Intra-Cellular sharply higher on it’s Bipolar drug

Intra-Cellular says lumateperone 42 mg met primary endpoint in Study 402

Intra-Cellular Therapies (ITCI) announced positive topline results from its Phase 3 clinical trial evaluating lumateperone as adjunctive therapy to lithium or valproate in the treatment of major depressive episodes associated with Bipolar I or Bipolar II disorder.

Intra-Cellular sharply higher on its bi-polar drug

In Study 402, once daily lumateperone 42 mg met the primary endpoint for improvement in depression as measured by change from baseline versus placebo on the MADRS total score.

Lumateperone 42 mg also met the key secondary endpoint, the CGI-BP-S Depression Score.

The lower lumateperone dose, 28 mg, showed a trend for a dose-related improvement in symptoms of depression but the results did not reach statistical significance.

Lumateperone demonstrated a favorable safety profile and was generally well-tolerated in the trial.

Lumateperone was successful in treating bipolar disorders

The most commonly reported adverse events that were observed at a rate greater than or equal to 5% and at least twice the rate of placebo were somnolence, dizziness, and nausea.

Rates of akathisia, restlessness, extrapyramidal symptoms, and changes in weight were similar to placebo.

This trial, in conjunction with our previously reported positive Phase 3 monotherapy study, Study 404, forms the basis for our sNDA for the treatment of bipolar depression in patients with Bipolar I or II disorder as monotherapy and adjunctive therapy which we expect to submit to the FDA in late 2020 or early 2021.

Study 402 was conducted globally in five countries including in the U.S. A total of 529 patients with moderate to severe major depressive episodes associated with either Bipolar I or Bipolar II disorder were randomized 1:1:1 to lumateperone 42 mg, 28 mg or placebo, while being maintained on lithium or valproate as mood stabilizers.

Lumateperone 42 mg met the primary endpoint by demonstrating a statistically significant improvement compared to placebo at week 6, as measured by change from baseline on the MADRS total score.

In the intent-to-treat study population, the least squares mean reduction from baseline for lumateperone 42 mg was 16.9 points, versus 14.5 points for placebo. Lumateperone 42 mg also met the key secondary endpoint of statistically significant improvement on the CGI-BP-S Depression Score.

Lumateperone 28 mg showed a trend for a dose-related improvement in symptoms of depression.

Though not formally tested against placebo since it did not separate on the primary endpoint, lumateperone 28 mg demonstrated a statistically significant improvement versus placebo on the CGI-BP-S. Lumateperone was generally well-tolerated with a favorable safety profile in the trial.

Adverse events were mostly mild to moderate and similar to those seen in prior studies in bipolar depression and schizophrenia, with no new adverse events observed. These findings provide further evidence supporting lumateperone’s favorable safety and tolerability profile across different patient populations.

 Importantly, lumateperone was generally safe and well tolerated in the study, adds the analyst. Hazlett believes that if approved in this indication, lumateperone would be differentiated as a potential first-line treatment option in depressive episodes associated with both bipolar I and bipolar II disorders.

ITCI is up 76% to $32.51

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Rig counts unchanged last week!

Baker Hughes reports U.S. rig count unchanged at 254 rigs

Baker Hughes (BKR) reports that the U.S. rig count is unchanged from last week at 254 with oil rigs down 3 to 180, gas rigs up 3 to 72, and miscellaneous rigs unchanged at 2.

The U.S. Rig Count is down 650 rigs from last year’s count of 904, with oil rigs down 562, gas rigs down 90, and miscellaneous rigs unchanged at 2.

The U.S. Offshore Rig Count is unchanged at 13 and down 13 year-over-year.

https://stockwinners.com
Rig Counts unchanged- See Stockwinners.com Market Radar to read more

The Canada Rig Count is down 2 rigs from last week to 54, with oil rigs down 1 to 19, gas rigs down 1 to 35, and miscellaneous rigs unchanged at 0.

The international offshore rig count for April 2018 was 194. Stockwinners

The Canada Rig Count is down 96 rigs from last year’s count of 150, with oil rigs down 86, gas rigs down 10 and miscellaneous rigs unchanged at 0.

Brent crude is up 17 cents to $45.77 per barrel. West Texas Intermediate (WTI) crude is down 5 cents to $42.97 per barrel.

