|Bid||11.76 x 900|
|Ask||11.78 x 1200|
|Day's Range||11.63 - 11.97|
|52 Week Range||10.09 - 23.62|
|Beta (3Y Monthly)||1.40|
|PE Ratio (TTM)||N/A|
|Earnings Date||Aug 3, 2017 - Aug 7, 2017|
|Forward Dividend & Yield||N/A (N/A)|
|1y Target Est||29.71|
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) is a company with exceptional fundamental characteristics. Upon building...
This most-searched list is a feature included in Benzinga Pro's Newsfeed tool. It highlights stocks frequently searched by Benzinga Pro users on the platform. Soliton, Inc. (NASDAQ: SOLY ) shares were ...
Intra-Cellular Therapies' (ITCI) lead candidate fails to meet primary endpoint in one of the phase III studies evaluating it in bipolar depression patients. Shares fall.
Shares of biotech Intra-Cellular Therapies fell 15% in premarket trade Monday after the company announced disappointing results from a late-stage trial of its lead drug candidate lumateperone, a potential bipolar depression treatment. The trial, which evaluated 554 patients with bipolar disorder in the U.S., showed that lumateperone was no better than a placebo in helping to relieve symptoms of depression in patients with bipolar disorder. However, Intra-Cellular also announced positive results in a separate global trial of the drug looking at 381 patients with bipolar disorder from around the world. This Phase 3 trial met its primary endpoint; after six weeks of treatment, patients on the drug showed statistically-significant improvement over those on placebo. Intra-Cellular is also conducting a third trial of the drug, looking at it as an adjunctive therapy to lithium or valproate. In early July, Ritu Baral of Cowen said Intra-Cellular would need two positive trials to support filing a new drug application, or NDA. If both the U.S. and global trials looking at lumateperone showed positive results, the company would be able to file an NDA sometime in the second half of 2019, she wrote in a note to clients last week. But if only one of the trials was positive, the company would have to wait for data from the third trial -- evaluating lumateperone as an adjunctive therapy -- to come out. That data won't be available until 2020, she wrote. Shares of Intra-Cellular have gained 18.2% in the year to date through Friday, while the S&P 500 has gained 19.3%.
Intra-Cellular Therapies (NASDAQ: ITCI ) shares resumed trading after the company released mixed study results from two Phase 3 clinical trials evaluating lumateperone as monotherapy in the treatment of ...
Intra-Cellular Therapies Inc said on Monday its lead drug failed to meet the main goal of one of two late-stage studies in patients with major depressive episodes associated with bipolar disorder. The company's shares fell 6.5% before the opening bell. The treatment, lumateperone, which is being studied as a monotherapy for the condition, failed to show statistically significant improvement in the disease condition compared to placebo in the trial, the company said.
Intra-Cellular Therapies Inc. on Monday reported positive results from two late-stage trials of a treatment for bipolar depression. The New York-based company said the two phase 3 trials of lumateperone met their primary endpoints. In Study 404, that goal was change from baseline at week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo. Study 404 also met its key secondary endpoint, on the Clinical Global Impression Scale for Bipolar for Severity of Illness, or CGI-BP-S. That study produced positive results for patients with Bipolar type I and Bipolar type 2. "In Study 401, lumateperone did not separate from placebo," the company said in a statement. "A high placebo response was observed in the trial." Study 404 was conducted globally, including in the U.S. and included 381 patients. Study 401 was conducted only in the U.S. and involved 554 patients. "Consistent with previous studies in schizophrenia, lumateperone was well-tolerated in both bipolar depression studies, with a favorable safety profile," said the statement. Shares were halted for the news, but have gained 18.2% in 2019, while the S&P 500 has gained 19.3%.
Study 404 met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p
Biotech stocks saw muted sentiment in the holiday-shortened week ending July 5 after a strong rebound in the later part of the previous week. Activity was light, although news on clinical trial readouts ...
