Exocrine pancreatic insufficiency

Codexis Reports Fourth Quarter and Fiscal Year 2023 Financial Results

Retrieved on: 
Mittwoch, Februar 28, 2024
Therapy, Alnylam Pharmaceuticals, Senior, Enzyme, (glutamate—ammonia-ligase) adenylyltransferase, Doctor of Philosophy, Gene editing, Biotechnology, Roche, Pharmaceutical manufacturing, SAB, Telephone, McGill University, Phosphorylation, Research and development, Growth, DNA, ECO, RNA, Medication, Food, Nucleotide, Element, Administration, Exocrine pancreatic insufficiency, Central Waqf Council, Protein, Net, Small RNA, MBBS, RNA interference, Masad Damha, Video game

REDWOOD CITY, Calif., Feb. 28, 2024 (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, 2023, and provided a business update.

Key Points: 
  • Including enzyme sales related to PAXLOVID™, total revenues were $26.6 million in fourth quarter 2023 compared to $30.4 million in fourth quarter 2022.
  • Including enzyme sales related to PAXLOVID™, product revenues were $18.1 million in fourth quarter 2023 compared to $23.3 million in fourth quarter 2022.
  • Product gross margin, excluding enzyme sales related to PAXLOVID™, was 71% for fourth quarter 2023 compared to 44% in fourth quarter 2022.
  • Including enzyme sales related to PAXLOVID™, product gross margin for fourth quarter 2023 was 84% compared to 64% in fourth quarter 2022.

VIVUS Provides Update on Pipeline and Program Milestones

Retrieved on: 
Montag, Januar 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).”

Codexis Announces Purchase Agreement with Nestlé Health Science for CDX-7108

Retrieved on: 
Mittwoch, Dezember 27, 2023
ECO, Doctor of Philosophy, Exocrine pancreatic insufficiency, Medication, MBBS, Patient, Pharmaceutical industry

Under the terms of the agreement, Codexis will receive up to $45M in potential milestone payments, including a $5M upfront payment, as well as single-digit net-sales-based royalties.

Key Points: 
  • Under the terms of the agreement, Codexis will receive up to $45M in potential milestone payments, including a $5M upfront payment, as well as single-digit net-sales-based royalties.
  • Codexis will receive up to an additional $5M if Nestlé Health Science exercises an option to purchase two additional early-stage enzymes being developed for EPI.
  • Nestlé Health Science will be solely responsible for the continued development and commercialization of CDX-7108, including all associated costs.
  • With this asset purchase agreement, Nestlé Health Science may continue advancing the compound through the development process.

First Wave BioPharma Announces Streamlining of Clinical Pipeline with Non-Binding Term Sheet to Sell Niclosamide IBD Program

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Mittwoch, Dezember 27, 2023
IBD, Food, Economics, Diarrhea, FDA, WHO, Exocrine pancreatic insufficiency, COVID, BOCA, Intellectual property, Infection, World Health Organization, First wave, Patient, Inflammatory Bowel Diseases, Ulcerative colitis, Pharmaceutical industry

The non-binding term sheet includes a low seven-figure upfront payment to First Wave BioPharma for rights to Niclosamide, as well as economics related to future milestones and royalties.

Key Points: 
  • The non-binding term sheet includes a low seven-figure upfront payment to First Wave BioPharma for rights to Niclosamide, as well as economics related to future milestones and royalties.
  • Additional details of the transaction will be disclosed upon finalization and execution of the definitive agreement.
  • The drug is a potential non-steroidal anti-inflammatory therapy for the treatment of mild-to-moderate inflammatory bowel diseases (IBD).
  • Intellectual property for niclosamide formulations governing composition of matter and methods of use extends beyond 2040.

