Market News & Trends
Allyx Therapeutics Announces Expansion Into Parkinson’s Disease Clinical Research With Lead Compound Following IND Acceptance
Allyx Therapeutics recently announced the US FDA has accepted its Investigational New Drug Application (IND), enabling the company to proceed with clinical research in Parkinson’s…
Akari Therapeutics & Peak Bio Announce Definitive Agreement to Merge as Equals
Akari Therapeutics, Plc and Peak Bio Inc. recently announce a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate…
Elizabeth Hickman to Succeed Tim Scott as AustinPx CEO
AustinPx, developers of the next generation amorphous dispersion platform, KinetiSol Technology, and a contract development and manufacturing organization (CDMO), recently announced Elizabeth Hickman, Chief Business Officer, will succeed….
Indaptus Therapeutics Announces Positive Results From Second Cohort of Phase 1 Trial; Company Initiates Multi-Dose Cohort
Indaptus Therapeutics, Inc. recently announced positive results from the second cohort of its Phase 1 INDP-D101 trial. Patients continue to exhibit a broad immune response…
Unicycive Therapeutics Announces Orphan Drug Designation Granted for UNI-494 for the Prevention of Delayed Graft Function in Kidney Transplant Patients
Unicycive Therapeutics, Inc. recently announced the US FDA has granted orphan drug designation (ODD) to UNI-494 for the prevention of Delayed Graft Function (DGF) in kidney….
Neurogene Announces Expansion & Plans for More Rapid Patient Enrollment of Rett Syndrome Gene Therapy Clinical Trial
Neurogene Inc. recently announced the expansion of its ongoing Phase 1/2 gene therapy clinical trial for NGN-401 for female pediatric patients with Rett syndrome and…
GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the UK
GRI Bio, Inc. recently announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate…
Fortress Biotech & Cyprium Therapeutics Announce $4.1-Million Grant From NINDS to Further Develop Gene Therapy for Menkes Disease
Cyprium Therapeutics, Inc. recently announced the National Institute of Neurological Disorders and Stroke (NINDS) of the National Institutes of Health (NIH) has awarded a 3-year…
One of Northern Europe’s Largest Production Sites Successfully Taken Over by the Prange Group & Adragos Pharma
The Prange Group and its affiliate Adragos Pharma, one of Europe’s fastest growing CDMOs, has completed the acquisition transaction of Fresenius Kabi production site in…
Kinnate Biopharma Sells Investigational Pan-RAF Inhibitor to Pierre Fabre Laboratories
Kinnate Biopharma Inc. and Pierre Fabre Médicament, SAS recently announced their agreement to the sale of the company’s investigational pan-RAF inhibitor, exarafenib, and other pan-RAF…
Apalutamide Study Again Demonstrates the Advantages of Nanoforming Over Traditional Cancer Treatment Formulations
Nanoform Finland Plc recently announced it had received positive results from its own preclinical, in-vivo study of a nanocrystalline-enabled apalutamide oral formulation, which shows potential…
BioCina & NovaCina Forge Strategic Alliance to Offer Biologics Developers Integrated Drug Substance & Drug Product Solutions
BioCina Pty Ltd. and NovaCina Pty Ltd. recently announced a strategic partnership to provide integrated drug substance and drug product solutions for….
Idorsia & Viatris Enter Significant Global Research & Development Collaboration
Idorsia Ltd recently announced it has entered into agreements for a significant global research and development collaboration with Viatris Inc. for the global development and commercialization of two….
Simtra BioPharma Solutions Announces $250+ Million Investment to Expand Sterile Fill/Finish Manufacturing Site
Simtra BioPharma Solutions recently announced a $250+ million expansion of its sterile fill/finish manufacturing campus in Bloomington, IN….
vTv Therapeutics Announces $51-Million Private Placement From Healthcare-Focused Institutional Investors & the JDRF T1D Fund
vTv Therapeutics Inc. recently announced it has closed a private placement to healthcare-focused institutional investors, including a life sciences-focused institutional investor, Samsara BioCapital, LLC and…
Silo Pharma Completes Successful Dose-Ranging Study of SPC-15 Intranasal Therapeutic for PTSD
Silo Pharma, Inc. recently announced positive results from its non-GLP small animal dose-ranging study of SPC-15, an intranasal prophylactic treatment for anxiety and post-traumatic stress…
Dyadic Announces Strategic Partnership Agreement to Develop Affordable Rabies Prophylactics & Vaccines Using its Proprietary C1 Cell Microbial Protein Production Platform
Dyadic International, Inc. recently announced its Dutch subsidiary, Dyadic Nederland BV has entered into a strategic partnership agreement and collaboration with Rabian BV, a Dutch…
Arch Biopartners Has Pre-IND Meeting With FDA to Discuss Repurposing Cilastatin as a New Treatment to Prevent Acute Kidney Injury
Arch Biopartners Inc. recently announced it had a pre-investigational new drug application (PIND) meeting with the US FDA Division of Cardiovascular and Renal Products (DCRP)…
Denali Therapeutics Announces $500-Million Private Placement Equity Financing
Denali Therapeutics Inc. recently announced the company has entered into a securities purchase agreement with certain existing accredited investors to issue and sell an aggregate…
Bio-Rad Launches Vericheck ddPCR Replication Competent Lentivirus & Replication Competent AAV Kits for Cell & Gene Therapy Production
Bio-Rad Laboratories, Inc. recently announced the launch of the Vericheck ddPCR Replication Competent Lentivirus Kit and the Vericheck ddPCR Replication Competent AAV Kit. The kits provide rapid….
