Intra-Cellular Therapies Announces Positive Top-Line Results From the First Phase 3 Trial of ITI-007 in Patients With Schizophrenia and Confirms the Unique Pharmacology of ITI-007 in a Separate Positron Emission Tomography Study

  • ITI-007 60 mg once-daily met the primary and key secondary efficacy endpoints in the Phase 3 trial
  • ITI-007 60 mg significantly improved social functioning as measured by the Personal and Social Performance Scale
  • ITI-007 demonstrated a safety and tolerability profile that did not differ from placebo on key parameters of body weight, cardiovascular function and vital signs, glucose, lipids, prolactin, akathisia and other motoric disturbances

Intra-Cellular Therapies to Host a Conference Call Today at 8:30 a.m. ET to Discuss Results

NEW YORK, Sept. 16, 2015 -- Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced positive results from the first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia.

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Sirona Biochem Reaches Major Milestone by Successful Scale-Up of Skin Lightening Compound SBM-TFC-1067

Formulation Testing by Potential Licensee Gets Underway Shortly

VANCOUVER, BC--(September 15, 2015) - Sirona Biochem Corp. (TSX VENTURE: SBM) (ZSB.F) (ZSB.DE), (the "Company") is pleased to announce the successful scale-up of its skin lightening compound SBM-TFC-1067 ("1067").

Sirona Biochem commissioned its contract research organization (CRO) Roowin (www.roowin.com) for the scale-up of 1 kg of 1067 compound. The successful scale-up represents a major scientific breakthrough by Sirona's laboratory in Rouen, France. A quantity of 200 grams of 1067 was delivered last week for formulation and solubility testing by a major multinational corporation under a previously signed material transfer agreement.

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U.S. Food and Drug Administration's (FDA) Draft Guidance is Consistent With Evoke's Current Phase 3 Study Design and Endpoint for EVK-001

States Patients With Diabetic Gastroparesis May Have Unpredictable Gastric Emptying and Altered Absorption of Orally-Administered Hypoglycemic Drugs

SOLANA BEACH, Calif., Sept. 15, 2015 -- Evoke Pharma, Inc. (EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) diseases, today announced that its Phase 3 clinical trial design for EVK-001 (metoclopramide nasal spray) is consistent with the FDA's recommendations in the recently released draft guidance entitled Gastroparesis: Clinical Evaluation of Drugs for Treatment -- Guidance for Industry (Draft Guidance). The new Draft Guidance contains the FDA's current thinking on trial design and study endpoints for drug development in the treatment of gastroparesis.

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BriaCell Launches Development of Companion Diagnostic Product, BriaDx(TM)

Also Provides General Corporate Update Including Consolidation of Its Corporate Headquarters and Research Laboratories in San Francisco Bay Area; Attends NYC Biotechnology Conference and Posts Updated Investor Presentation

VANCOUVER, BC--( September 14, 2015) - BriaCell Therapeutics Corp (ANCCF) (TSX VENTURE: BCT) ("BriaCell", the "Company", or "BCT") is pleased to announce the initiation of its key research and development program pertaining to BriaCell's novel companion diagnostic product, which is to be called "BriaDx™".

President & CEO Dr. Joseph Wagner commented, "Since joining BriaCell in June, I have been very excited about the prospect of developing BriaDx™, a proprietary companion diagnostic product, to be co-developed with our BriaVax™ therapeutic cancer vaccine. Companion Diagnostics is a rapidly growing field, one that I have particular expertise in through my prior experiences. Our thesis is that a companion diagnostic such as BriaDx™ could maximize health outcomes and health economics by predicting which patients will most benefit from BriaVax™ treatment. Furthermore, we believe the strategy of co-developing BriaDx™ in parallel with BriaVax™ will maximize our likelihood of clinical trial success."

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Applied DNA Sciences Acquires Assets of DNA Manufacturer Vandalia Research

Strengthens Large Scale DNA Production and Broadens Market Reach

STONY BROOK, NY--(September 11, 2015) - Applied DNA Sciences, Inc. (APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology, product genotyping services and product authentication solutions, announced that it has acquired the assets of privately held Vandalia Research, Inc. for $1.5 million in cash.

Vandalia's core technology and intellectual property portfolio, allow for the large-scale production of specific DNA sequences using polymerase chain reaction (PCR). PCR can amplify a few copies of a piece of DNA, generating millions to billions of copies without the impurities of fermentation.

Vandalia's Triathlon™ PCR systems are self-contained and modular, can work together in mass production or can be used individually throughout the world, offering the advantage of delivering DNA locally and securely. The enclosed design should facilitate compliance with drug manufacturing guidelines in our quest to DNA mark individual doses as a major initiative in the war against counterfeit drugs.

Read more: Applied DNA Sciences Inc ( APDN )