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INO Stock Soars as FDA Backs Rolling BLA for Rare Lung Disease Drug
ZACKS· 2025-08-28 15:01
Key Takeaways Inovio stock rises 20.6% after the FDA allows a rolling BLA for INO-3107 in RRP.The company aims to seek priority review for INO-3107, cutting FDA review time to six months.INO-3107 has breakthrough therapy and orphan drug designations for RRP.Shares of Inovio Pharmaceuticals (INO) jumped 20.6% on Wednesday after the FDA agreed to the company’s rolling submission timeline for the biologics license application (BLA) seeking approval for INO-3107 in adult patients with recurrent respiratory papi ...
行业投资策略周报:司美MASH适应症获批-20250819
CAITONG SECURITIES· 2025-08-19 11:11
Core Insights - The report highlights the approval of semaglutide (Wegovy) for the treatment of metabolic dysfunction-associated steatotic liver disease (MASH) by the FDA, which is expected to enhance the market penetration of related products and diagnostic tools [7][10][15] - The report suggests that companies like Furuya Co., Ltd. will benefit from the growth opportunities in the MASH indication market due to the increasing prescription rates of semaglutide and the rising demand for diagnostic instruments [15][5] Industry Performance Review - As of August 15, 2025, the pharmaceutical and biotechnology sector's TTM-PE stands at 51.31 times, which is 110% higher than its historical low of 24.38 times [16] - The healthcare sector has shown a relative premium of 281% compared to the CSI 300 index, which is significantly above the average premium rate of 241% over the past decade [16] - The pharmaceutical and biotechnology sector experienced a 3.08% increase in the week from August 11 to August 15, 2025, ranking 10th among 27 sub-industries [20][24] Company Dynamics - Furuya Co., Ltd. is noted for its FibroScan series of liver fibrosis diagnostic instruments, which are the first globally to utilize transient elastography technology for non-invasive liver stiffness measurement [15] - The report emphasizes the strategic collaborations between Furuya and leading pharmaceutical companies to promote the clinical application and commercialization of new drugs [15] - The report identifies several companies that could be key players in the MASH treatment landscape, including innovative drug and device companies such as Furuya, Anglikon, and others [15]