CytoDyn Receives First Purchase Order from Chiral Pharma for Leronlimab

 CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing Vyrologix™ (leronlimab-Pro 140), a CCR5 antagonist with potential multiple therapeutic indications, announced today that Chiral Pharma Corporation in the Philippines placed its first purchase order for leronlimab under a Compassionate Special Permit (“CSP”) to treat critically ill COVID-19 patients in the Philippines. The Company expects to recognize revenues related to this purchase order upon fulfillment of the purchase order and the terms of the agreement.

Chris Recknor, M.D., Chief Operating Officer and Head of Clinical Development of CytoDyn, said, "Current Philippine CSP data is significant for 21% mortality rate which is below that observed in CD12.  One of the patient successes was recently reported last week on One News Philippines TV station. This patient had severe COVID-19 with deteriorating lung function despite treatment with antivirals and steroids. Testing was significant for high inflammation in the blood with Ferritin 17x elevated. Oxygen saturation on maximum oxygen flow was only 82% (normal >95%). Twenty hours after receiving 700 mg of leronlimab subcutaneously at the patient's home, the patient's heart rate decreased from 120s to low 90s. Shortly thereafter the patient regained appetite, improved lung function, and had reduced inflammation with Ferritin down to 4x elevated.  At week two, the patient successfully went off oxygen shortly after second dose also given at home.  At week three, the patient continued to improve in stamina and returned to routine physical activities. Inflammation markers were still elevated with Ferritin still two times elevated, so a third dose was given.  At week four, the patient is currently back to normal life activities."

Dr. Recknor further stated, “Although the CSP data is not randomized double-blinded control, the numerous case reports from the Philippine CSP are consistent with CD12 prespecified major endpoint metrics showing Vyrologix when combined with standard of care is better than standard of care alone (e.g. antivirals/dexamethasone) and may improve clinical outcome status four times better than standard of care at day 14 (p< 0.021) and reduce hospital stay by as much as 6 days (p<0.005) with a higher likelihood of returning to activities of daily living without limitations vs. placebo control in critical COVID patients."

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, “After we provided leronlimab, free of charge, for the first 100 patients in the Philippines for critically ill COVID-19 patients, we are now on a clear path to achieving revenue with our first purchase order today under CSP from Chiral Pharma. We are so proud to be able to provide leronlimab in the capital region where the use of intensive care unit (ICU) capacity is above 70% for COVID-19 patients with hospital beds in great shortage. We are equally excited about our EUA package (CMC, non-clinical and clinical sections) being prepared for submission to the Philippine FDA.“

About Vyrologix™ (Leronlimab) The U.S. Food and Drug Administration (FDA) granted CytoDyn Fast Track designation to explore two potential indications using leronlimab to treat Human Immunodeficiency Virus (HIV) and metastatic cancer. The first indication is combination therapy with HAART for HIV-infected patients, and the second is for metastatic triple-negative breast cancer (mTNBC). Leronlimab is an investigational humanized IgG4 mAb that binds to CCR5, a cellular receptor important in HIV infection, tumor metastases, and other diseases, including nonalcoholic steatohepatitis (NASH). Leronlimab has been studied in 16 clinical trials involving more than 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab combined with HIV standard care in patients with multi-drug resistance to current available classes of HIV drugs).

https://tylerpaper.com/ap/business/cytodyn-receives-first-purchase-order-from-chiral-pharma-corporation-for-use-of-leronlimab/article_9dec947f-7ba2-557a-b5ba-5a09de9909a4.html

Abbott cuts 2021 profit forecast on lower COVID-19 testing demand

 Abbott Laboratories on Tuesday cut its full-year 2021 profit forecast due to a projected drop in COVID-19 diagnostic testing demand, sending its shares down 4.1% before the bell.

"This has been driven by several factors, including significant reductions in cases in the U.S. and other major developed countries, accelerated rollout of COVID-19 vaccines globally and, most recently, U.S. health authority guidance on testing for fully vaccinated individuals," the drugmaker said.

