|Orexigen Shares Plummet Following FDA Decision; Glaxo, Theravance Report Positive Data from Two Studies Considering Efficacy|
|By Staff and Wire Reports|
|Wednesday, 11 June 2014 18:57|
Orexigen Therapeutics (NASDAQ: OREX) on announced that the FDA has issued a three-month extension for the review of Orexigen's new weight-loss drug, NB32.
The FDA report indicated the reason for the extension was to reach an agreement on the post-marketing obligation of cardiovascular outcomes.
Orexigen CEO Michael Narachi commented, "We are encouraged by the high level of engagement with the FDA, and are confident that we can reach agreement on the remaining post-marketing obligation."
Following the pre-market announcement, shares of Orexigen have fallen as much as 17 percent and were trading around the $5.62 mark, at last check.
Orexigen competitors, Arena Pharmaceuticals (NASDAQ: ARNA) and VIVUS (NASDAQ: VVUS) have received a ~5 percent and ~1 percent bump, respectively, in response to the announcement.
GlaxoSmithKline plc (NYSE: GSK) and Theravance, Inc. (NASDAQ: THRX) announced positive results from two phase III studies, which showed that patients with chronic obstructive pulmonary disease (COPD) who received the anticholinergic, Incruse(TM) Ellipta(R) (umeclidinium (UMEC) 62.5mcg), or umeclidinium 125mcg (an unlicensed dose) in addition to Relvar(R)/Breo(R) Ellipta(R) (fluticasone furoate/vilanterol, "FF/VI"), an inhaled corticosteroid / long-acting beta2-agonist combination, achieved an additional improvement in lung function (FEV1) compared to patients receiving FF/VI plus placebo.
The studies showed that for the primary endpoint of trough FEV1 at Day 85, the addition of UMEC 62.5mcg or UMEC 125mcg to FF/VI 100/25mcg resulted in a statistically significant improvement in lung function when compared with FF/VI 100/25mcg plus placebo in patients with COPD.
Darrell Baker, SVP and Head, Global Respiratory Franchise, GSK said: "These data are an important addition to the evidence base supporting the efficacy and safety of Incruse. These studies are also the first to investigate the combined effect of two of the newest medicines from our respiratory portfolio, both of which provide 24 hour efficacy. We will continue to progress our research to expand our understanding of how the combined use of these medicines may provide physicians with another treatment approach to meet the individual needs of their patients."
"We are pleased with the positive data from these two studies evaluating an open triple therapy, Incruse added to Relvar/Breo Ellipta," said Rick E Winningham, Chief Executive Officer, Theravance. "With the data reported today, we have further strengthened our understanding of Relvar/Breo Ellipta."
The full results of these studies will be posted onto clinicaltrials.gov and presented at a future scientific meeting.
Alder BioPharmaceuticals, Inc., (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing therapeutic antibodies for the treatment of migraine, autoimmune and inflammatory diseases, today announced that members of Alder's senior management team will present at two upcoming conferences in June: Wells Fargo Securities 2014 Healthcare Conference, Date: Tuesday, June 17, 2014, Time: 4:40 p.m. EDT, Location: Boston, MA and Washington Biotechnology & Biomedical Association (WBBA) 14th Annual Life Science Innovation Northwest, Date: Thursday, June 19, 2014, Time: 1:45 p.m. PDT, Location: Seattle, WA.
Aldeyra Therapeutics, Inc. (Nasdaq:ALDX), a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced its financial results for the first quarter ended March 31, 2014.
Amarantus Bioscience Holdings, Inc. (OTCQB:AMBS) and Brewer Sports International (BSI), today announced the addition of Cavendish Global as partner at the 3rd #C4CT (Coalition for Concussion Treatment) Concussion Awareness Summit, on Thursday, July 31, 2014 at the United Nations in New York City, NY.
Amgen (NASDAQ: AMGN) and AstraZeneca today announced that results from a Phase 2 study evaluating brodalumab in 168 patients with psoriatic arthritis were published in The New England Journal of Medicine (NEJM).
Argos Therapeutics, Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that Jeff Abbey, president and chief executive officer, will be presenting at the 2014 Wells Fargo Healthcare Conference on June 17, 2014, at 4:40 p.m. Eastern Time at The InterContinental Hotel in Boston, MA.
Authentidate Holding Corp. (Nasdaq:ADAT), a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that O'Connell (Ben) Benjamin, the company's CEO will present at the Newport Coast Securities 2014 National Sales & Equity Conference, being held on June 13, 2014 at the W Hotel in New York City.
