Anxiolytics

SHAREHOLDER ALERT: Robbins LLP Announces That Aquestive Therapeutics, Inc. (AQST) is Being Sued for Misleading Shareholders

Retrieved on: 
Thursday, March 4, 2021

Aquestive is a specialty pharmaceutical company that develops products to address unmet medical needs.

Key Points: 
  • Aquestive is a specialty pharmaceutical company that develops products to address unmet medical needs.
  • The Company's most advanced proprietary product candidate is Libervant (diazepam), the first oral diazepam-based therapy for the treatment of recurrent epileptic seizures.
  • If you suffered a loss due to Aquestive Therapeutics, Inc.'s misconduct, click here .
  • During the relevant period, Aquestive expressed that the process for obtaining FDA approval was on target and "as expected."

The Law Offices of Frank R. Cruz Announces Investigation of Aquestive Therapeutics, Inc. (AQST) on Behalf of Investors

Retrieved on: 
Thursday, March 4, 2021

The Law Offices of Frank R. Cruz announces an investigation of Aquestive Therapeutics, Inc. (Aquestive or the Company) (NASDAQ: AQST ) on behalf of investors concerning the Companys possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Aquestive Therapeutics, Inc. (Aquestive or the Company) (NASDAQ: AQST ) on behalf of investors concerning the Companys possible violations of federal securities laws.
  • Aquestive is a specialty pharmaceutical company.
  • Its most advanced proprietary product candidate is Libervant, a buccal soluble film formulation of diazepam for the treatment of recurrent epileptic seizures.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

TAAT Lifestyle & Wellness Ltd. (CSE: TAAT) (OTCQB: TOBAF) Brings ‘Same Format, Different Ingredients’ Model to Smoking Market

Retrieved on: 
Thursday, February 25, 2021

Today, burgers and seafood look, smell and taste like hamburger and crabmeat, respectively, while being made from plants.

Key Points: 
  • Today, burgers and seafood look, smell and taste like hamburger and crabmeat, respectively, while being made from plants.
  • TAAT Lifestyle & Wellness Ltd. (CSE: TAAT) (OTCQB: TOBAF) has brought the same format, different ingredients model to the smoking market like no one before.
  • About TAATLifestyle & Wellness Ltd.
    TAAT Lifestyle and Wellness has developed TAAT, which is a tobacco-free and nicotine-free alternative to traditional cigarettes offered in Original, Smooth and Menthol varieties.
  • By cutting through the overload of information in todays market, NNW brings its clients unparalleled visibility, recognition and brand awareness.

Positive BNC210 7-Day Dosing Pharmacokinetic Study Exceeds Blood Exposure Projected for Phase 2b PTSD Trial

Retrieved on: 
Monday, February 22, 2021

A pharmacometric analysis of data from the first Phase 2 PTSD trial (RESTORE) that read out in October 2018, modelled an exposure-response relationship between BNC210 blood levels and CAPS-5 scores (the primary endpoint measure in PTSD trials), and the potential for BNC210 to treat PTSD symptoms provided that adequate blood exposure could be achieved.

Key Points: 
  • A pharmacometric analysis of data from the first Phase 2 PTSD trial (RESTORE) that read out in October 2018, modelled an exposure-response relationship between BNC210 blood levels and CAPS-5 scores (the primary endpoint measure in PTSD trials), and the potential for BNC210 to treat PTSD symptoms provided that adequate blood exposure could be achieved.
  • The tablet formulation of BNC210 replaces the liquid suspension formulation used in RESTORE which did not provide sufficient blood exposure for efficacy in that Study.
  • The BNC210 tablet will be easier for the PTSD trial participants to administer and, unlike the liquid suspension formulation, is not dependent on food intake for maximal absorption and is therefore expected to result in substantially less variable exposure in the patients in the next Phase 2b PTSD study.
  • With the dose now selected, we can initiate manufacturing of the tablets, clinical site selection and regulatory filings in preparation for a Phase 2b trial with BNC210 in PTSD patients projected for mid-2021.

Joint feasibility assessment of Bionomics' BNC210 and EmpathBio's MDMA derivative EMP-01 treatment regimen for PTSD

Retrieved on: 
Wednesday, February 17, 2021

Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01.

