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Monday, April 8, 2024

BMS Sees Early ROI for $14B Karuna Buy with Phase III Schizophrenia Win

 Bristol Myers Squibb on Saturday unveiled interim data from the Phase III open-label EMERGENT-4 study, showing that the investigational antipsychotic KarXT (xanomeline and trospium) can elicit significant and sustained symptom improvement in patients with schizophrenia.

The results, presented at the Annual Congress of the Schizophrenia International Research Society (SIRS 2024), demonstrated that more than 75% of KarXT-treated patients saw at least a 30% improvement in symptoms at 52 weeks of follow-up, as measured by the Positive and Negative Syndrome Scale (PANSS) total score. The drop in PANSS score was 33.3 points from baseline.

Patients receiving KarXT also demonstrated a 1.7-point improvement in the Clinical Global Impression-Severity score. This score shift represents an improvement from being “markedly ill” at baseline to “moderately” or “mildly” ill after 1 year, according to BMS.

Roland Chen, senior vice president and head of immunology, cardiovascular and neuroscience development at BMS, in a statement said that EMERGENT-4’s data further establish KarXT’s ability to elicit a “continued and consistent meaningful reduction in symptoms of schizophrenia” through 52 weeks of follow-up in an outpatient setting.

The company will share more data from the EMERGENT program “later this year,” Chen said, adding that BMS will also have “continued conversations” with the FDA for KarXT’s ongoing review.

Originally developed by Karuna Therapeutics, KarXT is a muscarinic antipsychotic which, unlike existing schizophrenia therapies, does not block dopamine receptors. Instead, the treatment activates both the M1 and M4 Muscarinic acetylcholine receptors, in turn inducing improvements in the positive and negative symptoms of schizophrenia.

In December 2023, BMS acquired Karuna for $14 billion. KarXT is currently being reviewed by the FDA, with a PDUFA date in September 2024.

On Saturday at the SIRS 2024 Annual Congress, BMS also presented long-term safety data for KarXT from its Phase III EMERGENT clinical development program. Pooling data from EMERGENT-4 and EMERGENT-5—both of which are open-label studies—showed that KarXT was generally well-tolerated over 52 weeks of treatment, with an adverse event profile consistent with what had been established in prior trials.

KarXT also had an overall favorable effect on patients’ weight and metabolic profiles, with most patients losing weight after 52 weeks. However, KarXT did not meaningfully change total cholesterol, triglyceride and HbA1c levels.

Chen in a separate statement called these long-term data “extremely encouraging,” signaling that KarXT is not associated with “burdensome side effects” even after one year of follow-up. This safety and tolerability profile “underscores its potential to provide a meaningful and differentiated option for people living with schizophrenia,” he said.

https://www.biospace.com/article/bms-sees-early-roi-for-14b-karuna-buy-with-phase-iii-schizophrenia-win/

Merck Snaps Up Small Startup in $208M Deal, Seeks to Improve Safety of ADCs

 Merck has bought biotech startup Abceutics in a bid to develop safer antibody-drug conjugates and minimize their off-target effects on healthy cells, according to a Friday announcement from the University at Buffalo, whose laboratory created the spin-off company.

The pharma will put up to $208 million on the line for Abceutics’ payload-binding selectivity enhancer (PBSE) technology, which is meant to boost the safety of antibody-drug conjugates (ADCs). The companies did not disclose the specific breakdown of the deal’s overall potential value but said that Merck’s total consideration already includes its upfront payment as well as milestones for the candidates.

Abceutics’ PBSE platform, which was licensed from the University at Buffalo, works synergistically with ADCs, according to the announcement. The agents work by seeking out and neutralizing stray payload molecules from ADCs, which in turn could spare healthy cells from the off-target effects of treatment.

Joseph Balthasar, who launched Abceutics in 2020, in a statement sad that PBSEs are designed “to be administered along with ADCs to reduce the risk of side effects.” These molecules could potentially optimize the “therapeutic selectivity and efficacy of ADC therapy.” Balthasar is also the director of the Center for Protein Therapeutics at the University at Buffalo.