Capstone Therapeutics (OTCQB:CAPS) and its joint venture affiliate, LipimetiX Development, LLC ("JV"), announced today the initiation of dosing for the AEM-28 (Apo E mimetic peptide) Phase 1b/2a human clinical trial in refractory hypercholesterolemic subjects who are already on optimal cholesterol lowering therapy but are unable to reach target cholesterol levels.
Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that the independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 clinical study of CPX-351 (cytarabine:daunorubicin) Liposome Injection versus the conventional cytarabine and daunorubicin treatment regimen (commonly referred to as 7+3) as first-line therapy in older patients with high-risk (secondary) acute myeloid leukemia (AML) has completed a planned safety review and recommended that the study should continue as planned without any modifications.
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 Aron Knickerbocker, Chief Business Officer of Five Prime, will present at the 2014 Wells Fargo Healthcare Conference on Wednesday, June 18 at 1:50 PM Eastern Time.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced that CEO Michael Clayman, M.D., will present at the Wells Fargo Securities Research, Economics & Strategy 2014 Healthcare Conference at 3:00 p.m. Eastern Time on Wednesday, June 18, 2014 at the Intercontinental Hotel in Boston.
LeMaitre Vascular, Inc. (Nasdaq:LMAT) announced today that it will be participating in the Wells Fargo 2014 Healthcare Conference at the InterContinental Hotel, Boston, MA, on Tuesday, June 17, 2014.
Marrone Bio Innovations, Inc. (Nasdaq:MBII) today announced the closing of its previously announced offering of 5,175,000 shares of its common stock at a price to the public of $9.50 per share, which included 600,000 shares sold by an existing stockholder, Syngenta Ventures Pte. LTD., and 675,000 shares issued by MBI upon the exercise in full of the underwriters' option to purchase additional shares.
Masimo (NASDAQ: MASI) today announced that a new study published in the International Journal of Clinical Practice demonstrated that Masimo's noninvasive SpCO® helped clinicians improve detection of carbon monoxide (CO) poisoning in patients presenting to a large emergency department.
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), today announced positive results from a study that examined the potential clinical efficacy of MN-001 (tipelukast) for the treatment of pulmonary fibrosis.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, announced several new product introductions and corporate developments that will be discussed today at its annual meeting of shareholders.
Merit Medical Systems, Inc. (Nasdaq:MMSI), a leading manufacturer and marketer of proprietary disposable devices used primarily in cardiology, radiology and endoscopy, today announced that it will participate at the Wells Fargo Healthcare Conference being held June 17-18, 2014 at the Intercontinental Hotel in Boston.
MRI Interventions, Inc. (OTCQB:MRIC), a commercial stage medical technology company focused on creating innovative platforms for performing the next generation of minimally invasive surgical procedures in the brain and heart, today announced the Company will be presenting at two investment conferences in the month of June.
NanoString Technologies, Inc. (Nasdaq:NSTG), today announced that its management is scheduled to participate in the JMP Securities Healthcare Conference 2014 in New York.
Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the closing of the underwritten public offering priced on Thursday, June 5, 2014.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to announce new clinical data supporting the positive safety profile of NX-1207, the Company's lead compound in late Phase 3 testing for prostate enlargement (BPH or benign prostate hyperplasia).
Portola Pharmaceuticals (Nasdaq:PTLA) today announced that a Phase 2 proof-of-concept study in healthy volunteers demonstrated that andexanet alfa, a potential first-in-class Factor Xa inhibitor antidote, immediately reversed the anticoagulation activity of enoxaparin, a low molecular weight heparin and standard of care in venous thromboembolism prevention.
RedHill Biopharma Ltd. (Nasdaq:RDHL) (TASE:RDHL), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage proprietary drugs for the treatment of inflammatory and gastrointestinal diseases and related conditions, including cancer, today announced that Guy Goldberg, RedHill's Chief Business Officer, will be presenting at the Wells Fargo Securities 9th Annual Healthcare Conference, on Wednesday, June 18, 2014, at 14:25 EDT.
Symmetry Medical Inc. (NYSE:SMA), a leading global source of innovative medical device solutions, including surgical instruments, orthopedic implants, and sterilization cases and trays, announced today that it has launched the Dual Connection Offset Acetabular Reamer Driver through its OEM Solutions team.