Sage Therapeutics surges on its depression drug

Sage Therapeutics’ brexanolone achieves primary endpoint in Phase 3 trial

Sage Therapeutics announces results from Sage-547. See Stockwinners.com for details

Sage Therapeutics (SAGE) announced positive top-line results from two Phase 3 clinical trials with its proprietary i.v. formulation of brexanolone;

  • Study 202B in severe postpartum depression and
  • Study 202C in moderate PPD.

Brexanolone achieved the primary endpoint in both trials, a mean reduction from baseline in the Hamilton Rating Scale for Depression total score compared to placebo at 60 hours.

Patients treated with brexanolone demonstrated mean reductions from baseline in HAM-D total scores of 14 to 20 points at 60 hours maintained to 30 days in both trials.

Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies.

Sage believes these data will be sufficient to support submissions of regulatory applications seeking approval of brexanolone for PPD.

Sage plans to file a New Drug Application with the FDA in 2018.

MARINUS

Shares of Marinus Pharmaceuticals (MRNS) are also higher. The move comes after Sage Therapeutics announced that its Phase 3 clinical trial with its proprietary i.v. formulation of #brexanolone in severe postpartum depression achieved its primary endpoint.

#Marinus is preparing to initiate clinical trials with Captisol-enabled ganaxolone IV in patients with postpartum depression.

ANALYSTS VIEW

H.C. Wainwright analyst Joseph #Pantginis notes Ligand Pharmaceuticals (LGND) partner Sage Therapeutics announced positive top-line data of brexanolone for patients with moderate and severe postpartum depression. Recall that brexanolone is one of the “Big Six assets” at Ligand which is expected to receive a 3% royalty on sales, Pantginis tells investors in a research note. The analyst raised his price target for Ligand shares to $159 from $157 and keeps a Buy rating on the shares.

BMO Capital analyst Gary Nachman calls today’s Phase 3 data in post-partum depression a “very significant milestone” for Sage Therapeutics. The analyst sees a “high probability of approval” in the U.S. and Europe based on these data.

Further, he thinks they could potentially bode well for the anticipated SAGE-217 results in both major depressive disorder and for in postpartum depression. #Nachman reiterates an Outperform rating on Sage with an $80 price target.

PRICE ACTION

In Thursday’s trading SAGE is up 44% to $90.65 per share.


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Applebee’s sales continue to suffer

DineEquity revises FY17 outlook

DineEquity Revises its guidance. See Stockwinners.com for details

DineEquity (DIN) revises expectations for Applebee’s domestic system-wide comparable same-restaurant sales performance to range between negative 5.5% and negative 6.5%.

This compares to previous expectations of between negative 6.0% and negative 8.0%.

Reiterates expectations for IHOP’s domestic system-wide comparable same-restaurant sales performance to range between negative 1.0% and negative 3.0%.

Reiterates expectations for Applebee’s franchisees to develop between 20 and 30 new restaurants globally, the majority of which are expected to be international openings.

Reiterates expectations for Applebee’s closures to range between approximately 105 and 135 restaurants.

Reiterates expectations for IHOP franchisees and its area licensee to develop between 80 and 95 restaurants globally, the majority of which are expected to be domestic openings.

Revised expectations for IHOP closures to range between 25 and 30 restaurants. This compares to previous expectations of between 20 and 25 restaurants.

Revised expectations for Franchise segment profit to be between $297 million and $303 million. This compares to previous expectations of between $302 million and $314 million. This downward revision is primarily due to additional expected reserves related to the collectability of Applebee’s royalties.

Reiterates expectations for the Rental and Financing segments to generate approximately $38 million in combined profit.

Reiterates expectations for general and administrative expenses to range between $166 million and $172 million, including non-cash stock-based compensation expense and depreciation of approximately $22 million.

Reiterates expectations for interest expense to be approximately $62 million. Approximately $3 million is projected to be non-cash interest expense.

Reiterates expectations for weighted average diluted shares outstanding to be approximately 18 million shares.

Reiterates expectation for the income tax rate to be approximately 40%. Revised expectations for cash flows provided by operating activities to range between $64 million and $74 million. This compares to previous expectations of between $80 million and $90 million.

The decline is primarily due to the timing of fourth quarter 2017 marketing spend and projections for lower Franchise segment profit as discussed above.

Reiterates expectations for capital expenditures to be approximately $14 million. Revised expectations for adjusted free cash flow (See “Non-GAAP Financial Measures” below) to range between $60 million and $70 million. This compares to previous expectations of between $76 million and $86 million.

DIN closed at $42.96.


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Nomura is bullish on Tesla

Nomura sees Tesla selling all it can produce after Model 3 sedan spin

Model 3 production bottlenecks send  Tesla lower. See Stockwinners.com

In a research note titled “Better Than Advertised,” Nomura Instinet Romit Shah says he left test driving Tesla’s (TSLA) Model 3 sedan feeling the automaker will be selling as many cars as it can produce for a long time.

Taking the sedan for a spin reinforced the analyst’s view that Tesla’s addressable market opportunity is “perhaps much larger” than the BMW 3-series, Mercedes C class and Audi A4.

There is a “real passion” for the brand, which is “bigger than loyalty because much of the enthusiasm comes from people who have never owned a Tesla,” Shah tells investors in a research note.

The only comparable product the analyst sees is Apple’s (AAPL) iPhone. Apple succeeded because the world shifted from computers to smartphones and Apple had the best product, the analyst writes.

Similarly, he believes there is a secular shift today from internal combustion engines to electric vehicles and that Tesla has the best product.

If Tesla can overcome its operational challenges, it will see “unprecedented revenue growth and strong cash flows,” Shah concludes. He has a Buy rating on Tesla with a $500 price target.

The automaker closed yesterday down $1.66 to $304.39.

Production Rate

Tesla produced just over 440 Model 3 vehicles since the automaker began production in July, meaning the company built about 180 of the cars last month, electrek reports, citing sources familiar with the matter.

Tesla CEO Elon Musk, who hopes to ramp up production to 5,000 vehicles a week in December following production challenges, said on the company’s conference call he would not provide the number of vehicles produced in October as “people would just read too much into it.”


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