Cempra Announces Positive Topline Phase 3 Clinical Results for Oral Solithromycin in the Treatment of Community Acquired Bacterial Pneumonia

Solithromycin met the primary and secondary objectives of non-inferiority compared to moxifloxacin

CHAPEL HILL, N.C., Jan. 4, 2015 -- Cempra, Inc. (CEMP), a clinical-stage pharmaceutical company focused on developing antibiotics in the face of rising antibiotic resistant bacterial infections, today announced positive topline results from a global, pivotal Phase 3 clinical trial of solithromycin oral capsules (Solitaire-Oral) in the treatment of patients with community acquired bacterial pneumonia (CABP).

In the intent-to-treat population (ITT, all randomized patients), solithromycin met the primary objective of statistical non-inferiority (10% non-inferiority margin) of the early clinical response at 72 (-12/+36) hours after initiation of therapy compared to moxifloxacin. Solithromycin also met the secondary objectives of non-inferiority in clinical success at the short term follow up (SFU) visit, 5-10 days after the end of therapy, both in the ITT and clinically evaluable populations.

Stereotaxis Receives FDA Clearance of Vdrive(R) With V-CAS(TM) System Along With Regulatory Approval of Odyssey(R) System in Japan

ST. LOUIS, Jan. 5, 2015  -- Stereotaxis, Inc. (STXS) announced today that it has received 510(k) clearance by the Food and Drug Administration (FDA) for its Vdrive(R) with V-CAS(TM) Catheter Advancement System in the U.S., representing the Company's third Vdrive system product to be cleared for market entry. The Company also announced that it has received regulatory approval of its Odyssey(R) product line by the Japan Pharmaceuticals and Medical Devices Agency, the country's equivalent to the U.S. FDA.

Stereotaxis' Vdrive with V-Loop(TM) Variable Loop Catheter Manipulator received U.S. clearance in September 2014 and its Vdrive with V-Sono(TM) Intracardiac Echocardiography Catheter Manipulator has been available since 2013.

Conatus to Report Top-line Results From ACLF and Organ Impairment Clinical Trials of Emricasan

SAN DIEGO, Jan. 5, 2015  -- Conatus Pharmaceuticals Inc. (CNAT), a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced that it will report top-line results from three clinical trials in subjects with varying degrees of organ impairment -- the company's Phase 2 trial in patients with acute-on-chronic liver failure (ACLF), Phase 1 trial in patients with mild, moderate and severe hepatic impairment, and Phase 1 trial in patients with severe renal impairment -- after the market close on Thursday, January 8, 2015. Conatus will host a conference call and webcast with an associated presentation at 4:30 p.m. Eastern Time on Thursday, January 8, 2015, to discuss the trial results.

Tekmira Provides Update on TKM-PLK1 Phase I/II Clinical Study in Patients With Advanced Gastrointestinal Neuroendocrine Tumors and Adrenocortical Carcinoma

VANCOUVER, British Columbia, Dec. 31, 2014  -- Tekmira Pharmaceuticals Corporation (TKMR) (TKM), a leading developer of RNA interference (RNAi) therapeutics, today provided a status update on the Phase I/II clinical study in patients with advanced Gastrointestinal Neuroendocrine Tumors (GI-NET) and Adrenocortical Carcinoma (ACC).

Tekmira today reported that:

• Enrolment of the target patient numbers in these Phase I/II studies has been completed;
• To date, 55 patients, in the both the Phase I and Phase I/II studies have been treated at doses of >= 0.6 mg/kg, considered to be in the efficacious dose range based on preclinical studies. Of these, 31 patients comprise the target population of GI-NET or ACC patients;