Market News & Trends
Ocular Therapeutix Announces Accelerated Timelines for SOL-1 Registrational Trial of AXPAXLI in Wet AMD
Ocular Therapeutix, Inc. recently announced accelerated timelines for the SOL-1 Phase 3 registrational clinical trial of AXPAXLI in wet age-related macular degeneration (wet AMD). The…
Immuneering Granted Orphan Drug Designation for Pancreatic Cancer Treatment
Immuneering Corporation recently announced the US FDA has granted orphan drug designation to IMM-1-104 in the treatment of pancreatic cancer. IMM-1-104 is currently being evaluated…
Indaptus Therapeutics Initiates Unrestricted Enrollment of Patients on Decoy20 Weekly Dosing Based on Encouraging Safety Data
Indaptus Therapeutics, Inc. recently provided an update regarding key clinical advancements in its Phase 1 trial of lead drug candidate Decoy20. The Safety Review Committee…
Akari Therapeutics Announces Effectiveness of Form S-4 & General Meeting Date of November 7, 2024 Related to Peak Bio Merger
Akari Therapeutics, Plc recently announced the effectiveness of the Form S-4, originally filed with the SEC on September 13, 2024, related to the merger of…
FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs
Annovis Bio Inc. recently announced the successful outcome of the End-of-Phase 2 meeting with the US FDA on October 10, 2024. During the meeting, the…
Sapio Sciences Enhances Bioanalysis LIMS & ELN With Advanced Immunogenicity Capabilities
Sapio Sciences recently announced the addition of new immunogenicity bioanalysis features to its industry-leading lab informatics platform. These new capabilities in the Sapio LIMS (Laboratory Information…
NovaCina Expands Perth Facility to Offer Clinical Supplies Service for Global Market
NovaCina recently announced the expansion of its facility in Perth, Australia with the introduction of a high-tech SA25 GMP filling line to assist customers with small-batch…
Transgene Provides Update on Phase 2 Trial of Therapeutic Cancer Vaccine in Recurrent or Metastatic HPV16-Positive Cervical & Anogenital Cancers
Transgene recently announced its randomized Phase 2 study to evaluate TG4001 in combination with avelumab versus avelumab alone in patients with recurrent or metastatic HPV16-positive…
Inventiva Announces Financing to Advance NATiV3 Phase 3 MASH Study
Inventiva recently announced financing of immediately €94.1 million and up to €348 million, subject to satisfaction of specified conditions, to fund the completion of the…
Ardena Signs Agreement to Expand US Footprint With Acquisition of Advanced Drug Product Manufacturing Facility
Ardena recently announced it has signed a definitive agreement to acquire Catalent’s state-of-the-art facility in Somerset, NJ. This acquisition will significantly enhance Ardena’s capabilities in downstream…
Honeywell Technology to Power DevPro Biopharma’s Next-Generation Low-Emission Respiratory Inhaler
Honeywell recently announced a long-term supply agreement with DevPro Biopharma to develop a respiratory inhaler that enhances the well-being of patients while reducing carbon emissions associated…
MitoRx Therapeutics Announces Publication Showing Mitochondrial Sulfide Donor AP39 Significantly Alleviates Obesity
MitoRx Therapeutics recently announced a publication in Elsevier’s prestigious biomedical sciences journal Pharmacological Research. The work led by collaborators at Jagiellonian University Medical College showed…
TransCode Therapeutics Completes Initial Dosing of First Cohort in Phase 1 Trial With a microRNA-Targeted Technology
TransCode Therapeutics, Inc. recently announced it has dosed all patients in the first cohort of its Phase 1a dose-escalation clinical trial. The therapeutic candidate being…
Nanoscope Announces Plans to Submit BLA for Retinitis Pigmentosa Treatment
Nanoscope Therapeutics Inc. recently announced a productive FDA meeting for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP). Based on the regulatory…
Achieve Life Sciences Announces Completion of Enrollment in Clinical Trial & Successful Outcome of the First Data Safety Monitoring Committee Meeting
Achieve Life Sciences, Inc. recently announced an update on the ORCA-OL clinical trial, evaluating long-term exposure of the novel 3 mg cytisinicline treatment dosing regimen…
Palisade Bio Cleared to Commence Phase 1 Clinical Study for Ulcerative Colitis Treatment
Palisade Bio, Inc. recently announced it has received a No Objection Letter from Health Canada for its Phase 1 human clinical study for PALI-2108 for…
FDA Grants Orphan Drug Designation to Can-Fite’s Namodenoson for Pancreatic Cancer
Can-Fite BioPharma Ltd. recently announced the its oncology drug candidate, Namodenoson, has been granted Orphan Drug Designation by the US FDA for the indication of…
Panavance Therapeutics Provides Update on Phase 1 Clinical Trial of Misetionamide in Pancreatic Cancer
Panavance Therapeutics Inc. recently announced the presentation of interim data from its Phase 1 clinical study evaluating misetionamide (GP-2250) in combination with gemcitabine at the 2024…
BrainDos Formulated Dual GIP/GLP-1 Receptor Agonist Tirzepatide Outperforms Tirzepatide Solution in Preclinical Study
MetP Pharma AG, leveraging the proprietary nose-to-brain drug delivery technology BrainDos in internal and external product development and manufacturing programs, recently announced preclinical data showing…
Sonnet BioTherapeutics Enters Licensing Agreement With Alkem Laboratories
Sonnet BioTherapeutics Holdings, Inc. recently announced it has entered into a licensing agreement with Alkem Laboratories Limited for the research, development, manufacturing, marketing, and commercialization…