NLS Biotech News

Biotech Business – May 11, 2026

FDA extends sBLA review of Leqembi Iqlik

BioArctic’s partner Eisai has announced that the FDA has extended the review period by three months for the supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection, also known as Leqembi Iqlik, as a starting dose for the treatment of early Alzheimer’s disease.

Biotech Business – May 11, 2026

Oncopeptides to submit type II variation to expand Pepaxti label

Oncopeptides has announced its intention to submit a Type II variation application to the European Medicines Agency (EMA).

Biotech Business – May 11, 2026

Diamyd Medical provides business update

Diamyd Medical has announces that the initial phase of the strategic review, initiated following the discontinuation of the Phase 3 DIAGNODE-3 trial, has been completed.

Biotech Business – May 6, 2026

NextCell and FUJIFILM Biosciences launch commercial platform

The two companies have announced a global commercial launch resulting from their strategic collaboration.

Biotech Business – April 30, 2026

Xbrane submits ranibizumab biosimilar candidate to FDA

The company has submitted an application for approval (BLA) to the US Food and Drug Administration for its biosimilar candidate to LUCENTIS (ranibizumab).

Clinical trials

Clinical Trials – May 12, 2026

AnaCardio announces Phase 1b/2a results

AnaCardio has announced detailed results from its Phase 1b/2a GOAL-HF1 study evaluating AC01 in patients with heart failure with reduced ejection fraction (HFrEF).

Clinical Trials – May 6, 2026

Spago Nanomedical reports phase I/IIa study data

The independent Data Monitoring Committee (DMC) of the Tumorad-01 study declared that a primary endpoint, identifying the maximum tolerated dose, has been met and recommends that an additional two patients are enrolled at the dose level of 15 MBq/kg to provide a basis for defining a recommended phase II dose and completion of the phase I part of the study.

Clinical Trials – April 24, 2026

Takeda reports additional Phase 3 clinical insights on TAK-279

Takeda has announced new data, presented at the 2026 American Academy of Dermatology (AAD), from two Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).

Clinical Trials – April 22, 2026

Hemispherian initiates Phase 1/2a clinical trial

The company has announced the initiation of a first-in-human Phase 1/2a clinical trial of GLIX1 in patients with recurrent and progressive glioblastoma (GBM) and other high-grade gliomas.

Clinical Trials – April 22, 2026

Lytix Biopharma announces Phase II results

The company has announced final efficacy and safety results from its Phase II ATLAS-IT-05 study evaluating intratumoral ruxotemitide (LTX-315) in combination with pembrolizumab in patients with advanced melanoma who have progressed following prior checkpoint inhibitor therapy.

Clinical Trials – April 21, 2026

Novo Nordisk’s etavopivat met both co-primary endpoints in phase 3 trial

The company has announced the topline results from HIBISCUS, a phase 3 trial of once-daily oral etavopivat in adults and adolescents with sickle cell disease (SCD).

Clinical Trials – April 19, 2026

Evaxion’s AI-Immunology platform demonstrates 86% vaccine target precision

Evaxion has announced new data demonstrating that AI-Immunology identifies and selects the most therapeutically relevant vaccine targets.

Clinical Trials – April 15, 2026

Promising results about new Lyme disease vaccine candidate

Pfizer and Valneva’s Lyme disease vaccine candidate demonstrated strong efficacy in their Phase 3 VALOR trial.

Clinical Trials – April 13, 2026

Mendus starts clinical program in chronic myeloid leukemia

The company has completed preparations and received all regulatory approvals for the VITAL-CML trial.

Clinical Trials – April 13, 2026

Diamyd Medical discontinues Phase 3 trial and initiates strategic review

Diamyd Medical has announced that it will discontinue the Phase 3 DIAGNODE-3 trial evaluating retogatein (rhGAD65) in Stage 3 type 1 diabetes.

Profiles in Biotech

Profiles in Biotech – April 23, 2024

Mia Phillipson: Pioneering immunotherapies

Despite being the co-founder of Ilya Pharma and co-director at the Science for Life Laboratory (SciLifeLab), Dr. Mia Phillipson, considers herself a scientist foremost, not an entrepreneur.

Profiles in Biotech – November 28, 2023

Kristian Tryggvason: Reshaping the cell therapy sector

The previous founder and CEO of BioLamina has gone back to business development, and with his new company he aims to redefine cell therapy development even further.

Profiles in Biotech – July 28, 2021

Mathias Uhlén: Driven by curiosity and courage

Being a scientist or an entrepreneur is hard enough. Doing both at the same time sounds like an Olympic sport.

Profiles in Biotech – March 8, 2021

Sara Mangsbo – Scientist and entrepreneur

An academic and an entrepreneur, Dr. Sara Mangsbo, PhD, has found a way to integrate her skills and interests so that they complement and augment her passions.

Profiles in Biotech – January 7, 2021

Evelina Vågesjö: ”I want to see my work go beyond the lab”

What began as a project for Evelina Vågesjö’s doctoral thesis grew into groundbreaking drug candidates and delivery methods, followed not long afterwards, by a clinical-stage biopharmaceutical company.

Profiles in Biotech – October 8, 2020

Robert Langer: Making a difference in medicine

Massachusetts Institute of Technology (MIT) in the US has produced more than its share of engineers and computer scientists, but unlike many of his peers, alumnus Dr. Robert Langer, ScD, turned his chemical engineering skills to medicine, becoming one of the world’s leaders in perfecting effective drug delivery systems.

Profiles in Biotech – June 13, 2018

Britt Meelby Jensen: Accelerating Danish biotech business

She has been called the Danish biotech queen and she is not afraid of responsibility in her role as CEO. On the contrary, Britt Meelby Jensen enjoys leading, setting ambitious goals and accelerating company growth.

Profiles in Biotech – October 6, 2017

Next-generation biotech entrepreneurs

For young scientists and engineers, a startup can be part of early training and education.

Profiles in Biotech – December 16, 2016

Agnete Fredriksen: “You really need to have drive to make it work”

Academia and business don’t always mix, but Agnete B. Fredriksen of Norway has found the formula.

More biotech stories

Biotech Award - May 11, 2026

These are the winners of the Biotech Stars Awards

The Finnish Bioindustries Biotech Stars Awards were presented at the Made by Cells Biotech Forum on 29 April 2026 at Hanaholmen, Espoo, as part of the celebrations marking the 20th anniversary of Finnish Bioindustries.

Biotech article - April 20, 2026

In focus: Nasal drug delivery for quicker uptake

Nasal drug delivery is a dynamic area in pharmaceutical innovation. What was once a route for decongestants and allergy sprays is now being explored for everything from emergency treatments to vaccines – and even shows potential for future central nervous system therapies.

Biotech Business - April 16, 2026

EIB backs BioLamina with EUR 20 million

The European Investment Bank (EIB) is lending EUR 20 million to BioLamina to expand its development of laminin technologies.

Biotech Business - April 14, 2026

Alzinova initiates collaboration with Amsterdam UMC

The research collaboration aims to develop a blood‑based test that measures naturally occurring antibodies against toxic amyloid‑β oligomers in healthy individuals, based on Alzinova’s Aβ42CC oligomer technology.

Biotech Business - April 13, 2026

Alligator Bioscience gives update on mitazalimab

In parallel with ongoing partnering activities, Alligator is exploring alternative opportunities for phase 3 development of mitazalimab in first line metastatic pancreatic cancer.

Biotech Business - April 7, 2026

Biosergen Pauses Development of BSG005

Against the backdrop of a continued challenging financing environment, the Board of Directors of Biosergen has resolved to pause the development of BSG005.

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