NDA

Oculis Reports Q4 and Full Year 2023 Financial Results and Update on Company Progress

Retrieved on: 
Monday, March 18, 2024
Research, TNF, AON, Dexamethasone, Congress, International, International Financial Reporting Standards, Telecanthus, Inflammation, DME, Patient, SNP, NDA, American Academy, G&A, POC, Business analyst, IND, Abstract, DED, Bank statement, Genotype, Investment, Retina, Diabetic retinopathy, OCS, Safety, CHF, Pain, Stage 2, Pharmaceutical industry

Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis.

Key Points: 
  • Riad Sherif M.D., Chief Executive Officer of Oculis: “2023 was a remarkable milestone-rich year for Oculis.
  • These non-IFRS financial measures exclude the impact of items that the Company’s management believes affect comparability or underlying business trends.
  • The Company’s management uses these measures to better analyze its financial results and better estimate its financial outlook.
  • The resulting non-cash foreign exchange impact of such reclassification amounted to CHF 5.0 million or $5.7 million for the year ended December 31, 2023.

Aquestive Therapeutics Announces Pivotal Study for Anaphylm™ (epinephrine) Sublingual Film Successfully Meets Primary and Secondary Endpoints and Provides Clinical Development Update Following FDA Meeting

Retrieved on: 
Thursday, March 14, 2024
Blood pressure, Sinai Hospital, Anaphylaxis, Absorption, Angioedema, Plasma, Type, PD, Patient, Heart rate, Adrenaline, NDA, Epinephrine autoinjector, Cmax, Trial of the century, Mouth, Therapy, Safety, Oral medicine, Allergy, Vomiting, Swelling, FDA, Study, Food, Pharmaceutical industry

“We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive.

Key Points: 
  • “We are extremely pleased with the pivotal study results as well as our recent FDA interaction,” said Daniel Barber, President and Chief Executive Officer of Aquestive.
  • “We believe we have a clear understanding of the remaining clinical development steps necessary for a pre-NDA meeting with the FDA in the second half of the year.
  • These latest study results show that the sublingual administration of epinephrine provides rapid and sustained levels of epinephrine similar to approved treatments.
  • The FDA noted that substantial progress had been made in the Anaphylm clinical development program and did not outline any new clinical development requirements.

IgA Nephropathy Pipeline Dynamics Signal Further Treatment Evolution on the Horizon

Retrieved on: 
Thursday, March 14, 2024
Nephrology, Indoor Living, Novartis, Patient, Alnylam Pharmaceuticals, Perception, SGLT2, Immunoglobulin A, Budesonide, NDA, Record, Breakthrough therapy, UPCR, Atrasentan, Kidney, EGFR, Alexion, FDA, CHMP, Physician, Health, Pharmaceutical industry

For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study.

Key Points: 
  • For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study.
  • Spherix is the leading authority on IgAN market dynamics and will continue to provide insight into how nephrologists are treating and approaching care for their IgAN patients.
  • Patient Chart Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits.
  • Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

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.