24
Jun
2008
An unfortunate day indeed as Replidyne (NASDAQ: RDYN) has terminated their licensing deal with Asubio Pharma for its lead drug candidate Faropenem and subsequently is expecting a charge of approximately $4.1M. Recall, Replidyne discontinued enrollment in a late-stage study testing its faropenem medoxomil oral antibiotic as a treatment for patients with acute chronic bronchitis due [...]
19
May
2008
Replidyne (NASDAQ: RDYN) has been served with a Demand for Arbitration from MEDA Manufacturing alleging that the Company breached its obligations under a 2005 supply agreement. In April 2007, Replidyne provided notice to MEDA of its termination of the Supply Agreement in accordance with certain termination provisions, and believes that it did not have any [...]
09
May
2008
Yesterday Replidyne (NASDAQ: RDYN) held their annual shareholder meeting and 1Q08 conference call. With an anticipated burn rate of approximately $10M per quarter Replidyne’s current cash position just north of $78M positions operations to continue well into 2009. Considering the new strategic initiatives including restructuring, cash conservation and the difficult decision to terminate enrollment of [...]
23
Apr
2008
It is never a good feeling to wake up and hear that a pivotal late-stage clinical trial has terminated enrollment. However, there is a silver lining in such a difficult decision cloud…that is the sophisticated management at Replidyne (NASDAQ: RDYN) are savvy enough to examine the risk-reward profile for the continued burn of their remaining [...]
03
Apr
2008
It is no secret that Replidyne (NASDAQ: RDYN) is highly focused upon architecting and executing a new strategic alliance, to replace the Forest Labs (NYSE: FRX) deal that unwound, in order to shepherd the commercialization efforts of Faropenem. A form 8K was filed with the SEC by the Louisville headquarters announcing a retention bonus has [...]
28
Feb
2008
IMHO I remain incredibly optimistic about Replidyne’s (NASDAQ: RDYN), a leader in next-generation anti-infective products, direction (note: this in no why should be interpreted as investment advice). After being dealt a bum deal by the FDA re: a change in protocol for antibiotic trials, management at Replidyne has retrenched. With $90.3M in cash on the [...]
29
Jan
2008
***1/30 POST UPDATE*** Here is a link to the letter from the FDA, click (here) to read. There is not really too much to go on here, but …an FDA warning letter was recently issued relative to the antibiotic faropenem and the company filed an 8K with the SEC yesterday. “On January 22, 2008, Replidyne, [...]
09
Oct
2007
DISCLAIMER: This analysis in no way should be considered investment advice! In an effort to keep the modeling skills a bit more than dull combined with a deep-rooted curiosity about the development or lack-there-of by big pharma of new anti-infectives I remain fascinated with the progression of Replidyne’s (NASDAQ: RDYN) portfolio, particularly the antibiotic Faropenem [...]
25
Sep
2007
Replidyne, Inc. (NASDAQ: RDYN) was featured in the 24 September issue of BioCentury, The Bernstein Report on BioBusiness! The article features some of the companies earlier stage pipeline, particularly REP3123 a MetRS inhibitor in preclinical development that may be more effective for severe Clostridium difficile-associated diarrhea (CDAD) than ViroPharma (NASDAQ: VPHM) and Eli Lilly’s (NYSE: [...]
23
Oct
2006
Following Replidyne’s (NASDAQ: RDYN) receipt of a non-approvable letter from the FDA for Faropenem® there are numerous reasons why there is a sliver lining in this non-approvable letter cloud. First, and of paramount importance, the FDA had no SAFETY or Chemistry Manufacturing and Control issues. Second, the IP which covers composition of matter and methods [...]
08
Sep
2006
Merrill Lynch believes a decision should be reached by the FDA regarding Replidyne’s (NASDAQ: RDYN)Faropenem® approval for acute bacterial sinusitis by or before 20 October. One may be inclined to pay close attention to next Tuesday or Wednesday’s FDA panel review of rival Oscient Pharmaceutical (NASDAQ: OSCI) for Factive® also for the treatment of acute [...]
28
Jun
2006
Happy to see that Replidyne, Inc. (Nasdaq: RDYN) began trading this morning at 11:00am! Next stop…approval for Orapem™!
23
Jun
2006
Replidyne, Inc. (Nasdaq: proposed RDYN) intends to offer up to Wall St. 5 million shares priced between $14 and $16 in next weeks highly anticipated IPO. What makes me exceedingly bullish on this offering is that unlike many biotech IPO’s that transpire in the midst of Phase II or III and sometimes even during Phase [...]
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