(Bloomberg) -- Intra-Cellular Therapies Inc. shares could double if the company shows positive data in a pair of late-stage studies in bipolar depression next week, according to two analysts.Wall Street will want to see both trials reach their main goal of improving depression symptoms for shares to move higher, Cowen analyst Ritu Baral wrote in a July 1 note. She pegs the chance of succeeding at just over 50% for each study. Baral predicts shares could at least double if both studies succeed, but an investor survey suggests the stock may fall as much as 15% if only one does, she said. Both studies failing may send shares down 50% or more, she said.Drug development in neurological disorders like depression is fraught with pitfalls. Despite some recent successes in the field, investor skepticism has cost Intra-Cellular almost a third of its market value over the past 12 months. Analysts are more optimistic, with all nine tracked by Bloomberg holding a buy recommendation on the shares.The study results will be reported the week of the July 8, Sharon Mates, Intra-Cellular’s chief executive said last month.The Food and Drug Administration may consider approving the therapy, called lumateperone, even if only two of the three ongoing studies meet their goal, according to Cowen. Results from the third study aren’t expected until next year. Regulators are also reviewing the drug as a treatment for schizophrenia, and a panel of experts will discuss that application later this month with a verdict from the FDA due in September.RBC analyst Brian Abrahams last month estimated that Intra-Cellular had a 60% chance of hitting the primary endpoint on at least one study, and that could lead to a 50% share gain, “assuming at least positive trends in the other study” given the FDA’s “amenability to mixed data.” If Intra-Cellular were able to deliver in bipolar disorder as well as schizophrenia approval, that could drive a four-fold gain for the stock, Abrahams said.SVB Leerink’s Marc Goodman said the shares could fall by $2, or about 15%, on mixed data or by $6 if both studies failed. Both studies hitting their goal may add $7, or about 50%, to the stock price, Goodman said. He estimates lumateperone sales in bipolar depression could reach $500 million a year, while schizophrenia may bring in as much $400 million.Options investors are also bracing for a big move. July call options with the highest levels of open interest include $22.50 and $20 strikes, compared to the last closing price of $13.61. July puts with the highest level of open interest include $12.50 and $10 puts, or an open interest weighted average of $11.09, implying a downside of about 18% from the last closing price.Current drugs approved for treating bipolar depression include Sumitomo Dainippon Pharma Co.’s Latuda and AstraZeneca Plc’s Seroquel, as well as Allergan Plc and Gedeon Richter Nyrt’s Vraylar. Sage Therapeutics Inc. is also developing a new treatment for the depressive symptoms of bipolar disorder.To contact the reporters on this story: Cristin Flanagan in New York at firstname.lastname@example.org;Brian Welcher in Atlanta at email@example.comTo contact the editors responsible for this story: Catherine Larkin at firstname.lastname@example.org, Steven FrommFor more articles like this, please visit us at bloomberg.com©2019 Bloomberg L.P.
Investors need to pay close attention to Intra-Cellular Therapies (ITCI) stock based on the movements in the options market lately.
Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced the appointment of Karen Patruno Sheehy, Esq. In prior roles, Karen led compliance functions at Mallincrodt as Senior Vice President, Chief Compliance Officer and at Sanofi as Vice President, Head, North America Compliance.
