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
Aug. 5, 2014, 6:33 PM| 7 Comments
Aug. 5, 2014, 4:49 PM
Jul. 15, 2014, 9:12 AM
May. 6, 2014, 4:14 PM
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
Feb. 27, 2014, 4:04 PM
Feb. 27, 2014, 12:10 AM
- ACAD, AHT, AIRM, AL, ALIM, AMRN, APEI, ARNA, ATLS, AVD, BAGL, BCEI, BID, BIO, CEMP, CHUY, CLNE, CRM, DCO, DECK, ELGX, EPR, EVC, GPS, HALO, HTGC, KBR, KOG, LINE, MDVN, MELI, MENT, MNST, MTZ, NGD, NMBL, NOG, OLED, OVTI, PKT, PODD, REGI, ROST, SD, SFM, SLXP, SPLK, SPNC, SQNM, SWN, TESO, TUMI, UHS, WES, WG, WTR, XTEX, YOKU
Jan. 7, 2014, 12:39 PM
- Shares of Acadia Pharmaceuticals (ACAD -3.3%) are flagging and are now sitting at their lows of the day.
- Earlier, SA contributor EnhydrisPECorp named ACAD a "healthcare stock to avoid" in 2014, saying the shares may "bleed all year long until the [pimavanserin] NDA filing in Q4."
- Here's the simple rationale for the author's downbeat outlook: "Firstly, the company now has a market cap over $2B. Secondly, ACAD has no revenues. Thirdly, ACAD has mounting clinical trial costs."
- Notably, EnhydrisPECorp recommended investors short Sarepta Therapeutics on October 30 — since then, the stock is down 54%.
Nov. 25, 2013, 5:42 PM
Nov. 14, 2013, 9:26 AM
- Acadia Pharmaceuticals (ACAD) initiates a Phase 2 feasibility trial of pimavanserin in Alzheimer's disease psychosis (for which there are no treatments approved in the U.S.).
- The company says Phase 3 results in Parkinson's disease psychosis (that's -020) suggest the drug "may offer the potential for an important new therapeutic advance" in ADP. (PR)
- In a recent article, SA contributor Jason Napodano said "several pieces of evidence point to a successful outcome" in ADP. He calls the drug "the next blockbuster for psychosis."
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