Days after the FDA reiterated its demand for a new trial of AcelRx's pain drug Zalviso before it can reconsider a marketing application, the small biotech says it has garnered positive data from its late-stage study of another pain remedy in the pipeline.
The battering that AcelRx has been subjected to on Wall Street won't stop. The biotech announced that the FDA won't even sit down to discuss regulators' demand for a new clinical trial to assess the efficacy of its pain drug/device Zalviso. And increasingly skeptical investors weighed in on the biotech's most recent setback by pummeling shares once again.
When the FDA rejected AcelRx's drug/device Zalviso for pain last summer, the biotech said no new trials were required--suggesting it could be back in front of regulators quickly--and investors cut the value of shares by more than 30%. This morning the biotech said a new study is needed after all, and investors responded by sending shares down by more than 40%.
On the heels of FDA's rejection of the AcelRx New Drug Application for sublingually delivered postoperative pain killer Zalviso, CEO Richard King expounded on the "optical system errors" of the opioid drug's handheld, preprogrammed delivery device during a July 28 conference call with investors.
Shares of AcelRx took a painful 30% plunge on Monday morning as investors got a chance to respond to the biotech's announcement late Friday night that the FDA had rejected its application for Zalviso, its sufentanil sublingual microtablet drug/device system for fighting pain.
In the biotech and pharma industries, drug delivery is a crucial aspect of research and development. Finding new ways to deliver old drugs, ways to make a new drug more efficient or ways that make a...
The Redwood City, CA-based biotech is pocketing $30 million upfront from Germany's Gr ü nenthal, which will also pay up to $220 million more in milestones for the treatment, nabbing European and Australian marketing rights.
Following a well-defined trail of venture groups into late-stage investing, San Francisco-based Foresite Capital Management says it has wrapped a $100 million fund that will be heavily focused on the most disruptive and most promising late-stage technology it can find in biotech, genomics and diagnostics, among other healthcare fields.
AcelRx Pharmaceuticals shares got a big boost this morning after the biotech announced that its post-operative pain therapy--the Sufentanil NanoTab PCA (patient-controlled analgesia) System--was not only not inferior to the standard IV morphine but also beat it on a key measurement score while gaining kudos from nurses and patients.
AcelRx Pharmaceuticals has secured a $20 million loan from Hercules Technology Growth Capital. Earlier this year, the developer attempted to raise $86 million in its IPO, but, like many biotech