AMGN Gets FDA Date, TTPH On Track, SAGE Keeps Calm, Busy Months Ahead For XNCR

(RTTNews) - Amgen Inc.'s (AMGN) Biologics License Application for Evolocumab for the treatment of high cholesterol has been accepted for review by FDA - with a decision scheduled for Aug. 27, 2015.

Amgen's Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol or "bad" cholesterol, from the blood.

AMGN closed Monday's trading at $163.09, up 1.77%.

Cara Therapeutics Inc.'s (CARA) phase I single and multiple ascending dose trials for the tablet formulation of its lead product candidate CR845 for acute and chronic pain is underway, with top-line results anticipated this quarter.

The intravenous, or I.V., CR845 has already demonstrated significant pain relief and a favorable safety and tolerability profile in three phase II clinical trials in patients with acute postoperative pain. The company plans to request an End of phase II meeting with the FDA to discuss the design of phase III trials for I.V. CR845, in acute pain before the end of 2014.

A proof-of-concept phase II trial for I.V. CR845 for the treatment of uremic pruritus, a systemic condition with high prevalence in dialysis patients, which was initiated in August of this year, is ongoing. The company expects to report top-line dose-ranging pharmacokinetic (PK) and safety data from this trial before the end of 2014 and top-line efficacy results in the first half of 2015.

CARA closed Monday's trading at $8.75, up 1.04%.

Esperion Therapeutics Inc. (ESPR) expects top-line results from a phase II study evaluating ETC-1002 as a monotherapy in patients with hypercholesterolemia and hypertension in Q2 2015.

A phase IIb study of ETC-1002 in patients with hypercholesterolemia is underway, with top-line results expected in March 2015.

Last month, the company raised net proceeds of $91.6 million in a follow-on public offering, priced at $20.00 per share.

ESPR closed Monday's trading at $25.83, up 2.62%.

Puma Biotechnology Inc. (PBYI) has a couple of events to watch out for this quarter.

During this quarter, the company expects to complete and report data from an ongoing phase II randomized trial of PB272 as a first-line treatment for HER2-positive metastatic breast cancer; complete and report results from a phase II trial of PB272 as a neoadjuvant treatment for patients with HER2-positive breast cancer, and report additional data from a phase II clinical trial of PB272 in combination with Temsirolimus in fourth-line HER2-positive metastatic breast cancer.

PBYI closed Monday's trading 3.33% higher at $244.79.

Tetraphase Pharmaceuticals Inc. (TTPH) is on track to report top-line results from IGNITE 1, a phase III trial of its lead antibiotic candidate, Eravacycline, in complicated intra-abdominal infections in the first quarter of 2015.

Another phase III study, dubbed IGNITE 2, studying the efficacy and safety of intravenous and oral formulations of Eravacycline for the treatment of complicated urinary tract infections is underway, and the company expects to report top-line results in mid-2015.

Tetraphase continues to target submission of a New Drug Application for Eravacycline for both indications - complicated intra-abdominal infections and complicated urinary tract infections - by the end of 2015.

Last month, the company raised gross proceeds of $86.3 million from a public offering, priced at $19 per share.

TTPH closed Monday's trading at $23.88, down 0.17%.

SAGE Therapeutics Inc.'s (SAGE) phase 1/2 clinical trial of its drug candidate SAGE-547 in patients with super-refractory status epilepticus has met all primary and secondary efficacy and safety endpoints - with patients successfully weaned off their anesthetic agent.

Super-refractory status epilepticus is a critical condition in which the brain is in a state of persistent seizure.

SAGE-547 is designated as an orphan drug for the treatment of status epilepticus by the FDA.

The company went public on the NASDAQ Global Market on July 18, 2014, offering its shares at a price of $18 each.

SAGE closed Monday's trading at $36.99, down 4.47%.

The coming months promise to be a busy period for Xencor Inc. (XNCR) as there are a couple of catalysts coming its way.

The company plans to report preliminary *IgE reduction data from a phase 1a clinical trial of XmAb7195 in healthy subjects and allergic subjects in January 2015. (*Immunoglobulin E is a type of antibody which is released in response to an allergen).

The top-line data from a phase IIa trial of XmAb5871 in patients with moderate-to-severe rheumatoid arthritis are expected by the end of 2014.

XNCR closed Monday's trading 4.66% higher at $11.22.