Shares of Cardiff Oncology Inc. (NASDAQ:CRDF) were trading at $1.92, down 1.03, or 35%, after an update with the Polo-like kinase 1 (PLK1) inhibitor onvansertib, undergoing tests in the phase II trial called CRDF-004. The study is a randomized dose-finding effort evaluating onvansertib in combination with standard-of-care (SoC) regimens (FOLFIRI/bevacizumab [bev] or FOLFOX/bev) in patients with first-line, RAS-mutated metastatic colorectal cancer. In an intent-to-treat analysis, the data show dose-dependent benefits across multiple efficacy measures in patients receiving onvansertib with FOLFIRI/bev vs. those given either of the SoC regimens, Cardiff said. The PLK1 blocker approach when deployed with FOLFIRI/bev performed better than onvansertib with FOLFOX/bev, the firm noted.

Intellia’s nex-z moves ahead, but only for ATTR-PN for now

Following a clinical hold last October of Intellia Therapeutics Inc.’s Magnitude and Magnitude-2 phase III trials of CRISPR/Cas9 gene editing therapy nexiguran ziclumeran (nex-z) to treat transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and polyneuropathy (ATTR-PN), respectively, the U.S. FDA lifted the hold on Magnitude-2, pushing the company’s shares up by 22% in early trading Jan. 27. The company is in ongoing discussions with the agency concerning the Magnitude trial, but analysts suggest the lifted hold on Magnitude-2 is a positive for the whole program. The pause resulted due to a second case of grade 4 liver transaminase elevations in ATTR-CM patients participating in the Magnitude trial. The first occurred in May and appeared to be resolving, Intellia said at the time. The second resulted in the death of a patient in his early 80s by November.

Alphamab’s HER2 bispecific hits phase III gastric cancer endpoints

Suzhou Alphamab Co. Ltd.’s HER2 bispecific antibody, anbenitamab (KN-026), combined with chemotherapy has the potential to become a new standard of care for patients with HER2-positive gastric cancer who failed at least one prior line of therapy, according to newly released phase III results that show the combo cut disease progression risk by 75%. Published in Annals of Oncology, the randomized, double-blind, controlled, multicenter phase III KC-Wise trial evaluated anbenitamab combined with chemotherapy vs. standard-of-care treatment in patients with HER2-positive gastric or gastroesophageal junction cancer who previously failed first-line therapy containing trastuzumab.

Biopharma deal value peaks in 2025 after strong Q4

Full-year biopharma deal value in 2025 reached $292.55 billion, the highest annual total in BioWorld’s records, following $78.93 billion in the fourth quarter (Q4). The annual total is a 27% increase from the $230.53 billion recorded in 2024. Quarterly deal value increased sequentially throughout the year, rising from $67.6 billion in Q1 to $71.76 billion in Q2 and $74.26 billion in Q3. Fourth-quarter 2025 deal value was lower than Q4 totals of $80.65 billion in Q4 2024 and $87.31 billion in Q4 2023. Biopharma deal volume declined in 2025, however, with 1,173 transactions completed for the year, an 18% decrease from 1,429 in 2024.

Final reckoning shows 2025 was ‘brutal’ year for UK investment

After a “brutal” year, there is reason for optimism, with the fourth quarter seeing an upswing in deal numbers and the amount raised, according to the UK Bioindustry Association’s final tally of biotech financing in 2025. The £1.8 billion (US$2.47 billion) in venture capital attracted by the sector was 13.2% less than in 2024, and there was a very sharp fall in follow-on equity funding with only £95.8 million raised via this route. That was 94% less than in 2024. For the third year in a row, no companies completed an IPO in London. Yet, U.K. assets were in demand, with some biggish acquisitions, most notably, Merck & Co. Inc. buying Verona Pharma plc for $10 billion.

US childhood vaccines trapped in the crosshairs

Although the American Academy of Pediatrics (AAP) has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued yesterday is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations. The AAP criticized the CDC’s “arbitrary” changes, noting that the agency had adopted it without going through the standard process of consulting its Advisory Committee on Immunization Practices (ACIP) during a public meeting. Had the ACIP weighed in, the results might have been worse, though. Speaking on a podcast just a few days ago, the new ACIP chair seemed to question the need for polio, and even measles/mumps/rubella, vaccines.

Former Cytodyn CEO faces prison time, millions in restitution

Nader Pourhassan, the former president and CEO of Cytodyn Inc., was sentenced Friday to 30 months in prison for his role in a securities fraud scheme to deceive investors about the Vancouver, Wash.-based company’s development of leronlimab as a treatment for HIV and COVID-19. He also was ordered to pay more than $5.3 million in restitution and to forfeit more than $4.4 million in profits. The sentencing came more than a year after a federal jury convicted Pourhassan of four counts of securities fraud, two counts of wire fraud and three counts of insider trading.

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