Investors Are Watching Athersys Ahead Of Stem Cell Data; FDA Accepts Actavis' sNDA to Expand TEFLARO® Labeling Print E-mail
By Marilyn Mullen   
Wednesday, 04 February 2015 20:24
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 4, 2015.

Athersys, Inc. (NASDAQ: ATHX)
is a biotechnology company focused on developing therapies to treat inflammatory and immune, neurological, and cardiovascular diseases.  The company’s lead product in development is called MultiStem. MultiStem is a biologic product that uses stem cells taken from adult bone marrow or other tissues.

In April 2014, the company announced that 8-week interim results from a Phase 2 trial for ulcerative colitis did not meet primary endpoints.  Now, the company is expecting to release Phase 2 data of MultiStem in ischemic stroke patients near the end of the first quarter.  The company announced that the patient enrollment period for the study ended at the end of December.

This is a fairly large market opportunity, as approximately two million people across the globe suffer from a stroke each year.  On December 29, 2014 Athersys CEO stated: "With enrollment now finished, we look forward to the initial 90-day results from this study. An ischemic stroke can be a devastating event for a patient, and effective treatments for stroke are limited, resulting in substantial opportunities for new therapies. Based upon MultiStem's preclinical efficacy profile, its novel mechanisms of action, and a favorable safety profile demonstrated in preclinical and clinical settings, we believe that MultiStem could provide meaningful benefit to these patients. The results from this study are expected to provide significant insight into the potential for MultiStem therapy for the treatment of ischemic stroke."

The company recently presented at the 2015 Biotech Showcase in San Francisco.  The company will also be presenting at the 17th Annual BIO CEO and Investor Conference in New York on February 10 at 11:00 a.m. EST.

 


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Actavis plc (NYSE: ACT)
announced the U.S. FDA has accepted for filing Actavis' supplemental New Drug Application (sNDA) to expand the label for TEFLARO® (ceftaroline-fosamil) to treat cases of concurrent bacteremia in patients with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible isolates of Staphylococcus aureus (including Methicillin-susceptible and resistant isolates).

Concurrent bacteremia is a secondary infection that occurs when bacteria spreads from the primary site of infection to the blood stream. Concurrent bacteremia complicates infection treatment and in the most serious cases can be fatal.

"The incidence of S. aureusbacteremia and its complications has increased sharply in recent years due to the rise in frequency of invasive procedures, higher numbers of immunocompromised patients and greater resistance of S. aureus strains to available antibiotics," said David Nicholson, Senior Vice President, Global Brands Research and Development, Actavis. "We are pleased with the FDA's acceptance of this sNDA and believe a label expansion has the potential to make a meaningful difference for patients and physicians in desperate need of alternative treatment options."

The sNDA submission was based on a subset of data coming from two identical pivotal trials (CANVAS 1 and 2) comparing ABSSSI patients treated with TEFLARO monotherapy to patients treated with vancomycin plus aztreonam. Clinical response was evaluated at Test of Cure (TOC) and Study Day 3 in subjects who had S. aureus bacteremia at baseline in the microbiological modified intent-to-treat (mMITT) population. TEFLARO patients showed a comparable response at TOC (90%) and higher response at Study Day 3 (65%), compared to patients treated with vancomycin/aztreonam. Supportive evidence is provided by data from an investigator-conducted case control study, literature reports, microbiological surveillance, and animal model studies.

Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target of Q3 2015 to complete its review.



 
Also Wednesday:


 
Abiomed, Inc. (Nasdaq:ABMD),
a leading provider of breakthrough heart support technologies, today announced that Michael R. Minogue, Chairman, President and CEO, will present at the 2015 Leerink Global Healthcare Conference on February 11, 2015 at 1:00 p.m. EST.

Anavex Life Sciences Corp. (OTCQX:AVXL)
today announced that Christopher U. Missling, PhD, President and Chief Executive Officer, will present at the 17th Annual BIO CEO & Investor Conference on Tuesday, February 10, 2015 at 11:30 a.m. ET at the Waldorf-Astoria Hotel, Louis XVI room, in New York, NY.

