Precigen receives FDA platform designation
Precigen (NASDAQ:PGEN) received U.S. FDA platform technology designation for its AdenoVerse immunotherapeutic platform, which supports the company’s first commercial product, PAPZIMEOS.
Precigen (NASDAQ:PGEN) received U.S. FDA platform technology designation for its AdenoVerse immunotherapeutic platform, which supports the company’s first commercial product, PAPZIMEOS.
Insmed (NASDAQ:INSM) received FDA Priority Review for its supplemental New Drug Application seeking full approval of ARIKAYCE (amikacin liposome inhalation suspension) for treating Mycobacterium avium complex (MAC) lung disease.
Merck (NYSE:MRK) announced that Japan’s Ministry of Health, Labour and Welfare approved KEYJECT (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use across all indications approved for KEYTRUDA in Japan.
Novo Nordisk (NYSE:NVO) reported phase 3 topline results showing once-weekly CagriSema achieved weight loss and blood sugar reductions in adults with type 2 diabetes and obesity.
Cue Biopharma (NASDAQ:CUE) shares gained after the company reported positive results from a mid-stage study evaluating CUE-221 as a treatment for hives.
Novo Nordisk (NYSE:NVO) shares declined after the company presented its strategic ambitions for 2030 ahead of its Capital Markets Day, including long-term pipeline and obesity market targets.
GRAIL (NASDAQ:GRAL) shares rose sharply after U.S. Food and Drug Administration staff reviewers reported no major concerns regarding the safety and analytical performance of the company’s Galleri blood test designed to detect multiple cancers.
XORTX Therapeutics (NASDAQ:XRTX) announced plans to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration in the fourth quarter of 2026 for its XRx-026 gout program using the XORLO formulation of oxypurinol.
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Enhertu (trastuzumab deruxtecan) in the adjuvant treatment of adults with resected HER2-positive breast cancer.
Corcept Therapeutics (NASDAQ:CORT) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending approval of relacorilant combined with nab-paclitaxel for patients with platinum-resistant ovarian cancer.
Abeona Therapeutics (NASDAQ:ABEO) announced that Ultragenyx Pharmaceutical received U.S. Food and Drug Administration approval for FAYUVI (rebisufligene etisparvovec-hopf), a gene therapy for Sanfilippo syndrome type A.
BlossomHill Therapeutics (NASDAQ:BLSM) reported second quarter 2026 financial results and pipeline progress, highlighting its strengthened cash position following an upsized initial public offering.
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