Shares of Moderna Inc. (NASDAQ:MRNA) were trading at $36.92, down $5.08, or 12%, on word of a refusal-to-file (RTF) letter from the U.S. FDA regarding the seasonal influenza vaccine mRNA-1010. Moderna said the RTF move is “inconsistent with feedback” the company was given by regulators during pre-phase III as well as pre-submission talks. To hash out the path forward, Moderna has requested a type A meeting. The mRNA vaccine, designed to encode hemagglutinin surface glycoproteins for flu strains designated by the World Health Organization, has been submitted and accepted for review in the EU, Canada, and Australia.

Asthma TSLP bid succeeds for Upstream in asthma, stock tumbles

Upstream Bio Inc. rolled out top-line results from the phase II Valiant trial evaluating the safety and efficacy of verekitug in adults with severe asthma. The only known clinical-stage antagonist targeting the receptor for thymic stromal lymphopoietin (TSLP), verekitug met the study’s primary endpoint of a statistically significant and clinically meaningful reduction in the annualized asthma exacerbation rate (AAER) with every 12-week and every 24-week dosing. Specifically, the drug turned up a reduction in AAER of 56% when given at 100 mg every 12 weeks and 39% at 400 mg every 24 weeks compared with placebo. Shares of Upstream (NASDAQ:UPB) were trading at $14.56, down $13.25, or 47%, as Wall Street stacked the results against those gained by the likes of approved TSLP ligand binder Tezspire (tezepelumab), from Amgen Inc. and Astrazeneca plc, which was first cleared by the U.S. FDA near the end of 2021.

Microbiotica reports positive phase Ib data for live microbiome therapeutic

Microbiome specialist Microbiotica Ltd. announced positive data from a phase Ib study of MB-310, an orally administered live biotherapeutic product for treating ulcerative colitis, with 12 of 19 treated patients achieving clinical remission, compared to three of 10 patients in the placebo arm. Following the three-month treatment period, the 12 MB-310-treated patients who had responded entered a three-month follow-up and had sustained remission and complete resolution of rectal bleeding. There also were improvements in histological measures of disease activity and markers of mucosal damage in patients who responded to the twice daily therapy.

Boston Sci’s Farapulse better than thermal ablation at 4 years

Boston Scientific Corp. recently reported new four-year data on its Farapulse pulsed field ablation (PFA) platform which demonstrated that patients with paroxysmal atrial fibrillation achieved better long-term success than those treated with thermal ablation. The data comes as sales of the Farapulse system in the U.S. have begun to slow amid rising competition from other PFA technologies, particularly Medtronic plc’s Affera platform.

Ascletis raises $107M to advance oral GLP-1 to phase III trials

Ascletis Pharma Inc. raised HKD$843.53 million (US107.93 million) in a placement on the Hong Kong Stock Exchange (HKEX) to advance its lead program, ASC-30, a small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist that can be dosed once monthly subcutaneously and once daily orally for treating obesity. The placement, which took place on Feb. 10, consisted of 69.3 million new H shares priced at HKD$12.18 per share, Ascletis announced on the HKEX. Citi was the sole overall coordinator and placing agent. Roughly 90% of the funds raised will go toward launching global phase III trials of ASC-30 for treating obesity. The remaining 10% will go toward general corporate purposes.

Takeda’s oral narcolepsy drug steps closer to FDA approval

The U.S. FDA accepted, with priority review, Takeda Pharmaceutical Co. Ltd.’s NDA submission for oveprotexton (TAK-681), bringing the oral orexin receptor 2 agonist closer to clearance in narcolepsy type 1. Takeda filed oveporexton’s NDA after claiming dual phase III victories in the Firstlight (TAK-861-3001) and Radiantlight (TAK-861-3002) trials, in which the candidate hit all primary and secondary endpoints. With filing acceptance, the U.S. agency allotted a PDUFA target action date for the third quarter of 2026, according to the company’s announcement Feb. 10.

Madrigal adds siRNA approach to MASH pipeline in $4.4B Ribo deal

Continuing to build on the successful launch of Rezdiffra (resmetirom), Madrigal Pharmaceuticals Inc. is adding six preclinical-stage siRNA therapies to its metabolic dysfunction-associated steatohepatitis (MASH) pipeline in a deal with Ribo Life Science Co. Ltd. and its subsidiary, Ribocure Pharmaceuticals AB, that could be worth $4.4 billion if all milestones are achieved. Under the terms, Madrigal agreed to pay $60 million up front in exchange for an exclusive global license to develop, manufacture and commercialize the six compounds, which it said offer a gene silencing approach in MASH and may work in combination with Rezdiffra.

Targeting cholesterol deposition could treat lymphedema

The malfunction of lymphatic drainage that occurs in lymphedema leads to excessive cholesterol accumulation in the affected skin and lymphatic vessels, causing inflammation and fibrosis. However, surgery and the chemical reduction of accumulated cholesterol with cyclodextrin reduce inflammation and regenerate lymphatic vessels.

Also in the news

4basebio, 4Moving, Accurkardia, Argá, Arthrosi, Arraypatch, Avia Vascular, Baselaunch, Boost, Calla Lily, Cardiol, Celularity, Clario, Cortec, Cumulus, Dynavax, Enlivex, Evommune, Foghorn, Freespira, Generation, Hemogenyx, Hengrui, Iliad, Imagenebio, Kainova, Kdventures, Medivir, Merrylife, Merck, Milestone, Nektar, Okyo, Orsobio, Pfizer, Phio, Renovorx, Sanofi, Santa Ana, Satellos, Seastar, Shionogi, Sobi, Spectral AI, Spyglass, Sutro, Thermo Fisher, Trisalus, Vygon, Wat Medical, Xoma, Yatiri

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