Codexis Announces Enhanced Strategic Focus and Extends Projected Cash Runway to Mid-2026

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Donnerstag, Juli 20, 2023
Workforce, DNA, EPI, Probability, MBBS, Therapy, Exocrine pancreatic insufficiency, Bank statement, RNA, Ligation, Enzyme, Medication, Doctor of Philosophy, Messenger, Pharmaceutical manufacturing, Small RNA, RNA interference, Metabolism, Patient, ECO, Administration, Engineering, Growth, Conference, Fine chemical, Risk management, Pharmaceutical industry, Cryptocurrency, Protalix BioTherapeutics, Codexis

REDWOOD CITY, Calif., July 20, 2023 (GLOBE NEWSWIRE) -- Codexis, Inc. (NASDAQ: CDXS), a leading enzyme engineering company, today announced that, in alignment with its previously announced strategy to focus resources on programs with the strongest probability of creating significant value in the near-term and beyond, the Company intends to prioritize the advancement and commercialization of its Enzyme-Catalyzed Oligonucleotide (ECO) Synthesis™ platform and its highly complementary Pharmaceutical Manufacturing business. As part of this enhanced strategic focus, the Company is streamlining operations, including discontinuing investment in certain development programs, primarily in Biotherapeutics, consolidating operations to its headquarters and reducing headcount by approximately 25%. Codexis had $92.1 million in cash and cash equivalents as of June 30, 2023, and with these changes expects that this balance will be sufficient to fund its planned operations to mid-2026, providing the Company the opportunity to deliver on critical milestones related to its ECO Synthesis™ platform.

Key Points: 
  • As part of this enhanced strategic focus, the Company is streamlining operations, including discontinuing investment in certain development programs, primarily in Biotherapeutics, consolidating operations to its headquarters and reducing headcount by approximately 25%.
  • We believe Codexis is uniquely positioned to design and bring to market an enzymatic solution that addresses this challenge.
  • As of June 30, 2023, the Company had cash and cash equivalents of $92.1 million.
  • As of June 30, 2023, the Company had an estimated $92.1 million in cash and cash equivalents.

First Wave BioPharma Announces Initial Topline Results from Phase 2 SPAN Clinical Trial Investigating Enhanced Adrulipase Formulation

Retrieved on: 
Donnerstag, Juli 13, 2023
Biologics license application, EPI, CFA, Exocrine pancreatic insufficiency, Clinical trial, BOCA, First wave, CNA, Arbutus Biopharma, Patient, Data, Cystic fibrosis, SPAN, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BLA, Food, Safety, Malabsorption, Medical imaging, Pharmaceutical industry

Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase.

Key Points: 
  • Initial data from the study indicate the enhanced adrulipase formulation was safe and well tolerated and demonstrated an improvement over prior formulations of adrulipase.
  • First Wave BioPharma is continuing to assess the data and expects to report additional findings on primary and secondary endpoints in approximately eight weeks.
  • The Phase 2 SPAN clinical trial was designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients.
  • “Preliminary data from the Phase 2 SPAN clinical trial indicate our enhanced microgranule delivery formulation of adrulipase was safe and well tolerated,” said James Sapirstein, President and CEO of First Wave BioPharma.

First Wave BioPharma Chairman and CEO Issues Letter to Stockholders

Retrieved on: 
Mittwoch, Juli 5, 2023
Biologics license application, Patent, Intellectual property, Letter, EPI, Food, CFA, Exocrine pancreatic insufficiency, United States Patent and Trademark Office, Clinical trial, BOCA, Quality of life, First wave, Cystic fibrosis, Patent Cooperation Treaty, IP, CNA, PCT, Stomach, PERT, Public expenditure, World Organization of the Scout Movement, Capsule, Patient, Cystic Fibrosis Foundation, WIPO, Growth, SPAN, Health, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, CF, BLA, Safety, Gastrointestinal disease, Malabsorption, Pharmaceutical industry, Holding company, Shareholder

BOCA RATON, Fla., July 05, 2023 (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, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company’s clinical programs and recent events.

