Priority review

Cyclo Therapeutics Provides Business Update and Reports Full Year 2022 Financial Results

Retrieved on: 
Monday, March 20, 2023
Biotechnology, Genetics, Health, Clinical Trials, Society, Priority review, Expanded access, Cholesterol, SIMD, NPC1, CYTH, Organ dysfunction, Research, Cell, Dementia, Science, Death, Genetic disorder, Patient, HIV disease progression rates, Bank, Annual general meeting, NPC, Lysosome, AD, Therapy, Safety, Pharmaceutical industry, Nursing, EU

Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update.

Key Points: 
  • Cyclo Therapeutics, Inc. (Nasdaq: CYTH) (“Cyclo Therapeutics” or the “Company”), a clinical stage biotechnology company dedicated to developing life-changing medicines through science and innovation for patients and families living with diseases, today reported its financial results for the full year 2022 and provided a business update.
  • Further we continue to have encouraging strategic discussions across the industry,” commented N. Scott Fine, CEO of Cyclo Therapeutics.
  • Cyclo Therapeutics received Orphan Drug Designation for Trappsol® Cyclo™ to treat NPC1 in both the U.S. and EU and Fast Track and Rare Pediatric Disease Designations in the U.S.
  • Enrolled patients will be randomized across three study arms: 500 mg/kg or 1000 mg/kg of Trappsol® Cyclo™ and placebo.

Monte Rosa Therapeutics Announces Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, March 16, 2023
Lead, Finance, Public expenditure, SCLC, Chemistry, Food and Drug Administration, Horizon, NSCLC, GSPT1, Trial of the century, Lung cancer, PK, Fast Track, MGD, Cytokine, B-cell lymphoma, MTD, American Association for Cancer Research, Index, MYC, Research, AACR, Therapy, PD, Jennifer, Patient, Inflammation, FDA, VAV1, Cancer, Safety, Carcinoma, R, CDK2, Autoimmunity, Drug discovery, DLBCL, Treatment of lung cancer, Drug development, EORTC, Priority review, Process, Administration, Senior, Queen, Accelerated approval (FDA), Food, Research and development, Cryptocurrency, Pharmaceutical industry, G&A, IND

Initiated patient dosing in October of its Phase 1/2 clinical trial evaluating MRT-2359 for the treatment of MYC-driven solid tumors, including lung cancer.

Key Points: 
  • Initiated patient dosing in October of its Phase 1/2 clinical trial evaluating MRT-2359 for the treatment of MYC-driven solid tumors, including lung cancer.
  • When activated, VAV1 relays a signal cascade that results in immune cell activation and the secretion of several pro-inflammatory cytokines.
  • Net Loss: Net loss for the fourth quarter of 2022 was $30.8 million compared to $23.4 million for the fourth quarter of 2021, and $108.5 million for the year ended December 31, 2022, compared to $74.0 million for the year ended December 31, 2021.
  • Cash Position and Financial Guidance: Cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2022, were $268.1 million, compared to $351.4 million as of December 31, 2021.

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Innoviva Announces FDA Advisory Committee Meeting to Review Sulbactam-Durlobactam (SUL-DUR), an Investigational Targeted Antibiotic

Retrieved on: 
Monday, March 13, 2023
Science, Biotechnology, Research, Pharmaceutical, Health, FDA, Infectious Diseases, Clinical Trials, Priority review, CDC, Nephrotoxicity, Infection, WHO, Acinetobacter, Disease, Patient, Food, Committee, Therapy, Safety, Incidence, NDA, Colistin, Public, Mortality, PDUFA, Pharmaceutical industry

Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).

Key Points: 
  • Innoviva, Inc. (Nasdaq: INVA) (“Innoviva”), a diversified holding company with a portfolio of royalties and other healthcare assets, today announced that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee will convene April 17, 2023 to review data supporting the new drug application (NDA) for sulbactam-durlobactam (SUL-DUR).
  • SUL-DUR is an investigational targeted antibiotic for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex (Acinetobacter).
  • Infections caused by drug-resistant Acinetobacter are serious and life-threatening conditions associated with high morbidity and mortalityi.
  • The Committee will review data from studies involving SUL-DUR, including data from the landmark Phase 3 trial evaluating the safety and efficacy of SUL-DUR versus colistin in patients with infections caused by Acinetobacter.

FDA Accepts Mesoblast’s Resubmission of the Biologic License Application for Remestemcel-L In Children with Steroid-Refractory Acute Graft Versus Host Disease as a Complete Response and Sets Goal Date of August 2, 2023

Retrieved on: 
Wednesday, March 8, 2023
MSB, Bone marrow, PDUFA, Australia New Zealand Therapeutic Products Authority, Biomarker, OTP, FDA, MESO, Safety, Agency, Survival, Priority review, BLA, Mesoblast, Inflammation, Pharmaceutical industry

FDA considers the resubmission to be a complete response and has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.

Key Points: 
  • FDA considers the resubmission to be a complete response and has set a Prescription Drug User Fee Act (PDUFA) goal date of August 2, 2023.
  • “Over the last two years we have worked tirelessly to address the issues previously raised by FDA.
  • We look forward to working closely with the Agency over the review period with the aim to make remestemcel-L available as a therapy for children suffering from SR-aGVHD,” said Mesoblast Chief Executive Silviu Itescu.
  • If remestemcel-L receives FDA approval, it will be the first allogeneic “off-the-shelf” cellular medicine to be approved in the United States, and the first therapy for children under 12 years old with SR-aGVHD.

