report. GW Pharmaceuticalsâ GWPH cannabidiol
drug Epidiolex was the first medicine made from Cannabis sativa
plant species to win approval from the FDA. The drug is primarily
used to treat rare forms of epilepsy. Insys Therapeutics INSY is
developing a cannabidiol oral solution for epilepsy, infantile
spasms and Prader-Willi syndrome. However, the company filed for
bankruptcy earlier this week.
Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals, Inc. price | Zynerba
Pharmaceuticals, Inc. Quote
Zacks Rank & Stock to
Zynerba currently carries Zacks Rank #3 (Hold).
Anika Therapeutics Inc. ANIK is a better- ranked biotech stock,
sporting a Zacks Rank #1 (Strong Buy). You can see the
complete list of todayâs Zacks #1 Rank stocks here.
Anikaâs earnings per share estimates have
increased from $1.22 to $1.28 for 2019 and from $1.21 to $1.33 for
2020 over the past 60 days. The stock has rallied 18.2% so far this
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