Investigational New Drug

HYTN Welcomes Health Canada for Audit to Enhance GMP Capabilities

Retrieved on: 
Tuesday, April 9, 2024
Certification, Therapeutic Goods Administration, DEL, Sale, Psilocybin, IND, GMP, Cannabis, Investigational New Drug, Drug development, TGA, FDA, PIC/S, Pharmaceutical industry

VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.

Key Points: 
  • VANCOUVER, British Columbia, April 09, 2024 (GLOBE NEWSWIRE) -- HYTN Innovations Inc. (CSE: HYTN, “HYTN” or “The Company”), a leader in the development, formulation, and manufacturing of products containing psychoactive and psychotropic compounds, including cannabis, welcomed Health Canada’s conduct of a Drug Establishment License (DEL) audit.
  • The audit, which aims to expand the Company's Good Manufacturing Practices (GMP) capabilities, follows the recent achievement of GMP certification for HYTN's Kelowna production facility by Australia's Therapeutic Goods Administration (TGA) under the Pharmaceutical Inspection Co-operation Scheme (PIC/S) standard.
  • Securing a DEL will enhance HYTN's current GMP manufacturing capabilities, facilitating the development and sale of additional compounds and product variations.
  • HYTN has demonstrated its ability to manufacture these products according to GMP guidelines.

Cue Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results and Updated Business Highlights

Retrieved on: 
Monday, April 8, 2024
Research, SOC, Conference, CPI, Ono Pharmaceutical, Patient, Standard of care, Inflammation, Pembrolizumab, IND, Investigational New Drug, WT1, Nivolumab, SITC, FDA, Autoimmunity, Annual general meeting, Pharmaceutical industry

BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.

Key Points: 
  • BOSTON, April 08, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively modulate disease-specific T cells, today reported fourth quarter and full year 2023 financial results.
  • The increase was due to revenue earned from our strategic collaboration agreement entered into with Ono Pharmaceutical in the first quarter of 2023.
  • As of December 31, 2023, the Company had approximately $48.5 million in cash, cash equivalents and marketable securities compared with $76.3 million as of December 31, 2022.
  • We expect our current cash, cash equivalents, and marketable securities to fund operations into the first quarter of 2025.

ORYZON Announces U.S. FDA Clearance of CTEP-CRADA Phase I/II Clinical Trial Sponsored by NCI for Iadademstat Plus Immune Checkpoint Inhibitors in 1L Extensive Stage Small Cell Lung Cancer

Retrieved on: 
Monday, April 8, 2024
JHU, NCI, Development, Carcinoma, CRADA, National Cancer Institute, MSKCC, IND, Investigational New Drug, Genomics, Immune system, Bangladesh Technical Education Board, FDA, SCLC, Food, Pharmaceutical industry

This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.

Key Points: 
  • This will be the first clinical trial testing the combination of iadademstat with immune checkpoint inhibitors.
  • The trial ( NCT06287775 ) is entitled “A Phase I Dose Finding and Phase II Randomized Trial of Iadademstat Combined With Immune Checkpoint Inhibition Maintenance After Initial Chemoimmunotherapy in Patients With Extensive-Stage Small Cell Lung Cancer”.
  • “We are very pleased that NCI has received the regulatory approval from the FDA to initiate this first-in-human Phase I/II combination trial with iadademstat plus immune check point inhibitors” stated Dr. Carlos Buesa, Chief Executive Officer of Oryzon.
  • “The molecular mechanisms underlying the ability of iadademstat to render small cell lung cancer cells visible to the immune system while simultaneously enhancing immune activity to aggressively target these malignant cells have been clearly elucidated.

NurExone Reports Fourth Quarter and Year Ended December 31, 2023 Financial Results and Provides Company Update

Retrieved on: 
Tuesday, April 2, 2024
ODD, Research, Growth, Drug discovery, Exercise, NRX, CFO, RNA, Laboratory, Contract research organization, Regenerative medicine, Investigational New Drug, Safety, Spinal cord injury, Intellectual property, Plasma protein binding, Small RNA, FDA, Food, Cryptocurrency

TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.

Key Points: 
  • TORONTO and HAIFA, Israel, April 02, 2024 (GLOBE NEWSWIRE) -- NurExone Biologic Inc. (TSXV: NRX) (Germany: J90) (the “Company” or “NurExone”), a pioneering biopharmaceutical company, developing regenerative medicine therapies, today provided a business update and reported financial results for the fourth quarter and financial year ended December 31, 2023.
  • For the fourth quarter of 2023, expenses were US$0.31 million, compared to US$0.39 million in the previous year.
  • For the fourth quarter of 2023, expenses were US$0.40 million, compared to US$0.46 million in the previous year.
  • For the fourth quarter of 2023, expenses were US$0.02 million, compared to US$0.17 million in the previous year.

Ipsen and Sutro Biopharma announce exclusive global licensing agreement for an ADC targeting solid tumors

Retrieved on: 
Tuesday, April 2, 2024
ADR, Patient, SAN, SVP, Research, STRO, Cancer, IPN, Spacecraft, IND, Investigational New Drug, Development, ADC, Medicine

Ipsen secures exclusive global rights for development and commercialization of STRO-003, an antibody-drug conjugate, completing the final stages of pre-clinical development

Key Points: 
  • Ipsen secures exclusive global rights for development and commercialization of STRO-003, an antibody-drug conjugate, completing the final stages of pre-clinical development
    PARIS, FRANCE; SAN FRANCISCO, U.S., 02 April 2024 - Ipsen (Euronext: IPN; ADR: IPSEY) and Sutro Biopharma (NASDAQ: STRO, “Sutro”, “the Company”) today announced an exclusive global licensing agreement for STRO-003.
  • “The potential for ADCs in oncology is well-documented and we are excited by the addition of STRO-003, Ipsen’s first ADC candidate with best-in-class potential.” said Mary Jane Hinrichs, SVP and Head of Early Development at Ipsen.
  • “STRO-003 is a next-generation ROR1 ADC, leveraging Sutro’s site-specific technology to generate a highly stable conjugate, coupled with exatecan payloads, that have shown significant potential in solid tumors.
  • Payloads are the pharmaceutically active component to treat the cancer, attached to the antibody via a chemical linker.