Galera Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Corporate Updates

Retrieved on: 
Wednesday, March 8, 2023
Sale, PDUFA, New Drug Application, Literature, HNC, AESOP, NSCLC, Investment, Letter, GPC, SOM, FDA, NDA, Therapy, Chemoradiotherapy, University, Radiation therapy, SBRT, Survival, Cancer, Research, Incidence, Priority review, Mucositis, Head, Patient, File, Esophagitis, MD, Food, LAPC, Lung cancer, Pharmaceutical industry, Medical imaging, Cryptocurrency

MALVERN, Pa., March 08, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the fourth quarter and year ended December 31, 2022 and provided recent corporate updates.

Key Points: 
  • On February 15, 2023, the Company announced that the FDA accepted for filing and granted priority review to the NDA for avasopasem.
  • Research and development expenses were $8.1 million in the fourth quarter of 2022, compared to $9.2 million for the same period in 2021.
  • General and administrative expenses were $5.0 million in the fourth quarter of 2022, compared to $5.3 million for the same period in 2021.
  • As of December 31, 2022, Galera had cash, cash equivalents and short-term investments of $31.6 million.

Aldeyra Therapeutics Reports Full-Year 2022 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 9, 2023
Biotechnology, Pharmaceutical, Health, Geographic atrophy, Priority review, New Drug Application, Treatment, Ethanol, USP, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Clinical trial, Signs and symptoms, Research, Investigational New Drug, Allergic conjunctivitis, Telecanthus, Type, NDA, Disease, Therapy, Part, Patient, Food, RASP, Syndrome, FDA, Retinitis pigmentosa, Atopic dermatitis, LDL, Safety, PDUFA, Pharmaceutical industry, Vaccine, Systemic, Schirmer

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the year ended December 31, 2022.

Key Points: 
  • Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today reported recent corporate highlights and financial results for the year ended December 31, 2022.
  • The U.S. Food and Drug Administration (FDA) assigned a Prescription Drug User Fee Act (PDUFA) date of June 21, 2023.
  • ET today to discuss recent corporate highlights and financial results for the year ended December 31, 2022.
  • A live webcast of the conference call can be accessed via the Investors & Media page of the Aldeyra website at https://ir.aldeyra.com .

Seres Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Updates

Retrieved on: 
Tuesday, March 7, 2023
Health, Infectious Diseases, Stem Cells, Health Technology, Clinical Trials, Pharmaceutical, Biotechnology, History, Gastrointestinal tract, Priority review, Pharmacology, JAMA, JAMA Network Open, DSMB, Infection, David Berry (inventor), Cirrhosis, Journal, CDI, ACG, Therapy, UC, Incidence, The New England Journal of Medicine, Graft-versus-host disease, Max Healthcare, Research, Clostridioides difficile infection, Breakthrough therapy, Mayo Clinic, Hematopoietic stem cell transplantation, GI, American College of Gastroenterology, Data monitoring committee, Recurrence, Memorial Sloan Kettering Cancer Center, American Medical Association, Bloodstream infections, Patient, Cohort, University, Conference, FDA, NUALS Arts and Literary Annual Meet, Harvard Medical School, HRQOL, University of Chicago Medical Center, American College, Variometer, Safety, NEJM, PDUFA, Pharmaceutical industry, Vaccine, Cryptocurrency

Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2022 financial results and provided business updates.

Key Points: 
  • Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome therapeutics company, today reported fourth quarter and full year 2022 financial results and provided business updates.
  • In February 2023, Seres announced the publication of Phase 3 ECOSPOR IV trial results in JAMA Network Open and results were also shared at the IDWeek and American College of Gastroenterology (ACG) 2022 Annual Meetings.
  • Research and development expenses for the fourth quarter of 2022 were $46.2 million, compared with $36.8 million for the same period in 2021.
  • General and administrative expenses for the fourth quarter of 2022 were $22.4 million, compared with $20.5 million for the same period in 2021.

Oncolytics Biotech® Reports Fourth Quarter and Full Year 2022 Financial Results and Operational Highlights

Retrieved on: 
Friday, March 3, 2023
FDA, Immunotherapy, SITC, International, Pancreatic cancer, Clinical trial, Accelerated approval (FDA), Progression-free survival, Breast, Pelareorep, TSX, Breast cancer, Pulmonary toxicity, Food, Oncolytics Biotech, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ORR, Growth, Research, ONC, Safety, CAR, Society, Fast Track, Annual general meeting, PR, Society for Immunotherapy of Cancer, LINK, Priority review, Paclitaxel, Patient, Survival, Cryptocurrency, Medical imaging, Pharmaceutical industry, Video game, Satellite navigation device, PDAC

ET

Key Points: 
  • ET
    SAN DIEGO and CALGARY, Alberta, March 3, 2023 /PRNewswire/ -- Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the fourth quarter and full year ended December 31, 2022.
  • The net loss for the fourth quarter of 2022 was $8.6 million, compared to a net loss of $7.8 million in the fourth quarter of 2021.
  • The basic and diluted loss per share was $0.14 in the fourth quarter of 2022, compared to a basic and diluted loss per share of $0.14 in the fourth quarter of 2021.
  • General and administrative expenses for the fourth quarter of 2022 were $3.7 million and $11.5 million for the full year 2022, compared to $3.8 million for the fourth quarter of 2021 and $13.3 million for the full year 2021.