News

— Aimmune Plans to Release Full ARC002 Data at AAAAI Meeting in March 2016 — BRISBANE, Calif.--(BUSINESS WIRE)--Nov. 11, 2015-- Aimmune Therapeutics, Inc. (Nasdaq:AIMT), a biopharmaceutical company developing desensitization treatments for food allergies, today announced positive findings for its ARC002 clinical trial, a follow-on Phase 2 study of the company’s lead product candidate, AR101 for the treatment of peanut allergy. The open-label ARC002 trial, which enrolled patients 4-21 years of age who completed the ARC001 trial earlier this year, moved former placebo patients to active treatment and followed all patients through an additional 12-week maintenance period. - See more at: http://ir.aimmune.com/phoenix.zhtml?c=254097&p=irol-pressReleasesArticle&ID=2111480#sthash.8jiCk1bJ.dpuf

Savings Associated with Reduced Post-Operative Interventions Support Use of PROPEL MENLO PARK, Calif.--(BUSINESS WIRE)--Intersect ENT, Inc. (Nasdaq:XENT) today announced the presentation of a budget impact analysis demonstrating the value of PROPEL® steroid releasing implants when used for the treatment of patients with chronic sinusitis. The new data was presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 18th Annual Congress in Milan, Italy.

Dosing initiated in second of two Phase 3 registration studies for Paratek's omadacycline Phase 3 program designed to support approval in two indications: acute bacterial skin and skin structure infections and community acquired bacterial pneumonia BOSTON, Nov. 9, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK) today announced the dosing of the first patient in its Phase 3 clinical study of its lead drug candidate, omadacycline, for the treatment of Community Acquired Bacterial Pneumonia (CABP). This global Phase 3 study will assess the efficacy and safety of omadacycline compared with moxifloxacin in subjects with CABP.

– Six Patients with TRK Fusion Cancers Enrolled; All Remain on Study – – Three Patients with TRK Fusion Cancers Evaluable for Efficacy and All Show Objective Responses – – Company to Host Investor Conference Call and Webcast to Review the Data on Monday, November 9, 2015 at 8:00 a.m. EST – STAMFORD, Conn., Nov. 08, 2015 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced new results from its Phase 1 open-label, dose-escalation trial of LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK) signaling molecules, and the first preclinical data for its RET and FGFR programs. The data are being presented at the 2015 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston.

Limit of Detection as Low as 1 CFU/mL- Data Presented at AMP 2015 Annual Meeting LEXINGTON, Mass., Nov. 4, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, announced that data on its investigational T2Bacteria Panel will be presented today at the Association of Molecular Pathology (AMP) 2015 Annual Meeting in Austin, Texas. The data demonstrate the ability of T2Bacteria to provide the rapid and sensitive identification of six sepsis-causing bacteria, directly from whole blood, with limits of detection as low as 1 CFU/mL. The six clinically relevant bacteria included in the T2Bacteria Panel are: Staphylococcus aureus, Enterococcus faecium, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, and Acinetobacter baumannii.

BOSTON, Nov. 4, 2015 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq:PRTK) announced today that the U.S. Food and Drug Administration (FDA) has granted omadacycline Fast Track Designation for the development of omadacycline in Acute Bacterial Skin and Skin Structure Infections (ABSSSI), Community Acquired Bacterial Pneumonia (CABP), and Complicated Urinary Tract Infections (cUTI). Fast track designation facilitates the development, and expedites the review of drugs which treat serious or life-threatening conditions and fill an unmet medical need. Omadacycline, the first in a new class of tetracyclines known as aminomethylcyclines, is being developed as a once-daily oral and IV therapy to treat serious community-acquired bacterial infections, particularly when antibiotic resistance is of concern.

Adoption Driven by Need to Improve Sepsis Outcomes, Reduce Costs LEXINGTON, Mass., Oct. 29, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that Rhode Island Hospital, the principal teaching hospital of The Warren Alpert Medical School of Brown University, the University of Alabama at Birmingham Hospital and The Statens Serum Institut in Denmark are among the first adopters of its T2Candida® sepsis diagnostic. Run on the T2Dx Instrument, the T2Candida Panel detects Candida, the most lethal cause of sepsis. T2 Biosystems provides the first and only sepsis diagnostic that provides species specific results and does not require blood culture, delivering accurate results in three-to-five hours compared to two-to-six days for a blood culture.

LEXINGTON, Mass., Oct. 28, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that it received the Prix Galien USA 2015 Award for Best Medical Technology product. The award was presented at the Prix Galien USA Award ceremony at the American Museum of Natural History in New York City on October 27, 2015.

STAMFORD, Conn., Oct. 28, 2015 (GLOBE NEWSWIRE) -- Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced that the independent committee of the National Cancer Institute-Molecular Analysis for Therapy Choice (NCI-MATCH) clinical trial has chosen LOXO-101 as the sole, dedicated treatment arm for patients with tropomyosin receptor kinase, or TRK, gene fusions. The NCI-MATCH trial will initially enroll 3,000 patients with tumor biopsies available for comprehensive genomic profiling and assign these patients to an appropriate targeted therapy arm based on the molecular abnormalities of each tumor. NCI-MATCH, which began enrolling patients in August 2015, currently has 10 open treatment arms employing drugs from multiple sponsors, and plans to open as many as 25 additional arms over the next year. Each arm of the study pairs specific genetic alterations to a specific targeted treatment.

DURHAM, N.C., Oct 22, 2015 (GLOBE NEWSWIRE via COMTEX) -- Chimerix CMRX, -4.31% a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced initiation of dosing in SURPASS (ClinicalTrials.gov ID: NCT02439957), one of the two Phase 3 trials in the brincidofovir kidney transplant program. Both the SUSTAIN (ClinicalTrials.gov ID: NCT02439970) and SURPASS trials are evaluating brincidofovir for the prevention of cytomegalovirus (CMV) disease in kidney transplant recipients; both trials are now actively enrolling. Brincidofovir is an oral nucleotide analog that has shown in vitro antiviral activity against all five families of DNA viruses that affect humans, including herpesviruses and adenovirus, and demonstrated a clinically and statistically significant reduction in CMV infection in a Phase 2 trial in hematopoietic cell transplant (HCT) recipients. Based on that successful study, Chimerix designed and conducted the pivotal SUPPRESS trial for the prevention of clinically significant CMV infection in patients undergoing HCT which completed enrollment in June. Topline data from SUPPRESS are anticipated in early 2016.