Why Is Anew Medical (WENA) Stock Up

• Anew Medical (WENA) stock is rising on Tuesday on development plans.
• The company plans to advance its patented Klotho gene therapy program.

Anew Medical (NASDAQ:WENA) stock is soaring higher on Tuesday after the biopharmaceutical company announced advancement plans for its patented Klotho gene therapy program.

According to Anew Medical, it intends to advance this treatment for neurodegenerative disorders. It’s doing so alongside initial data showing Klotho levels may affect ALS, Alzheimer’s and Parkinson’s Disease.

Anew Medical intends to start clinical trials of its Klotho gene therapy program. The company will also work on diagnostic tools to allow for the measuring of Klotho levels. Finally, it plans to explore the ability to promote longevity in healthy individuals using its program.

https://investorplace.com/2024/07/why-is-anew-medical-wena-stock-up-51-today/

uniQure Positive Interim Data on Slowing Disease Progression in Phase I/II Trials in Huntington’s

 Achieved statistically significant, dose-dependent, and durable evidence of potential therapeutic benefit; Patients receiving high-dose AMT-130 showed 80% slowing of disease progression in the composite Unified Huntington’s Disease Rating Scale (cUHDRS) at 24 months compared to a propensity score-weighted external control ~

~ Achieved statistically significant lowering of CSF neurofilament light protein (NfL) compared to baseline at 24 months in patients treated with AMT-130; Mean CSF NfL levels for both doses were below baseline at 24 months ~

~ Granted first-ever Regenerative Medicine Advanced Therapy (RMAT) designation in Huntington’s disease; uniQure expects to meet with the FDA in the second half of 2024 to discuss potential for expedited clinical development ~

~ Investor conference call and webcast today at 8:30 a.m. ET ~

uniQure management will host an investor conference call and webcast today, Tuesday, July 9 at 8:30 a.m. ET. The event will be webcast under the Events & Presentations section of uniQure’s website at https://www.uniqure.com/investors-media/events-presentations, and following the event a replay will be archived for 90 days. Interested parties participating by phone will need to register using this online form. After registering for dial-in details, all phone participants will receive an auto-generated e-mail containing a link to the dial-in number along with a personal PIN number to use to access the event by phone. If you are joining the conference call, please dial in 15 minutes before the start time.

https://www.globenewswire.com/news-release/2024/07/09/2910220/0/en/uniQure-Announces-Positive-Interim-Data-Update-Demonstrating-Slowing-of-Disease-Progression-in-Phase-I-II-Trials-of-AMT-130-for-Huntington-s-Disease.html

Soligenix Expanded HyBryte™ Treatment Positive Outcomes in Early-Stage Cutaneous T-Cell Lymphoma

 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced an interim update on the open-label, investigator-initiated study (IIS) evaluating extended HyBryte™ treatment for up to 12 months in patients with early-stage cutaneous T-cell lymphoma (CTCL). The trial is sponsored by Ellen Kim, MD, Director, Penn Cutaneous Lymphoma Program, Vice Chair of Clinical Operations, Dermatology Department, and Professor of Dermatology at the Hospital of the University of Pennsylvania who was a leading enroller in the Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study for the treatment of early-stage CTCL. To date six patients have been enrolled and treated with HyBryte™ over a time period ranging up to 44 weeks. Patients have responded positively to HyBryte™ therapy with 75% (3 of the 4 subjects who have completed at least 12 weeks of therapy) already achieving "Treatment Success", as predefined in the study's protocol as ≥50% improvement in their cumulative mCAILS (modified Composite Assessment of Index Lesion Severity) score compared to Baseline. Of the three Treatment Successes, two were achieved within the first 12 weeks of treatment and the third within 18 weeks. Of the remaining three patients, two have only recently started HyBryte™ therapy and have not yet reached their first efficacy evaluation visit (i.e., at Week 6) and the other had a substantial improvement documented at the Week 18 visit, but has not yet achieved the success threshold. In addition, HyBryte™ appears to be safe and well tolerated in all patients, with no treatment-related adverse events reported to date.

https://www.prnewswire.com/news-releases/expanded-hybryte-treatment-demonstrating-positive-outcomes-in-early-stage-cutaneous-t-cell-lymphoma-302190262.html

Prescription-drug middlemen face more pressure from FTC in new report

 Largest pharmacy benefit managers have amassed market power at the expense of patients and independent pharmacies, FTC says

The U.S. Federal Trade Commission on Tuesday ramped up the pressure on prescription-drug middlemen who influence the accessibility and affordability of medications.

In a new report, the FTC detailed how just a handful of large pharmacy benefit managers have amassed market power that significantly impacts patients as well as independent pharmacists.

The six largest PBMs now manage 94% of all prescriptions filled in the U.S., according to the report. The industry's increasing vertical integration and concentration "has allowed PBMs to profit at the expense of patients and independent pharmacists," the FTC said in a release.

