Onyx's Stivarga Gets Priority Review from FDA; Celldex Reports Positive Results Print E-mail
By Staff and Wire Reports   
Monday, 29 October 2012 19:10
Below is a look at some of the headlines for companies that made news in the healthcare sector on October 29, 2012.

Bayer HealthCare
and Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX) announced the U.S. FDA granted priority review to the New Drug Application (NDA) filed at the end of August 2012 for Stivarga® (regorafenib) tablets to treat patients with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with two kinase inhibitors.

The submission was based upon data from the pivotal, global Phase III GRID study.


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Celldex Therapeutics, Inc. (NASDAQ: CLDX)
announced positive results demonstrating promising clinical effects in a Phase 1 study of CDX-1401 in solid tumors in combination with the toll-like receptor (TLR) agonists resiquimod and/or Poly ICLC (HiltonolTM). CDX-1401 is a fusion protein consisting of a fully human monoclonal antibody with specificity for the dendritic cell receptor DEC-205 linked to the NY-ESO-1 tumor antigen. The NY-ESO-1 antigen is expressed in a variety of cancer cells. Targeting protein antigens to the DEC-205 receptor on dendritic cells was pioneered by the late Ralph Steinman, MD, a member of Celldex's Scientific Advisory Board.

Dr. Steinman received the 2011 Nobel Prize in Physiology or Medicine for his discovery of the dendritic cell and its role in adaptive immunity. In preclinical studies, CDX-1401 has been shown to induce potent and broad immunity. The Phase 1 study of CDX-1401 is the first clinical study to demonstrate that an off-the-shelf vaccine that targets dendritic cells in vivo through DEC-205 can safely lead to robust humoral and cellular immunity when combined with TLR agonists in cancer patients - overcoming a significant challenge in the development of protein based vaccines.



Also Monday:



ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD)
, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in neurological and related central nervous system disorders, today announced that it will report its unaudited financial results for the third quarter ended September 30, 2012 on Monday, November 5, 2012, after the U.S. financial markets close.

Acorda Therapeutics, Inc. (Nasdaq: ACOR)
today announced that, due to severe weather on the East Coast of the United States, it will postpone its third quarter 2012 financial results press release and conference call to Wednesday, October 31, 2012 at 8:30 a.m. ET.

Arrowhead Research Corporation (NASDAQ:ARWR)
, a targeted therapeutics company, announced that David Lewis, Ph.D., Vice President Biology and Site Head of its Madison, WI research and development facility will present data today at the 8th Annual Meeting of the Oligonucleotide Therapeutics Society in Boston.

AstraZeneca (NYSE:AZN)
today announced the start of a Phase III study (FALCON), a global clinical trial which will involve 450 postmenopausal patients with hormone receptor-positive locally advanced or metastatic breast cancer who have not previously been treated with any hormonal therapy.

BIOLASE, Inc. (NASDAQ: BIOL)
, the World's leading biological dental laser manufacturer and distributor, today announced that the Company will host a conference call on Monday, November 5th, at 4:30 p.m. Eastern Standard Time to discuss its operating results for the third quarter and nine months ended September 30, 2012, and to answer questions.

BIOLASE, Inc. (NASDAQ: BIOL)
, the World's leading biological dental laser manufacturer and distributor, today announced that the Company will host a conference call on Monday, November 5th, at 4:30 p.m. Eastern Standard Time to discuss its operating results for the third quarter and nine months ended September 30, 2012, and to answer questions.

BioLife Solutions, Inc. (OTCBB: BLFS)
, a leading developer, manufacturer and marketer of proprietary clinical grade hypothermic storage and cryopreservation freeze media for cells and tissues, and contract aseptic media manufacturer, today announced the Company's novel biopreservation technology is being used in more than 50 clinical trial-stage cellular therapies, making it the leading choice in the emerging, high growth field of regenerative medicine.

Celldex Therapeutics, Inc. (NASDAQ: CLDX)
today announced positive results demonstrating promising clinical effects in a Phase 1 study of CDX-1401 in solid tumors in combination with the toll-like receptor (TLR) agonists resiquimod and/or Poly ICLC (HiltonolTM).

Compugen Ltd. (NASDAQ:CGEN)
announced today the postponement of both the issuance of its Third Quarter 2012 Financial Results Report and conference call with investors to Monday, November 5, 2012 at 10 a.m. ET.

