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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.
Wed, Mar. 11, 4:10 PM
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| 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.
Thu, Feb. 26, 4:39 PM
Nov. 10, 2014, 4:02 PM
Oct. 20, 2014, 8:27 AM
- In two Phase 2a clinical trials, privately-held Genervon Biopharmaceuticals' drug candidate for Amyotrophic Lateral Sclerosis (ALS), GM6 (known as GM604 in the ALS trial and GM608 in a Parkinson's disease study), showed encouraging disease-modifying results albeit in a small number of patients.
- In the ALS study, GM604 significantly reduced the decline in ALSFRS-R versus the historical control (p=0.0047). Seven of eight patients has their ALS disease progression slowed or stopped at week 12 after six doses of GM604. Five of seven treated patients had their forced air capacity (FVC) disease progression slowed or reversed at week 12 compared to historical placebo (-11.5% compared to -4.7% after treatment).
- In the Parkinson's study, the difference in the treated patients' UPDRS scores versus historical placebo at week 12 were statistically significant (p=0.0085). Changes in secondary clinical outcomes measures at week 2 were statistically significant at the one-tailed 10% level for four of eight patients.
- Genervon has submitted these results to the FDA for guidance on how to make GM6 available for ALS and PD patients. GM604 for ALS has been designated Fast Track and an Orphan Drug by the FDA.
- ALS-related tickers:(NYSEMKT:CUR) (NASDAQ:BCLI) (NASDAQ:MNOV) (NASDAQ:BIIB) (NASDAQ:CYTK)
- PD-related tickers: (NASDAQ:ACOR) (Pending:CVTS) (NASDAQ:ACAD) (OTCQX:CYNAF) (NASDAQ:IPXL) (OTCQB:TTNP) (OTCQB:SGTH) (NYSE:TEVA) (NASDAQ:ADMS) (NASDAQ:PRAN) (NASDAQ:CHTP) (NASDAQ:PRTA) (NASDAQ:FOLD) (NASDAQ:AVNR) (NYSE:BSX) (NYSE:MRK)
Oct. 8, 2014, 5:38 PM
Sep. 2, 2014, 9:18 AM
- The FDA designates Acadia Pharmaceuticals' (NASDAQ:ACAD) Nuplazid (pimavanserin) a Breakthrough Therapy for the treatment of Parkinson's disease psychosis. If approved, the serotonin inverse agonist will represent a distinctly different pharmacological approach to treating the condition.
- Parkinson's disease (PD) psychosis is the leading cause of nursing home placement for PD patients. There is no FDA-approved therapy currently available.
- BTD-labelled product candidates get an expedited FDA review.
Sep. 2, 2014, 9:11 AM
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