MNKD To Get Financing, PTIE, DRRX Vault, BMRN On Watch

(RTTNews) - BioMarin Pharmaceutical Inc. (BMRN) will be presenting the latest data from its ongoing phase 1/2 trial of BMN 673 for genetically-defined cancers, including breast cancer and ovarian cancer patients, with deleterious germline BRCA mutations at the European Cancer Congress on September 29, 2013.

The company is scheduled to initiate a phase III program of BMN 673 in germline BRCA mutation metastatic breast cancer by the end of September.

BMRN closed Friday's trading at $63.33, down 0.78%.

Epizyme Inc.'s (EPZM) investigational leukemia drug EPZ-5676 has received orphan drug designation from FDA.

A phase 1 clinical trial for EPZ-5676 was initiated in September 2012, and an expansion phase that will exclusively enroll acute leukemia patients in which the MLL gene is rearranged due to a chromosomal translocation (MLL-r) is expected to be initiated in the second half of 2013.

EPZM closed Friday's trading at $31.34, up 0.64%.

MannKind Corp. (MNKD) on Friday said that it has satisfied conditions for Deerfield's second tranche of convertible note financing, now that the company's phase III trials have met the primary efficacy endpoints and have not shown any adverse safety issue that would reasonably be expected to prevent approval of its investigational inhaled insulin, Afrezza.

MNKD closed Friday's trading 13.10% down at $5.77.

Effective at the start of trading on Monday, August 19, 2013, Stereotaxis Inc. (STXS) will have its listing transferred to the NASDAQ Capital Market from the NASDAQ Global Market.

STXS closed Friday's trading 1.22% higher at $4.16.

Pain Therapeutics Inc. (PTIE) rose over 35% to $3.11 and DURECT Corp. (DRRX) gained more than 17% to $1.23 on Friday after media reports of their partner Pfizer Inc. (PFE) loading into ClinicalTrials.gov, the information related to a phase I trial of PF-00345439 Formulation K.

The phase I study, which is designed to enroll 18 subjects, is not yet open for participant recruitment. This study will estimate the effects of food on oxycodone pharmacokinetics after administration of 40 mg doses of PF-00345439 Formulation K and to estimate its relative bioavailability compared to PF-00345439 Formulation X in the fasted state in healthy volunteers.

DURECT licensed Remoxy, an oral, long-acting oxycodone gelatin capsule, to Pain Therapeutics, which subsequently sublicensed it to King Pharmaceuticals which in turn was acquired by Pfizer in February 2011.

Pain Therapeutics and DURECT took a hit on May 10th of this year after Pfizer said that there is much to consider for seeking management endorsement to carry forward the Remoxy program.

Remoxy, which made its way till the FDA for review, was rejected twice in December 2008 and in June 2011 with a Complete Response Letter being issued on both the occasions. In the Complete Response Letter issued in June 2011, the FDA raised concerns related to, among other matters, the Chemistry, Manufacturing and Controls section of the NDA for REMOXY.

However, Pfizer has not officially announced that the phase I trial mentioned in the clinical trials registry is related to the Remoxy program.