Abceutics has collected several institutional backers since its launch, including the National Institutes of Health and the Buffalo Innovation Accelerator Fund, which provided the startup with $110,000 in early funds. It has also received $50,000 from the Empire State Development’s Division of Science, Technology and Innovation.

David Weinstock, vice president of oncology discovery at Merck Research Laboratories, said that Abceutics has already gone a long way in “translating this novel idea into reality.” The startup has generated several candidates for which it has “compelling early evidence.” he said.

“We look forward to further evaluating the potential of this innovative approach in the clinic,” Weinstock added.

Friday’s deal comes amid the biopharma industry’s continued ADC spending spree, with the market projected to reach nearly $30 billion in value by 2028, according to a March 2024 report by market intelligence firm Evaluate.

The sector in recent months has witnessed a flurry of dealmaking activity as industry movers have tried to broaden their ADC portfolios, beat competitors to the market and push the boundaries of the technology. Arguably the biggest turning point came in March 2023, when Pfizer inked one of the industry’s biggest acquisition contracts in the space, dropping $43 billion to buy ADC leader Seagen.

Since then, there have been several other high-value deals including J&J’s $2 billion acquisition of Ambrx in January 2024 and Genmab’s $1.8 billion buyout of ProfoundBio earlier this month. Roche is also investing heavily in the ADC space, signing a $1 billion contract earlier this year with China-based MediLink Therapeutics to develop a next-generation ADC agent.

https://www.biospace.com/article/merck-snaps-up-small-startup-in-208m-deal-seeks-to-improve-safety-of-adcs/

China Rebukes US 'Politicization' Of Trade Issues As Yellen Seeks 'Balanced' Economic Growth

U.S. Treasury Secretary Janet Yellen arrived in China last Thursday for a 6-day visit, a trip she said was necessary to "advance America’s economic and national security interests."

Treasury Secretary Janet Yellen said that the United States will launch two new initiatives with China and hold more economic dialogues aimed at addressing the increasing overcapacity in the world’s second-largest economy.

Following two days of extended dialogues with her Chinese counterpart, Vice Premier He Lifeng, Ms. Yellen announced that the two sides have agreed to establish a new initiative for “intensive exchanges on balanced growth in the domestic and global economies.”

These exchanges will facilitate a discussion around macroeconomic imbalances, including their connection to overcapacity,” she said in a statement.

“I intend to use this opportunity to advocate for a level playing field for American workers and firms.”

Ms. Yellen said she was “particularly concerned” about Beijing’s overproduction in certain sectors because of state subsidies and other policy support. A priority of the treasury secretary’s trip was to pressure Beijing to address the issue of overproduction, especially in new green-energy sectors such as solar, electric vehicles, and lithium-ion batteries.

“I think the Chinese realize how concerned we are about the implications of their industrial strategy for the United States, for the potential to flood our markets with exports that make it difficult for American firms to compete, and that other countries have the same concern,” she told reporters after announcing the new scheme in Guangzhou, a southern Chinese export hub.

China’s overcapacity involves its “entire macroeconomic and industrial strategy,” Ms. Yellen said. “It’s not going to be solved in an afternoon or a month.

“But I think they have heard that this is an important issue to us.”

The Treasury Department and China’s Ministry of Finance will assume the leadership role of the new group, Exchange on Balanced Growth in the Domestic and Global Economies, according to a statement issued by the Treasury Department.

However, as The South China Morning Post reports, China did not take all this criticism laying down.

Chinese Premier Li Qiang urged Washington not to politicise economic issues but to take an objective view on industrial capacity, during talks with US Treasury Secretary Janet Yellen in Beijing on Sunday.

"The United States should look at the capacity issue objectively and dialectically from the point of view of the market economy and from a global perspective, and on the basis of economic laws," Li said, according to official news agency Xinhua.

"The development of China's new energy industry will make an important contribution to the global green and low-carbon transformation," Li said.

