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IntelGenx announces short-term commerical objectives » 08:03
05/31/23
05/31
08:03
05/31/23
08:03
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IntelGenx Corp.…

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Over a week ago
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IntelGenx receives amended DEL license for third-party testing » 08:04
05/17/23
05/17
08:04
05/17/23
08:04
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IntelGenx has received an…

IntelGenx has received an amended Drug Establishment License from Health Canada, allowing the Company to conduct third-party testing. Analytical testing of finished products and intermediates is a significantly underserved market, which IntelGenx has decided to tap into. The Company views this as an attractive opportunity for short-term revenue generation. The amended DEL license could be of particular importance due to IntelGenx's possession of a controlled substance license. This allows IntelGenx to access a broader market for testing services, further increasing its market penetration and revenue opportunities.

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Over a month ago
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IntelGenx announces receipt of CRL from FDA for Buprenorphine Buccal Film » 08:16
04/27/23
04/27
08:16
04/27/23
08:16
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IntelGenx announced that…

IntelGenx announced that its co-developer, Chemo Research SL, through its agent and affiliate, Xiromed, has received a Complete Response Letter from the U.S. Food and Drug Administration regarding the submitted abbreviated new drug application for Buprenorphine Buccal Film. Xiromed and IntelGenx will contact FDA to discuss the CRL and assess the filing of a request for reconsideration of the CRL. Buprenorphine Buccal Film, which incorporates IntelGenx's VersaFilm technology in a novel formulation, is a generic version of Belbuca, an opioid that is used to manage chronic pain severe enough to require daily, around-the-clock, long-term treatment with an opioid, when other pain treatments are inadequate. Approved by the FDA in 2015, Belbuca is applied to the oral or buccal mucosa every 12 hours and comes in seven strengths ranging from 0.075 mg to 0.9 mg.

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Hot Stocks
IntelGenx announces FDA approval of RIZAFILM for treatment of acute migraine » 08:27
04/17/23
04/17
08:27
04/17/23
08:27
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IntelGenx announced that…

IntelGenx announced that the U.S. Food and Drug Administration, FDA, has approved the Company's RIZAFILM VersaFilm 505(b)(2) new drug application, NDA, for the treatment of acute migraine. In December 2018, IntelGenx entered into a definitive licensing, development and supply agreement with Gensco Pharma for the exclusive commercialization of RIZAFILM in the United States. Under the terms of the agreement, IntelGenx is entitled to receive royalty payments based on net profits of RIZAFILM; and is eligible to receive pre-specified payments upon the achievement of certain regulatory and commercial milestones. "Following a successful pre-approval inspection by the FDA of our Montreal manufacturing facility earlier this month, we are thrilled to reach this milestone and excited to soon introduce what will be the first oral thin film for the treatment of acute migraines available in the U.S.," said Andre Godin, IntelGenx's President and CFO. "According to the American Migraine Foundation, 39 million or 12% of Americans suffer from migraine, which is the second leading cause of disability nationwide. We are looking forward to working with our commercialization partner, Gensco, to bring this innovative migraine therapeutic to patients seeking convenient administration and quick relief from their pain. In addition to these benefits, RIZAFILM is well suited to the approximately 80% of patients who have migraine-related nausea3, as well as those who have difficulty swallowing."

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Over a quarter ago
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IntelGenx receives USPTO notice of allowance for loxapine patent » 08:15
02/21/23
02/21
08:15
02/21/23
08:15
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IntelGenx announced that…

IntelGenx announced that the United States Patent and Trademark Office has granted a Notice of Allowance for U.S. Patent Application 16/053,383, entitled "Loxapine Film Oral Dosage Form." This film formulation patent covers Loxapine oral film formulations designed for use in patients with anxiety and agitation associated with schizophrenia and bipolar 1 disorder, and is intended to protect IntelGenx' Loxapine VersaFilm product. The new, soon to be patented, Loxapine oral film technology is designed to provide quick onset and a simple administration process for schizophrenia and bipolar 1 disorder patients. Currently, the marketed loxapine product for agitation treatment in schizophrenia and bipolar mania is an inhaler that can only be administered at certified healthcare settings under supervision of a physician. IntelGenx's Loxapine VersaFilm is intended as a rescue medication which can be administered by caregivers and, therefore, has the potential to increase availability of the drug to patients.

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Hot Stocks
IntelGenx enters research collaboration with Per Svenningsson » 08:19
02/09/23
02/09
08:19
02/09/23
08:19
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IntelGenx announced a…

IntelGenx announced a research collaboration with Per Svenningsson, MD, PhD, of the Karolinska Institute, to plan and conduct a multicentre, randomized, double-blind, placebo-controlled clinical study to investigate the use of IntelGenx's Montelukast VersaFilm for the treatment of Parkinson's Disease. Dr. Svenningsson will serve as the Principal Investigator for the planned Study and will sponsor it through a 20 million Swedish Crowns grant awarded by the Swedish Research Council, Sweden's largest governmental research funding body. IntelGenx will supply Dr. Svenningsson with both active and placebo films to be used in the 18-month treatment regimen for study participants. Upon completion of the Study, IntelGenx will retain the intellectual property rights and use the findings to further develop its Montelukast VersaFilm program for Parkinson's disease treatment. The Study is currently expected to commence in the third quarter of 2023.

