Biocodex SAS

Plus, news about THX Pharma and Biocodex: 🏗️ Gubra’s venture unit: The Danish biotech and CRO operator, which is partnered with AbbVie and Boehringer Ingelheim, has created Gubra Ventures to build new independent biotech companies “without diluting Gubra’s core business,” the company said on Tuesday. CEO Markus Rohrwild said in a statement to Endpoints News that Gubra Ventures will create asset-centric companies that can derive from other biotechs or universities. Unlike other corporate VCs, Gubra isn’t dedicating a certain amount to its CVC, a spokesperson said. Zoë Johnson was named head of the unit. She was previously co-founder of London-based cardiometabolic biotech Melio Bio and chief scientific officer of Molecule to Medicine. — Kyle LaHucik 💰 Galecto prices $275M public offering: The company is selling about 14.5 million shares at $19.00 apiece. It said it intends to use the cash “for preclinical studies, clinical trials, and manufacturing” of its experimental antibodies. Last month, Galecto announced it would ask the FDA to start testing three antibodies in humans by the end of 2026. — Max Gelman 💶 THX, Biocodex team up on rare disease drugs: Biocodex will get licenses for two drug programs that could treat three rare diseases: Batten disease, Gaucher disease and Niemann-Pick type C disease. THX will receive a €12 million upfront payment ($14.2 million) and up to €161 million ($190.9 million) in milestones. — Max Gelman

Keytruda racks up another approval, this time in ovarian cancersFDA will rule on oveporexton in the third-quarterBiocodex picks up two rare disease programmes from THX PharmaRivaroxaban combo axed from major US stroke trialKeytruda racks up another approval, this time in ovarian cancersThe FDA on Tuesday approved both the infused and subcutaneous formulations of Merck & Co.'s Keytruda (pembrolizumab) in combination with chemotherapy, with or without bevacizumab, to treat adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 and who have received one or two prior systemic treatment regimens. While the PD-1 inhibitor brought in more than $30 billion in sales last year, it's rapidly approaching a 2028 patent expiration (see – Spotlight On: Merck & Co.'s fastest selling drugs in 2025).The approval was based on findings from the Phase III KEYNOTE-B96 trial, the first time an immunotherapy-based regimen has shown such a broad benefit in the specific patient population. In patients with PD-L1–positive tumours, the Keytruda regimen led to median progression-free survival of 8.3 months and median overall survival of 18.2 months; the placebo arm saw a benefit of 7.2 months and 14 months, respectively. Alongside Keytruda's approval, the FDA cleared the PD-L1 IHC 22C3 pharmDx test from Agilent Technologies as a companion diagnostic to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma whose tumours express PD-L1 and may be eligible for treatment.-Elizabeth EatonFDA will rule on oveporexton in the third-quarterAn application for Takeda's oral narcolepsy candidate was granted priority review on Tuesday, with a PDUFA date penciled in for the third quarter. Oveporexton (TAK-861) stands to become the first orexin agonist approved for narcolepsy type 1 (NT1) (see – ViewPoints: With oveporexton at the helm, Takeda’s orexin push gains steam).In July, the Japanese pharma reported that oveporexton met all primary and secondary goals in a pair of Phase IIl NT1 trials, and at the World Sleep conference in September shared detailed results showing that the majority of participants treated with a 2-mg dose achieved "normal" wakefulness (see – Spotlight On: Narcolepsy win provides more pipeline momentum for Takeda).The data were well received by physicians. A FirstWord survey fielded to neurologists found that more than half are very likely to prescribe oveporexton if it is approved (see – Physician Views Results: Strong prescriber interest suggests oveporexton could awaken orexin’s long-awaited potential)And that approval is looking likely. An expert told FirstWord that there is "no way" that regulators could refuse oveporexton because it "is the first drug that seems to work on all the symptoms and right from the start, and can completely change the life of a patient." For further feedback, see KOL Views Q&A: Takeda’s oveporexton is raising the bar for narcolepsy drugs, rival orexin agonists.-Elizabeth EatonBiocodex picks up two rare disease programmes from THX Pharma Biocodex padded its pipeline on Tuesday, thanks to a pair of licensing deals with THX Pharma. The drugmaker nabbed exclusive worldwide rights to Batten-1, an experimental treatment for juvenile Batten disease that's slated to enter Phase III testing this year; it's on track for a 2030 international launch.Biocodex also licensed US and Canadian rights for TX01 to treat Gaucher disease and Niemann-Pick type C disease. The programme is an adapted oral formulation of an already approved active substance.THX will receive €12 million ($14.3 million) upfront, and is eligible for up to €161 million ($191.5 million) in development and commercialisation milestone payments, plus double-digit tiered royalties. The company will be responsible for each asset's clinical development, while Biocodex will helm commercialisation activities in its respective territories. -Elizabeth EatonRivaroxaban combo axed from major US stroke trialThe US National Institutes of Health has halted one arm of a large clinical trial evaluating treatments to prevent strokes, after investigators determined that rivaroxaban combined with aspirin was linked to "an increase in safety events" and was unlikely to provide benefit over the current standard.The decision followed a routine review by an independent data safety and monitoring board overseeing the CAPTIVA study.The discontinued arm tested a low dose of the oral anticoagulant — marketed as Xarelto by Johnson & Johnson and Bayer — alongside daily aspirin in patients who had suffered a stroke attributed to stenosis of a major intracranial artery. CAPTIVA is enrolling up to 1683 participants and is designed to determine whether newer blood-thinning regimens outperform the current standard of care, clopidogrel plus aspirin.The study will now proceed by comparing ticagrelor, sold by AstraZeneca as Brilinta, plus aspirin against the clopidogrel-based standard therapy.-Anna Bratulic

Batten-1 is being prepared for a Phase III trial scheduled to commence in 2026. Credit: Stock-Asso / Shutterstock.com. THX Pharma (Theranexus) and Biocodex have entered a strategic licensing agreement to further the development of two drug candidates, Batten-1 and TX01, targeted at the Batten, Gaucher, and Niemann-Pick type C rare diseases. Under the agreement, Biocodex will hold an exclusive worldwide licence to develop and commercialise Batten-1, which has been developed by THX Pharma for juvenile Batten disease (CLN3). Additionally, Biocodex will receive exclusive rights in Canada and the US to develop and commercialise TX01, a new formulation of an existing molecule for treating Niemann-pick type C and Gaucher diseases. These are genetic disorders that result in severe neurological, visceral or haematological complications. THX Pharma is set to receive total payments up to €173m ($206.1m). This includes an upfront payment of €12m and as much as €161m in milestone payments associated with development and commercialisation achievements. Furthermore, the company will receive double-digit tiered royalties on net sales. It will lead clinical development with financial and scientific support from Biocodex, which will also handle market access and commercialisation within the licensed territories. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Batten-1 is being prepared for a Phase III trial scheduled to commence in 2026. Juvenile Batten disease (CLN3) is an ultra-rare neurodegenerative condition leading to cognitive decline, progressive vision loss, motor impairment, and early mortality. Currently, there are no approved treatments. The goal is for Batten-1 to become the first available therapy for this indication, with a planned international launch by 2030. The Batten-1 programme originated with the Beyond Batten Disease Foundation. TX01 utilises an adapted oral formulation of an already approved substance for Niemann-Pick type C disease and Gaucher disease type 1. The approach aims to enhance administration methods and better meet patients’ needs.