Regulation of tobacco by the U.S. Food and Drug Administration

Charlotte's Web Reports 2023 Third Quarter Financial Results

Retrieved on: 
Thursday, November 9, 2023

New CEO Reinvigorates Organizational Focus and Strategic Discipline; Washington D.C. Making Headway on Federal CBD Regulatory Framework

Key Points: 
  • New CEO Reinvigorates Organizational Focus and Strategic Discipline; Washington D.C. Making Headway on Federal CBD Regulatory Framework
    LOUISVILLE, Colo., Nov. 9, 2023 /PRNewswire/ - (TSX: CWEB) (OTCQX: CWBHF), Charlotte's Web Holdings, Inc. ("Charlotte's Web" or the "Company"), the market leader in full spectrum hemp extract wellness products, today reported financial results for the third quarter ended September 30, 2023.
  • On September 13, 2023, Charlotte's Web appointed Bill Morachnick, Chief Executive Officer of the Company.
  • "Since I joined Charlotte's Web in the late third quarter, I have been truly impressed by the talent, passion, and scientific expertise within the company," stated Bill Morachnick, the CEO of Charlotte's Web.
  • In early 2023, Charlotte's Web initiated a plan to move the production of topical products in-house.

Ascidian Therapeutics Raises $40 Million in Series A Extension Financing from Apple Tree Partners and Appoints Michael Ehlers as Interim CEO

Retrieved on: 
Wednesday, November 8, 2023

BOSTON, Nov. 8, 2023 /PRNewswire/ -- Ascidian Therapeutics, a biotechnology company focused on treating human diseases by rewriting RNA, today announced $40 million in Series A extension funding committed by Apple Tree Partners (ATP). The funds will be used to advance Ascidian's lead program, an RNA exon editor to halt the progression of Stargardt disease or other ABCA4 retinopathies, and additional programs in the company's pipeline. The company also announced that its founding CEO Michael Ehlers, M.D., Ph.D., will return as interim President and Chief Executive Officer, effective immediately. Dr. Ehlers, who also chairs Ascidian's Board of Directors and serves as Chief Scientific Officer at ATP as well as a venture partner at the firm, succeeds Romesh Subramanian, Ph.D., who is departing Ascidian.

Key Points: 
  • The company also announced that its founding CEO Michael Ehlers, M.D., Ph.D., will return as interim President and Chief Executive Officer, effective immediately.
  • Dr. Ehlers, who also chairs Ascidian's Board of Directors and serves as Chief Scientific Officer at ATP as well as a venture partner at the firm, succeeds Romesh Subramanian, Ph.D., who is departing Ascidian.
  • Today's announced financing follows ATP's initial $50 million Series A investment in Ascidian announced in October 2022.
  • Beyond its lead program, Ascidian is advancing programs with first-in-class potential in neurological and neuromuscular disorders.

SHAREHOLDER ALERT: The Gross Law Firm Notifies Shareholders of Brainstorm Cell Therapeutics Inc. of a Class Action Lawsuit and a Lead Plaintiff Deadline of January 2, 2024 – (NASDAQ: BCLI)

Retrieved on: 
Wednesday, November 8, 2023

Appointment as lead plaintiff is not required to partake in any recovery.

Key Points: 
  • Appointment as lead plaintiff is not required to partake in any recovery.
  • DEADLINE: January 2, 2024 Shareholders should not delay in registering for this class action.
  • The deadline to seek to be a lead plaintiff is January 2, 2024.
  • The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship.

Governments Need to Keep up with Innovative Breakthroughs to Benefit Public Health, Reveals International Survey Commissioned by PMI

Retrieved on: 
Wednesday, November 8, 2023

Over half of respondents (56 percent) believe their governments need to consider the role that smoke-free alternatives can play in eradicating cigarette use in their country.

Key Points: 
  • Over half of respondents (56 percent) believe their governments need to consider the role that smoke-free alternatives can play in eradicating cigarette use in their country.
  • “In the case of cigarettes, those paying the highest price are adult smokers in need of better options.
  • The survey reveals that citizens want their governments to embrace innovation and rely on scientific facts and data to guide their decision-making.
  • “Across the world, people are counting on their governments to stay on top of technological developments while ensuring innovative products are appropriately regulated,” said Verdeaux.

Lyra Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, November 7, 2023

WATERTOWN, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lyra Therapeutics, Inc. (Nasdaq: LYRA) (“Lyra” or the “Company”), a clinical-stage biotechnology company developing long-acting anti-inflammatory therapies for the localized treatment of chronic rhinosinusitis (CRS), today reported its financial results for the third quarter ended September 30, 2023 and provided a corporate update.  

Key Points: 
  • The Company plans to submit results of the BEACON study for presentation at an upcoming medical meeting.
  • In August 2023, Lyra announced completion of enrollment in the pivotal Phase 3 ENLIGHTEN I clinical trial.
  • Cash, cash equivalents and short-term investments as of September 30, 2023 were $102.6 million, compared with $116.2 million at June 30, 2023.
  • Net loss for the quarter ended September 30, 2023 was $15.7 million compared to $14.8 million for the same period in 2022.

