Warren, N.J. – September 21, 2026 -- PTC Therapeutics, Inc. (NASDAQ: PTCT) has completed its acquisition of ST-920, a BLA-stage, one-time AAV gene therapy for Fabry disease, from Sangamo Therapeutics, Inc.

PTC targets Q4 2026 completion of rolling BLA submission for accelerated approval

The company confirmed that a rolling Biologics License Application submission to the FDA seeking accelerated approval of ST-920, also known as isaralgagene civaparvovec, is expected to be completed in the fourth quarter of 2026.

Princeton – September 21, 2026 -- Made Scientific, Inc. has acquired an 85,000 sq. ft. clinical-to-commercial cell therapy manufacturing facility in East Norriton, Pennsylvania, from National Resilience, closing the transaction on September 18, 2026. The purchase expands the company's U.S. East Coast footprint to approximately 145,000 sq. ft. and 15 qualified GMP manufacturing suites across New Jersey and Pennsylvania.

Waltham, Mass. – September 21, 2026 -- The U.S. Food and Drug Administration has approved Mercy BioAnalytics' Investigational Device Exemption application for its Evident Ovarian Cancer Screening Test, clearing the way for the company's pivotal SOARA Clinical Validation Study pending Institutional Review Board sign-off.

Florence – September 21, 2026 -- The European Commission has granted marketing authorization for Ubeslo (obicetrapib 10 mg monotherapy) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg fixed-dose combination), marking the first global regulatory approval of obicetrapib for NewAmsterdam Pharma (Nasdaq: NAMS) and partner Menarini Group.

Gainesville, Fla. – September 21, 2026 -- Advita Ortho has launched Axis, a clinical research platform drawing on more than 20 years of shoulder arthroplasty data covering over 25,000 patients across 45 clinical sites worldwide.

Providence, R.I. – September 21, 2026 -- Nabsys 2.0, LLC has published the first study combining CRISPR/Cas9 with its proprietary Electronic Genome Mapping (EGM) technology, demonstrating a method to both evaluate CRISPR/Cas9 activity and direct EGM to target specific genomic regions rather than only genome-wide analysis.

The preprint, titled 'CRISPR/Cas9 Optimization Using Electronic Genome Mapping: Potential Role for Studying Human Genetic Disease,' was led by John F. Thompson, Ph.D., Principal Application Scientist at Nabsys, and posted on bioRxiv.

Beijing – September 21, 2026 -- T-MAXIMUM Pharmaceutical reported that two of three evaluable patients with refractory brain metastases from lung cancer achieved partial responses with roughly 80% tumor shrinkage after treatment with its allogeneic B7-H3-targeted CAR-T therapy, MT027, according to early data presented at the IASLC World Conference on Lung Cancer (WCLC 2026) in Seoul.

Jerusalem – September 21, 2026 -- Scinai Immunotherapeutics Ltd. (Nasdaq: SCNI) has regained compliance with Nasdaq's $1.00 minimum bid price rule after its American Depositary Shares closed at or above that threshold for 19 consecutive business days, Nasdaq Listing Qualifications confirmed in a September 18, 2026 letter.

Bridgewater, N.J. – September 21, 2026 -- The U.S. Food and Drug Administration has accepted Insmed Incorporated's supplemental New Drug Application (sNDA) for full approval of ARIKAYCE (amikacin liposome inhalation suspension) to treat Mycobacterium avium complex (MAC) lung disease, granting Priority Review with a PDUFA target action date of January 28, 2027.

Germantown, Md. – September 21, 2026 -- The U.S. Food and Drug Administration has granted platform technology designation to Precigen's AdenoVerse immunotherapeutic platform, the technology underlying the company's first commercial product, PAPZIMEOS, approved in August 2025 for recurrent respiratory papillomatosis (RRP) in adults.