Gasoline last traded at $1.31 per gallon up three cents on the day.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

American Airlines to fire 19,000 employees

American Airlines plans to cut 19,000 jobs if federal aid lapses, cuts to take effect October 1

In a regulatory filing, American Airlines (AAL) said:

“In short, American’s team will have at least 40,000 fewer people working Oct. 1 than we had when we entered this pandemic. We have worked to mitigate as many involuntary reductions as possible through voluntary programs.

Company says it will have 40,000 less employees on October 1

Across the mainline and regional carriers, more than 12,500 of our colleagues have made the difficult decision to leave the company permanently through early out programs or retirement.

Another 11,000 team members have offered to be on a leave of absence in October.

These are important life decisions and we respect and greatly appreciate the sacrifice these team members have made, and continue to make, for American and their fellow team members.

The pandemic has hurt airline the most

Even with those sacrifices, approximately 19,000 of our team members will be involuntarily furloughed or separated from the company on Oct. 1, unless there is an extension of the PSP…

The one possibility of avoiding these involuntary reductions on Oct. 1 is a clean extension of the PSP. Led by your labor unions, with the support of the industry, we have generated enormous bipartisan support for such an extension.

The overwhelming majority of members of both the U.S. House and Senate appreciate that saving jobs in the airline industry through this crisis will mean a quicker economic recovery in the months and years ahead.

And that preserving these essential service jobs will also mean continued commercial air service to all communities, small and large. But, despite this broad bipartisan support, a PSP extension is tied up in a larger COVID-19 relief package, which our elected officials haven’t yet been able to negotiate.

So we must prepare for the possibility that our nation’s leadership will not be able to find a way to further support aviation professionals and the service we provide, especially to smaller communities.”

AAL is down $0.45 to $13.00.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Momenta Pharmaceuticals sold for $6.5B

Johnson & Johnson to acquire Momenta Pharmaceuticals for $52.50/shr

Johnson & Johnson (JNJ) announced it has entered into a definitive agreement to acquire Momenta Pharmaceuticals (MNTA) in an all cash transaction for approximately $6.5 billion.

The transaction will include full global rights to nipocalimab (M281), a clinically validated, potentially best-in-class anti-FcRn antibody.

Momenta sold for $6.5B, Stockwinners

Nipocalimab gives Janssen the “opportunity to reach significantly more patients by pursuing indications across many autoimmune diseases with substantial unmet medical need in maternal-fetal disorders, neuro-inflammatory disorders, rheumatology, dermatology and autoimmune hematology.

Nipocalimab recently received a rare pediatric disease designation from the U.S. Food and Drug Administration.

Momenta’s expertise in FcRn mechanisms is especially important for nipocalimab as it supports and accelerates the development of a medicine designed to target a number of autoantibody-driven conditions across several of Janssen’s established therapeutic areas.

Janssen expects nipocalimab to contribute to its goals of achieving above-market growth over the mid and long term.

In addition to Momenta’s employees and lead asset nipocalimab, Janssen will acquire Momenta’s pipeline of clinical and preclinical assets.

Under the terms of the transaction, which was approved by the Boards of Directors of both companies, Vigor Sub, Inc. (Merger Sub), a newly formed wholly-owned subsidiary of Johnson & Johnson (the Company), will commence a tender offer to purchase all outstanding shares of Momenta for $52.50 per share.

The closing of the offer is conditioned on the tender of a majority of the outstanding shares of Momenta’s common stock on a fully diluted basis, as well as clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

The merger will be effected as soon as practicable after the closing of the tender offer. The transaction is expected to close in the second half of 2020.

While the closing of the transaction is expected to be modestly dilutive, the Company is maintaining its current 2020 Adjusted EPSi guidance range.

Looking ahead, the costs associated with the development of Momenta’s portfolio are expected to be incremental to planned R&D investment levels over the next few years given the value creation potential of our current portfolio, and thus expect this incremental investment in R&D to have an EPS impact worth approximately 10c-15c in 2021.

Shares of MNTA are up 69% to $52.14 in morning trading. 

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

New York sues to dissolve NRA

New York Attorney General James files lawsuit to dissolve NRA

New York Attorney General Letitia James has filed a lawsuit seeking to dissolve the National Rifle Association.

According to a statement, “Attorney General James charges the organization with illegal conduct because of their diversion of millions of dollars away from the charitable mission of the organization for personal use by senior leadership, awarding contracts to the financial gain of close associates and family, and appearing to dole out lucrative no-show contracts to former employees in order to buy their silence and continued loyalty.

