Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.
Wall Street took in stride mixed FDA briefing documents with regard to the upcoming adcom review of Bluebird Bio Inc.’s two gene therapy prospects, and shares of the company (NASDAQ:BLUE) closed at $3.61, up 63 cents, or 21%.
Shanghai Henlius Biotech Inc.’s anti-PD-1 monoclonal antibody serplulimab has generated positive data in a phase III trial as a first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC).
Following a negative phase II/III study of an investigational treatment for major depressive disorder, Praxis Precision Medicines Inc. is dropping staff from the payroll and refocusing the company’s resources on tremor and epilepsy. The Aria study of PRAX-114, a positive allosteric modulator extrasynaptic GABA receptor, missed its primary endpoint, statistical significance as measured on the Hamilton Depression Rating Scale. It also missed the study’s secondary endpoints.
Five-year survival rates for people with metastatic colorectal cancer haven’t budged much in recent decades but new data presented at the American Society of Clinical Oncology’s annual conference pushed the boundary enough to be notable.
Could Merus NV be on course to get the fourth “tumor agnostic” drug approved, a groundbreaking approach to cancer that focuses on mutations rather than location of the disease? According to a trial update revealed at the American Society of Clinical Oncology (ASCO) conference the biotech from Utrecht, the Netherlands, could join Merck & Co Inc., Bayer AG/Eli Lilly and Co. and Roche Holding AG with its early-to-mid stage candidate, zenocutuzumab.
After weeks of mounting speculation by backers of Gilead Sciences Inc., data from the phase III Tropics-02 study testing Trodelvy (sacituzumab govitecan) vs. physicians’ choice of chemotherapy rolled out June 4 at the American Society of Clinical Oncology (ASCO) meeting in Chicago. Wall Street had hoped for better.
Affibody AB and its development partners, Acelyrin Inc. and Inmagene Biopharmaceuticals Co. Ltd., are accelerating plans to move the interleukin-17A inhibitor izokibep (formerly ABY-035) into phase III studies in psoriatic arthritis following better-than-expected phase II efficacy combined with an apparently clean safety profile.
As the American Society of Clinical Oncology (ASCO) meeting began, researchers discussed abstracts related to findings due to roll out during the course of the weekend event. On the table June 3 were primary results from the double‐blind, placebo‐controlled, phase III Shine study of Imbruvica (ibrutinib) from Abbvie Inc. and Johnson & Johnson (J&J) in combination with bendamustine‐rituximab and rituximab maintenance therapy as a first‐line treatment for patients ages 65 and over with mantle cell lymphoma.
The world’s biggest cancer-focused conference began June 3 as more than 40,000 attendees are expected at the American Society of Clinical Oncology’s (ASCO) annual gathering. The conference is being held in live in Chicago and is also available virtually. Among the more than 2,500 abstract presentations in about 120 subject subcategories are potential breakthroughs in treating non-small-cell lung cancer from Immutep Ltd., Cullinan Oncology Inc. and Surface Oncology Inc. Each company has seen upticks in their stock value, some as much as 10%, during the week as the conference approached and their data are presented.
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