Target $52
Tuesday, August 3, 2021
NYC mandates COVID vaccine proof to enter indoor restaurants, venues, gyms
New Yorkers will need to show proof of COVID-19 vaccination to enter indoor businesses such as restaurants, entertainment venues and gyms, Mayor Bill de Blasio said Tuesday.
To gain entry to these establishments, New Yorkers will have to either present their paper COVID-19 vaccination card, the state-run Excelsior Pass or the city’s vaccine passport app.
The program, called “Key to NYC Pass,” will be rolled out beginning on Aug. 16 and enforcement by the city will start on Sept. 13, de Blasio said.
“This is crucial because we know it will encourage a lot more vaccinations,” de Blasio said. “If we’re going to stop the delta variant, the time is now.”
New York City will be the first big city in the country to implement such a requirement. The policy is similar to mandates issued in France and Italy.
“We have to do something different if we want to make an impact,” de Blasio said.
The restriction is de Blasio’s latest attempt to curb a startling spike in COVID-19 cases linked to the delta variant after the mayor refused to implement an indoor mask mandate for vaccinated and unvaccinated New Yorkers on Monday, despite Centers for Disease Control and Prevention recommendations to do so.
During a COVID briefing Monday morning, de Blasio said he “strongly recommends” fully vaccinated New Yorkers wear a mask indoors, especially around unvaccinated individuals, but stopped short of a mandate in public spaces.
The recommendation was based on science, data and strategy, according to de Blasio. A mandate was not issued because the city’s vaccination rate offers different opportunities, the mayor had said.
“Mask wearing is not a substitute for vaccinations,” de Blasio had added.
As of Tuesday morning, about 66% of adults in New York City were fully vaccinated, according to official data.
Last week, the mayor announced a vaccine or weekly testing mandate for all City of New York employees. On Monday, he went a step further and mandated all new city workers provide proof of COVID vaccination before their first day on the job. The city will not offer a weekly testing option for new employees, he said.
The city also began offering a $100 incentive to residents who get inoculated.
BioMarin gears up for two 'transformational' launches, Voxzogo and Roctavian: CEO
While BioMarin bested expectations with its second-quarter performance, the biotech is zeroed in on its two next-gen medicines. And no wonder: Those drugs, Voxogo and Roctavian, could completely transform the company, CEO J.J. Bienaimé said.
BioMarin’s Voxzogo to treat achondroplasia and its hemophilia A gene therapy Roctavian are up for potential approvals this year and next year, respectively—and analysts are keeping close tabs.
Voxzogo scored a European Medicines Agency recommendation in late June and is up for a potential approval in Europe in the coming weeks, Bienaime said on a conference call last week. BioMarin plans to launch in key markets within 4 to 8 weeks of approval. The drug is set for a November decision date with the FDA.
“Teams are currently in place and well-prepared for what could be BioMarin's largest brand yet,” chief commercial officer Jeff Ajer said on a conference call.
Voxzogo is intended for achondroplasia patients whose growth plates are still “open,” or those typically under 18. The disease affects bone growth and leads to dwarfism, and there are no approved treatments.
In a note to clients, Evercore ISI analyst Josh Schimmer said his team expects “good adoption” for the med on both sides of the Atlantic, noting that the drug has “blockbuster potential.” Still, competition could come in the form of Ascendis Pharma’s rival candidate, TransCon CNP, Schimmer noted.
For his part, Piper Sandler analyst Christopher Raymond predicts $600 million in sales for the medicine by 2025.
As for BioMarin's other key launch, Roctavian, that gene therapy’s debut is a year or more out—pending R&D and regulatory success.
Last summer, the FDA rejected the therapy, worried that the treatment's effects wouldn't last. The agency asked for longer-term data to review. Now, the company expects to have two-year follow-up numbers in time for a potential positive opinion from EMA’s Committee for Medicinal Products for Human Use in the second quarter of 2022. It plans to resubmit the drug to the FDA during the same timeframe.
That timeline would set up the medicine for potential EU and U.S. approvals in the third quarter and fourth quarter of 2022, respectively, Raymond wrote.
After speaking with specialists, Schimmer and his team believe the drug will have a “niche role” in the hemophilia A market. But with a $2 million price tag per dose, “even a small share of market can move the revenue needle meaningfully” for the company, Schimmer wrote.
The company expects the drugs will be "transformational to BioMarin upon potential approvals," CEO Bienaimé told analysts.
Overall in the second quarter, BioMarin posted a 17% increase in sales to $502 million thanks in part to the timing of orders in certain parts of the world. As a result, BioMarin execs cautioned about a reduction in volumes during the second half of the year.
