Repros' Proellex Receives FDA Guidance; BioLineRx Receives Regulatory Finnish Approval for BL-7010 Print E-mail
By Staff and Wire Reports   
Monday, 04 November 2013 19:35
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 4, 2013.

Repros Therapeutics Inc.® (Nasdaq: RPRX)
reported it has received guidance from the FDA regarding its clinical program for low dose oral Proellex in the treatment of uterine fibroids.

The Company currently has three open INDs for Proellex:  70,535 - oral treatment of fibroids STATUS: Full Clinical Hold;  76,631 – oral treatment for endometriosis STATUS: Partial Clinical Hold and in Phase 2;  112,576 – vaginal treatment for fibroids STATUS: Initiating Phase 2b

The Company held a meeting with the FDA on October 31, 2013 to discuss "going forward" plans for low dose oral Proellex in the treatment of uterine fibroids and to lift the clinical hold. In 2007, data had been discussed with the FDA based on the efficacy of a 12mg dose. The earlier study showed highly statistically significant results in achieving clinically relevant improvements in menstrual bleeding as well as symptoms associated with tumor bulk via a previously validated quality of life instrument (UFSQOL).

During the meeting with the FDA, the Agency provided guidance to the Company for endpoints it believed to be acceptable for the treatment of uterine fibroids. The Agency instructed the Company to submit a request for lifting of the full clinical hold at the same time it submits a new protocol. The Company will follow FDA's recommendations and submit the protocol and full hold lift in a timely fashion.

The Company will use the same design for the vaginal Phase 2b study and expects to start the two studies in early 2014. The Company has accounted for the costs of these studies in its current budget and these studies will not change the projected cash burn rate for 2014.



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BioLineRx (NASDAQ: BLRX)
announced it has received regulatory approval from the Finnish National Supervisory Authority for Welfare and Health (Valvira) to commence a Phase 1/2 safety trial for BL-7010, for the treatment of celiac disease. The study is expected to begin by the end of this year.

The Phase 1/2 study is a two-part (single and repeated), double-blind, placebo-controlled, dose escalation study of BL-7010 in up to 32 patients at a world-leading site for celiac disease research in Finland. The primary objective of the study is to assess the safety of single and repeated ascending doses of BL-7010 in well-controlled celiac patients. Secondary objectives include an assessment of the systematic exposure, if any, of BL-7010 in the study patients.

Professor Markku Maki, M.D., Ph.D., of the University of Tampere School of Medicine and the Tampere Center for Child Health Research in Finland, the responsible coordinating investigator of the trial, stated, "Celiac has become an increasingly problematic condition, with 1% of the world's current population suffering from this disease.



Also Monday:



AB Science SA (NYSE Euronext - FR0010557264 - AB)
, a pharmaceutical company specialized in research, development and marketing of protein kinase inhibitors (PKIs), announces the initiation of a clinical development program with masitinib in the treatment of Amyotrophic Lateral Sclerosis (ALS).

Allerayde SAB, Inc. (OTCQB:ASAB)
, with its subsidiary, Allerayde SAB Limited today announced that the Company has retained Morningstar Corporate Communication to handle its investor communication efforts.

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today that Joseph M. DeVivo, President and Chief Executive Officer, will present at the following investor conferences in late November.

athenahealth, Inc. (Nasdaq:ATHN)
, a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, today announced details regarding its Sixth Annual Investor Summit.

The VivaScope® cellular imaging system developed by Caliber Imaging & Diagnostics (OTCQB:LCDX), formerly Lucid, Inc., was featured in a video segment and article posted on Fox News on October 29. VivaScope allows doctors to offer their patients noninvasive optical biopsies of skin and to aid in the detection of skin cancer.

Cellular Dynamics International (Nasdaq:ICEL)
announced today that the company has received the Notice of Grant Award (NGA) from the California Institute of Regenerative Medicine (CIRM) to create a human induced pluripotent stem cell (iPSC) biobank from 3,000 individuals.

The Cooper Companies, Inc. (NYSE:COO)
today announced that it will release fourth quarter and full year 2013 financial results on Thursday, December 5, 2013 at 4:00 PM ET.

Cutera, Inc. (Nasdaq:CUTR)
, a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, today reported financial results for the third quarter ended September 30, 2013.

Empresas ICA, S.A.B. de C.V. (BMV:ICA) (NYSE:ICA)
, the largest infrastructure and construction company in Mexico, announced today the award of two hospital construction contracts, with a total value of approximately Ps. 1,157 million.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
, a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announced that its Chief Executive Officer, Jeffrey A. Duchemin, has been appointed by the Board of Directors to the additional positions of President and Director, effective immediately.

Harvard Bioscience, Inc. (Nasdaq:HBIO)
became a pure-play global developer, manufacturer and marketer of a broad range of tools to advance life science research on November 1, 2013.

Immunomedics, Inc. (Nasdaq:IMMU)
, a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported financial results for the first quarter ended September 30, 2013.

