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

APELLIS ALERT: Bragar Eagel & Squire, P.C. is Investigating Apellis Pharmaceuticals, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, November 3, 2023

Our investigation concerns whether the board of directors of Apellis have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Apellis have breached their fiduciary duties to the company.
  • Apellis is a commercial-stage biopharmaceutical company that focuses on the discovery, development, and commercialization of therapeutic compounds through the inhibition of the complement system for autoimmune and inflammatory diseases.
  • SYFOVRE is designed to provide comprehensive control of the complement cascade, part of the body’s immune system.
  • Apellis also stated that the company is evaluating an eighth reported event of retinal vasculitis, which Apellis had not yet confirmed.

Newly Elected Dermatologic Surgeons to Begin Leadership Terms at the 2023 ASDS Annual Meeting

Retrieved on: 
Friday, November 3, 2023

Schaumburg, IL, Nov. 03, 2023 (GLOBE NEWSWIRE) -- The American Society for Dermatologic Surgery (ASDS) is pleased to announce its newly elected leaders, whose terms will begin following the Society’s Annual Membership Meeting on Friday, Nov. 3, led by ASDS/A President Vince Bertucci, MD, FRCPC.

Key Points: 
  • Schaumburg, IL, Nov. 03, 2023 (GLOBE NEWSWIRE) -- The American Society for Dermatologic Surgery (ASDS) is pleased to announce its newly elected leaders, whose terms will begin following the Society’s Annual Membership Meeting on Friday, Nov. 3, led by ASDS/A President Vince Bertucci, MD, FRCPC.
  • The individuals elected to serve the Society will also serve in the same position for the same tenure with the Society’s advocacy arm, American Society for Dermatologic Surgery Association (ASDSA).
  • Dr. Mariwalla will proceed in succession from Vice President to President-Elect and assume the role of President for the 2024-25 term.
  • Dr. Hooper will present the 2023 financial report at the Annual Membership Meeting and serve her final year as the Society’s Treasurer in 2023-24.

Data on Early Clinical Benefit for INPEFA® (Sotagliflozin) Will Be Among Five Lexicon-Sponsored Presentations at the American Heart Association Scientific Sessions 2023

Retrieved on: 
Thursday, November 2, 2023

THE WOODLANDS, Texas, Nov. 02, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that five data presentations related to INPEFA® (sotagliflozin) will be delivered during the American Heart Association Scientific Sessions 2023, November 11-13, 2023, at the Pennsylvania Convention Center in Philadelphia, PA.

Key Points: 
  • “Our significant upcoming presence at the American Heart Association Scientific Sessions 2023 reflects the dedication of investigators to expanding the scientific evidence available to clinicians and payers as they make decisions around how to best utilize available treatment options in patients,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.
  • “We look forward to engaging with attendees and continuing to demonstrate both the clinical and economic value of INPEFA.”
    Details of the presentations are as follows:
    Sotagliflozin is associated with early clinical benefit for heart failure and atherosclerotic events – an oral presentation, Sunday, November 12, 2:10 - 2:15 p.m.
  • ET, Board #2122, presented by Slaven Sikirica, M.Sc., Lexicon Pharmaceuticals
    Sotagliflozin, a dual SGLT 1 and 2 Inhibitor, has high membrane affinity and hydrocarbon core location compared with empagliflozin – an ePoster, Sunday, November 12, 3:30 - 3:45 p.m.
  • ET, Board #2222, presented by Preston Mason, M.D., Brigham and Women’s Hospital, Boston, MA
    Relationship between left ventricular ejection fraction and ICD-10 codes among patients hospitalized with heart failure – a poster presentation, Saturday, November 11, 3:00 - 4:15 p.m.

GT Biopharma Reports Third Quarter 2023 Financial Results

Retrieved on: 
Wednesday, November 1, 2023

“We continue to move forward in advancing our novel portfolio of TriKE® nanobody assets,” said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma.

Key Points: 
  • “We continue to move forward in advancing our novel portfolio of TriKE® nanobody assets,” said Michael Breen, Executive Chairman and interim Chief Executive Office of GT Biopharma.
  • Following FDA acceptance, we plan to host a KOL event highlighting the anticipated Phase 1 clinical trial design and timelines for data.
  • The increase in interest income was due to higher interest rates offered by financial institutions in the three months and nine months ended September 30, 2023 as compared to the same comparable periods of 2022.
  • The increase in gain resulted due to a change in the fair value of the warrant liability during the three months and nine months ended September 30, 2023.

