Regeneron stock rose on Thursday after the biotech company reported adjusted income of $25.80 per share on $5.14 billion in second-quarter sales.
On average, analysts polled by FactSet expectedRegeneron Pharmaceuticals(REGN) to earn $17.94 per share on $3.96 billion in sales.
In the year-earlier period, Regeneron earnings were $7.16 per share on $1.95 billion in sales.
For the year, Regeneron gave some positive forecasts, but no specifics on earnings or sales. Analysts called for adjusted profit of $49.46 a share and $12.24 billion in sales.
—ORLADEYO®(berotralstat) net revenue of $28.5 million—
“The ORLADEYO launch is off to an excellent start because HAE patients want a safe and effective oral medicine to control their attacks and reduce their burden of therapy, and switching to ORLADEYO meets these needs for them,” said Charlie Gayer, chief commercial officer of BioCryst.
On June 15, 2021, the company announced the designs for REDEEM-1 and REDEEM-2, two upcoming pivotal trials with its oral Factor D inhibitor, BCX9930, in patients with paroxysmal nocturnal hemoglobinuria (PNH). REDEEM-1 is a randomized, open-label, active, comparator-controlled comparison of the efficacy and safety of BCX9930 (500 mg bid) monotherapy in approximately 81 PNH patients with an inadequate response to a C5 inhibitor. REDEEM-2 is a randomized, placebo-controlled trial to evaluate the efficacy and safety of BCX9930 (500 mg bid) as monotherapy versus placebo in approximately 57 PNH patients not currently receiving complement inhibitor therapy. The primary endpoint for both trials is the change from baseline in hemoglobin, assessed at weeks 12 to 24 in REDEEM-1 and at week 12 in REDEEM-2. Trial site start-up activities are now underway at sites around the world and both pivotal trials are expected to begin enrolling patients in the second half of 2021.
In the second half of 2021, the company also plans to initiate a proof of concept trial of oral BCX9930 (500 mg bid) in renal complement-mediated diseases. The trial will be a basket study including cohorts of patients with C3 glomerulopathy, IgA nephropathy and primary membranous nephropathy.
Conference Call and Webcast
BioCryst management will host a conference call and webcast at 8:30 a.m. ET today to discuss the financial results and provide a corporate update. The live call may be accessed by dialing 877-303-8027 for domestic callers and 760-536-5165 for international callers and using conference ID # 9886913. A live webcast of the call and any slides will be available online at the investors section of the company website at www.biocryst.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID # 9886913.
U.S. Food and Drug Administration assigned a Prescription Drug User Fee Act action date of December 4, 2021 –
– The supplemental New Drug Application is based on the phase 3 COSMIC-311 pivotal trial, which demonstrated significant improvement in progression-free survival with CABOMETYX versus placebo
New data on AB-729, Arbutus’ proprietary subcutaneously delivered RNAi agent, highlighted in four abstracts at the EASL International Liver Congress™; all AB-729 abstracts selected for best of ILC™
Announced two additional proof-of-concept clinical collaborations to evaluate AB-729 in combination with agents from Vaccitech plc and Antios Therapeutics, Inc.
Announced U.S. Food and Drug Administration (FDA) authorization to proceed with an Investigational New Drug (IND) application in a Phase 2a clinical trial to investigate the safety and anti-viral activity of AB-729 in combination with ongoing nucleos(t)ide analog (NA) therapy and short courses of Peg-IFNα-2a in subjects with chronic HBV
Presentation at EASL of pre-clinical data for AB-836, Arbutus’ proprietary oral capsid inhibitor, suggests the potential for increased efficacy and an enhanced resistance profile relative to previous generation capsid inhibitors
Conference Call and Webcast Scheduled Today at 8:45 AM ET
Arbutus will hold a conference call and webcast today, Thursday, August 5, 2021 at 8:45 AM Eastern Time to provide a corporate update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 2719108.
An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 2719108.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-716 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, met its primary endpoint of recurrence-free survival (RFS) for the adjuvant treatment of patients with surgically resected high-risk stage II melanoma. At an interim analysis, treatment with KEYTRUDA as a single agent showed a statistically significant and clinically meaningful improvement in RFS compared with placebo as adjuvant therapy for these patients. No new safety signals were observed. These results will be presented at an upcoming medical meeting. Based on these data, the U.S. Food and Drug Administration (FDA) has accepted a new supplemental Biologics License Application (sBLA) for KEYTRUDA for the adjuvant treatment of adult and pediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection. The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA), or target action, date of December 4, 2021.
