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Monday, May 13, 2024

Merck Ends Phase III Anti-TIGIT, Keytruda Skin Cancer Study with High Dropouts

 Following a high rate of adverse experience-related dropouts, Merck called it quits Monday on a Phase III trial of its anti-TIGIT antibody vibostolimab and anti-PD-1 therapy Keytruda in skin cancer. 

The late-stage study was evaluating vibostolimab as an adjuvant treatment to Keytruda in patients with resected, high-risk melanoma. The investigational anti-TIGIT antibody works by restoring antitumor activity by blocking the TIGIT receptor from binding to its ligands to help T lymphocytes destroy tumor cells.  

A pre-planned analysis revealed the high rate of dropouts, primarily due to immune-mediated adverse events, making it “highly unlikely that the trial could achieve a statistically significant improvement” in recurrence-free survival.

Based on the recommendation of an independent data monitoring committee, Merck said it is unblinding the study to offer Keytruda alone to patients who had been receiving the combination treatment and sharing the results with the scientific community and regulatory agencies. 

Keytruda is currently approved in two skin cancer indications for patients with metastatic or unresectable melanoma, and as an adjuvant for certain stages following surgery. Merck continues efforts to move its blockbuster anti-PD-1 therapy up to an earlier line of treatment. The company is pursuing an ongoing Phase III study combining Keytruda with Moderna’s individualized neoantigen therapy, V940, in patients with resected, high-risk melanoma. 

“We continue to ask the tough questions in an effort to fully explore the potential of novel coformulations and combinations that build on the foundation of Keytruda, with a goal to improve upon current standards of care and help even more patients with cancer,” Marjorie Green, head of oncology for Merck Research Laboratories, said in a statement. 

The Keytruda-vibostolimab coformulation is in ongoing Phase III trials for lung cancer. Merck pointed out in Monday’s announcement that interim safety reviews have not resulted in any study modifications in these studies.  

In December 2023, the company announced the combination treatment failed to meet endpoints in a Phase II study of metastatic non-small cell lung cancer patients with progressive disease after treatment with immunotherapy and chemotherapy.  

https://www.biospace.com/article/merck-halts-phase-iii-anti-tigit-keytruda-skin-cancer-study-with-high-dropouts-/

Incyte Plans to Buy Back up to $2.0 Billion of its Common Stock

 -Incyte Corporation (Nasdaq:INCY) (the “Company”) today announced that its Board of Directors approved a share repurchase authorization of $2.0 billion. The Company has commenced a modified “Dutch Auction” tender offer to repurchase shares of its common stock for an aggregate purchase price of up to $1.672 billion (the “tender offer”).

“This tender offer reflects our confidence in the future outlook of our business, the strength of our commercial product portfolio and our clinical development pipeline and Incyte’s long-term value. We believe the current valuation of Incyte stock makes repurchases of our stock an attractive investment and an opportunity to enhance long-term shareholder value,” said HervĂ© Hoppenot, Chief Executive Officer, Incyte. “Our strong balance sheet, cash flow and access to capital enable us to undertake this transaction while also preserving the flexibility to further add to the growth of our business through focused, strategic acquisitions.”

In addition, on May 12, 2024, Incyte entered into a separate stock purchase agreement with Julian C. Baker (a member of Incyte’s Board of Directors), Felix J. Baker, and entities affiliated with Julian C. and Felix J. Baker, including funds advised by Baker Bros. Advisors LP (collectively, the “Baker Entities”), to repurchase up to $328.0 million of the Company’s common stock. This would enable the Baker Entities to maintain their current ownership level of approximately 16.4 percent of Incyte’s outstanding common stock. The Baker Entities purchase will be at the same price per share as is determined and paid in the tender offer.

https://www.businesswire.com/news/home/20240513823141/en/

Verrica Q1 2024 Results

On May 13, 2024, Verrica Pharmaceuticals Inc (NASDAQ:VRCA) disclosed its financial results for the first quarter of 2024 through its 8-K filing. The company, a key player in dermatology therapeutics, is known for developing innovative treatments for skin diseases that require medical intervention. Among its notable products, YCANTH stands out as a leading treatment for molluscum contagiosum, a common and contagious skin condition.