PBMs, which manage prescription-drug benefits on behalf of insurers, large employers and other payers, have also been under scrutiny from members of Congress and state attorneys general who question whether their business practices are driving up drug prices.

The interim staff report from the FTC's policy planning office comes more than two years after the FTC first launched its inquiry into PBMs, saying it would require the industry's six largest players to turn over details on their business practices.

Some of those details have not been forthcoming, the agency said Tuesday, noting that it has demanded that the companies submit the required details promptly. If any companies fail to fully comply "or engage in further delay tactics," the agency said in the release, "the FTC can take them to district court to compel compliance."

FTC chair Lina Khan signaled in April that she would not wait long for companies to submit all their details but would look to inform the public promptly about any preliminary conclusions from the inquiry. The Commission voted 4-to-1 to allow staff to issue the interim report, the agency said.

The top three PBMs-CVS Health Corp.'s (CVS) CVS Caremark, Cigna Group's (CI) Express Scripts, and UnitedHealth Group Inc.'s (UNH) Optum Rx-processed nearly 80% of the roughly 6.6 billion prescriptions dispensed by U.S. pharmacies last year, the report said.

CVS Caremark said in a statement that its members on average pay less than $8 per 30-day supply of medication and that brand-name drug net prices have dropped several years in a row. "This is the work we do every day on behalf of the businesses who provide benefits to their employees," the company said.

Spokespeople for Express Scripts and Optum Rx did not immediately respond to requests for comment on the report. The Pharmaceutical Care Management Association, an industry trade group, has said that PBMs help health plan sponsors and consumers save money on prescriptions by creating networks of more affordable pharmacies, encouraging the use of generics, negotiating rebates from drug makers, and other services.

But the new report "lays out how dominant pharmacy benefit managers can hike the cost of drugs-including overcharging patients for cancer drugs," Khan said in a statement Tuesday.

Companies operating the country's largest PBMs also own major health insurers and specialty and retail pharmacies, the report noted. This "vertical integration" lets PBMs favor their own businesses, such as by steering patients to their affiliated pharmacies and away from smaller, independent pharmacies, the FTC said. Pharmacies affiliated with the three largest PBMs now account for more than two-thirds of all specialty drug revenue, according to the report.

Such practices have allowed the three largest PBMs' pharmacies to retain large amounts of dispensing revenue in excess of their estimated drug acquisition costs, the FTC said, including nearly $1.6 billion in excess revenue from just two cancer drugs in less than three years. The analysis suggests "a misalignment of incentives where PBMs are not lowering prices for drugs used by patients to treat severe diseases like prostate cancer and leukemia," the report said.

https://www.morningstar.com/news/marketwatch/2024070985/prescription-drug-middlemen-face-more-pressure-from-ftc-in-new-report

A 'deeper' S&P 500 pullback is coming, Piper Sandler warns

 Piper Sandler analysts are cautioning investors about a potential correction in the S&P 500, despite recent highs. Their note highlights a weakening market that could lead to a significant pullback.

In today's note warning of a potential correction, Piper Sandler stated: "Deteriorating market breadth and narrowing leadership" are the key concerns.

This means that fewer stocks are participating in the rally, and investors are focusing on a limited group of high-performing companies. They argue that this undermines the sustainability of the current upswing.

However, it goes against a separate note from the firm this week that said its analysts believe Wall Street will remain bullish until unemployment reaches 4.5% and they remain constructive. Even so, they flagged that most market downturns occur from either higher rates or unemployment.

Nevertheless, Piper Sandler said its technical indicators also point towards a correction. Piper Sandler's "40-week Technique indicator" shows a low number of stocks trending positively, suggesting weaker market internals.

While the recent jobs report might lead to a Fed rate cut, Piper Sandler says other factors are concerning.

"The MID and RTY are below their 50-day MAs and poised for a leg lower toward their respective 200-day MAs," the firm states, indicating a potential decline in mid-cap and small-cap stocks.

Despite maintaining its year-end target, Piper Sandler expects a "deeper pullback/correction in the coming months." They believe the S&P 500 is overdue for a 10% correction towards its long-term uptrend. In conclusion, Piper Sandler advises investors to be cautious. The current market dynamics suggest a correction is likely, and investors should prioritize vigilance over complacency.

https://www.investing.com/news/stock-market-news/pfizers-longtime-science-chief-mikael-dolsten-to-step-down-3511483

Antifa Radicals Elected To The French And European Parliaments

 by Jonathan Turley,

For many years, I have testified and written about Antifa and its growing anti-free speech philosophy. Some Democratic leaders have embraced this violent movement, which continues to gain strength on campuses and its cities across the nation. It is also a global movement. That is reflected in the alarming election of Antifa candidates to the French National Assembly as well as the European Parliament.  That is quite an accomplishment for a movement that President Joe Biden dismissed as “just an idea.”