Abbott generated billions in sales for its COVID-19 tests last year, but analysts have cautioned that demand is likely to fall this year.

The company now expects full-year adjusted profit from continuing operations of $4.30 to $4.50 per share. It had forecast at least $5 per share in January. Analysts expect $5.04 per share, according to Refinitiv data.

Abbott sees second-quarter adjusted profit from continuing operations of at least $1 per share, compared with analysts' estimates of $1.23 per share.

https://finance.yahoo.com/news/abbott-cuts-2021-profit-forecast-125827138.html

Rezolute: ‘Strong Buy’ Stock with 100% Upside Potential

 Every stock investor wants a strong return; that’s axiomatic, it’s why people get into the stock market to begin with. But the markets are inherently risky, and finding the sweet spot – the right combination of risk and reward – seems as much an art as a science. You can use science, however, to minimize the risk.

We’re talking about statistical science, the study of numbers, their patterns, and the relationships between them. This can give investors an objective view of the broader market or specific stocks, and can even be used to measure the success of those artists of the stock market, the professional traders and analysts.

We’ve used the tools on the TipRanks platform to sort through the publicly traded stocks and find three that are showing a solid combination of risk and reward. Specifically, we’ve looked for Strong Buy stocks that have recently received a thumbs up from an analyst – along with a price target suggesting 100% or better upside potential. Doubling your money sounds like a good return, so let’s find out what else these stocks have going for them.

Rezolute (RZLT)

We’ll start in the biopharmaceutical industry, where Rezolute specializes in developing drug therapies – new medications – for patients with difficult-to-treat metabolic conditions. These are frequently considered orphan diseases, illnesses that have very few patients and therefore a limited market.

Rezolute is currently working on two pipeline projects, both for conditions similar to or related to diabetes. The company’s leading drug candidate, RZ358, in currently undergoing a Phase 2b open-label study as a treatment for congenital hyperinsulinism (CHI), a rare pediatric disorder in which the pancreas produces too much insulin, causing extremely low blood sugar, with cascading effects on the whole body. RZ402, the second drug candidate, is in Phase 1 clinical trials. It is an orally dosed treatment for diabetic macular edema, one of the causes of diabetic-related blindness.

In its recent financial report for fiscal Q3 2021, Rezolute included development updates on both leading drug candidates. For RZ358, the company noted that the Phase 2b RIZE study is still enrolling patients and that top line data is expected to become available in 2H21. For the Phase 1 study of RZ402, Resolute announced that the trial is complete and that the initial results demonstrated that once-daily oral dosing is feasible. The company will initiate a Phase 1b trial in 3Q21, as a step toward Phase 2 studies.

In financial results, Rezolute reported having on hand $32 million available in cash and equivalents, enough to fund operations into the third calendar quarter of 2022.

H.C. Wainwright’s five-star analyst Douglas Tsao initiated his coverage of RZLT with an upbeat outlook, writing, “Rezolute is ready to enter the spotlight with two assets featuring novel mechanisms… Despite assets with promising data and differentiated mechanisms, Rezolute has largely been overlooked by the investment community, which we largely attribute to its entry into the public markets via a reverse merger and an OTC listing. However, with key catalysts upcoming and a recent up listing on the NASDAQ, we think it’s time for investors to pay attention to this story.”

Tsao gives the stock a Buy rating and $21 price target that implies an upside of 103% for the coming year. (To watch Tsao’s track record, click here.)

The Strong Buy consensus rating on RZLT shares is based on 3 recent reviews – and they are all positive, making the consensus unanimous. The shares are priced at $10.33, with a $25.33 average price target, making the one-year upside potential a robust 145%.

https://finance.yahoo.com/news/3-strong-buy-stocks-100-141738180.html

Supreme Court rebuffs J&J appeal over $2 billion baby powder judgment

 The U.S. Supreme Court on Monday declined to hear Johnson & Johnson's bid to overturn a $2.12 billion damages award to women who blamed their ovarian cancer on asbestos in the company's baby powder and other talc products.

