AFFX In Harmony, SRPT, IBIO Focusing On Ebola, PCYC Inks Deal With Roche

(RTTNews) - Affymetrix Inc. (AFFX) and privately held Ariosa Diagnostics Inc. have signed a multi-year supply agreement covering Affymetrix arrays and instruments to be utilized as part of Ariosa's Harmony Non-Invasive Prenatal Test.

The deal comes through after Ariosa's scientists successfully tested and implemented Affymetrix microarrays as part of a DNA quantification method for the Harmony test.

The Harmony prenatal test is a non-invasive blood test for pregnant women that can be used as early as 10 weeks into pregnancy. By evaluating cell-free DNA found in maternal blood, the test can assess the risk of Trisomy 21 (Down syndrome) in the fetus.

AFFX closed Thursday's trading 4.71% higher at $7.56.

Shares of iBio Inc. (IBIO) rose more than 35 percent on Thursday after the company confirmed its role in emergency response to Ebola virus disease outbreak.

The company said that its iBioLaunch technology has applicability to further development and production of antibodies that target the Ebola virus and that it has been collaborating with Caliber Biotherapeutics LLC on commercial opportunities for recombinant antibodies and antibody-related proteins based on the speed, efficiency, and cost advantages of producing pharmaceutical proteins in plants instead of with bioreactor-based manufacturing methods.

IBIO closed Thursday's trading at $1.89, up 35.97. In after-hours, the stock was up another 14.81% at $2.17.

Infinity Pharmaceuticals Inc.'s (INFI) phase 2a exploratory study of Duvelisib (IPI-145) in patients with mild, allergic asthma has failed to meet the primary endpoint of significantly improving the maximum early-phase or late-phase asthmatic response. However, clinical improvement was observed in the late-phase asthmatic response among patients who received 25 mg Duvelisib twice daily for five days - the highest dose tested - said the company.

Multiple secondary efficacy endpoints were significantly positive at the highest tested dose of Duvelisib, added Infinity Pharma.

Data from a phase 2 study evaluating doses of 0.5, 1 and 5 milligrams twice daily of Duvelisib plus Methotrexate versus placebo plus Methotrexate in patients with rheumatoid arthritis are anticipated by the end of the year.

INFI closed Thursday's trading at $13.24, down 0.08%.

Ironwood Pharmaceuticals Inc. (IRWD) has initiated a phase II clinical trial evaluating its prescription drug Linaclotide for the treatment of adults suffering from opioid-induced constipation.

Linaclotide is marketed in the United States under the brand names LINZESS and as CONSTELLA in the European Union.

LINZESS is indicated for adult men and women suffering from irritable bowel syndrome with constipation or chronic idiopathic constipation. CONSTELLA is indicated for adult men and women suffering from irritable bowel syndrome with constipation.

LINZESS was launched in the U.S. in December 2012 and CONSTELLA was launched in certain European countries in the second quarter of 2013.

Data from the phase II trial of Linaclotide in adult patients with opioid-induced constipation are expected in the second half of 2015.

IRWD closed Thursday's trading at $12.88, down 3.52%.

Pharmacyclics Inc. (PCYC) is all set to evaluate the safety, tolerability and preliminary efficacy of its lead cancer drug IMBRUVICA in combination with Roche's leukemia drug GAZYVA in patients with non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma. A master clinical drug supply agreement with Roche to this effect has been signed by Pharmacyclics.

Initially, a phase III study of the combination of IMBRUVICA and GAZYVA will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development.

PCYC closed Thursday's trading at $109.14, up 1.03%.

Sarepta Therapeutics Inc. (SRPT) announced promising early clinical results from phase I studies of its drug candidates - AVI-6002 and AVI-6003 - for the treatment of Ebola and Marburg virus, respectively.

Ebolavirus and Marburgvirus belong to the same virus family of Filoviridae.

The two phase I clinical studies were designed to characterize the safety, tolerability and pharmacokinetics of single doses of intravenous formulations of AVI-6002 or AVI-6003 in healthy adult volunteers.

According to the trial results, the compounds were found to be well-tolerated with no dose limiting level demonstrated. No clinically significant or dose-dependent effects were observed at any of the safety endpoints evaluated, added the company.

Isabelle Nuttall, the World Health Organization's director of global capacities, alert and response global capacities said that this week, the number of Ebola cases will cross 9,000, with the death toll topping 4,500.

SRPT closed Thursday's trading at $22.30, up 6.65%. In after-hours, the stock rose another 9.96% to $24.52.