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.
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.
Oct. 8, 2014, 5:38 PM
Sep. 2, 2014, 9:11 AM
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
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. 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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