Key Points: 
  • BOCA RATON, Fla., July 05, 2023 (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, President and CEO of First Wave BioPharma, has issued a Letter to Stockholders providing an update on the Company’s clinical programs and recent events.
  • We are pleased to announce that the last patient in the study has completed their last visit.
  • On June 22, 2023, First Wave held its 2023 Annual Meeting of Stockholders (the “Annual Meeting”) during which stockholders had the opportunity to vote on five proposals.
  • As always, I extend my appreciation to our stockholders for your continued support.

First Wave BioPharma Announces Final Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation

Retrieved on: 
Mittwoch, Juni 28, 2023
EPI, Food, CFA, Exocrine pancreatic insufficiency, Clinical trial, BOCA, First wave, CNA, PERT, Patient, Cystic fibrosis, SPAN, CF, Safety, Malabsorption, Pharmaceutical industry

The Phase 2 multi-center clinical trial ( NCT05719311 ) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients.

Key Points: 
  • The Phase 2 multi-center clinical trial ( NCT05719311 ) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving thirteen (13) patients.
  • The primary efficacy endpoint is the coefficient of fat absorption (CFA), with secondary endpoints of stool weight, signs and symptoms of malabsorption and coefficient of nitrogen absorption (CNA).
  • “Dosing the final patient is a key milestone in the Phase 2 SPAN clinical trial investigating our enhanced enteric microgranule delivery formulation of adrulipase for the treatment of EPI in CF patients,” said James Sapirstein, President and CEO of First Wave BioPharma.
  • Each patient will be started on a low dose of adrulipase.

First Wave BioPharma Strengthens Intellectual Property Estate

Retrieved on: 
Dienstag, Juni 27, 2023
Patent, EPI, CFA, Exocrine pancreatic insufficiency, United States Patent and Trademark Office, BOCA, First wave, Patent Cooperation Treaty, IP, PCT, CNA, World Organization of the Scout Movement, Publication, Patient, Cystic fibrosis, WIPO, SPAN, CFA Institute, Safety, Malabsorption, Pharmaceutical industry

The PCT includes 157 countries and covers virtually all worldwide industrialized markets.

Key Points: 
  • The PCT includes 157 countries and covers virtually all worldwide industrialized markets.
  • “The patent publications for our enhanced enteric microgranule delivery formulation of adrulipase and its use for the treatment of malabsorption highlight First Wave’s ability to introduce important drug innovations for the treatment of underserved disease indications,” said James Sapirstein, President and CEO of First Wave BioPharma.
  • The Phase 2b SPAN trial is designed to investigate the safety, tolerability, and efficacy of a new enteric microgranulation formulation of adrulipase.
  • Patients will be screened at baseline to ensure that they have a coefficient of fat absorption (CFA) of at least 80%.

First Wave BioPharma Reaches Enrollment Target for Phase 2 SPAN Adrulipase Clinical Trial in Cystic Fibrosis

Retrieved on: 
Dienstag, Juni 13, 2023
EPI, CFA, Exocrine pancreatic insufficiency, Clinical trial, First wave, CNA, Patient, Cystic fibrosis, SPAN, CFA Training College, Safety, Malabsorption, Pharmaceutical industry

The Phase 2 multi-center clinical trial ( NCT05719311 ) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients.

Key Points: 
  • The Phase 2 multi-center clinical trial ( NCT05719311 ) is designed to investigate the safety, tolerability and efficacy of an enteric microgranule delivery formulation for adrulipase in a titrated dose-escalation study involving an estimated twelve (12) patients.
  • James Sapirstein, Chief Executive Officer of First Wave BioPharma commented, “We are very pleased to have reached the enrollment target in our Phase 2b SPAN study of adrulipase.
  • The Phase 2b SPAN trial is designed to investigate the safety, tolerability, and efficacy of a new enteric microgranulation formulation of adrulipase.
  • The SPAN trial is an open-label study that will be conducted at three sites in the U.S. A total of 13 cystic fibrosis patients, all 18 years or older have been enrolled.