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

OTLK INVESTOR DEADLINE: Robbins Geller Rudman & Dowd LLP Announces that Outlook Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

Retrieved on: 
Monday, November 6, 2023
Class Action Lawsuit, Professional Services, Legal, Bevacizumab, FDA, Food, Agency, AMD, CMC, CASE, News, Regulation of tobacco by the U.S. Food and Drug Administration, Outlook, Safety, Therapy, Robbins Geller Rudman & Dowd LLP, BLA, Medical device, Tobacco, Pharmaceutical industry

), the Outlook Therapeutics class action lawsuit charges Outlook Therapeutics and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

Key Points: 
  • ), the Outlook Therapeutics class action lawsuit charges Outlook Therapeutics and certain of its top executive officers with violations of the Securities Exchange Act of 1934.
  • A lead plaintiff acts on behalf of all other class members in directing the Outlook Therapeutics class action lawsuit.
  • The lead plaintiff can select a law firm of its choice to litigate the Outlook Therapeutics class action lawsuit.
  • An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Outlook Therapeutics class action lawsuit.

Cybeats Highlights Favorable U.S. Cyber Policy, Executive Orders and Industry Advancement; White House Features Cybeats in Recent Release

Retrieved on: 
Tuesday, November 7, 2023
Internet of things, FDA, Nation, Policy, Food, NIST, Medical device, White House, Life, MDM, Executive order, Regulation of tobacco by the U.S. Food and Drug Administration, Federal Food, Drug, and Cosmetic Act, Administration, CSE, Artificial intelligence, CYBT, ETSI, FD, Ecosystem, Risk assessment, White, RTA, Privacy, Federal, Safety, AI, CISA, SBOM, EU

A U.S. White House statement released on October 31, 2023 followed a White House Executive Order on artificial intelligence ("AI"), that included novel software inventory requirements on AI.

Key Points: 
  • A U.S. White House statement released on October 31, 2023 followed a White House Executive Order on artificial intelligence ("AI"), that included novel software inventory requirements on AI.
  • This statement featured Cybeats as part of an innovative industry coalition in support of the White House on this new AI Executive order.1
    "At Cybeats, we've been dedicated to creating a solution for companies to manage the economic and security challenges of adopting SBOMs," said Dmitry Raidman, CTO, Cybeats.
  • "From the early days of our involvement with shaping SBOM standards, to now leading the SBOM management market, we're quite proud.
  • The FDA's Refuse-to-Accept ("RTA") authority as of March 29, 2023 emphasizes the significance of SBOM management solutions like SBOM Studio.

Aquestive Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023
Anaphylaxis, FDA, Emergency, Sale, PDUFA, Food, Seizure, Clobazam, Lennox–Gastaut syndrome, EBITDA, Adrenaline, Net, Attention deficit hyperactivity disorder, Regulation of tobacco by the U.S. Food and Drug Administration, Research, Clutch (eggs), Offering, Pharmacokinetics, Senior, Diazepam, PK, New Drug Application, Allergy, NDA, Therapy, Note, Patient, ADHD, Pharmaceutical industry, Video game, Bookkeeping

“We continue to successfully execute on our 2023 key initiatives as demonstrated by our third quarter 2023 results,” said Daniel Barber, Chief Executive Officer of Aquestive.

Key Points: 
  • “We continue to successfully execute on our 2023 key initiatives as demonstrated by our third quarter 2023 results,” said Daniel Barber, Chief Executive Officer of Aquestive.
  • The Company is on track to commence its initial Phase 3 pivotal PK study for Anaphylm in the fourth quarter 2023.
  • Total reported revenues were $13.0 million in the third quarter 2023, compared to $11.5 million in the third quarter 2022.
  • Aquestive is updating its full-year 2023 financial guidance based on third quarter 2023 results and updated outlook for the remainder of 2023.