Integra LifeSciences Holdings Corporation (Nasdaq:IART)
today announced that it intends to offer, subject to market conditions and other factors, 3,500,000 shares of its common stock in an underwritten public offering registered under the Securities Act of 1933, as amended. In connection with the offering, Integra expects to grant the underwriters a 30-day option to purchase an additional 525,000 shares of common stock.

InterMune, Inc. (NASDAQ: ITMN)
today announced that it plans to offer, subject to market and other conditions, 6,500,000 shares of its common stock in an underwritten public offering.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX)
will host a conference call tomorrow, Tuesday, November 5, 2013, at 8:30am ET to review the top-line results from the Phase 2 study of Zerenex™ (ferric citrate coordination complex) in non-dialysis dependent chronic kidney disease patients with elevated serum phosphorus and iron deficiency anemia. Keryx will announce the top-line results tomorrow morning, prior to the call.

Keryx Biopharmaceuticals, Inc. (Nasdaq:KERX),
a biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of renal disease, today announced its results for the third quarter ended September 30, 2013.

Luminex Corporation (NASDAQ: LMNX)
today announced financial and operating results for the third quarter ended September 30, 2013.  

NeoStem, Inc. (Nasdaq:NBS)
, a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), an internationally recognized contract development and manufacturing organization, announced today that PCT has entered into a collaboration with ATMI, Inc. (Nasdaq:ATMI), a global technology company and leader in single-use bioprocess solutions.

NuVasive, Inc. (NASDAQ: NUVA)
, a medical device company focused on developing minimally disruptive surgical products and procedures for the spine, announced today that it will host a meeting for investors and analysts at its NuVasive East office, 117 West Century Road, Paramus, NJ, 07652, on Thursday, November 14, 2013 from 8:30 a.m. to 11:00 a.m. ET.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
, a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the third quarter ended September 30, 2013, on Tuesday, November 12, 2013 prior to market open.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that Peter Langecker, M.D., PhD., President and Chief Executive Officer, will provide a corporate overview at the 19th annual BIO-Europe international partnering conference on November 6, 2013 at 9:45 GMT at the Messe Wien Exhibition and Congress Center, Vienna, Austria.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, will report third quarter 2013 results on Tuesday November 12, 2013.

Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR)
, a leading developer of placenta-based cell therapies, announced today that its PLacental eXpanded (PLX) cells proved to be safe in an animal study assessing maternal and fetal toxicity.

Sagent Pharmaceuticals, Inc. (Nasdaq:SGNT)
today announced the launch of Carboplatin Injection, an antineoplastic agent, in four preservative-free vial presentations. According to IMS, for the 12 months ending September 2013, the US market for Carboplatin Injection approximated $30 million.

SIGA Technologies, Inc. (Nasdaq:SIGA)
announced today that management will host a conference call and simultaneous webcast to provide a quarterly business update at 5:00 P.M. ET on Wednesday, November 6, 2013.

Spine Pain Management, Inc. (OTCQB:SPIN)
, a technology-driven, financial service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced its 8 month old San Antonio affiliate diagnostic center has expanded into the Austin, Texas market with the opening of a satellite center. Rapidly growing Austin, the State Capital, is the fourth largest city in TX and 11th in the Country with a population approaching one million.

Pursuant to its previously-announced rights offering, all stockholders and certain warrant holders of Stereotaxis, Inc. (Nasdaq:STXS) received subscription rights to purchase 1 share of common stock at a price of $3.00 per share for every 3 shares of stock that they held as of the record date of October 31, 2013 at 5:00 pm New York City time.

RadNet Inc. (Nasdaq:RDNT)
, a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of 251 fully-owned and operated outpatient imaging centers, announced today that David W. Stoller, M.D., F.A.C.R. has joined its network of providers as the National Director of Orthopaedic and Musculoskeletal Imaging.

Mercy, one of the earliest providers of telehealth for critical care in the U.S., and Royal Philips (NYSE: PHG, AEX: PHIA) today announced that they will collaborate to expand Mercy's telehealth services to include medical and surgical hospital units.

Vascular Solutions, Inc. (Nasdaq:VASC)
today announced that the Company is scheduled to present at the Barclays Select Growth Conference in New York City on Monday, November 18th at 2:50pm (EDT).

Veracyte, Inc. (Nasdaq: VCYT)
announced today the closing of its initial public offering of 5,000,000 shares of its common stock resulting in net proceeds of approximately $58.0 million after deducting underwriting discounts and commissions and estimated expenses.

Altus Formulation Inc., a private Montreal-based drug formulation and development company today announced that it has entered into a Development and Option Agreement ("D&O Agreement") with Zogenix, Inc. (Nasdaq:ZGNX), a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, to develop abuse deterrent formulations of Zohydro™ ER using Altus's proprietary, clinically validated Intellitab drug delivery platform.

Zogenix, Inc. (Nasdaq:ZGNX)
, a pharmaceutical company developing and commercializing products for the treatment of central nervous system disorders and pain, announced today that it intends to offer and sell $60 million of shares of its common stock in an underwritten public offering.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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