BioMarin’s second-quarter haul beat analyst estimates of $448 million. With the outperformance, the company upped its revenue guidance for 2021 despite “continued COV-19 headwinds on patient starts,” Raymond wrote.
For all of 2021, BioMarin now expects $1.79 billion to $1.88 billion in global sales.
Intercept charts new path to NASH approval for obeticholic acid
A year after the FDA handed Intercept Pharmaceuticals a disappointing ruling for its potential nonalcoholic steatohepatitis (NASH) medicine, the company thinks it's found a detour—as long as its safety holds up.
After months of deliberations with the FDA over the first half of the year, Intercept now has enough feedback to begin re-reviewing obeticholic acid's late-stage clinical trial and sort through additional safety data for the drug's long-sought NASH approval, CEO Jerome Durso told analysts on a call Thursday.
Those discussions came after Intercept's stinging FDA rejection for an accelerated approval last June. Intercept's drug, already approved for primary biliary cholangitis (PBC) as Ocaliva, looked poised to become the first approved in the hotly contested NASH arena with a specific nod in patients with liver fibrosis, or scarring.
NASH is a progressive fatty liver disease that largely stems from obesity, rather than alcohol misuse. The fat buildup can cause inflammation and scarring and, in some cases, may lead to cirrhosis, liver failure and cancer.
There are no approved drugs in the NASH field, although it has sent many pharma players tumbling trying. Analysts believe the disease could generate as much as $35 billion in annual sales.
Notable failures in NASH include Pfizer, which has recently canned three prospects, alongside companies like Genfit and NGM Biopharmaceuticals. Many hopefuls have been plagued by side effects that have caused trial patients to drop out, such as itchiness.
After multiple pandemic delays last year, the FDA told Intercept in a letter last June that obeticholic acid’s “predicted benefit … remains uncertain” and doesn’t warrant the safety risks.
At the time, the New York-based company said the agency wanted longer-term data from its phase 3 trial to back one of its endpoints, a reduction in liver fibrosis. The drug has been hit with even more safety concerns since then. In May, the FDA restricted the Ocaliva's approval in PBC, saying it could lead to liver failure in some patients with advanced cirrhosis.
Now, Intercept is looking to get back on track, and it’s leaning on its new chief medical officer, M. Michelle Berrey, M.D., to lead the way. The company’s goal is to have a presubmission meeting with the FDA by the first half of 2022, Durso said.
“As they become available, we’ll be evaluating safety and efficacy findings internally to inform our decision-making about a potential resubmission,” Durso told analysts.
To get there, Intercept will increase the number of independent pathologists to evaluate each clinical trial biopsy from one to three after the FDA raised questions about using a single pathologist, Berrey said.
This method is intended to eliminate potential bias and guarantee consensus among the experts, who will compare the biopsies at baseline and after 18 months on the treatment. If two of the pathologists are split on their reading, the third will break the tie.
Because this change will affect the trial's conclusions, Intercept will have the panel of pathologists re-review all of the biopsies from its late-stage effort, known as Regenerate. This includes 500 biopsies that weren't part of the interim analysis, Berrey said.
Intercept has also racked up new obeticholic acid safety data since that interim analysis in late 2019, with patients reporting more than double the amount of time on the drug, Berrey said.
The re-review process, which will be used in another phase 3 trial called Reverse studying patients with cirrhosis, will take until the first half of 2022. Until then, the company will be “evaluating internally and making data-driven decisions” on its potential NASH bid.
To RBC Capital Markets, Intercept’s data boost and new trial design will “have much more power" to determine a benefit for obeticholic acid patients, according to a note sent on Thursday. However, it “still remains unclear” exactly how well the treatment has to perform to satisfy regulators, particularly when considering safety, RBC analyst Brian Abrahams wrote.
Clorox stock hit as demand for wipes, disinfectants wanes
Clorox shares are under pressure after the company's fourth-quarter sales plunged due to consumer demand shifting away from products like disinfectants and wipes.
The company reported a 9% sales decrease and a 68% decrease in diluted net earnings per share for the fourth quarter. Clorox reported total quarterly net sales of $1.8 billion, down from $1.98 billion a year ago, and net income of $97 million, or 78 cents per diluted share, compared to $310 million, or $2.41 per diluted share, in the year-ago quarter.
Clorox's Health and Wellness segment, which includes cleaning, professional products, minerals and supplements, posted a 17% sales decrease for the quarter.
"Sales decreased in two of three businesses, primarily reflecting lower shipments of cleaning and disinfecting products in both the retail and professional channels as consumer demand decelerated," the company said in its earnings release. "Segment sales results were also impacted by negative product mix from the normalization of supply."
