UPDATE: Wedbush Reiterates Outperform Rating, Raises PT on Chelsea Therapeutics International on Successful Appeal
In a report published Wednesday, Wedbush reiterated its Outperform rating on Chelsea Therapeutics International (NASDAQ: CHTP), and raised its price target from $5.00 to $7.00.
Wedbush noted, “Chelsea's apparently successful appeal to the Office of New Drugs may reduce regulatory risk for Northera. Recall that Chelsea is developing Northera, a pro-drug of norepinephrine, as a treatment for neurogenic orthostatic hypotension (NOH)—an acute drop in blood pressure which can result in dizziness and injuries due to falls. At the end of March 2012, Chelsea received a complete response letter (CRL) for Northera instead of approval. The focus of a new reviewer in the Division of Cardiovascular and Renal Products (DCRP) changed from the OHQ as a primary endpoint to the mixed results for dizziness and durability—also concluding that the then ongoing ‘306b Phase 3 trial was unsuitable as a basis for resubmitting the NDA. Chelsea subsequently successfully appealed to the bosses of DCRP in CDER's Office of New Drugs and Northera now has a shot at approval–potentially without conducting another Phase 3 trial prior. The FDA suggested that Chelsea should resubmit the NDA and include the ‘306b results, which they plan to do in late Q2 under a Class 2 review (6 months), which could provide a PDUFA deadline for a second DCRP approval decision around year-end 2013.”
Chelsea Therapeutics International closed on Tuesday at $1.47.
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