Tempus AI, Inc. Class A Common StockTEM
▲ PositiveCapitalDemandrelevance
Morgan Stanley lifted its revenue outlook on reimbursement pricing, and Tempus raised full-year guidance with Q2 revenue up 21.6% YoY.
Impact on stocks 8
Biotech & Genomic Medicine▲ · 6 stocks
Tempus AI, Inc. Class A Common Stock
Daiichi Sankyo Company, Limited4568
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AstraZeneca PLCAZN
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Bristol-Myers Squibb CompanyBMY
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GSK plcGSK
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Merck & Company IncMRK
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Critical Materials & Supply Chain▲ · 1 stocks
Merck KGaAMRK
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Financials▲ · 1 stocks
Morgan StanleyMS
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Off-coverage companies 2
Insight PharmaceuticalsPrivate± Mixed
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LevelSet BioPrivate± Mixed
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Onco360 Named National Pharmacy Partner for AstraZeneca's Etcamah
Onco360 has been selected by AstraZeneca as a national pharmacy partner for Etcamah, also known as camizestrant, the company announced. The therapy is indicated for adult patients with hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of an ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. Etcamah is an estrogen receptor antagonist that binds to the ligand-binding domain of ERα, antagonizing both wild-type and mutated ESR1 and inducing proteasome-dependent degradation of ERα without agonizing it. Its approval was based on the phase 3 SERENA-6 study, in which Etcamah plus a CDK4/6 inhibitor reduced the risk of disease progression or death by 56% versus an aromatase inhibitor plus a CDK4/6 inhibitor, with median PFS of 16 months versus 9.2 months and a hazard ratio of 0.44. The most common adverse reactions, occurring in at least 20% of patients, included decreased neutrophils, leukocytes, hemoglobin, lymphocytes and platelets, along with visual disturbances and fatigue.
SUSMED's Blockchain Clinical Trial System Powers World's First Drug Approval
SUSMED, a Japanese company that develops therapeutic apps and clinical trial support systems, announced on September 16 that a drug tested in a clinical trial using its blockchain-based system has received domestic manufacturing and marketing approval. According to the company's research, this is the world's first drug approval based on the results of a corporate-sponsored clinical trial that used blockchain. The approved drug is Uekix Tablets, indicated for excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea syndrome, among other conditions. Viatris Pharmaceuticals obtained the approval, and SUSMED provided the system for the domestic clinical trial. SUSMED's SourceDataSync uses blockchain technology for data verification, checking whether records of patients' conditions and drug effects match the original records at medical institutions, with the aim of reducing manual confirmation work and data entry at medical institutions while maintaining the reliability of the records. Leading up to this approval, SUSMED conducted verification under the government's regulatory sandbox program, and in December 2020 received a response from the Ministry of Health, Labour and Welfare that blockchain-based data verification could replace conventional work. This was followed by a trial that began in November 2022, and in January 2023 the system was adopted for a trial in a different target disease. The key point this time is that a technology still in the verification stage was used in a clinical trial that led to drug approval, and SUSMED says that a separate comparative study showed a reduction in man-hours for clinical trial confirmation work and other tasks.