|Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ®; Ampio Announces Updates On the Regulatory Path for FDA Approval of Optina™|
|By Marilyn Mullen|
|Wednesday, 14 October 2015 19:24|
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 14, 2015.
Pfizer Inc. (NYSE: PFE) announced it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication.
"Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis," said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. "It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of XELJANZ in patients with chronic plaque psoriasis."
Psoriasis affects 7.4 million people in the United States.1 The most common form is plaque psoriasis, which affects about 80 percent of people who have the condition.2a Of those, as many as 20 percent have moderate to severe chronic plaque psoriasis.2b
Amgen (NASDAQ: AMGN) announced that its Board of Directors today declared a $0.79 per share dividend for the fourth quarter of 2015. The dividend will be paid on Dec. 7, 2015, to all stockholders of record as of the close of business on Nov. 16, 2015.
Cantex Pharmaceuticals, Inc. a clinical stage biopharmaceutical company developing medications that block critical mechanisms by which cancer spreads and resists treatment, today announced that it will present at The 14th Annual BIO Investor Forum to be held October 20-21, 2015 at the Parc 55 San Francisco. Stephen G. Marcus, M.D., Chief Executive Officer of Cantex, will provide an overview of the company's business and clinical-stage development pipeline, including its lead product, CX-01, during his presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference. Event: The 14th Annual BIO Investor Forum; Date: Tuesday, October 20, 2015; Presentation Time: 10:30 am (Pacific Time); Location: Parc 55 San Francisco, Fillmore Room. Dr. Marcus' presentation will be webcast live and made available as an archive on Cantex Pharmaceuticals' website, www.cantex.com.
Castlight Health, Inc. (NYSE: CSLT) today announced that American Electric Power (AEP) has selected the Castlight Enterprise Healthcare Cloud (EHC) to help its employees become healthcare consumers as they move to all consumer driven health plans (CDHP) in 2016. With Castlight, employees can better understand and manage their healthcare choices, lower their costs and improve their health outcomes. Human resources (HR) professionals benefit from powerful organizational insights to optimize their benefits utilization, increase benefits satisfaction, and drive reduced healthcare spend. American Electric Power is one of the largest electric utilities in the United States, delivering electricity to nearly 5.4 million customers across 11 states. Due to upcoming benefits changes, such as moving to consumer directed health plans (CDHPs), as well as to a single carrier, AEP will leverage Castlight's technology and services to support employees through these changes.
Cynosure, Inc. (Nasdaq: CYNO), which designs, manufactures and markets medical devices for aesthetic procedures and precision surgical applications worldwide, today announced that the Company will release its third-quarter 2015 financial results before the market opens on Tuesday, October 27, 2015 and host a conference call for investors and analysts that day at 9:00 a.m. ET. On the call, Chairman and Chief Executive Officer Michael Davin and President and Chief Financial Officer Timothy Baker will discuss Cynosure's financial results, as well as the Company's business outlook and strategy. Those who wish to listen to the conference call webcast should visit the "Investors" section of the Company's website at www.cynosure.com. The live call also can be accessed by dialing (877) 709-8155 or (201) 689-8881. If you are unable to listen to the live call, the webcast will be archived on the Company's website.
CytomX Therapeutics, Inc. (Nasdaq: CTMX), a biopharmaceutical company developing Probody™ therapeutics for the treatment of cancer, today announced the closing of its initial public offering of 7,666,667 shares of common stock at an initial public offering price of $12.00 per share, before underwriting discounts and commissions, which includes the exercise in full by the underwriters of their option to purchase up to 1,000,000 additional shares of common stock. The Company's common stock began trading on The NASDAQ Global Select Market on October 8, 2015, under the ticker symbol "CTMX." BofA Merrill Lynch, Jefferies LLC and Cowen and Company LLC acted as joint book-running managers for the offering. Oppenheimer & Co. served as manager for the offering. A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission on October 7, 2015. The offering was made solely by means of a prospectus, copies of which may be obtained from BofA Merrill Lynch, 222 Broadway, New York, NY 10038, Attention: Prospectus Department, or by email at [email protected]; Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 631-274-2806 or by fax at 631-254-7140.
