News
Mar 6
2016
Aimmune Therapeutics Announces Phase 2 Follow-On Study of AR101 for the Treatment of Peanut Allergy Demonstrated Increased Desensitization and Improved Tolerability with Low-Dose Maintenance
Mar 6
2016
— All Patients Who Completed 12 Weeks of Low-Dose Maintenance Therapy in the ARC002 Trial Were Desensitized to Levels of Peanut Protein Far Exceeding Those of Typical Accidental Exposures —
— Dr. J. Andrew Bird Presented Data Confirming Safety and Demonstrating Efficacy of AR101 for the Treatment of Peanut Allergy at the 2016 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Los Angeles —
LOS ANGELES--(BUSINESS WIRE)--Mar. 6, 2016-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing CODIT™(characterized oral desensitization immunotherapy) treatments for life-threatening food allergies, today announced data from the open-label ARC002 Phase 2 trial of its lead product candidate, AR101 for the treatment of peanut allergy. All patients who completed 12 weeks of low-dose maintenance therapy were desensitized to levels of peanut protein beyond the 250-300 mg typically found in one peanut kernel.
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Feb 29
2016
ZELTIQ Announces Fourth Quarter and Full Year 2015 Financial Results
Feb 29
2016
Full Year 2015 Revenue of $255.4 Million, up 46% Year-Over-Year; Announces New CoolAdvantage(TM) Family of Applicators With 35 Minute Treatment Times
PLEASANTON, CA -- (Marketwired) -- 02/29/16 --
READ MORE about ZELTIQ Announces Fourth Quarter and Full Year 2015 Financial Results
- Fourth quarter revenue of $78.2 million, up 54% year-over-year; Full year revenue of $255.4 million, up 46% year-over-year
- Fourth quarter net income of $40.6 million, or $0.99 per diluted share; Full year net income of $41.8 million, or $1.02 per diluted share
- Fourth quarter Adjusted EBITDA margin of 7.0%; Full year Adjusted EBITDA margin of 7.6%
- 387 systems shipped, compared to 354 systems in fourth quarter 2014, bringing total system installed base to 4,634 systems
- 273,112 revenue cycles shipped, up 57% from fourth quarter 2014
Feb 29
2016
Dermira Completes Patient Enrollment for DRM04 Phase 3 Pivotal Trials in Primary Axillary Hyperhidrosis
Feb 29
2016
Topline Results for Phase 3 ATMOS-1 and ATMOS-2 Clinical Trials Expected in 2Q 2016
MENLO PARK, Calif., Feb. 29, 2016 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to identifying, developing and commercializing innovative, differentiated therapies to improve the lives of patients with dermatologic diseases, today announced the completion of patient enrollment in its Phase 3 ATMOS-1 and ATMOS-2 clinical trials for DRM04 in primary axillary hyperhidrosis (excessive underarm sweating). Based on enrollment completing ahead of schedule, Dermira now expects to announce topline efficacy and safety data for both of these trials during the second quarter of 2016, compared with previous guidance of mid-2016.
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Feb 24
2016
ADMA Biologics Recognized as One of New Jersey’s “Best Places to Work 2016”
Feb 24
2016
RAMSEY, N.J., Feb. 24, 2016 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced today that the Company has been recognized as one of New Jersey’s “100 Best Places to Work 2016” by the Best Companies Group, a company dedicated to identifying and recognizing places of employment that are leading the way in defining the employee experience, and NJBIZ, a leading New Jersey-focused weekly business news publication.
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Feb 20
2016
Chimerix Announces Presentation of Detailed Results From Phase 3 SUPPRESS Trial at BMT Tandem Meetings
Feb 20
2016
Brincidofovir Shows On-Treatment Antiviral Effect in HCT Setting Despite Trial Not Meeting Primary Endpoint
Company to Host Conference Call on February 22 at 8:00 a.m. EST to Provide Additional Analyses and Plans for Further Clinical Development
DURHAM, N.C., Feb. 20, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced detailed results from its Phase 3 SUPPRESS trial of brincidofovir for the prevention of cytomegalovirus (CMV) in patients undergoing hematopoietic cell transplantation (HCT).
