Another phase III failure of Theravance Biopharma Inc.’s norepinephrine reuptake inhibitor, ampreloxetine, to treat symptomatic neurogenic orthostatic hypotension, this time in patients with the rare disease multiple system atrophy, means the end of the company’s R&D efforts. Cutting its workforce in half and terminating all development of ampreloxetine, its only pipeline product, the company’s shares (NASDAQ:TBPH) sank by 26%, or $4.89, to $14.06 in early trading March 3. The move leaves Theravance with Yupelri (revefenacin), approved by the U.S. FDA in 2018 for chronic obstructive pulmonary disease (COPD). Partner Viatris Inc. reported 2025 sales of $266.9 million. Theravance also has a financial interest in COPD and asthma drug Trelegy, following a 2002 collaboration with GSK plc.

Senators, patients demand action to end FDA regulatory roadblocks

A lot of distance lies between talking regulatory flexibility and actually being flexible. That message was driven home again this week after Uniqure NV disclosed in its latest earnings report that the U.S. FDA wants a sham-controlled study before it will consider approval of the company’s gene therapy, AMT-130, in Huntington’s, a rare disease currently affecting about 41,000 people in the U.S. The news broke just a few days after the Senate Aging Committee held a hearing titled “From regulator to roadblock: How FDA bureaucracy stifles innovation.” Despite the 21st Century Cures Act and other bills Congress has passed over the past decade to cut through bureaucratic delays in approving new treatments for rare diseases, Committee Chair Rick Scott, R-Fla., noted that “inconsistent review practices, shifting standards, and redundant, often-late-appearing data requests that, in many cases, may not be driven by safety concerns but by an overly cautious and rigid approach [continues to put] bureaucratic processes ahead of patients.”

China clears first JAK/ROCK drug for myelofibrosis

China’s National Medical Products Administration has approved Sino Biopharmaceutical Ltd.’s rovadicitinib, branded as Anxu, for first-line treatment of adults with intermediate- or high-risk primary myelofibrosis, as well as post polycythemia vera myelofibrosis (PPV-MF) or post-essential thrombocythemia myelofibrosis. The approval positions Sino Biopharm as a first mover in China with what the company describes as a global first-in-class dual JAK/ROCK inhibitor.

Boehringer drops OSE’s cancer drug in MASH, where GLP-1s march on

Boehringer Ingelheim GmbH is stopping development of OSE Immunotherapeutics SA’s BI-770371 in metabolic dysfunction-associated steatohepatitis (MASH), after the SIRPα antagonist failed to show efficacy in a phase II study. Codevelopment of BI-770371 will continue for oncology indications, however, which was the initial target of the duo’s €1.4 billion (US$1.6 million) partnership in 2018. Boehringer’s termination marks its third major MASH alliance dropped in the past five years.

Radnet acquires Gleamer for up to €230M

Radnet Inc. acquired Gleamer SAS for up to €230 million (US$267 million) as it continues to expand its position across imaging and acute diagnostic care, while accelerating its move toward AI-powered automated diagnostics. Gleamer will be integrated into Radnet’s subsidiary, Deephealth, strengthening its imaging portfolio, and positioning the company as the world’s largest provider of radiology clinical AI solutions.

Quell delivers first data showing Tregs prevent liver transplant rejection

Quell Therapeutics Ltd. has delivered the first clinical data indicating its chimeric antigen receptor (CAR) T regulatory cell therapy, QEL-001, can enable liver transplant patients to be weaned off long-term immunosuppression. Interim top-line data from the phase I/II trial of QEL-001 showed all five patients receiving standard-of-care immunosuppression with tacrolimus and everolimus were able to discontinue tacrolimus and to reduce everolimus monotherapy to the very low dose of 5 nanograms/mL. There was no evidence of rejection of transplanted livers over at least six months following withdrawal of tacrolimus, a calcineurin inhibitor.

Merck’s phase III RCC findings create buzz in HIF-2α

Data from the phase III Litespark-011 study testing the oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) from Merck & Co. Inc. when used with tyrosine kinase inhibitor Lenvima (lenvatinib, Eisai Co.) in advanced renal cell carcinoma sent ripples through the HIF-2α space. Merck rolled out the closely watched results March 2 during the American Society of Clinical Oncology Genitourinary Cancers Symposium in San Francisco. Among other players apart from Merck, Wall Street has been paying particular attention to Arcus Biosciences Inc., which is developing casdatifan.

Digital pathology speeds diagnostics, but tends to take shortcuts to do so

Computational pathology, which assesses molecular-level features of diseases directly from tissue images (rather than testing the tissue via methods such as staining or sequencing) is making rapid strides.

Med-tech outlook 2026: exits, financings, headwinds

What does med tech in 2026 look like? Uncertainty remains. Global investors are confident about exit opportunities in the year ahead. But financing will be targeted. For the med-tech companies, geopolitical tensions continue to create headwinds, particularly for the European firms navigating an uncertain macroenvironment created by the reciprocal tariffs on goods entering the U.S., their primary market. By contrast, U.S. companies are bullish and believe they are well-positioned to navigate macroeconomic pressures. Still, across both regions, there is confidence in the sector and companies remain focused on advancing their technologies to address clinical needs – innovating, conducting trials, presenting data, raising funds, and delivering products that improve patients’ lives.

Also in the news

Aardvark, Abbvie, Agios, Apellis, Argo, Ascendis, Bayer, Bioatla, Biomarin, Bioxytran, Blueprint Medicines, Bonesupport, Celldex, Celyn, Cogent, Conexeu, Cullgen, Dbv, Defence, Disc Medicine, Edison Oncology, Gleamer, Gyre, Innocare, Innovent, Intellia, Kairos, Lantheus, Longbio, Lynk, Medimaps, Merck, Nautilus, Novo Nordisk, Nrx, Opgen, Opus Genetics, Orbimed, Protagonist, Pulmatrix, Radiobotics, Radnet, Rhythm, Roche, Royalty, Sanofi, Scibase, Septerna, Sharp, Shoulder Innovations, Takeda, Telo Genomics, Uniqure, United, Upstream, Wisdom, Zymeworks