GNCA Zooms On Herpes Study Results, HART Is Now BSTG, More In Store For RDHL

(RTTNews) - Akari Therapeutics' (AKTX) lead drug candidate Coversin has demonstrated encouraging results in a patient diagnosed with paroxysmal nocturnal hemoglobinuria and resistant to Alexion's Soliris.

Paroxysmal nocturnal hemoglobinuria, or PNH, is an ultra-rare, life-threatening blood disorder in which uncontrolled activation of complement, a component of the immune system, results in chronic hemolysis (destruction of the patient's red blood cells).

Soliris (eculizumab) is the first and only therapy approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis.

According to the company, upon subcutaneous administration of Coversin, the patient demonstrated clinical and symptomatic improvement, complement inhibition (as measured by the CH50 assay) and a marked reduction of LDH (a marker of blood hemolysis). Based on the preliminary results, the company believes that all PNH patients with or without resistance should respond to Coversin.

AKTX closed Thursday's trading at $14.00, unchanged from the previous day's close.

Array BioPharma Inc. (ARRY) has entered into a partnership with Asahi Kasei Pharma Corp. for its Tropomyosin receptor kinase A inhibitors inflammation/pain program.

The partnership entitles Array to receive an upfront payment of $12 million, and up $64 million if certain development and commercialization milestones are achieved, and is eligible for up to double-digit royalties.

Asahi Kasei Pharma will have exclusive rights to develop and commercialize products in Japan, Korea, Taiwan and China for pain, inflammation and other non-cancer indications.

ARRY closed Thursday's trading at $2.95, up 1.37%.

Cardiovascular Systems Inc. (CSII) now expects its revenue for fiscal third quarter ended March 31, 2016 to range from $43.5 million to $44 million compared to its previously issued guidance range of $40.5 million to $42 million. The consensus revenue forecast among analysts polled by Thomson Reuters is $41.05 million.

In its fiscal 2016 third quarter, the company expects to take a one-time charge of roughly $4.5 million, related to restructuring, and a one-time charge of approximately $8 million to settle a lawsuit related to kickbacks probe.

The company is scheduled to report full third-quarter financial results on May 4, 2016.

CSII closed Thursday's trading at $10.37, up 2.27%.

The FDA has formally acknowledged receipt of 22nd Century Group Inc.'s (XXII) Modified Risk Tobacco Product application for BRAND A.

According to the company, BRAND A tobacco cigarettes contain less than 0.6 mg nicotine per cigarette and less than 0.05 mg nicotine yield per cigarette - a reduction in nicotine of at least 95% as compared to conventional cigarettes.

As per guidelines, the MRTP application process results in a "Final Review and Action" by FDA within the 360 days of the receipt of an application.

XXII closed Thursday's trading at $0.7830, up 0.73%.

Shares of Genocea Biosciences Inc. (GNCA) were up more than 94% on Thursday, following positive 12 month efficacy data from the company's phase II dose optimization trial evaluating GEN-003 for the treatment of genital herpes.

According to the trial results, GEN-003 demonstrated sustained and statistically significant reductions compared to baseline in the rate of viral shedding 12 months after dosing across multiple dose groups as well as sustained efficacy at multiple dose levels across secondary endpoints measuring the impact on clinical disease. GEN-003 was safe and well tolerated by patients, with no serious adverse events related to the vaccine in the trial.

A phase IIb study of GEN-003 in genital herpes is underway, and virologic efficacy data from this trial is expected to be reported in the third quarter of 2016 while clinical efficacy data at 6 months post dosing is expected around the end of 2016.

GNCA closed Thursday's trading at 7.74, up 94.96%.

Harvard Apparatus Regenerative Technology Inc. (HART) has changed its name to Biostage, Inc. and will trade under the Nasdaq symbol "BSTG" effective April 1, 2016.

The name change is said to reflect the evolution of the company's focus from commercializing bioreactors and research tools to the pioneering development of bioengineered organ implants for the esophagus, bronchus, and trachea. The new name will also eliminate market confusion with its former parent company Harvard Bioscience from which it was spun-out in November 2013.

HART closed Thursday's trading at $1.79, up 8.48%.

RedHill Biopharma Ltd. (RDHL) has reported encouraging top-line interim results from its ongoing phase IIa proof-of-concept study of oral dose RHB-104 in patients treated for relapsing-remitting multiple sclerosis.

In the study, dubbed CEASE-MS, positive safety and clinical signals were observed after 24 week treatment with RHB-104. Annualized relapse rate at 24 weeks compared favorably with previously reported pivotal studies of interferon beta-1a therapies Avonex and Rebif.

The final results of the completed 48 week study are expected during the second half of 2016.

RDHL closed Thursday's trading at $12.25, up 2.60%.