Latest news with #CASGEVY®
Associated Press
29-04-2025
- Business
- Associated Press
Biomay Obtains FDA Approval for Manufacturing of Cas9 Nuclease at Headquarters Site
The company announced its successful approval by the U.S. Food and Drug Administration (FDA) for the manufacturing, testing and release of recombinant Cas9 nuclease from its headquarters site. Cas9 is an essential component of CRISPR-based gene editing therapies, including CASGEVY® (exagamglogene autotemcel) developed and launched by Vertex Pharmaceuticals. Biomay's recent achievement refers to an inspection by the FDA's Center for Biologics Evaluation and Research (CBER) at Biomay's headquarters manufacturing site in Vienna, Seestadt in December 2024. No observation was found, and no Form FDA 483 was issued by the authority, allowing Biomay's headquarters site to supply Cas9 for the United States. Biomay operates two independent cGMP manufacturing sites, a headquarters facility in Vienna Seestadt, and a second site in Vienna downtown. The authority's approval of Biomay's headquarters site represents the company's second successful FDA inspection following the 2023 approval of Biomay's downtown facility. Biomay's headquarters site is a recently constructed, state-of-the-art biomanufacturing facility. Biomay AG is a privately owned and fully integrated Contract Development and Manufacturing Organization (CDMO) based in Vienna, Austria. Founded in 1984, the expression of recombinant proteins by utilizing E. coli has been Biomay's business focus from the very beginning. Today, Biomay offers cGMP services for manufacturing of therapeutic proteins, plasmid DNA (pDNA) and messenger RNA (mRNA). The company's scope of CDMO services comprises process and analytical development, cell banking, cGMP manufacturing of drug substance and aseptic filling of drug product.
Yahoo
12-04-2025
- Business
- Yahoo
CRISPR Therapeutics to Present at the 24th Annual Needham Virtual Healthcare Conference
ZUG, Switzerland and BOSTON, April 03, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that members of its senior management team will present at the 24th Annual Needham Virtual Healthcare Conference on Tue, April 8 at 12:45 p.m. ET. A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company's website at A replay of the webcast will be archived on the Company's website for 14 days following the presentation. About CRISPR Therapeutics Since its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit Investor Contact:+1-617-307-7503ir@ Media Contact:+1-617-315-4493media@
Yahoo
03-04-2025
- Business
- Yahoo
CRISPR Therapeutics to Present at the 24th Annual Needham Virtual Healthcare Conference
ZUG, Switzerland and BOSTON, April 03, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that members of its senior management team will present at the 24th Annual Needham Virtual Healthcare Conference on Tue, April 8 at 12:45 p.m. ET. A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company's website at A replay of the webcast will be archived on the Company's website for 14 days following the presentation. About CRISPR Therapeutics Since its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit Investor Contact:+1-617-307-7503ir@ Media Contact:+1-617-315-4493media@ in to access your portfolio
Yahoo
26-02-2025
- Business
- Yahoo
CRISPR Therapeutics to Present at the TD Cowen 45th Annual Health Care Conference
ZUG, Switzerland and BOSTON, Feb. 26, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that members of its senior management team will present at the TD Cowen 45th Annual Health Care Conference on Monday, March 3, 2025, at 10:30 a.m. ET. A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company's website at A replay of the webcast will be archived on the Company's website for 14 days following the presentation. About CRISPR TherapeuticsSince its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit Investor Contact:+1-617-307-7503ir@ Media Contact:+1-617-315-4493media@
Yahoo
29-01-2025
- Business
- Yahoo
CRISPR Therapeutics to Present at the Guggenheim SMID Cap Biotech Conference
ZUG, Switzerland and BOSTON, Jan. 29, 2025 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that members of its senior management team will present at the Guggenheim SMID Cap Biotech Conference on Wednesday, February 5, 2025, at 2:00 p.m. ET. A live webcast of the fireside chat will be available on the "Events & Presentations" page in the Investors section of the Company's website at A replay of the webcast will be archived on the Company's website for 14 days following the presentation. About CRISPR TherapeuticsSince its inception over a decade ago, CRISPR Therapeutics has evolved from a research-stage company advancing gene editing programs into a leader that celebrated the historic approval of the first-ever CRISPR-based therapy. The Company has a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular, autoimmune, and rare diseases. In 2018, CRISPR Therapeutics advanced the first-ever CRISPR/Cas9 gene-edited therapy into the clinic to investigate the treatment of sickle cell disease and transfusion-dependent beta thalassemia. Beginning in late 2023, CASGEVY® (exagamglogene autotemcel [exa-cel]) was approved in several countries to treat eligible patients with either of these conditions. The Nobel Prize-winning CRISPR technology has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts, CRISPR Therapeutics has formed strategic partnerships with leading companies including Vertex Pharmaceuticals. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Boston, Massachusetts and San Francisco, California. To learn more, visit Investor Contact:Susan Kim+ Media Contact:Rachel Eides +
