Major depressive disorder

Neuronetics Announces Expanded TMS Therapy Access Through Aetna® Health Plans

Retrieved on: 
Wednesday, July 19, 2023

Effective immediately, Aetna now allows transcranial magnetic stimulation (TMS) treatment to be ordered and conducted under the supervision of behavioral health nurse practitioners for patients with major depressive disorder (MDD).

Key Points: 
  • Effective immediately, Aetna now allows transcranial magnetic stimulation (TMS) treatment to be ordered and conducted under the supervision of behavioral health nurse practitioners for patients with major depressive disorder (MDD).
  • Also included in the update is the removal of a four-month psychotherapy trial before a patient becomes eligible to receive an initial course of treatment with TMS.
  • This policy update builds on recent momentum from both commercial and government payers to expand coverage to TMS Therapy.
  • Neuronetics is the only TMS company in the industry with a dedicated health policy team that partners with both providers and payers to advocate for health policy changes.

NeuroStar Achieves Milestone Regulatory Clearance in South Korea

Retrieved on: 
Monday, July 17, 2023

This marks the first international market where NeuroStar has obtained marketing authorization for the expanded indication and cutting-edge technologies.

Key Points: 
  • This marks the first international market where NeuroStar has obtained marketing authorization for the expanded indication and cutting-edge technologies.
  • The NeuroStar 3.7 platform standardizes the NeuroStar hardware globally and includes advancements designed to streamline a clinician’s workflow, such as a touchscreen display with a biometric fingerprint reader.
  • South Korea was also reported to have the greatest suicide rate among nations of the Organization of Economic Cooperation and Development (OECD)2.
  • As a market leader in TMS within the South Korean market, NeuroStar aims to fill this unmet need and has partnered with distributor DK Healthcare to expand access to NeuroStar TMS.

Vistagen Reports New Preclinical Data Supporting Itruvone (PH10) Nasal Spray’s Potential Antidepressant Activity via Peripheral Nasal Neurons without Entry into the Brain

Retrieved on: 
Monday, July 17, 2023

The study demonstrated that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma.

Key Points: 
  • The study demonstrated that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma.
  • “Itruvone’s unique mechanism of action is further demonstrated in this new carbon-labeled study,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • This can lead to unwanted side effects and create potential drug-drug interaction concerns for some individuals who require additional medications for other medical conditions.
  • In that study, itruvone was administered intranasally at a daily dose of 3.2 μg and 6.4 μg for 8 weeks.

Bragar Eagel & Squire, P.C. Is Investigating Shift4, Waldencast, Relmada, and DoubleVerify and Encourages Investors to Contact the Firm

Retrieved on: 
Monday, July 17, 2023

Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.

Key Points: 
  • Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.
  • Additional information about each case can be found at the link provided.
  • Specifically, the REL-1017 treatment showed a MADRS reduction of 14.8 points at Day 28 versus 13.9 points for placebo, a higher-than-expected placebo response.
  • On this news, DoubleVerify’s share price fell $1.69, or 5.8%, to close at $27.22 per share on May 2, 2023, thereby injuring investors.

BetterLife Highlights American College of Physicians’ Updated Guidelines for Treating Depression and Announces Closing of Private Placement

Retrieved on: 
Thursday, July 13, 2023

We believe that our compound, BETR-001, has the potential to overcome the hurdles faced by psychedelics, making it potentially a treatment for a broader and more inclusive range of patients.

Key Points: 
  • We believe that our compound, BETR-001, has the potential to overcome the hurdles faced by psychedelics, making it potentially a treatment for a broader and more inclusive range of patients.
  • BETR-001 is a non-hallucinogenic derivative of lysergic acid diethylamide (“LSD”) and covered by BetterLife’s pending patents.
  • Based on its neuro-receptor activity profile in preclinical studies, we believe that BetterLife’s BETR-001 has significant therapeutic potential in various neuro-psychiatric disorders.
  • The Units sold pursuant to the Offering will be subject to a four month hold period pursuant to applicable Canadian securities laws.