Key Points: 
  • Under the Memorandum of Understanding, Bionomics and EmpathBio propose to collectively explore a combination drug treatment regimen with Bionomics' BNC210 and EmpathBio's 3,4-Methylenedioxymethamphetamine (MDMA) derivative EMP-01.
  • The parties will explore whether the different mechanisms of action of EMP-01 and BNC210 may offer the potential for developing an improved treatment regimen for the treatment of Post-Traumatic Stress Disorder (PTSD).
  • BNC210 is Bionomics' lead drug candidate, which has been granted Fast Track designation by the US Food and Drug Administration (FDA) for the treatment of PTSD and other trauma-related and stress-related disorders.
  • We consider that EMP-01, a derivative of MDMA, being developed by EmpathBio could be a very interesting treatment regimen when combined with BNC210 for the treatment of PTSD.

BioXcel Therapeutics to Host Virtual Key Opinion Leader Event to Highlight BXCL501 as a Potential Treatment for Agitation and Opioid Withdrawal Symptoms

Retrieved on: 
Friday, February 12, 2021

The event aims to highlight BXCL501, the Companys investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (Dex), and its potential as a treatment option for multiple neuropsychiatric conditions.

Key Points: 
  • The event aims to highlight BXCL501, the Companys investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine (Dex), and its potential as a treatment option for multiple neuropsychiatric conditions.
  • Scott Zeller, MD, is an Assistant Clinical Professor of Psychiatry at the University of California-Riverside and Touro University medical schools.
  • Alan Breier, MD, is a Mental Health Research and Education Senior Professor of Psychiatry at Indiana University School of Medicine.
  • BXCL501 is an investigational, proprietary, orally dissolving thin film formulation of dexmedetomidine, a selective alpha-2a receptor agonist for the treatment of agitation and opioid withdrawal symptoms.

Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Retrieved on: 
Thursday, February 11, 2021

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.

Key Points: 
  • In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.
  • Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing").
  • Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
  • "I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics.

DGAP-News: Novamind Inc.: Novamind Announces Strategic Investment in Bionomics to Support PTSD Clinical Trial

Retrieved on: 
Thursday, February 11, 2021

In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.

Key Points: 
  • In addition, Cedar Clinical Research ("CCR"), a wholly owned subsidiary of Novamind based in Springville, Utah, will be evaluated by Bionomics as a clinical research site to conduct Bionomics' Phase IIb trial examining BNC210.
  • Novamind's Strategic Investment is included in Bionomics' latest round of financing, which was underwritten by Apeiron Investments and received commitments for AU$16,000,000 (approximately CAN$15,680,000, the "Bionomics Financing").
  • Proceeds from the Bionomics Financing will support the initiation of a Phase IIb trial for BNC210, planned for mid-2021.
  • "I'm happy to welcome Novamind as a strategic investor in Bionomics," said Dr. Errol De Souza, Executive Chairman of Bionomics.

$16 Million Capital Raise to Progress Bionomics BNC210 PTSD Trial

Retrieved on: 
Wednesday, February 10, 2021

Bionomics' lead drug BNC210 has already received Fast Track Designation from the FDA and I am confident of the strong potential of the upcoming Phase 2b PTSD trial to drive value for both patients and shareholders."

Key Points: 
  • Bionomics' lead drug BNC210 has already received Fast Track Designation from the FDA and I am confident of the strong potential of the upcoming Phase 2b PTSD trial to drive value for both patients and shareholders."
  • Bionomics' lead drug candidate BNC210, currently in development for initiation of a second Phase 2 trial for the treatment of PTSD, is a novel, proprietary negative allosteric modulator of the alpha-7 (7) nicotinic acetylcholine receptor.
  • Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc (known as MSD outside the United States and Canada).
  • Results of studies performed on our drug candidates and competitors' drugs and drug candidates may vary from those reported when tested in different settings.

ANI Pharmaceuticals Announces Launch of Prazosin Hydrochloride (“HCl”) Capsules

Retrieved on: 
Monday, February 1, 2021

ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Prazosin HCl Capsules USP, 1mg and 2mg, following the U.S. Food and Drug Administrations (FDA) approval of the Companys prior approval supplement application (PAS).

Key Points: 
  • ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced the launch of Prazosin HCl Capsules USP, 1mg and 2mg, following the U.S. Food and Drug Administrations (FDA) approval of the Companys prior approval supplement application (PAS).
  • "Launch of Prazosin HCl is ANIs fourteenth re-commercialization of a previously discontinued abbreviated new drug application (ANDA) product.
  • Prazosin HCl Capsules are indicated for the treatment of hypertension, to lower blood pressure.
  • ANI Pharmaceuticals, Inc. is an integrated specialty pharmaceutical company developing, manufacturing, and marketing branded and generic prescription pharmaceuticals.