“KEYNOTE-716 is the first Phase 3 study to evaluate adjuvant therapy solely for stage IIB and IIC melanoma – an area with high unmet need,” said Dr. Jason Luke, director, Cancer Immunotherapeutics Center at UPMC Hillman Cancer Center. “By moving immunotherapy with KEYTRUDA to earlier stages of melanoma, we have the opportunity to reduce the risk of recurrence for high-risk stage II patients compared to observation alone following complete resection.”
The Lambda variant of COVID-19 may be more resistant to vaccines and is highly infectious, researchers at Japan's University of Tokyo have warned in a new scientific paper published on July 28. The study is yet to be peer reviewed.
Like the Delta variant, Lambda is highly transmissible but Japanese researchers believe that three mutations in the variant's spike proteins make it more resistant to antibodies induced by vaccination.
Lambda, which is also known as the C.37 variant, is responsible for 1,037 cases of COVID-19 in the U.S., according to data from the GISAID Initiative, which promotes the rapid sharing of information about influenza and coronaviruses.
The variant was first identified in Peru in August, 2020, where it has now become the dominant strain of the virus, and it has been reported in 29 countries including the U.S.
Researchers at the University of Tokyo published their paper at bioRxiv, a "preprint server for biology," last Wednesday ahead of the paper's peer review.
In lab experiments, they identified three mutations in the Lambda variant's spike protein—called RSYLTPGD246-253N, 260 L452Q and F490S—that make it more resistant to neutralization by antibodies that are induced through vaccination. This makes the strain more resistant to vaccines than the original COVID-19 strain first identified in Wuhan, China.
The research team also identified two further mutations—T76I and L452Q—that make the Lambda variant highly infectious. They also warn that the World Health Organization's classification of Lambda as a Variant of Interest (VOI) rather than a Variant of Concern (VOC) might lead some people to take the threat less seriously
The researchers write: "Because the Lambda variant is a VOI, it might be considered that this variant is not an ongoing threat compared to the pandemic VOCs."
"However, because the Lambda variant is relatively resistant to the vaccine-induced antisera, it might be possible that this variant is feasible to cause breakthrough infection," the paper says.
"Vaccine-induced antisera" refers to the antibodies that arise from vaccination.
The graphic below, provided by Statista, shows the seven-day rolling average of newly confirmed COVID cases per million people in the U.S. and E.U.
A graph shows the seven-day rolling average of newly confirmed COVID-19 cases per million in the U.S. and European Union (E.U.).STATISTA
Senior researcher Kei Sato told Reuters: "Lambda can be a potential threat to the human society," echoing the language of the paper he co-authored, which called Lambda and three other VOIs "potential threats" to society. Those three other variants are Eta, Iota and Kappa.
Dr. Pablo Tsukayama, a molecular microbiologist at Cayetano Heredia University in Lima, Peru, and one of the people who helped document Lambda, told Al Jazeera on July 27: "When we found it, it did not attract much attention."
"But we continued processing samples, and by March, it was in 50 percent of the samples in Lima. By April, it was in 80 percent of the samples in Peru," he said.
"That jump from one to 50 percent is an early indicator of a more transmissible variant," Tsukayama added.
SARS-CoV-2 Lambda, a new variant of interest, is now spreading in some South American countries; however, its virological features and evolutionary trait remain unknown. Here we reveal that the spike protein of the Lambda variant is more infectious and it is attributed to the T76I and L452Q mutations. The RSYLTPGD246-253N mutation, a unique 7-amino-acid deletion mutation in the N-terminal domain of the Lambda spike protein, is responsible for evasion from neutralizing antibodies. Since the Lambda variant has dominantly spread according to the increasing frequency of the isolates harboring the RSYLTPGD246-253N mutation, our data suggest that the insertion of the RSYLTPGD246-253N mutation is closely associated with the massive infection spread of the Lambda variant in South America.
Highlights
Lambda S is highly infectious and T76I and L452Q are responsible for this property
Lambda S is more susceptible to an infection-enhancing antibody
RSYLTPGD246-253N, L452Q and F490S confer resistance to antiviral immunity
