|Sorrento Announces Completion of Enrollment in the TRIBECA™ Study; Nanosphere Announces Fourth Quarter and Full Year 2014 Results|
|By Marilyn Mullen|
|Wednesday, 28 January 2015 20:05|
Sorrento Therapeutics, Inc. (NASDAQ: SRNE), announced the last patient in (total n = 111 patients) has been randomized in the ongoing TRIBECA™ (TRIal establishing bioequivalence [BE] between Cynviloq™ and Albumin-bound paclitaxel*) registrational trial.
Patients were enrolled globally from sites in USA, Eastern Europe, and Asia. The ongoing safety assessment from treated patients continues to reveal no unexpected adverse events and the data is consistent with the toxicity profile reported in the literature with albumin-bound paclitaxel. Previously, Sorrento announced positive pharmacokinetic (PK) data from the first eight (8) patients enrolled in the TRIBECA study.
Nanosphere, Inc. (Nasdaq:NSPH), reported preliminary financial results for the fourth quarter and fiscal year ended December 31, 2014.
Nanosphere achieved record revenues for the full year and fourth quarter of 2014. Preliminary revenues for the fourth quarter and full year 2014 were $4.6 million and $14.3 million, respectively, compared to $3.4 million and $10.0 million in the fourth quarter and full year 2013. Year-over-year revenue growth was driven predominantly by blood stream infection test purchases by U.S.-based microbiology laboratories. New customer placements for the fourth quarter of 2014 were 47, up sequentially from 30 in the third quarter of 2014 and 35 in the fourth quarter of 2013. Nanosphere plans to release full fourth quarter and fiscal year 2014 results as well as guidance for 2015 and hold an investor call in conjunction with the filing of its annual report on Form 10-K.
"We see continued and accelerated adoption of our expanding infectious disease test menu," said Michael McGarrity, Nanosphere's president and chief executive officer. "Our placement and revenue growth are clear indicators of demand for our products and are a validation that we are building a competitive foothold in the U.S. molecular microbiology market."
Nanosphere also announced that on January 26, 2015, Roger Moody notified Nanosphere that he would be stepping down as Nanosphere's Chief Financial Officer effective on February 11, 2015. In connection with Mr. Moody's resignation, Nanosphere has appointed Ann Wallin, Nanosphere's Vice President of Finance and Accounting, as interim Chief Financial Officer and as Chief Accounting Officer effective after Mr. Moody's departure on February 11, 2015. Also effective January 26, 2015, Sheli Z. Rosenberg, Nanosphere's Chair of the Board of Directors, advised the Company that she has resigned from the Board of Directors. The Board intends to form an Executive Committee of the Board to discharge the function of Chairman of the Board on an interim basis and conduct search for a successor Chair.
"I would like to thank both Sheli Rosenberg and Roger Moody for their service to Nanosphere," continued McGarrity.
Nanosphere also announced today that it has received a warning letter from the FDA resulting from inspections of the Company's facility in Northbrook, Illinois by the FDA's Chicago District Office that occurred in March 2014. The warning letter relates to deficiencies in the Company's quality system regulation. Nanosphere takes this matter seriously and is in the process of evaluating the corrective actions required to address the matters raised in the warning letter.
Nanosphere also is in the process of preparing a response to the warning letter and intends to respond fully to the issues raised by the FDA within 15 business days as requested by the FDA, and to work diligently and expeditiously to resolve the issues raised by the FDA. The warning letter does not restrict the manufacture, production or shipment of any of Nanosphere's products, nor require the withdrawal of any product from the marketplace. However, failure to promptly address the issues raised in the warning letter to the FDA's satisfaction or to comply with U.S. medical device regulatory requirements in general could result in regulatory action being initiated by the FDA. These actions could include, among other things, product seizures, injunctions and civil money penalties.
Advaxis, Inc. (Nasdaq:ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, announced an update related to the Phase 2 open-label clinical study of ADXS-HPV (ADXS11-001) in patients with persistent or recurrent cervical cancer with documented disease progression being conducted by the Gynecologic Oncology Group (GOG), now part of NRG Oncology.
Auspex Pharmaceuticals, Inc. (Nasdaq:ASPX), a biopharmaceutical company dedicated to developing innovative medicines for people with movement disorders and other rare diseases, today announced the closing of its previously announced underwritten public offering of 4,600,000 shares of its common stock at a public offering price of $56.50 per share.
FutureWorld Corp. (OTC: FWDG), a leading provider of advanced technologies and solutions to the global cannabis industry, announced that CB Scientific, a subsidiary of FutureWorld Corp., has reached a definitive wholesale agreement with American Green (OTC: ERBB).
Galena Biopharma, Inc. (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will present a corporate update at the 17th Annual BIO CEO & Investor Conference.
