CF Pharmtech Inc. raised HK$607.67 million (US$78.12 million) through the sale of 41.19 million H shares on the Hong Kong Stock Exchange (HKEX) Oct. 8. The proceeds will be used to advance the Suzhou, China-based drug developer’s portfolio of inhalation candidates for respiratory diseases.
More than a decade after the last idiopathic pulmonary fibrosis (IPF) treatment gained U.S. FDA approval, Boehringer Ingelheim GmbH’s Jascayd (nerandomilast) is set to hit the market following the agency’s green light on Oct. 7. While expected to offer a modest benefit over existing therapies, Jascayd, an orally administered preferential inhibitor of phosphodiesterase 4B with breakthrough therapy status, is viewed by analysts as the first of several potential advancements in the IPF space over the next few years.
While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.
Allrock Bio Inc. secured $50 million in a series A round co-led by Versant Ventures and Westlake Biopartners to advance ROC-101, an oral pan-rho-associated protein kinase (ROCK) inhibitor to treat pulmonary arterial hypertension and pulmonary hypertension with interstitial lung disease.
Three-year-old Areteia Therapeutics Inc. hit the primary endpoint in its Exhale-4 phase III study of dexpramipexole for eosinophilic asthma, bringing the oral small molecule one step closer to the U.S. market, where it could challenge currently approved injectable anti-IL-5/5R biologics.
Activity in some clinical parameters is leading Atyr Pharma Inc. to plan a sit-down with regulators, even though the tRNA synthetase-derived drug efzofitimod missed its primary endpoint of steroid tapering in the phase III Efzo-Fit study against the interstitial lung disease pulmonary sarcoidosis (PS). CEO Sanjay Shukla said his firm maintains “a high degree of conviction” regarding the candidate. “But I want to make sure we have the best briefing book possible” before consulting with the U.S. FDA, which will happen as soon as possible.
Several South Korean biotech and biopharmaceutical companies completed IND submissions or won nods to start clinical trials in either the U.S. or South Korea, including SK Bioscience Co. Ltd., Genosco Inc., Pimedbio Inc., Sillajen Inc. and Ami Pharm Co. Ltd.
South Korea’s Ministry of Food and Drug Safety approved Moderna Inc.’s Spikevax LP.8.1 vaccine as an updated shot for COVID-19 targeting the LP.8.1 variant, according to Moderna Korea’s announcement Sept. 1. The regulatory clearance comes days after the U.S. FDA accepted, on Aug. 27, Moderna’s supplemental BLAs for two of its COVID-19 vaccines, Spikevax and Mnexspike.
Following positive data from competitors earlier this year, United Therapeutics Corp. rolled out impressive and unexpected phase III results of nebulized Tyvaso (treprostinil) for idiopathic pulmonary fibrosis (IPF), setting the stage for an sNDA filing with the U.S. FDA next year. If approved for the indication, United, of Silver Spring, Md., and Research Triangle Park, N.C., could tap into what analysts say is a $4 billion-plus market.
French vaccines specialist Osivax SAS has been awarded $19.5 million by the U.S. Biomedical Advanced Research and Development Authority (BARDA) to fund work on its universal influenza A vaccine.