As discussed in my new book, “The Indispensable Right: Free Speech in an Age of Rage,” I explore the history of Antifa as a movement that began in Germany:

“Antifa originated with European anarchist and Marxist groups from the 1920s, particularly Antifaschistische Aktion, a Communist group from the Weimar Republic before World War II. Its name resulted from the shortening of the German word antifaschistisch. In the United States, the modern movement emerged through the Anti- Racist Action (ARA) groups, which were dominated by anarchists and Marxists. It has an association with the anarchist organization Love and Rage, which was founded by former Trotsky and Marxist followers as well as offshoots like Mexico’s Amor Y Rabia. The oldest U.S. group is likely the Rose City Antifa (RCA) in Portland, Oregon, which would become the center of violent riots during the Trump years. The anarchist roots of the group give it the same organizational profile as such groups in the early twentieth century with uncertain leadership and undefined structures.”

Despite the denial of its existence by figures like Rep. Jerry Nadler (D., N.Y.), I have long written and spoken about the threat of Antifa to free speech on our campuses and in our communities. This includes testimony before Congress on Antifa’s central role in the anti-free speech movement nationally.

As I have previously written, it has long been the “Keyser Söze” of the anti-free speech movement, a loosely aligned group that employs measures to avoid easy detection or association.  Yet, FBI Director Chris Wray has repeatedly pushed back on the denials of Antifa’s work or violence. In one hearing, Wray stated “And we have quite a number” — and “Antifa is a real thing. It’s not a fiction.”

We have continued to follow the attacks and arrests of Antifa followers across the country, including attacks on journalists.

Some Democrats have played a dangerous game in supporting or excusing the work of Antifa. Former Democratic National Committee deputy chair Keith Ellison, now the Minnesota attorney general, once said Antifa would “strike fear in the heart” of Trump. This was after Antifa had been involved in numerous acts of violence and its website was banned in Germany.

Ellison’s son, Minneapolis City Council member Jeremiah Ellison, declared his allegiance to Antifa in the heat of the protests this summer. During a prior hearing, Democratic senators refused to clearly denounce Antifa and falsely suggested that the far right was the primary cause of recent violence. Likewise, Joe Biden has dismissed objections to Antifa as just “an idea.”

It is at its base a movement at war with free speech, defining the right itself as a tool of oppression. That purpose is evident in what is called the “bible” of the Antifa movement: Rutgers Professor Mark Bray’s Antifa: The Anti-Fascist Handbook.

Bray emphasizes the struggle of the movement against free speech: “At the heart of the anti-fascist outlook is a rejection of the classical liberal phrase that says, ‘I disapprove of what you say but I will defend to the death your right to say it.’”

Bray admits that “most Americans in Antifa have been anarchists or antiauthoritarian communists…  From that standpoint, ‘free speech’ as such is merely a bourgeois fantasy unworthy of consideration.”

The movement continues to take hold among parties on the left. An Antifa leader who is on France’s national security watchlist was elected to the National Assembly as a member of the New Popular Front leftist bloc.  Raphaël Arnault will represent Vaucluse in Provence in the French parliament after winning with 54.98 per cent of the vote, according to Le Figaro.

French President Emmanuel Macron and his moderate party worked with the New Popular Front in a power deal to defeat conservatives.

Antifa was part of that front.

In Italy, Ilaria Salis, a school teacher by trade from Milan, Italy, has been elected to the European Parliament despite being arrested in 2023 in Budapest for allegedly taking part in the organized attack by Antifa on attendees of an event commemorating the anniversary of the siege of the Buda castle by the Soviet forces in 1945. Salis’ far-left green alliance Alleanza Verdi e Sinistra (AVS) succeeded in securing the seat with the backing of far-left Jean-Luc Mélenchon’s La France Insoumise (LFI) party — a member of the New Popular Front alliance.

These two milestones were secured only with the help of mainstream parties and leaders who continue to delude themselves about Antifa and its true agenda. While convenient allies now to win elections, these same leaders could soon find themselves the next reactionaries denounced by these same radical groups as they gain greater power.

https://www.zerohedge.com/political/antifa-radicals-elected-french-and-european-parliaments

Mesoblast Resubmits Application in Graft-Versus-Host Disease

  Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, announced today it has resubmitted its BLA for approval of Ryoncil^® (remestemcel-L) in the treatment of children with SR-aGVHD.

The filing comes after Mesoblast was informed by FDA at the end of March that, following additional consideration, the available clinical data from the Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed BLA for remestemcel-L for treatment of pediatric patients with SR-aGVHD. As a result, the filing addresses remaining CMC (Chemistry, Manufacturing, and Control) items.

https://www.biospace.com/article/releases/mesoblast-resubmits-biologics-license-application-bla-with-united-states-food-and-drug-administration-fda-for-approval-of-ryoncil-in-children-with-steroid-refractory-acute-graft-versus-host-disease-sr-agvhd-/