Auris Medical Holding AG (NASDAQ: EARS)
, a clinical-stage biopharmaceutical company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced that Thomas Meyer, Ph.D., Chairman and CEO, will present at the Leerink Global Healthcare Conference on Wednesday, February 11, 2015 at 2:15 p.m. EST at the Waldorf Astoria Hotel in New York.

Avinger, Inc. (Nasdaq:AVGR)
today announced the closing of its underwritten initial public offering of 5,000,000 shares of its common stock at a public offering price of $13.00 per share.

Capricor Therapeutics, Inc.(OTCBB:CAPR)
, a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has signed definitive agreements for the sale of approximately $7.0 million of the Company's common stock to select investors at a price of $4.25 per share.

CAS Medical Systems, Inc. (Nasdaq:CASM)
, a medical technology company that develops, manufactures and markets non-invasive patient monitoring products, today announced that it intends to offer $8.0 million worth of its common stock in an underwritten public offering, subject to market and other conditions. In addition, the Company intends to grant the underwriter an option to purchase additional shares equal to up to 15% of the aggregate number of shares to be sold in the offering.

Cellular Biomedicine Group Inc. (Nasdaq:CBMG)
, a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced that an interview with Dr. William (Wei) Cao, Chief Executive Officer for the Company, conducted by Stock News Now (SNN Incorporated) at last month's J.P. Morgan Healthcare Conference in San Francisco, is now available online.

Coherus BioSciences, Inc. (Nasdaq:CHRS)
, a late-stage clinical biologics platform company focused on the global biosimilar market, today announced that it will participate in a fireside chat at the 2015 Leerink Global Healthcare Conference on Wednesday, February 11 at 1:50 pm ET in New York City.

The Cooper Companies, Inc. (NYSE:COO)
today announced it will release first quarter 2015 financial results on Thursday, March 5, 2015, at 4:00 PM ET.

Enzymotec Ltd. (Nasdaq:ENZY)
, a developer, manufacturer and marketer of innovative bio-active lipid ingredients, today announced that the Company will release financial results for the fourth quarter and full year ended December 31, 2014 on Wednesday, February 18, 2015, before the market opens.

FEI (Nasdaq:FEIC)
and the Tsinghua University Branch of National Center for Protein Sciences Beijing announce a collaboration to establish a joint new training and research program for cryo-electron microscopy (cryo-EM) in structural biology.

Five Prime Therapeutics, Inc. (Nasdaq:FPRX)
, a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics for cancer and inflammatory diseases, today announced that Lewis T. "Rusty" Williams, M.D., Ph.D., President and Chief Executive Officer, will present at the 2015 Leerink Global Healthcare Conference on Wednesday, February 11, 2015 at 8:25 AM Eastern Standard Time.

Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today announced that the company is scheduled to present at the 2015 Leerink Global Healthcare Conference on Thursday, February 12, 2015, at 2:40 p.m. EST.

Immunomedics, Inc., (Nasdaq:IMMU)
announced today that it intends to offer, subject to market conditions and other considerations, $85,000,000 aggregate principal amount of Convertible Senior Notes due 2020 (the "Convertible Notes") in a private placement under the Securities Act of 1933, as amended (the "Securities Act").

INC Research Holdings, Inc. (Nasdaq:INCR)
, a leading, global Phase I to IV contract research organization, today announced the appointment of David Y. Norton to the Company's Board of Directors.

KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced its submission to Australia's Therapeutic Goods Administration (TGA) for ATX-101 (deoxycholic acid), its potential first-in-class treatment for improving submental fullness associated with submental (under the chin) fat.

LDR Holding Corporation (Nasdaq:LDRH)
, a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that it will report financial results for the fourth quarter ended December 31, 2014 after the market close on Wednesday, February 18, 2015.

