BioVie Shares Rise After FDA Approves Phase 2 Study

 BioVie Inc. shares were up 24% to $6.75 after the company said the U.S. Food and Drug Administration has authorized the company to initiate a Phase 2 study assessing NE3107's potential pro-motoric impact in Parkinson's disease patients.

The company said the NM201 study is a double-blind, placebo-controlled, safety, tolerability, and pharmacokinetics study in Parkinson's disease participants treated with carbidopa/levodopa and NE3107 involving 40 patients.

The company has an active Phase 3 trial studying NE3107 in AD that is expected to have topline results by the end of 2022.

The company expects to initiate patient enrollment for the NM201 study before the end of 2021. Topline results are expected by the middle of 2022.

https://www.marketscreener.com/quote/stock/BIOVIE-INC-30558504/news/BioVie-Shares-Rise-24-After-FDA-Approves-Phase-2-Study-36788933/

Evotec SE launches public offering of American Depositary Shares

 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) announced today that it has commenced a public offering in the United States of up to 22,000,000 American Depositary Shares ("ADSs") representing 11,000,000 of its ordinary shares pursuant to a registration statement on Form F-1, as amended, filed with the U.S. Securities and Exchange Commission ("SEC"). Evotec expects to grant the underwriters a 30-day option to purchase up to an additional 3,300,000 ADSs. The sale of the ADSs and the issuance of the underlying ordinary shares will be made under exclusion of shareholders pre-emptive rights based on Evotec's existing authorized capital. Evotec has applied to list its ADSs on the Nasdaq Global Select Market under the symbol "EVO". The final price of the offered ADSs will be determined largely on the basis of the closing price of Evotec's shares on the Frankfurt Stock Exchange on the pricing date (expected for the week of 1 November, 2021) translated into U.S. dollars at the then prevailing exchange rate and using an ADS to share ratio of 2 to 1. BofA Securities and Morgan Stanley are acting as lead joint book-running managers for the offering. Citigroup, Jefferies, Cowen and RBC Capital Markets are acting as joint book-running managers for the offering. Evotec intends to use the net proceeds from the offering to expand its biologics manufacturing capacity in the United States, build additional J.POD capacity in Toulouse, France, expand its precision medicine platform, accelerate pipeline activities, expand its portfolio of EVOequity investments and the remainder for general corporate purposes. 

https://www.marketscreener.com/quote/stock/EVOTEC-SE-436047/news/PRESS-RELEASE-Evotec-SE-Announces-launch-of-public-offering-of-American-Depositary-Shares-36788269/

Cortexyme's Alzheimer's treatment fails to meet main goals in study

 Cortexyme Inc said on Tuesday its experimental oral pill failed to meet the main goals of improving cognitive and functional abilities in patients with mild-to-moderate Alzheimer's disease in a study.

The drug, atuzaginstat, is designed to target the P. gingivalis bacteria found in the brain of patients suffering from the memory robbing disease.

The mid-to-late stage study tested 643 patients and did not meet statistical significance in its goals, according to two scales measuring disease progression.

In a group of patients with the bacteria detected in their saliva, the drug showed 57% slowing of cognitive decline on a commonly used test but failed to show significant benefits on another scale, which is generally filled out by a patient's caregiver.

However, Cortexyme said the pill led to a reduction in the bacteria, which was associated with some improved outcomes at the end of the treatment period under the study. It plans to report the data to regulators to determine the path forward for the drug.

Alzheimer's treatments have come into focus since the U.S. health regulator approved Biogen's controversial drug Aduhelm in June. The drug is used to treat early stages of the disease.

"There's nothing that is approved for treating the really sick patients with mild-to-moderate disease, which is where we've shown an effect," said Cortexyme's chief medical officer Michael Detke. 

https://www.marketscreener.com/quote/stock/CORTEXYME-INC-58071836/news/Cortexyme-s-Alzheimer-s-treatment-fails-to-meet-main-goals-in-study-36789484/

Moderna chairman says booster could be yearly

 Moderna Chairman Noubar Afeyan indicated on Tuesday that his company's COVID-19 shot could require yearly boosters. 

"It may well need an annual booster, potentially varying on a year-to-year or every few years basis as the virus varies," Afeyan said on the Fox Business Network during an interview on "Mornings with Maria."