[Editor's Note: This article is updated each week with the latest insider moves.] The SEC has established numerous rules over the years to protect investors, including measures that prevent insiders from buying to take advantage of nonpublic information. Insiders have access to confidential information about a company. Sometimes that information could move the stock price once it goes public.For example, if an insider knows the company is about to announces earnings that are greater than estimated, the insiders could secretly buy options or shares.InvestorPlace - Stock Market News, Stock Advice & Trading TipsFortunately for us "outsiders," the SEC requires that insiders publicly disclose when they make a transaction in their company's stock. This means that we can find out when the insiders are buying. This can be a great indicator, especially if the price has recently made a large move downwards.This is because there are many reasons why an officer or a director of a company may decide to sell their stock -- they could simply need the money -- but an insider will only buy a stock for one reason! They believe that the stock is undervalued and that they will make a profit. * 7 F-Rated Stocks to Sell for Summer Due to the significant insider buying that has recently occurred, these stocks came up on my radar screen as potential investments to consider. Stocks to Buy With Insider Buying: Carnival Corp (CCL)Carnival Corp (NYSE:CCL) is a cruise ship company. The headquarters are in Miami, Florida, but it has worldwide operations.CCL has lost about 10% of its value since its June 20 earrings release disappointed investors. Concerns were not only about the earnings, but about the guidance as well. Since then, there have been some downgrades and price target reductions.Arnold Donald is the president and chief executive officer of CCL. He has been with the company for almost 20 years. Apparently Mr. Donald believes that this selloff is done. He just made a $1 million investment when he bought 22,000 shares around $45.31.Mr. Donald also made a similar size investment in December when the markets made the significant move lower and CCL was trading around current levels. He must believe that the stock is a good value at these levels. Denbury Resource (DNR)Denbury Resource (NYSE:DNR) is an independent oil and natural gas company involved in exploration, drilling and extraction. The company operates in the Gulf Coast and Rocky Mountain regions.DNR stock has been in a death spiral since October, when it was trading around $6.50 a share. Its most recent close was $1.24. That is an 80% decrease in shareholder value. A lot of this is due to the depreciation in natural gas prices that has occurred since then. There have also been concerns over acquisitions that the company was involved in.Christian Kendall is the president and CEO of Denbury, and he just invested $125,000 of his personal funds when he bought 100,000 shares. * The 7 Top Small-Cap Stocks Of 2019 Wall Street isn't too excited about DNR's future prospects. Currently, 11 firms follow it and the average rating is a hold, according to MarketWatch. Macerich (MAC)Macerich (NYSE:MAC) is real estate investment trust, or REIT. It acquires, manages and develops shopping centers throughout the United States.Some analysts have attributed the share price to the ongoing issues of traditional "brick and mortar" stores suffering from the Amazon (NASDAQ:AMZN) effect. After all, if retail store outlets aren't doing well, they will be closing, and this will in turn have a negative affect on malls and shopping centers.The stock of MAC has lost over 40% of its value over the past year. But two of its insiders think the selloff is overdone because they just made significant investments.Edward Coppola is the president of Macerich. He just invested $165,000 when he paid $32.88 for 5,000 shares. And Andrea Stephen is a director. She just bought 20,000 share at around $32.50. This is an investment of $650,000! Each of these insiders apparently believes that MAC has great future prospects. AbbVie (ABBV)AbbVie (NYSE:ABBV) is a research-based biopharmaceutical company. It develops and sells products that treat conditions such as chronic autoimmune diseasesOver the past year, shares of ABBV stock have lost about 20% of their value. This includes last week's drop of 15%. This dramatic plunge was due to the announcement that ABBV is buying Allergan (NYSE:AGN). Clearly some investors don't think that this deal makes good sense.Three insiders of AbbVie must think that this selling was irrational, though. All three made significant investments.Edward Rapp is a director of the company. He just invested $500,000 when he bought 7,500 shares at $67.30. Roxanne Austin, also a director, just invested $775,000 when she paid $67.50 for 11,500 shares.William Chase is the executive vice-president of finance and administration. He just bought 30,400 shares at a price of $67.30. That's $2 million! * The Top 8 Tech Stocks of 2019 (So Far) These insiders are already profiting. The stock is trading $5 higher than where they bought it. TG Therapeutics (TGTX)TG Therapeutics (NASDAQ:TGTX) is a biopharmaceutical company. It develops treatments for B-cell malignancies and auto immune diseases.Last