The suit specifically charges the NRA as a whole, as well as Executive Vice-President Wayne LaPierre, former Treasurer and Chief Financial Officer Wilson “Woody” Phillips, former Chief of Staff and the Executive Director of General Operations Joshua Powell, and Corporate Secretary and General Counsel John Frazer with failing to manage the NRA’s funds and failing to follow numerous state and federal laws, contributing to the loss of more than $64M in just three years for the NRA.

NY Attorney General Letitia James

In the complaint, Attorney General James lays out dozens of examples where the four individual defendants failed to fulfill their fiduciary duty to the NRA and used millions upon millions from NRA reserves for personal use, including trips for them and their families to the Bahamas, private jets, expensive meals, and other private travel.

In addition to shuttering the NRA’s doors, Attorney General James seeks to recoup millions in lost assets and to stop the four individual defendants from serving on the board of any not-for-profit charitable organization in the state of New York again.”

It further states that, “the NRA is alleged to have fostered a culture of noncompliance and disregard for internal controls that led to the waste and loss of millions in assets and contributed to the NRA reaching its current deteriorated financial state.

Vista Outdoor (VSTO), Stockwinners

The NRA’s internal policies were repeatedly not followed and were even blatantly ignored by senior leaders. Furthermore, the NRA board’s audit committee was negligent in its duty to ensure appropriate, competent, and judicious stewardship of assets by NRA leadership.

Specifically, the committee failed to assure standard fiscal controls, failed to respond adequately to whistleblowers, affirmatively took steps to conceal the nature and scope of whistleblower concerns from external auditors, and failed to review potential conflicts of interest for employees.

Smith & Wesson Brands (SWBI), Stockwinners

The lawsuit alleges that the four men instituted a culture of self-dealing, mismanagement, and negligent oversight at the NRA that was illegal, oppressive, and fraudulent.

They overrode and evaded internal controls to allow themselves, their families, favored board members, employees, and vendors to benefit through reimbursed expenses, related party transactions, excess compensation, side deals, and waste of charitable assets without regard to the NRA’s best interests.

Sturm, Ruger (RGR), Stockwinners

The complaint lays out numerous other instances in which LaPierre, Phillips, Powell, Frazer, and other executives and board members at the NRA abused their power and illegally diverted or facilitated the diversion of tens of millions of dollars from the NRA.

These funds were in addition to millions of dollars the four individual defendants were already receiving in grossly excessive salaries and bonuses that were not in line with the best practices and prudent standards for evaluating and determining compensation.”

Stocks to Watch

Companies in the firearm space include Sturm, Ruger (RGR), Smith & Wesson Brands (SWBI), and Vista Outdoor (VSTO).

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Lexicon shares jump on it’s type 2 diabetes drug

Lexicon says all four Phase 3 sotagliflozin studies met primary objectives

Lexicon Pharmaceuticals (LXRX) announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS.

All four Phase 3 sotagliflozin studies met their primary objectives of lowering A1C in patients with type 2 diabetes.

The observed safety profile of sotagliflozin in these studies was generally consistent with that of approved SGLT2 inhibitors.

Diarrhea, an event consistent with gastrointestinal SGLT1 inhibition, was generally more common on sotagliflozin than placebo, although it was not a meaningful cause of treatment discontinuation.

Genital mycotic infections were dose-related.

The absolute increase in the incidence of genital mycotic infections over placebo ranged from 0% to 3.7% in studies of the 200 mg dose and from 3.2% to 6.3% in studies of the 400 mg dose.

In one study, sotagliflozin showed less hypoglycemia than glimepiride, and in the other three studies, the incidences of hypoglycemia in patients on sotagliflozin were similar to those on placebo.

Lexicon does not intend to pursue any regulatory approvals of sotagliflozin for type 2 diabetes in the absence of a strategic partnership for the commercialization of sotagliflozin in such indication.

In the Phase 3, multicenter, randomized, double-blind, placebo-controlled SOTA-MONO study, sotagliflozin 400 mg and 200 mg as monotherapy was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes and inadequate glycemic control.

The study enrolled 142 patients on sotagliflozin 400 mg, 107 patients on sotagliflozin 200 mg and 150 patients on placebo. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg and 200 mg significantly reduced A1C in patients with type 2 diabetes and inadequate glycemic control on diet and exercise alone.

Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes, with similar incidences of hypoglycemia on sotagliflozin and placebo.

