Novo Nordisk was banking on the inflammatory benefits of its investigational therapy ziltivekimab to improve cardiovascular outcomes. Last week’s Phase 3 failure dashed not just the Danish pharma’s hopes but that of other drugmakers working on the same pathway.

Original title: “Novo’s late-stage IL-6 stumble shakes inflammation space”

Regulators assess PB016 vedolizumab biosimilar applications

Original title: “Polpharma Biologics gains FDA and EMA review acceptances”

Ziltivekimab's failure in a key trial hurt spurred share sell-offs for Novo and other biotechs, as it suggested trouble for different cardiovascular drugs that also target inflammation.

Original title: “Novo setback casts doubt on a new way to treat heart disease”

Novo Nordisk's IL-6 inhibitor ziltivekimab failed to reduce the risk of cardiovascular events in the late-stage trial, dashing hopes for an edge in the hyper-competitive cardiometabolic space.

Original title: “Novo's IL-6 inhibitor fails in cardiovascular Phase 3, plunging shares more than 9%”

Clinical worsening was a composite of death, hospitalization for worsening disease, and other progression measures. The components are not equivalent. Were there downsides? Yes. The Lancet reported more treatment discontinuations related to adverse events on ralinepag than on placebo. Who funded the trial? United Therapeutics, which developed the drug. The trial was randomized, double-blind, and placebo-controlled. What is PAH? A rare ... Clinical worsening was a composite of death, hospitalization for worsening disease, and other progression measures. The components are not equivalent. Were there downsides? Yes. The Lancet reported more treatment discontinuations related to adverse events on ralinepag than on placebo. Who funded the trial? United Therapeutics, which developed the drug. The trial was randomized, double-blind, and placebo-controlled. What is PAH? A rare progressive disease in which lung arteries narrow and stiffen, raising pressure and straining the right side of the heart. Published Lancet results show ralinepag reduced clinical worsening in PAH by 55%. The drug is still investigational and not FDA-approved. Treatment has improved substantially over three decades, and the paper is clear that long-term survival remains poor. The trial population reflects modern practice rather than untreated disease. Eighty percent of participants were already on two background therapies, and 70% were in the milder of the two functional classes that dominate PAH trials. That does not invalidate a randomized, double blind, placebo-controlled trial published in a major journal, and the design is the strongest available. It does mean the framing in company materials, which describes the results as exceptional and as potentially redefining PAH treatment, is promotional language rather than a scientific characterization. Context helps explain why an 18-point difference matters here. Pulmonary arterial hypertension is a rare disease in which the arteries carrying blood from the heart to the lungs narrow and stiffen.

Original title: “Lancet Results Show Ralinepag Cut Clinical Worsening by 55 Percent in Pulmonary Arterial Hypertension”

The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10 to 3 in favor of Replimune’s immunotherapy for advanced melanoma in combination with Bristol Myers Squibb’s Opdivo, but trial design was a major sticking point as the panel deliberated.

Original title: “Replimune overcomes ‘messy data’ to secure positive adcomm vote for melanoma therapy”

The positive vote came despite persistent concerns from FDA scientists and positions the company to bounce back from two earlier rejections.

Original title: “Replimune melanoma drug wins support of FDA panel”

Cema-cel received RMAT and fast track designations for first-line consolidation therapy in MRD-positive large B-cell lymphoma based on phase 2 ALPHA3 data. Natera highlights positive interim futility analysis from Allogene Therapeutics' MRD-guided ALPHA3 trial in large B-cell lymphoma. News release. Natera, Inc. April 13, 2026. Accessed July 29, 2026. https://tinyurl.com/2nbas8y8 · A randomized, open-label study evaluating the efficacy and safety of cemacabtagene ansegedleucel in participants with minimal residual disease after response to first line therapy for large B-cell lymphoma (ALPHA3). ClinicalTrials.gov. The FDA has granted regenerative medicine advanced therapy (RMAT) and fast track designations to cemacabtagene ansegedleucel (cema-cel) for the treatment of adult patients with large B-cell lymphoma (LBCL) who achieved a complete or partial response after first-line therapy but tested positive for minimal residual disease (MRD), according to a news release from the developer, Allogene Therapeutics.¹ · The designations were based on an interim futility analysis from the phase 2 ALPHA3 trial (NCT06500273), an ongoing, randomized, open-label study evaluating cema-cel as frontline consolidation therapy compared with observation in this MRD-positive population. “The FDA's decision to grant both RMAT and fast track designations provides additional validation for the strategy we defined with the ALPHA3 trial and strengthens our ability to work closely with the agency on an efficient path to advance cema-cel as a first-line consolidation therapy for [LBCL],” Zachary Roberts, MD, PhD, president and chief executive officer of Allogene Therapeutics, stated in the press release.¹ “There is a shared goal across the treatment community to reach patients earlier in their disease course and reduce the barriers that limit access to CAR T therapy. At a protocol-defined data cutoff, triggered when the 24th patient enrolled in the ongoing study arms completed the day 45 MRD assessment, 58.3% (n = 7/12) of patients in the cema-cel arm achieved MRD negativity compared with 16.7% (n = 2/12) in the observation arm; an absolute difference of 41.6%. Published literature and cross-study benchmarks cited in the release suggested that MRD clearance differences of 25% to 30% may translate into clinically meaningful improvement at study completion. Natera, whose CLARITY MRD assay was used in the trial, separately reported that plasma circulating tumor DNA (ctDNA) levels decreased from baseline by a median of 97.7% in the cema-cel arm at the day 45 assessment compared with a median 26.6% increase in the observation arm, a rise that might suggest molecular disease progression in the absence of intervention.2

Original title: “Cema-Cel Receives FDA RMAT, Fast Track Designations in First-Line LBCL | CancerNetwork”

First-in-human evaluation of infinitopes’ therapeutic platform

Original title: “Vista trial begins dosing in precision cancer vaccine study”

First IBAT inhibitor for PBC cholestatic pruritus

Original title: “Lynavoy recommended for EU approval by the CHMP”

During a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. The committee voted 9-3 against approval of deramiocel.

Original title: “FDA reviewers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting”

During a perplexing advisory committee meeting in which FDA reviewers focused largely on the Phase 3 HOPE-3 trial’s secondary endpoint of cardiac function, experts pointed to “very fragile” data. The committee voted 9-3 against approval of deramiocel.

Original title: “FDA advisers vote against approval of Capricor’s DMD therapy in chaotic adcomm meeting”

At a contentious meeting with possible implications for other rare disease drugmakers, outside experts ultimately determined that Capricor didn't prove deramiocel's benefits in Duchenne-related cardiomyopathy.

Original title: “Capricor Duchenne cell therapy voted down by FDA panel”