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ACAD

Acadia

$13.90

-1.33 (-8.73%)

17:19
08/06/18
08/06
17:19
08/06/18
17:19

Acadia announces exclusive license agreement with Neuran on Trofinetide

ACADIA Pharmaceuticals and Neuren Pharmaceuticals announced that they have entered into an exclusive North American License Agreement for the development and commercialization of trofinetide for Rett syndrome and other indications. Neuren retains rights to develop and commercialize trofinetide for all indications outside of North America. ACADIA plans to initiate a Phase 3 randomized, double-blind placebo-controlled study evaluating trofinetide in the second half of 2019 following completion of additional manufacturing activities. This study will evaluate trofinetide and placebo in approximately 180 girls with Rett syndrome and will measure the Rett Syndrome Behavior Questionnaire, a caregiver assessment, and the Clinical Global Impression of Improvement, a physician assessment, as co-primary efficacy endpoints. Trofinetide is a novel synthetic analog of the amino-terminal tripeptide of IGF-1 designed to treat the core symptoms of Rett syndrome by reducing neuroinflammation and supporting synaptic function. In the central nervous system, IGF-1 is produced by both of the major types of brain cells - neurons and glia. IGF-1 in the brain is critical for both normal development and for response to injury and disease. Trofinetide has been granted U.S. Food and Drug Administration Fast Track Status and Orphan Drug Designation in the U.S. and Europe. Under the terms of the License Agreement, Neuren is eligible to receive US $10 million upfront plus potential milestone payments of up to $455M. In addition, Neuren is eligible to receive tiered, escalating, double-digit percentage royalties on net sales of trofinetide in North America and one third of the market value of any Rare Pediatric Disease Priority Review Voucher, if awarded by the U.S. FDA upon approval of a New Drug Application for trofinetide. The potential milestone payments to Neuren consist of US $105 million subject to achievement of development milestones in Rett syndrome and Fragile X syndrome and up to US $350 million subject to achievement of thresholds of annual net sales of trofinetide in North America. ACADIA will fund and execute the remaining development for trofinetide in Rett syndrome in North America, except for the completion by Neuren of certain in-progress preparatory activities.

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ACAD Acadia
$13.90

-1.33 (-8.73%)

04/26/18
JPMS
04/26/18
NO CHANGE
JPMS
Overweight
JPMorgan still sees low risk of Acadia drug being pulled from market
JPMorgan analyst Cory Kasimov continues to see a low, "but not zero," risk of Acadia Pharmaceuticals' Nuplazid being pulled from the market. Yesterday's CNN report is "mostly noise" and "nothing new," Kasimov told investors last night in a research note. The analyst, however, says he can appreciate the impact of the FDA Commissioner indicating he would "take another look" at the drug's safety profile. Kasimov predicates his views on the formal FDA review and the agency's initial statement that Nuplazid's safety profile is consistent with the label, as well as additional commentary he received yesterday from management. The analyst views yesterday's pullback in shares of Acadia as "fundamentally unjustified based on current information." He kept an Overweight rating on the stock. Shares of Acadia are up 5% to $15.95 in early trading.
08/06/18
PIPR
08/06/18
DOWNGRADE
Target $19
PIPR
Neutral
Acadia downgraded to Neutral from Overweight at Piper Jaffray
Piper Jaffray analyst Danielle Brill downgraded Acadia Pharmaceuticals to Neutral and cut her firm's price target for the shares to $19 from $61 after taking over coverage of the name. The stock closed Friday down 27c to $15.22. The recent negative headlines related to potential Nuplazid safety issues will continue to weigh on sales and the shares for the foreseeable future, Brill tells investors in a research note. Further, the analyst does not have a high level of conviction for positive data from Acadia's near-term catalysts, namely the Phase 2 major depressive disorder data in September and the Phase 2 negative schizophrenia symptoms readout in the first half of 2019.
08/06/18
08/06/18
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Intel (INTC) downgraded to Equal Weight from Overweight at Barclays with analyst Blayne Curtis saying he believes upside in the shares will be challenging until the company's margins bottom. 2. Immune Pharmaceuticals (IMNP) downgraded to Hold from Buy at Maxim with analyst Jason McCarthy citing the company's delisting from Nasdaq and evaluation of strategic options as it seeks to resolve its financing overhang. 3. Flowers Foods (FLO) downgraded to Equal Weight from Overweight at Consumer Edge. 4. CommScope (COMM) downgraded to Hold from Buy at Jefferies with analyst George Notter saying after "further reflection" from the earnings call and conversations with industry contacts, he believes CommScope's Mobility division performance will not improve this year or next. 5. Acadia (ACAD) downgraded to Neutral from Overweight at Piper Jaffray with analyst Danielle Brill saying the recent negative headlines related to potential Nuplazid safety issues will continue to weigh on sales and the shares for the foreseeable future. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
08/06/18
08/06/18
NO CHANGE

Fly Intel: Today's top analyst calls on Wall Street
Check out today's top analyst calls from around Wall Street, compiled by The Fly. INTERCEPT DOUBLE UPGRADED AT GOLDMAN: Goldman Sachs analyst Salveen Richter double upgraded Intercept Pharmaceuticals (ICPT) to Buy from Sell and raised his price target for the shares to $157 from $46. The analyst said Ocaliva in fatty liver disease nonalcoholic steatohepatitis is the crux of Intercept's value proposition and that he's positive into the Phase 3 Regenerate interim readout in the first half of 2019. Intercept should benefit from Ocaliva's global first-mover advantage in NASH, Richter said. In late morning trading, Intercept shares are up 12%. BUCKINGHAM UPGRADES SQUARE TO BUY: Buckingham upgraded Square (SQ) to Buy from Neutral and raised its price target to $85 from $65. Analyst Chris Brendler said the strong Q2 results reduced his concerns about high valuation and competition and said there is no reason why Square will not continue to report better then expected core revenue growth into 2020. Brendler said long-run adjusted EBITDA margins of 40%-50% justify a higher valuation. PIPER CUTS ACADIA TO NEUTRAL: Piper Jaffray analyst Danielle Brill downgraded Acadia Pharmaceuticals (ACAD) to Neutral from Overweight and cut her firm's price target on shares to $19 from $61 after taking over coverage of the name. The recent negative headlines related to potential Nuplazid safety issues will continue to weigh on sales and the shares for the foreseeable future, Brill said. Further, the analyst does not have a high level of conviction for positive data from Acadia's near-term catalysts, namely the Phase 2 major depressive disorder data in September and the Phase 2 negative schizophrenia symptoms readout in the first half of 2019. BARCLAYS CUTS INTEL TO EQUAL WEIGHT: Barclays analyst Blayne Curtis downgraded Intel (INTC) to Equal Weight from Overweight and cut his price target for the shares to $53 from $62. The analyst believes upside in the shares will be challenging until the company's margins bottom. JEFFERIES SAYS OHIO INCIDENT NOT A RISK TO CHIPOTLE TRAFFIC: After analyzing digital engagement with the brand from last week and compared to the Virginia incident last July, Jefferies analyst Andy Barish does not believe the illnesses at the Ohio restaurant put Chipotle Mexican Grill's (CMG) traffic trends at risk. The analyst believes Chipotle's procedures were followed in Ohio, the number of cases was not substantiated, and the company did a better job controlling the narrative and taking action. Barish kept a Buy rating on Chipotle shares with a $550 price target.

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