XNCR News & Events

In a regulatory filing, Xencor (XNCR) disclosed that on March 4, the company received a notice of termination of an Amended and Restated Collaboration and License Agreement, effective as of June 1, 2024, with Genentech and F. Hoffmann-La Roche, pursuant to which Genentech has elected to terminate the agreement in its entirety for convenience. The effective date of the termination of the agreement is September 4, 2026, Xencor stated. "Roche had previously announced, in connection with the reporting of its 2024 financial results in January 2025, that it removed efbalropendekin alfa, an engineered cytokine-Fc fusion protein and the sole active collaboration product under the Agreement, from its development pipeline, and the Company has expected Genentech's administrative termination of the Agreement. During the first half of 2024, the Company ceased all cost-sharing development activities by electing to opt-out of co-development under the Agreement. Genentech assumed sole responsibility for all clinical, regulatory and commercial activities for certain collaboration products, including efbalropendekin alfa," the filing stated.

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).

Xenco announced that Alexion Pharmaceuticals informed Xencor that it has taken the position that the Licensee does not owe any additional royalties for sales of Ultomiris in the United States and that the Licensee does not intend to make any future payments for sales in the United States. Based on current operating plans, Xencor expects to end 2026 with between $380 million and $400 million in cash, cash equivalents and marketable debt securities, and to have sufficient cash resources to fund research and development programs and operations into mid-2028. "Xencor has reasonably assumed that the multiple licensees of our XmAb Fc domains and technologies remit payments in accordance with the terms of their respective agreements. One licensee has expressed disagreement regarding payments for net sales of Ultomiris in the United States, and we plan to work toward a resolution in this matter. Importantly, we have not observed a change in payments related to ex-U.S. sales," said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. "We have updated our year-end cash guidance and conservatively adjust our operating runway estimate into mid-2028."