September, shares of TGTX lost about 65% of their value, dropping from $12.50 to $5.25. This was due to disappointing results in one of their drug trials.The stock traded sideways from then through March when it started to make a recovery. Since then the shares have more than doubled in value.Michael Weiss is the CEO and president of TG Therapeutics. Mr. Weiss must believe that this rally is going to continue. He just bought 50,000 shares at a price of $7.04, an investment of $350,000.Wall Street agrees with Mr. Weiss that this stock is undervalued. According to MarketWatch, the 6 firms that follow it all have buy ratings on it. The average target price is $19, more than 100% higher than the most recent close. GigaMedia (GIGM)GigaMedia (NASDAQ:GIGM) provides digital entertainment services. Through its subsidiary FunTown, it provides online gaming.GigaMedia's customers may be having fun, but this year its shareholders sure haven't been. The prices of the shares have fallen from around $3 to $2.36.I am not sure why the share price has dropped. Chang Ming Huang doesn't seem to know why the price has dropped either. He is the CEO of the company. On June 19 he bought 57,885 shares at $2.50. That is $145,000. He also invested an additional $95,000 earlier in the month. * 7 Stocks to Buy for a Dovish Fed No firms on Wall Street officially follow GIGM, but some investors think that it could be a bullish dynamic when a company isn't followed. This is because if they invest before it is 'discovered' by The Street, they may be in it before the big players get involved and it makes a dramatic move upwards. Calithera Biosciences (CALA)Calithera Biosciences (NASDAQ:CALA) discovers and develops small molecule drugs that are used to treat cancer.Over the past 3 months, shares of CALA have fallen from $6 to $4. Most of this drop occurred in mid-June when the company announced that it was going to issue more shares. It had spiked just before this when they announced positive results from a trial.Maybe they announced the share offering because management felt that they could get a higher price. Investors disagreed and sold the stock. They feel that the negative results of the stock dilution will far outweigh the positives that came from the trial.Susan Molineaux Ph.D is the president and CEO of CALA. Christopher Molineaux Ph.D is Senior Vice-President of Development. And they both seem to believe the stock will rally from current levels because these two insiders each just purchased 50,000 shares at $3.88, a total investment of almost $400,000.As of the time of this writing Mark Putrino did not hold any positions in the aforementioned securities. More From InvestorPlace * 2 Toxic Pot Stocks You Should Avoid * 7 F-Rated Stocks to Sell for Summer * 7 Stocks to Buy for the Same Price as Beyond Meat * 7 Penny Marijuana Stocks That Are NOT Cheap Stocks Compare Brokers The post 7 Stocks on Sale the Insiders Are Buying appeared first on InvestorPlace.
"Since 2006, value stocks (IVE vs IVW) have underperformed 11 of the 13 calendar years and when they beat growth, it wasn't by much. Cumulatively, through this week, it has been a 122% differential (up 52% for value vs up 174% for growth). This appears to be the longest and most severe drought for value […]
Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at JMP Securities Life Sciences Conferences Conference in New York. The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.
If you're interested in Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), then you might want to consider its beta (a...
Investors need to pay close attention to Intra-Cellular (ITCI) stock based on the movements in the options market lately.
Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has announced a Psychopharmacologic Drugs Advisory Committee meeting to be held on July 31, 2019 to discuss the New Drug Application (NDA) for lumateperone with the proposed indication of treatment of schizophrenia in adults. Lumateperone is a novel investigational drug with an NDA currently under review by FDA as a treatment of schizophrenia in adults.
Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at Jefferies 2019 Global Healthcare Conference in New York. The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.
The market suffered a sharp selloff on Monday as China announced new tariffs effective June 1 on $60 billion of imports from the U.S. That action was response to the Trump administration's decision the previous week to raise tariffs from 10% to 25% on $200 billion of imports from China after the Chinese delegation reneged on several key provisions of a new trade deal. The administration did mend fences on the trade front elsewhere to bring its full attention to bear on China. In addition, aluminum and steel tariffs on Canada were dropped.
Intra-Cellular Therapies, Inc. (ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 2019 RBC Capital Markets Global Healthcare Conference in New York. The live and archived webcast can be accessed under "Press Releases & Events" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Intra-Cellular Therapies is developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases and diseases of the elderly, including Parkinson's and Alzheimer's disease.