AEZS One Step Closer, AKTX To Report Data In April, CBIO On The Move

(RTTNews) - Aeterna Zentaris Inc. (AEZS) (AEZS.TO) is gearing up to file a new drug application seeking approval of Macrilen for the evaluation of growth hormone deficiency in adults in the third quarter of this year.

Macimorelin is an orally-active small molecule that stimulates the secretion of growth hormone. This compound carries orphan drug designation of the FDA for diagnosis of growth hormone deficiency in adults.

AEZS closed Thursday's trading at $3.05, up 5.17%.

Akari Therapeutics' (AKTX) investigational drug Coversin has been granted Fast Track designation by the FDA for the treatment of paroxysmal nocturnal hemoglobinuria in patients resistant to approved drug Soliris (eculizumab).

Akari is evaluating Coversin in two phase II clinical trials. The first phase II trial is evaluating Coversin in patients with paroxysmal nocturnal hemoglobinuria (PNH) who have never received a complement blocking therapy. Interim results from this ongoing Phase 2 trial will be presented at the Research and Development Day to be held on April 24, 2017 in New York.

The second Phase 2 trial is evaluating Coversin in patients with PNH and C5 polymorphisms resistant to Eculizumab.

AKTX closed Thursday's trading at $7.00, up 5.26%.

A U.S. district court on Thursday ruled that the patents protecting AstraZeneca's (AZN) Zomig Nasal Spray, indicated for the acute treatment of migraine with or without aura in adults, are not invalid and are infringed by Lannett Co. Inc.'s (LCI) abbreviated new drug application.

The U.S. commercialization rights to Zomig rest with Impax Pharmaceuticals (IPXL).

IPXL closed Thursday's trading at $12.65, down 1.56%.

Shares of Catalyst Biosciences Inc. (CBIO) were up more than 7% in extended trading on Thursday after the European Patent Office indicated that there is no opposition to the company's patent covering improved next-generation coagulation Factor VIIa, Marzeptacog alfa.

The company has selected INC Research (INCR), a global contract research organization to conduct a phase II/III clinical trial of Marzeptacog alfa (activated) in individuals with hemophilia A & B with inhibitors.

The phase II part of phase II/III subcutaneous efficacy trial of Marzeptacog alfa (activated) is expected to be initiated in the fourth quarter of 2017.

CBIO closed Thursday's trading at $9.24, down 12.08%. In after-hours, the stock was up 7.68% to $9.95.

Genmab A/S' (GMXAY.OB) collaboration partner Janssen Biotech Inc., has decided to pull the plug on phase II study of Daratumumab in three types of relapsed or refractory non-Hodgkin's lymphoma.

The company decided to stop the trial as two cohorts of the study did not reach the predefined futility thresholds of overall response rates (ORR) of 50%, and 30%, respectively.

However, other ongoing and planned studies with Daratumumab in lymphomas and other cancers outside multiple myeloma will continue as planned.

GMXAY.OB closed Thursday's trading at $101.00, down 2.25%.

The FDA has lifted the partial clinical hold on Karyopharm Therapeutics Inc.'s (KPTI), clinical trials for investigational cancer drug Selinexor (KPT-330).

A partial clinical hold to pause enrollment in Selinexor trials was imposed by the FDA on March 10, 2017 due to incomplete information in the existing version of the investigator's brochure (IB), including an incomplete list of serious adverse events (SAEs) associated with Selinexor.

Now that the partial clinical hold has been lifted, enrollment may resume in all Selinexor studies in hematologic malignancies, including the STORM study in refractory multiple myeloma, the SADAL study in relapsed/refractory diffuse large B-cell lymphoma (DLBCL), and the STOMP study of Selinexor and backbone therapies in multiple myeloma. In addition, Investigator Sponsored Trials in hematologic malignancies with Selinexor may resume accruing patients, noted the company.

KPTI closed Thursday's trading at $12.78, up 6.77%.

Proteostasis Therapeutics Inc. (PTI) now expects to report preliminary phase I data from at least 8 cystic fibrosis subjects from a cohort of stable Orkambi patients dosed with PTI-428 for 7 days followed by a 7-day follow-up period, in the second quarter. The data were supposed to have been reported in the first quarter.

Data from the 28-day dosing cohort in phase I clinical trial of PTI-428 are expected in the second half of 2017.

PTI closed Thursday's trading at $10.89, down 1.89%. In after-hours, the stock was down 12.76% to $9.50.