ACRX Plunges On Zalviso News, CTIC Persists, HTBX On Fire, PIP Cuts Head Count

(RTTNews) - AcelRx Pharmaceuticals Inc. (ACRX) plunged nearly 37% on Monday after being asked by the FDA to conduct an additional clinical study for its investigational pain drug-device Zalviso.

Zalviso, which is a patient-activated, non-invasive analgesic system for the management of moderate-to-severe acute pain in adult patients in the hospital setting, was issued a complete response letter last July.

The FDA had then sought bench data demonstrating a reduction in the incidence of optical system errors which require premature drug cartridge change, changes to the Instructions for Use for the device, and additional data to support the shelf life of the product in order for Zalviso to be approved. Accordingly, the company has performed the bench testing and two Human Factors studies.

AcelRx said it plans to meet with the FDA to discuss and clarify the need and potential objectives of an additional clinical study for Zalviso.

ACRX closed Monday's trading at $5.51, down 36.96%.

ContraVir Pharmaceuticals Inc. (CTRV) is all set to initiate a pivotal phase 3 study of its lead drug candidate, FV-100, for the prevention of debilitating shingles-associated pain known as post-herpetic neuralgia in the second quarter 2015.

The phase 3 study will build upon prior clinical results for FV-100, including phase 1 trials as well as a large phase 2 clinical trial in shingles patients, which demonstrated excellent safety and tolerability for FV-100, noted the company.

Shares of ContraVir were uplisted to the NASDAQ Capital Market from the OTC marketplace as recently as February 27, 2015.

CTRV closed Monday's trading at $4.49, down 2.49%.

CTI BioPharma Corp. (CTIC) and Baxter International Inc. (BAX) announced positive top-line results from a phase 3 registration clinical trial of Pacritinib for the treatment of patients with primary or secondary myelofibrosis.

The trial, dubbed PERSIST-1, met its primary endpoint in the intent-to-treat population with statistically significant activity observed in patients irrespective of their initial platelet count, including patients with very low platelet counts at study entry, a condition known as severe or life-threatening thrombocytopenia, according to the companies.

CTI BioPharma and Baxter have an agreement in place to jointly commercialize Pacritinib in the U.S. while Baxter has exclusive commercialization rights for all indications outside the U.S.

CTIC closed Monday's trading at $2.82, up 6.42%.

EDAP TMS SA (EDAP) has decided to seek clearance of Ablatherm HIFU in the U.S. by way of a Direct De Novo 510(k) application as opposed to the Pre-Market Approval application amendment, which it had been pursuing. The decision follows a recent meeting, which the company had with the FDA.

The company markets Ablatherm for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer outside the U.S.

EDAP closed Monday's trading at $3.58, down 8.91%.

Heat Biologics Inc.'s (HTBX) product candidate HS-410 for the treatment of non-muscle invasive bladder cancer has been granted Fast Track designation by the FDA.

HS-410 is currently being evaluated in a randomized phase 2 trial in combination with Bacillus Calmette-Guérin (BCG) and as monotherapy for the treatment of non-muscle invasive bladder cancer.

HTBX touched a new high of $10.90 on Monday before closing the day's trading 12.93% higher at $8.30.

KYTHERA Biopharmaceuticals Inc.'s (KYTH) investigational drug ATX-101 for double chin has been unanimously recommended for approval by the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee. The redulatory agency's final decision is set for May 13, 2015.

In other news, the company announced yesterday that it has commenced an underwritten public offering of $125 million of shares of its common stock.

KYTH closed Monday's trading at $51.17, down 3.69%.

As part of a realignment plan, biodefense company PharmAthene Inc. (PIP) plans to reduce its staffing levels by approximately two thirds.

PharmAthene also noted that its President and CEO Eric Richman will no longer serve as an Officer of the company after March 11, 2015, but will remain a member of the Board of Directors.

PIP closed Monday's trading 3.41% down at $1.70.

Spectrum Pharmaceuticals' (SPPI) New Drug Application for Captisol-Enabled Melphalan has been accepted for review by the FDA, and a decision is scheduled for October 23, 2015.

The company is seeking FDA approval for Captisol-Enabled Melphalan for use as a high-dose conditioning treatment prior to autologous hematopoietic (progenitor) stem cell transplantation (AHCT) in patients with multiple myeloma (MM), an orphan drug designation.

SPPI closed Monday's trading at $6.10, down 2.56%.