ACRX Deeply Pained, ISIS Cuts A Deal, AQXP Reaches Enrollment Target

(RTTNews) - Shares of AcelRx Pharmaceuticals Inc. (ACRX) were down more than 27% in extended trading on Monday after the company revealed that its request for a Type B meeting with the FDA, to clarify the agency's belief that an additional clinical study is needed in order to approve Zalviso, has been denied.

The investigational pain drug-device Zalviso is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

The company was issued a Complete Response Letter for its new drug application for Zalviso last July, and the FDA had then sought data demonstrating a reduction in the incidence of system errors, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product. But in March of this year, the company was notified by the FDA that an additional clinical study to assess the risk of inadvertent dispensing and overall risk of dispensing failures is also required in order to approve Zalviso.

AcelRx believes that an additional clinical study should not be required to demonstrate the safety and efficacy of the Zalviso System beyond what has already been established in the Phase 3 clinical studies, as well as the bench testing and Human Factors studies.

ACRX closed Monday's trading at $4.20, up 4.22%. In after hours, the stock was down 27.38% to $3.05.

Aquinox Pharmaceuticals Inc. (AQXP) has reached its target enrollment of 50 patients in its phase II trial of AQX-1125 for the treatment of atopic dermatitis.

The trial, dubbed KINSHIP, is a randomized, double-blind, multicenter, placebo-controlled study evaluating the efficacy and safety of AQX-1125 in adult patients with mild to moderate atopic dermatitis as a proof-of-concept trial in this indication.

Top line data from the study are anticipated by the first quarter of 2016.

AQXP closed Monday's trading at $6.72, down 3.17%.

Baxter International Inc. (BAX) has filed for European Approval of MM-398, an investigational treatment for post-Gemcitabine metastatic pancreatic cancer.

Baxter has exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan while Merrimack retains commercialization rights in the United States, and PharmaEngine, Inc. holds the rights to commercialize MM-398 in Taiwan.

Merrimack completed the rolling submission of the New Drug Application for MM-398, as a treatment for post-Gemcitabine metastatic pancreatic cancer, to the FDA last month.

MACK closed Monday's trading 1.68% higher at $12.12.

BioLineRx Ltd. (BLRX) has successfully completed the dose escalation stage of its ongoing phase 2 study of BL-8040, and commenced the expansion stage at the optimal dose of this novel treatment for acute myeloid leukemia.

Top-line results from the study are anticipated in the fourth quarter of 2015.

BLRX closed Monday's trading at $2, up 4.71%.

CytoDyn Inc. (CYDY.OB) has submitted the full phase 3 protocol synopsis for PRO 140, its novel self-injectable antibody for the treatment of HIV, to the FDA, and the study is all set to start after 30 days.

In a recently completed phase 2b treatment substitution trial, 98% of all patients treated with PRO 140 successfully passed four weeks of monotherapy without virologic failure.

CYDY.OB closed Monday's trading at $0.86, up 7.50%.

CytRx Corp. (CYTR) rose more than 19% on Monday following encouraging interim analysis data from its two ongoing phase 1b Aldoxorubicin combination studies pairing Aldoxorubicin with either Gemcitabine or Ifosfamide.

According to the data, the combinations was well tolerated, and even at the lowest dose level of Aldoxorubicin, impressive tumor responses were observed so far in patients with bone cancer (osteosarcoma) and a variety of soft tissue sarcomas.

CYTR closed Monday's trading at $4.41, up 19.19%.

Isis Pharmaceuticals Inc. (ISIS) has licensed ISIS-FXIRx, its antisense investigational drug in clinical development for the prevention of thrombosis to Bayer HealthCare in a deal worth $155 million.

As part of the clinical development program, Bayer plans to evaluate the therapeutic profile of ISIS-FXIRx in patients for whom currently available anticoagulants may not be used, such as in patients with a high risk of bleeding due to multiple co-morbidities.

Isis is eligible to receive up to $155 million in near-term payments, including an immediate $100 million up-front payment and a $55 million payment upon advancement of the program following a phase II study in patients with compromised kidney function.

ISIS closed Monday's trading at $59.66, up 2.44%. In after hours, the stock was up 3.08% to $61.50.