HRTX Buys Time, ORMP On Watch, KOOL Loses Heat, SUPN On A High, PFE Trials Flop

(RTTNews) - Regenerative medicine company Aastrom Biosciences Inc. (ASTM) is strengthening its balance sheet by having agreed to sell up to $15 million in shares of common stock to Lincoln Park Capital Fund, LLC, an institutional investor, over a thirty-month period subject to certain limitations and conditions.

The company's investigational product Ixmyelocel-T, a unique multicellular therapy, is under a phase 2b study for the treatment of advanced heart failure due to ischemic dilated cardiomyopathy. The study results are expected in Q2 2015.

ASTM closed Monday's trading at $3.42, down 7.82%.

Heron Therapeutics Inc. (HRTX) dropped 8 percent on Monday to close at $11.50 on news that the resubmission of its Sustol NDA to the U.S. Food and Drug Administration will be delayed by a quarter. The company had previously planned to resubmit the NDA by the end of the first quarter of 2014.

Sustol is being developed for chemotherapy-induced nausea and vomiting.

Oramed Pharmaceuticals Inc. (ORMP) surged more than 21 percent on Monday to close at $25.92, following the announcement that it will be announcing phase IIa clinical trial results of ORMD-0801 oral insulin capsule on January 30, 2014 at an investor conference taking place at the Tel Aviv Stock Exchange in Tel Aviv, Israel.

The phase IIa trial of ORMD-0801 was conducted in the U.S. under the auspices of the FDA and was designed to show the drug's overall safety profile for the treatment of type 2 diabetes.

Pfizer Inc.'s (PFE) two phase III trials of Dacomitinib in patients with refractory advanced non-small cell lung cancer have failed to meet their primary endpoint.

One phase III trial, dubbed ARCHER 1009 trial, which included patients previously treated with chemotherapy (second/third line), did not meet its objective of demonstrating statistically significant improvement in progression-free survival when compared with lung cancer drug Tarceva.

The second phase III trial known as NCIC CTG BR.26 trial, which included patients with advanced non-small cell lung cancer after standard therapy with both chemotherapy and an EGFR tyrosine kinase inhibitor did not meet its objective of prolonging overall survival compared to placebo.

A third phase III trial, dubbed ARCHER 1050, evaluating dacomitinib versus gefitinib in treatment-naïve (without prior treatment) patients with EGFR-mutant advanced NSCLC is underway, and results from this trial are expected in 2015.

PFE closed Monday's trading at $29.66, down 1.43%.

Supernus Pharmaceuticals Inc. (SUPN) has been issued a European patent and Canadian patent for SPN-812, its novel non-stimulant product candidate for the treatment of Attention Deficit Hyperactivity Disorder.

The patents provide protection for SPN-812 with expiration that is no earlier than 2029, according to the company.

SPN-812 successfully completed phase IIa trial in adults with ADHD in 2011. The company has completed the development of several extended release formulations of SPN-812 that will be tested in a pharmacokinetic study in the first half of 2014 to select the final formulation for use in phase IIb trial.

SUPN touched a new 52-week high of $10.05 on Monday before closing at $9.44.

ThermoGenesis Corp. (KOOL) fell 13.12 percent to $2.45 on Monday after it agreed to sell roughly 3.33 million shares of common stock at $2.00 each to institutional investors.

The purchasers will also receive warrants to purchase up to approximately 1.66 million shares of common stock at an exercise price of $2.81 per share. The warrants are non-exercisable for six months after the closing of the financing and have a term of 5 years.

ThermoGenesis will receive gross proceeds of about $6.67 million resulting from the private placement financing, which is expected to close on or about January 30, 2014.