Kudrna's Stock Market Talk

On June 21, 2012, Depomed (DEPO) announced the acquisition of the product Zipsor (diclofenac potassium) Liquid Filled Capsules from privately-held Xanodyne Pharmaceuticals, Inc. Zipsor is a non-steroidal anti-inflammatory drug (NSAID) indicated for relief of mild to moderate acute pain in adults. The product uses the proprietary ProSorb delivery technology (developed by AAIPharma Services Corp) to deliver a finely dispersed, rapidly absorbed formulation of diclofenac.

Zipsor is the lowest prescription-strength diclofenac available. The ProSorb technology allows for rapid delivery and dispersion of the medicine. The low-dose offers minimal systemic drug exposure. Depomed believes these advantages will help them drive Zipsor sales in the coming years. (more…)

On June 5, 2012, Abbott Labs (NYSE:ABT) and Neurocrine Biosciences (NASDAQ:NBIX) announced that they had initiated a pivotal phase 3 clinical study designed to evaluate the safety and efficacy of elagolix in female patients with endometriosis. Abbott designed the protocol of the trial after over a year of back-and-forth discussion with the U.S. FDA, but chose not to pursue a formal SPA to avoid further delay in the start of the program. (more…)

On April 17, 2012, Depomed (DEPO) announced it had completed a Type B “pre-NDA” meeting with the U.S. FDA regarding the results of the three phase 3 clinical trials for Serada (extended-release gabapentin tablets). Following the meeting, management believes the data from the BREEZE-1, -2, and -3 trials “warrants submission of an NDA for the FDA’s review and consideration” for the treatment of menopausal hot flashes. (more…)

This morning, InVivo Therapeutics (NVIV) announced significant news relating to the advancement of the company’s biopolymer scaffolding device to treat acute spinal cord injury. Management recently met with the U.S. FDA to discuss the Investigational Device Expemption (IDE) and the planned human clinical study. Talks centered around the inclusion / exclusion criteria, along with defining the starting and stopping points for the trial. This is a first of its kind program, and one that we’ve written about previously as being potentially revolutionary for the treatment of acute spinal cord injury. (more…)

We recommend investors keep an eye on Spherix, Inc. (SPEX). The stock has a history of quick rallies on news, followed by quick sell-offs on subsequent dilutive financings. The company has several catalysts coming up over the next few quarters that could provide meaningful opportunities for investors. (more…)

On April 10, 2012, Titan Pharmaceuticals (TTNP) announced it has entered into a definiative agreement to issue 6.517 million shares of common stock to institutional investors at $0.85 per share. The registered direct offering will provide gross proceeds of approximately $5.5 million in cash to Titan. Titan plans to use the proceeds to fund the preparation of a NDA for Probuphine, expected in October 2012, along with working capital and general corporate purposes. (more…)

We’ve got a new research report out today reiterating our ‘Neutral‘ position on DARA BioSciences, Inc. (DARA). In the report we highlight many of the recent events at the company over the past five months. (more…)

On March 26, 2012, Dr. Hsiao D. Lieu, MD, FACC, Nile Therapeutics’ (NLTX) Vice President of Clinical Research, presented the results from the company’s phase 1 safety and pharmacokinetic / pharmacodynamic (PK/PD) clinical trial with cenderitide at the 61th annual Scientific Session of the American College of Cardiology (ACC) meeting held in Chicago, IL. The poster presentation (board #628) was titled, “Initial Experience with Subcutaneous Infusion of Cenderitide in Patients with Chronic Heart Failure.” (more…)