Biotech - Today Stories
Stoke Therapeutics and Biogen have initiated the global Phase III EMPEROR trial of zorevunersen (previously known as STK‑001) for children and adolescents with Dravet syndrome. This pioneering antisense oligonucleotide is designed to boost expression of the healthy SCN1A gene, potentially addressing not just seizure frequency but also cognitive and behavioral impairments. The study will enroll approximately 150 patients across the United States, United Kingdom, Europe, and Japan. Participants will undergo 8 weeks of baseline monitoring followed by 52 weeks of treatment, beginning with two 70 mg loading doses and transitioning to two 45 mg maintenance doses. The primary outcome measure is the reduction in major motor seizure frequency, with secondary outcomes assessing improvements in behav…
German pharmaceutical company Bayer and U.S.-based Kumquat Biosciences have entered into an exclusive global license and collaboration agreement to develop and commercialize Kumquat’s KRAS G12D inhibitor. Under the deal, Kumquat will initiate and complete the Phase 1a clinical trial while Bayer will assume responsibility for later-stage development and commercialization. The asset received FDA approval for its investigational new drug (IND) application in July 2025 and addresses KRAS G12D mutations—common in pancreatic, colorectal, and non‑small cell lung cancers, yet currently lacking effective therapies. Kumquat stands to receive up to $1.3 billion in milestones, upfront payments, and tiered royalties, plus an option for profit‑loss sharing in the U.S. This partnership aligns Kumquat’s d…
Almirall selects second target in AI Drug Creation collaboration
Expanded collaboration builds on Absci’s successful de novo molecule design for difficult‑to‑drug targets in the first stage of the collaboration with Almirall
Barcelona, Spain, August 7, 2025 – Almirall (BME: ALM), a global biopharmaceutical company focused on medical dermatology, and Absci Corporation (Nasdaq: ABSI), a clinical-stage biopharmaceutical company advancing breakthrough therapeutics with generative AI, today announced the expansion of their ongoing AI Drug Discovery collaboration with Almirall’s selection of a second target aimed at dermatological indications.
The expansion of the collaboration follows the successful delivery of AI-designed, functional antibody leads against a difficult-to-drug target—the fi…
Paris, August 6, 2025. Sanofi announces the completion of its acquisition of Vigil Neuroscience, Inc. (“Vigil”). This acquisition strengthens Sanofi’s early-stage pipeline in neurology with VG-3927, a novel, oral, small-molecule TREM2 agonist, which will be evaluated in a phase 2 clinical study in patients with Alzheimer’s disease. In addition, the acquisition of Vigil’s preclinical pipeline will further strengthen Sanofi’s research in various neurodegenerative diseases.
In June 2024, Sanofi made a $40 million strategic investment in Vigil that included the exclusive right of first negotiation for an exclusive license, grant, or transfer of rights to research, develop, manufacture, and commercialize VG-3927.
Under the terms of the acquisition agreement, Sanofi and Vigil have agreed to…
GlaxoSmithKline (GSK) has struck a major licensing agreement with Jiangsu Hengrui Pharmaceuticals granting GSK exclusive global rights—outside Greater China—to Hengrui’s clinical‑stage COPD drug HRS‑9821 along with 11 additional early‑stage programmes across respiratory, immunology, inflammation and oncology. The deal involves a $500 million upfront payment, with total potential milestone and royalty payments of up to $12 billion if all development and commercial targets are met. HRS‑9821 is a PDE3/4 inhibitor being developed for chronic obstructive pulmonary disease, intended to address persistent shortness of breath and provide maintenance therapy regardless of background treatment. Hengrui will lead early development of the 11 other programmes up to completion of phase I trials, while G…
One Biosciences, a Paris‑based precision oncology techbio spin‑out from Institut Curie founded in 2020, has secured €15 million in a Series A funding round. Co‑led by Redmile Group and Blast, the round also saw participation from Galion.exe, Invus, Adamed Technology, Sofinnova Partners, Polytechnique Ventures, and Kima Ventures. These funds will advance the clinical and strategic development of its flagship OneMap™ platform—an AI‑powered, single‑cell transcriptomic tool designed to decode tumour heterogeneity in routine biopsy samples.