Deaf-Talk, Inc. (PINKSHEETS: MGQG)
, dba DT Interpreting (DTI), the industry leader in on-demand video sign language interpreting, today announced that commencing November 1, 2012, the Company will introduce non-English video interpreting service, initially focused on Spanish, Russian, Arabic, Cantonese, Mandarin and Vietnamese languages.

Dendreon Corporation (Nasdaq: DNDN)
today announced that in light of Hurricane Sandy, the Company has rescheduled the release of its third quarter 2012 earnings results.

Depomed, Inc. (NASDAQ: DEPO)
today announced that it will release third quarter fiscal year 2012 financial results after the market closes on Monday, November 5, 2012.

Today PlanPrescriber (www.planprescriber.com), a wholly owned subsidiary of eHealth, Inc. (NASDAQ: EHTH), released a list of nine costly mistakes that people typically make when trying to enroll in a Medicare Advantage plan. PlanPrescriber provides educational and comparison tools for Medicare insurance products that allow customers to compare Medicare products side-by-side, connect with knowledgeable, licensed agents, and enroll in select products online or over the phone.

GTx, Inc. (Nasdaq: GTXI)
today announced that a per protocol interim safety review on Friday, October 26, 2012, by an independent Data Safety Monitoring Board (DSMB) recommended that GTx continue clinical development as planned with its two pivotal Phase III trials of enobosarm (GTx-024) for the prevention and treatment of muscle wasting in patients with non-small cell lung cancer.

Haemonetics Corporation (NYSE: HAE)
today reported second quarter 2013 net revenue of $218.2 million, up 22%, GAAP net income of $6.5 million, down 53%, and diluted earnings per share of $0.25, down 53%.

iCAD, Inc. (Nasdaq: ICAD)
, a leading provider of advanced imaging and radiation therapy for the early identification and treatment of cancer, today announced growing demand for and adoption of its Xoft® Axxent® Electronic Brachytherapy System® for intraoperative radiation therapy (“IORT”).

IsoRay Inc. (NYSE MKT: ISR)
, a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a booth at the 54th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, featured its procedural solutions and sophistication from years of experience in lateral approach spine surgery at the North American Spine Society (NASS) 2012 Annual Meeting.

Orgenesis Inc. (OTCBB:ORGS)
(“Orgenesis” or the “Company”), a development-stage company with a novel therapeutic technology dedicated to converting a patient’s own liver cells into functioning insulin-producing cells as a treatment for diabetes, announced today that it has recently met with U.S. Food and Drug Administration’s (“FDA”) Center for Biologics Evaluation and Research (“CBER”) experts, briefing them on the scientific progress the Company has made to-date within the field of transdifferentiation and the promise those advancements may hold for the treatment of diabetes.

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
today announced that it has rescheduled its third quarter 2012 financial report and conference call due to Hurricane Sandy.

ProPhase Labs, Inc. (NASDAQ: PRPH)
(www.ProPhaseLabs.com) announced today that it has rejected the revised and unsolicited, non-binding proposal from Matrixx Initiatives, Inc. ("Matrixx") to acquire the Company for $1.60 per share in cash.

Sigma-Aldrich Corporation (Nasdaq: SIAL)
today announced the launch of a redesigned website for China, www.sigmaaldrich.com/china, which offers more relevant content, improved search results, enhanced product detail pages and a completely translated homepage.

Sun Healthcare Group, Inc. (NASDAQ: SUNH)
today announced its operating results for the third quarter ended Sept. 30, 2012.

Synthetic Biologics, Inc. (NYSE MKT: SYN)
, a developer of synthetic biologics and innovative medicines for serious diseases and unmet medical needs, announced today that it has entered into definitive stock purchase agreements with accredited investors to raise approximately $10.8 million in a private placement financing.

Vermillion, Inc. (NASDAQ: VRML)
, a leading molecular diagnostics company, will hold a conference call on Monday, November 12, 2012 at 4:30 p.m. Eastern time to discuss results for the third quarter ended September 30, 2012.

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
today announced that it has rescheduled its third quarter 2012 earnings press release and conference call, which were originally scheduled for today, Monday, October 29.



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