Once hailed by former Gilead Sciences Inc. CEO and President John Milligan as "the beginning of a very important NASH franchise," the oral apoptosis signal-regulating kinase 1 (ASK1) inhibitor selonsertib has again failed to meet the primary endpoint in a phase III trial. Top-line results of the Stellar-3 study for patients with bridging fibrosis due to nonalcoholic steatohepatitis (NASH) did not meet the prespecified week 48 primary endpoint of a ≥ 1-stage histologic improvement in fibrosis without worsening of the condition after failing to meet a similar endpoint for NASH patients with compensated cirrhosis in Stellar-4. Read More
Mateon Therapeutics Inc. and Oncotelic Inc. completed the merger they announced on April 17. Oncotelic becomes a wholly owned subsidiary of Mateon, and the combined company has a pipeline of TGF-beta RNA therapeutics for late-stage cancers, including gliomas, pancreatic cancer and melanoma. Read More
HONG KONG – SK Biopharmaceuticals Co. Ltd., a spin-off from Korean conglomerate SK Holdings Co. Ltd., inked a joint research agreement with Twoxar Inc., a U.S.-based artificial intelligence (AI)-driven biopharma, to discover and develop drugs for non-small-cell lung cancer (NSCLC). Read More
The U.S. government shutdown was a contributing factor why no biopharma companies graduated to the public ranks in January. However, it was a hectic period after that, with a total of 11 companies completing their IPOs in the U.S. by the end of the first quarter, collectively raising about $1.07 billion. That figure was down 10.3% from the $1.2 billion raised by 14 companies listing on U.S. exchanges in the first quarter last year. Read More
A new study by the Georgetown Lombardi Comprehensive Cancer Center and the National Cancer Institute indicates that Oncotype DX-guided treatment could cut the cost of first year breast cancer care in the U.S. by $50 million. JNCI published the results of the study on Wednesday. Genomic Health Inc. of Redwood City, Calif., produces Oncotype DX. Read More
It should be motoring to profitability, but nine months after the U.S. launch of its new antibiotic, Zemdri (plazomicin), Achaogen Inc. has filed for Chapter 11 bankruptcy and is now selling off its assets. There can be no more potent illustration of the mismatch between antibiotics and market forces, nor of how despite numerous measures to incentivize antibiotic discovery and development, the system isn't working. Read More
Astellas Pharma U.S. Inc., of Northbrook, Ill., and Amgen Inc., of Thousand Oaks, Calif., Thursday became the latest biopharma companies making settlements with the U.S. Department of Justice (DoJ) to resolve allegations that they illegally paid the Medicare copays for their drugs through purportedly independent foundations, thus violating the anti-kickback law. Read More
Alexion Pharmaceuticals Inc., of New Haven, Conn., reported first-quarter revenues of $1.14 billion, a 23% year-over-year increase, as compared to consensus estimates of about $1.1 billion, with non-GAAP earnings per share of $2.39, a 42% year-over-year increase, vs. estimates of $2.20. Read More
Navan Technologies Inc., of South San Francisco, said it closed a seed investment round led by Amgen Ventures, High-Tech Gründerfonds, Hemi Ventures and other institutional and private investors. Navan is developing cell and gene therapies using its nonviral Nanostraw platform based on technology licensed from Stanford University. Read More
Zymeworks Inc., of Vancouver, British Columbia, said Daiichi Sankyo Co. Ltd., of Tokyo, exercised its option for a commercial license to an immuno-oncology bispecific built on Zymeworks' Azymetric and Efect platforms. Zymeworks said it expects to receive a $3.5 million milestone payment based on Daiichi Sankyo's selection of the first of up to three lead candidates under collaboration agreements between the companies. Read More
