EU drug regulator OKs Pfizer COVID pill for high-risk patients

 The European Union's drug regulator on Thursday gave the green light to Pfizer Inc's antiviral COVID-19 pill for treating adults at risk of severe illness, as the region scrambles to boost its arsenal to fight the Omicron variant.

The endorsement by the European Medicines Agency (EMA) for a conditional approval, if followed as usual by the European Commission, allows EU member states to deploy the drug after the regulator gave guidance for its emergency use late last year.

Italy, Germany and Belgium are among a handful of EU countries that have bought the drug, branded as Paxlovid.

The United States in December authorised Paxlovid and Merck's similar drug molnupiravir.

EU health commissioner Stella Kyriakides said the bloc was now making good progress on lining up treatments, which she described as a second line of defence after vaccines.

"Paxlovid is the first oral antiviral for home use in our portfolio, and has the potential to make a real difference for persons at high risk of progression to severe COVID," she said.

Merck's pill is also under review in the EU, but is taking longer to approve because the company revised its trial data in November, saying the drug was significantly less effective than previously thought.

These oral drugs, especially Pfizer's, are seen as promising new treatment options that can be taken at home at the onset of COVID-19 symptoms to help prevent hospitalizations and deaths.

"We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of Paxlovid globally," Pfizer Chief Executive Albert Bourla said in a statement.

Paxlovid, a two-drug antiviral regimen, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to data from the company's clinical trial. Recent lab data suggests the drug retained its effectiveness against the Omicron variant as well.

https://finance.yahoo.com/news/1-eu-drug-regulator-green-141454833.html

Alkermes upped to Overweight from Hold by Cantor

 Target $32

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

Preclinical Data Show Potential for Genprex ONCOPREX in Treating Colon Cancer

 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its collaborators published positive preclinical data for the use of Genprex’s ONCOPREX® Nanoparticle Delivery System for delivery of a FAS DNA plasmid to treat metastatic colorectal cancer. Published in the journal Cancers1, the preclinical study found that tumor selective ONCOPREX nanoparticles carrying FAS DNA plasmids suppress human colon tumor growth in vivo in mouse models, indicating that this may be an effective therapy for human colorectal cancer.

The manuscript, "Restoring FAS Expression via Lipid-Encapsulated FAS DNA Nanoparticle Delivery Is Sufficient to Suppress Colon Tumor Growth In Vivo," provides data indicating that complete loss of FAS expression is often observed in metastatic human colorectal tumors. Using Genprex’s ONCOPREX system to deliver the FAS gene, the researchers found that overexpression of codon usage-optimized FAS in metastatic mouse colon-tumor cells enabled FASL-induced elimination of FAS positive tumor cells in vitro, suppressed colon tumor growth, and increased the survival of tumor-bearing mice in vivo.

"These positive preclinical data validate that the ONCOPREX Nanoparticle Delivery System can be used to deliver tumor suppressor genes other than TUSC2, which we are using in lung cancer studies with REQORSA, to address multiple types of cancer," said Mark S. Berger, MD, Chief Medical Officer at Genprex. "The data also provide early support for FAS as a tumor suppressor gene in colorectal cancer. With this compelling data, Genprex is positioned to expand its oncology programs in the future and to further explore use of its delivery system for other therapeutic genes, alone or in combination with other approved cancer therapies, to provide new therapeutic approaches for patients with serious medical conditions and unmet medical needs. We will continue to evaluate FAS using our ONCOPREX delivery platform as a potential pipeline addition within our oncology program."

https://finance.yahoo.com/news/preclinical-data-show-potential-genprex-162300347.html