OneMap™ aims to deliver high-resolution tumour profiles within two weeks to guide treatment decisions, improve patient selection, support therapy development, and optimise clinical trials . One Biosciences has already raised over €20 million including seed f…
Sanofi is set to acquire London‑based biotech company Vicebio in a deal valued at USD 1.15 billion, with additional milestone payments up to USD 450 million pending R&D progress. The acquisition, expected to close in Q4 2025, adds Vicebio’s non‑mRNA vaccine candidates targeting respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) to Sanofi’s portfolio. Integral to the agreement is access to Vicebio’s innovative “Molecular Clamp” technology. This platform stabilises viral proteins in their prefusion state, allowing the creation of fully liquid combination vaccines that are easier to store, distribute and administer in standard refrigerated conditions. The acquisition aligns with Sanofi’s ongoing push into respiratory vaccines—complementing its existing flu and RSV programm…
Thermo Fisher Scientific has reached an agreement to acquire Sanofi’s sterile drug product manufacturing facility in Ridgefield, New Jersey. The site, specializing in fill‑finish and packaging of aseptic injectable medications, currently employs over 200 staff who will transfer to Thermo Fisher upon deal completion. The acquisition is expected to close in late 2025 and aligns with both companies’ strategic initiatives to bolster U.S. pharmaceutical manufacturing.
Sanofi is ramping up investments in U.S. manufacturing and research, targeting at least $20 billion by 2030. Thermo Fisher, which is committing roughly $2 billion to enhance its domestic production capacity, views the Ridgefield location as a key asset. CEO Marc Casper highlighted that the acquisition strengthens Thermo Fisher’s a…
Sun Pharmaceutical Industries has launched its novel oral treatment LEQSELVITM (deuruxolitinib) 8 mg tablets in the US for adults with severe alopecia areata. The debut follows an out‑of‑court settlement and licensing agreement with Incyte Corporation, resolving all pending patent disputes and clearing the path for the drug’s US rollout.
LEQSELVITM, acquired through Sun Pharma’s $576 million purchase of Concert Pharmaceuticals, is a JAK1/JAK2 inhibitor that offers a much‑needed treatment for severe hair loss. In Phase III trials (THRIVE‑AA1/AA2), about one‑third of patients experienced at least 80 % scalp hair regrowth in 24 weeks.
Analysts project annual US sales of $400 million by fiscal year 2030, with peak potential of $900 million. Stock market analysts expect the launch and legal cle…
Sino Biopharmaceutical, a major Hong Kong–listed biotech, is set to acquire the remaining 95.09% of Shanghai’s LaNova Medicines for up to US $950.9 million, completing a full takeover pending regulatory approval within 30 business days. This move builds on Sino’s initial 4.91% investment in November 2024, when it participated in LaNova’s US $42 million Series C1 funding round.
Founded in 2019, LaNova has developed a rich pipeline of antibody-based cancer treatments, including LM‑299 (an anti‑PD‑1/VEGF bispecific antibody currently in Phase 1), LM‑108 (a CCR8‑targeting mAb in Phase 2), and LM‑302 (a Claudin 18.2‑targeting ADC in Phase 3). It has also already attracted licensing interest from global players: LM‑299 was licensed to Merck in a deal worth up to US $3.3 billion, and earlier asse…
Bavarian Nordic has confirmed a substantial new contract to supply its MVA‑BN® smallpox/mpox vaccine to an undisclosed European nation, strengthening the region’s readiness against biological threats. The recurring order, part of Europe’s growing focus on public health security, is valued at over DKK 200 million. With this latest agreement alongside other global deals, Bavarian Nordic has now secured over DKK 3 billion (approx. USD 400 million) in public preparedness contracts for 2025, meeting its full-year guidance.
Paul Chaplin, CEO of Bavarian Nordic, stated the deal underscores Europe’s commitment to vaccine preparedness amid evolving geopolitical risks. The MVA‑BN® vaccine, already approved in the U.S. and EU, continues to be a cornerstone of government immunisation strategies. In ad…
Takeda’s investigational oral orexin receptor 2 agonist, oveporexton (TAK‑861), achieved significant success in two pivotal Phase III trials—FirstLight and RadiantLight—targeting narcolepsy Type 1. Data released on 14 July 2025 showed the drug met all primary and secondary endpoints, delivering notable improvements in wakefulness, daytime sleepiness, cataplexy control, attention, quality of life and overall daily functioning versus placebo. Jefferies analysts highlighted the high statistical significance (p < 0.001), and project peak sales of around $3 billion for this agent alone, with broader orexin-targeted therapies potentially doubling that
This marks a major turnaround for Takeda’s orexin agonist strategy following the 2021 discontinuation of TAK‑994 due to safety issues. Ovepore…
AbbVie has entered into an exclusive licensing agreement with Ichnos Glenmark Innovation (IGI), a joint venture between Glenmark Pharmaceuticals and Ichnos Sciences, to develop and commercialize ISB 2001—a trispecific T-cell engager targeting BCMA, CD38, and CD3—for relapsed or refractory multiple myeloma.
Under the terms, AbbVie will acquire rights to ISB 2001 across North America, Europe, Japan, and Greater China, providing IGI with a $700 million upfront payment and up to $1.225 billion in milestone payments.
ISB 2001, currently in Phase 1 trials, has demonstrated an overall response rate of 84% in patients naive to CAR-T or T-cell engager therapies, and 71% in those previously treated, including those refractory to anti-CD38 therapy.
