The much-ballyhooed website trumprx.gov went online late Feb. 5, and with it came the promise of the “world’s lowest prices” on prescription drugs. “It’s the biggest thing to happen in health care, I think, in many, many decades,” U.S. President Donald Trump said as he disclosed the opening of the direct-to-consumer portal, a signature piece of his most-favored-nation drug pricing initiative. Several Democratic senators are scrutinizing the program for anti-kickback violations.
Priovant’s brepo impresses in phase II cutaneous sarcoidosis trial
On the heels of an NDA submission for brepocitinib in dermatomyositis, Priovant Therapeutics Inc. disclosed data showing the dual TYK2/JAK1 inhibitor surpassed expectations in a phase II study in cutaneous sarcoidosis, another chronic inflammatory skin condition with limited treatment options. The company, one of the “Vant” companies of Roivant Sciences Ltd., plans to launch a phase III study this year. All told, it’s been a busy start to the year for Roivant, according to CEO Matt Gline, with further readouts coming this year, including phase II data for Pulmovant Inc.’s mosliciguat in pulmonary hypertension associated with interstitial lung disease and a readout for a potentially registrational study of Immunovant Inc.’s IMVT-1402 in rheumatoid arthritis. Shares of Roivant (NASDAQ:ROIV) were trading up nearly 20% at midday.
Bayer’s asundexian cuts stroke risk 26% in phase III win
Bayer AG’s oral factor XIa (FXIa) inhibitor asundexian significantly reduced ischemic stroke by 26% in patients following a noncardioembolic ischemic stroke or high-risk transient ischemic attack in the phase III Oceanic-Stroke study. The study is the first successfully completed phase III trial of an FXIa inhibitor demonstrating superiority in preventing stroke compared to placebo.
2026 kicks off with $10.8B January financing haul
Total biopharma financings rose to $10.79 billion in January 2026, up from $9.08 billion in December. The monthly total nearly matched the January 2024 record of $10.9 billion, far exceeding the $6.82 billion average monthly haul in 2024.
Paragonix’s Kidneyvault extends kidney preservation to 29 hours
Paragonix Technologies’ Kidneyvault portable renal perfusion system managed to preserve and enable the reallocation of a donor kidney for more than 29 hours, despite prolonged ischemic time, multiple handoffs and two commercial flights. Through the period the Kidneyvault maintained stable hypothermic preservation, preventing the organ from being discarded and allowing it to be transplanted into a patient.
Medtronic to pay Applied Medical $382M in antitrust ruling
A jury in a U.S. District Court unanimously found that Medtronic plc. violated federal and state antitrust laws relating to its blood sealing surgical devices and must pay $382 million in damages to Applied Medical Resources Corp.
Idorsia gets FDA-backed route to approval for oral Fabry drug
After keeping the faith when it failed in the Modify phase III trial in October 2021, Idorsia Ltd. now has a clear route to market for lucerastat, an oral therapy for Fabry disease. Armed with data from 107 patients who entered a long-term, open-label study after lucerastat missed the primary endpoint of reducing neuropathic pain in the Modify trial, Idorsia said it has aligned with the U.S. FDA on a registration program. This will consist of two trials that are intended to demonstrate the drug is more effective than intravenously administered enzyme replacement therapy in preserving renal function in patients with the X-linked inherited disorder.
Heart intervention device-maker Insight lands $143M SSE IPO
Insight Lifetech Co. Ltd. listed on the Shanghai Stock Exchange’s STAR market via an unprofitable biotech track reinstated last year, with the Feb. 5 IPO raising ¥998.64 million (US$143.93 million). The Shenzhen, China-based cardiovascular intervention device-maker had priced 57 million shares at ¥17.52 each to reach a market capitalization of ¥20.98 billion. On the first day of trading, company shares (SSE:688712) closed 183% higher.
More biopharma IPOs: Agomab raises $200M, Spyglass gets $150M
Another two biopharma companies priced IPOs on Nasdaq to raise a combined $350 million, becoming the fourth and fifth drug developers to debut in 2026. Agomab Therapeutics NV, of Antwerp, Balgium, sold 12.5 million American depositary shares, representing an equal number of common shares, at $16 each, raising $200 million in gross proceeds. Spyglass Pharma Inc., of Aliso Viejo, Calif., raised $150 million through its offering of 9.38 million shares of common stock at $16 each. At midday, Agomab’s shares (NASDAQA:AGMB) were trading down by 15% to $13.50, while Spyglass’ shares (NASDAQ:SGP) had not yet begun trading.
A humanized mouse mimics Fcγ receptor biology in antibody assays
Scientists at Ghent University have created a mouse model that incorporates human versions of the receptors that recognize the fragment crystallizable (Fc) region of immunoglobulin G (IgG), one of the most abundant antibodies in the blood and a key mediator of essential immune functions such as cellular activation, pathogen elimination and the regulation of inflammatory responses. These human Fcγ receptors allow the humanized mouse to more accurately reproduce IgG-driven biology, enabling more reliable and safer preclinical assays before evaluating monoclonal antibodies in clinical trials with people.
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