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Friday, November 1, 2024

ESSA Pharma halts Phase II study of masofaniten in prostate cancer

 ESSA Pharma has terminated the Phase II clinical trial of masofaniten, a new prostate cancer treatment.

Masofaniten, previously known as EPI-7386, is an investigational oral, small-molecule androgen receptor (AR) inhibitor.

The decision to halt the trial, which was assessing masofaniten in combination with enzalutamide versus enzalutamide alone in patients with metastatic castration-resistant prostate cancer (mCRPC), was based on an interim review.


Agreed upon by the board of directors and senior management, the review indicated a higher-than-expected PSA90 response in patients treated solely with enzalutamide.

The Phase II trial was an open-label, two-arm, 2:1 randomised study which planned to enrol 120 patients.

At the time of the interim analysis, 52 patients had been enrolled and had at least one prostate-specific antigen (PSA) measurement post-baseline, with 41 patients having completed a minimum of three months follow-up.

Additionally, no clear efficacy benefit was observed when masofaniten was combined with enzalutamide. A futility analysis suggested a low probability of achieving the prespecified primary endpoint.

ESSA Pharma president and CEO David Parkinson said: "We designed this randomised study to rigorously evaluate the clinical benefit of adding masofaniten to enzalutamide.

“We made the difficult decision to terminate this Phase II study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate.


https://finance.yahoo.com/news/essa-pharma-halts-phase-ii-121413142.html

Pediatrix Q3, update

 Pediatrix Medical Group, Inc. (NYSE: MD), a leading provider of physician services, today reported earnings of $0.23 per share for the three months ended September 30, 2024. On a non-GAAP basis, Pediatrix reported Adjusted EPS of $0.44.

For the 2024 third quarter, Pediatrix reported the following results:

  • Net revenue of $511 million;
  • Net income of $19 million; and
  • Adjusted EBITDA of $60 million.

“Our third quarter operating results modestly exceeded our expectations, driven primarily by strength in same-unit revenue,” said James D. Swift, M.D., Chief Executive Officer of Pediatrix Medical Group. “During the quarter, we successfully completed our previously announced transition to a hybrid revenue cycle management structure, and we remain on track to complete our portfolio management plans by the end of 2024. We believe that a more focused portfolio, with enhanced support for our affiliated practices, will enable stronger financial performance and benefit all of our stakeholders.”

Portfolio Management Update

As previously disclosed, during the second quarter of 2024, Pediatrix formalized its practice portfolio management plans, resulting in a decision to exit almost all of its affiliated office-based practices, other than maternal-fetal medicine, and during and subsequent to the end of the 2024 second quarter, the Company completed the exit of its primary and urgent care service line through two separate transactions. In aggregate, the office-based practices that the Company intends to exit and the primary and urgent care clinics that have been divested contributed net revenue of approximately $200 million in 2023. As previously disclosed, Pediatrix expects that the annualized favorable impact to Adjusted EBITDA resulting from its portfolio management plans to be approximately $30 million, based on 2023 financial information.

The Company continues to expect to complete these exits prior to the end of 2024.

2024 Outlook

Pediatrix anticipates that its 2024 Adjusted EBITDA, as defined above, will be in a range of $205 million to $215 million. This outlook reflects Adjusted EBITDA for the first nine months of 2024 of $155.3 million.

https://www.businesswire.com/news/home/20241101131596/en/

Pro-Dex Profit in Fiscal 2025 First Q

 Net sales for the three months ended September 30, 2024, increased $3.0 million, or 25%, to $14.9 million from $11.9 million for the three months ended September 30, 2023. The increase is driven primarily by $1.1 million in increased repairs of the surgical handpiece we sell to our largest customer as well as the shipment of that customer's next generation handpiece to satisfy its limited market release.

Gross profit for the threemonths ended September 30, 2024, increased $1.5 million, or 41%, compared to the year-ago period. Gross margin increased by 4 percentage points to 35% during the three months ended September 30, 2024, compared to 31% during the corresponding year-ago period, due primarily to a favorable product mix.

Operating expenses (which include selling, general and administrative, and research and development expenses) for the quarter ended September 30, 2024, increased $312,000, or 17%, to $2.1 million compared to $1.8 million for the corresponding quarter in 2023. The increase relates primarily to increased general and administrative expenses relating to higher personnel costs and higher bonus accruals.

Our operating income for the quarter ended September 30, 2024, increased $1.2 million or 64%, to $3.0 million compared to $1.8 million for the prior fiscal year's corresponding quarter. The increase reflects our increased sales and gross profit, as described above.

