Breaking News

Over a week ago
Show Full Stories

X

To view all stories in expanded form, please subscribe.
Send Info
Hot Stocks
Intra-Cellular announces clincial highlights » 08:05
05/07/20
05/07
08:05
05/07/20
08:05
ITCI

Intra-Cellular

$18.38 /

+0.43 (+2.40%)

Lumateperone in Bipolar…

Lumateperone in Bipolar Depression: We have completed patient enrollment in Study 402, our Phase 3 study evaluating lumateperone as adjunctive therapy in bipolar depression, and anticipate reporting topline results from this study in mid-2020. ITI-214 in Heart Failure: Clinical conduct in our Phase 1/2 clinical trial of ITI-214, our phosphodiesterase 1 inhibitor, in patients with chronic systolic heart failure has been completed. This study evaluates the hemodynamic profile and safety of single ascending doses of ITI-214. We anticipate reporting topline results from this trial in the second quarter of 2020. Other Clinical Programs: We are continuing necessary activities to advance our other development programs and to ensure patient safety in accordance with recent FDA guidelines for clinical trial conduct in the COVID-19 pandemic environment. These programs include our lumateperone clinical program in major depressive disorder, our long-acting injectable program of lumateperone, our ITI-214 program in Parkinson's disease and the initiation of early stage clinical studies for ITI-333, our novel, oral modulator of mu opioid and serotonin receptors for the treatment of opioid and other substance use disorders, pain, and mood disorders. We will provide additional updates on our clinical programs as the current environment evolves.

ShowHide Related Items >><<
ITCI Intra-Cellular
$18.38 /

+0.43 (+2.40%)

03/03/20 BTIG
Intra-Cellular price target lowered to $68 from $73 at BTIG
02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
Earnings
Intra-Cellular reports Q1 EPS (73c), consensus (93c) » 08:04
05/07/20
05/07
08:04
05/07/20
08:04
ITCI

Intra-Cellular

$18.38 /

+0.43 (+2.40%)

Reports Q1 revenue…

Reports Q1 revenue $1.08M, consensus $1.44M. "In the midst of these unprecedented times we are proud of the agile adaptation of our organization to successfully execute a virtual launch of CAPLYTA, a new treatment option for adult patients suffering from schizophrenia," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "Beyond our commercial efforts, we also continue to make progress in the advancement of our development programs, having completed patient enrollment in our Phase 3 clinical trial evaluating lumateperone as an adjunctive treatment in bipolar depression and clinical conduct in our proof-of-mechanism study evaluating ITI-214 in patients with heart failure."

ShowHide Related Items >><<
ITCI Intra-Cellular
$18.38 /

+0.43 (+2.40%)

03/03/20 BTIG
Intra-Cellular price target lowered to $68 from $73 at BTIG
02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
Over a month ago
Hot Stocks
Intra-Cellular initiates promotional activities for CAPLYTA » 08:34
04/02/20
04/02
08:34
04/02/20
08:34
ITCI

Intra-Cellular

$14.41 /

-0.96 (-6.25%)

Intra-Cellular Therapies…

Intra-Cellular Therapies announced it has successfully initiated its promotional activities associated with the launch of CAPLYTA. CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults. A national CAPLYTA launch meeting, which included the Company's full sales force and its entire commercial leadership team, was held during the week of March 23, 2020 using remote meeting technology in recognition of the current COVID-19 environment. The Company's sales organization is now actively engaging healthcare providers with the goal of providing comprehensive education on CAPLYTA. The sales force is fully equipped with remote product presentation and sampling capability. These activities are complemented by expanded digital outreach programs. The LYTAlink program offerings consist of coverage and reimbursement services, out-of-pocket copay support for commercially insured patients, medication compliance communications, and patient assistance relief specifically for those without insurance. LYTAlink is designed to be the link between CAPLYTA and the eligible schizophrenia patients who may benefit from this program.

