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

Optinose Reports Third Quarter 2023 Financial Results and Operational Updates

Retrieved on: 
Jeudi, novembre 9, 2023

YARDLEY, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) --  Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended September 30, 2023, and provided operational updates.

Key Points: 
  • We are pleased with the progress we made in the third quarter towards our 2023 operating objectives while sharply reducing expenses.
  • Today’s results show that we are outperforming our initial expectations for 2023 XHANCE net revenues while operating far more efficiently and preparing our organization for a successful launch in 2024.
  • Previously, the Company expected XHANCE net revenues for the full year of 2023 to be between $64.0 to $70.0 million.
  • Members of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today.

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

Retrieved on: 
Jeudi, novembre 9, 2023

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

Retrieved on: 
Mercredi, novembre 8, 2023

SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- 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.

Key Points: 
  • SAN DIEGO, Nov. 08, 2023 (GLOBE NEWSWIRE) -- 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.

Don Hardison Appointed Chairman of the Board at Geneoscopy

Retrieved on: 
Jeudi, novembre 9, 2023

Geneoscopy , a life sciences company focused on developing diagnostic tests for gastrointestinal health, has appointed Don Hardison as Chairman of its Board of Directors.

Key Points: 
  • Geneoscopy , a life sciences company focused on developing diagnostic tests for gastrointestinal health, has appointed Don Hardison as Chairman of its Board of Directors.
  • Having previously served as a strategic advisor to Geneoscopy before joining the board in February 2023, Hardison is well-acquainted with the company's vision and strategy.
  • In his expanded role as Chairman of the Board, he will provide insight and guidance as Geneoscopy prepares to commercialize its flagship product – ColoSense™, a noninvasive, stool-based, at-home screening test designed to detect colorectal cancer and advanced adenomas in average-risk individuals.
  • "As an advisor and board member, I have been impressed by what Geneoscopy has accomplished, and I'm honored to assume the role of Chairman of the Board at Geneoscopy during this exciting inflection point for the company," said Hardison.

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Jeudi, novembre 9, 2023

The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

Atea Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Mercredi, novembre 8, 2023

BOSTON, Nov. 08, 2023 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea” or the “Company”), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a business update.

Key Points: 
  • We’ve quickly completed enrollment of the   60-patient lead-in cohort and initial results are expected in early 2024," continued Dr. Sommadossi.
  • Currently, Atea anticipates providing an update after each of these interim analyses are completed with the first update expected to occur in the first quarter of 2024.
  • Cash, Cash Equivalents and Marketable Securities: $595.1 million at September 30, 2023 compared to $608.1 million at June 30, 2023.
  • Income Tax Expense: Income tax expense was $0.2 million for the quarter ended September 30, 2023 compared to a benefit of $3.8 million for the quarter ended September 30, 2022.

OmniAb Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Jeudi, novembre 9, 2023

OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and nine months ended September 30, 2023, and provided operating and partner program updates.

Key Points: 
  • OmniAb, Inc. (NASDAQ: OABI) today reported financial results for the three and nine months ended September 30, 2023, and provided operating and partner program updates.
  • As of September 30, 2023, OmniAb had cash, cash equivalents and short-term investments of $96.6 million.
  • Financial results prior to November 1, 2022, are presented on a carve-out basis derived from Ligand’s historical accounting records, as if OmniAb were an independent company.
  • OmniAb management will review third quarter 2023 financial results as part of a Research & Technology virtual event being held today at 11:00 a.m. Eastern time.

Better Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Jeudi, novembre 9, 2023

New Patent Issued: In September 2023, Better Therapeutics patent - "Managing lifestyle and health interventions with predictive analytics" - was issued in the European Union (EU).

Key Points: 
  • New Patent Issued: In September 2023, Better Therapeutics patent - "Managing lifestyle and health interventions with predictive analytics" - was issued in the European Union (EU).
  • Showcased AspyreRx at First Promotional Meeting: In October 2023, Better Therapeutics announced its participation at the American College of Lifestyle Medicine’s 2023 Annual Meeting.
  • Further Strengthen Financial Position: Better Therapeutics expects to further strengthen its financial position in the fourth quarter to extend its financial runway.
  • Better Therapeutics periodically provides other information for investors on its corporate website, http://www.bettertx.com , and its investor relations website, https://investors.bettertx.com .

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

Retrieved on: 
Mercredi, novembre 8, 2023

Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, announces that a class action lawsuit has been filed on behalf of investors who 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: 
  • Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, announces that a class action lawsuit has been filed on behalf of investors who 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.
  • 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 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.

Adicet Reports Third Quarter 2023 Financial Results and Provides Business Updates

Retrieved on: 
Mercredi, novembre 8, 2023

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the third quarter ended September 30, 2023.

Key Points: 
  • Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, today reported financial results and operational highlights for the third quarter ended September 30, 2023.
  • In October 2023, Adicet presented new preclinical data building on the potential of Adicet’s allogeneic gamma delta platform as a promising approach to target prostate cancer.
  • Financial Results for Third Quarter 2023:
    Research and Development (R&D) Expenses: R&D expenses were $26.2 million for the three months ended September 30, 2023, compared to $16.6 million during the same period in 2022.
  • Cash Position: Cash and cash equivalents were $183.3 million as of September 30, 2023, compared to $257.7 million as of December 31, 2022.