As expected, Robert Kennedy was confirmed today as the next secretary of the U.S. Department of Health and Human Services (HHS) on a mostly party-line vote of 52-48. Sen. Mitch McConnell, R-Ky., a polio survivor, was the only Republican to vote against Kennedy’s confirmation. Meanwhile, the uncertainty hanging over the FDA and other HHS agencies increased this week when President Donald Trump issued an executive order calling for large-scale reductions in force across all federal agencies and limiting agency hires to one employee for every four who are departing. After the election when Trump nominated Kennedy to head HHS, many FDA employees started looking for an exit, Chad Landmon, chair of Polsinelli’s Hatch-Waxman and biologics practice, told BioWorld. That’s accelerated in recent weeks, leading to a brain drain and loss of institutional knowledge at the FDA, he added.
Moleculin’s Miracle phase III in AML gets reduced timeline, stock burst
The market took a strong liking to the latest U.S. FDA guidance for Moleculin Biotech Inc.’s upcoming Miracle phase III trial in cancer. The agency helped accelerate the timeline for the pivotal late-stage study for treating acute myeloid leukemia patients who are refractory to or relapse after induction therapy by amending the IND protocol that allows for an earlier than anticipated unblinding of the preliminary primary efficacy data. Those results will include complete remission and safety/tolerability numbers. The MB-108 treatment is annamycin combined with cytarabine. The company’s stock (NASDAQ:MBRX) had soared 595% at midday to $2.92 a share.
Ligachem gets rights to Daan’s antibody for solid tumor ADCs
Ligachem Biosciences Inc. landed another exclusive licensing deal to develop and commercialize antibody-drug conjugates (ADCs), this time with T-cell receptor (TCR) therapy specialist Daan Biotherapeutics Inc. for a cancer-targeting antibody. The deal includes exclusive, worldwide rights to a solid tumor-targeting antibody for use in developing ADC therapies for indications with high unmet needs, including lung cancer and colon cancer. The financial terms of the deal were undisclosed due to confidentiality agreements, but includes an up-front payment, development and commercial milestone payments and sales-based royalties.
Aardvark stock sinks first day; IPO to fund obesity drugs
Raising $94.2 million in gross proceeds, Aardvark Therapeutics Inc. became the fifth biopharma company to list on Nasdaq so far in 2025. The company priced 5.89 million shares at $16 each, the low end of its price range. It plans to use the funds to advance clinical development of ARD-101 for Prader-Willi syndrome and hypothalamic obesity and ARD-201 for obesity. Proceeds also will go toward other clinical and preclinical programs and R&D activities, and to cover working capital, operating expenses, capital expenditures and other general corporate purposes. Shares (NASDAQ:AARD) fell 24% to $12.17 by midday Feb. 13, the first day of trading.
BIO CEO 2025: The quest for next-gen obesity meds
While first-generation glucagon-like peptide-1 (GLP-1) receptor agonists have clearly taken the obesity market by storm, generating billions of dollars for Novo Nordisk A/S and Eli Lilly and Co., several other companies are developing follow-on products that could clean up the tolerability and adherence issues of Wegovy (semaglutide) and Zepbound (tirzepatide). Five companies gathered in New York on Feb. 10, at the Biotechnology Innovation Organization’s CEO and Investor Conference, to discuss how their efforts will impact a disease space that affects two out of every five people and could potentially disrupt a number of associated comorbidities, including type 2 diabetes and cardiovascular disease. Between tolerability, frequency of administration and delivery methods, there is plenty of room for improvement over the current breakthrough drugs for weight loss, the panelists said.
Radiopharm’s radiotracer F18-Pivalate successfully detects brain metastases
Radiopharm Theranostics Ltd.’s radiotracer RAD-101 (F18-Pivalate) successfully detected brain metastases in a variety of primary solid tumors in a phase II study. Published in the European Journal of Nuclear Medicine and Molecular Imaging, the study detected brain metastases using the radiotracer I8F-RAD-101 in a hybrid imaging test that combines positron emission tomography and multiparametric magnetic resonance imaging (PET-mpMRI). The study investigated the imaging characteristics of brain metastases in 12 treatment-naïve patients and 10 patients who had previously been treated with brain radiation. All brain metastases, regardless of the tumor of origin, were detected with 18F-RAD-101 PET-mpMRI with a high tumor-to-background ratio.