Chelsea Notes "Abnormal Trading Activity" Surrounding PDUFA Action

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Shares of
Chelsea Therapeutics International Ltd.CHTP
have been volatile throughout Friday, halting three times on a circuit breaker before 11:35 a.m. EST. Investors are positioning themselves ahead of a very important PDUFA date for Northera (droxipoda), expected out sometime Friday afternoon. The PDUFA action for a candidate like Northera is extremely important as the FDA could offer approval. The PDUFA date is important as the action implies if the pharma company with make-it with the pending drug for the short-term. According to fda.gov, the PDUFA allows the FDA to "collect fees from companies that produce certain human drug and biological products."
FDA Advisory Panel
In a press release on January 14, Chelsea announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 16-1 to recommend the approval of Northera. Even though the FDA is not bound by this recommendation, as noted in the release, the Food and Drug Administration will "take it into consideration".
Adam F. Chimes in on Odds of Approval
On Wednesday, Adam Feuerstein, Wall Street's definitive biotech source, reported his prediction on the odds that the FDA will approve the experimental drug Northera. Feuerstein estimates that Northera has a 70% chance of passing on Friday. The source noted his concern on the "small chance FDA delays the Northera decision given the short amount of time between Friday's approval decision date and last month's positive advisory panel. A short delay for administrative reasons -- meaning no requirements for additional clinical data -- won't matter much and may actually benefit Chelsea since the orphan indication clock doesn't start ticking until approval."
Share Action
Shares took a slow climb to approximately 11% since this morning before plunging to around 14% prior to the first halt on the circuit breaker. Trading was halted again almost immediately after the resume with shares dipping to approximately 19%. Shares hit a low of $3.65, down 35.34%, before rebounding. Chelsea Therapeutics halted again around 11:29 a.m. EST, down only 11%.
8-K Filing
Chelsea Therapeutics release an 8-K filing on its response to the "Abnormal Trading Activity". The company reported that no decision regarding Northera has been received as of 11:45 a.m. EST.
Northera Drug History
Chelsea's Northera is an experimental drug for the treatment of neurogenic orthostatic hypotension (NOH), a disease characterized by low blood pressure. Although the drug has been received favorably by the FDA, the reviewer has concerns surrounding Northera's clinical trials. Chelsea Therapeutics and its investors also remain concerned over the possible FDA label that would limit the drug's use to 1-2 weeks. Interim Chief Executive Officer of Chelsea Therapeutics Joseph G. Oliveto previously commented, "Chelsea is committed to improving the lives of patients with nOH, a debilitating disorder which often severely limits a person's ability to perform routine daily activities. We are appreciative of the FDA bringing our Northera NDA before the Cardiovascular and Renal Drugs Advisory Committee, and for the Committee's thoughtful discussion of the application."
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Posted In: NewsFDAMediaAdam FeuersteinCRDAC
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