CYTR Plunges, FDA Nod For AMGN, Shire, SCMP Gives Up On Cobiprostone

(RTTNews) - Acasti Pharma Inc.'s (ACST) Bioavailability Bridging study of CaPre completed dosing of all subjects in the month of May, and results are expected to be reported later this year.

CaPre is being developed for the management of hypertriglyceridemia.

ACST closed Monday's trading at $1.30, unchanged from the previous day's close.

The FDA has approved a new monthly administration single-dosing option for Amgen's (AMGN) cholesterol-lowering medication Repatha.

Till yesterday, the approved options were subcutaneous administration of Repatha 140 mg every 2 weeks or 420 mg once monthly in abdomen, thigh, or upper arm. In order to administer 420 mg, 3 Repatha injections are given consecutively within 30 minutes.

The newly approved Repatha Pushtronex system, which is an on-body infusor with prefilled cartridge, is designed to provide 420 mg of Repatha in a single dose. The Pushtronex system will be available to patients in the U.S. in early August, noted the company.

The U.S. Wholesale Acquisition Cost (WAC) price of Repatha is $14,100 annually, whether it is delivered monthly via Pushtronex system or every two weeks via SureClick autoinjector.

AMGN closed Monday's trading at $160.18, down 0.57%.

Shares of Coherus BioSciences Inc. (CHRS) were up over 27% on Monday, following positive topline results for CHS-1701 pharmacokinetic and pharmacodynamic biosimilarity study.

CHS-1701 is a biosimilar candidate to Amgen Inc.'s (AMGN) Neulasta.

Neulasta was approved by the FDA in January 2002 and by the European Medicines Agency in August 2002 to decrease the risk of infection associated with treatment for cancer. Neulasta had worldwide sales of $4.59 billion in 2014 and $3.6 billion in the first nine months of 2015.

The BLA submission for CHS-1701 is anticipated in the third quarter 2016.

CHRS closed Monday's trading at $21.93, up 27.35%.

Shares of CytRx Corp. (CYTR) plunged over 67% in after-hours on Monday, following disappointing results from the company's phase III clinical trial of Aldoxorubicin in patients with relapsed or refractory soft tissue sarcomas.

In the trial, which compared Aldoxorubicin with investigator's choice therapy for progression free survival, there was no significant difference between the two arms.

However, the objective response rate and disease control, showed a near doubling in the Aldoxorubicin arm compared to investigator's choice, including in patients who previously received treatment with doxorubicin, added the company.

The company plans to conduct a subsequent analysis of progression free survival and response data from the trial in the fourth quarter of this year.

CYTR closed Monday's trading at $2.51, up 11.06%. In after hours, the stock fell 67.53% to $0.81.

DelMar Pharmaceuticals Inc. (DMPI.OB), which trades over the counter, will begin trading on the NASDAQ Capital Market at the opening of trading on Tuesday, July 12, 2016 under the ticker symbol DMPI.

Commenting on the transition, Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals said, "Our listing on the NASDAQ marks the achievement of a major corporate milestone for our Company and is a testament to the progress that our team has made over the past few years. We believe that listing on NASDAQ will position us to broaden our shareholder base, increase appeal to institutional investors, provide improved liquidity and ultimately contribute to increasing shareholder value."

DMPI.OB closed Monday's trading at $9.38, up 3.65%.

Japan-based Nichi-Iko Pharmaceutical Co. has agreed to acquire Sagent Pharmaceuticals Inc. (SGNT) via an all-cash tender offer followed by a second-step merger, for $21.75 per share, equivalent to a total consideration of roughly $736 million.

The acquisition price represents a premium of approximately 40.3% to Sagent's closing price of $15.50 per share on July 8, 2016. The transaction, which has been unanimously approved by the Nichi-Iko and Sagent Boards of Directors, is expected to close in the second quarter of Nichi-Iko's fiscal year ending March 2017, subject to customary regulatory approvals.

SGNT closed Monday's trading at $21.65, up 39.68%.

Shire plc's (SHPG) Xiidra 5%, a twice-daily eye drop solution, has been greenlighted in the U.S. for the treatment of the signs and symptoms of dry eye disease in adult patients, thus becoming the company's first FDA-approved medicine in ophthalmics.

Xiidra is dosed twice per day, approximately 12 hours apart, in each eye. It is expected to be launched in the United States in the third quarter of 2016.

SHPG closed Monday's trading at $186.31, down 1.01%.

Sucampo Pharmaceuticals Inc. (SCMP) has decided to pull the plug on Cobiprostone development for oral mucositis in head and neck cancer patients as a prespecified futility analysis of a phase 2a study indicated insufficient clinical benefit. This is the second mid-stage trial of Cobiprostone that has failed.

In April of this year, the company announced that its phase IIa study of Cobiprostone in patients with proton pump inhibitor-refractory non-erosive reflux disease did not meet its primary endpoints.

SCMP closed Monday's trading at $11.20, down 2.52%.