Genmab A/S (NASDAQ:GMAB) announces positive results from the second part of a Phase 3 clinical trial, CASSIOPEIA, evaluating daratumumab as maintenance treatment versus no treatment in newly diagnosed multiple myeloma (MM) patients who are eligible for autologous stem cell transplantation.
Part 2, conducted by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and and Janssen Research & Development, LLC, a unit of Johnson & Johnson (NYSE:JNJ), met the primary endpoint of progression-free survival at a pre-planned interim analysis with 47% less risk of cancer progression or death (hazard ratio = 0.53).
The independent Data Monitoring Committee has recommended unblinding the data.
Licensee Janssen Biotech plans to discuss the submission of marketing applications for the indication with health authorities.
Daratumumab, marketed by Janssen under the brand name Darzalex, was first approved in the U.S. in November 2015 for previously treated MM patients.
Brazilian health regulator Anvisa reports that a volunteer has died in the Phase 3 clinical trial evaluating AstraZeneca (AZN -0.5%) and Oxford University’s COVID-19 vaccine candidate, dubbed AZD1222 by the company.
No details are available about the event other than that the person was Brazilian.
The only other publicized adverse event was a participant in the U.K. who developed a rare spinal inflammatory disorder after inoculation, later deemed unlikely related to the vaccine.
Shares were down as much as 3.2% intraday before recovering.
Teladoc Health (NYSE:TDOC) announces launch of Mental Health Care, its new telemedicine service enabling employees to count on convenient, stigma-free access to high-quality psychiatrists, psychologists and therapists from the convenience of their phone, web or mobile app.
The new service also creates the first telemedicine solution to offer both general medical and mental health care from the same platform, enabling a more holistic and seamless approach to care.
The launch builds on the success of the company’s mental health footprint in Canada with their Mental Health Navigator and disability products.
The October 2019 study commissioned by Teladoc Health, found that mental health challenges are extremely common, with 61% of respondents saying that symptoms have affected their job performance.
“With our Mental Health Care service, Teladoc Health continues to remove barriers and providing easy access to care so employees can feel comfortable getting the confidential help they need, and employers can have the confidence to say they are providing the right resources.” said Dr. Tim Foggin, Canadian Medical Director.
In an interview, Operation Warp Speed chief Moncef Slaoui stated that he expects the U.S. trials evaluating Johnson & Johnson (JNJ -0.3%) and AstraZeneca’s (AZN -1.2%) COVID-19 vaccine candidates to resume as early as this week.
The trials were paused to allow time to investigate possible safety signals.
Align Technology (NASDAQ:ALGN): Q3 Non-GAAP EPS of $2.25 beats by $1.52; GAAP EPS of $1.76 beats by $1.30.
Revenue of $734.1M (+20.9% Y/Y) beats by $182.55M.
Gross margin of 72.7% vs. 68% consensus and Operating margin of 24.1% vs. 9.7% consensus.
Shares +16.74%.