Bragar Eagel & Squire, P.C. Is Investigating Shift4, Waldencast, Chegg, and Relmada and Encourages Investors to Contact the Firm

Retrieved on: 
Tuesday, July 11, 2023

Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.

Key Points: 
  • Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.
  • Specifically, the Company is conducting an analysis regarding certain accounting issues in connection with the sale of certain Obagi products for the Vietnam market.
  • Then, on May 1, 2023, Chegg held a conference call to discuss its results for the first quarter of 2023.
  • On the call, Rosensweig stated that "since March, we saw a significant spike in student interest in ChatGPT.

Bragar Eagel & Squire, P.C. Is Investigating Shift4, Waldencast, Chegg, and Relmada and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 6, 2023

Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.

Key Points: 
  • Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.
  • Specifically, the Company is conducting an analysis regarding certain accounting issues in connection with the sale of certain Obagi products for the Vietnam market.
  • Then, on May 1, 2023, Chegg held a conference call to discuss its results for the first quarter of 2023.
  • On the call, Rosensweig stated that "since March, we saw a significant spike in student interest in ChatGPT.

Small Pharma Announces Management Team Change

Retrieved on: 
Wednesday, July 5, 2023

Mr. Rands commented: “I started Small Pharma with a vision to create innovative pharmaceutical products based on known compounds that could be transformative for people suffering from mental health disorders.

Key Points: 
  • Mr. Rands commented: “I started Small Pharma with a vision to create innovative pharmaceutical products based on known compounds that could be transformative for people suffering from mental health disorders.
  • I am immensely proud of the Small Pharma team of scientists and innovators whom I have had the privilege of working alongside, and who have made this progress possible.”
    Mr. Rands founded Small Pharma in 2015, building the team and infrastructure to enable significant clinical milestones, including the achievement of the first placebo-controlled proof-of-concept results for N,N-dimethyltryptamine (“DMT”) in patients with Major Depressive Disorder.
  • During his time at Small Pharma, Peter assembled a world-class team that has achieved multiple research and development milestones and positive trial results, establishing the Company as a leader amongst psychedelic biotechnology companies.
  • On behalf of the board of directors and the Small Pharma team, I want to thank Peter for his leadership.

Bragar Eagel & Squire, P.C. Is Investigating Seagate, Chegg, Relmada, and DoubleVerify and Encourages Investors to Contact the Firm

Retrieved on: 
Saturday, July 1, 2023

Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.

Key Points: 
  • Our investigations concern whether these companies have violated the federal securities laws and/or engaged in other unlawful business practices.
  • This historic foreign direct product enforcement case and settlement represents the largest standalone administrative penalty in BIS history.
  • Then, on May 1, 2023, Chegg held a conference call to discuss its results for the first quarter of 2023.
  • On this news, DoubleVerify’s share price fell $1.69, or 5.8%, to close at $27.22 per share on May 2, 2023, thereby injuring investors.

Small Pharma Reports Financial Results for the Fiscal Year Ended February 28, 2023 and Recent Business Highlights

Retrieved on: 
Wednesday, June 28, 2023

LONDON, June 28, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, has today published its financial results for the fiscal year ended February 28, 2023. A complete copy of the audited consolidated financial statements prepared in accordance with International Financial Reporting Standards and the corresponding management’s discussion and analysis can be found under the Company’s profile on SEDAR at www.sedar.com. Unless otherwise indicated, all currency references are in Canadian dollars.

Key Points: 
  • LONDON, June 28, 2023 (GLOBE NEWSWIRE) -- Small Pharma Inc. (TSXV: DMT) (OTCQB: DMTTF) (the “Company” or “Small Pharma”), a biotechnology company focused on short-duration psychedelic-assisted therapies for mental health conditions, has today published its financial results for the fiscal year ended February 28, 2023.
  • Financial Highlights (including post-period events)1:
    Cash on hand as of February 28, 2023 was approximately $18.5 million.
  • Cash used in operating activities was $22.2 million for the 12 months ended February 28, 2023.
  • Small Pharma has advanced its clinical program of SPL026, with ongoing exploratory studies to evaluate additional formulations and treatment populations.