|Insys Shares Fall Following Publication Of Cleveland Research Report; Halozyme Receives Favorable FDA Decision|
|By Staff and Wire Reports|
|Thursday, 31 July 2014 18:56|
Shares of Insys Therapeutics (NASDAQ: INSY) dropped 10 percent Thursday. The company experienced selling pressure as news hit that Cleveland Research showed that both Express Scripts and CVS will be reviewing new drug debuts on a quarterly basis.
The research report noted that Insys' Subsys product could be excluded from sale if it doesn't add either clinical or financial value. Cleveland Research commented further saying formulary changes suggest ESRX will block Vertex's Incivek in favor of J&J/Medivir. ESRX may look to exclude Gilead's Sovaldi or other competing products in Hepatitis C once new drugs reach the market later this year.
Shares of Insys Therapeutics closed at $27.03, down 10.14 percent.
Halozyme Therapeutics (NASDAQ: HALO) received notice Thursday that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration voted in favor of HyQvia, which it was working with along with Baxter (NYSE: BAX).
The drug treats patients with primary immunodeficiency (PI), and according to the FDA, has a favorable risk/benefit profile. The vote was 15-1; HyQVia was previously approved for use in Europe in 2013.
HyQvia is used in Europe as replacement therapy in adults who have primary immunodeficiency syndromes and in treatment for myeloma or leukemia.
After being halted, Halozyme has resumed trading and was recently up seven percent at $9.90. The shares had traded up to $10.70 on the open, but have since backed off. Given the recent run up in the price of Halozyme, FDA approval may have been priced in to a large degree.
Air Methods Corporation (Nasdaq:AIRM) will report financial results for the second quarter ended June 30, 2014 after the close of the market on Thursday, August 7, 2014.
Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a global provider of spinal fusion technologies, announced today financial results for the second quarter ended June 30, 2014.
Amicus Therapeutics (Nasdaq:FOLD) today announced a conference call and live audio webcast on Thursday, August 7, 2014 at 5:00 p.m. ET to discuss financial results for the second quarter ended June 30, 2014.
Bacterin International Holdings, Inc. (NYSE MKT:BONE), a leader in the development of bone graft material and coatings for medical applications, today announced that it intends to offer shares of its common stock and warrants to purchase common stock in an underwritten public offering pursuant to an effective shelf registration statement.
BioTelemetry, Inc. (Nasdaq:BEAT), the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the second quarter ended June 30, 2014.
Brewer Sports International (BSI), a multi-faceted global sports advisory firm, and Amarantus BioScience Holdings, Inc. (OTCQB:AMBS), a biotechnology company focused on the discovery and development of novel diagnostics and therapeutics related to cell cycle dysregulation, endoplasmic reticulum stress, neurodegeneration and apoptosis, will be hosting the 3rd Alzheimer's-Focused #C4CT Summit powered by MDM Worldwide at the United Nations today.
Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, announced today that the Company will host a conference call and live audio webcast on Thursday, August 7, 2014, at 4:30 p.m. ET to report second quarter 2014 financial results and provide a corporate update.
CareDx, Inc. (Nasdaq:CDNA) a molecular diagnostics company focused on the development and commercialization of clinically differentiated, high value, non-invasive surveillance solutions for transplant recipients and Allegheny General Hospital (AGH), a leading transplant center located in Pittsburgh, today announced the enrollment of the first patients in a clinical study to assess the usefulness of cell-free DNA technology in diagnosing rejection in heart transplant recipients.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that it will report financial results for the second quarter ending June 30, 2014, on Thursday, August 7, 2014, before the market opens. Chimerix's management team will host a live conference call and audio webcast at 8:30 a.m. ET on Thursday, August 7, 2014 to discuss the Company's results and provide a business overview.
Ocera Therapeutics (Nasdaq:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced that it will release its second quarter financial results on August 11, 2014 at approximately 4:00 p.m. Eastern Time.
Fate Therapeutics, Inc. (Nasdaq:FATE), a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, announced today that it has completed a long-term debt financing of up to $20 million with Silicon Valley Bank.
Greatbatch, Inc. (NYSE:GB), today announced results for its second quarter ended July 4, 2014 highlighted by 14% and 23% growth in GAAP operating income and GAAP diluted EPS, respectively and 7% improvement in both adjusted operating income and adjusted diluted EPS.
GrowBLOX Sciences, Inc. (OTCQB:GBLX) a medical marijuana research and development company, announced that CEO Craig Ellins is in high demand by top tier publications, reporters, and journalists as an expert in the medical marijuana industry.
The NASDAQ OMX Group, Inc. (Nasdaq:NDAQ) announced that trading of HealthEquity, Inc. (Nasdaq:HQY), one of the nation's largest dedicated health savings custodians, commenced on The NASDAQ Stock Market on July 31, 2014.
KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH) today announced it will release its second quarter 2014 operating results and will host an investor call and webcast at 4:30 p.m. ET on Thursday, August 7, 2014.
Lucid, Inc. (OTCQB:LCDX), operating as Caliber Imaging & Diagnostics, today announced that members of its Board of Directors invested $16.1 million in the Company through the purchase of its common stock at $0.55 per share.
Marinus Pharmaceuticals, Inc. (Nasdaq:MRNS), a biopharmaceutical company dedicated to the development of innovative neuropsychiatric therapeutics, today announced the pricing of its initial public offering of 5,625,000 shares of its common stock at a public offering price of $8.00 per share, before underwriting discounts.
Ocular Therapeutix (Nasdaq:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, will visit the NASDAQ MarketSite in Times Square in celebration of its initial public offering (IPO) which occurred on The NASDAQ Stock Market on July 25, 2014.
Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery, development and commercialization of novel antibodies for the potential treatment of diseases that involve protein misfolding or cell adhesion, announced today that the first patient with Parkinson's disease has been successfully dosed in a Phase 1 multiple ascending dose clinical trial of PRX002, a potential disease-modifying treatment for Parkinson's disease.
Rockwell Medical, Inc. (Nasdaq:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the second quarter ended June 30, 2014.
SIGA Technologies, Inc. (Nasdaq:SIGA) announced today that management will host a conference call and simultaneous webcast to provide a quarterly business update at 4:30 P.M. ET on Monday, August 4, 2014.
TriVascular Technologies, Inc. (Nasdaq:TRIV), manufacturer of the Ovation Prime™ Abdominal Stent Graft System, today announced that Christopher Chavez, President and CEO, will be presenting at the Canaccord Genuity 34th Annual Growth Conference on August 14, 2014 in Boston.
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, and Solasia Pharma K.K. ("Solasia"), a developer of oncology pharmaceuticals in-licensed for commercialization in major markets throughout the world, announced today an amendment and restatement of their License and Collaboration Agreement for darinaparsin (Zinapar™ or ZIO-101) and related organoarsenic molecules.