RSMD Branches Out, HOPE For CAPR, Aeolus' Clinical Hold Lifted, SGEN On Track

(RTTNews) - Aeolus Pharmaceuticals Inc. (AOLS.OB) is now free to initiate its planned human safety study of AEOL 10150, an investigational treatment for the lung and delayed effects of acute radiation exposure, now that the clinical hold on the study imposed by FDA has been lifted.

The FDA had placed the proposed phase I study in healthy normal volunteers for AEOL 10150 as a treatment for Lung-ARS on clinical hold on September 22, 2014, asking the company to address specific concerns in order to allow for the initiation of studies.

AOLS.OB closed Monday's trading at $0.20, down 2.45%.

Astellas Pharma Inc. and Medivation Inc.'s (MDVN) supplemental New Drug Application for XTANDI in metastatic castration-resistant prostate cancer, which include head-to-head data comparing XTANDI and hormonal therapy Bicalutamide (Casodex), has been accepted for review by the FDA.

The regulatory agency's decision date is set for October 22, 2016.

The head-to-head data included in the sNDA are from two phase II studies, dubbed TERRAIN and STRIVE, which demonstrated an advantage for XTANDI over Bicalutamide.

XTANDI received its first FDA approval in August 2012 for the treatment of patients with metastatic castration-resistant prostate cancer who have previously received chemotherapy drug, docetaxel (Taxotere). The drug was approved for use in men with metastatic castration-resistant prostate cancer who have not received chemotherapy in September 2014.

Medivation and Astellas have a global agreement to jointly develop and commercialize XTANDI, and sales of the drug in the U.S. are split evenly between the two companies.

The U.S. net sales of XTANDI, as reported by Astellas, are expected to range between $1.14 billion and $1.18 billion in 2015.

MDVN closed Monday's trading at $32.36, down 1.22%.

Bellicum Pharmaceuticals Inc.'s (BLCM) lead product candidate BPX-501 has been tagged orphan drug by FDA for the treatment of immunodeficiency and graft versus host disease, following stem cell transplant.

BPX-501 is currently being evaluated in multiple phase 1/2 clinical trials in adults and pediatric patients with leukemias, lymphomas, and genetic blood diseases in the U.S. and Europe.

BLCM closed Monday's trading 6.95% higher at $10.62.

Capricor Therapeutics Inc.'s (CAPR) phase I/II clinical trial of CAP-1002 in Duchenne Muscular Dystrophy (DMD)-related cardiomyopathy has treated the first patient, and enrollment in the trial is underway.

The trial, dubbed HOPE-Duchenne, is designed to enroll 24 patients.

Cardiomyopathy is currently the leading cause of death in patients with DMD now that other treatments are available to mitigate other aspects of the disease process, according to the company.

CAPR closed Monday's trading at $2.43, unchanged from the previous day's close.

Shares of Corium International Inc. (CORI) were up over 8% on Monday, following positive topline interim results from a phase I clinical study of Corplex Memantine transdermal delivery system for the treatment of Alzheimer's disease.

According to the study results, after a single application of the once-weekly Corplex Memantine product candidate, plasma concentrations approached steady state at day 7, and were comparable to the plasma concentrations of 28 mg oral Namenda XR, an FDA-approved drug for the treatment of moderate to severe dementia of the Alzheimer's type, at day 7.

CORI closed Monday's trading at $5.85, up 8.53%.

ResMed (RMD) is all set to acquire privately held Brightree LLC, a provider of cloud-based software to improve clinical and business performance in the post-acute care industry, for $800 million in cash.

The acquisition is expected to strengthen ResMed's global leadership in connected healthcare solutions, adding to software revenue growth opportunities. Resmed expects the deal to be immediately accretive to gross margins and non-GAAP diluted earnings per share after close and beyond.

On completion of the transaction, Brightree will continue to operate as a separate entity under the Brightree brand name. The company will be managed independently, with its headquarters remaining in Atlanta. ResMed expects Brightree employees, including Brightree President and CEO Dave Cormack, to continue in their current roles.

RMD closed Monday's trading at $59.26, up 0.61%.

Seattle Genetics Inc. (SGEN) has initiated a phase 1/2 clinical trial of its investigational antibody-drug conjugate Vadastuximab talirine in combination with Celgene's approved Vidaza in patients with previously untreated myelodysplastic syndrome.

Additionally, a phase III clinical trial to evaluate Vadastuximab talirine in combination with hypomethylating agents like Vidaza in previously untreated older AML patients is planned to begin by the third quarter of 2016.

SGEN closed Monday's trading at $30.52, up 0.30%.