Shares of Travere Therapeutics Inc. (NASDAQ:TVTX) fell $5.28, or 41%, to trade midday at $7.60 after the San Diego-based firm disclosed top-line two-year confirmatory secondary endpoint results from the pivotal, head-to-head phase III study called Protect with the approved endothelin and angiotensin II receptor antagonist Filspari (sparsentan) in IgA nephropathy (IgAN) vs. angiotensin II receptor antagonist irbesartan, which first became available in 1997. Filspari turned up long-term kidney function preservation and achieved a clinically meaningful difference in estimated glomerular filtration rate (eGFR) in the total and chronic slope vs. irbesartan, narrowly missing statistical significance in eGFR total slope while hitting the bar in eGFR chronic slope for purposes of regulatory review in the EU. Filspari is available for IgAN under accelerated clearance in the U.S., having been given the nod in February. The company will engage with regulators and expects to submit an sNDA in the first half of next year for full approval in the U.S.

Chinabio 2023: Cansino, Gracell, Immuneonco’s C-suites offer IPO insights in China, US 

Raising capital has always been a challenge for small to medium biotech firms worldwide, but the economic whiplash and the wider downturn across international markets post-pandemic have pushed Chinese biotechs to make-it-or-break-it scenarios for crossing the IPO threshold, speakers at the Chinabio Partnering Forum 2023 said in Shanghai. For William W. Cao, CEO of Chinese CAR T-cell therapy developer Gracell Biotechnologies Inc., the decision to pursue a public listing on Nasdaq and success in doing so in January 2021 came during a period of intense negative clout from the onset of the COVID-19 pandemic and the resulting increasing crackdowns and pressure from the U.S. government on Chinese and Asian firms. “[The situation] did not look very promising,” Cao said.

No pulling punches in adcom hearing on implantable diabetes combo product

Intarcia Therapeutics Inc. is going toe-to-toe today with the U.S. FDA before the Endocrinologic and Metabolic Drugs Advisory Committee over the approvability of ITCA-650, a twice-yearly implantable exenatide-device combination product intended to improve glycemic control in adults with type 2 diabetes. Intarcia, a business unit of I2o Therapeutics Inc., didn’t pull any punches as it presented data showing that ITCA-650 is in line with the GLP-1 products the FDA already has approved, especially when it comes to incidents of acute kidney injury, which Intarcia, pointing to warning labels on approved products, said is a class-wide risk. Another point of contention between the sponsor and the regulator is the variability in drug delivery over the life of the implant. Intarcia claimed FDA reviewers misinterpreted the variability data, while the review team stuck to its interpretation and took issue with the sponsor’s definition of device failure and the lack of a communication mode that would inform a patient of a malfunction.

Inventiva licenses NASH candidate for Japan, South Korea development

Inventiva SA is getting $10 million up front and the possibility of $231 in clinical, regulatory and commercial milestones by licensing its nonalcoholic steatohepatitis (NASH) candidate to Hepalys Pharma Inc. to sell in Japan and South Korea. Hepalys said it will conduct phase I studies of lanifibranor in Japan and that it will pay for all the studies needed for NDAs in the two countries. Top-line data from Inventiva’s phase II study of the PPAR agonist in NASH hit the primary efficacy endpoint, resulting in a 44% reduction of hepatic fat and a greater than 30% liver triglyceride reduction. Inventiva owns 30% of newly created Hepalys, which is from Catalys Pacific. Inventiva’s stock (NASDAQ:IVA) was up 11% at midday to $4.19 per share.

Everest licenses Asian rights to Kezar’s autoimmune drug zetomipzomib 

Everest Medicines Ltd. is in-licensing Kezar Life Sciences Inc.’s phase II autoimmune disease candidate, zetomipzomib, in a deal worth $132 million for greater China, South Korea and southeast Asia rights. Kezar’s lead molecule, also known as KZR-616, is a first-in-class, selective immunoproteasome inhibitor with potential for multiple autoimmune diseases. Terms call for Everest, of Shanghai, to pay Kezar, of San Francisco, $7 million up front and up to $125.5 million in clinical and commercial milestone payments, as well as tiered sales royalties. In exchange, Everest gains exclusive rights to develop and commercialize zetomipzomib in greater China, South Korea, Singapore, Malaysia, Thailand, Indonesia, Vietnam and the Philippines for a range of autoimmune diseases, including lupus nephritis.

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