The justices turned away a J&J appeal and left in place a Missouri state court ruling in litigation brought by 22 women whose claims were heard together in one trial.

The Missouri Court of Appeals, an intermediate state appellate court, last year ruled against J&J's bid to throw out the compensatory and punitive damages awarded to the plaintiffs but reduced the total to $2.12 billion from the $4.69 billion originally decided by a jury.

J&J has argued that a decision by a Missouri circuit court judge to consolidate disparate baby powder-related claims from the plaintiffs - including 17 women from outside the state - for a trial before a single jury violated the New Brunswick, New Jersey-based company's due process rights under the U.S. Constitution. J&J also has argued that the size of the jury's damages award violated its due process rights.

The Missouri Supreme Court, the state's highest court, in November declined to hear J&J's appeal of the Missouri Court of Appeals ruling, prompting the company to appeal to the U.S. Supreme Court.

J&J said in court papers that it faces more than 19,000 other cases that could be affected by the outcome of this litigation.

The plaintiffs, nine of whom have died and are now represented by their estates, have argued that Missouri courts have jurisdiction over out-of-state claims like those brought in this litigation. One of the products that the out-of-state plaintiffs said they had used was manufactured in Missouri.

Lawyers for the plaintiffs also have argued that the large punitive damages awarded by the jury in this case were justified by J&J's conduct. Lawyers for the plaintiffs said in court papers it is common practice for courts to consolidate cases at trial when the facts in each claim are essentially the same.

The Missouri Court of Appeals concluded that it was reasonable to infer from the evidence that J&J "disregarded the safety of consumers" in its drive for profit despite knowing its talc products caused ovarian cancer. It also found "significant reprehensibility" in J&J's conduct.

In addition to reducing the damages, the Missouri Court of Appeals dismissed two of the 17 out-of-state plaintiffs.

In court papers, J&J said the case followed a "winning formula" devised by plaintiffs' lawyers of bringing claims in jurisdictions where they can get dozens of out-of-state plaintiffs to testify in a single trial, prejudicing the jury and resulting in "outsized" damages awards.

In the Missouri trial, the company said, the jury awarded each plaintiff an identical punitive damages award of $25 million, regardless of the facts specific to each plaintiff or whether they were alive or dead. The company also said the jury awarded punitive damages much larger than the "already staggering" compensatory damages, which J&J has called a further violation of its due process rights.

Justice Samuel Alito did not participate in the Supreme Court's decision not to take up the appeal, likely because he owns J&J stock. Justice Brett Kavanaugh, whose father - now retired - was a longtime lobbyist for the toiletries industry, also did not take part. The justices do not explain why they step aside in certain cases.

A 2018 Reuters investigation https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer found that J&J knew for decades that asbestos, a carcinogen, was present in its talc products. Internal company records, trial testimony and other evidence showed that from at least 1971 to the early 2000s, J&J's raw talc and finished powders sometimes tested positive for small amounts of asbestos.

The company said in May 2020 https://www.reuters.com/article/us-johnson-johnson-babypowder/johnson-johnson-to-stop-selling-talc-baby-powder-in-u-s-and-canada-idUSKBN22V32U it would stop selling its baby powder talc in the United States and Canada, citing changes in consumer habits and what it called "misinformation" about the product's safety amid numerous legal challenges. In its statement https://www.jnj.com/our-company/johnson-johnson-consumer-health-announces-discontinuation-of-talc-based-johnsons-baby-powder-in-u-s-and-canada, J&J said it remained "steadfastly confident in the safety of talc-based Johnson's Baby Powder."

https://finance.yahoo.com/news/1-u-supreme-court-rebuffs-134526313.html

Moderna files for full U.S. approval of COVID-19 vaccine

 Moderna Inc on Tuesday filed for full U.S. approval of its COVID-19 vaccine, becoming the second drugmaker to do so after Pfizer Inc and its German partner BioNTech sought full clearance for their vaccine last month.

