68.67 0.00 (0.00%)
Pre-Market: 8:00AM EST
|Bid||0.00 x 1000|
|Ask||68.67 x 1100|
|Day's Range||64.48 - 69.68|
|52 Week Range||56.50 - 193.56|
|Beta (3Y Monthly)||2.49|
|PE Ratio (TTM)||N/A|
|Earnings Date||Nov 12, 2019|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||109.11|
Hagens Berman urges Sage Therapeutics, Inc. (SAGE) investors who have suffered losses in excess of $100,000 on purchases prior to December 5, 2019 to submit their losses now to learn if they qualify to recover compensable damages. The firm has opened an investigation into Sage and investors may have valuable claims under the federal securities laws.
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that it plans to advance SAGE-718, a novel, first-in-class, oxysterol-based positive allosteric modulator (PAM) of N-methyl-D-aspartate (NMDA) receptors, to a Phase 2 placebo-controlled clinical trial in patients with Huntington’s disease (HD). The planned progression of SAGE-718 is based on results from Phase 1 studies evaluating the safety and tolerability of SAGE-718, including an open-label cohort of patients with HD.
HENDERSONVILLE, TN / ACCESSWIRE / December 9, 2019 / The Law Offices of Timothy L. Miles, who has been leading the fight to protect shareholder rights for over 18 years, is investigating whether certain ...
Morgan Stanley analyst Matthew Harrison maintained an Overweight rating for Sage but lowered the price target from $217 to $125. H.C. Wainwright analyst Douglas Tsao reiterated a Neutral rating and reduced the price target from $160 to $87. Raymond James analyst Dane Leone maintained a Market Perform rating.
The stock was 4% higher in premarket trading on Friday after losing more than half its value on Thursday.
Sage Therapeutics' (SAGE) phase III study on pipeline candidate SAGE-217 for the treatment of major depressive disorder fails to meet the primary endpoint.
Shares of Sage Therapeutics collapsed Thursday after the biotech company's depression treatment, dubbed SAGE-217, failed to meet its key goal at day 15 in a late-stage study.
(Bloomberg Opinion) -- Investors in Sage Therapeutics Inc. woke up Thursday to every biotech investor’s nightmare. The company’s closely watched lead medicine, SAGE-217, failed to hit a key mark in a critical trial in patients with major depressive disorder. The stock was down a bruising 55% in early trading, cutting the firm’s market value by more than $4 billion. Investors have a tough decision to make. They could join the many abandoning ship, assuming that the drug isn’t as effective as hoped and that additional continuing studies of the drug may fail. Or they can see this as a buying opportunity of an oversold stock. Sage’s executives spent a call with analysts Thursday outlining several reasons for optimism, and depression trials are notoriously difficult and fickle. Eating a significant loss or betting on recovery will both take a strong stomach.Drugs to treat depression almost always have a tough path to market. Patient improvement is difficult to assess, placebo effects are real and variable, and it’s hard to ensure drug compliance. Plenty of drugs have succeeded in mid-stage trials only to run into difficulty when tested in a larger population. Sage’s drug is both riskier and more promising because it takes a novel approach to treating the condition rapidly. Sage has a few explanations for why the drug failed this study even though it succeeded in a late-stage trial in postpartum depression patients earlier this year. Some patients may not have taken the drug as directed or at all, which could have influenced results. The study also included a higher proportion of patients with less severe symptoms than previous tests. Sage also pointed to the fact that the drug worked better at interim endpoints as evidence that the drug is active and that the study was “directionally” positive. Optimistic investors may find this convincing. But there are plenty of valid reasons for the stock sell-off, too. The drug’s impact was substantially less pronounced than in previous studies, which may mean that it simply isn’t that potent and raises concerns that its effect may fade over time. Even compelling after-the-fact explanations of failed trials are somewhat unreliable. The company’s positive earlier trial in patients with major depressive disorder looked at a small number of patients; it may have exaggerated the drug’s impact. If the medicine does make it to market, it may treat a narrower group of patients than the company had once anticipated. Sage could mount a comeback in a generally buoyant biotech market if future trials confirm that this failure was an unlucky fluke or if regulators are receptive to its various arguments. That’s a ride for only brave and patient investors; another failure would be received even less kindly than this one, and even good depression drugs are a gamble. To contact the author of this story: Max Nisen at firstname.lastname@example.orgTo contact the editor responsible for this story: Daniel Niemi at email@example.comThis column does not necessarily reflect the opinion of the editorial board or Bloomberg LP and its owners.Max Nisen is a Bloomberg Opinion columnist covering biotech, pharma and health care. He previously wrote about management and corporate strategy for Quartz and Business Insider.For more articles like this, please visit us at bloomberg.com/opinion©2019 Bloomberg L.P.
On Thursday morning, Sage announced that a Phase 3 trial of its depression drug SAGE-217 failed to perform better than a placebo in reducing depression after 15 days. Its stock is down about 60%.
The Cambridge-company's shares fell by more than half on Thursday morning, shaving more than $3 billion off its market value.