In addition, the Health and Wellness segment saw a 104% pretax earnings decrease, which the company attributed to lower sales, gross margin contraction, higher advertising investments and a noncash charge of $28 million, or 17 cents, in connection with investments and related arrangements made with a professional products business unit supplier. Excluding this charge, Clorox's adjusted diluted net earnings per share came in at 95 cents, a 61% decrease versus the year-ago quarter, primarily due to lower sales, higher manufacturing and logistics costs and increased commodity costs which were partially offset by cost savings initiatives.
Clorox's Household segment saw fourth-quarter sales decrease 8% due to lower sales in its bags and wraps and grilling businesses due to "unfavorable price mix and decreased shipments from moderating consumer demand." Pretax earnings fell 31% due to lower sales and higher manufacturing and logistics costs. In its Lifestyle segment, quarterly sales dropped 3% due to unfavorable price mix and lower shipments in its water filtration and food businesses. Pretax earnings fell 22% due to higher manufacturing and logistics costs and lower sales.
Meanwhile, international sales in the quarter increased 5%, driven by higher shipments from the company's acquisition in a Saudi joint venture. Pretax earnings in the segment also increased 70% due to higher sales and gross margin expansion.
For the full 2021 fiscal year, Clorox delivered sales growth of 9% driven primarily by higher shipments due to COVID-19 across all reportable segments.
The company's total net sales for the year came in at $7.34 billion, compared to $6.72 billion for fiscal 2020. Net income for the year came in at $710 million, or $5.58 diluted EPS, compared to $939 million, or $7.36 diluted EPS, a year-ago, representing a 24% decrease in diluted EPS. Excluding noncash items, adjusted EPS was $7.25, representing a 2% decrease.Net cash provided by operations fell 17% to $1.3 billion in fiscal year 2021, compared to $1.5 billion in fiscal year 2020. Clorox delivered overall cost savings of $120 million for the fiscal year.
"Fiscal year 2021 was an extraordinary year for Clorox, with the pandemic putting us through the test of volatility, including rapid changes in consumer demand and inflationary pressure, which is reflected in our fourth quarter results," Clorox CEO Linda Rendle said.
Rendle noted Clorox has made progress on expanding its production capacity and has nearly doubled its e-commerce business over the past two years as a result of its investments and higher levels of consumer engagement.
Looking ahead at fiscal 2022, Clorox forecasts a sales decrease between 2% and 6% during the first half of the year. Sales are expected to normalize toward the lower end of the company's sales growth target of 3% to 5% in the second half of the year. The company expects consumer demand to be the largest headwind impacting sales in fiscal year 2022.
The company also expects diluted earnings per share between $5.05 to $5.35 and adjusted earnings per share between $5.40 to $5.70. Starting in the first quarter, adjusted EPS will exclude the company's long-term strategic investment in digital capabilities and productivity enhancements to provide "greater visibility into the underlying operating performance of the overall business."
Clorox will invest approximately $500 million over the next five years, including about $90 million in fiscal year 2022, toward digital capabilities and productivity enhancements, including to replace its enterprise resource planning system to "generate efficiencies and better position the company in supply chain, digital commerce, innovation and brand building over the long term."
https://www.foxbusiness.com/markets/clorox-stock-hit-demand-wipes-disinfectants-lower
Moderna Receives FDA Fast Track for Respiratory Syncytial Virus (RSV) Vaccine
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for mRNA-1345, its investigational single-dose mRNA vaccine against respiratory syncytial virus (RSV) in adults older than 60 years of age.
"We are pursuing an mRNA RSV vaccine to protect the most vulnerable populations – young children and older adults," said Stéphane Bancel, Chief Executive Officer of Moderna. "We are studying mRNA-1345 in these populations in an ongoing clinical trial and we look forward to sharing data when available. The Fast Track designation for older adults underscores the urgent need for a vaccine against RSV. With our investments in science and manufacturing, we have taken eleven infectious disease vaccines into human clinical trials. We have accelerated research and development of our infectious disease therapeutic area and we will continue to advance our mRNA vaccines into new areas of high unmet need."
Respiratory syncytial virus is a common respiratory virus that generally causes cold-like symptoms. In the United States and areas with similar climates, RSV infections occur primarily during fall, winter, and spring. Most people recover in a week or two, but RSV can be serious, especially for infants and older adults. RSV is the most common cause of bronchiolitis and pneumonia in children younger than one year of age in the United States and can result in pneumonia and respiratory distress in older adults. According to the U.S. Centers for Disease Control and Prevention, in the United States, RSV leads each year, on average, to approximately 58,000 hospitalizations among children younger than five years old, 177,000 hospitalizations among adults 65 years and older and 14,000 deaths among adults 65 years and older. There is no approved vaccine available today for RSV.
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