Steatorrhea

VIVUS Provides Update on Pipeline and Program Milestones

Retrieved on: 
Monday, January 8, 2024
Patient, Quality of life, HIV/AIDS, Bloating, Diarrhea, Inflammatory bowel disease, ABPM, Chronic pain, Enzyme replacement therapy, Cystic fibrosis, Heart, Degenerative disease, Exocrine pancreatic insufficiency, Comorbidity, Steatorrhea, Obesity, HIV, Amylase, Orthostatic hypertension, Phentermine, Heart failure, Exercise, Pharmaceutical industry

CAMPBELL, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced pipeline updates and program milestones.

Key Points: 
  • CAMPBELL, Calif., Jan. 08, 2024 (GLOBE NEWSWIRE) -- VIVUS LLC, a biopharmaceutical company committed to the development and commercialization of innovative therapies that focus on advancing treatments for patients with serious unmet medical needs, today announced pipeline updates and program milestones.
  • “VIVUS has been continuously dedicated to addressing the therapeutic needs of patients with serious medical conditions and life-limiting diseases, including exocrine pancreatic insufficiency, obesity and pulmonary arterial hypertension,” said John Amos, Chief Executive Officer at VIVUS LLC.
  • QSYMIA® is now the number one branded oral product in the US for obesity treatment.
  • Moreover, VIVUS is actively developing pipeline products focusing on bone marrow transplant preparation (VI-0609) and diabetes treatments (VI-0809 and VI-0810).”

First Wave BioPharma Chairman and CEO Issues Letter to Shareholders Highlighting Recent Accomplishments and Outlook for 2024

Retrieved on: 
Thursday, January 4, 2024
IBD, Food, Economics, Artificial intelligence, Letter, FDA, Cystic fibrosis, Gastrointestinal disease, Stanford University, Gastroparesis, Niclosamide, BOCA, Steatorrhea, Growth, Investment, First wave, Patient, Pharmaceutical industry

BOCA RATON, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024.

Key Points: 
  • BOCA RATON, Fla., Jan. 04, 2024 (GLOBE NEWSWIRE) -- First Wave BioPharma, Inc., (NASDAQ: FWBI), (“First Wave BioPharma” or the “Company”), a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases, today announced that James Sapirstein, Chairman and CEO of First Wave BioPharma, has issued a Letter to Stockholders highlighting the Company’s recent accomplishments and plans for 2024.
  • The close of 2023 has been an exciting period for First Wave BioPharma, highlighted by the recently announced potential business combination with ImmunogenX.
  • The non-binding term sheet includes a low seven-figure payment to First Wave BioPharma along with economics related to future milestones and royalties.
  • 2024 has the potential to be a year of significant growth for First Wave BioPharma, and once again, I thank all of our stockholders for your continued support.

Codexis Reports First Quarter 2023 Financial Results

Retrieved on: 
Thursday, May 4, 2023
DNA, Adjusting entries, EPI, Enzyme, MBBS, Therapy, Advanced General Aviation Transport Experiments, Exocrine pancreatic insufficiency, Steatorrhea, NGS, Ligation, Medication, Mass meeting, Research, Doctor of Philosophy, Small RNA, Investigational New Drug, Patient, Administration, RNA interference, IND, General Administration of Press and Publication, Rare-earth element, Pharmaceutical industry, Video game, Fine chemical, Protalix BioTherapeutics, Codexis, Chemistry, Pfizer

REDWOOD CITY, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced financial results for the first quarter ended March 31, 2023, and provided a business update.

Key Points: 
  • Company Reiterates 2023 Total Revenue Guidance with Adjustments to Product vs. R&D Revenue Mix and Range on Gross Margin
    REDWOOD CITY, Calif., May 04, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced financial results for the first quarter ended March 31, 2023, and provided a business update.
  • Including these enzyme sales, first quarter 2023 total revenues were down 63% compared to $35.3 million in the prior year.
  • Product gross margin for first quarter 2023 was 46% compared to 72% in first quarter 2022; the decrease was largely driven by variability in the product mix and reflects the volume of lower margin products sold during first quarter 2023.
  • Codexis provided an update to its 2023 financial guidance issued on February 23, 2023.

