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

Amarin: Small Changes in Inflammatory Markers Between Icosapent Ethyl and Placebo

 Amarin Corporation plc (NASDAQ:AMRN) today announced an exploratory post hoc sub-analysis of REDUCE-IT serum samples that found statin-treated patients allocated to icosapent ethyl (IPE) had limited differences in certain lipid and inflammatory biomarkers compared with statin-treated patients allocated to mineral oil placebo. These findings are consistent with prior reported data and support previous analyses that demonstrated the majority of benefit from IPE was from achieved eicosapentaenoic acid (EPA) levels in REDUCE-IT. This sub-analysis was published online today in the journal Circulation.

In the landmark REDUCE-IT cardiovascular outcomes study, IPE achieved 25 percent relative risk reduction of major adverse cardiovascular events (MACE, 5-point composite endpoint: cardiovascular death, non-fatal heart attack, non-fatal stroke, coronary revascularization, or unstable angina). This also included relative risk reductions of 31 percent, 28 percent and 20 percent in heart attacks, strokes and cardiovascular deaths, respectively. As previously presented, the only marker that seems to have strong association with reductions in MACE from the REDUCE-IT study is serum EPA levels; these data were previously presented at the American College of Cardiology Scientific Sessions in 2020.i

“Regardless of biomarker pathway, effects were small on an absolute scale for both icosapent ethyl and for placebo, and changes in values were mostly below the limits of quantification in this exploratory sub-analysis,” said Deepak L. Bhatt, M.D., M.P.H., Executive Director of Interventional Cardiovascular Programs at Brigham and Women’s Hospital and Professor of Medicine at Harvard Medical School, principal investigator of REDUCE-IT and co-author of the biomarker sub-analysis. “While the mechanisms of action contributing to the reduction of cardiovascular events with icosapent ethyl are not completely understood and are likely multi-factorial, previous studies have clearly demonstrated the anti-inflammatory effects of EPA. The current analysis of REDUCE-IT finds a difference in inflammatory markers between icosapent ethyl and placebo, however, the absolute magnitude of these differences is too small to explain the substantial reduction in clinical events seen in the REDUCE-IT trial, which is most likely due to the approximate 400% increase in EPA levels.”

https://finance.yahoo.com/news/reduce-exploratory-post-hoc-biomarker-200500772.html

Immunome Starts Phase 1b Study of IMM-BCP-01 for COVID-19

 

• First study subject has been dosed in a single dose/dose escalation study of recently diagnosed COVID-19 patients

• Study will evaluate safety as the primary end point with pharmacokinetics (PK) and virology as secondary assessments

https://finance.yahoo.com/news/immunome-announces-initiation-phase-1b-120000878.html

Theseus started at Buy by Wainwright

 Target $22

https://finviz.com/quote.ashx?t=THRX&ty=c&ta=1&p=d