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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
- Acadia Pharmaceuticals (ACAD +0.3%) Q2 results: Collaboration Revenues: $28K; Operating Expenses: $21.8M (+127.1%); Operating Loss: ($21.7M) (-135.9%); Net Loss: ($21.5M) (-136.3%); Loss Per Share: ($0.22) (-50.0%); Quick Assets: $354.5M (+90.8%).
- No guidance given.
Aug. 5, 2014, 4:49 PM
- ACADIA Pharma (NASDAQ:ACAD): Q2 EPS of -$0.22 misses by $0.03.
- Revenue of $0.03M (-93.3% Y/Y) misses by $0.23M.
Jul. 15, 2014, 9:12 AM
- Acadia Pharmaceuticals (NASDAQ:ACAD) hires Stephen Davis as EVP, CFO and Chief Business Officer reporting to CEO Uli Hacksell, Ph.D. Mr. Davis joins the company from Heron Therapeutics where he was EVP and COO.
May 6, 2014, 4:14 PM
- Acadia Pharmaceuticals (ACAD -5.1%) collaborative revenue: $30K (-92.8%); operating loss: ($18M) (-172.7%); net loss: ($17.8M) (-191.8%); cash, cash equiv & marketable securities: $369.3M (+98.8%).
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.
- CC at 5 ET
- ACAD -1.7% AH
Feb. 27, 2014, 4:04 PM
- ACADIA Pharmaceuticals Inc. (ACAD): Q4 EPS of -$0.13
- Revenue of $0.04M (-89.5% Y/Y) misses by $0.27M.
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."
Nov. 1, 2013, 8:32 AM
- Acadia Pharmaceuticals (ACAD) announces the publication of Phase 3 pimavanserin results in PDP.
- The data, published today in The Lancet, shows "pimavanserin met the primary endpoint ... by demonstrating highly significant improvement in psychosis compared to placebo on the 9-item SAPS-PD scale."
- "The mean change in SAPS-PD score represented a 37% improvement for pimavanserin versus 14% for placebo," the company notes. (PR)
- ACAD +6% premarket
Oct. 14, 2013, 2:51 PM
- Acadia Pharmaceuticals (ACAD +9.3%) is enjoying a strong session.
- Perhaps helping to tip sentiment is SA Contributor Brian Nichols, who says the company's antipsychotic drug pimavanserin has "the greatest sales potential since Lipitor" — good news, considering Lipitor is the best-selling drug in pharmaceutical history.
- Nichols goes on to predict peak global sales of $20.45B, and says his "five key points ... suggest that sales could be even greater."
- As for a target price, Nichols says three times sales for companies with assumed blockbusters (cited are Alexion and Pharmacyclics) isn't unreasonable, and just to be on the safe side, the author discounts peak sales by "a whopping 50%," then multiplies $10B times three to get a valuation of ~$30B.
- Ultimately, Nichols says "a target price over $300 is not unrealistic." This represents upside of around 1,295% from Friday's close.
Oct. 11, 2013, 9:26 AM
- It appears a large number of NPS Pharmaceuticals (NPSP) shares were sold Friday morning at $32 each.
- The company itself was not a part of the transaction. According to NPSP, "these were shares that were held by Takeda that they sold to Jefferies in a block trade and Jefferies has re-sold the shares through its sales distribution network."
- Thursday evening, Cramer recommended "ringing the register on pretty much any biotech that's smaller than $10B." Stocks mentioned: NPSP, ISIS, CLDX, ACAD, TSRO
Oct. 10, 2013, 12:45 PM
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