Company Overview and Recent Developments

Verrica Pharmaceuticals continues to focus on its flagship product, YCANTH, which recently achieved significant milestones including a permanent J-Code from CMS and new chemical entity status from the FDA. These developments are likely to enhance the product's market penetration and usage. Furthermore, Verrica is advancing its pipeline with VP-315, a promising candidate for the treatment of basal cell carcinoma, with Phase 2 results anticipated later in the quarter.

Financial Performance Insights

For Q1 2024, Verrica reported a revenue of $3.83 million, a substantial increase from $37,000 in the same period last year, primarily driven by the sales of YCANTH which contributed $3.23 million. This performance significantly exceeds analyst expectations, which estimated revenue at $2.78 million for the quarter. However, the company's net loss widened to $20.33 million, or $0.44 per share, compared to a net loss of $6.59 million, or $0.15 per share, a year ago. This increase in loss was influenced by higher operating expenses, which surged to $22.43 million from $7.13 million, reflecting expanded commercial activities and ongoing research and development efforts.

Balance Sheet and Liquidity Position

As of March 31, 2024, Verrica's financial position showed $48.94 million in cash and cash equivalents, down from $69.55 million at the end of 2023. The total assets stood at $66.31 million, while total liabilities were reported at $64.80 million. This liquidity position underscores the company's ongoing investment in its commercial and development activities.

Non-GAAP Financial Measures

Verrica also provided non-GAAP financial measures, adjusting for stock-based compensation and non-cash interest expenses. The adjusted net loss for the quarter was $17.78 million, or $0.38 per share, providing a slightly more favorable view of the company's financial health by excluding non-cash charges.

Strategic Outlook and Forward-Looking Statements

Looking ahead, Verrica is optimistic about the potential for YCANTH following the implementation of the permanent J-Code. The company also anticipates significant clinical advancements with its VP-315 study results expected soon. These developments could play a crucial role in shaping Verrica's future, both clinically and commercially.

Overall, while Verrica Pharmaceuticals Inc (NASDAQ:VRCA) faces challenges in terms of widening losses, its strategic advancements and robust product pipeline offer potential pathways for growth and value creation in the competitive dermatology therapeutics market.

https://finance.yahoo.com/news/verrica-pharmaceuticals-inc-vrca-reports-131226096.html

Takeda, AC Immune in Option and Licence Agreement, Including on Alzheimer's Treatment

  Takeda to receive exclusive option to license global rights to ACI-24.060, a potential first-in-class active immunotherapy designed to delay or slow Alzheimer’s disease progression

− AC Immune to receive upfront payment of $100 million upon closing and be eligible for an option exercise fee and additional potential milestones of up to approximately $2.1 billion

− AC Immune to host conference call and webcast today at 8:30 a.m. ET

AC Immune management will host a conference call and webcast today at 8:30 a.m. ET to provide a brief overview of the agreement.

Monday, May 13 at 8:30 a.m. ET 
Participants wishing to ask questions or to join the event via phone may call the following numbers 10 – 15 minutes before conference start:

United States

+1 (1) 631 570 56 13

Switzerland / Europe

+41 (0) 58 310 50 00

United Kingdom

+44 (0) 207 107 06 13

Other international numbers available

HERE

Webcast: 
https://event.choruscall.com/mediaframe/webcast.html?webcastid=YteAZhdg 
Please note that there is a function to type in your questions via webcast.

A live and archived webcast will also be accessible in the Investors section of the Company's website at https://www.acimmune.com/.

https://www.businesswire.com/news/home/20240510475155/en/

CareCloud Gets xpression of Interest in Being Acquired at $5 a Share

 CareCloud, Inc. (the “Company” or “CareCloud”) (Nasdaq: CCLD, CCLDP and CCLDO), a leader in healthcare technology solutions for medical practices and health systems nationwide, today released details regarding its receipt of an unsolicited, non-binding indication of interest dated March 4, 2024, to acquire the Company for $5.00 per share of its common stock, and the $25 redemption price per share of its 8.75% Series B Cumulative Redeemable Perpetual Preferred Stock (“Series B Preferred Stock”). The indication of interest was subject to satisfactory due diligence.

The letter made no mention of the treatment of the Company’s 11% Series A Cumulative Redeemable Perpetual Preferred Stock (“Series A Preferred Stock”), which the Company believes was due to their respective redemption provisions on a change of control that enables a buyer to take the Company private while leaving the Series A Preferred Stock as a publicly traded security. The Company’s Board of Directors thoroughly evaluated the indication of interest and determined it was in the Company’s best interests to decline it in its present form.

