Indivior PLC ADR (OTCPK:INVVY): Q2 GAAP EPS of $0.10.
Revenue of $215M (-19.8% Y/Y)
Wednesday, July 31, 2019
Daiichi Sankyo Company reports Q1 results
Daiichi Sankyo Company (OTCPK:DSNKY): Q1 GAAP EPS of ¥66.77.
Revenue of ¥249.24B (+10.4% Y/Y)
Tuesday, July 30, 2019
Gilead Q2 revenues flat; earnings up 3.5%; guidance raised
Gilead Sciences (NASDAQ:GILD) Q2 results ($M): Revenues: 5,685 (+0.7%); Product sales: 5,607 (+1.2%); HIV sales: 4,041 (+10.3%).
Key product sales: Biktarvy: 1,116 (+999%); Genvoya: 980 (-15.5%); Truvada: 718 (-6.1%); Odefsey: 387 (+0.5%); Descovy: 358 (-11.2%); Yescarta: 120 (+76.5%).
Net income: 1,880 (+3.5%); non-GAAP net income: 2,331 (-6.5%); EPS: 1.47 (+5.8%); non-GAAP EPS: 1.82 (-4.7%).
2019 guidance: Product sales: $21.6B – 22.1B from $21.3B – 21.8B.
Shares up 1% after hours.
Gilead Sciences (NASDAQ:GILD) Q2 results ($M): Revenues: 5,685 (+0.7%); Product sales: 5,607 (+1.2%); HIV sales: 4,041 (+10.3%).
Key product sales: Biktarvy: 1,116 (+999%); Genvoya: 980 (-15.5%); Truvada: 718 (-6.1%); Odefsey: 387 (+0.5%); Descovy: 358 (-11.2%); Yescarta: 120 (+76.5%).
Net income: 1,880 (+3.5%); non-GAAP net income: 2,331 (-6.5%); EPS: 1.47 (+5.8%); non-GAAP EPS: 1.82 (-4.7%).
2019 guidance: Product sales: $21.6B – 22.1B from $21.3B – 21.8B.
Shares up 1% after hours.
NEC buys OncoImmunity to boost AI-based cancer research
Japanese multinational NEC has bought the Norway-based bioinformatics firm OncoImmunity, which develops proprietary machine learning software to support cancer R&D.
Following the acquisition for an undisclosed sum, OncoImmunity will become a subsidiary of NEC operating under the name of NEC OncoImmunity AS.
OncoImmunity focuses on research into the emergence of neoantigens – biomarkers that appear on tumour cells after they develop that can be used as a target for drugs.
Founded in 2014 OncoImmunity develops software that aims to select patients for immunotherapy, identifying neoantigen targets for personalised cancer vaccines and cell therapies, quickly enough to be used in the clinic.
The acquisition fits with NEC’s drug development strategy announced in May, which is based around using artificial intelligence (AI) to interrogate genomic data to discover neoantigen targets.
It is already working with France’s Transgene to create vaccine-based therapies targeting neoantigens.
Early stage clinical trials in head and neck cancer and ovarian cancer trials have already been cleared by the FDA and applications in the UK and France are under review.
NEC said that the OncoImmunity acquisition is “integral” to support this programme and develop its immunotherapy pipeline.
Under the new arrangements NEC will focus on drug discovery while NEC OncoImmunity will continue its neoantigen prediction service.
OncoImmunity’s CEO Richard Stratford said: “The OncoImmunity AS team are delighted to be joining the NEC Group and firmly believe that the union will realise great synergies, marrying the mutual strengths of OncoImmunity AS’s and NEC’s neoantigen prediction pipelines with NEC’s expertise in AI, data management and security.
“These synergies will help strengthen NEC’s individualised immunotherapy programmes, whilst simultaneously positioning NEC OncoImmunity AS as the leading neoantigen prediction service provider in the field.”
There are a whole host of companies using AI techniques in drug development: UK-based Exscientia and BenevolentAI have a series of tie-ups with various big pharma companies that hope to use the technology to reduce failure rates and discover new approaches to targeting diseases.
Clogged Leg Arteries May Not Require Invasive Surgery
Less invasive treatment of severely clogged leg arteries appears to be as effective as open surgery, according to a new study.
Researchers followed patients with critical limb ischemia, which is the most severe form of clogged leg arteries. It can lead to slow healing of leg wounds, gangrene and amputation.