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Feb 16
2016
BIND Therapeutics and Synergy Pharmaceuticals Announce Collaboration to Develop ACCURINS® with Proprietary Uroguanylin Analogs for Targeting Gastrointestinal Receptors on Tumors
Feb 16
2016
CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)-- BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine company developing targeted and programmable therapeutics called ACCURINS®, and Synergy Pharmaceuticals Inc. (NASDAQ: SGYP), a biopharmaceutical company pioneering the development of uroguanylin analogs as potential new treatments for functional gastrointestinal (GI) disorders and inflammatory bowel disease (IBD), today announced they have entered into a research collaboration to engineer ACCURINS® incorporating Synergy’s proprietary uroguanylin analogs to explore the potential targeting of guanylate cyclase-C (GC-C) receptors expressed on tumors, specifically GI malignancies. Upon achievement of proof-of-concept, the companies anticipate expanding the collaboration to enhance the potential effect of uroguanylin-based ACCURINS® by incorporating therapeutic payloads.
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Feb 10
2016
TransEnterix Finalizes FDA Submission Process Related to SurgiBot System 510(k) Application
Feb 10
2016
- Continue to anticipate SurgiBot FDA clearance by the end of the first quarter of 2016 -
- Strengthens balance sheet with $18M of equity raised -
RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- TransEnterix, Inc. (NYSE MKT: TRXC), a medical device company that is pioneering the use of robotics and flexible instruments to improve minimally invasive surgery, today announced the following:
READ MORE about TransEnterix Finalizes FDA Submission Process Related to SurgiBot System 510(k) Application
- Completes FDA Response. TransEnterix has successfully completed its response to the U.S. Food and Drug Administration (FDA) related to the pending 510(k) application submitted for clearance of the company's SurgiBot™ System.
- Strengthens Balance Sheet. Since September 30, 2015, the Company has raised $18 million(1) in net proceeds at an average price of $3.23 per share under its $25 million "at-the-market" (ATM) equity sales facility that was established in February 2015. There is no further availability under this facility. The proceeds from these sales will be utilized to continue to support investments for the commercialization of the ALF-X® system in Europe, as well as the SurgiBot in the United States, following FDA clearance.
- Files New ATM Facility. Following the successful completion of the prior ATM facility, the Company has entered into a new ATM facility that allows it the option to raise up to $43.6 million in equity from time to time through January 2017. The Company has no obligation to sell any shares under this facility.
Feb 10
2016
Cidara Receives Orphan Drug Designation for Novel Echinocandin, CD101 IV, in Candidemia and Invasive Candidiasis
Feb 10
2016
Orphan designation follows QIDP and Fast Track status for CD101 IV
SAN DIEGO--(BUSINESS WIRE)--Feb. 10, 2016-- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its antifungal drug candidate, CD101 IV, for the treatment of candidemia and invasive candidiasis.
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Feb 8
2016
Chimerix Presents Positive Results From Brincidofovir Pivotal Study in Animal Model for Smallpox
Feb 8
2016
100 Percent Survival Demonstrated in Animals Treated Immediately With Brincidofovir at Time of Confirmed Infection
DURHAM, N.C., Feb. 08, 2016 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today presented positive results from a pivotal study of its antiviral, brincidofovir, in an animal model for smallpox at the ASM Biodefense and Emerging Diseases Research Meeting in Arlington, Virginia.
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Feb 5
2016
The Lancet Infectious Diseases Publishes Positive Phase 3 Study Results for Cempra's Oral Solithromycin in Community-Acquired Bacterial Pneumonia
Feb 5
2016
Solithromycin met primary and secondary objectives of non-inferiority compared to moxifloxacin, a potent fluoroquinolone
Cempra plans to complete a New Drug Application (NDA) submission to the FDA for the treatment of CABP during the first half of 2016
The FDA has granted Fast Track designation for solithromycin IV and capsules for the treatment of CABP
CHAPEL HILL, N.C., Feb. 05, 2016 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics in the face of rising antibiotic resistant bacterial infections, today announced the publication of positive results from its pivotal Phase 3 clinical trial of solithromycin oral capsules in the treatment of patients with community-acquired bacterial pneumonia (CABP) in The Lancet Infectious Diseases. The article, titled, "Efficacy and safety of oral solithromycin versus oral moxifloxacin for the treatment of community-acquired bacterial pneumonia: a global, double-blind, multi-centre, randomized, active-controlled, non-inferiority trial (SOLITAIRE-ORAL)" appears in the February 4th online issue and will be published in a future print issue of the journal.
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