CureVac

Vaccine makers' stocks surged after the US reported its first bird flu death, with Moderna, Novavax, and CureVac seeing significant gains. Companies are developing mRNA vaccines for the virus. The CDC reported the death involved the H5 strain, with 66 US cases since last year. Risk to the public remains low, with no human transmission recorded.

The ASPIRE trial results published in the Journal of Endourology show that the stone-free rate (SFR) achieved through steerable ureteroscopic renal evacuation (SURE) was noninferior to standard ureteroscopy (URS) for nephrolithiasis. The SURE procedure, performed with the FDA-cleared CVAC device, demonstrated higher effectiveness across various stone sizes, with better outcomes in stone clearance and residual stone volume compared to URS. Safety was comparable between both methods.

Arcturus Therapeutics, a leader in mRNA medicines, leverages strategic partnerships, a diverse pipeline, and innovative delivery technology to maintain its competitive edge. Facing regulatory hurdles and competition, it focuses on expanding into new therapeutic areas and global markets, aiming for continued growth and development in the biotech industry.

The mRNA Therapeutics Market was valued at USD 11.82 billion in 2023 and is projected to reach USD 48.65 billion by 2032, with a CAGR of 17.04%. The market's growth is driven by mRNA-based vaccines against COVID-19, advancements in mRNA-based cancer therapies, and regulatory approvals. North America leads the market, followed by Europe, while Asia Pacific is expected to grow the fastest.

Many biotechs that rose during the pandemic have faced challenges as their COVID-19 candidates faltered. CureVac, after its mRNA vaccine's low efficacy, restructured and partnered with GSK. Novavax, despite FDA approval, struggled with uptake and faced a clinical hold on its flu/COVID shot. Inovio Pharmaceuticals, once a frontrunner with DNA-based tech, faced controversy and delayed its FDA application. Veru's antiviral sabizabulin was denied EUA and now focuses on GLP-1 related treatments.

GSK sues Moderna for patent infringement on mRNA vaccine technology, claiming Moderna's COVID-19 vaccines rely on GSK's foundational patents from a team led by Christian Mandl at Novartis. GSK seeks damages and licensing fees.

UK High Court upheld patent EP 1 893 196 for enzalutamide, rejecting generics' claim of obviousness. The patent, owned by UC Regents and licensed to Astellas, covers the prostate cancer drug Xtandi. Parallel proceedings are pending in Europe.

mRNA-based pharmaceuticals' licensing agreement deal values grew 800% from 2019 to 2024YTD, reaching $3.8bn in 2024. Global sales for innovator mRNA-based pharmaceuticals were $22bn in 2023, projected to increase to $26.2bn by 2030. Major companies like GSK and Bristol Myers Squibb are investing in mRNA therapeutics, with GSK restructuring a $1.57bn agreement with Curevac and Bristol Myers Squibb collaborating with Repertoire Immune Medicines for up to $1.87bn. The US HHS committed $176m to Moderna for mRNA-based influenza vaccines, highlighting the technology's potential for pandemic preparedness.

S.B., A.D., T.J.F., I.M.G., L.G., R.K.J., G.K., J.M.L., G.V.L., K.P.-J., H.I.S., J.T., R.R.W., M.W., Y.L.W. have disclosed various financial interests, including funding, advisory roles, patents, and equity. C.M.B., E.B., M.W.B., and K.P. declare no competing interests.