(RTTNews.com) - The week that just passed by was light in terms of clinical trial news but was newsy one in terms of FDA announcements.
Here are a few things that happened in the week.
DompÃ© farmaceutici SpA's Oxervate won FDA approval on August 22, becoming the first drug for the treatment of neurotrophic keratitis, a rare disease affecting the cornea of the eye.
Kala Pharmaceuticals' (KALA) Inveltys, the first twice-daily (BID) ocular corticosteroid to treat post-operative inflammation and pain following ocular surgery, was greenlighted by the U.S. regulatory agency on August 22.
Obalon Therapeutics Inc. (OBLN), the maker of the first and only FDA approved swallowable, gas-filled balloon for weight loss, was one of the top gainers of the week, returning 63%. The Company has offered to sell approximately 5.5 million shares of common stock in a private placement at a price of $1.82 per share. The private placement, which will result in gross proceeds of $10 million, is expected to close on or about August 27, 2018.
Lannett Company Inc. (LCI) has been hitting new lows ever since it lost a contract with Jerome Stevens Pharmaceuticals. The stock lost nearly 62% of its value in the week.
Now, here are some of the pharma/biotech stocks to watch out for in the week starting August 27.
1. Esperion Therapeutics Inc. (ESPR)
Esperion is a late-stage pharmaceutical company developing convenient, cost-effective, once-daily, oral therapies for the treatment of patients with elevated low density lipoprotein cholesterol (LDL-C).
The company has two LDL-C lowering therapies in development namely, the Bempedoic acid/Ezetimibe combination pill and Bempedoic acid.
Today (Aug.25), the Company presented final data from CLEAR Harmony, a phase III study designed to see if Bempedoic acid is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.
The new data showed that patients on Bempedoic acid who were on a maximally tolerated statin dose had significantly fewer instances of new-onset or worsening diabetes than those on placebo who were on a maximally tolerated statin dose.
Watch out for...
Top-line results from a 12-week, pivotal phase III study of the Bempedoic acid/ Ezetimibe combination pill in atherosclerotic cardiovascular disease patients on maximally tolerated statin background therapy are expected this month.
ESPR closed Friday's trading at $49.08, up 0.49%.
2. Xenon Pharmaceuticals Inc. (XENE)
Xenon Pharma is a clinical stage biopharmaceutical company developing therapeutics for neurological disorders.
The clinical stage drug candidates include XEN1101 and XEN901, both of which are being developed for the treatment of epilepsy, and XEN007 for the treatment of hemiplegic migraine, a rare and debilitating neurological disorder. There is also a partnered clinical program with Genentech - GDC-0310 to treat pain.
Watch out for...
Results from a phase 1b double-blind, placebo-controlled, randomized cross-over TMS (transcranial magnetic stimulation) study of XEN1101 in healthy subjects are expected this month.
XENE closed Friday's trading at $11.85, unchanged from the previous day's close.
3. Tetraphase Pharmaceuticals Inc. (TTPH)
Tetraphase Pharma's New Drug Application for Eravacycline for the treatment of complicated intra-abdominal infections is under FDA review, with a decision expected on August 28, 2018.
In clinical trials, twice-daily IV Eravacycline was well tolerated and achieved high clinical cure rates in patients with complicated intra-abdominal infections.
The drug candidate also showed statistical non-inferiority to two widely used comparators - Merck's Invanz (ertapenem) and AstraZeneca's Merrem (meropenem) - for the primary efficacy endpoint of clinical response at the test-of-cure (TOC) visit.
If approved, Stifel analysts expect IV Eravacycline to hit peak sales of $350 million.
TTPH closed Friday's trading at $3.10, up 2.31%.
4. Akcea Therapeutics Inc. ( AKCA )
The FDA is scheduled to announce its final decision on Akcea's Waylivra (Volanesorsen), proposed for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS), on August 30, 2018.
Waylivra is co-developed by Akcea and Ionis Pharmaceuticals Inc. (IONS).
In May of this year, an FDA panel had voted 12-8 to recommend the approval of Waylivra. The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.
Currently, there are no approved therapies for the treatment of FCS. If approved, Waylivra would be the first therapy indicated for FCS patients.
Jefferies' analyst Eun Yang has estimated peak sales of Waylivra at around $150 million.
AKCA closed closed Friday's trading at $32.63, down 4.34%.
5. Aquestive Therapeutics Inc. (AQST)
Aquestive Therapeutics, which listed its IPO on the Nasdaq Global Market as recently as July 25, is gearing up for another major event.
The Company's investigational product Sympazan (AQST-120) for the treatment of seizures associated with Lennox-Gastaut Syndrome is under FDA review, with a decision expected on August 31, 2018.
Sympazan is an oral soluble film formulation of clobazam, a benzodiazepine used as an adjunctive therapy for seizures associated with Lennox-Gastaut Syndrome.
Clobazam, marketed under brand name Onfi in the United States, is currently available in either tablet form or liquid suspension.
If approved, the Company anticipates launching Sympazan by the end of 2018.
AQST closed Friday's trading at $15.73, down 1.26%.
Read the original article on RTTNews (http://www.rttnews.com/2929477/week-ahead-in-pharmaceuticals-5-stocks-to-watch-espr-ttph-aqst.aspx)
For comments and feedback: contact firstname.lastname@example.org