Category Archives: Press Releases
XenoPort Reports Results from a Phase 2b
XenoPort, Inc. (Nasdaq:XNPT) announced today preliminary top-line results from a Phase 2b clinical trial of arbaclofen placarbil (also known as AP) as adjunctive therapy in patients with gastroesophageal reflux disease (GERD) who do not experience complete relief of GERD symptoms while being treated with proton pump inhibitors (PPI). In this study, subjects who experienced GERD [...]
ACUROX(R) Tablets New Drug Application Accepted for Filing With a Priority Review Classification
ACUROX(R) Tablets New Drug Application Accepted for Filing With a Priority Review Classification Acura Pharmaceuticals, Inc. (Nasdaq:ACUR) today announced that it has been informed by King Pharmaceuticals Research and Development Inc. (King) that King’s New Drug Application (NDA) for ACUROX® (oxycodone HCl) Tablets was accepted for filing by the US Food and Drug Administration (FDA) [...]
FDA Accepts ANX-530 NDA for Filing
ADVENTRX Pharmaceuticals, Inc. (NYSE Amex: ANX) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for its product candidate ANX-530 (vinorelbine injectable emulsion), or Exelbine. The filing of the Exelbine NDA means the FDA has made a threshold determination that it is sufficiently complete to [...]
Corcept Therapeutics Announces Positive Phase 3 Study
Corcept Therapeutics Incorporated (NASDAQ:CORT – News) today announced positive top-line results from its Phase 3 study of CORLUX for the treatment of Cushing’s Syndrome. The study evaluated the response of two patient groups to CORLUX treatment: one included patients who were glucose intolerant and one included patients who were hypertensive. Statistically significant improvement in the [...]
Myrexis Reports Anti-Tumor Activity in a Subset of Patients From Ongoing Phase 2 Azixa
Myrexis. (Nasdaq: MYRX) a biotechnology company focused on discovering, developing, and commercializing novel treatments for cancer, today announced a poster presentation of its lead product candidate Azixa(TM) (verubulin, MPC-6827) at the 2010 Society for Neuro-Oncology Scientific Meeting and Education Day in Montreal, Canada. Dr. Sean Grimm of the Northwestern University Brain Tumor Institute was the [...]
FDA Issues Complete Response Letter to Biodel Regarding New Drug Application for Linjeta™
Biodel Inc. (Nasdaq: BIOD) announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) requesting additional information regarding the company’s new drug application (NDA) for Linjeta�cent; (human insulin [rDNA origin]) injection 100IU/mL for the treatment of type 1 and type 2 diabetes mellitus to improve glycemic control. The [...]
FDA Issues Complete Response Letter for Lorcaserin New Drug Application
Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) and Eisai Inc. announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding Arena’s New Drug Application (NDA) for lorcaserin. Lorcaserin is intended for weight management, including weight loss and maintenance of weight loss, in patients who are obese (Body Mass Index, or BMI, [...]
BPAX Nasdaq To Present at Cancer Immunotherapy Conference
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX – News) will present at the Cancer Immunotherapy: A Long Awaited Reality conference taking place on October 21, 2010, at the New York Academy of Medicine in New York. Stephen M. Simes, BioSante’s president & chief executive officer, will speak at 11:00 am EDT, and will provide an overview of [...]
BPAX: Initiated – JAGNote by Roth Capital Partners, LLC
BPAX: Nasdaq, Initiated – The firm initiated coverage of the shares with a Buy rating and price target of $4.
Alexza: FDA declines treatment for agitation
Alexza Pharmaceuticals, Inc. (Nasdaq:ALXA – News) Alexza Pharmaceuticals Inc., the Mountain View, Calif., drug developer, said on Monday that the U.S. Food and Drug Administration declined to clear for marketing AZ-004, a potential rapid treatment for agitation in patients with schizophrenia or bipolar disorder. The drug, generically loxapine, is taken by inhalation. In a complete [...]