Net income for the quarter ended September 30, 2024, increased to $2.5 million, or $0.75 per diluted share, compared to net loss of $615,000, or $0.17 per diluted share, for the quarter ended September 30, 2023. Our net income for the quarter ended September 30, 2024, contains unrealized gains on our marketable equity investments of $433,000 while our net loss for the quarter ended September 30, 2023, includes unrealized losses on investments of $2.6 million. All of our investments are recorded at estimated fair value, and the period-to-period valuation can be highly volatile.

Biogen, Eisai Completes Rolling Submission for LEQEMBI for Subcutaneous Early Alzheimer's

  Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that Eisai has completed the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. LEQEMBI is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD). If the FDA accepts the BLA, the Prescription Drug User Fee Act (PDUFA) action date (target date for completion of examination) will be set. 

The BLA is based on data from the Clarity AD (Study 301) open-label extension (OLE) and modeling of observed data. If approved by the FDA, the LEQEMBI autoinjector could be used to administer LEQEMBI at home or at medical facilities, and the injection process is expected on average to take about 15 seconds. As part of the subcutaneous autoinjector 360 mg weekly maintenance regimen under review, patients who have completed the biweekly intravenous (IV) initiation phase would receive weekly doses that maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils* which can continue to cause neuronal injury even after the amyloid-beta (Aβ) plaque has been cleared from the brain.

https://www.prnewswire.com/news-releases/eisai-completes-rolling-submission-to-us-fda-for-leqembi-lecanemab-irmb-biologics-license-application-for-subcutaneous-maintenance-dosing-for-the-treatment-of-early-alzheimers-disease-under-the-fast-track-status-302293541.html

BMS Delivers Q3 Beat, Raises 2024 Guidance Amid Strong Demand for Legacy and Newer Drugs

 

Bristol Myers Squibb’s third-quarter results benefited from sales of its legacy brands Eliquis and Revlimid, as well as growth portfolio products such as Abecma, Breyanzi and Reblozyl.

Bristol Myers Squibb on Thursday touted strong year-over-year growth in the third quarter of 2024, with sales handily beating the consensus estimate driven by its legacy and newer products.

On the strength of the Q3 performance, BMS raised its full-year revenue guidance, now expecting a year-over-year increase of around 5%—up from its previous forecast of the upper end of low-single-digit growth. The outlook for the company’s full-year diluted earnings-per-share (EPS) was also lifted to $0.75 to $0.95, from the previous range of $0.60 to $0.90.

“Our overall business mix is beginning to transform as our growth portfolio is becoming a bigger component,” CEO Christopher Boerner said during an investor call on Thursday, touting the combination of its pipeline—which is approaching several “near-term catalysts”—and a “disciplined focus on expense management.”

These factors, Boerner said, are key to the company’s “focus on executing in the near term while laying the groundwork for long-term sustainable growth.”

In Q3, BMS reported total global revenues of $11.9 billion–8% year-over-year growth at constant currencies—and a 6% beat versus the consensus estimate of $11.3 billion.

In an investor note, William Blair analyst Matt Phipps credited BMS’ strong quarter to the reliable performance of its legacy brands—including Revlimid and Eliquis—and the “traction” of its growth portfolio brands such as Breyanzi, Abecma and Reblozyl, which “all beat consensus estimates.”

Truist Securities analyst Srikripa Devarakonda in an investor note said the multiple myeloma drug Revlimid declined “less than anticipated.” Its sales dipped 1% in the quarter to $1.4 billion but still exceeded the consensus of $1.1 billion. The blood thinner Eliquis continues to be BMS’ top-performing asset, jumping 11% year-over-year to bring in just over $3 billion in Q3.

BMS’ earnings call was primarily focused on its newly approved schizophrenia therapy Cobenfy, which won the FDA’s nod in September 2024. Boerner said the drug had “multibillion-dollar potential” and will help the company accelerate its growth, though the company’s optimism appeared to be largely measured.

BMO Capital Markets analyst Evan Seigerman in an investor note said that “while we appreciate conservatism in neuropsych, management commentary has been somewhat muted around revenue expectations,” particularly as “launch is expected to be a slow build in schizophrenia.”

By contrast, Seigerman expects Alzheimer’s psychosis as a stronger opportunity for Cobenfy “in terms of sentiment.” Cobenfy is currently in Phase III development for this indication.

“While we are encouraged by Bristol’s progress in the quarter on top line and expenses, the transformative change Bristol needs will come from its pipeline,” Seigerman wrote.