Cystic Fibrosis Foundation Commits Up to $15.5M in Additional Funding for Potential Enzyme Therapy

Retrieved on: 
Tuesday, April 4, 2023
Vitamins, Supplements, Other Health, Other Philanthropy, Other Science, Pharmaceutical, Research, Fund Raising, Genetics, Foundation, Stem Cells, Science, Philanthropy, Clinical Trials, Medical Supplies, General Health, Biotechnology, Alternative Medicine, Health, Valencia CF Foundation, Anagram, Food, Exocrine pancreatic insufficiency, Malnutrition, Steatorrhea, Digestion, Enzyme, Eating, Protein, MD, Water, Cystic fibrosis, Carbohydrate, Drug discovery, Bloating, Therapy, CF, Animal feed, Nursing, Pharmaceutical industry

In addition, the therapy would be available as either a tablet that can be dissolved in water, or granules that could be mixed with soft food.

Key Points: 
  • In addition, the therapy would be available as either a tablet that can be dissolved in water, or granules that could be mixed with soft food.
  • The drug is non-porcine, which means it contains non-animal derived enzymes, and is designed to break down fats, proteins, and carbohydrates.
  • The Foundation previously provided $20.4 million in funding to Synspira Therapeutics , Anagram’s predecessor, bringing the total commitment to $35.9 million.
  • Innovators who are interested in pursuing programs in cystic fibrosis can learn about specific funding opportunities .

Codexis and Nestlé Health Science Announce Interim Results from Phase 1 Clinical Trial of CDX-7108 for Exocrine Pancreatic Insufficiency

Retrieved on: 
Thursday, February 23, 2023
Safety, Doctor of Philosophy, MBBS, Pancreatitis, Cystic fibrosis, Pancreatic cancer, Investigational New Drug, Partnership, SAD, IND, EPI, PERT, Steatorrhea, Patient, Stomach, MAD, GI, Exocrine pancreatic insufficiency, Medicine, Science, Single, SAE, Pharmacokinetics, Pharmaceutical industry, Codexis

“We are excited by the early clinical data for CDX-7108, the most advanced candidate from our partnership with Nestlé Health Science,” said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Codexis.

Key Points: 
  • “We are excited by the early clinical data for CDX-7108, the most advanced candidate from our partnership with Nestlé Health Science,” said Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Codexis.
  • “This interim Phase 1 data suggests that CDX-7108 could be that potential new option and we are excited to move forward to a Phase 2 clinical trial.
  • Codexis and Nestlé Health Science expect to file an Investigational New Drug (IND) application for the Phase 2 study by the end of 2023.
  • The Phase 2 study is expected to be conducted over approximately 12 months, with topline data expected in 2025.

Codexis Reports Fourth Quarter and Fiscal Year 2022 Financial Results

Retrieved on: 
Thursday, February 23, 2023
NGS, JD, Depreciation, Doctor of Philosophy, DNA, MBBS, Merck, National Center for Advancing Translational Sciences, General Administration of Press and Publication, Genomics, Metabolism, Investigational New Drug, Workforce, Partnership, IND, IEM, EPI, Terminal deoxynucleotidyl transferase, Exocrine pancreatic insufficiency, Steatorrhea, Mass meeting, Patient, R, Fabry disease, MAI, Enzyme, PKU, Probability, Synthetic biology, ROFN, Serum, Doctor of Science, Takeda Pharmaceutical Company, General counsel, Rhode Island Division of Commercial Licensing and Regulation, Administration, Roche, Cryptocurrency, Pharmaceutical industry, Fine chemical, Video game, Phenylketonuria, Takeda, Fabry, Codexis, Science

REDWOOD CITY, Calif., Feb. 23, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced financial results for the fourth quarter and fiscal year ended December 31, 2022 and provided a business update.

Key Points: 
  • Total revenues for the fourth quarter 2022 were $30.4 million, an increase of 24% from $24.5 million in the fourth quarter 2021.
  • R&D revenues for the fourth quarter 2022 were $7.1 million compared to $7.5 million in the fourth quarter 2021.
  • Product gross margin for the fourth quarter 2022 was 64% compared to 60% in the fourth quarter 2021, driven by changes in sales mix.
  • Selling, General & Administrative expenses for the fourth quarter 2022 were $12.3 million, compared to $11.7 million in the fourth quarter 2021.

First Wave BioPharma Announces Phase 2 Adrulipase Combination Trial Data to be Presented at the 2023 Digestive Disease Week (DDW) Conference

Retrieved on: 
Tuesday, February 21, 2023
CF, Patient, DDW, Cystic fibrosis, Safety, Steatorrhea, Human, CP, Incidence, Body mass index, Clinical trial, EPI, Translation, Exocrine pancreatic insufficiency, Absorption, Open-label trial, Defecation, PERT, Survival, Combination, PPE, Candace Pert, BOCA, First wave, Conference, SPAN, Case Western Reserve University School of Medicine, Pharmaceutical industry, CFA

The conference is taking place May 6-9, 2023, in Chicago.

