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Zevra Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Updates

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Thursday, March 28, 2024
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CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023. 

Key Points: 
  • ET
    CELEBRATION, Fla., March 28, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today provided corporate updates and reported its financial results for the fourth quarter and year ended December 31, 2023.
  • “We made solid progress on our key priorities in 2023,” said Neil F. McFarlane, President and Chief Executive Officer of Zevra.
  • Overview of Q4 2023 and FY 2023 Financial Results:
    Net revenue for Q4 2023 was $13.2 million, compared to prior year Q4 net revenue of $2.2 million.
  • ET, to discuss its corporate and financial results for Q4 and FY 2023.

TFF Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 28, 2024
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FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.

Key Points: 
  • FORT WORTH, Texas, March 28, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today reported financial results for the fourth quarter and full year 2023.
  • For TFF TAC, the Company presented data showing that eight out of eight patients successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • In the fourth quarter 2023, the Company announced the appointment of three new members of its Board of Directors, including Thomas B.

TFF Pharmaceuticals Announces Updated Data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) Clinical Programs

Retrieved on: 
Wednesday, March 27, 2024
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FORT WORTH, Texas , March 27, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, today announced updated data from the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Key Points: 
  • “Based on the totality of these clinical data, we believe TFF TAC and TFF VORI have the potential to establish a new and significantly improved form of delivery for these two life-saving medicines.
  • The updated safety and efficacy data are based on the cutoff date of March 8, 2024.
  • The ongoing Phase 2 trial of TFF TAC is an open-label study in lung transplant patients who require reduced tacrolimus blood levels due to kidney toxicity.
  • The Company will host a conference call today at 4:30 pm Eastern Time, to discuss updated data for the Tacrolimus Inhalation Powder (TFF TAC) and Voriconazole Inhalation Powder (TFF VORI) clinical programs.

Gamida Cell Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Company Update

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Wednesday, March 27, 2024
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BOSTON, March 27, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today provided a business update and reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Gamida Cell will become a private company, wholly owned by Highbridge, and the company’s outstanding ordinary shares are expected to be canceled.
  • The company has confirmed coverage with payers who cover more than 90% of commercial lives, exceeding the 2023 goal of 70%.
  • The full year Net Revenue included $1.1 million of net review for the fourth quarter of 2023.

Paychex Recognized for Excellence in Health & Well-being by Business Group on Health

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Tuesday, April 9, 2024
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For the 10th time, Paychex has been recognized for the company’s commitment to providing comprehensive and innovative benefits programs that advance the health and well-being of over 16,000 employees.

Key Points: 
  • For the 10th time, Paychex has been recognized for the company’s commitment to providing comprehensive and innovative benefits programs that advance the health and well-being of over 16,000 employees.
  • Paychex is also one of 10 companies to earn additional acknowledgment for a commitment to employees’ emotional well-being through mental health programs.
  • “This is the 10th time Paychex has been honored by Business Group on Health for delivering strategic health and well-being programs that support our employees,” said John Gibson , Paychex president and CEO.
  • “In addition, their novel and impactful approaches focused on critical workforce issues, such as mental health and health equity.

New Genialis RNA Biomarker Accurately Predicts KRAS Outcomes in Lung Cancer Patients

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Tuesday, April 9, 2024
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Genialis , the RNA-biomarker company, today presented a poster on a new AI/ML classifier, Genialis™ krasID, that accurately predicts clinical benefit in a real-world cohort of patients who received sotorasib, a KRAS inhibitor currently approved for KRAS G12C non-small cell lung cancers.

Key Points: 
  • Genialis , the RNA-biomarker company, today presented a poster on a new AI/ML classifier, Genialis™ krasID, that accurately predicts clinical benefit in a real-world cohort of patients who received sotorasib, a KRAS inhibitor currently approved for KRAS G12C non-small cell lung cancers.
  • Genialis krasID analyzes foundational aspects of KRAS biology using RNA-sequencing and a machine learning algorithm comprising numerous biologic signatures.
  • Taken together, these early results demonstrate that the Genialis krasID classifier can predict response and stratify durable benefit in experimental and clinical settings.
  • Last week, Genialis announced the addition of two new partners as it assembles the world’s most ethnographically diverse cancer data sets .

TFF Pharmaceuticals Announces Update on Clinical Programs

Retrieved on: 
Wednesday, March 20, 2024
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FORT WORTH, Texas, March 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, is announcing data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration.

Key Points: 
  • “However, after a rigorous assessment of our pipeline, including the significant capital and resources required to progress both clinical development programs, we will focus our clinical development efforts and financial resources on TFF TAC.
  • In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • The Company will host a conference call on Wednesday, March 27, 2024, at 4:30 PM Eastern Time, to discuss updated clinical data for the TFF TAC and TFF VORI.

aTyr Pharma Announces Fourth Quarter and Full Year 2023 Results and Provides Corporate Update

Retrieved on: 
Thursday, March 14, 2024
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SAN DIEGO, March 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced fourth quarter and full year 2023 results and provided a corporate update.

Key Points: 
  • SAN DIEGO, March 14, 2024 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq: LIFE) (“aTyr” or the “Company”), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced fourth quarter and full year 2023 results and provided a corporate update.
  • Based on current enrollment projections, the Company anticipates completing enrollment in the study in the second quarter of 2024.
  • Interested parties may access the call by registering here in order to obtain a dial in, personalized passcode and webcast information.
  • Links to a live audio webcast and replay may be accessed on the aTyr website Events page at: http://investors.atyrpharma.com/events-and-webcasts .

Clene Reports Full Year 2023 Financial Results and Recent Operating Highlights

Retrieved on: 
Wednesday, March 13, 2024
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In December 2023, Clene reported new data from the ongoing open-label extension of the HEALEY ALS Platform Trial.

Key Points: 
  • In December 2023, Clene reported new data from the ongoing open-label extension of the HEALEY ALS Platform Trial.
  • Clene plans to submit additional data to the FDA to advance the CNM-Au8 accelerated approval discussions in 2024.
  • In December 2023, Clene announced the publication of a peer-reviewed article describing brain target engagement by CNM-Au8.
  • Clene expects that its resources as of December 31, 2023, will be sufficient to fund its operations into the fourth quarter of 2024.

GenSight Biologics Reports Cash Position as of March 31, 2024, and Provides Business Update

Retrieved on: 
Thursday, April 4, 2024
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GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2024 and provided a business update.

Key Points: 
  • GenSight Biologics ("GenSight Biologics" or the "Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of March 31, 2024 and provided a business update.
  • Once the AAC/AAP program resumes, the Company estimates that the cash runway would be extended to the end of Q1 2025.
  • GenSight successfully manufactured two Drug Substance (DS) batches of LUMEVOQ® meeting Good Manufacturing Practice (GMP) standards in September and November 2023.
  • As of March 31, 2024, GenSight Biologics’ number of outstanding shares was 78,370,724 ordinary shares.