Consensus peak sales estimate for Cobenfy is $5.4 billion. BMS expects to see a “sales ramp” for Cobenfy starting in the second half of 2025, following broad access in Medicare and Medicaid patients, Chief Commercialization Officer Adam Lenkowsky said during Thursday’s investor call.

https://www.biospace.com/business/bms-delivers-q3-beat-raises-2024-guidance-amid-strong-demand-for-legacy-and-newer-drugs

Thursday, October 31, 2024

Chinese researchers develop AI model for military use on back of Meta's Llama

 Top Chinese research institutions linked to the People's Liberation Army have used Meta's publicly available Llama model to develop an AI tool for potential military applications, according to academic papers and analysts.

In a June paper reviewed by Reuters, six Chinese researchers from three institutions, including two under the People's Liberation Army's (PLA) leading research body, the Academy of Military Science (AMS), detailed how they had used an early version of Meta's Llama as a base for what it calls "ChatBIT".

The researchers used the Llama 2 13B large language model (LLM) that Meta released in February 2023, incorporating their own parameters to construct a military-focused AI tool to gather and process intelligence, and offer accurate and reliable information for operational decision-making.

ChatBIT was fine-tuned and "optimised for dialogue and question-answering tasks in the military field", the paper said. It was found to outperform some other AI models that were roughly 90% as capable as OpenAI's powerful ChatGPT-4. The researchers didn't elaborate on how they defined performance or specify whether the AI model had been put into service.

"It's the first time there has been substantial evidence that PLA military experts in China have been systematically researching and trying to leverage the power of open-source LLMs, especially those of Meta, for military purposes," said Sunny Cheung, associate fellow at the Jamestown Foundation who specialises in China's emerging and dual use technologies including AI.

Meta has embraced the open release of many of its AI models, including Llama. It imposes restrictions on their use, including a requirement that services with more than 700 million users seek a license from the company.

Its terms also prohibit use of the models for "military, warfare, nuclear industries or applications, espionage" and other activities subject to U.S. defence export controls, as well as for the development of weapons and content intended to "incite and promote violence".

However, because Meta's models are public, the company has limited ways of enforcing those provisions.

In response to Reuters questions, Meta cited its acceptable use policy and said it took measures to prevent misuse.

"Any use of our models by the People's Liberation Army is unauthorized and contrary to our acceptable use policy," Molly Montgomery, Meta's director of public policy, told Reuters in a phone interview.

The Chinese researchers include Geng Guotong and Li Weiwei with the AMS's Military Science Information Research Center and the National Innovation Institute of Defense Technology, as well as researchers from the Beijing Institute of Technology and Minzu University.

"In the future, through technological refinement, ChatBIT will not only be applied to intelligence analysis, but also ... strategic planning, simulation training and command decision-making will be explored," the paper said.

China's Defence Ministry didn't reply to a request for comment, nor did any of the institutions or researchers.

Reuters could not confirm ChatBIT's capabilities and computing power, though the researchers noted that its model incorporated only 100,000 military dialogue records, a relatively small number compared with other LLMs.

"That's a drop in the ocean compared to most of these models (that) are trained with trillions of tokens so ... it really makes me question what do they actually achieve here in terms of different capabilities," said Joelle Pineau, a vice president of AI Research at Meta and a professor of computer science at McGill University in Canada.

The research comes amid a heated debate in U.S. national security and technology circles about whether firms such as Meta should make their models publicly available.

U.S. President Joe Biden in October 2023 signed an executive order seeking to manage AI developments, noting that although there can be substantial benefits to innovation," there were also "substantial security risks, such as the removal of safeguards within the model".

This week, Washington said it was finalising rules to curb U.S. investment in artificial intelligence and other technology sectors in China that could threaten national security.

Pentagon spokesman John Supple said the Department of Defense recognised that open-source models had both benefits and drawbacks, and that "we will continue to closely monitor and assess competitors' capabilities".

'COOKIE JAR'

Some observers say China's strides in developing indigenous AI, including setting up scores of research labs, have already made it difficult to keep the country from narrowing the technology gap with the United States.

In a separate academic paper reviewed by Reuters, two researchers with the Aviation Industry Corporation of China (AVIC) - which the United States has designated a firm with ties to the PLA - described using Llama 2 for "the training of airborne electronic warfare interference strategies".

China's use of Western-developed AI has also extended into domestic security. A June paper described how Llama had been used for "intelligence policing" to process large amounts of data and enhance police decision-making.

The state-run PLA Daily published commentary in April on how AI could help "accelerate the research and development of weapons and equipment", help develop combat simulation and improve military training efficiency".

"Can you keep them (China) out of the cookie jar? No, I don't see how you can," William Hannas, lead analyst at Georgetown University's Center for Security and Emerging Technology (CSET), told Reuters. A 2023 paper by CSET found 370 Chinese institutions whose researchers had published papers related to General Artificial Intelligence - helping drive China's national strategy to lead the world in AI by 2030.

