Plus   Neg

All Is Well With ACRS, First Avastin Biosimilar In The Works, CLRB Abuzz

Pharma 111616

Shares of Aclaris Therapeutics Inc. (ACRS) were up more than 6% in extended trading on Tuesday, following positive results from two pivotal phase III trials of its lead product candidate A-101 40% Topical Solution for the treatment of seborrheic keratosis.

Seborrhoeic keratoses, or SK, are one of the most common noncancerous skin growths that some people get as they age. These skin growths can be removed by cryotherapy, excision or laser treatment. But these methods may be painful or can result in pigmentary changes or scarring at the treatment site.

The two trials, SEBK-301 and SEBK-302, met all primary and secondary endpoints, achieving clinically and statistically significant clearance of SK lesions.

The company plans to submit a New Drug Application for A-101 to the FDA in the first quarter of 2017. If approved, A-101 would be the first FDA-approved topical treatment for SK.

ACRS closed Tuesday's trading at $23.43, up 4.04%. In after-hours, the stock was up 6.27% to $24.90.

Amgen (AMGN) and Allergan plc. (AGN) are seeking FDA approval for ABP 215, a biosimilar candidate to Roche's Avastin.

Avastin, the first angiogenesis inhibitor to be approved by the FDA in 2004, is indicated for the treatment of metastatic colorectal cancer, non-small cell lung cancer, HER2-negative breast cancer, glioblastoma, renal cell carcinoma and cervical cancer. Sales of Avastin in 2015 totaled CHF 6,684 million, up 9% over the prior year.

The biosimilar candidate ABP 215 is the most advanced of the four oncology biosimilar medicines that Amgen and Allergan are collaborating on. The companies believe this submission is the first Avastin biosimilar application submitted to the FDA.

AMGN closed Tuesday's trading at $147.06, up 0.44%.

Cellectar Biosciences Inc. (CLRB) has selected INC Research (INCR) as the contract research organization to oversee its NCI-supported phase II clinical trial of CLR 131 in patients with multiple myeloma and select hematologic malignancies.

The company plans to initiate the trial during the first quarter of 2017.

The National Cancer Institute (NCI) had granted $2 million to support the phase II clinical study of CLR 131 in August of this year.

The company anticipates that the $2 million grant will cover approximately 50 percent of the study's cost, and the terms of the grant allow Cellectar to pursue an additional $3 million for a pivotal Phase III trial of CLR 131.

CLRB closed Tuesday's trading at $2.35, up 26.35%.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT