NEOS Gets Much Needed Attention, AKRX Breathes Easy, INCY Halts Study

(RTTNews) - An Audit Committee, which probed Akorn Inc.'s (AKRX) accounting and other matters, has concluded the investigation and found no fraud or intentional misconduct by the company's management or accounting personnel.

The investigation concerning the accounting errors involving transactions related to sales to wholesalers, direct purchasers and other related transactions was initiated last April.

AKRX closed Wednesday's trading at $25.98, down 5.42%.

BIND Therapeutics Inc.'s (BIND) phase II trial with BIND-014 in patients with KRAS mutant or squamous histology non-small cell lung cancer, dubbed iNSITE 1, is fully enrolled, and data is expected to be available by the end of the first quarter of 2016.

The company's phase II multi-tumor trial with BIND-014 in patients with cholangiocarcinoma, cervical cancer, bladder cancer, and head and neck cancers is known as iNSITE 2.

In the iNSITE 2 trial, enrollment of at least 20 patients each has been completed in the advanced cervical cancer and head and neck cancer cohorts. A decision is expected on whether to advance to the second stage of the study for head and neck cancer by the end of the first quarter of 2016 and early in the second quarter of 2016 for the cervical cancer cohort.

Due to slower than anticipated enrollment, the company is discontinuing enrollment in the cholangiocarcinoma and bladder cancer cohorts in the iNSITE 2 trial.

BIND closed Wednesday's trading at $1.75, down 4.89%.

Eli Lilly and Co. (LLY) is partnering with Roche Diagnostics on its ongoing development of a commercially scalable cerebrospinal fluid assay for amyloid-beta 1-42, which has gained acceptance as a tool to aid in the diagnosis of Alzheimer´s disease.

Under this non-exclusive agreement, Lilly is responsible for certain milestone payments upon successful completion of key development objectives. Roche is responsible for the development, registration, and commercialization of the new test.

LLY closed Wednesday's trading at $81.76, down 0.24%.

Shares of Incyte Corp. (INCY) were down more than 13% in extended trading on Wednesday, following the company's decision to pull the plug on a phase 2 sub-study of Jakafi in colorectal cancer.

The phase II sub-study was testing Jakafi in combination with Bayer's chemotherapy drug Stivarga in patients with relapsed or refractory metastatic colorectal cancer (CRC) and high C-reactive protein.

The decision to stop the sub-study was made after a planned interim analysis of the high CRP subgroup demonstrated that Jakafi plus Stivarga did not show a sufficient level of efficacy to warrant continuation.

Jakafi is an approved drug for treatment of people with polycythemia vera, a type of blood cancer, and intermediate or high-risk myelofibrosis, a serious bone marrow disorder.

Incyte markets Jakafi in the U.S. while Novartis markets the drug as Jakavi outside the United States.

Incyte expects full year 2015 Jakafi net product revenues to range between $580 million and $590 million. The company is scheduled to report Q4 and full year 2015 financial reports on February 11, 2016.

INCY closed Wednesday's trading at $74.99, down 1.38%. In after hours, the stock fell 13.22% to $65.08.

Merck's (MRK) Biologics License Application for Bezlotoxumab for prevention of Clostridium difficile infection recurrence has been accepted for priority review by the FDA - with a decision date set for July 23, 2016.

Bezlotoxumab is also under review with the European Medicines Agency.

MRK closed Wednesday's trading at $50.37, down 2.10%.

Shares of Neos Therapeutics Inc. (NEOS) were up over 16% in extended trading on Wednesday, following FDA approval of the company's Adzenys XR-ODT for the treatment of attention deficit hyperactivity disorder, or ADHD, in patients six years and older.

ADHD is one of the most common childhood disorders and can continue through adolescence and adulthood. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior and hyperactivity (over-activity), according to the National Institute of Mental Health.

Adzenys XR-ODT, also known as NT-0202, becomes the first and only approved extended-release orally disintegrating tablet for the treatment of ADHD.

Approved via the 505(b)(2) regulatory pathway, Adzenys XR-ODT is bioequivalent to a previously approved mixed amphetamine salts extended-release capsule (Adderall XR), one of the most commonly prescribed medications for the treatment of ADHD. The drug will be available in six dosage strengths.

The launch and product shipments of Adzenys XR-ODT will begin in the second quarter of 2016, according to the company.

NEOS closed Wednesday's trading at $9.42, up 0.86%. In after hours, the stock was up 16.45% to $10.97.

Recro Pharma Inc. (REPH) has initiated a pivotal phase III clinical trial of intravenous Meloxicam for acute postoperative pain in patients following "mini" abdominoplasty surgery.

The study is designed to enroll about 200 patients, and primary efficacy endpoint is the summed pain intensity difference over the first 24 hours compared to placebo. Recro expects to report top-line results from this phase III study by year end 2016.

REPH closed Wednesday's trading at $7.92, down 1.00%.