SOTA-SU was a 507-patient, randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg added to a sulfonylurea, alone or in combination with metformin, in patients with type 2 diabetes who had inadequate glycemic control on a sulfonylurea or metformin alone.

The primary endpoint was the change in A1C from baseline to Week 26. Patients were followed for a total of 79 weeks. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in patients with type 2 diabetes who were on sulfonylurea alone or in combination with metformin with inadequate glycemic control on a sulfonylurea or metformin alone at Week 26.

Importantly, A1C reduction persisted through 79 weeks. Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes.

Mean estimated glomerular filtration rate was estimated at Week 79, and was similar for sotagliflozin and placebo. Despite the presence of sulfonylurea background therapy, the incidences of hypoglycemia were similar on sotagliflozin and placebo.

SOTA-GLIM was a 954-patient, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel group, multicenter Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg compared to glimepiride or placebo added to metformin in patients with type 2 diabetes who had inadequate glycemic control with metformin therapy.

The primary objective of the study was to demonstrate the non-inferiority of sotagliflozin 400 mg compared to glimepiride on A1C at Week 52.

Patients were followed for a total of 52 weeks. The study met its primary objective, as the change from baseline in A1C reduction to Week 52 was the same on sotagliflozin 400 mg and glimepiride, and the 95% confidence interval excluded the pre-specified margin of non-inferiority.

Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes, with less hypoglycemia on sotagliflozin than glimepiride. SOTA-INS was a 571-patient, randomized, double-blind, placebo-controlled, parallel group, multicenter, 52-week Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg and 200 mg or placebo in patients with type 2 diabetes who had inadequate glycemic control on basal insulin alone or in addition to oral antidiabetic agents.

The primary endpoint was a change in A1C from baseline to Week 18. Patients were followed for a total of 52 weeks. The study met its primary endpoint, demonstrating that sotagliflozin 400 mg and 200 mg significantly reduced A1C in patients with type 2 diabetes who had inadequate glycemic control on basal insulin alone or in addition to oral antidiabetic agents.

Importantly, A1C reduction persisted at the same magnitude at 52 weeks.

Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes. Despite the presence of background insulin therapy, the incidences of hypoglycemia were similar on sotagliflozin and placebo.

LXRX closed at $2.10, last traded at $3.25.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Monopar files for patent for Covid-19 treatment

Monopar, NorthStar file provisional patent for development, use of RITs

Monopar Therapeutics (MNPR) and NorthStar Medical Radioisotopes announced that a provisional patent application entitled “Precision Radioimmunotherapeutic Targeting of the Urokinase Plasminogen Activator Receptor for Treatment of Severe COVID-19 Disease” has been filed with the U.S. Patent and Trademark Office.

The patent application offers hope for Covid-19 patients, Stockwinners

This application covers novel compositions and uses of cytotoxic radioisotopes attached to antibodies that bind to uPAR, thereby creating precision targeted radiotherapeutics for the treatment of severe COVID-19 and other respiratory diseases.

Advanced COVID-19 patients frequently develop severe, life-threatening, pulmonary inflammation as a result of a viral induced cytokine storm.

The development of this cytokine storm is associated with a high rate of mortality in severe COVID-19 patients, even with oxygen support and mechanical ventilation.

A severe immune reaction in which the body releases too many cytokines into the blood too quickly. Cytokines play an important role in normal immune responses, but having a large amount of them released in the body all at once can be harmful. A cytokine storm can occur as a result of an infection, autoimmune condition, or other disease. It may also occur after treatment with some types of immunotherapy.

Signs and symptoms include high fever, inflammation (redness and swelling), and severe fatigue and nausea. Sometimes, a cytokine storm may be severe or life threatening and lead to multiple organ failure. Also called hypercytokinemia.

uPRITs have been designed with the goal of selectively destroying the aberrantly activated white blood cells responsible for causing the cytokine storm.

If successful, healthy tissue would be spared in the process as the uPAR target is primarily only present on this unique class of white blood cells and not in healthy tissue.

The co-inventors of the provisional patent application are James Harvey, Chief Scientific Officer of NorthStar, and Andrew P. Mazar, Chief Scientific Officer of Monopar.

If granted, the patent would offer exclusivity to Monopar and NorthStar for the development and potential use of uPRITs in the treatment of severe COVID-19 and other respiratory diseases.

This provisional patent application leverages the therapeutic radioisotope expertise of NorthStar and the translational expertise of Monopar to create a novel, targeted radioimmunotherapeutic.

