Sanofi's Phase 3 Trials of Multiple Sclerosis Drug Partially Paused by FDA

 Sanofi SA said Thursday that the Food and Drug Administration has paused some U.S.-based Phase 3 trials of drug tolebrutinib for treatment of multiple sclerosis and the muscle-weakness condition myasthenia gravis.

The U.S. regulator based its actions on a limited number of drug-induced liver injury cases, the French pharmaceutical company said.

Sanofi said new enrollments in the U.S. have been paused, and those who have taken part in the trial for fewer than 60 days will stop taking the drug.

Patients who have completed at least 60 days in the studies should continue treatment, Sanofi said.

The majority of affected patients were found to have pre-existing conditions that made them predisposed to drug-induced liver injuries, which were reversible after discontinuing the drug, the company said.

Study enrollment outside of the U.S. continues with revised study protocols and safety monitoring, Sanofi said.

The company said it is still confident in tolebrutinib's potential as an oral treatment for multiple sclerosis.

https://www.marketscreener.com/quote/stock/SANOFI-4698/news/Sanofi-s-Phase-3-Trials-of-Multiple-Sclerosis-Drug-Partially-Paused-by-FDA-40863385/

UHS: UPDATE ON 2Q OPERATING RESULTS, REVISES 2022 FULL YEAR EARNINGS GUIDANCE

 Universal Health Services, Inc. (NYSE: UHS) announced today that, due to a significant shortfall in operating results experienced during April and May of 2022, as compared to the comparable periods included in our previously provided annual operating results forecast, we are revising our forecast for the year ended December 31, 2022.

Based upon our consolidated results of operations for April and May of 2022, we estimate that our adjusted net income attributable to UHS will approximate $2.05 to $2.15 per diluted share for the three-month period ended June 30, 2022. The lower than expected earnings projected for the second quarter of 2022 was due primarily to lower than expected patient volumes, revenues and income generated at our acute care hospitals. During April and May of 2022, our acute care hospitals experienced a significant decline in COVID-related patients, as compared to the first quarter of 2022. The decrease in COVID-related patient volumes during the second quarter of 2022 was not offset by an equivalent increase in non-COVID-related patients resulting in significant shortfalls in revenues and earnings as compared to our original forecasts for that period. Although the decreased patient volumes at our acute care hospitals has relieved some of the staffing shortages and related cost escalations previously experienced at those facilities, recovery from the effects of the labor pressures has been occurring at a somewhat slower pace than expected.  During April and May of 2022, patient volumes, revenues and income generated at our behavioral health care facilities were also below our expectations. However, the shortfalls from internal expectations experienced within our behavioral health segment were relatively consistent with those experienced during the first quarter of 2022.

In the announcement of our financial results for the first quarter of 2022 (as released on April 25, 2022), we indicated that, given the continued uncertainties related to the COVID-19 pandemic, as well as the healthcare staffing shortage and its unfavorable impact on our labor costs and behavioral health patient volumes, we may make reductions to our 2022 full year operating results forecast at a future date if the unfavorable operating trends experienced during the first quarter of 2022 did not improve.  Based upon the operating trends and financial results experienced during April and May of 2022, as discussed above, along with our financial results for the first quarter of 2022, we are decreasing our guidance ranges for the year ended December 31, 2022 for each of the following: (i) net revenues; (ii) earnings before interest, taxes, depreciation & amortization, and the impacts of other income/expense and net income attributable to noncontrolling interests ("Adjusted EBITDA, net of NCI"), and; (iii) adjusted net income attributable to UHS per diluted share ("Adjusted EPS-diluted").

https://finance.yahoo.com/news/universal-health-services-inc-provides-113000537.html

Nurix Application Cleared for More Indications

 NX-1607 is being evaluated in multiple immuno-oncology indications, including a range of solid tumor types

Phase 1 clinical trial now enrolling patients in U.K. with plans to expand to clinical sites in the U.S.

https://finance.yahoo.com/news/nurix-therapeutics-announces-clearance-investigational-120000588.html

Vaxart, hVIVO to Develop World’s First Human Omicron Challenge Model

 Model will be used in Vaxart’s Phase II Omicron Challenge Trial

Open Orphan subsidiary hVIVO to manufacture challenge virus and conduct characterization study

Vaxart, Inc. (Nasdaq: VXRT) today announced an agreement with hVIVO Services Limited, a subsidiary of Open Orphan plc (AIM: ORPH) under which hVIVO will conduct a characterization study and, if successful, develop a human challenge model based on the Omicron variant of SARS-CoV-2 with the intent to conduct a subsequent Phase II Human Challenge Trial (HCT) of Vaxart’s oral COVID-19 vaccine pill candidate.