LifeVantage Corporation (Nasdaq:LFVN)
today reported financial results for its second quarter and six months ended December 31, 2014.

MediWound Ltd. (Nasdaq:MDWD)
, a fully-integrated, biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that Gal Cohen, MediWound's Chief Executive Officer, will ring the NASDAQ Stock Market Closing Bell on February 5, 2015 in recognition of the American Burn Association's Burn Awareness Week taking place from February 1-7, 2015.

OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED)
, a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, announced that patient dosing has begun in the double-blinded, placebo-controlled, randomized Phase 2 clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of patients with first-line advanced-stage non-small cell lung cancer (NSCLC).

OraSure Technologies, Inc. (Nasdaq:OSUR)
, a market leader in oral fluid diagnostics, today announced its consolidated financial results for the full-year and fourth quarter ended December 31, 2014.

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 the closing of its underwritten offering of 4,893,616 ordinary shares at a public offering price of $11.75 per share, which includes the exercise in full by the underwriters of their option to purchase up to 638,297 additional ordinary shares.

Phibro Animal Health Corporation (Nasdaq:PAHC)
will host a webcast and conference call to review second quarter financial results. A news release containing quarterly results is expected to be issued after the market closes on Tuesday, February 10, 2015.

PRA Health Sciences, Inc. (Nasdaq:PRAH)
will release its fourth quarter and year end 2014 results after the market closes on Wednesday, February 18, 2015.

Premier, Inc. (Nasdaq:PINC)
announced today that it has purchased the remaining 40 percent interest in SVS, LLC d/b/a S2S Global, that it did not already own, for $14.5 million.

ProQR Therapeutics N.V. (Nasdaq:PRQR)
, an innovative biopharmaceutical company engaged in the discovery and development of RNA-based therapeutics for the treatment of severe genetic disorders, today announced that Daniel de Boer, Chief Executive Officer, will take part in a fireside chat at the 2015 Leerink Global Healthcare Conference on Wednesday, February 11, 2015 at 2:40 pm EST in New York, NY, USA.

Repligen Corporation (Nasdaq:RGEN)
today announced that the Company will present at the 2015 Leerink Global Healthcare Conference to be held February 11-12 at the Waldorf Astoria hotel in New York.

RestorGenex Corporation (OTCQB:RESX)
, a specialty biopharmaceutical company focused on developing products for ophthalmology, oncology and dermatology, today announced that Stephen Simes, chief executive officer of RestorGenex, is scheduled to present at the 17th Annual BIO CEO & Investor Conference in New York City.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced the appointment of Ely Benaim, M.D. as Chief Medical Officer. In this role,

Sientra, Inc. (Nasdaq:SIEN), a medical aesthetics company, announced today that Hani Zeini, Founder and Chief Executive Officer of Sientra, will present at the 2015 Leerink Global Healthcare Conference.

Stemline Therapeutics, Inc. (Nasdaq:STML)
, announced today that Ivan Bergstein, M.D., Stemline's CEO, will present at the 17th Annual BIO CEO & Investor Conference on Tuesday, February 10, 2015 at 10:00 AM ET.

TG Therapeutics, Inc. (Nasdaq:TGTX) today announced that Michael S. Weiss, the Company's Executive Chairman and Interim Chief Executive Officer, will present at the 17th Annual BIO CEO & Investor Conference, being held at the Waldorf Astoria Hotel in New York City.

Tornier N.V. (Nasdaq:TRNX), a global medical device company focused on providing solutions to orthopaedic extremity surgeons, announced today that it will report financial results for the fourth quarter and full year ended December 28, 2014 after the close of the regular trading market on Tuesday, February 24, 2015.

Wright Medical Group, Inc. (Nasdaq:WMGI) today announced that it will host a conference call on Wednesday, February 25, 2015, at 3:30 p.m. Central Time to discuss the Company's operating results for its fourth quarter ended December 31, 2014.



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