NDA

Eton Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Thursday, March 14, 2024
Administration, Growth, Nitisinone, Patent, Patient, NDA, Orange Book, Trial of the century, Diurnal, Carglumic acid, Research and development, FDA, Endocrinology, Physician, Pharmaceutical industry

Eton reported fourth quarter 2023 product sales and royalty revenue of $7.3 million, representing a 109% year-over-year increase and 4% growth over the third quarter of 2023, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid.

Key Points: 
  • Eton reported fourth quarter 2023 product sales and royalty revenue of $7.3 million, representing a 109% year-over-year increase and 4% growth over the third quarter of 2023, driven primarily by the ongoing momentum of ALKINDI SPRINKLE and Carglumic Acid.
  • Eton generated $0.4 million of operating cash during the fourth quarter of 2023, with total cash and cash equivalents of $21.4 million as of December 31, 2023.
  • Total net revenues were $7.3 million for the fourth quarter of 2023, compared to $8.5 million for the fourth quarter of 2022.
  • As previously announced, Eton Pharmaceuticals will host its fourth quarter 2023 conference call as follows:

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

Retrieved on: 
Wednesday, March 13, 2024
Research, Hypersensitivity, Glucose, Deafness, Congestion, Ascites, Furosemide, Cerebral edema, Growth, Edema, Kidney, Ototoxicity, Diuresis, Tinnitus, Bruise, New Drug Application, Patient, Coma, Oliguria, History, NYHA, NDA, Benign prostatic hyperplasia, IDN, Blood volume, Embolism, Insurance, Thrombosis, Trial of the century, Heart failure, Investment, CO2, Urine, Dehydration, Creatinine, Urinary retention, Erythema, Pharmacy, Chronic kidney disease, Organic acid, Patent, Hypoproteinemia, Internationalized domain name, BUN, Huber loss, FDA, Government, GTN, Cirrhosis, Hepatic encephalopathy, Azotemia, Uric acid, Anuria, Pharmaceutical industry

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.

Sol-Gel Reports Full-Year 2023 Financial Results and Corporate Developments

Retrieved on: 
Wednesday, March 13, 2024
Orphan drug, Growth, NESS, Nevoid basal-cell carcinoma syndrome, Disease, Patient, Research, European Medical Association, NDA, Acquisition, Prescription, EMA, Dermatology, Clinical trial, IQVIA, BCC, FDA, Sol–gel process, Carcinoma, Food, Pharmaceutical industry

On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened.

Key Points: 
  • On November 30, 2023, Sol-Gel announced that it had begun Phase 3 testing of SGT-610 for Gorlin syndrome, with the first patient screened.
  • In addition, TWYNEO increased its broad commercial formulary coverage, with over 6 million additional lives covered between December 2022 and December 2023 per MMIT Analytics.
  • Based on Sol-Gel's financing and adoption of cost-saving measures during 2023, the company continues to maintain its cash runway into the second half of 2025.
  • The decrease in revenues in 2023 resulted mainly from the milestone payment from Galderma related to the FDA approval of Epsolay in 2022.

Liquidia Corporation Reports Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, March 13, 2024
Research, PRINT, SVB, Patient, Pulmonary hypertension, Sale, NDA, PTAB, Orthostatic hypertension, Promotion, Safety, Security, PAH, FDA, Food, Cryptocurrency

ET

Key Points: 
  • ET
    MORRISVILLE, N.C., March 13, 2024 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA) (Liquidia or the Company) today reported financial results for the full year ended December 31, 2023.
  • ET to discuss the 2023 financial results and provide a corporate update.
  • In December 2023, the previous ruling by the Patent Trial and Appeal Board (PTAB) that all of the claims in U.S. Patent No.
  • The year ended December 31, 2023 included a $2.3 million loss on extinguishment of debt related to repayment of the A&R SVB LSA in January 2023.

Clene Reports Full Year 2023 Financial Results and Recent Operating Highlights

Retrieved on: 
Wednesday, March 13, 2024
ACT, Disease, Natural history, Survival, ALS, CNM, Risk, Patient, Biomarker, EAP, Mortality, NDA, Data, FDA, AFL, Pharmaceutical industry

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.

Nicox Updates on Corporate, Pipeline and Financing Perspectives and Will Hold a Webcast on March 18, 2024

Retrieved on: 
Wednesday, March 13, 2024
Mont Blanc, IOP, OCT, Whistler, Glaucoma, Ocular hypertension, Fluticasone, Database, Intraocular pressure, NCX, COVID-19, Patient, NDA, BlackRock, Sale, Bausch & Lomb, Therapy, Retina, Allergic conjunctivitis, Safety, Patent, Telecanthus, FDA, Corporation, Food, Pharmaceutical industry

“Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.