The U.S. Food and Drug Administration's emergency use approval allowed the health regulator to authorize the vaccines during the pandemic, based on a minimum number of COVID-19 infections among the trial population and two months of safety data for vaccine recipients.

Full approval for the COVID-19 vaccines, which will be based on six months of trial data, could be an important step in allaying vaccine hesitancy in the United States and other wealthy nations.

Moderna said it will continue to submit data to the FDA on a rolling basis over the coming weeks, with a request for a priority review. On completion of the submission, the agency will notify the company when it is formally accepted for review, Moderna added.

Cambridge, Massachusetts-based Moderna has an agreement with the U.S. government to supply 300 million doses of its COVID-19 vaccine, which is authorized or approved for use in more than 40 countries.

More than 151 million doses of Moderna's vaccine have been distributed around the United States, with roughly 124.5 million shots administered as of May 30, according to the U.S. Centers for Disease Control and Prevention.

Over 135 million people or nearly 41% of the total U.S. population has been fully vaccinated as of May 30, according to the CDC data.

Moderna said in April its vaccine showed strong protection against the coronavirus six months after people received their second shot, with efficacy of more than 90% against all cases of COVID-19 and more than 95% against severe COVID-19.

https://finance.yahoo.com/news/1-moderna-files-full-u-115154715.html

Biogen, Bio-Thera: Positive Results From Phase 3 Study

 The comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis

 Biogen Inc. (Nasdaq: BIIB) and Bio-Thera Solutions, Ltd. (688177.SH) today announced results from the Phase 3 study of BAT1806, a proposed biosimilar referencing ACTEMRA®/RoACTEMRA® (tocilizumab). The study met its primary endpoints, demonstrating equivalence to the reference medicine in patients with moderate to severe rheumatoid arthritis (RA) inadequately controlled by methotrexate therapy. The primary endpoint in the study was the American College of Rheumatology 20 percent response criteria (ACR20).

ACTEMRA/RoACTEMRA’s primary indication is for moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis, systemic juvenile idiopathic arthritis, giant cell arteritis and cytokine release syndrome. Biosimilars are products that demonstrate similar efficacy and safety to the originator’s reference product, with the advantage that they can be more affordable for patients and healthcare systems. In 2020 global sales of ACTEMRA were 2.8 billion CHF. Biogen has exclusive regulatory, manufacturing and commercial rights to BAT1806 in all countries excluding China (including Hong Kong, Macau and Taiwan).

https://finance.yahoo.com/news/biogen-bio-thera-announce-positive-113000165.html

Paratek: FDA Approves NUZYRA® (omadacycline) Oral Only Dosing

 Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s supplemental New Drug Application (sNDA) for the oral-only dosing regimen of NUZYRA® for the treatment of adults with community-acquired bacterial pneumonia (CABP).

“The approval of an oral-only dose regimen for NUZYRA in pneumonia represents a significant opportunity to offer clinicians the ability to treat patients in either the outpatient or primary care setting. Treating in this way potentially reduces or eliminates hospitalizations and the associated risk and costs from a hospital stay,” said Adam Woodrow, President and Chief Commercial Officer of Paratek. “With the community expansion well under way we will broaden our promotional efforts to include this new dosing option and are particularly excited to bring primary care practitioners a new, safe and effective oral antibiotic in time for the upcoming pneumonia season."

Approved by the FDA on October 2, 2018, NUZYRA is a novel antibiotic with both once-daily oral and intravenous (IV) formulations for the treatment of CABP and acute bacterial skin and skin structure infections (ABSSSI). The recently approved oral-only dose for CABP has an initial dose of 300 mg twice on day one and 300 mg once daily thereafter for a total of 7 to 14 days. A modernized tetracycline, NUZYRA is specifically designed to overcome tetracycline resistance and exhibits activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative, and atypicals including other drug-resistant strains.

https://finance.yahoo.com/news/paratek-pharmaceuticals-announces-fda-approval-114500543.html