Bayer is among the most-mentioned companies across news items over the past 12 hours, according to Factiva data, after it lifted its guidance for the full year and delivered a sales beat in the second quarter, despite posting a net loss. The German pharmaceutical-and-agricultural company said that sales rose to EUR12.82 billion for the quarter from EUR10.85 billion the year prior, beating consensus expectations which saw them at EUR12.29 billion. The company's quarterly net loss narrowed to EUR298 million from EUR2.34 billion the year prior, but said that earnings before interest and taxes were affected by net special charges of EUR2.11 billion including impairment losses related to its agricultural division.
Thursday, August 4, 2022
BioCryst Pharma Shares Rise 21% After FDA Drops Partial Hold on BCX9930
BioCryst Pharmaceuticals Inc. shares rose 21% to $13.49 after the company said that the U.S. Food and Drug Administration lifted its partial clinical hold on the BCX9930 program.
The company will resume enrollment in global clinical trials under revised protocols at a reduced dose of 400 mg twice daily of BCX9930.
This includes trials in patients with paroxysmal nocturnal hemoglobinuria and with C3 glomerulopathy, immunoglobulin A nephropathy and primary membranous nephropathy.
Clinical evidence and recent laboratory studies have informed the company's hypothesis that crystals form in the kidneys of some patients. The company believes that lowering the dose to 400 mg and ensuring adequate hydration will dilute the concentration of drug in the urine below the threshold where crystals can form.
On April 8, BioCryst said the company had voluntarily paused enrollment in BCX9930 clinical trials while it investigated observed elevations in serum creatinine seen in some patients at the 500 mg twice-daily dose. The FDA subsequently placed the program on a partial clinical hold. Patients already enrolled in the trials and demonstrating clinical benefit were able to continue on therapy.
UK's Mediclinic to be bought by consortium in $4.49 billion deal
South Africa's Remgro said on Thursday it will buy British hospital chain operator Mediclinic International in a consortium with MSC Mediterranean Shipping for an equity value of about 3.7 billion pounds ($4.49 billion).
African monkeypox cases not concentrated among gay men: WHO
Monkeypox outbreaks in Africa are not concentrated among gay men, unlike in other parts of the world, experts from the World Health Organization (WHO) and the Africa CDC said on Thursday.
Outbreaks of the viral disease have been reported from 78 countries, mostly in Europe, and 98% of cases outside the countries in Africa where it is endemic have been reported in men who have sex with men, the WHO says.
But in Africa, where repeated outbreaks have been documented since the 1970s, the pattern of transmission is different, the experts said.
"Currently 60% of the cases that we have - the 350 - 60% are men, 40% are women," said epidemiologist Dr Otim Patrick Ramadan, who was answering questions on monkeypox at a media briefing organised by the WHO's regional office in Africa, and who was referring to the continent's number of current cases.
He said that more than 80% of cases in Africa were in countries where transmission had happened before, and that typically people were initially exposed to the virus through contact with animals carrying it, before passing it to household members.
He added that women typically took care of sick people at home, which was one of the factors in the spread among women.
Dr Ahmed Ogwell Ouma, acting director of the Africa Centres for Disease Control and Prevention (CDC), told a separate media briefing there was no evidence that transmission among gay men was a specific factor in African outbreaks.
"We've been collecting data on monkeypox since 1970 and that particular indicator, men having sex with men, has never come up as a significant issue here in Africa," he said.
More than 18,000 cases of monkeypox have been reported worldwide in what the WHO has declared to be a global health emergency.
Monkeypox spreads via close contact and tends to cause flu-like symptoms and pus-filled skin lesions.
Public health agencies have stressed that although in many countries the outbreaks are concentrated among men who have sex with men, anyone can contract the virus through prolonged close contact or from particles on items such as bedding or towels.
Amgen to buy ChemoCentryx for $3.7 billion
Amgen Inc said on Thursday it would buy ChemoCentryx Inc for $3.7 billion to gain access to the company's anti-inflammation drug.
Amgen will pay $52 per share in cash, which represents a premium of nearly 116% to ChemoCentryx's closing price on Wednesday.
ChemoCentryx makes Tavneos, a drug approved to treat patients with a rare form of blood vessel inflammation. The therapy brought in sales of $5.4 million in the first full quarter since its launch.
The company has three drugs in early-stage trials to treat inflammatory diseases and is also developing a cancer drug.
AstraZeneca, Merck: LYNPARZA OKed in EU as Breast Cancer Adjuvant
AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.
This approval by the EC was based on results from the Phase 3 OlympiA trial and follows the recommendation for approval of LYNPARZA in this setting by the European Medicine Agency’s Committee for Medicinal Products for Human Use. The results were published in The New England Journal of Medicine in June 2021. In OlympiA, LYNPARZA demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS), reducing the risk of invasive breast cancer recurrences, new cancers, or death by 42% (HR=0.58; [99.5% CI, 0.41-0.82]; p<0.0001) versus placebo.
Aurinia Financial and Operational Results
Net revenue increased to $28.2 million for Q2 2022; Maintains net revenue guidance range of $115-$135 million from sales of LUPKYNIS® (voclosporin) for 2022
Continued increases in LUPKYNIS Patients on Treatment; Steady Conversion Rates and Payor Coverage
EMA review of LUPKYNIS remains on track with decision expected by the end of Q3 2022
$391.7 million of cash and investments as of June 30, 2022
Conference call to be hosted today at 8:30 a.m. ET
Aurinia will host a conference call and webcast to discuss the quarter ended June 30, 2022 financial results today, Thursday, August 4, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. In order to participate in the conference call, please dial +1 (877) 407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.
https://finance.yahoo.com/news/aurinia-reports-second-quarter-six-100000525.html
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