TG Therapeutics (TGTX) CEO shared data and regulatory update

 On January 27, 2022, TG Therapeutics, Inc. (the “Company”) participated in a webcast fireside chat during the B. Riley Securities’ 2022 Virtual Oncology Investor Conference. During the webcast, Michael S. Weiss, Chief Executive Officer of the Company, shared a data and regulatory update. Mr. Weiss noted that the Company was nearing completion of a submission to the U.S. Food and Drug Administration (FDA) of updated Overall Survival (OS) analyses from the UNITY-CLL Phase 3 study evaluating the investigational U2 combination (UKONIQ® (umbralisib) and ublituximab) compared to the control arm of obinutuzumab plus chlorambucil and that the FDA imposed a partial clinical hold on select studies of U2 and its components for chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

With regard to the data update, Mr. Weiss noted that the updated OS results from the UNITY-CLL study, showed an improvement from the preliminary data originally shared with the FDA, and previously disclosed on November 30, 2021, which was at that time an OS hazard ratio of 1.23 and when censoring for COVID-19 related deaths a hazard ratio of 1.04. An OS hazard ratio above 1.00 implies potential risk that the investigational therapy is causing harm and below 1.00 implies the possibility the drug is improving survival. The UNITY-CLL study was not powered for OS. Neither the original preliminary results nor the updated preliminary results were statistically significant, and the results are expected to change over time as more events occur. The original preliminary OS Hazard Ratio and the updated information discussed today were as of the same data cutoff date of September 2021.

With regard to the partial clinical hold, Mr. Weiss noted that no new patients may be enrolled to the select CLL/NHL studies identified by FDA, however patients on these studies who are deriving clinical benefit can continue on therapy once they have been reconsented. Mr. Weiss also noted that the partial clinical hold was not based on any new information provided by the Company to the FDA but appears to be based on the same data and concerns that gave rise to the previously announced Oncologic Drug Advisory Committee (ODAC) meeting, which is set to take place in the March/April 2022 timeframe. Most studies included in the partial clinical hold were previously closed to new enrollment or were on Company administrative hold to new enrollment. The Company does not expect to provide an update on the partial clinical hold prior to the ODAC meeting.

https://www.streetinsider.com/Corporate+News/TG+Therapeutics+%28TGTX%29+CEO+shared+data+and+regulatory+update/19514697.html

HCA Healthcare Q4 Earnings Lag Estimates, Issues FY22 Guidance

 HCA Healthcare, Inc. (NYSE: HCA) today announced financial and operating results for the fourth quarter ended December 31, 2021.

Key fourth quarter metrics (all percentage changes compare 4Q 2021 to 4Q 2020 unless otherwise noted):

• Revenues totaled $15.064 billion

• Net income attributable to HCA Healthcare, Inc. totaled $1.814 billion, or $5.75 per diluted share

• Adjusted EBITDA totaled $3.149 billion

• Cash flows provided by operating activities totaled $2.443 billion

• Same facility admissions and same facility equivalent admissions increased 0.6 percent and 4.1 percent, respectively

"The Omicron surge started to influence our business in early December. Overall, our teams continued their tremendous response, and the effects of the pandemic’s ever-changing conditions were managed well as reflected in our fourth quarter financial results," said Sam Hazen, Chief Executive Officer of HCA Healthcare. "Across many dimensions of our business, our teams demonstrated an impressive ability to adjust quickly and effectively to three different surges during the year and deliver for our patients, our communities, and our colleagues."

Revenues in the fourth quarter of 2021 increased to $15.064 billion, from $14.293 billion in the fourth quarter of 2020. Net income attributable to HCA Healthcare, Inc. totaled $1.814 billion, or $5.75 per diluted share, compared to $1.426 billion, or $4.13 per diluted share, in the fourth quarter of 2020. Results for the fourth quarter of 2021 include gains on sales of facilities of $563 million, or $1.33 per diluted share.

For the fourth quarter of 2021, Adjusted EBITDA totaled $3.149 billion, compared to $3.118 billion in the fourth quarter of 2020. Adjusted EBITDA is a non-GAAP financial measure. A table providing supplemental information on Adjusted EBITDA and reconciling net income attributable to HCA Healthcare, Inc. to Adjusted EBITDA is included in this release.