Radioimmunotherapy uses an antibody labeled with a radionuclide to deliver cytotoxic radiation to a target cell. In cancer therapy, an antibody with specificity for a tumor-associated antigen is used to deliver a lethal dose of radiation to the tumor cells.

On June 16, 2020, Monopar and NorthStar announced a 50/50 collaboration to couple Monopar’s MNPR-101 uPAR targeting monoclonal antibody to a therapeutic radioisotope provided by NorthStar.

MNPR closed at $6.91.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

American Airlines raises money!

American to sell more than $1.5B in shares, borrows $500M

American Airlines (AAL) announced proposed underwritten public offerings of $750,000,000 of shares of its common stock and $750,000,000 aggregate principal amount of its convertible senior notes due 2025.

The company intends to grant the underwriters of the offerings a 30-day option to purchase, in whole or in part, up to $112,500,000 of additional shares of Common Stock in the Common Stock Offering and a 30-day option to purchase, in whole or in part, up to $112,500,000 aggregate principal amount of additional Convertible Notes in the Convertible Notes Offering, in each case solely to cover over-allotments, if any.

The company expects to use the net proceeds from the Common Stock Offering and the Convertible Notes Offering for general corporate purposes and to enhance the company’s liquidity position.

The company also announced it intends to enter into a new $500M Term Loan B Facility due 2024 concurrently with the closing of the offering of the Notes.

12-Month chart of American Airlines stock

The company expects to use a portion of the net proceeds from the offering of the Notes and borrowings under the Term Loan to refinance its delayed draw term loan facility which the company and the Guarantor entered into on March 18, 2020 and is scheduled to mature on March 17, 2021, with the remainder for general corporate purposes and to enhance the company’s liquidity position.

AAL closed at $16.00.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Boeing 737-Max Recertification Flight is set for later this month

Boeing 737-Max Recertification Flight is scheduled for later this month

Boeing (BA) is targeting late June for a recertification flight on the grounded 737 Max, Bloomberg’s Alan Levin and Julie Johnsson report.

Boeing 737-Max recertification flight set for late June

The company separately is notifying airlines of an important fix to the grounded jetliner’s wiring, said two people familiar with the planning who asked not to be named discussing sensitive matters.

A draft of revised pilot training for the plane, which has been parked around the world since March 2019 as a result of two fatal crashes that killed 346 people, is also being shared with airlines, the people said.

Grounded 737-Max planes

The moves were strong indications that Boeing is finally nearing the end of the jet’s 15-month grounding and controversy that has engulfed the company after the two fatal crashes.

The flight by Federal Aviation Administration pilots to certify that the plane meets safety regulations is one of the critical remaining milestones. However, the people cautioned that the date hasn’t been finalized and has shifted repeatedly as Boeing completed its final work for regulators.

Boeing’s goal has been to return the 737 Max, a critical source of revenue, to commercial service in the third quarter. The company restarted manufacturing the single-aisle jet late last month, ending a five-month halt to work in its 737 factory in the Seattle suburb of Renton, Washington.

The company is revising a software system implicated in the two crashes that repeatedly drove down the noses of the jets due to a malfunction. Reviews of the plane’s safety following its March 13, 2019, grounding also discovered additional flaws that needed upgrading, including its flight-control computer, how electrical wires were bundled and software issues.

The FAA on Wednesday said it won’t approve the plane for passenger service until it is satisfied that all safety-related issues have been addressed.

BA is down 5% to $206.00

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

American Airlines reports improved bookings, Shares fly!

American Airlines to fly 55% of July 2019 domestic capacity in July 2020

American Airlines (AAL) announced that, “in response to improving demand for air travel,” American is planning to fly 55% of its domestic schedule and nearly 20% of its international schedule in July 2020 compared to the same period last year.

The airline’s July systemwide capacity amounts to approximately 40% of July 2019 flying.

The company added: “American saw an increase in demand in May. By the last week of May, the airline carried a daily average of about 110,000 customers per day – an increase of 71% over the approximately 32,000 average daily customers the airline served in April.

Compared to the spring, American is increasing frequency of flying from hubs, including Dallas Fort Worth International Airport and Charlotte Douglas International Airport to destinations customers are searching and booking most, with increased flying to major cities in Florida, Gulf Coast cities as well as mountain destinations.

AAL shares jump 35% on improved bookings

The airline also increased frequency of flying to Asheville, North Carolina, Savannah, Georgia, and Charleston, South Carolina for business and leisure travelers.”