Key Points: 
  • “Nicox is focusing its resources on the Denali Phase 3 pivotal trial of its lead asset NCX 470 in glaucoma.
  • We are reducing costs, including the size of the organization, and are exploring advancing NCX 1728, through collaborations.
  • In January 2024, Nicox expanded the territory of the exclusive licensing agreement with Harrow, Inc., to include Canada.
  • The Company is financed to at least November 2024, based on focusing exclusively on the development of NCX 470.

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

Retrieved on: 
Tuesday, March 12, 2024
Kidney, Drug, Patient, ESRD, Prospective payment system, NDA, Investment, Annual report, Medicare, FDA, CMS, Hand

CorMedix’s TDAPA application remains under review, and CMS has confirmed that it is working toward a July 1st effective implementation for TDAPA.

Key Points: 
  • CorMedix’s TDAPA application remains under review, and CMS has confirmed that it is working toward a July 1st effective implementation for TDAPA.
  • Pending a timely implementation of TDAPA, CorMedix intends to launch in the outpatient setting in July 2024.
  • Operating expenses during the fourth quarter of 2023 were $15.7 million, compared with $8.4 million in the fourth quarter of 2022, an increase of approximately $7.3 million.
  • The management team of CorMedix will host a conference call and webcast today, March 12, 2023, at 8:30 AM Eastern Time, to discuss recent corporate developments and financial results.

Winston & Strawn Introduces Winston Legal Solutions

Retrieved on: 
Wednesday, April 3, 2024
Consulting, Other Professional Services, Legal, Professional Services, Private law, Warner Bros. Discovery EMEA, International law, Winston & Strawn, Face, -elect, NDA

Winston & Strawn LLP introduces Winston Legal Solutions , a lower-cost option for delivering transactional, litigation, and regulatory legal services targeted to low-complexity and routine legal tasks.

Key Points: 
  • Winston & Strawn LLP introduces Winston Legal Solutions , a lower-cost option for delivering transactional, litigation, and regulatory legal services targeted to low-complexity and routine legal tasks.
  • “Winston Legal Solutions is deeply rooted in our core mission to deliver legal excellence in everything we do,” said Winston Chairman Tom Fitzgerald and Chair-Elect Steve D’Amore.
  • “With Winston Legal Solutions, we can offer ‘right-staffing’ solutions for certain litigation and transactional services.
  • Winston Legal Solutions is Winston’s next step in its continuing evolution to provide clients with innovative solutions to their needs.

Zai Lab Partner Bristol Myers Squibb Announces Pivotal KRYSTAL-12 Confirmatory Trial Evaluating KRAZATI (adagrasib) Meets Primary Endpoint of Progression-Free Survival for Patients with Pretreated KRASG12C-Mutated Locally Advanced or Metastatic...

Retrieved on: 
Monday, April 1, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Lung cancer, BMY, NMPA, Development, NSCLC, Cetuximab, Progression-free survival, New Drug Application, Patient, Neoplasm, Shanda, NDA, Cancer, Bristol Myers Squibb, Pancreatic cancer, CRC, Safety, PFS, FDA, PDUFA, Pharmaceutical industry

The study remains ongoing to assess the additional key secondary endpoint of overall survival.

Key Points: 
  • The study remains ongoing to assess the additional key secondary endpoint of overall survival.
  • Results of the confirmatory trial showed that KRAZATI demonstrated a statistically significant and clinically meaningful benefit in PFS and ORR compared to standard-of-care chemotherapy as a second-line or later treatment for these patients.
  • KRAZATI had no new safety signals and the safety data was consistent with the known safety profile.
  • Zai Lab thanks the patients and investigators involved in the KRYSTAL-12 clinical trial.

Quince Therapeutics Provides Business Update and Reports Fourth Quarter and Fiscal 2023 Financial Results

Retrieved on: 
Monday, April 1, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, A-T, DSP, Disease, SPA, Half-life, Hematology, Patient, NDA, EU4, Acquisition, Standard of care, Pivotal, Cancer, Quality of life, Biology, AIDE, Investment, Clinical trial, Therapy, NEAT, FDA, Pharmaceutical industry

Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.

Key Points: 
  • Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company developing an innovative drug delivery technology designed to leverage a patient’s own biology to deliver rare disease therapeutics, today provided an update on the company’s development pipeline and reported financial results for the fourth quarter and fiscal year ended December 31, 2023.
  • Pivotal Phase 3 NEAT clinical trial will be conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food & Drug Administration (FDA).
  • Expect to report Phase 3 NEAT topline results in the second half of 2025 with a potential NDA submission in 2026, assuming positive study results.
  • Quince estimates there are an aggregate of approximately 10,000 patients with A-T in the U.S., U.K., and EU4 countries.