SUPN Gets Attention, AST For The Long Haul, OCUL To File NDA In Q2, ZGNX Slumps

(RTTNews) - Akebia Therapeutics Inc. (AKBA) has completed enrollment in the third and final cohort of its phase 2 clinical study evaluating AKB-6548, a once-daily oral therapy, in patients with anemia related to chronic kidney disease who are undergoing dialysis.

The company expects to report top-line results from the study in the third quarter of 2015.

AKBA closed Tuesday's trading at $11.43, down 0.17%.

Alcobra Ltd.'s (ADHD) phase II safety and tolerability study of a single administration of MDX in adolescent patients with ADHD has achieved its primary endpoint. In the study, MDX showed good tolerability and no safety concerns were identified, according to the company.

A separate study evaluating MDX in adolescents and adults with Fragile X Syndrome is currently underway, and results are expected to be reported by the end of 2Q15.

ADHD closed Tuesday's trading at $7.11, up 0.99%.

Asterias Biotherapeutics Inc. (AST) is a stock worth putting on your radar as the company expects multiple, meaningful clinical milestones over the next 24 months.

The company recently initiated patient enrollment in a dose-escalation phase 1/2a clinical trial of AST-OPC1 in patients with complete cervical spinal cord injury (SCI). The trial is an open-label, single-arm study testing three escalating doses of AST-OPC1 in patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI. The dose escalation will start with three patients being dosed 2 million cells and escalate into two five-patient cohorts at 10 million and 20 million cells, respectively.

The company expects the safety data readout from the initial low-dose, 2 million cell cohort and initiation of the 10 million cell cohort in the second quarter of 2015.

The company said that its AST-VAC2 allogeneic dendritic cell-based cancer vaccine will be investigated for initial measures of clinical activity and safety in a phase 1/2a trial in non-small cell lung cancer, and expects to complete and transfer the manufacturing process for AST-VAC2 to its development partner in the second quarter of this year.

AST closed Tuesday's trading at $5.99, down 0.66%.

Ocular Therapeutix Inc. (OCUL) plans to submit a New Drug Application for OTX-DP for the treatment of post-surgical ocular inflammation and pain in the second quarter of 2015.

The company reported positive topline phase 3a clinical trial data of OTX-DP in 247 patients, achieving statistically significant improvement both in pain and in the reduction of inflammatory cells, yesterday.

A phase 3b clinical trial of OTX-DP for the treatment of ocular inflammation and pain following cataract surgery is underway, with topline results expected by the end March, 2015.

The other upcoming events to watch out for are the completion of enrollment in a phase 2b trial evaluating OTX-TP for the treatment of glaucoma and ocular hypertension, with data expected in the fourth quarter of 2015; initiation of phase 3 clinical trials of OTX-DP for the treatment of allergic conjunctivitis in the middle of 2015 and completion of a phase 2 exploratory clinical trial of OTX-DP for the treatment of inflammatory dry eye disease, with data expected in the fourth quarter of 2015.

OCUL touched a new high of $40.93 on Tuesday before closing the day's trading at $39.46.

Puma Biotechnology Inc. (PBYI) has initiated a phase II trial of its investigational drug PB272 (neratinib) for the extended adjuvant treatment of breast cancer.

The trial, designed to enroll 70 patients will evaluate PB272 monotherapy in HER2-positive early stage breast cancer patients who have previously received adjuvant treatment with Genentech's Herceptin.

The company added that patients will receive extended adjuvant treatment with its experimental breast cancer therapy Neratinib for a period of one year. Patients will receive primary prophylaxis with high dose loperamide (16 mg per day initially) in order to attempt to reduce the Neratinib-related diarrhea. The primary endpoint of the trial is reduction in the incidence and severity of diarrhea.

The company anticipates initial results from this trial to be available by year-end 2015, which would enable NDA filing for Neratinib in the extended adjuvant setting, which is currently anticipated for the first quarter of 2016.

PBYI closed Tuesday's trading at $236.61, up 2.58%.

Supernus Pharmaceuticals Inc. (SUPN) plans to initiate phase III clinical testing of SPN-810 for impulsive aggression in patients who have attention deficit hyperactivity disorder, or ADHD, during the fourth quarter of 2015. The company is scheduled to meet with the FDA during the second quarter to review the scale and its request for a special protocol assessment.

A phase IIb trial of SPN-812 for ADHD is also expected to be initiated during the fourth quarter of this year.

SUPN closed Tuesday's trading at $9.93, up 0.30%. In after-hours, the stock was up 3.93% at $10.32.

Shares of medical device company Synergetics USA Inc. (SURG) were up more than 7% in extended trading on Tuesday, following better-than-expected results for the second quarter of fiscal year 2015.

The net income for the three months ended January 31, 2015 increased roughly to $1.0 million or $0.04 per share on total sales of $18.2 million. Analysts polled by Thomson Reuters expected the company to earn $0.02 per share on sales of $17.61 million. In Q2 of fiscal 2014, the company reported a loss of $0.2 million or $0.01 per share and sales of $15 million.

The company ended January 31, 2015 with cash of approximately $8.9 million, and $2.75 million in interest-bearing debt.

SURG closed Tuesday's trading at $4.67. In after-hours, the stock was up 7.06% at $4.99.

United Therapeutics Corp. (UTHR) touched a new high on Tuesday after the company was granted FDA approval for Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-2 (IL-2), and 13-cis-retinoic acid (RA), for the treatment of pediatric high-risk neuroblastoma.

The approval was based on demonstration of improved event-free survival and overall survival in a multicenter, open-label, randomized trial of Unituxin conducted by the Children's Oncology Group.

UTHR closed Tuesday's trading at $163.84, up 2.12%.

Zogenix Inc. (ZGNX) is scheduled to begin a phase 3 clinical trial for ZX008, an orphan drug candidate for the treatment of Dravet syndrome, in the third quarter of this year.

Dravet syndrome, also known as Severe Myoclonic Epilepsy of Infancy (SMEI), is a rare and catastrophic form of intractable epilepsy that begins in infancy. (* definition by Dravet Syndrome Foundation).

Another drug in the company's pipeline - Relday, a unique long-acting injectable formulation of risperidone for the maintenance treatment of schizophrenia, is expected to be ready for phase 3 studies in the first half of 2016.

Seeking to strategically shift focus to ZX008 and Relday, Zogenix has agreed to sell its Zohydro ER (hydrocodone bitartrate) business to Pernix Therapeutics (PTX) for $100 million plus regulatory and sales milestones up to $283.5 million.

Zohydro ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

ZGNX closed Tuesday's trading at $1.67, down 2.34%. In after-hours, the stock was down 9.58% at $1.51.