The firm  said: “While international demand continued to be diminished, today marked the return of service to eight international destinations.

These include service from Dallas-Fort Worth to Amsterdam, Paris and Frankfurt, as well as service from Miami to Antigua in the Caribbean and Guayaquil and Quito in South America. American also restored additional service to London from Chicago and New York. 

The airline said: “American Airlines will begin reopening Admirals Club lounges in phases, beginning June 22, after making improvements to adapt the clubs and product offerings to reinforce the well-being of customers and everyone who works in the clubs…

American will continue to adhere to CDC guidelines, use enhanced cleaning measures and provide limited food and beverage offerings to help ensure the well-being of customers and team members.”

AAL is up 35% to $16.05.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

ARCA Biopharma shares soar on possible COVID-19 treatment

ARCA Biopharma announces AB201 development program for coagulopathy

ARCA biopharma (ABIO) announced a new development program to evaluate AB201, a potent, selective inhibitor of tissue factor as a potential treatment for COVID-19 associated coagulopathy and the related inflammatory response.

Coagulopathy (also called a bleeding disorder) is a condition in which the blood’s ability to coagulate (form clots) is impaired. This condition can cause a tendency toward prolonged or excessive bleeding (bleeding diathesis), which may occur spontaneously or following an injury or medical and dental procedures.

CAC is one of the most serious adverse effects seen in COVID-19 patients.

AB201 has previously undergone clinical testing through Phase 2 in more than 700 patients for other indications, generating substantial safety data, which the Company believes may enable more rapid development.

ARCA anticipates filing an Investigational New Drug application with the U.S. Food and Drug Administration in the third quarter and initiating late-stage clinical testing in the second half of this year.

TF is the protein responsible for initiating the primary or extrinsic coagulation pathway.

TF has been identified as playing a central role in the inflammatory response to viral infections and in the process of viral dissemination.

AB201, a single-chain, 85 amino acid, recombinant protein, has previously undergone Phase 1 and Phase 2 testing in more than 700 patients, including as an anti-thrombotic agent in the setting of acute myocardial infarction, where it showed efficacy in inhibiting the TF pathway and was well tolerated at therapeutic doses.

Recent research suggests that the disease syndrome caused by coronavirus may have much in common with other coagulopathic disorders in which the blood’s ability to coagulate is impaired by consumption of clotting factors.

For example, filovirus infections such as Ebola and other hemorrhagic fevers are characterized by dysregulated activation of the TF pathway, resulting in abnormal systemic coagulation and related inflammation, leading to organ failure and mortality.

Recent mechanistic discoveries, as well as data from studies in non-human primates given lethal doses of Ebola or Marburg filoviruses demonstrating mortality reductions, decreases in inflammatory biomarkers and reduction in viral load, indicate that AB201 may have important antiviral and anti-inflammatory activity in addition to its anticoagulant effects.

Collectively, the Company believes these observations provide a strong rationale for investigating AB201 as a treatment for COVID-19, the disease caused by SARS CoV-2 virus.

COVID-19 disease is associated with a significant incidence of coagulation-related adverse events, including stroke, MI, pulmonary emboli, and disseminated intravascular coagulation, a condition in which small blood clots develop throughout the bloodstream.

A commonly used biomarker for assessing coagulation activation is a D-dimer test, which is elevated in approximately 50% of hospitalized COVID-19 patients and is directly associated with adverse clinical outcomes.

In Ebola or Marburg NHP models, AB201 inhibited the DIC process, as measured by lowered D-dimer levels, which the Company believes provides further support for its therapeutic potential for CAC. The Company believes the efficacy of AB201 against COVID-19 disease may not be affected by potential mutations of the SARS CoV-2 virus, would be additive with therapeutics inhibiting virus-cell binding or viral RNA polymerase, and could be effective against other coagulopathy-associated viruses.

The Company anticipates filing an IND application for AB201 as a potential treatment for COVID-19 with the FDA in the third quarter of this year. In collaboration with the Colorado Prevention Center, the University of Colorado’s Academic Research Organization directed by Marc Bonaca, MD, a vascular and anti-coagulation clinical trialist, a Phase 2B/3 clinical trial protocol is being developed for hospitalized COVID-19 patients with elevated D-dimer levels.

Pending FDA concurrence and obtaining trial funding, ARCA estimates initiating late-stage clinical testing of AB201 in the second half of 2020.