Afeyan added that the impact and death toll of the pandemic have been unlike anything experts have seen in the past century. Because of this, uncertainty surrounding what the virus may look like in the future is difficult to surmount.

"We just don't know how this virus is going to travel from being a pandemic all the way to potentially an endemic virus we have to get used to living with," he said. 

"I think if we end up there, there will be a continuous need for boosting," he added.

Afeyan also said that the "initial vaccination will do a very good job of protecting us if we get infected."

Last week, the Centers for Disease Control and Prevention (CDC) approved mixing and matching boosters, meaning people who are eligible for additional shots can decide which brand of vaccine to get as all three Food and Drug Administration (FDA) authorized vaccines are considered “extraordinarily safe” and “effective.”

CDC Director Rochelle Walensky said that her agency would "not articulate a preference" for which brand's booster shot people should get.

Recent data from the CDC also indicated that vaccinated Americans are currently getting their booster shots at a faster pace than those who are getting their first vaccine dose.

As of last week, roughly 340,000 people were getting booster shots each day, compared to a daily average of 157,605 people who received their first vaccine shot during the same time period.

https://thehill.com/policy/healthcare/578448-moderna-chairman-says-booster-could-be-yearly

Cleveland Clinic testing Anixa breast cancer vaccine

 Researchers at Cleveland Clinic have opened a study for a vaccine seeking to prevent triple-negative breast cancer, which is regarded as the strongest and most deadly form of the disease.

The first phase of the trial will determine how strong of a vaccine dose patients with early-stage triple-negative breast cancer can tolerate, according to a release from the clinic.

“We are hopeful that this research will lead to more advanced trials to determine the effectiveness of the vaccine against this highly aggressive type of breast cancer,” the Cleveland Clinic's G. Thomas Budd, who serves as the study's principal investigator, said in the statement. 

Triple-negative breast cancer does not usually respond to hormonal or targeted therapies. It accounts for only about 12 to 15 percent of all breast cancers, but causes a disproportionately high percentage of breast cancer-related deaths, the clinic's release added.

“This vaccine approach represents a potential new way to control breast cancer,” Vincent Tuohy, the primary inventor of the vaccine, said in the statement. 

The clinic's hope is that the vaccine, developed with Anixa Biosciences, would eventually be administered to healthy women to prevent the severe form of cancer from developing entirely, Budd said. 

The study is funded by the Department of Defense and open to non-clinic patients. Its participants will include 18 to 24 patients who have finished treatment for early-stage triple-negative breast cancer in the last three years and are tumor-free but considered high-risk for recurrence, the clinic added. 

The study is estimated to be completed in September of next year.

https://thehill.com/policy/healthcare/578540-cleveland-clinic-testing-breast-cancer-vaccine

UHS acute care volume, revenue rose, COVID-driven labor shortage shuttered behavioral

 Universal Health Services (UHS) capped off its third quarter with above-expected performance across its acute care segment that was "largely offset" by its hamstrung behavioral care business.

Overall, the for-profit system brought in $218.4 million in net income, or $2.60 per diluted share, during the third quarter of 2021, a dip below the $241.3 million it reported during the same time last year.

Net revenues improved 8.4% year over year, growing from $2.91 billion to $3.16 billion during the quarter.

The report places UHS’ year-to-date net income at $752.5 million, up from the $635.2 million it reported for the same nine-month period of 2020. Year-to-date net revenues during the same intervals increased 10.6% from $8.47 billion to $9.37 billion.

During the past quarter, UHS saw a 12.4% and 10.9% year-over-year rise in adjusted patient admissions and adjusted patient days, respectively—increases partially fueled by COVID-19 patients returning to the system's hospitals.

However, UHS said that it was also able to haul in more revenue from these and other acute care patients than it had in previous waves.

Excluding the impact of government stimulus received during 2020, net revenue per adjusted admission and net revenue per adjusted patient day increased 1.3% and 2.7% year over year, respectively. Quarterly net revenues generated from acute care services increased 13.4% during the same periods, again excluding 2020's governmental stimulus.

"This COVID surge resulted in increased revenues due to the higher acuity and incremental government reimbursement associated with COVID patients," Filton said. "Unlike previous surges, however, non-COVID volumes including emergency room visits and elective and/or scheduled procedures were not crowded out and in fact were running at or near pre-pandemic levels. As a result, acute care revenues were higher and managed to offset the premium labor costs and increased supply expense associated with the COVID patients.”