ShowHide Related Items >><<
ITCI Intra-Cellular
$14.41 /

-0.96 (-6.25%)

03/03/20 BTIG
Intra-Cellular price target lowered to $68 from $73 at BTIG
02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
Hot Stocks
Intra-Cellular announces availability of CAPLYTA for adults with schizophrenia » 07:33
03/23/20
03/23
07:33
03/23/20
07:33
ITCI

Intra-Cellular

$13.46 /

+0.555 (+4.30%)

Intra-Cellular Therapies…

Intra-Cellular Therapies announced that CAPLYTA is now available to pharmacies in the U.S. CAPLYTA is an oral, once daily medicine approved for the treatment of schizophrenia in adults. The efficacy of CAPLYTA 42 mg was demonstrated in two placebo-controlled trials, showing a statistically significant benefit over placebo on the primary endpoint, the Positive and Negative Syndrome Scale total score. The most common adverse reactions for the recommended dose of CAPLYTA vs. placebo were somnolence/sedation and dry mouth. In pooled data from short term studies, mean changes from baseline in weight gain, fasting glucose, triglycerides and total cholesterol were similar between CAPLYTA and placebo. The incidence of extrapyramidal symptoms was 6.7% for CAPLYTA and 6.3% for placebo. The company said, " We recognize this is an extraordinary and challenging time with COVID-19; we are monitoring developments closely and we will adapt our approach as appropriate. To complement our current launch plan, we have developed remote capabilities for detailing, sampling and peer to peer interactions designed to ensure physicians are properly educated on CAPLYTA. We will also rely more heavily on digital promotion to augment the remote interactions of our sales colleagues. We have substantial product supply in the U.S. with long expiry dating to support expected demand. Each 30-capsule pack of CAPLYTA covers once daily dosing for one month. Sample packs of 10 capsules are available for healthcare professionals."

ShowHide Related Items >><<
ITCI Intra-Cellular
$13.46 /

+0.555 (+4.30%)

03/03/20 BTIG
Intra-Cellular price target lowered to $68 from $73 at BTIG
02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
Over a quarter ago
Recommendations
Intra-Cellular price target lowered to $68 from $73 at BTIG » 07:18
03/03/20
03/03
07:18
03/03/20
07:18
ITCI

Intra-Cellular

$21.87 /

+1.42 (+6.94%)

BTIG analyst Robert…

BTIG analyst Robert Hazlett lowered the firm's price target on Intra-Cellular to $68 from $73 but keeps a Buy rating on the shares. The analyst notes that the company is preparing for a launch of Caplyta in schizophrenia this month, but with a slightly later launch date than previously expected, he is reducing his U.S. sales estimates for the drug by $15M to $85M this year and by $24M to $232M next year. Hazlett remains confident in the drug's material potential based on its "novel pharmacology", which leads to a relative lack of adverse effects compared to other atypicals.

ShowHide Related Items >><<
ITCI Intra-Cellular
$21.87 /

+1.42 (+6.94%)

02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
01/31/20 JPMorgan
Intra-Cellular downgraded to Neutral on high Caplyta expectations at JPMorgan
Hot Stocks
Intra-Cellular expects to initiate clinical program for ITI-333 in 2020 » 07:38
03/02/20
03/02
07:38
03/02/20
07:38
ITCI

Intra-Cellular

$21.10 /

+0.65 (+3.18%)

The company said,…

The company said, "We plan to develop ITI-333, our novel, oral modulator of mu opioid and serotonin receptors, for the treatment of opioid and other substance use disorders, pain, and mood disorders. The pharmacological profile has the potential to translate into clinical utility as a therapeutic to ease opioid withdrawal symptoms and drug craving associated with opioid use disorder as well for analgesia with minimal addictive potential. This pharmacological profile was presented at ACNP in December 2019. We expect to initiate our clinical program in 2020."