Prompted by the indication of interest, the Company retained an investment bank to examine and evaluate the terms of its Series A Preferred Stock, including the differing redemption rights afforded to Series A preferred stockholders as compared to Series B preferred stockholders, and to make recommendations to the Board of Directors that may be beneficial to the Company and its shareholders.

https://www.globenewswire.com/news-release/2024/05/13/2880375/16541/en/CareCloud-Capital-Structure-Update.html

Sunday, May 12, 2024

Revolving door for mentally ill puts all New Yorkers in danger

“The system is just broken,” said retired NYPD detective and John Jay College adjunct professor Michael Alcazar. “If he’s violent and emotionally disturbed . . . they should just keep him in the hospital. Somebody is dropping the ball.”

Alcazar was speaking of Nicholas Babilonia Jr., a violent, mentally ill man with the charming nom de guerre of Ice Pick Nick.

Ice Pick has 37 arrests and likes to roam around the East Village assaulting people. He threatens to kill people, chases residents and waves around his weapon of choice. As Sunday’s Post explained, the NYPD is well aware of Ice Pick’s issues.

They pick him up and stick him in Bellevue, where he’s treated for mental-health issues.

He’s let go in days, maybe just hours, and is right back on the streets.

A similar case is Shaquan Cummings, another mentally ill man, who on Friday in Harlem stabbed an 11-year-old in the head.

And in Times Square on Saturday, Cyril Destin is suspected of being the man who stood up from his walker, pulled out a knife and stabbed a random tourist.

Like Ice Pick, these two are no strangers to the justice system. Cummings has around 20 arrests. Destin,
The police know who these menaces are.

They are a small number of mentally ill vagrants who terrorize neighborhoods and transit hubs, ticking time bombs who are picked up and let go for low-level harassment, spewing profanity or spitting on a passerby.

That is, until they push someone in front of a train. After which, a person is dead, and they are in prison for life.

That’s certainly where Ice Pick is headed, says East Village resident Garrett Rosso. “If he doesn’t get that help, he’s either going to kill someone, or going to kill himself.”

“Defunders” say the mentally ill need assistance, not police intervention, yet they stand in the way of that actually happening. Homeless advocates have pushed court case after court case to prevent involuntary institutionalization and medication. They want sleeping on the streets to be legal and to enable narcotics usage with injection sites.

“Although preserving the rights of people with severe mental illness to be treated in the least restrictive settings is noble, it has allowed many people . . . to be rehospitalized in what has been termed the ‘revolving door’ of acute hospital admissions,” notes Dr. Daniel Yohanna in the American Medical Association’s Journal of Ethics.

“The term ‘dying with one’s rights on’ was coined by Darold Treffert in 1973 to describe how the laws have gone too far in protecting the rights of individuals at the expense of their safety and well-being.”

Fifty years ago. That’s at least how long New York has been grappling with this issue.
Mayor Adams’ idea is to target 100 of the “hardest to reach” homeless, often mentally ill New Yorkers to get them off the street. In November, he claimed more than half had been brought to a shelter or put in a hospital bed.

Mayoral wake-up call

We want this to succeed, but Adams must bring new urgency to this initiative after last weekend’s incidents. Cummings and Destin weren’t reached before someone else got hurt.

Ice Pick Nick wasn’t either; he was arrested Thursday for threatening someone with a metal pipe.

Mr. Mayor, these three were also among the “hardest to reach.”

Let’s not take no for an answer anymore.

And for the liberal social justice and legal groups that would prevent the city from treating these men with a lawsuit or lobbying, think about what is the best possible outcome for us — and them.

We can’t say it better than Chris Ryan, an East Village resident quoted in Sunday’s Post about Ice Pick Nick: “Anyone who thinks they’re being empathetic or charitable by letting this guy rot out on the street, provoking the next violent encounter, has to examine their own perspectives.”

https://nypost.com/2024/05/12/opinion/revolving-door-for-mentally-ill-vagrants-puts-all-new-yorkers-in-danger/

Putin taps civilian economist to run defense, replacing Shoigu in surprise move

 Russian President Vladimir Putin tapped a civilian economist as his surprise new defence minister on Sunday in an attempt to gird Russia for economic war by trying to better utilise the defence budget and harness greater innovation to win in Ukraine.

