JNJ News & Events

Catch up on the weekend's top five stories with this list compiled by The Fly: 1) KKR (KKR) is working on a sale of CoolIT Systems, hoping to fetch a price tag in excess of $3B, Oliver Barnes and Antoine Gara of The Financial Times reports, citing people familiar with the matter. This is a massive increase from the unit's $270M valuation when KKR bought a majority stake in 2023. 2) Dr. Vinay Prasad, who issued several controversial decisions, including having refused to accept Moderna's (MRNA) application for a new mRNA flu vaccine and refused an application for a Huntington's drug's review from UniQure (QURE), is leaving the agency at the end of April, reported The New York Times' Christina Jewett on Friday evening, citing a Health and Human Services spokesman. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Biotech stocks that could be impacted by the news include Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Avidity Biosciences (RNA), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Moderna (MRNA), Novavax (NVAX) and Lexeo Therapeutics (LXEO). 3) Plug Power (PLUG) plans to offer hydrogen electricity, as much as 250 megawatts, in an auction President Donald Trump is eager to make happen later this year, Will Wade and Naureen Malik of Bloomberg reports, citing chairman Andy Marsh. PJM Interconnection, which is facing power shortages due to surging consumption by data centers to power AI, has been urged by the Trump administration to hold an emergency auction to bolster supplies. 4) Prudential (PRU) disclosed yesterday that on March 6, the Prudential Gibraltar Financial Life Insurance Co., a subsidiary of Prudential Financial, issued a press release in Japan reporting instances of the unauthorized removal of information by certain employees of PGFL seconded to financial institutions in Japan. The investigation confirmed that 11 employees in total removed 379 instances of information at seven contracted agencies. The removed information pertained to operational matters such as sales performance at the assigned agencies. "After confirming the content of all cases with the agencies, no issues were identified that would raise concerns under the Unfair Competition Prevention Act, nor was there any inappropriate removal of contract information," Prudential Gibraltar Financial said. 5) Activist investor Starboard Value has built a stake in Lamb Weston (LW) and has been pushing to company to speed up improvements and cost cutting to boost stock performance, Lauren Thomas of The Wall Street Journal reports, citing people familiar with the matter. Starboard is now one of the largest shareholders in the company, the sources added.

Dr. Vinay Prasad, who issued several controversial decisions, including having refused to accept Moderna's (MRNA) application for a new mRNA flu vaccine and refused an application for a Huntington's drug's review from UniQure (QURE), is leaving the agency at the end of April, reported The New York Times' Christina Jewett on Friday evening, citing a Health and Human Services spokesman. Publicly traded large-cap drugmakers include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY). Biotech stocks that could be impacted by the news include Sarepta (SRPT), Xencor (XNCR), PTC Therapeutics (PTCT), Biohaven (BHVN), Edgewise Therapeutics (EWTX), Design Therapeutics (DSGN), Ultragenyx (RARE), Avidity Biosciences (RNA), Dyne Therapeutics (DYN), Wave Life Sciences (WVE), MeiraGTx (MGTX), uniQure (QURE), Regenxbio (RGNX), Moderna (MRNA), Novavax (NVAX) and Lexeo Therapeutics (LXEO).

Johnson & Johnson announced that the U.S. Food and Drug Administration approved Tecvayli plus Darzalex Faspro for the treatment of adults with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. "This approval offers a potential new standard of care as early as second line and brings a novel treatment approach for the 40% of patients with multiple myeloma who experience disease relapse," the company stated.

The Food and Drug Administration approved teclistamab in combination with daratumumab hyaluronidase-fihj, Tec-Dara, to treat adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy. "This decision, which was issued 55 days after filing, marks the third approval under the new Commissioner's National Priority Voucher pilot program," the regulator stated. The FDA granted the approval to Johnson & Johnson's Janssen Biotech.