ABIO is up 206% to $12.16.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Moderna shares jump on Fauci comments, possible COVID-19 vaccine

Moderna rises as Fauci comments on COVID vaccine potential highlighted

Shares of Moderna (MRNA) are trading higher, which is being attributed to comments made earlier this week by Dr. Anthony Fauci, the U.S. National Institute of Allergy and Infectious Diseases Director who has become one of the faces of the Trump administration’s COVID-19 response.

Fauci highlighted Moderna’s COVID-19 vaccine candidate, as well as another one in development at Oxford University, in an interview with National Geographic this week, telling the publication that he believes that the U.S. will have a vaccine ready for general use as soon as January “When we look at the immune response that you can induce with a modest dose – one that’s feasible to be translated into humans – and the amount of time it takes to get to that level of immunity, it is really quite impressive,” Fauci was quoted as saying when discussing both Moderna’s vaccine candidate and the one being developed at Oxford.

Modernal shares are higher on its vaccine potentail

“It is also really easy to scale up with these two, in the sense of making a lot of doses pretty quickly,” he reportedly added.

Dr. Fauci has been government’s leading Covid-19 expert

The interview, published two days ago, may be getting added attention after The Boston Business Journal published a recap with the headline “Fauci singles out Moderna’s coronavirus vaccine as reason for optimism” yesterday afternoon.

Moderna, Inc. (MRNA) is a clinical stage biotechnology company. It develops therapeutics and vaccines based on messenger RNA for the treatment of infectious diseases, immuno-oncology, rare diseases, and cardiovascular diseases.

Covid 19 has killed thousands of people worldwide

As of February 15, 2019 the company had 11 programs in clinical trials and a total of 20 development candidates in six modalities comprising prophylactic vaccines, cancer vaccines, intratumoral immuno-oncology, localized regenerative therapeutics, systemic secreted therapeutics, and systemic intracellular therapeutics. Moderna, Inc. also has a collaboration with Lonza Ltd. for the manufacture of mRNA-1273, a COVID-19 vaccine.

MRNA is up 9.5% to $53.50.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

Smile Direct receives patent for its concept

SmileDirectClub granted patent for SmileShop retail concept

SmileDirectClub (SDC) announced it has been issued a patent for its SmileShop intellectual property from the United States Patent & Trademark Office.

SmileDirect receives patent for its concept, Stockwinners

The patent, U.S. Patent No. 10,636,522, further strengthens the telehealth dentistry pioneer’s efforts to bring affordable, accessible oral care to more people through its unique and innovative teledentistry platform and direct-to-consumer business model.

The patent ensures no clear aligner competitor will be able to duplicate SmileDirectClub’s unique model for 18 years.

The patent encompasses the unique SmileShop concept and process, including scheduling of an appointment at a SmileShop, sending the scheduling confirmation to the customer, conducting the intraoral scan, generating a treatment plan, receiving approval of the treatment plan by a licensed dentist or orthodontist, producing aligners in accordance with the treatment plan, and sending those aligners to the customer.

Smile Direct eliminates the middle man, Stockwinners

SmileDirectClub’s clear aligner therapy platform has helped more than 1,000,000 customers achieve a straighter and brighter smile.

Furthermore, the company announced it is making plans to slowly reopen its SmileShops beginning in May in the U.S., Canada, Germany, Australia, New Zealand, the UK and Ireland as local governments begin to lift business restrictions.

After its shops temporarily closed in March, SmileDirectClub, one of North America’s largest 3D printing manufacturers, dedicated some of its capacity to producing 3D printed personal protective equipment to help in the fight against COVID-19.

Smile Direct has an alliance with WalMart, Stockwinners

The company has shipped more than 40,000 face shields to medical organizations, elder care facilities, dentists and orthodontists during this time, and will supply all of its SmileShop team members with face shields and other PPE along with staggered appointment times, temperature scans and other social distancing measures to ensure a safe, sanitary experience upon reopening.

SDC closed at $5.39, it last traded at $7.20.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

L Brands shares tumble after buyer backs out of the deal

Sycamore Partners had agreed in February to acquire 55% of the company

Shares of L Brands fell sharply after Bloomberg reported that Sycamore Partners is seeking to terminate its agreement with the company regarding the Victoria’s Secret brand.

Bloomberg cites a court complaint filed by Sycamore in a Delaware court.

