ACADIA Pharmaceuticals Inc.NASDAQ
Wed, Aug. 24, 9:17 AM
Thu, Aug. 4, 7:24 PM
- Acadia Pharmaceuticals (ACAD -1.9%) has fallen another 3.3% after hours following a Q2 report with a bigger-than-expected loss as it launched a new drug aimed at Parkinson's disease psychosis.
- It's early days for Nuplazid, approved by the FDA at the end of April as the first to treat hallucinations and delusions associated with PD psychosis. The drug launched in the U.S. in June.
- The company posted a net loss of $71.3M (includes $13.9M of noncash stock-based compensation expense). R&D costs rose to $20.5M; selling, general and administrative costs unsurprisingly increased to $50.8M from a year-ago $21.1M.
- Net product sales came to $97,000 in June, during which doctors could prescribe a 30-day trial (no revenue recognized) for patients.
- Cash, equivalents and investment securities were $412.6M at quarter's end.
- Press Release
Thu, Aug. 4, 4:09 PM
Wed, Aug. 3, 5:35 PM
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Thu, Jul. 21, 11:01 AM
Wed, Jul. 20, 11:00 AM
Fri, Jun. 24, 7:01 AM
- Cerner (NASDAQ:CERN) upgraded to Buy from Neutral with $65 (14% upside) price target by SunTrust Robinson.
- Catalent (NYSE:CTLT) upgraded to Outperform from Market Perform with a $26 (midpoint)(10% upside) price target by Wells Fargo. Upgraded to Buy from Neutral by Bank of America.
- Centene (NYSE:CNC) upgraded to Overweight from Equal Weight by Barclays. Price target raised to $82 (17% upside) from $76.
- Valeant Pharmaceuticals (NYSE:VRX) downgraded to Neutral from Overweight by JPMorgan. Price target lowered to $35 (57% upside) from $50.
- AveXis (NASDAQ:AVXS) downgraded to Hold from Buy by Jefferies. Price target lowered to $39 (3% downside risk) from $42.
- Surgical Care Affiliates (NASDAQ:SCAI) downgraded to Neutral from Buy by JPMorgan. Price target maintained at $48 (3% upside).
- ACADIA Pharmaceuticals (NASDAQ:ACAD) downgraded to Neutral from Buy by Bank of America.
- Express Scripts Holdings (NASDAQ:ESRX) downgraded to Underweight from Equal Weight by Morgan Stanley. Price target raised to $70 (9% downside risk) from $67.
- Perrigo (NYSE:PRGO) downgraded to Hold from Buy by Argus Research.
- CVS Health (NYSE:CVS) downgraded to Equal Weight from Overweight by Morgan Stanley. Price target lowered to $104 (11% upside) from $111.
Fri, May 6, 9:11 AM
Thu, May 5, 4:31 PM
- ACADIA Pharma (NASDAQ:ACAD): Q1 EPS of -$0.45 misses by $0.03.
- Revenue of $4K (flat Y/Y) misses by $0.146M.
Wed, May 4, 5:35 PM
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Mon, May 2, 9:13 AM
Sat, Apr. 30, 10:00 PM
- The FDA approves ACADIA Pharmaceuticals' (NASDAQ:ACAD) Breakthrough Therapy-tagged NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson's disease (PD) psychosis, the first medication OK'd by the agency for the indication.
- NUPLAZID is a non-dopaminergic antipsychotic that acts as a selective serotonin inverse agonist that preferentially targets 5-HT2A receptors while avoiding activity at common targets like dopamine.
- About 40% of the 1M Americans with PD have psychosis, characterized by hallucinations and delusions, diminished quality of life and significant caregiver burden.
- The approval is a big win for the company considering its New Drug Application (NDA) was supported by only one successful Phase 3 study (ACP-103-020). The data package included results from three other trials, but none met the primary endpoint. Normally, the FDA requires two studies to prove efficacy.
- Management will host a conference call on Monday, May 2 at 8:30 am ET to discuss the approval. The U.S. market launch will commence in June.
- Read now Acadia: Approval Likely For Parkinson's Disease Psychosis Drug
- Update: Shares are up 7% premarket on increased volume.
Fri, Apr. 1, 5:39 PM
Wed, Mar. 30, 9:21 AM
Tue, Mar. 29, 8:03 AM
- Nasdaq halted trading in ACADIA Pharmaceuticals (NASDAQ:ACAD) at 7:00 am ET this morning pending news.
- The Ad Comm review of NUPLAZID (pimavanserin) is today.
- Previously: Ad Comm review of ACADIA Pharma's NUPLAZID tomorrow; shares up 15% premarket on optimism for positive vote (March 28)
- Update: Ad Comm votes 12 - 2 in favor of approval.
Mon, Mar. 28, 12:47 PM