AKER Up On Aero-Med Deal, Allergy Under The Weather, RGLS Falls On Clinical Hold

(RTTNews) - Shares of Akers Biosciences Inc. (AKER) leaped over 30% on Monday as the company signed the first distribution agreement for BreathScan OxiChek with Aero-Med, a division of Cardinal Health.

BreathScan OxiChek is Akers' second generation disposable breath test to rapidly determine levels of oxidative stress (free radicals) in the body.

Aero-Med's target market for BreathScan OxiChek includes anti-aging, functional and integrative health and wellness treatment practitioners, and it has already placed orders for OxiChek.

Akers' product Revenue for the three months ended March 31, 2016 was $738,023, representing an increase of 79% over the corresponding quarter last year. Looking ahead, the company is optimistic that it will materially outperform 2015 in fiscal 2016.

AKER closed Monday's trading at $2.54, up 32.29%.

Shares of Allergy Therapeutics (AGY.L) dropped to 52-week low on Monday, after the company announced that its exploratory phase II dose-ranging study of GrassMATAMPL was not able to determine a recommended dose for the phase III trial.

GrassMATAMPL is an ultra-short course subcutaneous allergen specific immunotherapy administered prior to the grass pollen season.

The next dose range finding study is planned to start in 2017. Allergy Therapeutics noted that it will await the outcome of an End of Phase II meeting with the FDA, scheduled later in 2016, before progressing into Phase III.

AGY.L touched a 52-week low of $18.05 on Monday before closing the day's trading at $20.79, down 11.53%.

Emergent BioSolutions Inc. (EBS) has been awarded a task order valued at up to $21.9 million by the Biomedical Advanced Research and Development Authority to develop and manufacture three cGMP lots of a Zika vaccine for use in a phase I clinical trial.

According to the World Health Organization, as of 15 June 2016, 60 countries and territories report continuing mosquito-borne transmission of which 46 countries are experiencing a first outbreak of Zika virus since 2015, with no previous evidence of circulation, and with ongoing transmission by mosquitos and 14 countries reported evidence of Zika virus transmission between 2007 and 2014, with ongoing transmission.

EBS closed Monday's trading at $27.24, down 7.16%.

Shares of GW Pharmaceuticals plc (GWPH) rose more than 6% on Monday, following positive results from the first phase III trial of the company's investigational medicine Epidiolex for the treatment of Lennox-Gastaut syndrome.

The company reported positive results from a pivotal phase 3 trial of Epidiolex for the treatment of Dravet syndrome in March of this year.

The company looks forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017.

GWPH closed Monday's trading at $88.49, up 6.22%.

Puma Biotechnology Inc. (PBYI) has submitted its Marketing Authorization Application to the European Medicines Agency for Neratinib.

The company is seeking approval of Neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer that has previously been treated with Herceptin-based adjuvant therapy.

The company intends to submit the NDA for Neratinib to the FDA in mid-2016.

PBYI closed Monday's trading at $27.80, down 9.21%.

Shares of Regulus Therapeutics Inc. (RGLS) plunged over 53% in extended trading on Monday, following clinical hold on the company's drug candidate RG-101 for the treatment of chronic hepatitis C virus.

The FDA initiated the clinical hold after Regulus reported a second serious adverse event of jaundice. The serious adverse event occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going phase I US study 117 days after receiving a single dose of RG-101.

Three studies evaluating RG-101 are underway, and timelines of the studies' follow-up results are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits.

RGLS closed Monday's trading at $5.01, down 5.29%. In after hours, the stock was down 53.89% to $2.31.

Tobira Therapeutics Inc. (TBRA) has reported encouraging results from preclinical studies of its lead product candidate Cenicriviroc.

Cenicriviroc reduced Inflammation and fibrosis in animal models of chronic liver and kidney disease including non-alcoholic steatohepatitis (NASH), the company noted.

The company expects to report top-line primary analysis results of its phase 2b study of Cenicriviroc in patients with NASH and liver fibrosis, dubbed CENTAUR, in the third quarter of 2016.

TBRA closed Monday's trading at $14.34, up 10.90%.

Zynerba Pharmaceuticals Inc. (ZYNE) has reported positive top line results from a phase 1 multiple rising dose clinical trial of ZYN002 cannabidiol (CBD) gel in 24 healthy volunteers and 12 patients with epilepsy.

ZYN002 cannabidiol gel is in development for the treatment of epilepsy, osteoarthritis and Fragile X Syndrome.

In the phase I study, ZYN002 CBD gel has been found to be safe and well-tolerated at all dose levels.

The company also announced the results in epilepsy patients in the single rising dose trial. The results demonstrated that ZYN002 is safe and well tolerated in patients with epilepsy.

The company has initiated the baseline phase of the phase II clinical trial of ZYN002 CBD gel in adult patients with refractory epilepsy, dubbed STAR 1 study. Dosing in this trial is expected to begin in the third quarter of 2016.

In addition to STAR 1 in refractory epilepsy, Zynerba also expects to initiate two phase II trials for ZYN002 CBD gel in osteoarthritis and Fragile X Syndrome during the second half of 2016. Top line results from all three studies are anticipated in the first half of 2017.

ZYNE closed Monday's trading at $7.09, down 7.32%.