Vaxcyte Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, November 6, 2023
PCV, FDA, Genetically modified bacteria, IND, Ageing, Food, Biologics license application, Immunization, Advisory Committee on Immunization Practices, Second Half, IPD, CMC, G&A, Net, Research and development, Stage 2, Regulation of tobacco by the U.S. Food and Drug Administration, Investment, R, Infant, Licensure, Data monitoring committee, Growth, Advisory Committee, General Administration of Sport of China, Success, Safety, Administration, BLA, SAN, Pharmaceutical industry, Vaccine, Cryptocurrency, Fine chemical

-- $1.4 Billion in Cash, Cash Equivalents and Investments as of September 30, 2023 --

Key Points: 
  • Initiation of the Phase 1/2 study in the fourth quarter of 2023.
  • Cash Position: Cash, cash equivalents and investments were $1,434.2 million as of September 30, 2023, compared to $957.9 million as of December 31, 2022.
  • The increase was due primarily to higher personnel-related expenses related to the growth in G&A employees as the Company continues to scale.
  • Net Loss: For the three months ended September 30, 2023, net loss was $92.7 million, compared to $57.9 million for the same period in 2022.

SHAREHOLDER ALERT: Levi & Korsinsky Notifies Brainstorm Cell Therapeutics Inc. (BCLI) Investors of a Class Action Lawsuit and Upcoming Deadline

Retrieved on: 
Monday, November 6, 2023
Food, Biologics license application, Telephone, CASE, Court, Regulation of tobacco by the U.S. Food and Drug Administration, NEXT, LLP, Levi, COST, CLASS, Cryptocurrency

NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.

Key Points: 
  • NEW YORK, Nov. 06, 2023 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Brainstorm Cell Therapeutics Inc. ("Brainstorm Cell" or the "Company") (NASDAQ: BCLI) of a class action securities lawsuit.
  • CLASS DEFINITION: The lawsuit seeks to recover losses on behalf of Brainstorm Cell investors who were adversely affected by alleged securities fraud between August 15, 2022 and September 27, 2023.
  • Follow the link below to get more information and be contacted by a member of our team:
    BCLI investors may also contact Joseph E. Levi, Esq.
  • For seven years in a row, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report as one of the top securities litigation firms in the United States.

OTLK INVESTOR ALERT: Robbins Geller Rudman & Dowd LLP Announces that Outlook Therapeutics, Inc. Investors with Substantial Losses Have Opportunity to Lead the Outlook Therapeutics Class Action Lawsuit

Retrieved on: 
Saturday, November 4, 2023
Bevacizumab, FDA, Food, Agency, AMD, CMC, CASE, News, Regulation of tobacco by the U.S. Food and Drug Administration, Outlook, Safety, Therapy, BLA, SAN, Tobacco, Pharmaceutical industry

), the Outlook Therapeutics class action lawsuit charges Outlook Therapeutics and certain of its top executive officers with violations of the Securities Exchange Act of 1934.

Key Points: 
  • ), the Outlook Therapeutics class action lawsuit charges Outlook Therapeutics and certain of its top executive officers with violations of the Securities Exchange Act of 1934.
  • A lead plaintiff acts on behalf of all other class members in directing the Outlook Therapeutics class action lawsuit.
  • The lead plaintiff can select a law firm of its choice to litigate the Outlook Therapeutics class action lawsuit.
  • An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff of the Outlook Therapeutics class action lawsuit.

BRAINSTORM SHAREHOLDER ACTION REMINDER: Faruqi & Faruqi Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Barclays To Contact Him Directly To Discuss Their Options

Retrieved on: 
Saturday, November 4, 2023
FDA, Food, News, Court, Advertising, Regulation of tobacco by the U.S. Food and Drug Administration, Woman, LLP, ALS, BLA, Cryptocurrency, Pharmaceutical industry, Brainstorm

NEW YORK, Nov. 04, 2023 (GLOBE NEWSWIRE) -- Faruqi & Faruqi, LLP, a leading national securities law firm, is investigating potential claims against Brainstorm Cell Therapeutics Inc. (“Brainstorm” or the “Company”) (NASDAQ: BCLI) and reminds investors of the January 2, 2024 deadline to seek the role of lead plaintiff in a federal securities class action that has been filed against the Company.

Key Points: 
  • Faruqi & Faruqi is a leading minority and Woman-owned national securities law firm with offices in New York, Pennsylvania, California and Georgia.
  • On September 27, 2023, the U.S. Food and Drug Administration ("FDA") issued a briefing document rejecting Brainstorm Cell's experimental ALS drug.
  • Despite this, Brainstorm Cell opted for the regulatory procedure of "filing over protest" and still filed the BLA.
  • Faruqi & Faruqi, LLP also encourages anyone with information regarding Brainstorm’s conduct to contact the firm, including whistleblowers, former employees, shareholders and others.

