Thu, Sep. 3, 9:12 AM
Thu, Sep. 3, 8:16 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.
Mon, Aug. 31, 4:08 PM
- PTC Therapeutics (PTCT -6.2%) initiated with Buy rating and $90 (135% upside) price target by Citi.
- Patterson Companies (PDCO -1.1%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $54 (18% upside) from $48.
- Acadia Pharmaceuticals (ACAD -4.1%) upgraded to Overweight from Neutral with a price target of $48 (30% upside) by Piper Jaffray.
- Boston Scientific (BSX -1.9%) upgraded to Buy from Neutral with a $20 (19% upside) price target by Goldman Sachs.
- CR Bard (BCR -1.8%) upgraded to Buy from Neutral with a $220 (14% upside) price target by Goldman Sachs.
- Sarepta Therapeutics (SRPT -2.7%) upgraded to Overweight from Neutral by Piper Jaffray. Price target raised to $48 (34% upside) from $28.
- Bristol-Myers Squibb (BMY -1.8%) upgraded to Neutral from Underweight by Piper Jaffray. Price target maintained at $61 (2% upside).
- MacroCure (MCUR -3.7%) downgraded to Neutral from Outperform by Credit Suisse. Price target lowered to $5 (63% upside) from $15.
Thu, Aug. 27, 9:14 AM
Fri, Aug. 21, 5:36 PM
Fri, Aug. 7, 3:30 PM
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Wed, Aug. 5, 5:35 PM
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Tue, Jun. 16, 12:14 PM
- Pooled data from 268 patients in two Phase 3 trials evaluating Acadia Pharmaceuticals' (ACAD +2.4%) Nuplazid (pimavanserin) for the treatment of Parkinson's disease (PD) psychosis show a substantial benefit versus placebo. The improvement in psychosis, measured by the SAPS-PD scale, is highly statistically significant (p<0.001). The data were presented at the 19th International Congress of Parkinson's Disease and Movements Disorders in San Diego, CA.
- Pimavanserin is a small molecule selective serotonin inverse agonist that targets receptors, called 5-HT2A, that play a key role in psychosis.
- PD affects as many as 6M people worldwide with about 40% (2.4M) experiencing psychosis. There are no approved treatments for the condition.
- The company plans to submit a New Drug Application (NDA) for Nuplazid for PD psychosis later this year.
Thu, May 7, 4:03 PM
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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.
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