Coherus: Positive Final Overall Survival Results in Phase 3 Trial in Nasopharyngeal Carcinoma

 Toripalimab plus chemotherapy resulted in a 37% reduction in the risk of death, HR=0.63, versus chemotherapy alone, in nasopharyngeal carcinoma patients –

– No treatments are approved for NPC in the US; if approved, toripalimab will address a critical unmet need –

 Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) announced the final overall survival (OS) results of the JUPITER-02 study presented today at the American Society for Clinical Oncology (ASCO) Annual Meeting. JUPITER-02 is a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC).

The final analysis of the JUPITER-02 clinical trial (NCT03581786) demonstrated a statistically significant and clinically meaningful improvement in OS for NPC patients who were treated with toripalimab in combination with gemcitabine and cisplatin chemotherapy, versus chemotherapy treatment alone. Median OS has not been reached in the toripalimab arm versus 33.7 months for chemotherapy treatment alone, HR=0.63 (95% CI 0.45-0.89); P=0.0083.

https://finance.yahoo.com/news/coherus-announces-positive-final-overall-213000009.html

Ultragenyx, Mereo: Positive Data from Ongoing Phase 2/3 Study of Bone Disorder Therapy

Pediatric data show substantial induction of bone production in 1 week and a large increase in bone formation within 3 months of initiating monthly setrusumab treatment

Phase 3 sites beginning to screen patients

Conference call to discuss data planned for 5 p.m. Eastern Time

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) and Mereo BioPharma Group plc (NASDAQ: MREO) today announced data from the dose-selection Phase 2 portion of the Phase 2/3 Orbit study showing that setrusumab rapidly induced bone production in OI-affected patients. Across all patients evaluated setrusumab demonstrated statistically significant increases in levels of serum P1NP, a sensitive marker of bone formation, and a substantial and significant improvement in bone mineral density (BMD) by 3 months.

Ultragenyx will host an investor conference call today, Monday, June 5, at 2 p.m. PT / 5 p.m. ET to discuss the results. The live and replayed webcast of the call will be available through the company’s website at https://ir.ultragenyx.com/events-presentations. To participate in the live call, please register by clicking on the following link (registration link), and you will be provided with dial in details. The replay of the call will be available for one year.

https://finance.yahoo.com/news/ultragenyx-mereo-biopharma-announce-positive-200000830.html

Appeals court to hear arguments about ObamaCare preventive coverage

 A federal appeals court will hear arguments Tuesday about whether to continue a pause of a Texas district court’s ruling that struck down an ObamaCare provision requiring insurers to cover preventive services for free.

Last month, the U.S. Court of Appeals for the 5th Circuit temporarily paused Judge Reed O’Connor’s decision until a panel could hear oral arguments on whether the pause should be continued during the appeals process.

Keeping the stay in place until the court rules on the merits of the case would allow the Department of Health and Human Services to continue to mandate most insurance companies cover the HIV prevention drug PrEP as well as a range of preventive services like annual physicals, cancer screenings and Pap tests with no cost-sharing for patients.

The Affordable Care Act requires insurers to cover more than 100 preventive health services recommended by the U.S. Preventive Services Task Force. The provision is broadly popular, and has been in effect since 2010.

A lawsuit put forward by a group of conservative Texas employers and individuals challenged that requirement, arguing the take force’s members are not appointed by the president or confirmed by the Senate, yet its recommendations are binding.

O’Connor agreed with most of the arguments, and his ruling invalidated the entire task force.

The judge also invalidated the law’s requirement that health plans cover HIV treatment. He said the mandate forced the plaintiff, a Christian employer and well-known GOP donor, to pay for insurance that violated his religious beliefs.

O’Connor’s ruling applied nationwide, even though the lawsuit only concerned one company.

The administration appealed in April and requested a stay of the nationwide impact of the ruling, arguing the court overstepped its authority by expanding a targeted injunction against a single company to an order that impacts the entire country.

The administration and public health advocates have warned that striking down the requirement for insurers and employers to cover preventive services without cost-sharing would jeopardize access to needed services for more than 150 million people.