On February 20, L Brands and Sycamore Partners, a private equity firm specializing in consumer and retail investments, announced a strategic transaction that would position Bath & Body Works as a standalone public company and separate Victoria’s Secret Lingerie, Victoria’s Secret Beauty and PINK into a privately-held entity.

Sycamore Partners is seeking to terminate its agreement to acquire a controlling stake in Victoria’s Secret from L Brands, Bloomberg’s Ed Hammond and Elizabeth Fournier report, citing a court filing. Sycamore in February had agreed to purchase 55% of the lingerie chain and take it private, leaving L Brands with a minority interest, the authors note.

Sales at Victoria’s Secret have been declining recently, Stockwinners

Before the pandemic disrupted the U.S. retail sector, Victoria’s Secret was struggling with plunging sales, and all of its U.S. retail locations are currently closed, the authors say.

Victoria’s Secret’s sales had been slowing for years , as the company wrestled with changing consumers tastes and how its customers shopper. 

Sycamore sues to cancel the deal, Stockwinners

L Brands, Inc. (LB) today announced that Sycamore Partners delivered a notice on April 22, 2020 purporting to terminate the Feb. 20, 2020 transaction agreement  (“Transaction Agreement”) relating to the sale of a 55% interest in Victoria’s Secret Lingerie, Victoria’s Secret Beauty and PINK (collectively, Victoria’s Secret) announced on Feb. 20, 2020. 

Sycamore Partners also filed a lawsuit in the Court of Chancery of the State of Delaware on April 22, 2020 seeking a declaratory judgment that its termination of the Transaction Agreement is valid. 

L-Brands has been under pressure to create value for share holders, Stockwinners

L Brands believes that Sycamore Partners’ purported termination of the Transaction Agreement is invalid.  L Brands will vigorously defend the lawsuit and pursue all legal remedies to enforce its contractual rights, including the right of specific performance. 

L Brands intends to continue working towards closing the transactions contemplated by the Transaction Agreement.

LB is down 21% to $9.57.

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.

AVX sold for about $3.7B

AVX to be acquired by Kyocera for $21.75 per share in cash

AVX Corp. (AVX) announced that Kyocera and AVX have entered into a definitive merger agreement providing for the acquisition by Kyocera of all the outstanding shares of common stock of AVX not owned by Kyocera pursuant to an all-cash tender offer for $21.75 per share, followed by a squeeze-out merger in which all of the outstanding shares of AVX common stock not tendered in the Tender Offer will be converted into the right to receive $21.75 per share of common stock, in cash.

Kyocera currently owns approximately 72% of the outstanding shares of AVX common stock.

Following completion of the Transaction, AVX will become a wholly owned subsidiary of Kyocera.

Kyocera buys the rest of AVX shares that it did not own, Stockwinners

The $21.75 offer price represents a 44.6% premium over AVX’s closing price on November 26, 2019 and a 42.1%, 42.4%, and 34.9% premium over AVX’s 1-, 3- and 12- month average closing share price, respectively.

As previously announced, following receipt of a proposal from Kyocera to acquire all of the outstanding shares of AVX common stock that Kyocera does not own for a price of $19.50 in cash, the AVX board of directors appointed a special committee consisting of three independent directors of AVX for purposes of evaluating and negotiating a potential transaction with Kyocera.

AVX Corp. sold to Kyocera, Stockwinners

Following the formation of the Special Committee, Kyocera and the Special Committee have been in discussions and negotiations regarding Kyocera’s proposal to acquire all of the outstanding shares of common stock of AVX not owned by Kyocera.

The board of AVX, acting on the recommendation of the Special Committee, has approved the Transaction and determined to recommend that the AVX stockholders tender their shares in the Tender Offer.

The Transaction is subject to customary closing conditions and is not subject to any financing condition. Kyocera has announced that it currently expects the Transaction to close in the fourth quarter of Kyocera’s fiscal year ending March 2020.

The Tender Offer will be subject to customary conditions and will not be subject to any minimum condition.

AVX is a leading worldwide manufacturer, supplier, and reseller of a broad line of electronic components, interconnect, sensing and control devices, and related products. Electronic components and connector, sensing and control products manufactured or resold by AVX are used in many types of end use products, including those in telecommunications, automotive, transportation, energy harvesting, consumer electronics, military/aerospace, medical, computer, and industrial markets. 

STOCKWINNERS

To read timely stories similar to this, along with money making trade ideas, sign up for a membership to Stockwinners.

This article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility.