NEW YORK, April 08, 2016  -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ANAVEX 3-71 for the treatment of Frontotemporal dementia (FTD).

 

Frontotemporal dementia describes a clinical syndrome associated with progressive shrinking of the frontal and temporal anterior lobes of the brain.  It causes a decline in language and/or behavioral changes, which include inappropriate social conduct, lack of empathy, blunted emotions or agitation, neglect of personal hygiene and a decrease in energy and motivation.  To date, no treatment has been shown to slow its progression and the prognosis for people with FTD is poor.  FTD afflicts an estimated 50,000 to 60,000 patients in the United States and represents an estimated 10 to 20 percent of all dementia cases.

MADISON, Wis., April 07, 2016 -- Cellectar Biosciences, Inc. (CLRB) (“Cellectar” or the “company”), an oncology-focused biotechnology company, announced today that on April 6, 2016, the NASDAQ Listing Qualifications Panel (the “panel”) issued a determination granting the company’s request for the continued listing of its common stock on the NASDAQ Capital Market (“NASDAQ”).

 

The company’s continued listing on NASDAQ is subject to, among other things, the company evidencing compliance with the minimum $2.5 million stockholders’ equity requirement by May 16, 2016.  Cellectar must also provide the panel with updated information regarding its ability to maintain compliance for a period of one year.

 

“We are pleased with the panel’s decision to support Cellectar’s continued listing on NASDAQ,” said Jim Caruso, president and CEO of Cellectar Biosciences. “We are confident in our capability to successfully satisfy the required evidence of compliance.”

NEW YORK, April 06, 2016  -- Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced it delivered an oral presentation and presented several posters featuring data on ITI-007, the Company’s lead drug candidate at the 5th Biennial Schizophrenia International Research Society (SIRS) Conference being held in Florence, Italy.

 

The oral presentation and two poster presentations featured additional efficacy and safety data from ITI-007-301, the Company’s recently completed Phase 3 clinical trial in patients with schizophrenia. An additional poster presentation featured data from the ITI-007 Positron Emission Tomography (PET) study in patients with schizophrenia. Top-line data from both trials were announced in September 2015 and subsequently presented at the 54th annual meeting of the American College of Neuropsychopharmacology (ACNP) in December 2015.

BAUDETTE, Minn., April 5, 2016  -- ANI Pharmaceuticals, Inc. ("ANI") (ANIP) today announced that it has received approval from the U.S. Food and Drug Administration ("FDA") of the Abbreviated New Drug Application ("ANDA") for Oxycodone HCl Capsules, 5mg.  Trailing twelve-month sales for the product are $7.5 million according to IMS Health.

 

Arthur S. Przybyl, ANI's President and CEO stated, "When launched, this will be our third commercial Schedule II narcotic product. In addition, we have received a target action date of January 2, 2017 from the FDA for another Schedule II narcotic product. We remain hopeful that we will obtain three additional Schedule II narcotic product approvals within the next 12 months."