Fractyl Health Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, April 1, 2024
Research, Glucose, Health, Congress, Obesity, Human, Drug discovery, Exercise, Glycated hemoglobin, DMR, ADAS, Partnership, Insulin, IDA, Patient, Weight loss, Michigan Medicine, Diabetes, Public expenditure, IDE, University, IPO, Tropism, Peptide, Transgene, Insulin resistance, Animal, NUB, Type 2 diabetes, Pancreas, Investigational New Drug, Therapy, Food, Marketing, FDA, Engineering, Annual general meeting, Pharmaceutical industry

BURLINGTON, Mass., April 01, 2024 (GLOBE NEWSWIRE) -- Fractyl Health (Nasdaq: GUTS), a metabolic therapeutics company focused on pioneering new approaches for the treatment of type 2 diabetes (T2D) and obesity, today reported its fourth quarter and full year 2023 financial results and provided a business update.

Key Points: 
  • “In addition, we expect to complete enrollment of our pivotal Revitalize-1 study and are excited to report topline data in the fourth quarter of 2024.
  • The Company expects to complete enrollment in the first half of 2024 and report topline data in the fourth quarter of 2024.
  • In December 2023, Fractyl presented preclinical findings in an oral presentation at the World Congress of Insulin Resistance Diabetes and Cardiovascular Disease 2023 Annual Meeting.
  • Cash Position: As of December 31, 2023, Fractyl had approximately $33.2 million in cash and cash equivalents.

Fortress Biotech Reports 2023 Financial Results and Recent Corporate Highlights

Retrieved on: 
Thursday, March 28, 2024
AstraZeneca, Exercise, Fortification, New Drug Application, Patient, GBM, CRL, NDA, Menkes, Minocycline, Therapy, Marketing, Radiation, CKPT, Rosacea, Investigational New Drug, Erythema, Safety, BLA, Fortress Biotech, Food, Red, Amyloidosis, Dermatology, Carcinoma, FDA, Hyperhidrosis, Mustang Bio, Menkes disease, PDUFA, Pharmaceutical industry

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”), an innovative biopharmaceutical company focused on acquiring and advancing assets to enhance long-term value for shareholders through product revenue, equity holdings and dividend and royalty revenue, today announced financial results and recent corporate highlights for the full-year ended December 31, 2023.

Key Points: 
  • Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2023, we built a significant amount of momentum to position our Company to achieve multiple milestones in 2024.
  • In March 2024, the FDA accepted the NDA and has set a PDUFA goal date of November 4, 2024.
  • In December 2023, the FDA issued a complete response letter (“CRL”) for the cosibelimab BLA.
  • Fortress’ consolidated net revenue totaled $84.5 million for the full year ended December 31, 2023, which included $59.7 million in net revenue generated from our marketed dermatology products.

Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States

Retrieved on: 
Wednesday, March 27, 2024
FACC, Obesity, Gastroparesis, Metoclopramide, Diabetes, Patient, Volunteering, MD, IND, Nausea, European, Investigational New Drug, Safety, Pharmacokinetics, Phase, Conditional sentence, Vomiting, FDA, Bloating, Pharmaceutical industry

Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.

Key Points: 
  • Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.
  • Renexxion and Dr. Falk Pharma will now expand patient enrollment for the ongoing global multi-center 320 patient placebo-controlled Phase 2b MOVE-IT study in gastroparesis to clinical sites in the United States (ClinicalTrials.gov ID: NCT05621811).
  • Furthermore, naronapride has already demonstrated dose-dependent accelerated gastric emptying in a GI transit study of healthy human volunteers.
  • We are aligned in our belief in the transformative power of naronapride to revolutionize treatment for gastroparesis patients and its ability to reshape the gastroparesis treatment landscape.”

Inventiva reports its 2023 full-year results

Retrieved on: 
Wednesday, March 27, 2024
DSM-IV codes, NMPA, Acceleration, Partnership, Patient, Income tax, G&A, BofA Securities, MASH, Equity, SUSAR, IND, Marketing, Bank statement, IRB, Clinical trial, Investigational New Drug, European Investment Bank, Fatty liver disease, Type 2 diabetes, T2D, Euronext Paris, EIB, Phase, Optimism, NAFLD, Sino Biopharmaceutical Limited, Pharmaceutical industry

Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.

Key Points: 
  • Frédéric Cren, Chairman, CEO and cofounder of Inventiva, stated: “Inventiva achieved several clinical and financial milestones in 2023.
  • R&D expenses for the fiscal year ended December 31, 2023, amounted to (€110.0) million compared to (€60.5) million in 2022.
  • Net financial income was (€5.1) million for the fiscal year ended December 31, 2023, compared to €2.8 million in 2022.
  • Income tax amounted to (€0.6) million for the 2023 fiscal year, compared to €0 million for 2022.

Aprea Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, March 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.