22.11.2016 17:23:56
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What's In The Offing For These Biotech Stocks?
(RTTNews) - Only a few weeks left until the end of the year, and now is the time to take a look at some of the potential catalysts of biotech stocks that might be announced before 2016 closes. The Nasdaq Biotechnology index has gained nearly 14% in the last two weeks, following Donald Trump's victory over Hillary Clinton in the U.S. presidential election.
There have been a number of interesting developments so far this month pertaining to clinical trials - some positive and some disappointing.
Palatin Technologies Inc. (PTN), Ionis Pharmaceuticals Inc. (IONS), Adaptimmune Therapeutics PLC (ADAP) and The Female Health Co. (FHCO) gained big this month on positive clinical trial news while Achillion Pharmaceuticals Inc. (ACHN) Innocoll Holdings PLC (INNL) Trillium Therapeutics Inc. (TRIL), Anthera Pharmaceuticals Inc. (ANTH) and Acorda Therapeutics Inc. (ACOR) have taken a beating on disappointing outcomes of clinical trials.
Now, let's take a look at some of the stocks with potential clinical trial catalysts that are worth following over the rest of the year.
1. ACADIA Pharmaceuticals Inc. (ACAD)
ACADIA Pharma is focused on developing medicines for patients with central nervous system (CNS) disorders.
The company has one FDA-approved drug, NUPLAZID, known generically as Pimavanserin, for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis.
Pimavanserin is also being explored in other indications like Alzheimer's disease agitation, Alzheimer's disease psychosis and schizophrenia.
The top-line results from a phase II study evaluating Pimavanserin for the treatment of Alzheimer's disease psychosis are expected by the end of 2016.
ACAD is currently trading at $28.63, down 3.05%.
2. Achaogen Inc. (AKAO)
Achaogen is committed to developing antibacterials to treat multi-drug resistant gram-negative infections.
The company's lead product candidate is Plazomicin, which is under phase III trials for two serious bacterial infections namely, complicated urinary tract infections, dubbed EPIC, and carbapenem-resistant Enterobacteriaceae, known as CARE.
The top-line results from both the EPIC and CARE clinical trials are anticipated by the end of 2016.
AKAO is currently trading at $4.87, up 0.21%.
3. Aradigm Corp. (ARDM)
Aradigm is involved in developing inhalation drug products for the prevention and treatment of severe respiratory diseases.
The company's most advanced investigational product is Pulmaquin, a once-a-day novel inhaled formulation of Ciprofloxacin, a widely prescribed antibiotic.
Pulmaquin is under 2 phase III trials for the treatment of patients with non-cystic fibrosis bronchiectasis (non-CF BE) who have chronic lung infections with Pseudomonas aeruginosa, dubbed ORBIT-3 and ORBIT-4.
The top line data from both the trials are expected to be available this quarter (Q4, 2016).
ARDM is currently trading at $5.15, up 1.78%.
4. Cerecor Inc. (CERC)
Cerecor is focused on developing drugs for patients with neurological and psychiatric disorders.
The company's lead product candidate is CERC-501 that is under phase II trials for substance use disorders (e.g., nicotine, alcohol and/or cocaine) and for adjunctive treatment of major depressive disorder (MDD).
The top-line data from a phase II study of CERC-501 for smoking cessation is expected in December.
Another immediate catalyst to watch out for is the top-line data from a phase II study of CERC-301 as an oral, adjunctive treatment of major depressive disorder that is expected this month.
CERC is currently trading at $5.30, up 4.35%.
5. GW Pharmaceuticals plc (GWPH)
GW Pharma is involved in the development of plant-derived cannabinoid therapeutics. The company has 1 marketed cannabinoid prescription drug Sativex and a deep pipeline of additional cannabinoid product candidates.
Sativex is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside of United States. It is not approved in the U.S. yet.
A phase II study of Sativex in children with spasticity due to cerebral palsy is underway - with data expected this quarter (Q4 2016).
GWPH is currently trading at $119.86, down 1.40%.
6. Horizon Pharma plc (HZNP)
Horizon Pharma markets a portfolio of medicines through its orphan, rheumatology and primary care business units.
The company expects topline data from its phase III trial of Actimmune in Friedreich's ataxia in late December.
Actimmune is approved in the U.S. for use in two rare diseases - to reduce the frequency and severity of serious infections associated with Chronic Granulomatous Disease, and to slow the worsening of severe, malignant osteopetrosis.
Sales of Actimmune are $80.5 million this year-to-date, up a modest 1% over the comparable year-ago period.
HZNP is currently trading at $21.45, up 0.19%.
7. Novan Inc. (NOVN)
Novan is a pharmaceutical company that is focused on dermatology and it IPO'ed as recently as September of this year.
The company's most advanced drug candidate is SB204, which is under phase III testing for the treatment of acne vulgaris, or acne. Results from the pivotal trials of SB204 are expected in the first quarter of 2017.
Next in the pipeline is SB206 for the treatment of viral skin infections, such as warts caused by human papillomavirus, or HPV. A phase II proof-of-concept trial of SB206 is underway, and top-line results are expected this quarter (Q4, 2016).
NOVN is currently trading at $22.70, up 2.99%.
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