Provectus Biopharmaceuticals Inc. to List on NYSE MKT; Teva Announces FDA Acceptance of sNDA Filing for QNASL® Print E-mail
By Staff and Wire Reports   
Tuesday, 13 May 2014 18:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on May 13, 2014.
Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT) a development-stage oncology and dermatology biopharmaceutical company, announced today that its shares of common stock have been approved for listing on the NYSE MKT. Shares will begin trading on the NYSE MKT on Friday May 16, 2014. The company’s ticker symbol will remain “PVCT” but it will withdraw its shares from quotation on the OTCQB concurrent with listing its shares on the NYSE MKT.

“Listing on the NYSE MKT is a huge milestone for Provectus Biopharmaceuticals, and I take a great deal of personal satisfaction from this news. I believe that this will enhance our shareholder value as well as broaden our shareholder base and heighten our corporate profile in the capital markets.”

Dr. Craig Dees, PhD, CEO of Provectus said, "Listing on the NYSE MKT is a huge milestone for Provectus Biopharmaceuticals, and I take a great deal of personal satisfaction from this news. I believe that this will enhance our shareholder value as well as broaden our shareholder base and heighten our corporate profile in the capital markets.”

NYSE MKT is a fully integrated trading venue within the NYSE Euronext community and leverages the NYSE’s advanced and innovative market model to offer a premier venue for listing and trading the stocks of small companies. The venue utilizes the trading, connectivity and routing technologies of the NYSE platform and offers superior price discovery, superior liquidity and reduced trading volatility. Listed companies benefit from issuer-selected Designated Market Makers (DMM) that utilize world-class NYSE trading systems to discover and improve prices, dampen volatility, add liquidity and enhance value. In addition, NYSE MKT-listed companies gain access to the brand visibility and are eligible for the issuer services enjoyed by the NYSE Euronext community.

“We welcome Provectus to the NYSE community and look forward to a strong partnership with the Company and its shareholders,” said Scott Cutler, Executive Vice President and Head of Global Listings at NYSE Euronext. “Provectus will join other pharmaceutical companies that benefit from NYSE’s trusted and reliable platform to raise capital.”



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Teva Pharmaceuticals Industries Ltd., (NYSE:TEVA)
announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s supplemental new drug application (sNDA) for a lower dose QNASL® (beclomethasone dipropionate) Nasal Aerosol for the treatment of seasonal and perennial allergic rhinitis in children 4-11 years of age. QNASL is a waterless intranasal corticosteroid spray currently available for the treatment of nasal symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in patients 12 years of age and older.

“We are very pleased the FDA has accepted for review the sNDA for QNASL®. If the FDA approves the new indication for QNASL®, it will become the first waterless HFA nasal allergy treatment approved for patients as young as 4 years of age,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “The low-dose formulation demonstrates our commitment to the development of innovative treatment options for all patients with respiratory conditions, including nasal allergies.”

The sNDA filing includes data from three double-blind, placebo-controlled studies that evaluated the safety and efficacy of QNASL® in children with allergic rhinitis (AR). The data demonstrated that once-daily treatment with QNASL® provided significant nasal allergy symptom relief in pediatric subjects with SAR and PAR when compared with placebo. In all three studies the safety profile of QNASL® was similar to that of placebo and adverse events were consistent with those seen in previous clinical studies.

“With approximately 10 percent of all children in the U.S. living with allergic rhinitis, there is a need for new treatment options that can help children and their caregivers better manage the often bothersome symptoms of nasal allergies,” said Dr. William Storms, MD, practicing allergist, clinical professor at the University of Colorado Health Sciences Center and founder of the William Storms Allergy Clinic in Colorado Springs, CO. “In my practice, I’ve found that identifying the right treatment option for my younger patients can be quite difficult. That’s why the potential to offer a safe and effective waterless treatment option, such as QNASL®, may prove to be an exciting new prospect for many practicing allergists treating pediatric allergy patients.”

QNASL® is a waterless nasal allergy aerosol available only by prescription. When used once a day, QNASL® delivers 24-hour relief of nasal allergy symptoms in patients with different types of nasal allergies, such as indoor, outdoor, seasonal and year round.



Also Tuesday:



Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today reported financial results for the first quarter ended March 31, 2014, and provided an update on the Company's clinical programs.

Biodel Inc. (Nasdaq:BIOD)
today reported financial results for the second fiscal quarter ended March 31, 2014 and provided an update on recent corporate and drug candidate portfolio developments.

Celladon Corporation (Nasdaq:CLDN)
, a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced financial results for the first quarter ended March 31, 2014.

Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, announced today it will report financial results for the fiscal third quarter ended March 31, 2014, on Thursday, May 15, 2014.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced financial results for the first quarter ended March 31, 2014, and provided updates on its clinical development programs.

Corium International, Inc. (Nasdaq:CORI)
, a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited results from operations for both the second fiscal quarter and the six months ended March 31, 2014.

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today reported clinical development updates and announced financial results for the first quarter ended March 31, 2014.

Galectin Therapeutics Inc. (Nasdaq:GALT)
, the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, today reported its financial results for the quarter ended March 31, 2014.

Harris & Harris Group, Inc. (Nasdaq:TINY)
, an investor in transformative companies enabled by disruptive science, notes the announcement by portfolio company, Metabolon, Inc., that it has entered into a collaboration agreement with GlaxoSmithKline ("GSK") to provide metabolomic profiling services and to collaborate on other research projects leveraging Metabolon's DiscoveryHD4™ platform.

Inogen, Inc. (Nasdaq:INGN)
, a medical technology company offering innovative respiratory products for use in the home care setting, today reported financial results for the three months ended March 31, 2014.

Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
reported today positive new study findings showing that the Company's NX-1207 Phase 2 treatment for localized low-risk prostate cancer did not affect testosterone levels in treated men.

Anthony Nolan, the UK blood cancer charity, and Pacific Biosciences of California, Inc., (Nasdaq:PACB) announced today that Anthony Nolan is the world's first stem cell registry to invest in an innovative new technology for advanced tissue typing.

Pacific Health Care Organization, Inc. (OTCQB: PFHO)
today announced its financial results for the first quarter ended March 31, 2014

Phibro Animal Health Corporation (Nasdaq:PAHC)
today reported its financial results for its March 2014 fiscal third quarter and provided guidance for its June 2014 fiscal fourth quarter and fiscal year.

PMX Communities Inc. (OTCQB:PMXO)
cannabis expansion targets California.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, today reported financial results for the three months ended March 31, 2014.

Repros Therapeutics Inc® (Nasdaq:RPRX)
today announced it has reached the enrollment goal of 120 subjects in the second of two previously announced head-to-head studies, ZA-304, comparing Androxal® to the leading U.S. testosterone replacement therapy.

SANUWAVE Health, Inc. (OTCQB:SNWV) today reported financial results for the three months ended March 31, 2014 and provided a business update.

SPARK, the premier physical education brand of School Specialty, Inc. (OTCQB:SCOO), which is a leading distributor of innovative and proprietary products, programs and services to the education marketplace, today announced that the President's Council on Fitness, Sports & Nutrition (PCFSN) has selected the SPARK Programs as a 2014 PCFSN Community Leadership Award honoree.



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