Below is a look at some of the headlines for companies that made news in the healthcare sector on August 12, 2014.
Pfizer Inc. (NYSE: PFE) announced top-line results from two placebo-controlled studies conducted in China with Lyrica® (pregabalin) in patients with postherpetic neuralgia (pain after shingles or PHN) and painful diabetic peripheral neuropathy (pDPN), respectively. The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo.
The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores (0-10 numeric rating scale), a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed (p=0.0002). The safety profile in this study was consistent with the known profile for Lyrica. The most common adverse events reported for subjects given Lyrica were dizziness, oedema peripheral, dry mouth and somnolence.
PHN is a type of peripheral neuropathic pain caused by nerve damage. PHN symptoms include continued burning or electric shock-like pain.
The pDPN study was a 11-week randomized, double-blind, multi-center, placebo-controlled study evaluating the efficacy, safety and tolerability of pregabalin 300 mg/day in the treatment of subjects with pDPN. For the primary efficacy parameter, endpoint mean pain score (0-10 numeric rating scale), a treatment difference of -0.28 points for pregabalin relative to placebo was observed (p=0.0559). The safety profile of pregabalin in this study was consistent with the known profile for Lyrica. The most common adverse events reported by subjects given Lyrica were dizziness and somnolence.
pDPN is a form of permanent nerve damage characterized by burning, shooting, pins-and-needles pain in the feet and hands.
Full results for both studies will be submitted for publication when analyses are complete.
Shares of Conatus Pharmaceuticals (NASDAQ: CNAT) are up more than nine percent in Monday’s pre-market session in a sympathy move to Intercept Pharmaceuticals (NASDAQ: ICPT).
After Monday’s close, Intercept reported endpoints were met in a trial testing of obeticholic acid to treat liver disease. In addition, Intercept reported better-than-expected second quarter earnings. Following a series of analyst upgrades, shares of Intercept are now up 45 percent in the pre-market session.
Similarly, Conatus is working to treat a series of liver diseases. The surge higher in Intercept shares is likely encouraging to Conatus’s solution and leads to industry revaluation.
Conatus shares were last up 9.4 percent, while Intercept shares had gained 47 percent.
Aegerion Pharmaceuticals, Inc. (Nasdaq:AEGR) today announced the pricing of its offering of $300 million aggregate principal amount of 2.00% convertible senior notes due 2019 to persons that they reasonably believe to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the "Securities Act").
Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L), a leading designer and manufacturer of rapid diagnostic screening and testing products, reports its financial results for the second quarter and six months ended June 30, 2014.
Akorn, Inc. (Nasdaq:AKRX), a niche pharmaceutical company, announced today that it has completed its previously announced acquisition of VPI Holdings Corp., the parent company of VersaPharm Incorporated, for $440 million.
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today provided a corporate update and reported financial results for the second quarter 2014.
Apricus Biosciences, Inc. (Nasdaq:APRI), a biopharmaceutical company advancing innovative medicines to meet the needs of patients, today announced it has entered into a common stock purchase agreement with Aspire Capital Fund, LLC .
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of bone graft materials and bioactive coatings for medical applications, announced today The Spine Journal has published positive results reported on the evaluation of OsteoSelect® DBM Putty in a rabbit posterolateral spinal fusion model.
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of bone graft material and coatings for medical applications, today reported financial results for the second quarter ended June 30, 2014.
Federico Pignatelli, former Chairman and Chief Executive Officer of BIOLASE, Inc. (Nasdaq:BIOL), today began a new campaign on behalf of BIOLASE stockholders to ensure BIOLASE Directors and executive management are held accountable for their statements and for business results.
Cellular Biomedicine Group Inc. (Nasdaq:CBMG) today announced that it has treated the final patient in its Phase IIb trial to further evaluate the safety and efficacy of their proprietary adipose-derived mesenchymal precursor cell (haMPC)-based therapy ReJoinTM for Knee Osteoarthritis (KOA).
Celladon Corporation (Nasdaq:CLDN), a clinical-stage biotechnology company applying its leadership position in the field of gene therapy and calcium dysregulation, today announced the pricing of an underwritten public offering of 4,000,000 shares of its common stock at $9.50 per share.
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 third fiscal quarter and the nine months ended June 30, 2014.
Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced that its enlighten laser platform received U.S. Food and Drug Administration 510(k) clearance for the treatment of benign pigmented lesions. enlighten is the first and only dual wavelength (532 nm/1064 nm) and dual pulse duration picosecond laser system cleared for sale in the United States.
Enzymotec Ltd. (Nasdaq:ENZY), a developer, manufacturer and marketer of innovative bio-active lipid ingredients, announced the initiation of a clinical study on Autism Spectrum Disorder (ASD) symptoms.
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 financial results for the second quarter ended June 30, 2014 and announced that an independent Data Monitoring Committee (iDMC), following its first scheduled interim data review of the Company's Phase 2 PUMA study of PROHEMA®, supported the continuation of the study.
Foundation Healthcare, Inc. (OTC Markets:FDNH), which focuses on the development and management of surgical hospitals and related ancillary services, announced today the Company's financial results for the second quarter which ended June 30, 2014.
Greatbatch, Inc. (NYSE:GB) today announced that it has acquired CCC Medical Devices (CCC), the globally-respected active implantable medical device (AIMD) systems developer and manufacturer, effective immediately.
Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today reported financial results for the quarter ended June 30, 2014.
Intra-Cellular Therapies, Inc. (Nasdaq:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system disorders, today announced its financial results for the second quarter ended June 30, 2014, and provided a corporate update, including that it has successfully completed an End-of-Phase 2 meeting with the United States Food and Drug Administration for its lead drug candidate ITI-007 for the treatment of schizophrenia.
IRADIMED CORPORATION (Nasdaq:IRMD), the leading provider of non-magnetic intravenous (IV) infusion pump systems that are safe for use during magnetic resonance imaging (MRI) procedures, today announced financial results for the three months ended June 30, 2014.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced the appointment of Theodore "Ted" Schroeder to its board of directors effective August 11, 2014.
Kips Bay Medical, Inc. (Nasdaq:KIPS), a medical device company focused on manufacturing and commercializing its external saphenous vein support technology, eSVS® Mesh, for use in coronary artery bypass grafting, or CABG, surgery, today provided a business update and announced financial results for its second quarter ended June 28, 2014.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it will be participating in the Canaccord Genuity 34th Annual Growth Conference at the InterContinental Hotel, Boston, MA, on Thursday, August 14, 2014.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced financial results for its fiscal fourth quarter and fiscal year ended June 30, 2014, provided an update on recent business highlights, and provided financial guidance for its fiscal year ending June 30, 2015.
Pacific Health Care Organization, Inc., (OTCQB: PFHO) today announced its financial results for the second quarter ended June 30, 2014.
Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing novel differentiated therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, reported its financial results for the second quarter ended June 30, 2014, and provided recent corporate highlights.
Receptos, Inc. (Nasdaq:RCPT), a biopharmaceutical company developing therapeutic candidates for the treatment of immune and metabolic diseases, today provided development program updates and announced financial results for the second quarter ended June 30, 2014.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that it has strengthened its leadership team with the appointment of Arthur P. Bertolino as Executive Vice President and Chief Medical Officer.
Revance Therapeutics, Inc. (Nasdaq:RVNC), a biopharmaceutical company developing botulinum toxin products for use in aesthetic and therapeutic indications, today reported financial results for the three months ended June 30, 2014.
StemCells, Inc. (Nasdaq:STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today provided a business update and reported financial results for the second quarter ended June 30, 2014.
Stericycle, Inc. (Nasdaq:SRCL) will host investor meetings on Wednesday, September 3rd by Dan Ginnetti, CFO, at the Barrington Research Growth Conference at the Four Seasons Hotel in Chicago.
T2 Biosystems, Inc. (Nasdaq:TTOO) today announced the closing of its initial public offering of 5,980,000 shares of its common stock at an initial public offering price of $11.00 per share, which includes the exercise in full by the underwriters of their option to purchase up to 780,000 additional shares of common stock.
Verde Media Group Inc. (OTC:VMGI) through its Verde Media Biotechnology Division (VMBD) announces plans for genetically modifying a proprietary strain of yeast to produce cannabis-identical phytocannabinoids, including D9 tetrahydrocannabinol and cannabidiol.
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