NeuroSigma Announces FDA 510(k) Submission for Second Generation Monarch eTNS System

Retrieved on: 
Tuesday, November 7, 2023

LOS ANGELES, Nov. 07, 2023 (GLOBE NEWSWIRE) -- NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System™ (Monarch 2.0).

Key Points: 
  • LOS ANGELES, Nov. 07, 2023 (GLOBE NEWSWIRE) -- NeuroSigma today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its second-generation Monarch eTNS System™ (Monarch 2.0).
  • The Monarch eTNS System was the first-ever wearable medical device to receive FDA clearance as a treatment for pediatric ADHD, and the 510(k) submission is the first step in the FDA review process to obtain clearance for Monarch 2.0.
  • Compared to the first-generation Monarch eTNS System, Monarch 2.0 has a smaller form factor, streamlined user interface, and an improved, longer duration battery.
  • “Submission of the 510(k) for Monarch 2.0 is an important milestone for NeuroSigma and we look forward to working with FDA to obtain clearance,” said Colin Kealey, M.D., President and CEO of NeuroSigma.

Minerva Neurosciences Reports 2023 Third Quarter Financial Results and Business Updates

Retrieved on: 
Tuesday, November 7, 2023

BURLINGTON, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the third quarter ended September 30, 2023.

Key Points: 
  • BURLINGTON, Mass., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central nervous system disorders, today reported business updates and financial results for the third quarter ended September 30, 2023.
  • Research and development (R&D) expense: For the three months ended September 30, 2023 and 2022, R&D expense was $3.4 million and $2.4 million, respectively.
  • For the nine months ended September 30, 2023 and 2022, R&D expense was $8.0 million and $11.5 million, respectively.
  • For the nine months ended September 30, 2023 and 2022, non-cash interest expense was $6.1 million and $5.5 million, respectively.

Philip Morris International to Present at Chief Executives for Corporate Purpose (CECP) CEO Investor Forum 2023

Retrieved on: 
Tuesday, November 7, 2023

Philip Morris International Inc. (PMI) (NYSE: PM)’s Chief Executive Officer, Jacek Olczak will hold a presentation and Q&A session at the CECP CEO Investor Forum 2023 on Tuesday, November 14, 2023, at 11:00 a.m.

Key Points: 
  • Philip Morris International Inc. (PMI) (NYSE: PM)’s Chief Executive Officer, Jacek Olczak will hold a presentation and Q&A session at the CECP CEO Investor Forum 2023 on Tuesday, November 14, 2023, at 11:00 a.m.
  • Philip Morris International (PMI) is a leading international tobacco company working to deliver a smoke-free future and evolving its portfolio for the long term to include products outside of the tobacco and nicotine sector.
  • Smoke-free products accounted for approximately 36.2% of PMI’s total third-quarter 2023 net revenues.
  • For more information, please visit www.pmi.com and www.pmiscience.com
    View source version on businesswire.com: https://www.businesswire.com/news/home/20231107938425/en/

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Brainstorm Cell Therapeutics Inc. (BCLI) Investors

Retrieved on: 
Tuesday, November 7, 2023

Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) securities between August 15, 2022 and September 27, 2023, inclusive (the “Class Period”).

Key Points: 
  • Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) securities between August 15, 2022 and September 27, 2023, inclusive (the “Class Period”).
  • Brainstorm Cell investors have until January 2, 2024 to file a lead plaintiff motion.
  • Investors suffering losses on their Brainstorm Cell investments are encouraged to contact the Law Offices of Howard G. Smith to discuss their legal rights in this class action at 888-638-4847 or by email to [email protected] .
  • On November 10, 2022, Brainstorm Cell disclosed that the U.S. Food and Drug Administration (“FDA”) had rejected its New Biologics License Application (“BLA”) for its ALS treatment, NurOwn.

The Law Offices of Frank R. Cruz Announces the Filing of a Securities Class Action on Behalf of Brainstorm Cell Therapeutics Inc. (BCLI) Investors

Retrieved on: 
Tuesday, November 7, 2023

The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) securities between August 15, 2022 and September 27, 2023, inclusive (the “Class Period”).

Key Points: 
  • The Law Offices of Frank R. Cruz announces that a class action lawsuit has been filed on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) securities between August 15, 2022 and September 27, 2023, inclusive (the “Class Period”).
  • Brainstorm Cell investors have until January 2, 2024 to file a lead plaintiff motion.
  • On November 10, 2022, Brainstorm Cell disclosed that the U.S. Food and Drug Administration (“FDA”) had rejected its New Biologics License Application (“BLA”) for its ALS treatment, NurOwn.
  • On this news, Brainstorm Cell’s stock price fell $1.22, or 42.2%, to close at $1.67 per share on November 10, 2022, thereby injuring investors.