Vaxart is developing an oral COVID-19 vaccine pill and is the first company to progress to a Phase II clinical trial with an oral candidate. Vaxart is now also the first company to announce the intent to test a vaccine candidate through a COVID-19 human challenge study using the now prevalent Omicron variant, rather than the original Wuhan strain.

hVIVO is a specialist contract research organization (CRO) and global leader in testing infectious and respiratory disease products using HCTs.

https://finance.yahoo.com/news/vaxart-announces-agreement-hvivo-develop-120000154.html

Endo misses $38 million interest payment amid bankruptcy talks

 Drugmaker Endo International said on Thursday it has missed a $38 million interest payment, amid discussions with a group of unsecured bondholders that have urged the company to avoid filing for bankruptcy.

Endo, which has been weighed down by litigation over the opioid epidemic in the United States, has discussed the possibility of filing for bankruptcy protection in several recent public filings.

Other pharmaceutical companies that have filed for Chapter 11 to address opioid claims include Purdue Pharma, the maker of OxyContin, and Mallinckrodt PLC, a generic opioid manufacturer that recently emerged from bankruptcy.

Dublin, Ireland-based Endo said in a Thursday filing with the U.S. Securities and Exchange Commission that the missed loan payment will not immediately impact daily operations because the company has $1.4 billion in liquidity. The missed payment triggers a 30 day window before an official default on its loan.

Endo did not immediately respond to a request for comment.

A group of unsecured bondholders has recently formed to lobby the company to stay out of bankruptcy. The group said on Monday it has proposed alternate restructuring options, including a cash tender offer or a debt-for-debt exchange, that would reduce Endo's interest expenses without the disruption of a Chapter 11 filing.

Endo has reported $660 million of total funded debt maturities through the end of March 2027.

State and local governments have filed more than 3,000 lawsuits against drugmakers, distributors and pharmacies alleging they helped fuel the deadly U.S. opioid epidemic. Opioids were involved in more than 80,000 overdose deaths in 2021, according to statistics produced by the White House office of drug control policy.

Endo has settled opioid lawsuits brought by several states in recent months, agreeing to pay $65 million to Florida, $26 million to West Virginia, and $25 million to Alabama.

https://finance.yahoo.com/news/drugmaker-endo-misses-38-million-160020605.html

Walgreens keeps forecast as waning COVID vaccine demand weighs

 Walgreens Boots Alliance Inc on Thursday maintained its full-year earnings forecast due to declining COVID vaccinations, even as the drugstore retailer beat quarterly estimates on the back of strength in its UK-based Boots business.

Shares of the second-biggest U.S. drugstore retailer by store count fell 4% to $39.14 amid broader market weakness.

The company said it still expects low single-digit growth in its adjusted earnings for the year and warned on costs related to investments in labor and in its new consumer health business.

"Given the uncertainty of the COVID environment, we are not surprised to see that management did not raise FY22 guidance despite the beat," Evercore ISI analyst Elizabeth Anderson said.

Walgreens has benefited from gains from administering COVID-19 vaccines to cushion the impact of losses from low prescription volumes and over-the-counter sales of health and wellness products in recent quarters due to the pandemic.

The company had put its Boots business up for sale in January as it renewed its focus on domestic healthcare.

But on Tuesday, Walgreens said it would scrap the plan to sell the business as no buyer came up with an adequate offer for the 173-year old chain.

Walgreens will continue to look at alternatives for strategic divestments, Chief Executive Officer Rosalind Brewer said on Thursday.

Last year, the company launched Walgreens Health, a unit that provides pharmacy and primary care services in stores, at home or a doctor's office and via mobile app.

The unit brought in sales of $596 million in the quarter.

"We will remain laser focused in building out our Walgreens Health business, which is expected to be a significant percentage of our earnings growth," Brewer said.

The company reported an adjusted profit of 96 cents per share in the third quarter, above analysts' estimate of 92 cents, as per Refinitiv.

https://finance.yahoo.com/news/walgreens-profit-plunges-opioid-settlement-112511778.html

Novartis leans toward spinoff of generic drugs unit

 Novartis prefers a spinoff of its generic drug unit over a potential sale to private equity firms, Bloomberg News reported on Thursday, citing people familiar with the matter.

A challenging macro environment for leveraged buyouts has made the sale route difficult and Novartis sees a separate listing of the Sandoz business as more likely, the report said. (https://bloom.bg/3yt7Iu2)

The Swiss pharmaceutical group in October said it had started a strategic review of the Sandoz unit as price pressures mounted in the off-patent drug sector.

On Thursday, Novartis reiterated its previous statement that "the strategic review is ongoing, all options remain on the table and the company plans to provide an update before the end of the year". 

https://finance.yahoo.com/news/1-novartis-leans-toward-spinoff-163331447.html