Milestone in Vascular Regeneration Program, Aastrom Biosciences (NASDAQ:ASTM)
March 24th, 2010
No comments
The final patient has been treated ongoing multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI.
This patient received intramuscular injections of either Aastrom’s tissue repair cells (TRCs) or electrolyte solution (placebo) for the treatment of critical limb ischemia (CLI), the end-stage of peripheral arterial disease. TRC-based cellular therapies are produced from a small sample of bone marrow taken from a patient. ASTM’s TRC technology greatly expands the cell populations for direct delivery to the damaged tissues of the same patient.
Categories: Independent Equity Research
ReNeuron Group (RENE.L) announced the placing of 94.4 M new ordinary shares with existing and new institutional and qualifying individual shareholders on 2/22/10. This placement was comprised 2 closings and will trade on AIM.
Shares of Amylin Pharma (NASDAQ: AMLN) are rising by about 10% during early trading today on the issuance of a Complete Response Letter (CRL) from FDA for its once-weekly formulation of its diabetes drug Byetta (exenatide), which would be marketed as Bydureon. The issues raised in the CRL appear to be minor and related to labeling issues with expected resubmission in the next few weeks and likely Class I (60-day) review designation by the FDA upon resubmission by AMLN. Eli Lilly (NYSE: LLY) and Alkermes (NASDAQ: ALKS) also have stakes in the drug, with ALKS also trading up 10% and LLY up slightly during early trading.
Reported a lower FY09 net loss of $23.216 M or $0.65 per share with higher revenues versus a net loss of $30.036 M, or $1.12 per share for FY08.
Reported a smaller FY09 net loss of $27.02 M or $0.25 per share, an increase in revenues but, increased operational losses; versus a net loss of $29.08 M, or $0.35 per share for 2008.
