Press Releases

BioFactura Funded $16 Million Contract Option for its Smallpox Biodefense Therapeutic

Frederick, Maryland, October 2, 2023:  BioFactura, Inc. today announced a contract option activation of over $16 million by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, as part of its prime contract valued at over $77 million … Continue reading

October 2, 2023 Press Releases

BioFactura Publishes Phase 1 Data on its Ustekinumab Biosimilar

Frederick, Maryland, September 11, 2023:  BioFactura, Inc. announced the publication of the phase 1 study for BFI-751, a biosimilar candidate to Stelara (ustekinumab) (Jeffrey N. Hausfeld, Rodeina Challand, Kristi McLendon et al; Pharmacokinetic Profiles of a Proposed Biosimilar Ustekinumab (BFI-751): Results From a Randomized Phase 1Trial. Clinical Pharmacology, in Drug Development, 2023, 0(0) 1–12). Pairwise comparisons … Continue reading

September 11, 2023 Press Releases

BioFactura and CuraTeQ Sign Exclusive License for BFI-751—A Biosimilar to Stelara

Frederick, Maryland, July 10, 2023:  BioFactura, Inc. today announced that CuraTeQ Biologics Private Limited, a wholly owned subsidiary of Aurobindo Pharma Limited, has entered into an exclusive license to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara (Ustekinumab). Ustekinumab is a recombinant monoclonal antibody that works by blocking both interleukins IL-12 and IL-23 and is used … Continue reading

July 10, 2023 Press Releases

BioFactura Announces Activation of a $15.9M Contract Option for its Smallpox Biodefense Therapeutic

Frederick, Maryland, July 14, 2022:  BioFactura Inc. (“BioFactura”) today announced its second contract option activation of $15.9 million from the Biomedical Advanced Research and Development Authority (BARDA) to advance development of an antibody cocktail therapeutic for the treatment of smallpox. This funding is part of BioFactura’s prime contract valued at up to $68.2 million for the … Continue reading

July 14, 2022 Press Releases

BioFactura Announces MTA with Rani Therapeutics

Frederick, Maryland, September 9, 2021:  BioFactura Inc. (“BioFactura”), a leading developer of high-value biosimilar and biodefense drugs using its patented StableFast™ platform, announces an agreement with Rani Therapeutics (“Rani”) to assess its Ustekinumab Biosimilar (BFI-751) in combination with Rani’s RaniPill™ platform.  BFI-751 is being developed by BioFactura Australia Pty Ltd, a subsidiary of BioFactura, as a biosimilar … Continue reading

September 9, 2021 Press Releases

BioFactura announces initiation of Phase I study of BFI-751, a Stelara® (ustekinumab) biosimilar

Frederick, Maryland, May 25, 2021: BioFactura, a leading developer of high-value biosimilar and biodefense drugs using its patented StableFastTM platform, announces today the initiation of a pivotal PK (pharmacokinetics) Phase 1 Clinical Trial for its Ustekinumab Biosimilar (BFI-751), to assess the effects on healthy human volunteers compared to the biologic medicine, Stelera®. This is the first … Continue reading

May 25, 2021 Press Releases