More than two years into the conflict, which has cost both sides heavy casualties, Putin proposed Andrei Belousov, a 65-year-old former deputy prime minister who specialises in economics, to replace his long-term ally, Sergei Shoigu, 68, as defence minister.

Putin wants Shoigu, in charge of defence since 2012 and a long-standing friend and ally, to become the secretary of Russia's powerful Security Council, replacing incumbent Nikolai Patrushev, and to also have responsibilities for the military-industrial complex, the Kremlin said.

Patrushev will get a new, as yet unannounced, job.

The changes, certain to be approved by parliamentarians, are the most significant Putin has made to the military command since sending tens of thousands of troops into Ukraine in February 2022 in what he called a special military operation.

Kremlin spokesman Dmitry Peskov said the change made sense because Russia was approaching a situation like the Soviet Union in the mid-1980s, when the military and law enforcement authorities accounted for 7.4% of gross domestic product (GDP).

That, said Peskov, meant it was vital to ensure such spending aligned with and was better integrated into the country's overall economy, which was why Putin now wanted a civilian economist in the defence ministry job.

"The one who is more open to innovations is the one who will be victorious on the battlefield," Peskov said.

Belousov, a former economy minister known to be very close to Putin, shares the Russian leader's vision of rebuilding a strong state, and has also worked with Putin's top technocrats who want greater innovation and are open to new ideas.

Belousov has played an important role in overseeing Russia's drone programme.

The shake-up, which caught the elite off-guard, indicates Putin is doubling down on the Ukraine war and wants to harness more of Russia's economy for the war after the West sought, but failed so far, to sink the economy with sanctions.

ECONOMIC WAR

Russia's economists have so far largely ensured economic stability and growth despite the toughest sanctions ever imposed on a major economy, even though the failings of the Russian military were laid bare shortly after the invasion.

"The proposal to appoint one of the main court economists and the main state minister in the economic bloc to head the Defence Ministry may mean that Putin is planning to win the war with the defence industry plants and international markets," said Alexander Baunov, a former Russian diplomat who is now a senior fellow at the Carnegie Russia Eurasia Center.

"The winning strategy in this case will not be mobilisations and breakthroughs, but slow pressure on Ukraine with the superior power of the Russian military-industrial complex and the economy as a whole, which, apparently, is supposed to be made to work more effectively for the front and rear."

Putin's move, though unexpected, preserves balance at the top of the complex system of personal loyalties that make up the current political system.

The shake-up gives Shoigu a job that is technically regarded as senior to his defence ministry role, ensuring continuity and saving Shoigu's face. Valery Gerasimov, the chief of Russia's General Staff and someone with a more hands-on role when it comes to directing the war, will remain in post.

Shoigu was heavily criticised by Russian military bloggers for a series of retreats the Russian military was forced to make in 2022. Yevgeny Prigozhin, the leader of the Wagner mercenary group and one of Shoigu's fiercest critics, led an abortive mutiny he hoped would topple Shoigu last year before agreeing to call it off. Prigozhin was later killed in a plane crash.

Mark Galeotti, director of the London-based Mayak Intelligence consultancy, said the defence minister's job in Russia at a time of war was to ensure the military had everything it needed, while Gerasimov's job was the "key one" as he now reported directly to Putin, the commander-in-chief.

"In that context, having an economist, someone who has been speaking about the need to basically subordinate much of the economy to the needs of the defence sector, makes a certain amount of sense. It is now essentially a financial administrator's job and Belousov can do that," said Galeotti.

The change is likely to be seen as an attempt by Putin to subject defence spending to greater scrutiny to ensure funds are effectively spent after a Shoigu ally and deputy defence minister, Timur Ivanov, was accused by state prosecutors of taking kickbacks worth nearly $11 million.

Putin left Alexander Bortnikov and Sergei Naryshkin, the chiefs of the Federal Security Service (FSB) and the Foreign Intelligence Service (SVR), in their posts.

Sergei Lavrov, the country's veteran foreign minister, will also stay in his job, the Kremlin said.

https://www.yahoo.com/news/putin-proposes-sacking-defence-minister-182453851.html