UHS’ behavioral health care services saw a 2.7% and 2.1% year-over-year decline in adjusted admissions and adjusted patient days as the most recent COVID-19 surge presented "significant challenges" for the segment, Filton said.

"Volumes were pressured throughout the quarter due to the capping of bed capacity, in some cases to properly isolate COVID patients and in other cases because of a shortage of appropriate patient care personnel," he said. "Generally behavioral patient days during this quarter ran 4% to 6% below comparable pre-pandemic levels."

Filton characterized the workforce shortage as the primary factor limiting its business. But whereas acute care hospitals are able to raise wages to secure contract nurses and maintain services, UHS had trouble finding anyone to fill in for the lower-paying behavioral nursing positions, he said.

These labor pressures have so far been "very much tied" to COVID-19's resurgence, with UHS seeing greater vacancies—and therefore reduced services—in markets that were hardest hit during the delta wave, Filton said. As vaccination rates increase and new cases taper off, he said he was optimistic the system will see relief on the labor front. 

"We remain pretty bullish about the idea that if COVID volumes overall recede, as they have started to do, I think, in the last four, five, six weeks, we’ll start to see some easing of those labor pressures," he said. "Maybe not immediately, because I do think there is a time lag associated with a lot of these commitments of traveling and temporary nurses, and I think we saw that in Q1 where even as COVID volumes declined as early as January 2021 it took a while for us to enjoy the benefits of that.”

In the meantime, UHS has continued to combat the high levels of workforce churn with retention initiatives and a "record" number of new hires, Filton said. 

King of Prussia, Pennsylvania-based UHS owns and operates 27 acute care hospitals, 40 outpatient facilities, 333 behavioral health facilities, an insurance offering and other related services. It employs approximately 89,000 people.

The system reported $11.6 billion in full-year 2020 revenues, which was up 1.6% from the previous year’s $11.4 billion despite the pandemic.

UHS' latest earnings fell below the street’s consensus estimate of $2.76 earnings per share, whereas revenue exceeded analysts’ expectations of $3.11 billion for the quarter.

As of Sept. 30, the system said it had roughly $190 million of cash and cash equivalents.

The Pennsylvania-based system’s performance lags that recently reported by fellow for-profit systems Tenet Health and HCA Healthcare. Both acknowledged the return of COVID-19 cases and patient volumes but improved their net incomes compared to the third quarter of 2020.

https://www.fiercehealthcare.com/hospitals/uhs-q3-net-income-dips-nearly-10-year-over-year-to-218-4m

CDC Extends Cruise Line Health Rules Until Mid-January

 Federal health officials on Monday extended for nearly three more months its rules that cruise ships must follow to sail during the pandemic.

The U.S. Centers for Disease Control and Prevention said the extension makes only “minor modifications” to rules already in effect. The agency said that after Jan. 15, it plans to move to a voluntary program for cruise companies to detect and control the spread of COVID-19 on their ships.

The current regulations, called a conditional sailing order, were scheduled to expire on Nov. 1.

The CDC imposed the first no-sail order on cruise lines in March 2020, after most companies sailing in U.S. waters had agreed to suspend voyages. The CDC issue technical guidelines for the industry five months later, and began approving trial sailings this spring.

Cruises have since sailed from Florida and other parts of the country. Most lines require adult passengers to show proof of vaccination against COVID-19.

The CDC noted on Twitter that since it first issued restrictions on sailing, cruise lines have developed and implemented health and safety protocols to manage COVID-19 and have resumed cruising.

A cruise industry trade group pledged to continue working with CDC on health measures on board ships. It cited the CDC announcement as evidence that lines have made a successful — if only partial — return since the pandemic shut down the industry worldwide.

Laziza Lambert, a spokeswoman for the Cruise Lines International Association, said in a statement that, “Cruising has successfully resumed in the United States” with measures that have limited the risk of COVID-19 for passengers and crew members. She said the CDC announcement shows that the health agency and the Biden administration “recognize the cruise industry’s successful resumption of operations.”

Industry officials have complained that the government took a much tougher stance against cruising — shutting it down entirely last year — than it took toward airlines and other parts of the travel industry.

https://www.usnews.com/news/business/articles/2021-10-25/cdc-extends-cruise-line-health-rules-until-mid-january