ADHD Gets Attention, BioLife To Uplist Stock, TRGT Misses Goal, CEMP On A High

(RTTNews) - Alcobra Ltd.'s (ADHD) phase IIb clinical trial with its experimental drug MG01CI in adults with predominantly inattentive attention deficit hyperactivity disorder has demonstrated a statistically significant improvement over placebo.

The company noted that there were no significant differences in adverse event profiles between treatment and placebo groups in the study.

ADHD closed Monday's trading 5.25% higher at $18.04.

BioLife Solutions Inc. (BLFS.OB) is seeking to uplist its common stock on the NASDAQ Capital Market and is taking some coordinated steps to support its effort. The company is planning to implement a reverse stock split by a ratio of not less than one-for-four and not more than one-for-sixteen (1:4 up to 1:16, or anywhere in-between), while maintaining or reducing the number of authorized shares at any ratio.

In an effort to meet the minimum shareholder equity requirement for listing on the NASDAQ Capital Market, BioLife's two debt holders have agreed to convert the company's entire secured debt of approximately $14 million in principal and accrued interest into equity in connection with the company's next equity financing.

BLFS.OB closed Monday's trading at $0.56, down 5.08%.

BioLineRx (BLRX) rose as much as 30 percent to $3.34 in intraday trading on Monday after the company reported promising initial phase II results of its drug candidate BL-8040 in acute myeloid leukemia.

According to the early results, BL-8040, as a stand-alone therapy and in combination with high-dose Cytarabine (Ara-C), has been found to be safe at all doses tested to date, and triggers substantial mobilization of cancer cells from the bone marrow to the peripheral blood, thereby increasing the vulnerability of the cells to chemotherapy treatment, noted the company.

Cempra Inc. (CEMP) plans to submit a phase III study protocol of drug candidate Taksta in patients with prosthetic joint infections to the FDA early next year and discuss its strategy with the regulatory agency in the first half of 2014.

The company expects top-line results of Solitaire-Oral, the first global phase 3 study of solithromycin in patients with community-acquired bacterial pneumonia in mid-2014.

CEMP touched a new high of $13.63 on Monday before closing at $13.50, up 3.69%.

Cubist Pharmaceuticals Inc.'s (CBST) pivotal phase III clinical trial of its antibiotic candidate ceftolozane/tazobactam in complicated intra-abdominal infections has met the primary endpoint.

The data from a phase III trial of ceftolozane/tazobactam compared to levofloxacin in patients with complicated urinary tract infections (cUTI), which were reported last month, have also been positive.

CBST closed Monday's trading 5.94% higher at $66.51.

Endo Health Solutions (ENDP) has agreed to acquire NuPathe Inc. (PATH) for $2.85 per share in cash, or roughly $105 million. In addition to the upfront cash payment, NuPathe shareholders will receive rights to receive additional cash payments of up to $3.15 per share if specified net sales of NuPathe's migraine treatment ZECUITY are achieved over time.

The transaction is expected to be accretive to Endo's adjusted diluted earnings per share within the first 12 months of closing.

ENDP closed Monday's trading 3.21% higher at $65.91.

NeoStem Inc. (NBS) expects data readout from a phase II trial of its lead product candidate AMR-001 for the treatment of patients with left ventricular dysfunction following acute ST segment elevation myocardial infarction (STEMI) in the third quarter of 2014.

AMR-001 is an autologous adult stem cell product. The phase II trial, dubbed PreSERVE AMI, has completed the target population of 160 patients.

NBS closed Monday's trading at $6.09, down 1.62%.

OncoSec Medical Inc. (ONCS.OB) touched a new high of $0.40 on Monday before closing at $0.37, following positive interim data from its ongoing phase II trial of OMS-I100 in the treatment of metastatic melanoma.

PharmAthene Inc.'s (PIP) SparVax rPA anthrax vaccine program has been placed on clinical hold by FDA. A phase II clinical study of SparVax rPA was expected to begin by the end of this year. The study has not enrolled any subjects to date and accordingly, there have been no adverse events reported.

The FDA will provide details of the basis for the clinical hold within thirty days, said the company.

PIP closed Monday's trading at $1.90, down 5%.

Tekmira Pharmaceuticals Corp. (TKMR) (TKM.TO) has received a $5 million milestone from its partner Alnylam Pharmaceuticals Inc. (ALNY), which recently initiated a phase III trial with ALN-TTR02.

ALN-TTR02, which is enabled by Tekmira's lipid nanoparticle technology, is an RNAi therapeutic targeting transthyretin for the treatment of TTR-mediated amyloidosis.

TKMR closed Monday's trading 3.15% higher at $7.54.

Targacept Inc. (TRGT) dropped more than 31 percent to $4.06 in extended trading on Monday because a phase 2b clinical trial of its drug candidate TC-5619 as an augmentation therapy for the treatment of negative symptoms of schizophrenia did not meet the primary outcome measure.

The company has decided not to pursue further development of TC-5619 as a treatment for either schizophrenia or Alzheimer's disease.

Consistent with its strategy of acquiring small, growing pharmaceutical companies, OPKO Health Inc. (OPK) has agreed to acquire Laboratorio Arama de Uruguay Limitada, which is domiciled in Montevideo, Uruguay. The transaction, which will add to OPKO's growing South American presence, is expected to close in January 2014.

OPK closed Monday's trading at $9.09, up 1.34%.

Valeant Pharmaceuticals International Inc. (VRX) (VRX.TO) has agreed to acquire Solta Medical Inc. (SLTM) for $2.92 per share in cash, which equates to a transaction value of approximately $250 million. The purchase price represents a 40% premium to Solta's closing share price on December 13, 2013, the last trading day prior to announcement.

The transaction is expected to close in the first quarter of 2014, and Valeant expects the transaction, once completed, to be immediately accretive to its cash earnings per share.

VRX closed Monday's trading at $110.92, up 3.83%.

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