“Critical limb ischemia is usually not an emergency, and there is time to determine the most appropriate course of therapy,” said Dr. Jonathan Lin, a surgery resident at the University of California, Davis Health.
One treatment for critical limb ischemia is open surgery, in which a section of vein from the patient (or synthetic material) is used to bypass the blockage. This enables blood to reach the lower leg and foot.
Another option is a less invasive endovascular procedure, in which a thin, flexible tube and wire are inserted through a small incision in the groin and guided to the blocked area to open it. It is then kept open by inserting a stent.
Open surgery requires hospital admission and about a month of recovery. Endovascular procedures can be done on an outpatient basis and on patients who aren’t healthy enough for open surgery.
In this study, researchers analyzed the medical records of more than 16,000 patients in California, average age 71. They had either open bypass first (36%) or an endovascular procedure first (64%) for critical limb ischemia between 2005 and 2013.
Compared to those who had open surgery, patients who had an endovascular procedure had longer amputation-free survival. They were also less likely to require a major amputation below or above the knee; slightly more likely to require another procedure or surgery to restore blood flow; and no more likely to die, even though many had serious health problems such as kidney failure, heart failure and diabetes.
The study was published July 30 in the journal Circulation: Cardiovascular Quality and Outcomes.
“The data here suggest that in the grand scheme of things, an endovascular-first approach is at least not producing a worse result,” Lin said in a journal news release.
“Regardless, the type of therapy a patient will receive needs to be a decision that patients and their physicians arrive at together,” Lin said.
Critical limb ischemia is on the rise as the U.S. population ages. It’s estimated that the number of patients who undergo amputation due to the condition will more than double from 1.6 million to 3.6 million by the year 2050.
More information
Vascular Cures has more on critical limb ischemia.
SOURCE: Circulation: Cardiovascular Quality and Outcomes, news release, July 30, 2019
Amarin Q2 2019 Earnings Preview
Amarin (NASDAQ:AMRN) is scheduled to announce Q2 earnings results on Wednesday, July 31st, before market open.
The consensus EPS Estimate is -$0.01 (+90.0% Y/Y) and the consensus Revenue Estimate is $99.54M (+89.1% Y/Y).
Over the last 2 years, amrn has beaten EPS estimates 63% of the time and has beaten revenue estimates 75% of the time.
Over the last 3 months, EPS estimates have seen 4 upward revisions and 0 downward. Revenue estimates have seen 4 upward revisions and 0 downward.
FDA clears new streamlined diagnostic testing procedure for Lyme disease
The FDA expanded the marketing indications of a line of diagnostic tests to include checks for Lyme disease—the first cleared by the agency to use a new parallel testing method.
Developed by Zeus Scientific, the tests run two enzyme immunoassays either concurrently or sequentially instead of following the traditional two-step process to detect the disease, which includes a subsequent western blot procedure to detect target proteins and antibodies.
“With today’s action, clinicians have a new option to test for Lyme that is easier to interpret by a clinical laboratory due to the streamlined method of conducting the test,” the FDA’s Tim Stenzel, director of the agency’s in vitro diagnostics office, said in a statement.
“These tests may improve confidence in diagnosing a patient for a condition that requires the earliest possible treatment to ensure the best outcome for patients,” Stenzel said.
According to the latest published data from the Centers for Disease Control and Prevention (CDC), the incidence of Lyme disease has been on the rise. Over 42,700 cases were reported to the CDC in 2017, up 17% compared to the year before—mostly in the northeastern U.S. as well as in the states of Wisconsin and Minnesota.
“With nearly 30% of early Lyme disease cases being potentially missed by the current [standard two-tiered testing] algorithm due to the insensitivity of immunoblot tests, we are ecstatic to have successfully improved one of the most challenging aspects of diagnosis: detecting the disease early, before a robust immune response has been developed by some patients,” said Zeus’ Chief Commercial Officer Chris Howard, who described the new method as being able to detect up to 30% more cases.
The 510(k) clearances were granted to four Zeus Elisa systems that search for the specific antibodies linked to the bacterial infection that causes Lyme disease, forgoing the western blot test entirely and relying on enzyme immunoassays.
The fully automatable procedure developed by Zeus—which received the first FDA clearance for a Lyme disease screening test over 30 years ago—begins with its Elisa Borrelia VlsE1/pepC10 IgG/IgM test system, and is followed by an Elisa IgG, IgM or combination IgG/IgM test.
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