2022 Guidance

Today, the Company issued the following estimated guidance for 2022:

			2022 Guidance Range
Revenues			$60.0 to $62.0 billion
Net Income Attributable to HCA Healthcare, Inc.			$5.550 to $5.835 billion
Adjusted EBITDA			$12.55 to $13.05 billion
EPS (diluted)			$18.40 to $19.20 per diluted share

Capital expenditures for 2022, excluding acquisitions, are estimated to be approximately $4.2 billion, a 17% increase from $3.577 billion in 2021.

The Company’s 2022 guidance contains a number of assumptions, including, among others, the Company’s current expectations regarding the impact of the COVID-19 pandemic, and excludes the impact of items such as, but not limited to, gains or losses on sales of facilities, losses on retirement of debt, legal claims costs and impairment of long-lived assets.

https://finance.yahoo.com/news/hca-healthcare-reports-fourth-quarter-123000572.html

PDS Biotech Announces Preclinical Data for PDS0202 Universal Influenza Vaccine

 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune® and Infectimune™ T-cell activating technologies, today announced preclinical data for its universal flu vaccine, which was shown to be effective against multiple strains of the influenza virus.

Due to the existence of multiple strains of flu, a new seasonal flu vaccination is usually developed to provide protection against the strains predicted to be prevalent in an upcoming flu season. As a result, the protective efficacy of the current vaccines varies widely from season to season. PDS Biotechnology is developing a new generation of flu vaccines with the potential to provide long-lasting, and broad protection against multiple strains of the virus. We believe that the successful development of a universal flu vaccine could eliminate the need to create a vaccine to protect against each year’s predicted variants. According to the World Health Organization, influenza causes 3 to 5 million cases and approximately 290,000 to 650,000 deaths each year.

PDS0202 combines PDS Biotech’s proprietary Infectimune™ technology with proprietary COBRA (Computationally Optimized Broadly Reactive Antigens) designed by renowned influenza expert Dr. Ted Ross. PDS Biotech announced an agreement with the University of Georgia to license the COBRA antigens.

The NIAID-sponsored preclinical work was performed by Dr. Jerold Woodward at the University of Kentucky College of Medicine and Dr. Ted Ross at the University of Georgia, in collaboration with PDS Biotech. Dr. Ted Ross is Principal Investigator at the National Institute of Allergy and Infectious Diseases (NIAID) Collaborative Influenza Vaccine Innovation Center (CIVICs) located at the University of Georgia. The studies demonstrated the ability of PDS0202 to promote robust induction of broadly neutralizing influenza -specific antibodies, flu-specific CD4 (helper) and CD8 (killer) T-cells, as well as long-lasting memory T-cells. This well characterized and robust immune response to the COBRA antigens suggests strong potential for broad and long-term protection against multiple strains of influenza.

https://finance.yahoo.com/news/pds-biotech-announces-preclinical-data-130000744.html

Todos, NLC Meet Primary and Secondary Endpoints in Phase 2l Trial of Oral Covid Antiviral

 Phase 2 Study NLC-V-01 closed early after interim data analysis due to positive clinical efficacy

Primary endpoint of time to clinical improvement reached with average reduction of 2.7 days in the Tollovir group vs. the placebo group

 No COVID-related deaths in Tollovir™ group vs. 22% COVID-related deaths in placebo group

Lead clinical site Shaare Zedek Medical Center now permits the use of Tollovir™ in hospitalized COVID-19 patients on a compassionate use basis

Company preparing Phase 2/3 clinical trial to support Emergency Use Authorizations

Company to host conference call today at 9:15am ET to discuss the positive Phase 2 trial results

Company to make a corporate presentation for Emerging Growth Conference today at 3:00pm ET

https://www.globenewswire.com/news-release/2022/01/27/2374328/0/en/Todos-Medical-and-NLC-Pharma-Announce-Primary-and-Secondary-Endpoints-Met-in-NLC-V-01-Phase-2-Clinical-Trial-of-Oral-Antiviral-3CL-Protease-Inhibitor-Tollovir-in-the-Treatment-of-H.html