IRADIMED CORPORATION (Nasdaq:IRMD), the only provider of non-magnetic intravenous (IV) infusion pump systems for use during magnetic resonance imaging (MRI) procedures, announced today that it has resumed domestic distribution of the DERS option for its MRI compatible mRidium 3860 IV infusion pump systems.
Luminex Corporation (NASDAQ: LMNX) today announced that management will present at the 2015 Leerink Global Healthcare Conference to be held February 11-12, 2015, in New York, NY.
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that the IND (Investigational New Drug) Application for MN-001 (tipelukast) for the treatment of NASH (nonalcoholic steatohepatitis) has been accepted and is now open with the FDA (U.S. Food and Drug Administration).
NanoString Technologies, Inc. (Nasdaq:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today announced that its management is scheduled to present at the 2015 Leerink Global Healthcare Conference in New York.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced that it will provide an online Web simulcast of its 2014 fourth quarter conference call on Wednesday, February 11, 2015.
Natus Medical Incorporated (Nasdaq:BABY) today announced financial results for the three months and full year ended December 31, 2014.
Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the inner and middle ear, today announced the closing of its follow-on public offering of 2,932,500 shares of its common stock (including 382,500 shares that were offered and sold pursuant to the full exercise of the underwriters' option to purchase additional shares) at a price to the public of $29.25 per share, for total gross proceeds of approximately $86 million before deducting underwriting discounts and commissions and other offering expenses. All of the common stock was sold by Otonomy.
Oxford Immunotec Global PLC (Nasdaq:OXFD), a global, commercial-stage diagnostics company focused on developing and commercializing proprietary tests for the management of immune-regulated conditions, today announced that it has commenced an underwritten offering of its ordinary shares.
Performant Financial Corporation (Nasdaq:PFMT) announced that it has entered into an agreement to acquire Premier Healthcare Exchange, Inc. ("PHX") for $130 million.
Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, will release fourth quarter and full year 2014 financial results after market close on Wednesday, February 11, 2015.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing potential new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive cancers, today announced the closing of its previously announced public offering of 4,600,000 shares of common stock at a public offering price of $36.75 per share, including 600,000 shares sold pursuant to the full exercise of the underwriters' option to purchase additional shares of common stock.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an Israeli biopharmaceutical company primarily focused on late clinical-stage, proprietary, orally-administered drugs for inflammatory and gastrointestinal diseases, including gastrointestinal cancers, today announced that Dror Ben-Asher, RedHill's Chief Executive Officer, will be presenting at the 17th Annual BIO CEO & Investor Conference on Monday, February 9, 2015, at 14:00 EST in the Park South room at the Waldorf Astoria in New York City.
RestorGenex Corporation (OTCQB:RESX), a specialty biopharmaceutical company focused on developing products for oncology, ophthalmology and dermatology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for RES-529 for the treatment of glioblastoma multiforme.
SAGE Therapeutics (Nasdaq:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today announced management will participate in three upcoming healthcare investor conferences, as follows: Canaccord Genuity Rare Disease, BioPharma 1x1 Day on Tuesday, Feb. 3, 2015, in New York; Leerink Global Healthcare Conference, with a presentation at 11:10 a.m. ET on Thursday, Feb. 12, 2015, in New York; SunTrust Robinson Humphrey One-on-One Orphan Drug Day on Monday, Feb. 23, 2015 in New York.
Stevia Corp. (OTCQB: STEV), an international farm management company and healthcare company focused on the commercial development of products that support a healthy lifestyle, including stevia and hemp and their compounds, is pleased to announce that the company expects the current 2015 spring harvest to exceed 3,000 tons achieving a 50% increase over the 2014 spring harvest and a 300% increase over the 2013 spring harvest.
Vascular Solutions, Inc. (Nasdaq:VASC) today announced that it has entered into an agreement to acquire a 26,000-square-foot building located at 6420 Sycamore Court North in Maple Grove, Minnesota.
Vitae Pharmaceuticals, Inc. (Nasdaq:VTAE), a clinical stage biotechnology company, today announced the closing of its previously announced underwritten public offering.
Vocera Communications, Inc. (NYSE:VCRA), the leading provider of integrated, intelligent communication solutions for mission-critical mobile environments, today announced that Santa Clara Valley Medical Center has been selected to receive a Safety Net Grant to join the Experience Innovation Network, Vocera's research collaborative focused on the discovery and adoption of innovations that restore the human connection in healthcare.
Zafgen, Inc. (Nasdaq:ZFGN) today announced the closing of its underwritten public offering of 3,942,200 shares of its common stock at a price of $35.00 per share before underwriting discounts, which includes the full-exercise of the underwriters' option to purchase an additional 514,200 shares of common stock at the public offering price, less the underwriting discounts.