Kudrna's Stock Market Talk

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 May 4, 2012, the U.S. FDA is expected to rule on the approval of Alexza Pharmaceuticals’ (ALXA) Adasuve (Staccato loxapine) for the treatment of acute agitation in patients with schizophrenia and bipolar disorder. The decision has already been delayed by three months from the original (“PDUFA”) action date set by the FDA of February 4, 2012. I view the decision as make-or-break for Alexza, a company that has already significantly reduced its staff in an effort to limit operating burn ahead of the decision. (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…)

On March 26, 2012, Neurocrine Bio (NBIX) announced results from the company’s phase 2a program with NBI-98854, a VMAT2 inhibitor for the treatment of tardive dyskinesia (TD). We believe the results were overall a positive for the company, despite what management referred to as “inconsistent and incorrect application of the efficacy assessment protocol” at one of the eight sites used during the trial. When this site was removed (post-hoc), analysis of the primary and secondary endpoints showed encouraging results, we believe strong enough to warrant movement into a larger-scale phase 2b study. (more…)

Earlier in the week, Aastrom filed an S3 registering 4.526 million shares of Class A warrants that relate back to the companies January 2010 financing. These warrants are exercisable by the holders at $2.52 per share. (more…)

This morning, Pozen (POZN) announced positive results from the company’s two pivotal phase 3 clinical trials studying PA32540, a novel, coordinated-delivery tablet of immediate-release omeprazole (40mg) and delayed release aspirin (325mg). In total, both phase 3 trials enrolled a total of 1,049 subjects at risk for developing aspirin-associated ulcers. (more…)