(Bloomberg) -- Sage Therapeutics Inc. lost almost two-thirds of its value after an experimental treatment for major depressive disorder failed to reach its primary target in a key study.The late-stage trial, dubbed “Mountain,” showed patients receiving SAGE-217 didn’t get more relief than those taking a placebo for two weeks, regardless of the dose. The results cast doubt on the future of the drug, which had been a key part of investors’ broadly bullish stance on Sage.The shares tumbled a record 62% to the lowest level in more than two years, wiping out more than $4.6 billion in in market value.Given past trial results, Wall Street had hoped the medicine would show a benefit at both day 15 and through longer-term follow-up. That wasn’t the case. Even when looking only at patients with more severe disease who faithfully took the medicine -- the group most likely to respond to treatment -- the drug didn’t significantly ease depression more than placebo after 42 days.The study miss “will surprise the entire community” and force the stock to be range-bound between $50 and $90, according to Jefferies analyst Andrew Tsai. “The next steps are bit murky now and creates some near-term stock volatility,” he said in a note.“It’s clear the study didn’t meet its primary endpoint, but if you look at the rest of the data points, even from the original analysis, it’s pretty clear that the study directionally is very supportive of drug activity,” Sage Chief Executive Officer Jeff Jonas said by phone.A sub-group analysis conducted after the original review suggested that patients with more severe depression and those who actually took a high dose of the medicine, with measurable amounts of it in their bloodstream, responded to treatment, the company said in a statement. Those getting a lower dose of the drug did no better than those on placebo.Two patients developed serious adverse events after getting the high dose, including one who attempted suicide and who who developed a bile duct stone. Both patients had suffered from similar struggles before starting the trial.“Nine percent of the overall population had undetectable drug levels,” Jonas said. “This is a long-acting drug, so low levels like that really indicates they just didn’t take the drug.” The challenge of patients not taking the drug was limited to a small number of sites, he said.A key selling point for SAGE-217 compared to existing medicines has been its rapid activity, which Jonas says was showcased by signs of improvement as early as day three. That, combined with a safety profile that may allow it to try a higher dose, gives the company hope, Jonas said.The drug likely missed its primary target because of some “very simple technical factors,” Jonas said.Stifel analyst Paul Matteis was also reluctant to throw in the towel and recommended that clients buy shares after Thursday’s plunge.“These data will inevitably take the ‘halo effect’ off SAGE-217 in the eyes of investors,” he wrote in a research note. “But, in our minds, we still think the drug has blockbuster potential, even if that may be delayed.”The failure marks Sage’s first setback with the drug after delivering earlier-stage wins and two pivotal studies showing benefit in major depressive disorder and postpartum depression. Three other large trials of the drug are still underway.Jonas said the company intends to continue analyzing the results and discuss the findings with U.S. regulators. Additional data are expected to be presented at an upcoming medical congress.(Updates with share movement in third paragraph, adds analyst commentary starting in the second paragraph)To contact the reporter on this story: Bailey Lipschultz in New York at firstname.lastname@example.orgTo contact the editors responsible for this story: Catherine Larkin at email@example.com, Michelle Fay CortezFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Sage Therapeutics Inc said on Thursday its experimental drug failed to improve condition of patients with severe depression in a late-stage study, setting up the drugmaker to lose about $4 billion in valuation when the market opens. The hotly anticipated data was expected to allow the company to widen its reach in the multi-billion dollar depression market it entered with its first-approved drug, Zulresso, for postpartum depression. SVB Leerink analyst Marc Goodman had said in a note ahead of the trial results that a late-stage trial failure would be a major disappointment to investors and a setback for the company as it would be the first "chink in the armor" in the Sage story.
Shares of Sage Therapeutics Inc. plummeted 59% toward a 2-year low to pace all premarket decliners Thursday, after the biopharmaceutical company said a Phase 3 study of its SAGE-217 for the treatment of major depressive disorder failed to meet the primary endpoint. The study did not result in a statistically significant reduction compared with placebo, but SAGE-217 was well tolerated and showed a similar safety profile as seen in earlier studies. "Notwithstanding the finding on the primary endpoint, the drug displays good activity on most measures. We understand that drug development is an iterative process," said Chief Executive Jeff Jonas. "In this study, we've gathered new data on SAGE-217, data we believe support our hypothesis that SAGE-217 has a unique profile with the potential for rapid and robust onset with durable effect." The stock has run up 56% year to date through Wednesday, while the iShares Nasdaq Biotechnology ETF has rallied 25% and the S&P 500 has gained 24%.
Sage Therapeutics (NASDAQ: SAGE), a biopharmaceutical company developing novel therapies for people with debilitating brain disorders, today reported topline results from the pivotal Phase 3 MOUNTAIN Study evaluating the effect of SAGE-217 on depressive symptoms in adults with major depressive disorder (MDD). The MOUNTAIN Study did not meet its primary endpoint of a statistically significant reduction from baseline compared to placebo in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15. SAGE-217 30 mg, given once-daily as an oral treatment, was associated with a mean reduction of 12.6 in HAM-D total score compared to 11.2 for placebo (p=0.115). Patients in the SAGE-217 30 mg group achieved statistically significant reductions in the HAM-D total score at Days 3, 8 and 12 (p<0.018 for each timepoint). The SAGE-217 development program includes five other pivotal studies, two of which have reported positive data, one in MDD and one in postpartum depression (PPD), and three of which are ongoing.
Before we spend days researching a stock idea we like to take a look at how hedge funds and billionaire investors recently traded that stock. Russell 2000 ETF (IWM) lagged the larger S&P 500 ETF (SPY) by more than 10 percentage points since the end of the third quarter of 2018. This means hedge funds […]
Sage Therapeutics, Inc. (SAGE), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating disorders of the brain, today announced that on Monday, December 2, 2019, the Compensation Committee of Sage’s Board of Directors granted non-qualified stock options to purchase an aggregate of 4,200 shares of its common stock, and 700 performance restricted stock units (PSUs) to two new employees under Sage’s 2016 Inducement Equity Plan. The 2016 Inducement Equity Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Sage (or following a bona fide period of non-employment), as an inducement material to such individual's entering into employment with Sage, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.
Shareholder rights law firm Robbins LLP is investigating whether certain officers and directors of Sage Therapeutics, Inc. breached their fiduciary duties to shareholders.