“This Court should enter the requested partial stay of the final judgment pending appeal to preserve the status quo of 13 years and to protect the rights of 150 million Americans who are not parties to this case,” the administration argued in its most recent court filing.

A separate panel will eventually hear arguments on the merits of the case, but there is no hearing date set.

The groups will likely continue to advocate for the conservative-leaning 5th Circuit to overturn the ruling in a battle that could eventually head to the Supreme Court.

https://thehill.com/policy/healthcare/4035514-appeals-court-to-hear-arguments-about-obamacare-preventive-coverage/

Adams looks to house migrants in private homes as well as houses of worship

 New York City Mayor Eric Adams (D) on Monday unveiled a plan for houses of worship to shelter migrants in the city as Republican governors of southern border states send migrants north to New York.

“As we continue to tackle this humanitarian crisis, I’m proud that through this new partnership with New York Disaster Interfaith Services, New York City’s faith community will be able to provide shelter to asylum seekers in need at houses of worship throughout the five boroughs,” Adams said in a Monday announcement.

The two-year partnership will allow up to 50 houses of worship or other faith-based spaces to offer overnight shelter for up to 19 single adult men at each location, according to a release from the mayor’s office. 

The faith-based spaces will continue to offer their normal activities during the day, and the city will open five “daytime centers” for programming during the day. 

The program will increase the city’s space for migrants by nearly 1,000 beds, and will also “connect asylum seekers with local communities.”

Adams also said Monday that it’s his “vision” to “take the next step to … faith-based locales and then move to a private residence.” 

“There are residents who are suffering right now because of economic challenges. They have spare rooms,” Adams said. 

If there’s a way around certain rules, he said, “we can take that $4.2 billion — $4.3 [billion] maybe, now — that we potentially may have to spend and we can put it back in the pockets of everyday New Yorkers, everyday houses of worship, instead of putting it in the pockets of corporations.”

The city continues to care for over 46,000 asylum seekers, according to the mayor’s office .

The influx of migrants in part comes as GOP governors to bus or fly thousands of migrants north to Democrat-led cities in protest of immigration at the U.S.-Mexico border — and amid the end of the pandemic-era Title 42 immigration policy.

“This influx of asylum seekers is a serious crisis, one that New York City is facing largely on our own. It’s unfair and it’s not right that New York is going through this,” Adams said, adding that through the end of May the city has spent more than $1.2 billion on the crisis.

Adams had suggested last month that some of the migrants be housed in school gyms.

The mayor stressed that the current situation is not sustainable. “We cannot continue to sustain this with the inflow that we’re receiving. So, because we are managing this, I don’t want anyone to believe that this is sustainable, because it is not,” he said, adding that “we need real immigration reform.”

https://thehill.com/homenews/state-watch/4035720-adams-looks-to-house-migrants-in-private-homes-houses-of-worship/

Crypto exchange Binance, CEO hit with charges in SEC lawsuit

 Binance and the cryptocurrency exchange’s CEO have collectively been hit with numerous charges from the Securities and Exchange Commission (SEC). 

With its 13 total charges, the SEC complaint accused Binance Holdings, CEO Changpeng Zhao, BAM Trading and BAM Management US Holdings of committing breaches of the Securities Act and the Exchange Act, two U.S. laws pertaining to securities. The agency’s filing of the complaint took place Monday. 

Changpeng Zhao, founder and chief executive officer of Binance, attends the Viva Technology conference in Paris, June 16, 2022. (Benoit Tessier/File Photo / Reuters Photos)

The announcement that the SEC had moved to file the charges impacted the prices of many cryptocurrencies, with those of Bitcoin, Ethereum, Cardano, Ripple and Solana experiencing decreases afterward. 

The SEC claimed BAM Trading and BAM Management were formed by Binance and its chief executive in an effort to "evade U.S. federal securities laws by claiming that BAM Trading operated the Binance.US platform independently and that U.S. customers were not able to use the Binance.com platform," things the agency argued were not true. The regulator accused Binance, Zhao and other executives of being aware of violating U.S. securities laws, with one purportedly saying "we are operating as a f---ing unlicensed securities exchange in the USA bro" in late 2018, according to the filing.