eHealth, Inc. (NASDAQ: EHTH), the nation's first and largest private health insurance exchange, announced today that the company plans to release third quarter 2015 financial results on October 29, 2015. Chief Executive Officer Gary Lauer and Chief Financial Officer Stuart Huizinga will host the earnings conference call beginning at 5 p.m. Eastern Time on October 29th to discuss these results. Individuals interested in listening to the conference call may do so by dialing (877) 930-8066for domestic callers and (253) 336-8042for international callers. The participant passcode is 58828855. A telephone replay will be available two hours following the conclusion of the call for a period of 7 days and can be accessed by dialing (855) 859-2056for domestic callers and (404) 537-3406for international callers. The call ID for the replay is 58828855. The live and archived webcast of the call will also be available on the company's website at www.ehealthinsurance.com under the Investor Relations section.
International Stem Cell Corporation (OTCQB: ISCO), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, announced today that the Company will make an oral presentation on the comprehensive results of its preclinical development of human parthenogenetic neural stem cells (hPNSCs) for the treatment of Parkinson's Disease at Neuroscience 2015 in Chicago. Session Title: Therapeutics of Parkinson's Disease: Preclinical Studies; Session Date and Time: Tuesday Oct 20, 2015 8:00 AM - 10:15 AM; Location/Room: McCormick Place/N230; Session Number: 463. "The comprehensive data collected from our extensive GLP studies serve as proof of safety and efficacy for our planned clinical trial for the treatment of Parkinson's Disease in Australia. We look forward to providing an update on the status of our regulatory submission to the Australian government in the near future," said Russell A. Kern, Ph.D. chief scientific officer of ISCO. ISCO's Parkinson's disease program uses human parthenogenetic neural stem cells (hPNSC) which are a novel therapeutic cellular product derived from the Company's proprietary human pluripotent stem cells. hPNSC are self-renewing multipotent cells that are precursors for the major cells of the central nervous system. The ability of hPNSC to differentiate into dopaminergic neurons and express neurotrophic factors to protect the nigrostriatal system offers a new opportunity for the treatment of Parkinson's disease.
Nutranomics, Inc. (OTC PINK: NNRX), a diversified nutraceutical formulator, supplement manufacturer and marketer of Nutranomics® health supplements, today issued a Shareholder Letter. The Letter details challenges the Company endured during the last year, reports operational improvements to date, establishes strategies to regain sales momentum and provides options to finance the Company's growth. Pegasystems Inc. (NASDAQ: PEGA), the software company empowering the world's leading enterprises with strategic business applications, today announced it will report financial results for the third quarter of 2015 on Tuesday, October 27, after market close. A conference call and audio-only Webcast will be conducted at 5:00 p.m. EDT on Tuesday, October 27, 2015. Members of the public and investors are invited to join the call and participate in the question and answer session by dialing 1-877-407-3982 (domestic), 1-201-493-6780 (international), or via Webcast by logging onto www.pega.com at least five minutes prior to the event's broadcast and clicking on the Webcast icon in the Investorssection. A replay of the call will also be available on www.pega.com by clicking the Earnings Calls link in the Investors section.
OncoSec Medical Incorporated (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced financial results for the fourth quarter and fiscal year ended July 31, 2015. "We made significant progress in fiscal year 2015, including the addition of several key employees, meeting important clinical milestones, and continued strengthening of our balance sheet," said Punit Dhillon, President and CEO of OncoSec. "Immuno-oncology continues to give rise to groundbreaking new treatments and is shifting the cancer treatment paradigm. I am very excited about the prospects for OncoSec as we develop therapies that aim to harness the immune system to fight cancer and address a great unmet medical need in oncology: anti-PD-1 non-responders. OncoSec's talented and professional team has the experience, insight, and resources to advance our R&D and clinical efforts to capture the value in this opportunity."
Simavita Limited (ASX:SVA) (TSX VENTURE:SV), a global leader in the digital healthcare sector, is pleased to announce that funding for the supply its Smart Incontinence Management (SIM™) technology to the rehabilitation wards of two large public hospitals in Queensland has been approved following successful applications made under the Queensland Department of Health's New Technology Funding and Evaluation Program ("NTFEP").