Ardelyx Reports Third Quarter 2023 Financial Results and Updates 2023 U.S. IBSRELA® Net Sales Revenue Guidance

Retrieved on: 
Tuesday, October 31, 2023

WALTHAM, Mass., Oct. 31, 2023 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • “Demonstrating consistent, quarter-over-quarter growth of IBSRELA prescriptions during the third quarter, we achieved a 22 percent increase in net sales revenue.
  • We have raised our full year U.S. net sales revenue guidance for IBSRELA, reflecting the important benefit this product is offering to patients.
  • Driven by increased demand for IBSRELA, the company reported net sales revenue of $22.3 million in the third quarter, 22 percent quarter-over-quarter growth compared to the second quarter of 2023.
  • Ardelyx currently expects full-year 2023 U.S. net product revenue for IBSRELA to be between $76.0 and $78.0 million.

New Data Relating to Sotagliflozin to be Presented at the American Society of Nephrology (ASN) Kidney Week 2023 Annual Meeting

Retrieved on: 
Monday, October 30, 2023

THE WOODLANDS, Texas, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that analyses of clinical study results relating to sotagliflozin, as well as data from a Lexicon-supported scientific study of patients hospitalized with heart failure who also had chronic kidney disease (CKD), will be presented during the American Society of Nephrology (ASN) Kidney Week Annual Meeting, November 2-5, 2023, at the Pennsylvania Convention Center in Philadelphia, PA.

Key Points: 
  • THE WOODLANDS, Texas, Oct. 30, 2023 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that analyses of clinical study results relating to sotagliflozin, as well as data from a Lexicon-supported scientific study of patients hospitalized with heart failure who also had chronic kidney disease (CKD), will be presented during the American Society of Nephrology (ASN) Kidney Week Annual Meeting, November 2-5, 2023, at the Pennsylvania Convention Center in Philadelphia, PA.
  • Details of the presentations are as follows:
    Efficacy and Safety of Sotagliflozin in Patients with Type 1 Diabetes and Chronic Kidney Disease [TH-PO1144] – Late-Breaking Clinical Trial poster presentation, Thursday, November 2, 10:00 a.m. – 12:00 p.m.
  • ET, Exhibit Hall, Pennsylvania Convention Center, presented by Vikas Sridhar, M.D., University of Toronto
    Sotagliflozin and Kidney and Cardiorenal Outcomes in SCORED [FR-OR45] – an oral presentation, Friday, November 3, 5:06 - 5:15 p.m.
  • ET, Exhibit Hall, Pennsylvania Convention Center, presented by Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer
    “Across the various data presented, we seek to address the challenges and complications of diabetes and chronic kidney disease,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer.

Kirby McInerney LLP Reminds Investors That a Class Action Lawsuit Has Been Filed on Behalf of Kenvue Inc. (KVUE) Investors and Encourages Investors to Contact the Firm Before December 8, 2023

Retrieved on: 
Monday, October 30, 2023

Investors have until December 8, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.

Key Points: 
  • Investors have until December 8, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
  • On November 12, 2021, Johnson & Johnson announced the creation of Kenvue as a wholly owned consumer health subsidiary.
  • On May 3, 2022, Johnson & Johnson and Kenvue jointly announced that the price of Kenvue’s IPO would be $22 per share.
  • Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation.

Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

Retrieved on: 
Monday, October 30, 2023

The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.

Key Points: 
  • The FDA has granted priority review and assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 30, 2024.
  • The FDA is not currently planning to hold an advisory committee meeting to discuss the application.
  • For the vast majority of patients in the relapsed setting, there is no standard of care and no approved therapy.
  • Updated data was recently disclosed when the Company announced the completion of its rolling NDA submission on September 11, 2023.

Brainstorm Cell Therapeutics Inc. (BCS) Investor Notice: Robbins LLP Reminds Investors of Class Action Against Brainstorm Cell Therapeutics Inc.

Retrieved on: 
Monday, November 6, 2023

Robbins LLP reminds 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: 
  • Robbins LLP reminds 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.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Brainstorm Cell Therapeutics Inc. (BCLI) on Behalf of Investors

Retrieved on: 
Monday, November 6, 2023

Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) investors concerning the Company’s possible violations of the federal securities laws.

Key Points: 
  • Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Brainstorm Cell Therapeutics Inc. (“Brainstorm Cell” or the “Company”) (NASDAQ: BCLI ) investors concerning the Company’s possible violations of the federal securities laws.
  • You can also contact Charles H. Linehan, of GPM at 310-201-9150, Toll-Free at 888-773-9224, or via email at [email protected] to learn more about your rights.
  • 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.
  • Whistleblower Notice: Persons with non-public information regarding Brainstorm Cell should consider their options to aid the investigation or take advantage of the SEC Whistleblower Program.