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Pharma Business – October 19, 2026

Ascendis wins CHMP backing for achondroplasia drug

Danish Ascendis Pharma has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), recommending EU approval of once-weekly TransCon CNP (navepegritide) for children with achondroplasia.

Clinical Trials – October 19, 2026

BioInvent publishes first-in-human data for BI-1808

BioInvent has published results from the first clinical study of its anti-TNFR2 antibody BI-1808 in Clinical Cancer Research. In the Phase 1 dose escalation, no maximum tolerated dose was reached and all treatment-related side effects were grade 1 or 2.

Pharma article – October 19, 2026

Genetic Analysis presents ulcerative colitis risk test at UEG Week

Norwegian microbiome diagnostics company Genetic Analysis is presenting results today at UEG Week 2026 in Barcelona on GA-map IBD Precision Dx, a test designed to identify, at diagnosis, which ulcerative colitis patients are at risk of an aggressive disease course.

Clinical Trials – October 19, 2026

Calluna completes dosing in Phase 2 IPF trial

Calluna Pharma has completed dosing in its Phase 2 AURORA study of CAL101 in idiopathic pulmonary fibrosis (IPF). Topline results are expected in the first quarter of 2027.

Profiles in Business – October 18, 2026

Biopharma Pioneer: Sesselja Ómarsdóttir

Sesselja Ómarsdóttir has spent her career moving between academia and industry, from lichen chemistry in an Icelandic lab to leading Genis today. She talks about mentorship, curiosity, and what it means to keep one foot in each world.


Pharma Business – October 16, 2026

Sobi wins CHMP backing for Tryngolza

Stockholm-based Sobi has received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP), recommending an expanded indication for Tryngolza (olezarsen) to treat adults with severe hypertriglyceridemia (sHTG).

Opinion & debate

Clinical Trials

Clinical Trials – October 19, 2026

Evaxion’s cancer vaccine responses hold at three years

Danish Evaxion reports that all patients in its Phase 2 trial of the personalized cancer vaccine EVX-01 in advanced melanoma kept their clinical responses at the three-year follow-up, with no tumor progression observed.

Clinical Trials – October 19, 2026

BioInvent publishes first-in-human data for BI-1808

BioInvent has published results from the first clinical study of its anti-TNFR2 antibody BI-1808 in Clinical Cancer Research. In the Phase 1 dose escalation, no maximum tolerated dose was reached and all treatment-related side effects were grade 1 or 2.

Clinical Trials – October 19, 2026

Calluna completes dosing in Phase 2 IPF trial

Calluna Pharma has completed dosing in its Phase 2 AURORA study of CAL101 in idiopathic pulmonary fibrosis (IPF). Topline results are expected in the first quarter of 2027.

Clinical Trials – October 15, 2026

Modus Therapeutics pauses enrollment in sevuparin study

Modus Therapeutics has temporarily paused enrollment in Part 2 of its Phase IIa study of sevuparin in chronic kidney disease (CKD) with anemia after a serious adverse event in one patient. The company’s preliminary assessment is that the proof-of-concept readout will slip to the first quarter of 2027.

Clinical Trials – October 14, 2026

Xbrane completes enrollment in pivotal nivolumab biosimilar trial

Swedish biosimilar developer Xbrane Biopharma has fully recruited the pivotal clinical trial of Xdivane, its biosimilar candidate to Bristol Myers Squibb’s cancer immunotherapy Opdivo (nivolumab).

Clinical Trials – October 12, 2026

Elicera’s CAR T-cell therapy shows strong Phase I results

Eight out of twelve patients with B-cell lymphoma and no remaining curative treatment options achieved a complete metabolic response after treatment with Elicera Therapeutics’ ELC-301. The results come from the now-completed Phase I part of the Swedish CARMA study.

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NLS Insight

Business article – November 4, 2024

Navigating the Financial Landscape: Downsizing

Downsizing a company is one of the most difficult decisions a chief executive can make, after which comes the equally painful decision of when to do it.

Financial landscape – November 8, 2024

Navigating the Financial Landscape: Bankruptcy

Four months after XNK Therapeutics, located in Huddinge, Sweden, declared bankruptcy, the clinical-stage biotechnology company’s building and physical assets were sold and the lease agreement transferred to BioLamina. 

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