LLY Heartbroken, DERM Testing New Uses For Old Drug, COLL Will Have To Wait

(RTTNews) - With the FDA not being able to complete the review of Collegium Pharmaceutical Inc.'s (COLL) New Drug Application for Xtampza ER in time, it's going to be another anxious wait for the investors.

The FDA's decision on Xtampza ER, an abuse-deterrent analgesic for chronic pain, was scheduled for October 12, 2015.

Michael Heffernan, Collegium's Chairman and CEO said, "We are confident in the Xtampza ER program and our NDA submission. We continue to work closely with the FDA as they complete their review."

COLL closed Monday's trading at $20.09, down 2.81%. In after-hours, the stock was down another 5.43% to $19.00.

Dermira Inc. (DERM) has completed patient enrollment - reaching the target of 225 patients - in its first phase III study of Cimzia in adult patients with moderate-to-severe chronic plaque psoriasis, dubbed CIMPASI-2.

Dermira is all set to receive a milestone payment of $7.3 million from UCB Pharma S.A., following completion of patient enrollment in the CIMPASI-2 study. The company has an exclusive licensing agreement with UCB for the development and commercialization of Cimzia.

Two additional phase III studies of Cimzia in moderate-to-severe chronic plaque psoriasis, dubbed CIMPASI-1 and CIMPACT, are underway and enrollment is continuing in these studies.

The company expects topline efficacy and safety data from the CIMZIA phase III clinical development program in 2017.

Cimzia was first approved by the FDA in 2008 for the treatment of moderate to severe Crohn's disease; in 2009, for treatment of moderate to severe rheumatoid arthritis; in September 2013, for the treatment of active psoriatic arthritis (PsA) and in October 2013, for active ankylosing spondylitis.

Cimzia, which is marketed in 58 countries, generated global sales of 797 million Euros in 2014 compared to 594 million Euros in 2013.

DERM closed Monday's trading at $24.53, down 6.16%.

Edge Therapeutics Inc.'s (EDGE) lead product candidate for treating patients that have suffered an aneurysmal subarachnoid hemorrhage, also known as a ruptured brain aneurysm, has received orphan drug designation from the European Commission.

A phase 1/2 study of EG-1962 in patients with ruptured brain aneurysm, dubbed NEWTON, completed enrollment as recently as May of this year. Favorable outcomes were reported in 67% of EG-1962 treated patients at study mid-point, according to the company.

EG-1962 was granted orphan drug designation by the FDA in June of this year.

The company went public on October 1, 2015, offering its shares at a price of $11.00 each. The stock closed Monday's trading at $18.65, up 5.97%.

Eli Lilly and Co. (LLY) has decided to pull the plug on its phase III trial of Evacetrapib for high-risk atherosclerotic cardiovascular disease due to insufficient efficacy, following the recommendation of the independent data monitoring committee.

The phase III trial, dubbed ACCELERATE, was evaluating the potential blockbuster Evacetrapib in approximately 12,000 patients with high-risk atherosclerotic cardiovascular disease, and the company was looking forward to receiving the results in 2016.

LLY closed Monday's trading at $79.44, down 7.78%.

Endologix Inc. (ELGX) has received FDA approval for its AFX2 Bifurcated Endograft System for the treatment of abdominal aortic aneurysms.

Abdominal aortic aneurysm, commonly called triple A, is a swelling (aneurysm) of the abdominal aorta - the largest blood vessel that provides blood to the tissues and organs of the abdomen as well as to the pelvis and lower limbs.

The newly approved device is the latest innovation in the company's AFX Endovascular AAA family of products.

Endologix plans to commercially launch the device in the U.S. in the first quarter of 2016.

ELGX closed Monday's trading at $13.30, up 0.61%.

The FDA has green-lighted NuVasive Inc.'s (NUVA) X-Core Mini Cervical Corpectomy System, thus becoming the first ever cervical corpectomy cage to receive 510(k) clearance.

The X-Core Mini Cervical Corpectomy System is an expandable titanium vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture or osteomyelitis, in addition to the reconstruction following a corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.

NUVA closed Monday's trading at $51.61, up 1.28%.

Sequenom Inc. (SQNM) has entered into a clinical collaboration with University Medical Center Hamburg-Eppendorf in Germany to evaluate the clinical utility of liquid biopsy in colorectal cancer.

The technology of profiling circulating cell-free tumor DNA in blood has the potential to overcome the challenges and limitations associated with current methods such as imaging, colonoscopy, and invasive biopsies, according to the company.

SQNM closed Monday's trading at $2.02, down 4.27%.

Teva Pharmaceutical Industries Ltd. (TEVA), which is the first to file its Abbreviated New Drug Application for generic Avodart, has launched the product in the U.S.

The branded Avodart, marketed by GlaxoSmithKline plc (GSK), which is used to treat the symptoms of benign prostatic hyperplasia in men with an enlarged prostate, had annual sales of roughly $467 million in the United States, according to IMS data as of July 2015.

TEVA closed Monday's trading at $59.20, up 0.41%.