Edema

Cogent Biosciences Reports First Quarter 2024 Financial Results

Retrieved on: 
tisdag, maj 7, 2024

WALTHAM, Mass. and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2024.

Key Points: 
  • and BOULDER, Colo., May 07, 2024 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, today provided a business update and announced financial results for the first quarter ended March 31, 2024.
  • Cogent remains on track to complete enrollment in PEAK by the end of 2024 and report top-line results by the end of 2025.
  • G&A expenses include non-cash stock compensation expense of $5.0 million for the first quarter of 2024 as compared to $2.9 million for the first quarter of 2023.
  • Net Loss: Net loss was $58.3 million for the first quarter of 2024 compared to a net loss of $38.6 million for the first quarter of 2023.

BioCryst Reports First Quarter 2024 Financial Results and Provides Business Update

Retrieved on: 
måndag, maj 6, 2024

RESEARCH TRIANGLE PARK, N.C., May 06, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq:BCRX) today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

Key Points: 
  • These two successes helped us exceed our revenue projections for the quarter and, as a result, we are increasing our revenue guidance for 2024,” said Charlie Gayer, chief commercial officer of BioCryst.
  • Interest expense was $24.5 million in the first quarter of 2024, compared to $27.4 million in the first quarter of 2023 (-10.6 percent y-o-y).
  • Our references to our first quarter 2024 “non-GAAP pro forma” financial measures of adjusted net loss and adjusted earnings per share constitute non-GAAP financial measures.
  • ET today to discuss the financial results and provide a corporate update.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
onsdag, april 24, 2024

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Excision BioTherapeutics to Present Positive Data from its HSV-1 Keratitis Program, EBT-104, at the ASGCT 2024 Annual Meeting

Retrieved on: 
måndag, april 22, 2024

Herpes Simplex Keratitis (HSK), caused by the infection of herpes simplex virus type 1 (HSV-1) in the cornea, is a major cause of blindness worldwide.

Key Points: 
  • Herpes Simplex Keratitis (HSK), caused by the infection of herpes simplex virus type 1 (HSV-1) in the cornea, is a major cause of blindness worldwide.
  • Although current anti-HSV-1 therapies interfere with viral DNA replication, they do not eliminate HSV-1 reservoirs or prevent recurrence.
  • CRISPR/Cas-mediated gene editing can potentially address the underlying causes of the disease by directly eliminating the latent HSV-1 reservoirs.
  • The 440 guide RNA pairs formed with these 42 PlmCasX guide RNAs were tested in tissue culture for DNA excision efficiency.

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

Retrieved on: 
fredag, april 12, 2024

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

Rakuten Medical's Poster Presentation at AACR 2024 Demonstrates Reduction in Photoimmunotherapy-induced Edema in Mice with COX-2 Inhibition

Retrieved on: 
fredag, april 12, 2024

In the study presented in this poster, Rakuten Medical developed a mouse tumor model to assess edema following photoimmunotherapy and evaluated various steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) for edema reduction using the model.

Key Points: 
  • In the study presented in this poster, Rakuten Medical developed a mouse tumor model to assess edema following photoimmunotherapy and evaluated various steroidal and non-steroidal anti-inflammatory drugs (NSAIDs) for edema reduction using the model.
  • It was also confirmed that the reduction in edema with meloxicam was not associated with a loss of therapeutic benefit based on measurement of tumor growth.
  • Control mice did not generate edema, but mice treated with conjugate plus light showed a light-dose dependent increase in edema volume which peaked at 6h post light delivery.
  • The reduction in edema with meloxicam did not have negative impact on tumor growth inhibition.

Endonovo Closes Asset Purchase Agreement for a Minimum of $50M With SofPulse, Inc

Retrieved on: 
torsdag, mars 28, 2024

With completion of the APA, both Endonovo and SofPulse, Inc. share a strategic vision and a commitment for long term growth.

Key Points: 
  • With completion of the APA, both Endonovo and SofPulse, Inc. share a strategic vision and a commitment for long term growth.
  • The APA transaction for the purchase of Endonovo assets and IP by SofPulse, Inc. is now closed, pending the customary regulatory approvals.
  • Key points of the APA include:
    Agreement to engage Adeptus, a qualified third party's asset valuation firm.
  • Agreement for SofPulse Inc. to issue $50 million in freely traded stock through an S-1 registration, priced at $5.00 per share to Endonovo.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
lördag, april 6, 2024

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

scPharmaceuticals Inc. Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update

Retrieved on: 
onsdag, mars 13, 2024

BURLINGTON, Mass., March 13, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the fourth quarter and full-year ended December 31, 2023, and provided a business update. 

Key Points: 
  • Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023.
  • Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022.
  • Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022.
  • scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022.

MediciNova Announces New Data and Results of MN-166 (ibudilast) in Chlorine Gas-induced Acute Lung Injury Presented at the 63rd Annual Meeting of the Society of Toxicology

Retrieved on: 
tisdag, mars 12, 2024

In this study, single-dose and multi-dose treatments were evaluated.

Key Points: 
  • In this study, single-dose and multi-dose treatments were evaluated.
  • The primary endpoint was the mean change in the pulmonary function measure PaO2/FiO2, which is the ratio of arterial oxygen partial pressure to fractional inspired oxygen.
  • Additional endpoints included survival, lung mechanics, lung injury, and edema formation evaluated by chest x-ray.
  • Cl2 gas concentration of 210 ppm x 30 min was expected to result in a 20 - 30% mortality rate (Fukuda 2015).