ARD-201

Plus, news about Aardvark Therapeutics, RA Capital, Gilead and EpiFrontier: 📊 Karyopharm’s late-phase myelofibrosis data: The company’s drug selinexor achieved one co-primary endpoint but missed on the other in a Phase 3 study in patients with myelofibrosis. The drug hit on spleen volume reduction but didn’t achieve statistical significance on an absolute total symptom score. Karyopharm plans to discuss the data and its supplemental NDA filing plan with the FDA. RA Capital, meanwhile, is pumping $30 million into the company via a private placement. Selinexor is approved as Xpovio for certain cancers, and the drug reeled in $146 million in total revenue in 2025. The company laid off 20% of its workforce last year amid a hunt for “strategic alternatives.” — Kyle LaHucik 📁 Rezolute moves forward with low blood sugar drug despite failed study: The company says it would continue to seek approval for ersodetug after discussions with the FDA. Regulators told Rezolute “to submit study reports and analysis datasets,” according to a Rezolute press release . Ersodetug failed a Phase 3 study in December 2025, and the company plans to have another update in the second half of 2026. — Max Gelman 🐜 Aardvark pauses Phase 2 trials of second obesity asset : Following the voluntarily halt of the Phase 3 trial of ARD-101 several weeks ago due to a cardiac signal, Aardvark has now put the Phase 2 studies of its only other pipeline product on hiatus. This will allow it to “conduct a comprehensive review” of the data on the pill, it said . ARD-201 is a combination of ARD-101 with Merck’s DPP-4 inhibitor Januvia. One study aimed to test whether it can aid weight loss when added to a GLP-1 agonist, and the other whether it can help patients who had already lost around 15% of their weight on GLP-1 therapy keep the weight off. The biotech said it would give further information on the program in the second quarter of 2026. — Elizabeth Cairns 🚀 RA Capital launches another SPAC: An affiliate of the life sciences investment firm has penciled in plans for a $50 million IPO for a blank check company. The special purpose acquisition company aims to take a biotech to the public markets. In its IPO paperwork on Tuesday, Research Alliance Corp. III notes the “wave of in-licensing assets from ex-US jurisdictions into newly formed companies that have gone on to be acquired or go public.” That includes RA-backed companies like Aiolos Bio, Metsera and Candid Therapeutics. “We believe that similar newly formed companies will continue to be formed and could become suitable merger targets,” the SPAC wrote in its S-1. RA has invested in such companies lately, including Solstice Oncology and Slate Medicines . RA’s last SPAC, Research Alliance Corp. II, liquidated in 2022. The firm’s first blank check company took Point Biopharma public in 2021, and the radiopharma company was then acquired by Eli Lilly in 2023. — Kyle LaHucik 🛑 Gilead ends Phase 2 Marburg trial: The company withdrew the study of obeldesivir before enrolling participants because the “Marburg outbreak in Rwanda was declared over,” according to an update to the US federal trials database. Gilead previously tried testing the oral tablet for RSV and Covid-19 . — Kyle LaHucik 💰 EpiFrontier gets grant for up to $32M: The money will fund Phase 2 studies of EPF-001, a small molecule G9a inhibitor designed to treat patients with sickle cell disease and beta thalassemia. The grant comes from the Japan Agency for Medical Research and Development. — Max Gelman

Paused trials were testing Aardvark Therapeutics\' ARD-201 in combination with a GLP-1.\n When Aardvark Therapeutics announced earlier this month that it was pausing a phase 3 trial of its lead metabolic candidate, investors could take solace in the fact that the biotech’s obesity program remained untouched. Those good feelings have now melted away, as Aardvark has elected to put the kibosh on two phase 2 trials of its oral weight loss asset ARD-201.The paused trials were testing ARD-201’s ability to prevent weight gain and to promote weight loss in combination with a GLP-1 drug and lifestyle changes, Aardvark said in a full-year earnings release March 23. Aardvark announced its intent to run the two trials last August following promising preclinical data.The pause comes as the San Diego biotech “conducts a comprehensive review of the data” on ARD-201, which is a combination of the gut-targeting taste receptor agonist ARD-101 and a DPP-4 inhibitor.ARD-101 was the subject of Aardvark’s prior voluntary pause, with its phase 3 trial for the rare genetic disease Prader-Willi syndrome shut down due to “reversible cardiac observations at above target therapeutic doses.” ARD-101 is designed to stimulate enteroendocrine cells of the digestive tract to provoke the release of GLP-1 and the satiety hormone cholecystokinin, all with the goal of reducing hunger. Prader-Willi syndrome is marked by hyperphagia, where patients constantly want to eat because they never feel full.William Blair analysts said in a note this morning that they believed the “clinical risk of ARD-101 is elevated, as the cardiac events could be mechanism-based and call into question the therapeutic window of ARD-101.”“As a potential silver lining to the phase 3 pause, the occurrence of the cardiac events could allow early unblinding of the study ... pending discussions with the FDA,” the analysts added in the March 24 note. “This could provide a path forward by allowing early signals of efficacy to be detected, which would better position Aardvark to design and conduct the second registration-enabling study.”In a statement yesterday, Aardvark founder and CEO Tien Lee, M.D., said patient safety “will always be our highest priority.”“We are actively engaging with the FDA with urgency to determine the best path forward for our programs,” Lee added.As recently as December, William Blair analysts had suggested that ARD-201 could “serve as an oral and more tolerable alternative” to the approved GLP-1 blockbusters from Eli Lilly and Novo Nordisk. The fact that “both the maintenance and induction settings are being investigated offer investors multiple shots on goal,” the analysts noted at the time.The decision to pause ARD-201’s trials means Aardvark’s entire pipeline is now on hold. News of ARD-101’s temporary halt sent Aardvark’s share price spiraling down by 54% in early March. After initially trading around $16 per share following its $94 million IPO last year, Aardvark’s stock closed trading Monday at $4.06.