The defendants "were free to and did transfer" customer crypto assets "as Defendants pleased, at times commingling and diverting them in ways that properly registered brokers, dealers, exchanges, and clearing agencies would not have been able to do," the SEC complaint alleged. 

The filing claimed "billions" of funds were sent to an account held by Zhao-owned Merit Peak Limited that were "subsequently transferred to a third party apparently in connection with the purchase and sale of crypto assets." The SEC accused Binance of sending funds to Sigma Chain, a Zhao-controlled firm that allegedly "engaged in wash trading that artificially inflated the trading volume of crypto assets securities" on Binance.US.

As part of the complaint, Binance and BAM Trading face allegations of doing unregistered work in exchange, broker-dealer and clearing agency functions, as well as accusations of "multiple unregistered offers and sales of crypto asset securities and other investment schemes," according to the SEC. BAM Trading and BAM Management also allegedly "misled investors about non-existent trading controls" for Binance.US.

Binance issued a statement on the SEC complaint, saying it "intend[s] to defend our platform vigorously." It said it had "engaged in extensive good-faith discussions to reach a negotiated settlement to resolve [the SEC’s] investigations," accusing the agency of "an effort to rush to claim jurisdiction ground from other regulators" and of wanting to "make headlines."

"Any allegations that user assets on the Binance.US platform have ever been at risk are simply wrong, and there is zero justification for the Staff’s action in light of the ample time the Staff has had to conduct their investigation," the company said. "All user assets on Binance and Binance affiliate platforms, including Binance.US, are safe and secure, and we will vigorously defend against any allegations to the contrary."

The company also noted that the SEC’s "actions are limited in reach" due to Binance not being a U.S.-based exchange. It "remains committed to productive engagement to ensure the next generation of cryptocurrency regulation fosters innovation while implementing and ensuring important consumer protections," Binance said. 

In its complaint filed Monday, the SEC asked for several things in terms of a final judgment, including to permanently bar the defendants from further alleged violations of securities laws, to force them to give up "ill-gotten gains," and to subject them to fines. 

It sought a permanent injunction against them "directly or indirectly" conducting unregistered securities transactions, as well as against them acting as an unregistered exchange, broker, dealer or clearing house, according to the filing. It also asked the court to forbid Zhao from "acting as an officer or director of any issuer whose securities are registered" with the SEC or "required to file reports" to it. 

In the meantime, it submitted a request for various measures as "temporary and preliminary injunctive relief" from the court.

Binance and Zhao are also facing legal action from another U.S. regulator, the Commodity Futures Trading Commission.

https://www.foxbusiness.com/markets/crypto-exchange-binance-ceo-hit-charges-sec-lawsuit

Musk's Neuralink valued at about $5 billion despite long road to market

 

Elon Musk's brain implant startup Neuralink, which was valued at close to $2 billion in a private fundraising round two years ago, is now worth around $5 billion based on privately executed stock trades described to Reuters by five sources with knowledge of the matter.

Some purchases by bullish investors boosted the valuation in recent months, ahead of Neuralink's May 25 announcement that U.S. regulators had approved a human trial on its brain chip, the sources said.

Experts have said it could take several years for Neuralink to secure commercial use clearance. Kip Ludwig, former program director for neural engineering at the U.S. National Institutes of Health (NIH), said he "optimistically" expected Neuralink to take at least 10 more years to commercialize its brain implant. The company also faces other challenges that include federal probes into its handling of animal research.

Following the trial's approval, however, Neuralink shares were marketed privately to investors in recent days at a $7 billion valuation, equivalent to $55 per share, according to an email seen by Reuters. Reuters could not establish whether the seller found buyers for that price. The email cited the U.S. Food and Drug Administration's (FDA) approval of the clinical trial as grounds for the deal being "sweeter."

Neuralink executives and Musk did not respond to requests for comment.

Musk has expressed grand ambitions for Neuralink, saying its chip would allow healthy and disabled people alike to pop into neighborhood facilities for speedy surgical insertions of devices to treat obesity, autism, depression and schizophrenia. He even sees them being used for web-surfing and telepathy. A Neuralink executive recently gave more modest short-term objectives, such as helping paralyzed patients communicate through computerized text without typing.