"We hope the US could work with China to adhere to the basic market economy norms of fair competition and open cooperation, while refraining from politicising economic and trade issues or overstretching the concept of national security," Li said.

"The secretary provided her views on the shared objective of a healthy economic relationship that provides a level playing field for workers and businesses in both the US and China," it said.

Yellen meeting with Chinese Premier Li Qiang at the Great Hall of the People in Beijing on Sunday.

Additionally as Frank Fang detailed via The Epoch Timesanother plan set up by the Treasury Department and the People’s Bank of China is dedicated to combating “illicit finance and financial crime.”

U.S. and Chinese officials will have their first exchange on the issue in the “coming weeks.”

“This new effort will enable the U.S. and China to share best practices and provide updates on the actions we are each taking to close loopholes in our respective financial systems,” Ms. Yellen said in the statement.

China characterized the two-day talks between Ms. Yellen and Mr. He as “candid, pragmatic, and constructive.”

According to a summary of the meetings published by state media Xinhua, the two sides agreed to discuss a series of issues under the economic and financial working groups, such as “sustainable finance” and “balanced growth” in the two countries and other economies.

The United States and China set up two working groups last year to deal with economic and financial issues. The first meeting of the financial issue working group was held in Washington on April 4.

But as Fang explains further, issues over support for Russia remain a sticking point as well as growing demands for tariffs.

Russia

During the two-day talks with her Chinese counterpart, Ms. Yellen also raised Washington’s concerns about the regime’s ties with Russia.

Ms. Yellen said she warned the regime of “significant consequences” if Chinese companies provided material aid to Russia’s invasion of Ukraine.

“We’ve been clear with China that we see Russia as gaining support from goods that China, Chinese firms are supplying to Russia,” she told reporters.

She said the Chinese side told her that “it is their policy not to provide Russia with military support.”

“Neither of us want this to be an issue with our bilateral relationship. So we’re working together,” Ms. Yellen said.

Tariffs

Ms. Yellen heads to Beijing on April 6 afternoon for two more days of talks with senior Chinese officials, including Premier Li Qiang and the People’s Bank of China governor Pan Gongsheng.

Steven Hayes, president of the Florida-based advocacy group Americans for Fair Taxation, urged the Treasury secretary to “retaliate” against Beijing’s dumping by restricting Chinese imports and relocating the supply chain.

The Chinese regime is trying to use state subsidies to “destroy” U.S. business, Mr. Hayes said in an interview with NTD, a sister outlet of The Epoch Times, on April 4.

Beijing knows “if they bring products over at a low enough price, that U.S. businesses will not be able to stay in business long enough to compete, because they’re not getting the same subsidies,” he said. Their purposes were to drive American firms out of business, “and then they can raise the prices from China and have free reign.”

En route to China, Ms. Yellen told reporters that she “won’t rule out“ the possibility that the Biden administration would impose tariffs or other trade barriers on China to protect U.S. green energy industries negatively impacted by China’s overproduction.

Steven Mosher, president of the Population Research Institute and author of a new book, “The Devil and Communist China,” suggested that Washington should respond to communist China’s industrial overcapacity with heavy tariffs.

“I think the tariffs should actually be increased to match the level of the subsidies that the Chinese Communist Party is providing industry,” Mr. Mosher told NTD.

“They are very dependent on their export base now, because the domestic sector of the economy is quite blank, [and] frankly, floundering,” he said.

“Now, it’s the time to put pressure on them.”

On Monday evening, her last night in China, Yellen visited Jing-A Brewing Co. in Beijing — co-founded by an American — where she ordered a Flying Fist IPA, a beer made with American hops.

She took a sip and called it “excellent.”

https://www.zerohedge.com/geopolitical/china-rebukes-us-politicization-trade-issues-yellen-seeks-balanced-economic-growth

Transgender 'Human Doll' Lectures JK Rowling About What A Woman Is

 by Steve Watson via Modernity.news,

In a bizarre news segment, a transgender person who used to refer to himself as the “human Ken doll” attempted to lecture JK Rowling on what a woman really is, declaring that the author should “stick to what she knows.”

