News

- SUPPRESS Did Not Achieve Primary Endpoint for Prevention of Clinically Significant CMV Infection After HCT - - Detailed Data Analysis to Follow - - Company to Hold Conference Call Today at 8:30 a.m. ET - DURHAM, N.C., Dec. 28, 2015 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that its Phase 3 SUPPRESS trial of brincidofovir in patients undergoing hematopoietic cell transplantation (HCT) did not achieve its primary endpoint for the prevention of clinically significant cytomegalovirus (CMV) infection through Week 24 after transplant.

STAMFORD, Conn., Dec. 22, 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 the enrollment of the first patient in its Phase 1 trial of LOXO-101 in pediatric patients with advanced solid or primary central nervous system (CNS) tumors. LOXO-101 is the only selective inhibitor of the tropomyosin receptor kinase (TRK) protein family in clinical development.

CHAPEL HILL, N.C., Dec. 22, 2015 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced it has successfully completed enrollment of 250 patients in the United States and Australia for its Phase 3 trial in urogenital gonorrhea. Under a CRADA (Cooperative Research and Development Agreement) with the National Institute of Allergy and Infectious Diseases (NIAID), the Phase 3 trial has been amended to include up to an additional 60 patients, consisting of women and adolescents with culture-proven gonorrhea.

TORONTO – Cynapsus Therapeutics Inc. (NASDAQ: CYNA) (TSX: CTH), a specialty central nervous system (“CNS”) pharmaceutical company developing and preparing to commercialize a fast-acting, easy-to-use, sublingual thin film for the on-demand management of debilitating OFF episodes associated with Parkinson’s disease (“PD”), today announced that it has successfully completed the CTH-200 bridging study comparing APL-130277 to subcutaneous apomorphine. In addition, the Company provided an update on European clinical plans.

LEXINGTON, Mass., Dec. 09, 2015 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) today announced the closing of its underwritten public offering of 3,500,000 shares of common stock at a public offering price of $9.75 per share, before underwriting discounts, for gross proceeds of $34,125,000. In addition, T2 Biosystems has granted the underwriters a 30-day option to purchase up to an additional 525,000 shares of common stock at the public offering price, less the underwriting discount. All of the shares of the common stock sold in the offering were offered by T2 Biosystems.

Collaboration will deliver healthcare professionals and consumers enhanced value and access to leading facial and body aesthetic innovations FORT WORTH, Texas and PLEASANTON, Calif., Dec. 8, 2015 /PRNewswire/ -- Galderma, a global leader in skin health, and ZELTIQ® Aesthetics, Inc. (Nasdaq: ZLTQ), a medical technology company focused on developing its proprietary controlled-cooling technology platform, today announced a new collaboration across the companies' innovative aesthetic brands and offerings. Effective immediately, the creation of this nationwide collaboration between two of the fastest-growing companies in the aesthetic space will provide healthcare professionals and consumers with greater access to a robust range of technologically-advanced and scientifically-proven beauty solutions for facial rejuvenation and non-invasive fat reduction.

Pivotal Trial Designed to Demonstrate Non-Inferiority of Taksta Compared to Oral Zyvox(R) (linezolid) CHAPEL HILL, N.C., Dec. 8, 2015 (GLOBE NEWSWIRE) -- Cempra, Inc. (Nasdaq:CEMP), a clinical-stage pharmaceutical company developing antibiotics to meet critical medical needs in the treatment of bacterial infectious diseases, today announced that the first patient has been dosed in its Phase 3 clinical trial to evaluate the safety and efficacy of oral Taksta™ (CEM-102, sodium fusidate, the sodium salt of fusidic acid) as a potential treatment for acute bacterial skin and skin structure infections (ABSSSI). Cempra is developing Taksta exclusively in the United States as an oral treatment for ABSSSI and refractory bone and joint infections.

Enrollment Continues for Third and Final CIMZIA Phase 3 Trial in Patients With Moderate-to-Severe Plaque Psoriasis MENLO PARK, Calif., Nov. 19, 2015 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a specialty biopharmaceutical company focused on bringing innovative and differentiated products to dermatologists and their patients, today announced the completion of patient enrollment for the global CIMPASI-1 clinical trial of CIMZIA® (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis. The first clinical trial, CIMPASI-2, completed enrollment in September 2015, and the third and final trial in the clinical development program, CIMPACT, continues to enroll patients. Dermira expects to announce topline efficacy and safety data from the CIMZIA Phase 3 clinical development program in 2017, consistent with previous guidance, based on current patient enrollment projections for CIMPACT and following completion of the 48-week blinded treatment period for all three trials. CIMZIA is not currently approved for the treatment of psoriasis by any regulatory authority worldwide.

STAMFORD, Conn., Nov. 17, 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 the closing of its previously announced underwritten public offering of 2,875,000 shares of common stock at a public offering price of $26.50 per share, which included the exercise in full by the underwriters of their option to purchase 375,000 additional shares of common stock to cover over-allotments. Gross proceeds to Loxo Oncology from this offering were approximately $76.2 million. Loxo Oncology intends to use the net proceeds from this offering for general corporate purposes, which may include funding research and development, increasing its working capital, acquisitions or investments in businesses, products or technologies that are complementary to its own, and capital expenditures.

-- Single Ascending Dose Study-Results Demonstrate Excellent Safety and Tolerability and Support Once-Weekly IV Dosing -- -- Management to Host Webcast and Conference Call Tomorrow at 8:00 a.m. ET -- SAN DIEGO, Nov. 16, 2015 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq:CDTX), a biotechnology company developing novel anti-infectives and immunotherapies to treat fungal and other infections, today announced positive data from the company's Phase 1 single ascending dose (SAD) clinical trial of its antifungal drug candidate, CD101 IV, in healthy volunteers. CD101 IV is a novel, long-acting echinocandin that Cidara is developing for the treatment and prevention of serious, invasive fungal infections, including candidemia and invasive candidiasis. The company also reported financial results for the three and nine months ended September 30, 2015.