Otsuka Holdings Co., Ltd.

Novartis has identified farabursen as a good fit for its burgeoning kidney disease portfolio.\n Novartis has committed another $1.7 billion to its ambition to become a kidney disease leader. The Swiss drugmaker is making the outlay, around half of which is upfront, to buy Regulus Therapeutics for a rare renal disease drug that is set to enter phase 3 in the third quarter.Regulus published top-line data from a phase 1b trial of its lead candidate, farabursen, in March. The trial enrolled patients with autosomal dominant polycystic kidney disease (ADPKD). People who received the oligonucleotide every other week for three months had statistically significant increases in urinary PC1 and PC2, proteins that inversely correlate with disease severity.Height-adjusted total kidney volume (htTKV), a predictor of renal insufficiency, increased 0.05% over four months in patients on farabursen. HtTKV grew 2.58% in the placebo cohort. Buoyed by the data, Regulus forged ahead with plans to start a phase 3 trial that could support a filing for accelerated approval.Novartis has identified farabursen as a good fit for its burgeoning kidney disease portfolio. The company has agreed to pay $7 a share upfront to acquire Regulus. The upfront payment, which amounts to $800 million, is more than double the closing price of Regulus’ stock Tuesday. Novartis has agreed to pay another $7 a share if Regulus achieves a milestone tied to the regulatory approval of farabursen. The total value, should all these targets be hit, would reach $1.7 billion.  Regulus has designed its phase 3 trial to support a filing for accelerated approval based on htTKV after 12 months. The trial will serve as its own confirmatory study, with the biotech tracking changes in a measure of kidney function, eGFR, out to 24 months to support full approval.If approved, farabursen will enter a market already served by Otsuka’s Jynarque. Otsuka said (PDF) U.S. sales “increased significantly” over the first three months of the year because ADPKD prescriptions rose. Regulus told investors in January that Jynarque is only used in about 7% of the addressable population, a fact the biotech’s CEO Joseph Hagan said is “in large part because of its safety and tolerability profile.”Regulus claimed farabursen is a multibillion-dollar opportunity. Novartis wants to seize the opportunity to advance the kidney care business that it has built out through deals such as the $3.2 billion Chinook Therapeutics acquisition and development of internal programs. The commercial portfolio now includes Fabhalta and Vanrafia. 

TAIPEI, April 24, 2025 /PRNewswire/ -- Primo Biotechnology Co., Ltd. ("Primo") proudly announces that its Taoyuan pharmaceutical facility has successfully passed inspection by Taiwan Food and Drug Administration (TFDA) and has been award dual certification for PIC/S GMP and GDP. This achievement demonstrates Primo's dedication to meeting international quality standards for nuclear medicine production and sets the stage for global market growth. Continue Reading Primo Partners with ABX to Bring PB01 Closer to Taiwan’s Prostate Cancer Market. Since initiating construction in 2023, Primo has focused on establishing a high-efficiency, internationally compliant facility. By integrating advanced and automated production system with over 30 years of the team's radiopharmaceutical manufacturing experience in medical centers, the company achieved certification in less than two years. This milestone not only strengthens domestic supply capabilities but also accelerates clinical trial progress for new drug candidates and builds international client confidence—paving the way for expanded partnerships in the global markets. Furthermore, Primo obtained TFDA market approval in April 2025 for Fluorodeoxyglucose F-18 (18F-FDG). This essential radiopharmaceutical for PET/CT imaging plays a key role in diagnosing cancers as well as neurological and cardiac conditions. The commercial launch of F-18 FDG is expected positively contribute to the company's operational performance. Beyond F-18 FDG, Primo is actively developing a broad portfolio of radio theranostics radiopharmaceuticals. Recognizing the high technical and regulatory barriers within this field, Primo is also expanding into CRO (Clinical Research Organization) and CDMO (Contract Development and Manufacturing Organization) services. By integrating drug development, pre-clinical trials and manufacturing into its radiopharmaceutical platform. Primo enables close collaboration with partners and supports the acceleration of new drug approvals. In addition to GMP and GDP certification, Primo is licensed by Taiwan's Atomic Energy Council for the safe transport of radioactive materials. By following GDP standards, Primo ensures secure and efficient delivery of radiopharmaceuticals. Its strategic location, just 30 minutes from Taoyuan International Airport, provides a logistical edge for global operations. Securing PIC/S GMP and GDP certifications is a significant milestone for Primo. The company will continue to strengthen its manufacturing and research capabilities, enhancing its competitiveness in the global nuclear medicine market. By partnering with leading medical institutions worldwide, Primo is committed to delivering high-quality diagnostic and therapeutic radiopharmaceuticals to patients worldwide. About Primo Biotechnology Co., Ltd. Primo is a leading biotech company specializing in the development and manufacturing of radiopharmaceuticals. With internationally certified facilities, Primo is committed to using precision molecular imaging technology to bring hope and a future to cancer patients. Headquartered in Taipei, the company collaborates with domestic and international partners to drive advancements in precision cancer care. For more information, visit and follow on Facebook and LinkedIn. SOURCE Primo Biotechnology Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

In return for the licenses, Astex will receive 19% of Mosaic Therapeutics’ equity, with a further 3% to follow if milestones are hit.\n Mosaic Therapeutics has secured the latest pieces in its combination medicine strategy by licensing two clinical stage tumor drugs from fellow British biotech Astex Pharmaceuticals.The small molecules in question are ASTX029, an ERK1/2 inhibitor that has completed a phase 2 study, and ASTX295 an MDM2 antagonist that has undergone a phase 1 trial. Both candidates have demonstrated “single-agent activity as monotherapies, enabling use in combination therapies,” Mosaic explained in an April 24 release.In return for the licenses, Astex—which is owned by Otsuka Pharmaceutical—will receive 19% of Mosaic’s equity, with a further 3% to follow if milestones are hit.Cambridge, U.K.-based Mosaic secured a $28 million series A two years ago to fund its ambition to “resolve cancer’s complexity to power new treatments for patients.” In practice, this means combing through large datasets to identify combinations of oncology drugs that could increase their effectiveness in biomarker-defined patient populations.This morning’s deal “significantly accelerates Mosaic’s development path,” the biotech\'s chair Edward Hodgkin said in the April 24 release, meaning the company now expects to launch its first clinical study of a combination treatment next year. “The in-licensing of these two clinical stage assets provides a step change in our development pipeline, allowing Mosaic to progress targeted drug combinations in novel biomarker-defined settings and enabling the delivery of precision medicines for patients who currently have few therapeutic options,” added Hodgkin, who is also managing partner of Mosaic’s backer Syncona Investment Management.Astex, which like Mosaic is based in Cambridge in England, has a strong track record of working with Big Pharma in the past, including collaborating with the Novartis Institutes for BioMedical Research on breast cancer med Kisqali and AstraZeneca on its breast cancer treatment Truqap in the mid-2000s. More recently, the biotech secured a 2023 deal with Merck & Co.“We recognise the significance of Mosaic’s platform, which has identified these two assets as anchor components of a pipeline of potential combination products,” Astex’s CEO and co-founder Harren Jhoti, Ph.D., said in the release. “Both drug targets are well-characterised drivers of many cancers, and we are excited to be working with the experienced team at Mosaic to expand the Company’s pipeline in combination therapies with high unmet medical need.”