This collaboration enhances AbbVie's oncology pipe…
ScienceMachine, a biotech startup founded in 2024, has secured funding from investors including Basis (VC), Opal Ventures, and Vento. The company, headquartered in San Francisco with a presence in London, has developed 'Sam', an AI-powered platform designed to automate and accelerate bioinformatics research.
'Sam' functions as an AI data scientist, capable of structuring and analyzing complex biological data to uncover new insights, thereby enhancing R&D capabilities. The platform aims to support biotech and pharmaceutical companies in expediting their research processes and achieving breakthroughs more efficiently.
With a small team of 2-10 employees, ScienceMachine is poised to expand its operations and further develop its AI technologies.
Epitopea, a transatlantic cancer immunotherapeutics company, has announced the formation of a dedicated clinical team and the expansion of its research team as it accelerates the development of its RNA-based immunotherapies. The company is focused on creating off-the-shelf treatments targeting Cryptigen™ tumor-specific antigens (TSAs), which are aberrantly expressed antigens derived from non-coding regions of the genome, commonly referred to as "junk DNA."
The establishment of a clinical team marks a significant milestone in Epitopea's transition from a preclinical to a clinical-stage company. This move is supported by the company's proprietary CryptoMap™ platform, which enables the identification of novel Cryptigen™ TSAs shared across patients with the same tumor type. These antigens serv…
Actithera, a radiopharmaceutical biotech pioneering precision radioligand therapies, has closed an oversubscribed Series A round of $75.5 million. The financing was co-led by founding investor M Ventures alongside new leads Hadean Ventures, Sofinnova Partners and 4BIO Capital, with participation from Bioqube Ventures, Surveyor Capital and others.
Proceeds will underwrite the clinical development of Actithera’s lead fibroblast activation protein (FAP)-targeting radioligand candidate across multiple oncology indications and fuel expansion of its proprietary three-pillar discovery platform. This chemistry-driven platform combines covalent-targeting strategies, rational drug design and isotope-agnostic radiochemistry to maximize tumour residence time, ensure rapid systemic clearance and enhanc…
ANGLE plc has announced a significant milestone: the 100th peer-reviewed publication supporting its Parsortix® system, a liquid biopsy platform designed to isolate and analyse circulating tumour cells (CTCs) from blood samples. This achievement underscores a decade of research across 24 cancer types, including breast, ovarian, and prostate cancers, conducted by 42 institutions in 15 countries.
The landmark study, conducted by Italy's Fondazione IRCCS, focused on triple-negative breast cancer. Researchers utilised the Parsortix system to harvest intact cancer cells from patient blood samples, enabling whole genomic sequencing (WGS). The sequencing data, analysed using machine learning algorithms, identified key cancer genes associated with DNA proliferation and repair. The authors concluded…
Aurobindo Pharma has secured European Commission marketing authorisation for Dazublys, a biosimilar to trastuzumab, developed by its subsidiary CuraTeQ Biologics. This approval follows the European Medicines Agency’s CHMP positive opinion in April 2025, confirming Dazublys’ comparable quality, safety, and efficacy to Herceptin.
Dazublys is indicated for HER2-positive metastatic and early breast cancers, as well as metastatic gastric cancer. It will be available as a 150 mg powder for infusion across EU member states.
This marks CuraTeQ’s third EMA-approved biosimilar, following Dyrupeg and Zefylti, and the fourth overall in the EU, including Bevqolva approved by the UK’s MHRA. Aurobindo aims to launch at least 10 biosimilars across oncology and immunology by 2030.
Alvotech and Advanz Pharma have announced an expansion of their strategic partnership to include the commercialization of AVT10, a proposed biosimilar to Cimzia® (certolizumab pegol), across Europe. This addition marks the only known biosimilar candidate to Cimzia currently in development globally, targeting chronic rheumatic diseases, particularly in women of childbearing age.
This agreement builds upon their existing collaboration, which now encompasses biosimilars referencing over ten originator biologics, including treatments for autoimmune and inflammatory diseases. The partnership covers all 30 European Economic Area member countries, as well as the UK and Switzerland, with plans to launch the first biosimilars in Europe starting in Q4 2025.
Alvotech will oversee the development an…
Stefan Oelrich, President of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has called for the establishment of a European equivalent to the Nasdaq stock exchange to invigorate biotech innovation across the continent. This proposal aims to address the challenges European biotech companies face in securing funding and scaling operations compared to their U.S. counterparts.
Oelrich emphasized that Europe's fragmented regulatory environment and inconsistent drug pricing mechanisms hinder the growth of its biotech sector. He pointed out that many FDA-approved drugs in the U.S. never reach European markets due to these barriers, stifling innovation and patient access to new treatments.
The concept of a "European Nasdaq" seeks to provide a centralized platform for…
