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.
Every story in this section, newest first — page 53 of 373.
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.
Namib Minerals (NASDAQ:NAMM) completed dewatering at its Redwing Mine in Zimbabwe, achieving the first step in its five-step mine restart pathway ahead of its original fourth-quarter 2026 target.
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.
Einride (NASDAQ:ENRD) announced a strategic collaboration with NVIDIA (NASDAQ:NVDA) to develop the next generation of its Einride Driver autonomous trucking system.
VinFast Auto (NASDAQ:VFS) began U.S. sales of the 2027 model year VF 8 electric SUV, featuring updated technology, safety systems and driver-assistance features.
Sunshine Silver Mining & Refining (NYSE:SSMR) expanded its consolidated mineral rights in Idaho’s Silver Valley by approximately 14,100 acres, increasing its land position to about 38,000 acres.
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.
Ethan Allen Interiors (NYSE:ETD) announced that its Board of Directors has started a formal CEO succession process and expects to name its next chief executive by June 30, 2027.
Vertical Aerospace (NYSE:EVTL) appointed Fabrice Brégier as Chair of its Board of Directors, effective September 21, 2026, as the company advances development of its electric vertical take-off and landing (eVTOL) aircraft.
Ennis (NYSE:EBF) reported revenue of $102 million for the quarter ended August 31, 2026, an increase of $3.3 million, or 3.3%, compared with the same period last year.
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.
Paramount Skydance (NASDAQ:PSKY) and Warner Bros. Discovery (NASDAQ:WBD) shares gained after reports that Paramount Skydance was advancing settlement discussions with California’s attorney general over the proposed merger.
Accenture (NYSE:ACN) shares rose after the company announced a partnership with AI lab Anthropic to support artificial intelligence model evaluation and testing.
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.
nVent Electric (NYSE:NVT) declared a regular quarterly cash dividend of $0.21 per ordinary share, payable on November 6, 2026, to shareholders of record as of October 23, 2026.
Cadeler (NYSE:CDLR) signed a memorandum of understanding with Vattenfall to develop next-generation offshore wind operations and maintenance solutions through Cadeler’s Nexra service platform.
Asian shares mostly moved higher on Monday as investors monitored developments ahead of an expected meeting between U.S. President Donald Trump and Chinese President Xi Jinping covering trade, artificial intelligence and geopolitical issues.
Brent crude and West Texas Intermediate oil prices declined to their lowest levels in about a week as traders responded to renewed hopes for a diplomatic solution to the Middle East conflict.
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.
Joby Aviation (NYSE:JOBY) announced that an aircraft equipped with its autonomy technology completed the first autonomous flight across the United States, covering 3,199 miles without control inputs from its onboard safety pilot.
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.
Got a second for a cookie? 🍪Essential cookies keep Grafa running smoothly. A few optional ones help us see what's working so we can make it better. You're in control — change your mind any time. Cookie policy · Privacy policy