Shareholder Alert: Robbins LLP Informs Shareholders of Class Action Filed Against Brainstorm Cell Therapeutics Inc. (BCS)

Retrieved on: 
Friday, November 3, 2023
FDA, Complaint, Food, Biologics license application, Biotechnology, Viability, Person, News, Regulation of tobacco by the U.S. Food and Drug Administration, ALS, LLP, Efficacy, Gene, Cellular, BLA, SAN, Pharmaceutical industry

SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Robbins LLP informs investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) securities between August 15, 2022 and September 27, 2023.

Key Points: 
  • SAN DIEGO, Nov. 03, 2023 (GLOBE NEWSWIRE) -- Robbins LLP informs investors that a shareholder filed a class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Brainstorm Cell Therapeutics Inc. (NASDAQ: BCLI) securities between August 15, 2022 and September 27, 2023.
  • Brainstorm Cell is a biotechnology company that develops and commercializes autologous cellular therapies for the treatment of neurodegenerative diseases.
  • For more information, submit a form , email Aaron Dumas, Jr., or give us a call at (800) 350-6003.
  • What Now: Similarly situated shareholders may be eligible to participate in the class action against Brainstorm Cell Therapeutics Inc. Shareholders who want to act as lead plaintiff for the class should contact Robbins LLP.

Editas Medicine Announces Third Quarter 2023 Results and Business Updates

Retrieved on: 
Friday, November 3, 2023
FDA, Research, Regenerative Medicine Advanced Therapy, Food, Spinal muscular atrophy, Biogen, SCD, Life, Public expenditure, TDT, Cas9, Sickle cell disease, Regulation of tobacco by the U.S. Food and Drug Administration, Poster, Society, ASH, Commercialization, HSC, File, Fetal hemoglobin, Collaboration, Lead, Beta thalassemia, Anemia, Multiple sclerosis, Bone marrow, Therapy, Patient, BLA, MS, Pharmaceutical industry, Cryptocurrency, Edith A. Perez, Editas Medicine, EU

CAMBRIDGE, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today reported financial results for the third quarter 2023 and provided business updates.

Key Points: 
  • CAMBRIDGE, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Editas Medicine, Inc. (Nasdaq: EDIT), a clinical-stage genome editing company, today reported financial results for the third quarter 2023 and provided business updates.
  • Cash, cash equivalents, and marketable securities as of September 30, 2023, were $446.4 million compared to $480.0 million as of June 30, 2023.
  • The increase is primarily related to an upfront payment for the non-exclusive Cas9 license to Vor Bio in the third quarter of 2023.
  • Editas Medicine plans to participate in the following scientific and medical conference:
    Editas Medicine plans to participate in the following investor events:

Prime Medicine Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Friday, November 3, 2023
Gene editing, International Symposium on Endovascular Therapy, FDA, Research, Food, Rhodopsin, Human, Congress, Fragile X syndrome, G&A, Liver, CFTR, Chromosomal translocation, Regulation of tobacco by the U.S. Food and Drug Administration, Cell, Initial, R, Society, ASH, RHO, Tissue, Lung, Cystic fibrosis, Prime editing, Gene, Composition, Abstract, LNP, Eye, Safety, European Society of Clinical Microbiology and Infectious Diseases, Investment, CGD, Patient, Retina, NHP, Patent, D, Vaccine, Pharmaceutical industry, Fine chemical, Beef cattle, Video game, Cryptocurrency, IND

CAMBRIDGE, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results and provided business updates for the third quarter ended September 30, 2023.

Key Points: 
  • 11,795,452 --
    CAMBRIDGE, Mass., Nov. 03, 2023 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today reported financial results and provided business updates for the third quarter ended September 30, 2023.
  • Together, these encouraging results mark meaningful progress toward the clinic and support our strategy of simultaneously advancing multiple programs forward.
  • In August 2023, Prime Medicine received Rare Pediatric Drug designation (RPDD) from the U.S. Food and Drug Administration (FDA) for PM359.
  • Year-to-date, Prime Medicine continues to make significant progress, executing against key initiatives to drive its Prime Editing platform forward.