BURLINGTON, Mass., May 26, 2016 - Flexion Therapeutics, Inc. (FLXN) announces that yesterday it received written responses from the U.S. Food & Drug Administration (FDA) to questions the company had submitted in advance of a pre-NDA meeting regarding Flexion’s lead product candidate, Zilretta (also known as FX006). The FDA clearly indicates in its responses that the safety and efficacy data from the registration program for Zilretta are “acceptable to support filing of an NDA submission.” Based on this positive FDA feedback, the in-person pre-NDA meeting has become unnecessary and the FDA responses will serve as the official meeting minutes.  

 

Michael Clayman, M.D., President and Chief Executive Officer of Flexion, stated, “The endorsement from the FDA for the Zilretta NDA submission represents a major milestone in the development of this drug candidate and brings us one step closer to making it available to the many millions of knee osteoarthritis (OA) patients who lack good pain-relief options. We intend to submit the NDA in the fourth quarter of this year.”

MIN-117 meets primary and secondary endpoints

 

Reduction in depressive symptoms demonstrated

Good tolerability and safety profile observed

Positive effect on sleep architecture shown

Differentiated mechanism of action

 

WALTHAM, Mass., May 26, 2016 -- Minerva Neurosciences, Inc. (NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system (CNS) disorders, today announced positive top line results from a Phase IIa clinical trial in major depressive disorder (MDD) with MIN-117, an antidepressant drug candidate with a differentiated mechanism of action targeting adrenergic alpha 1a, alpha 1b, 5-HT1A, 5-HT2A receptors, serotonin and the dopamine transporter.             

Patent Covers Paclitaxel  Drug Conjugate for Targeted Delivery of Paclitaxel to Cancer Cells

 

MADISON, Wis., May 25, 2016 -- Cellectar Biosciences, Inc. (CLRB) (“the Company”), an oncology-focused biotechnology company, today announces that the United States Patent and Trademark Office has issued U.S. Patent No. 9,345,718 on May 24, 2016, which covers CLR 1603, a phospholipid ether-paclitaxel conjugate.

 

This specific PDC product patent is based on one of a series of patent applications designed to protect both composition of matter and method of use for phospholipid drug conjugates, or PDCs, developed with Cellectar’s proprietary phospholipid-ether delivery vehicle conjugated with any existing or future cytotoxic agents, including chemotherapeutics such as paclitaxel, for targeted delivery to cancer cells and cancer stem cells.  Phospholipid ethers act as a cancer targeting drug vehicle delivering cytotoxic compounds like paclitaxel directly to cancer cells, thus limiting the drug’s exposure to healthy cells and increasing the potency of the drug at lower concentrations. 

CAMBRIDGE, Mass.-- Sarepta Therapeutics, Inc. (SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they are continuing their review and internal discussions related to our pending NDA for eteplirsen and will not be able to complete their work by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016. The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

 

About Sarepta Therapeutics

Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of rare, infectious and other diseases. For more information, please visit us at www.sarepta.com.