The Brazilian-British OnlyFans ‘personality’ born Rodrigo Alves, now known as ‘Jessica Alves’, has undergone so much plastic surgery that he can barely speak or move, including implants and ‘enhancements’ resulting in an appearance that resembles cartoon-like spoof of a woman.

Yet in a clip from an interview on GB News, Alves claimed “I don’t believe that I am a woman, I AM a woman,” adding “even my birth certificate has been changed to ‘born a female.'”

“I never felt like a man, therefore I am a woman,” Alves further declared before going on to claim “it’s very sad to read the headlines lately about JK Rowling.”

“She’s doesn’t understand anything of what she is talking about,” Alves proclaimed, adding “she’s not a trained doctor, she’s a book writer.”

The host responded, “she might argue that she’s a woman though,” to which Alves responded “I’m also a woman.”

“Her remarks are not necessary, they are very indelicate, they are very hurtful,” Alves further suggested, going on to call Rowling “transphobic.”

“You do not comment on people’s race, you do not comment on people’s gender, those are subjects that you don’t point out and talk about,” Alves further decreed.

This person is clearly mentally ill, having previously undergone countless surgeries in an effort to look like a plastic doll.

As we highlighted yesterday, Rowling was widely praised for posting a lengthy explanation of what a woman is, as she continues to be outspoken in defence of women’s rights.

*  *  *

https://www.zerohedge.com/political/transgender-human-doll-lectures-jk-rowling-about-what-woman

Esperion new data on bempedoic acid in Diverse Populations

 Patients With Obesity Who Took NEXLETOL Were 23% Less Likely to Experience a Major Adverse Cardiovascular Event (MACE-4) Compared to Placebo –

– NEXLETOL Demonstrated Clinical Benefit in Historically Underrepresented Groups: Women and Hispanic/Latinx Patients With and Without Cardiovascular Disease (CVD) –

– CLEAR Outcomes Sets New Standards for Diversity and Inclusion with Enrollment of 48% Women and 17% Hispanic/Latinx Patients –

https://www.globenewswire.com/news-release/2024/04/07/2858842/0/en/Esperion-Presents-Important-New-Data-from-CLEAR-Outcomes-at-ACC-24-Highlighting-Value-of-NEXLETOL-bempedoic-acid-Tablets-in-Diverse-Populations-Including-Women-Hispanics-Latinx-and.html

Supernus gets CRL for Parkinson med delivery device

 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-830. SPN-830 is an investigational apomorphine infusion device for the continuous treatment of motor fluctuations (“off” episodes) in Parkinson’s disease (PD) under U.S. Food and Drug Administration (FDA) review.

The FDA has issued a Complete Response Letter (CRL) in response to the Company’s New Drug Application (NDA) for SPN-830. The CRL indicates that the review cycle for the application is complete, but that the application is not ready for approval in its present form.

The CRL mentions two areas that require additional review by the FDA or additional information to be provided to the FDA. The first area relates to product quality. The Company recently submitted additional product quality data to the FDA which it has not yet reviewed. The second relates to the master file for the infusion device which is proprietary to the device manufacturer. The Company plans to discuss with the device manufacturer the provision of the requested information and the steps required for the resubmission of the NDA for SPN-830. No clinical safety or efficacy issues were identified as a requirement for approval. The FDA completed in February 2024 a successful preapproval inspection of the device manufacturer’s facility.

“We remain committed to bringing SPN-830 to the market as an important treatment option for PD patients who experience motor fluctuations associated with off episodes. We will work with the FDA to address the CRL and to successfully resubmit our SPN-830 NDA,” said Jack Khattar, President & CEO of Supernus.

https://www.globenewswire.com/news-release/2024/04/08/2859160/19871/en/Supernus-Provides-Regulatory-Update-for-SPN-830.html

Outset Medical started at Buy by BTIG

 Target $6

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