News Headlines

1. Andelyn Biosciences To Implement Curator® Platform To Develop And Manufacture Gene Therapy AAV9-GM2 For Queen's University To Treat GM2 Gangliosidoses 9/21/2026

   Andelyn Biosciences, Inc., a leading patient-focused cell and gene therapy Contract Development and Manufacturing Organization (CDMO), has partnered with Queen’s University to develop and manufacture AAV9-GM2, a gene therapy candidate for the treatment of GM2 gangliosidoses, such as Tay-Sachs and Sandhoff diseases.

2. Andelyn Biosciences And Its Curator® Platform Achieve First FDA-Approved Commercial Gene Therapy Manufacturing Milestone Following The FDA's Approval Of Ultragenyx's Fayuvi™ For The Treatment Of Sanfilippo Syndrome Type A (MPS IIIA) 9/21/2026

   Andelyn Biosciences (“Andelyn”), a leading and patient-focused cell and gene therapy Contract Development and Manufacturing Organization (“CDMO”), today announced that it is now manufacturing Fayuvi™ (rebisufligene etisparvovec-hopf), an FDA-approved gene therapy, for commercial supply at its Columbus, Ohio facility. 

3. WuXi XDC Out-Licenses WuXiTecan-2 Payload-Linker Technology Platform To Ona Therapeutics To Advance Novel ADC Research And Development 9/17/2026

   WuXi XDC Cayman Inc. ("WuXi XDC", stock code: 2268.HK), a leading global CRDMO (Contract Research, Development, and Manufacturing Organization) specializing in antibody-drug conjugates (ADCs) and other bioconjugates, today announced an out-licensing collaboration with Ona Therapeutics on WuXi XDC's proprietary WuXiTecan-2 payload-linker technology platform.

4. Upperton Granted MHRA Licence For Annex 1 Aligned Sterile Manufacturing Facility 9/17/2026

   Upperton, a UK-based contract development and manufacturing organisation (CDMO), today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has approved a variation to its existing Manufacturing and Importation Authorisation for Investigational Medicinal Products (MIA(IMP)) licence, extending its scope to include the company’s new Annex 1-aligned sterile manufacturing facility at Trent Gateway, Nottingham.

5. ProBio And Kun Tuo Announce Strategic Collaboration To Deliver Integrated CDMO-CRO Solutions For Advanced Therapies 9/16/2026

   ProBio, a leading global contract development and manufacturing organization (CDMO) focused on biologics and cell and gene therapies (CGT), today announced a strategic collaboration with Kun Tuo, an IQVIA company and leading clinical research organization (CRO) in China.

6. Cellares And GenomeFrontier Therapeutics Partner To Evaluate Automated Manufacturing For GF-CART01 On The Cell Shuttle Platform 9/16/2026

   Cellares, the first Integrated Development and Manufacturing Organization (IDMO), and GenomeFrontier Therapeutics, a Taiwanese cell therapy company developing novel virus-free CAR-T therapies, today announced a partnership to evaluate automated manufacturing for GF-CART01, GenomeFrontier’s investigational CAR-T cell therapy, on Cellares’ Cell Shuttle platform.

7. Ono Received Manufacturing And Marketing Approval In Japan For XCOPRI Tablets For The Treatment Of Patients With Partial-Onset Seizures, With Or Without Secondary Generalized Seizures 9/16/2026

   Ono Pharmaceutical Co., Ltd. (Headquarters: Osaka, Japan; President and COO: Toichi Takino; “Ono”) today announced that Ono received manufacturing and marketing approval of XCOPRI (generic name: cenobamate) Tablets 12.5 mg, 50 mg, 100 mg, 200 mg (‟XCOPRI”) for the treatment of patients with partial-onset seizures, with or without secondary generalized seizures.

8. Hovione Opens New Facility At New Jersey Campus, Doubling U.S. Spray Drying Capacity 9/16/2026

   Hovione, a globally-integrated pharmaceutical Contract Development and Manufacturing Organization (CDMO), has opened 89 Twin Rivers, a new 31,000-square-foot facility at its East Windsor, N.J. campus that doubles the company's U.S. spray drying capacity and further reinforces Hovione´s global leadership in this technology platform.

9. 3PBIOVIAN Appoints Ponchi Kantt-Neaz As Global Executive Business Director, Marking A Milestone In Its oCommercial Strategy 9/16/2026

   3PBIOVIAN has appointed Ponchi Kantt-Neaz as Global Executive Business Director, marking an important milestone in the company’s global commercial strategy and further strengthening its commercial leadership as the company continues to expand its presence in the global CDMO market.

10. Tempest Secures Exclusive Option To License Clinical-Stage CD7-Targeted Lentiviral In Vivo CAR-T Platform 9/15/2026

    Tempest Therapeutics, Inc. (Nasdaq: TPST) (“Tempest”), a clinical-stage biotechnology company developing in vivo CAR-T therapies designed to reset dysfunctional immunity in cancer and autoimmune disease, today announced that it has entered into an exclusive option agreement with Hebei Senlang Biotechnology Co., Ltd. (“Senlang”).