Fri, Nov. 6, 5:38 PM
Mon, Nov. 2, 9:00 AM
- The FDA accepts under Priority Review ACADIA Pharmaceuticals' (NASDAQ:ACAD) New Drug Application (NDA) for Breakthrough Therapy-tagged NUPLAZID (pimavanserin) for the treatment of Parkinson's disease (PD) psychosis. The PDUFA date is Sunday, May 1, so the agency's decision should happen no later than Friday, April 29.
- NUPLAZID is a non-dopaminergic antipsychotic that acts as a selective serotonin inverse agonist that preferentially targets 5-HT2A receptors. About 40% of the 1M Americans with PD have psychosis, characterized by hallucinations and delusions, diminished quality of life and significant caregiver burden.
- Breakthrough Therapy status allows for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the NDA. Priority Review shortens the review clock to six months from the usual ten.
- Shares are up 8% premarket on increased volume.
Thu, Sep. 3, 9:12 AM
Thu, Sep. 3, 8:12 AM
- Acadia Pharmaceuticals (NASDAQ:ACAD) is up 10% premarket on modest volume in response to the company's filing of a New Drug Application (NDA) seeking approval for Breakthrough Therapy-tagged NUPLAZID (pimavanserin) for the treatment of psychosis associated with Parkinson's disease. The company also requested Priority Review status which will reduce the review clock to six months from ten, if granted.
- NUPLAZID is a selective serotonin inverse agonist that targets 5-HT2A receptors that play a key role in psychosis.
Thu, Aug. 27, 9:14 AM
Fri, Aug. 21, 5:36 PM
Thu, Mar. 12, 12:45 PM
Thu, Mar. 12, 9:14 AM
Wed, Mar. 11, 5:36 PM
Wed, Mar. 11, 4:26 PM
- Acadia Pharmaceuticals (NASDAQ:ACAD) plunges 22% after hours on robust volume in response to the company's announcement that it is postponing its Nuplazid (pimavanserin) New Drug Application (NDA) from Q1 until H2. The delay is due to the additional time required to complete the preparations of systems to support commercial manufacturing and supply.
- Interim CEO Steve Davis says, "We have concluded that additional time is needed to complete the readiness of our commercial manufacturing systems. While we are very disappointed with the change in timing, we believe that this is the prudent course of action to take. We are working expeditiously to ensure that our systems are robust and ready for FDA review and commercial launch. Importantly, we remain confident in the safety and efficacy package supporting the NDA of Nuplazid, which received Breakthrough Therapy designation from the FDA last year."
- Nuplazid, if approved, is indicated for the treatment of Parkinson's disease-associated psychosis.
Tue, Mar. 10, 3:51 PM
- Traders spread their love beyond the rumored acquisition target-stoked up move of Acadia Pharmaceuticals (ACAD +17.7%) to Geron (GERN +12.3%). Shares are up on a whopping 24M shares. Speculators are betting that Geron will be taken out, possibly by Johnson & Johnson (JNJ -0.8%), after the latter was outbid by AbbVie (ABBV +0.9%) for Pharmacyclics (PCYC).
- Previously: Geron gets boost from AbbVie-Pharmacyclics deal (March 5)
- Previously: Acadia Pharma now +17.7% as it cancels out of another conference (March 10)
Tue, Mar. 10, 2:10 PM| Tue, Mar. 10, 2:10 PM | 4 Comments
Tue, Mar. 10, 1:13 PM
- H.C. Wainwright maintains Buy rating on Acadia Pharmaceuticals (NASDAQ:ACAD) with $50 price target. Implied upside 19%.
- "Based on the clear beneficial safety profile for Nuplazid for PD+P over available atypical antipsychotics, we reiterate our bullish view regarding the PD+P indication and that the PD market alone (given the significant unmet need) is sufficient to support our $50 PT. We continue to see AD+P as a high risk, free call option potentially providing additional upside for investors," firm says.
- SA author Investing Healthcare calls ACAD "the biggest goldmine for acquirers in 2015." Potential buyers include AstraZeneca (NYSE:AZN), AbbVie (NYSE:ABBV), and Otsuka Pharmaceuticals.
Oct. 8, 2014, 5:38 PM
Sep. 2, 2014, 9:11 AM
Feb. 27, 2014, 4:27 PM
- The planned NDA submission for pimavanserin remains on track for near the end of the year, says the company. "In parallel, we are conducting pre-commercial activities to prepare for the planned future launch of pimavanserin and we are planning additional studies in our life cycle management program."
- Cash (and equivalents) on hand of $185.8M vs. $108M thanks to May's equity offering. Cash use will be up this year as company preps for launch, but company expects cash levels to be above $120M at year's end.
- Press release, Q4 results
- CC at 5 ET
- ACAD -1.7% AH
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