ALDR Gains As Pain Wanes, APRI Disappoints, PBYI's NDA Filing Delayed Yet Again

(RTTNews) - Affymetrix Inc. (AFFX) has determined that the unsolicited merger proposal submitted by Origin Technologies Corp. on March 22, 2016 does not constitute a Superior Proposal, and has recommended against that deal.

The company is encouraging stockholders to vote for the proposed merger with Thermo Fisher Scientific Inc. (TMO) at the upcoming Special Meeting of Affymetrix stockholders, which is scheduled on March 31, 2016.

Affymetrix signed an agreement in January of this year to be acquired by Thermo Fisher for $14 a share in cash, or a purchase price of approximately $1.3 billion. On March 21, 2016, Origin Technologies, a newly created shell entity formed by a group of former Affymetrix executives, offered to buy Affymetrix for $16.10 per share in cash, equivalent to a total value of $1.5 billion. With Affymetrix turning down the takeover offer, Origin, on March 22, 2016, raised its offer to $17.00 per share from its earlier offer of $16.10 per share in cash.

After engaging in talks with Origin, this is what Affymetrix had to say, "While the Board found the $3.00 per share premium offered in the Origin Proposal, taken by itself, to be attractive, the Board found the risks to initiating and consummating a potential transaction with Origin outweighed the potential benefit of a higher offer from Origin".

AFFX closed Monday's trading at $14.10, down 5.56%.

Shares of Alder BioPharmaceuticals Inc. (ALDR) rose more than 49% on Monday, following positive top-line data from two clinical trials evaluating ALD403 for migraine prevention.

A phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine over the entire 12 week study period, meeting both primary and secondary efficacy endpoints.

A phase I study demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.

ALDR closed Monday's trading 49.59% higher at $25.70. In after-hours, the stock was up another 4.47% to $26.85.

Shares of Apricus Biosciences Inc. (APRI) plunged over 54% to touch a new low of $0.61 on Monday as the company's investigational drug Fispemifene failed to achieve statistical significance in key clinical benefit endpoints in a phase 2b proof-of-concept study in men with secondary hypogonadism and sexual dysfunction.

According to the study results, while Fispemifene at 450mg demonstrated statistically significant improvements in total, percent free and percent bioavailable testosterone compared to placebo, the magnitude of the increase was not sufficient to achieve statistical significance for either the erectile function primary endpoint or low libido secondary endpoint.

APRI closed Monday's trading at $0.71, down 47.21%. In after hours, the stock was up 3.52% to $0.73.

Aralez Pharmaceuticals Inc.'s (ARLZ) (ARZ.V) New Drug Application for YOSPRALA for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers has been accepted for review by the FDA.

The regulatory agency's decision on YOSPRALA is set for September 14, 2016.

ARLZ closed Monday's trading at $3.72, up 3.91%.

KemPharm Inc. (KMPH) is all set to initiate human clinical trials of KP511 in the second quarter of 2016.

KP511 is being developed as an abuse-deterrent, extended-release (ER) prodrug for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatments are inadequate (KP511/ER).

The company plans to seek approval of KP511/ER under Section 505(b) (2) of the Federal Food, Drug and Cosmetic Act with an anticipated New Drug Application submission as early as 2018.

KMPH closed Monday's trading at $14.67, down 3.80%.

Merit Medical Systems Inc. (MMSI) has received FDA clearance for Corvocet Biopsy System, which is intended for use in obtaining core biopsy samples from the liver, kidney, prostate, breast, lung and various other soft tissue tumors.

The Corvocet Biopsy System marks Merit's first entry into the biopsy market, and is scheduled to be introduced in the United States over the next thirty days or so, with European release following receipt of the CE mark.

MMSI closed Monday's trading at $17.71, up 0.80%.

Neothetics Inc.'s (NEOT) LIPO-202, which failed to meet co-primary composite and secondary endpoints in phase III trials for the reduction of central abdominal bulging, is now being developed in a modified formulation.

Consequently, the company plans to initiate a phase 2 trial with a modified formulation of LIPO-202 in the third quarter of 2016 for the reduction of central abdominal bulging, and topline data are anticipated in first quarter of 2017.

Neothetics also plans to initiate a phase II proof of concept study of LIPO-202 for the reduction of localized fat deposits under the chin (submental fat) in the third quarter of 2016, which the company anticipates having top-line data from by year end 2016.

In order to put a lid on expenses, following the failure of phase III trials, the company has reduced its headcount from 17 to 9 [full-time] employees.

NEOT closed Monday's trading at $0.58, down 16.21%.

Puma Biotechnology Inc. (PBYI) now plans to submit its New Drug Application for the approval of Neratinib for the treatment of extended adjuvant breast cancer that has previously been treated with a trastuzumab-containing regimen in mid-2016. This is the third delay for filing the Neratinib NDA.

On July 22, 2014, the company had announced it planned to file for regulatory approval of Neratinib in the first half of 2015. On December 2, 2014, the company announced that it intended to delay its proposed timeline for filing the NDA until the first quarter of 2016.

Puma has recently conducted a series of meetings and communications with the FDA, with the purpose of providing the regulatory agency with the data from Neratinib's non-clinical and clinical development programs that will form the basis of the company's NDA for Neratinib.

PBYI closed Monday's trading at $35.37, down 4.35%. In after hours, the stock was down 11.68% to $31.24.

The FDA has turned down Takeda Pharmaceutical Co. Ltd. (TKPYY.OB) and H. Lundbeck A/S's supplemental new drug application for Brintellix in treating certain aspects of cognitive dysfunction in Major Depressive Disorder.

Last month, an FDA panel had voted 8 to 2 in support of the companies' claim of effectiveness of Brintellix in the additional indication. Therefore, the FDA giving thumbs down to the label update of Brintellix comes as a disappointment to the two companies which were expecting a regulatory nod.

The FDA approved Brintellix on September 30, 2013 for the treatment of Major Depressive Disorder in adults. The drug raked in sales of $95 million in 2015.

TKPYY.OB closed Monday's trading at $24.10, up 0.79%.