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Hot Stocks
IntelGenx, Arwan enter supply agreement for RIZAPORT » 08:20
01/23/23
01/23
08:20
01/23/23
08:20
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IntelGenx entered into an…

IntelGenx entered into an exclusive supply agreement for RIZAPORTwith ARWAN Pharmaceuticals Industries Lebanon in various countries in the Middle East and North Africa region, including Lebanon, Kuwait, Saudi Arabia, United Arab Emirates, Jordan, Iraq, , Libya, Oman, Yemen, Qatar, Bahrain, Egypt, Sudan, Kenya, Nigeria, Mauritius, Cameroon, Afghanistan, Tajikistan, Kazakhstan, Turkmenistan, and Uzbekistan. Under the terms of the Agreement, IntelGenx will supply the Product to ARWAN, which will have the exclusive right to register and commercialize it in the Territory.

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Hot Stocks
IntelGenx receives fourth, final loan tranche from Atai Life Sciences » 08:28
01/09/23
01/09
08:28
01/09/23
08:28
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, ATAI

Atai Life Sciences

$1.80 /

-0.845 (-32.01%)

IntelGenx Technologies…

IntelGenx Technologies announced that its wholly-owned subsidiary, IntelGenx, has received a fourth and final term loan tranche in the amount of U.S.$3 million pursuant to its amended and restated secured loan agreement with atai Life Sciences. The obligations under the Loan are guaranteed by the Company.

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ATAI Atai Life Sciences
$1.80 /

-0.845 (-32.01%)

IGXT IntelGenx
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ATAI Atai Life Sciences
$1.80 /

-0.845 (-32.01%)

01/09/23 Canaccord
Atai Life Sciences price target lowered to $11 from $27 at Canaccord
01/09/23 Loop Capital
Atai Life Sciences price target lowered to $10 from $18 at Loop Capital
01/09/23 Citi
Atai Life Sciences price target lowered to $10 from $20 at Citi
01/06/23 EF Hutton
Atai Life Sciences price target lowered to $15 from $23 at EF Hutton
ATAI Atai Life Sciences
$1.80 /

-0.845 (-32.01%)

ATAI Atai Life Sciences
$1.80 /

-0.845 (-32.01%)

ATAI Atai Life Sciences
$1.80 /

-0.845 (-32.01%)

Hot Stocks
IntelGenx, UPEI collaborate to evaluate performance of VetaFilm in dogs, cats » 08:14
12/07/22
12/07
08:14
12/07/22
08:14
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IntelGenx announced a…

IntelGenx announced a research collaboration with the University of Prince Edward Island, UPEI, to assess palatability, owner-perceived acceptability, and ease of administration of IntelGenx's VetaFilm platform in healthy dogs and cats. Through a series of studies, the collaboration will evaluate: the acceptance rate of various VetaFilm placebo formulations in dogs and cats at first exposure; preference between flavours of VetaFilm placebo formulations in dogs and cats changes in acceptance rates over longer periods; and, owner perception of ease of administration, acceptance and other behaviors associated with VetaFilm placebo formulations. "We are thrilled to combine our efforts with one of North America's leading veterinary universities," said Dr. Horst G. Zerbe, CEO of IntelGenx. "There are a number of clinical advantages with administering drugs to pets via our VetaFilm platform. Studies have demonstrated that, when administering capsules and tablets to dogs and cats, there can be a delay in reaching the stomach. But more importantly, certain medication can cause significant mucosal damage when allowed to sit in the esophagus for a prolonged period, which is often the case when 'dry-pilling'. Finally, from a pharmacokinetic standpoint, buccal absorption may decrease the overall amount of drug required as first pass metabolism would be largely avoided. All that said, we believe offering VetaFil products that address subjective preferences of both pets and their owners and will be key to the platform's commercial success."

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Hot Stocks
IntelGenx receives FDA PDUFA date for RIXAFILM » 07:39
11/22/22
11/22
07:39
11/22/22
07:39
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IntelGenx announced that…

IntelGenx announced that the U.S. Food and Drug Administration, FDA, has accepted for review its Class 2 response to the 2020 Complete Response Letter for its 505(b)(2) New Drug Application, NDA, for RIZAFILM VersaFilm. The FDA has assigned a Prescription Drug User Fee Act, PDUFA, goal date of April 17, 2023 for completion of the review of the RIZAFILM NDA. "We are pleased to receive confirmation that the FDA is commencing its review of our NDA resubmission, and are looking forward to continuing to work with the Agency to make RIZAFILM VersaFilm available to acute migraine patients in the United States," commented Dr. Horst G. Zerbe, CEO of IntelGenx.

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