19.08.2015 09:11:00
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Cannabis On A High, PTN Jumps On Sprout News, TNXP At Ease, Watch APHB On Friday
(RTTNews) - AmpliPhi Biosciences Corp.'s (APHBD.OB) common stock has been approved for listing on the NYSE MKT, and is expected to begin trading on the NYSE MKT under the ticker APHB on August 21, 2015.
The company, which is focused on developing bacteriophage-based antibacterial therapies to treat drug resistant infections, has 3 product candidates - AmpliPhage-001 for the treatment of lung infections caused by Pseudomonas aeruginosa in cystic fibrosis patients; AmpliPhage-002 for the treatment of S. aureus infections (including methicillin-resistant MRSA); and AmpliPhage-004 for the treatment of C. difficile infections.
APHBD.OB closed Tuesday's trading at $8.80, down 1.23%.
Cannabis Science Inc. (CBIS.PK) expects to accelerate its current FDA targeted drug development programs and raise a capital in the range of $15 million to $25 million. The company is also planning to formally pursue a contemplated up listing to NASDAQ. Cannabis said that it expects to begin filing the complete new structure program with no reverse split by the end of the month.
CBIS.PK closed Tuesday's trading at $0.03, up 118.13%.
KYTHERA Biopharmaceuticals Inc. (KYTH) has submitted a Marketing Authorization Application in the European Union, seeking approval for ATX-101 as a treatment for the reduction of submental fat.
ATX-101 was approved by the FDA in April 2015, under the name KYBELLA, and received authorization from Health Canada in July 2015, under the name BELKYRA.
KYTH closed Tuesday's trading at $74.67, down 0.36%.
Lannett Company Inc. (LCI) has received FDA approval for its Abbreviated New Drug Application for Aripiprazole Oral Solution 1 mg/mL, the generic version of the antidepressant drug ABILIFY, manufactured by Otsuka/Bristol-Myers.
Lannett's generic Aripiprazole 1 mg/ml Oral Solution product is one of two to be approved by FDA, and shipping of this medication has commenced. The oral solution 1 mg/mL dosage has been discontinued by the brand manufacturer.
According to IMS, annual total sales of Aripiprazole 1 mg/ml Oral Solution at Average Wholesale Price (AWP) were approximately $76 million.
LCI closed Tuesday's trading at $52.41, down 2.06%.
Matinas BioPharma Holdings Inc.'s (MTNB.OB) lead drug candidate MAT2203, which is being developed for the treatment of serious and life-threatening fungal infections, has been designated as a Qualified Infectious Disease Product with Fast Track status.
The QIDP and Fast Track designations have been granted for the use of MAT2203 in the treatment of invasive candidiasis, a condition with increasing rates of drug resistance to established anti-fungal products.
A phase 2a NIH/NIAID-funded clinical study with MAT2203 in patients with refractory mucocutaneous candidiasis is expected to commence during the third quarter of 2015, with data expected in the first quarter of 2016, or earlier under certain circumstances.
MTNB.OB closed Tuesday's trading at $0.98, up 15.29%.
Shares of Omeros Corp. (OMER) rose more than 72% on Tuesday as the company announced additional positive data from its phase 2 clinical trial of OMS721 for the treatment of thrombotic microangiopathies.
Thrombotic microangiopathies, or TMAs, are a rare, debilitating and life-threatening disorders characterized by multiple thrombi (clots) in the microcirculation of the body's organs, most commonly the kidney and brain.
Initial trial data released in February of this year showed that all three patients with atypical hemolytic uremic syndrome (aHUS), a form of TMA, in the first cohort treated with the lowest dose of OMS721 showed improvement in platelet counts when compared to baseline levels.
The data released yesterday relates to the second (mid-dose) cohort and data to date from its third (high-dose) cohort. In the mid-dose cohort, the two patients with plasma therapy-resistant aHUS demonstrated a 47% increase in mean platelet count, resulting in both patients having counts in the normal range while the first patient in the high-dose cohort demonstrated a 63% improvement in platelet count, returning to normal levels.
The company noted that compassionate use of OMS721 in aHUS patients has begun and that it looks forward to advancing to the fixed-dose stage of the trial and discuss phase III trial design with the FDA later this year.
OMER closed Tuesday's trading at $25.03, up 72.03%.
Following FDA approval of a privately-held company's drug for sexual desire disorder, shares of Palatin Technologies Inc. (PTN) were up more than 27% in extended trading on Tuesday.
Palatin is also developing a drug for the treatment of female sexual dysfunction. The drug candidate - Bremelanotide - is under a phase III study in the U.S., which is designed to enroll about 550 premenopausal women with hypoactive sexual desire disorder (HSDD). The initial data from the study is anticipated in the middle of calendar year 2016.
PTN closed Tuesday's trading at $0.94, down 9.62%. In after-hours, the stock was up 27.66% to $1.20.
Tonix Pharmaceuticals Holding Corp.'s (TNXP) phase II study of TNX-102 SL for the treatment of patients with military-related post-traumatic stress disorder, dubbed AtEase, recently reached 50% of its target enrollment goal of 220 patients. The company expects to report top line data in the first half of 2016.
TNXP closed Tuesday's trading 5.16% higher at $7.33.
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