"There is too much collaboration going on between China's best scientists and the U.S.' best AI scientists for them to be excluded from developments," Hannas added.

https://www.marketscreener.com/quote/stock/META-PLATFORMS-INC-10547141/news/Exclusive-Chinese-researchers-develop-AI-model-for-military-use-on-back-of-Meta-s-Llama-48229173/

Polymarket’s $2.4 Billion Election Boom: The Web3 Prediction Market Gains Traction

 One of this year’s most anticipated events—the U.S. presidential election—is approaching rapidly. With Vice President Kamala Harris and former President Donald Trump locked in a close race, Polymarket, the Web3 prediction market platform, is experiencing a surge in activity like never before.

In October, the platform registered a record trading volume of $2.4 billion. This reflects not only such (literally) high-stakes event as the U.S. election, but also Polymarket’s own rising popularity.

Indeed, compared to the 2020 election, Polymarket’s trading volume has grown by a factor of 47. The number of monthly active traders skyrocketed from slightly over 2,000 four years ago to over 214,000 now (source: Dune Analytics).

Polymarket is one of the notable real-world applications of blockchain technology. Its decentralized nature allows for cost-effective, accessible, and 24/7 trading.

Its primary user base comes from the crypto community, a trend underscored by a notable skew toward pro-Trump bets. While official polls suggest a close race, 65% of Polymarket wagers currently back the Republican nominee, reflecting the community sentiment. Yet, the platform is also gaining traction beyond the crypto crowd, surfing on the election betting fever.

This surge in interest is a good thing for overall crypto adoption, but Polymarket’s success isn’t without controversy, including wash trading allegations and an ambiguous legal standing in the U.S.

How Polymarket works

Polymarket is a Web3 platform allowing users to buy and sell shares in probabilities of real-world events, from elections to sports outcomes. It's built on Polygon, an Ethereum layer-2 allowing faster and cheaper transactions. Its smart contracts automate transaction execution, ensuring transparency and security.

Unlike traditional betting platforms, Polymarket doesn’t act as the “house” or take opposing sides, thus canceling the risks of potentially unfair usage of the house knowledge. It is a purely peer-to-peer (P2P) marketplace where prices are determined by supply and demand. Prices on the platform reflect collective probabilities, shifting as users buy and sell shares, much like a stock market. All trades are denominated in USDC, a stablecoin pegged to the U.S. dollar.

Since users maintain control of their funds through self-custodial wallets, Polymarket does not access users’ private funds.

Being decentralized, it's globally accessible, with the exception of the U.S. After a $1.4 million fine from the country’s Commodity Futures Trading Commission (CFTC) for offering event-based contracts, the platform reduced its services in the U.S. while expanding globally.

Controversies around Polymarket

A recent Fortune article brought attention to controversies surrounding Polymarket. Analysts from blockchain firms Chaos Labs and Inca Digital reported signs of wash trading on the platform. Wash trading is a form of market manipulation where shares are bought and sold repeatedly to inflate the platform’s volume. Such practices are generally banned in traditional finance as they can create misleading signals about actual demand. According to the analysts, up to a third of Polymarket’s volume was artificially boosted.

The company’s representatives responded by pointing out the transparency of their platform – which allowed the researchers to detect such patterns. Some speculate that such activity could be linked to "airdrop farming," where users engage in high-frequency trades to qualify for potential token giveaways. Since Polymarket charges no transaction fees (only small amounts paid to liquidity providers), the platform’s structure may encourage this practice.

Though Polymarket has yet to issue its own token, speculations around its possible launch remain. Issuing a token could be a way for the platform to boost its activity, attract new users, and reward the existing ones.

Polymarket also previously faced scrutiny over a "whale" trader who reportedly boosted Donald Trump’s odds on the platform. However, these trades could also be strategic rather than an attempt to influence market sentiment.

Amid these controversies, Polymarket has drawn interest beyond the crypto community. Coverage in mainstream media outlets such as Newsweek, The Wall Street Journal, Vox, and Fortune is raising awareness and attracting new users, with many opening crypto wallets to join. The election betting fever helps drive broader crypto adoption, exposing non-crypto audiences to Web3 applications that are straightforward and relevant to everyday interests.

One major unresolved issue is Polymarket’s compliance in the U.S. Despite appointing a former CFTC head J. Christopher Giancarlo on its advisory board in 2022, the platform remains restricted in the U.S. With both Trump and Harris signaling support for a more favorable regulatory environment for crypto, Polymarket could hope for an eventual approval in this key jurisdiction.

https://www.marketscreener.com/quote/cryptocurrency/BITCOIN-BTC-USD-45553945/news/Polymarket-s-2-4-Billion-Election-Boom-The-Web3-Prediction-Market-Gains-Traction-48224665/