Key Points: 
  • The conference is taking place May 6-9, 2023, in Chicago.
  • “The research presented at DDW 2023 is intended to highlight the potential benefits that adrulipase may offer in the treatment of EPI above and beyond PERT, the current standard of care,” stated James Sapirstein, President and CEO of First Wave BioPharma.
  • Adding a synthetic lipase like adrulipase to PERT has demonstrated the potential to improve fat absorption and overall nutrition of CF patients.
  • The digestive standard of care for both CF and chronic pancreatitis (CP) patients with EPI are commercially available PERTs.

First Wave BioPharma Announces First Patient Screened for Phase 2 SPAN Adrulipase Trial in Cystic Fibrosis

Retrieved on: 
Thursday, February 2, 2023
Safety, EPI, Patient, CF, First wave, Steatorrhea, Quality of life, Cystic fibrosis, Exocrine pancreatic insufficiency, SPAN, Malabsorption, CFA, Clinical trial, First, CNA, BOCA, Pharmaceutical industry

Patient dosing is expected to commence by mid-February with topline results from the study to be available by mid-2023.

Key Points: 
  • Patient dosing is expected to commence by mid-February with topline results from the study to be available by mid-2023.
  • “We are very pleased that patient screening has begun so soon after initiating the Phase 2 clinical trial,” said James Sapirstein, President and CEO of First Wave BioPharma.
  • “This urgency speaks to the collective focus of First Wave’s clinical development team, the investigators and trial sites, and our CRO partner to conduct a successful Phase 2 clinical trial.
  • “Exocrine pancreatic insufficiency is a debilitating condition that is challenging to manage for individuals with cystic fibrosis with currently available porcine-derived therapies,” said Dr. Steven Boas, founder of the Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago.

First Wave BioPharma Announces Expansion of Adrulipase Intellectual Property Portfolio

Retrieved on: 
Wednesday, January 25, 2023
Food, PERT, EPI, IND, First wave, Stomach, Steatorrhea, Cystic fibrosis, Exocrine pancreatic insufficiency, Intellectual property, Therapy, CP, Capsule, IP, Patient, Patent, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, Investigational New Drug, BOCA, Research, Pharmaceutical industry

Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile.

Key Points: 
  • Provisional Patent application involving composition of matter improvements designed to enhance adrulipase’s delayed release profile.
  • This filing adds to the growing intellectual property (IP) portfolio governing adrulipase, which includes patent applications governing adrulipase formulation and methods of use and the utilization of enteric formulations in the delivery of adrulipase.
  • Upon IND clearance, First Wave expects to initiate a Phase 2 trial at the beginning of 2023.
  • “Enhancing the IP portfolio protecting adrulipase and the microgranule drug delivery formulation is an important value-building opportunity for First Wave as we prepare to soon initiate the Phase 2 clinical trial of adrulipase in exocrine pancreatic insufficiency associated with cystic fibrosis and chronic pancreatitis,” said James Sapirstein, President and CEO of First Wave BioPharma.

First Wave BioPharma Announces Initial Clinical Sites for its Phase 2 Trial of Enhanced Microgranule Delivery Formulation of Adrulipase

Retrieved on: 
Monday, December 5, 2022
Nutrient, Conference, Ulcerative colitis, Capsule, Weight loss, Acquisition, CP, Digestion, Clinical trial, Cystic fibrosis, Diarrhea, Security (finance), EPI, CF, M.D, Cystic Fibrosis Foundation, Yarrowia, Exocrine pancreatic insufficiency, PERT, First wave, Disease, Niclosamide, FW, Steatorrhea, Patient, Fats, Pharmaceutical industry

First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.

Key Points: 
  • First Wave BioPharma met with each of the investigators during the recently-held North American Cystic Fibrosis Conference in Philadelphia.
  • This ‘pill burden’ presents a substantial challenge for EPI patients,” said Dr. Steven Boas, M.D, founder of the Cystic Fibrosis Institute and Cystic Fibrosis Center of Chicago.
  • First Wave BioPharma is a clinical-stage biopharmaceutical company specializing in the development of targeted, non-systemic therapies for gastrointestinal (GI) diseases.
  • First Wave is advancing two Phase 2 clinical programs built around adrulipase for the treatment of exocrine pancreatic insufficiency (FW-EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP).