While uncertainty often casts a shadow on the Street, U.S. investors welcomed the presidential and congressional election results with a late-night surge that carried into this morning. The Dow Jones peaked at 1,380.47 points this morning, up 3.27% from yesterday and hitting its highest point of the year so far. That welcome extended to the biotech sector, with the BioWorld Index, which covers more than 500 companies, up 17.06% for the year, compared with a 12.28% increase for the year on Friday. Much of the focus has been on what a second Trump administration might mean for the life sciences sector, but the Senate lane shift to Republican control also could have a big impact in terms of tax policies and oversight.

GSK CEO on Trump win: Watching RFK impact, US-China relations

“I think elections are like pregnancy. … Everyone puts all of the energy into D-day – the birth. We’ve had the gender reveal, but what really, really matters is what happens now and the path ahead.” That was the instant response of Emma Walmsley, CEO of GSK plc, reacting to breaking news from the U.S. that Donald Trump has won a second term in office. She has met President Trump both in the U.K. and in the U.S., and said GSK “worked very successfully” with his 2016 to 2020 administration, including through the COVID-19 pandemic. The ramifications are yet to unfold, but one particular concern is the amount of influence that is given to Robert F. Kennedy Jr., a vocal anti-vaccine proponent, who Trump has said will get a “big role” in health care.

Two to Tango: Brain cancer drugs go further into development

In a pipeline shakeup, Tango Therapeutics Inc. has halted enrollment in a phase I/II study in order to push two other brain cancer drugs into development. TNG-908 had success in treating non-CNS solid tumors such as non-small-cell lung cancer (NSCLC) and pancreatic cancer but missed the minimum pharmacokinetic exposure in clinical efficacy for treating glioblastoma (GBM). Tango said it now will direct the halted study’s resources toward developing TNG-456 for treating GBM, NSCLC and other solid tumors, and TNG-462 in treating multiple tumor types, such as NSCLC and pancreatic cancer. The company’s stock (NASDAQ:TNGX) had sagged 41% at midday, with shares trading at $3.04 each.

FDA lifts clinical hold on Carsgen’s CAR Ts following warnings

The FDA has lifted a clinical hold on Carsgen Therapeutics Holdings Ltd.’s. CAR T products after issuing the company a warning letter following a December 2023 FDA inspection that found the company violated good manufacturing practices at its Research Triangle Park facility in Durham, N.C. Following the inspection, the agency issued a Form 483 and placed clinical holds on U.S. clinical trials of Carsgen’s CAR T trials, including zevorcabtagene autoleucel (zevor-cel, CT-053), an autologous CAR T targeting B-cell maturation antigen; satricabtagene autoleucel (satri-cel, CT-041), an autologous CAR T product targeting Claudin18.2; and CT-071, an autologous CAR T product targeting GPRC5D. During the December 2023 FDA inspection, the agency discovered that procedures related to the manufacturing of the CAR T-cell products were not conducted in accordance with good manufacturing practices.

Celltrion unveils two new preclinical antibody-drug conjugates

Celltrion Inc. posted preclinical study results of two new antibody-drug conjugate (ADC) candidates – CT-P70 and CT-P71 – at the World ADC 2024 conference in San Diego Nov. 6, with plans to move the assets into clinical trials. Poster presentations of both ADC candidates “drew significant attention from the attendees” at the oncology meeting, Incheon, South Korea-based Celltrion said, while highlighting its efforts to transition from a biosimilar maker to a novel therapy developer. CT-P70 was described as a c-MET-targeting asset; CT-P71 is a Nectin-4-based ADC candidate. Both cancer pipelines were conjugated with PBX-7016 (trastuzumab), a novel camptothecin (HY-16560) derivate co-developed by Celltrion and Gyeonggi-do, South Korea-based ADC biotech Pinotbio Inc.

Also in the news

Antiverse, Avet, Avicanna, Beam, Biocartis, Biofactura, Biovaxys, Bridgebio, Bright Minds, Defence, Ichnos Glenmark Innovation, Insignis, Intra-Cellular Therapies, Ionis, Karolinska, Neurocrine, Neuropace, Nouscom, Nxera, Organon, Probiogen, Protagenic, Royalty, Syndax, Teva, Transgene, Vaccinex, Verrica, Veru