ShowHide Related Items >><<
ITCI Intra-Cellular
$21.10 /

+0.65 (+3.18%)

02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
01/31/20 JPMorgan
Intra-Cellular downgraded to Neutral on high Caplyta expectations at JPMorgan
Hot Stocks
Intra-Cellular expects results from Phase 1/2 trial of ITI-214 in 1H20 » 07:37
03/02/20
03/02
07:37
03/02/20
07:37
ITCI

Intra-Cellular

$21.10 /

+0.65 (+3.18%)

The company said,…

The company said, "We intend to pursue the development of our phosphodiesterase program for the treatment of several CNS and non-CNS conditions with a focus on diseases where excessive PDE1 activity has been demonstrated and/or increased inflammation is an important contributor to disease pathogenesis. Our Phase 1/2 clinical trial of escalating single doses of ITI-214, our phosphodiesterase 1 inhibitor, evaluating hemodynamic effects and safety in patients with systolic heart failure, is nearing completion. Assessment of vital signs, left ventricular contractility and power using echocardiography, and ectopic arrythmias using continuous ECG monitoring are being made following the administration of ITI-214. The trial evaluates three dose cohorts 10 mg, 30 mg and 90 mg, and no safety concerns have been identified to date. We anticipate reporting topline results from this trial in the first half of 2020."

ShowHide Related Items >><<
ITCI Intra-Cellular
$21.10 /

+0.65 (+3.18%)

02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
01/31/20 JPMorgan
Intra-Cellular downgraded to Neutral on high Caplyta expectations at JPMorgan
Hot Stocks
Intra-Cellular plans to initiate Phase 2 trial of lumateperone in MDD in 2020 » 07:36
03/02/20
03/02
07:36
03/02/20
07:36
ITCI

Intra-Cellular

$21.10 /

+0.65 (+3.18%)

The company said,…

The company said, "We have commenced our program of lumateperone in MDD. In order to explore the effect of different modes of drug administration and the potential for rapid-onset antidepressant activity, our program includes the assessment of novel formulations of lumateperone and other novel compounds. Pharmacokinetic studies evaluating these novel formulations are currently ongoing. We anticipate initiating a Phase 2 clinical trial in major depressive disorder in 2020."

ShowHide Related Items >><<
ITCI Intra-Cellular
$21.10 /

+0.65 (+3.18%)

02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
01/31/20 JPMorgan
Intra-Cellular downgraded to Neutral on high Caplyta expectations at JPMorgan
Hot Stocks
Intra-Cellular plans to initiate Phase 1 trial of LAI formulation in 2020 » 07:35
03/02/20
03/02
07:35
03/02/20
07:35
ITCI

Intra-Cellular

$21.10 /

+0.65 (+3.18%)

The company said,…

The company said, "Within the lumateperone portfolio, we are also developing a long-acting injectable formulation to provide more treatment options to patients suffering from schizophrenia. We have completed the preclinical development of an LAI formulation and plan to initiate a Phase 1 clinical trial in 2020."

ShowHide Related Items >><<
ITCI Intra-Cellular
$21.10 /

+0.65 (+3.18%)

02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
01/31/20 JPMorgan
Intra-Cellular downgraded to Neutral on high Caplyta expectations at JPMorgan
Hot Stocks
Intra-Cellular expects results from Phase 3 trial of lumateperone in mid-2020 » 07:35
03/02/20
03/02
07:35
03/02/20
07:35
ITCI

Intra-Cellular

$21.10 /

+0.65 (+3.18%)

The company said,…

The company said, "Our global adjunctive bipolar depression Phase 3 trial, Study 402, is ongoing. We anticipate reporting topline results from this trial in mid-2020. We have commenced an additional Phase 3 study, Study 403, evaluating lumateperone as monotherapy in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder. Subject to the results of Study 402 and our interactions with the FDA regarding our bipolar depression program, in late 2020 we expect to submit a supplemental new drug application to the FDA for regulatory approval for lumateperone for the treatment of bipolar depression."

ShowHide Related Items >><<
ITCI Intra-Cellular
$21.10 /

+0.65 (+3.18%)

02/20/20
Fly Intel: Top five analyst initiations
02/19/20 Evercore ISI
Intra-Cellular initiated with an Outperform at Evercore ISI
02/18/20 Cantor Fitzgerald
Intra-Cellular price target raised to $47 from $43 at Cantor Fitzgerald
01/31/20 JPMorgan
Intra-Cellular downgraded to Neutral on high Caplyta expectations at JPMorgan

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.