The stock transactions at a valuation of around $5 billion have been carried out by shareholders such as employees and the company's early backers, rather than Neuralink selling new shares to investors. Such so-called secondary trades are an imperfect gauge of a company's value; their volume is thin and they lack the wider market consensus of a fundraising round or initial public offering (IPO).

Neuralink's valuation jump in secondary trades is in sharp contrast to other startups. About 85% of pre-IPO companies are currently valued in secondary trades at an average discount of 47% to their last funding round, according to data provider Caplight.

In Neuralink's last known fundraising in 2021, it raised $205 million at an approximately $2 billion valuation, according to data provider Pitchbook.

Many of the recent stock sales have been to relatively small investors, who typically focus more on getting a slice of a company owned by Musk than scrutinizing its valuation. The maximum amount sought for the Neuralink shares marketed for sale at a $7 billion valuation was just $500,000, according to the email seen by Reuters.

Sim Desai, chief executive of Hiive, an online platform where the shares are traded, said demand for Neuralink stock has been "tremendous." He pegged the valuation that buyers are willing to pay at around $4.5 billion.

Some biomedical experts are skeptical. Arun Sridhar, a scientist and entrepreneur who specializes in neuromodulation, called Neuralink's valuation "bonkers" based on how early the brain implant is in its clinical development.

"A study to assess safety and tolerability is in no shape or form valid to justify a $5 billion valuation," said Sridhar, who helped launch Galvani Bioelectronics, a developer of implants backed by GSK Plc and Alphabet Inc's Verily Life Sciences. Galvani is not a competitor of Neuralink because its implants under development will be installed in an artery to the spleen to help treat rheumatoid arthritis, rather than the brain.

INVESTIGATIONS

The FDA initially rejected Neuralink's request for a human trial last year, citing safety reasons, Reuters has reported. Even after securing approval, the company faces several challenges.

Neuralink has come under scrutiny from U.S. lawmakers after Reuters reported in May that its animal-research board may have violated conflict-of-interest regulations. Neuralink employees who sat on that board, which oversees the welfare of the animals that were being tested, also stood to benefit from the implant's quick development. Neuralink stock that some of the employees hold has jumped around 150% in value in just two years, based on the secondary trades.

The law enforcement arm of the U.S. Department of Agriculture has been investigating Neuralink for potential animal-welfare violations. Neuralink staff told Reuters last year that the company was rushing and botching surgeries on monkeys, pigs and sheep, resulting in far more animal deaths than necessary, as Musk pressured staff to receive FDA approval.

The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.

Neither Musk nor Neuralink have responded to multiple requests for comment on the probes or the Reuters reports.

https://www.marketscreener.com/business-leaders/Elon-Musk-1364/news/Exclusive-Musk-s-Neuralink-valued-at-about-5-billion-despite-long-road-to-market--44038257/

Elon Musk says China will initiate AI regulations

 

The Chinese government will seek to initiate artificial intelligence regulations in its country, billionaire Elon Musk said on Monday after meeting with officials during his recent trip to China.

Musk did not elaborate further and made his remarks in a Twitter Space with Democratic presidential candidate Robert F. Kennedy Jr. on Monday.

"It's worth noting that on my recent trip to China, I went to senior leadership there. I think we had some very productive discussions on artificial intelligence risks, and the need for some oversight and regulation," said Musk, owner of Twitter and Tesla Inc chief executive.

"And my understanding from those conversations is that China will be initiating AI regulation in China."

Reuters was not immediately able to reach Chinese officials for comment outside of normal business hours.

Musk departed Shanghai on Thursday, wrapping up a two-day trip to China in which he met senior Chinese government officials including the highest-ranking vice premier.

Musk met with China's foreign, commerce and industry ministers in Beijing. He also met with Chinese Vice Premier Ding Xuexiang on Wednesday, a source familiar with the matter said.

China's cyberspace regulator unveiled draft measures in April for managing generative artificial intelligence services, saying it wants firms to submit security assessments to authorities before they launch their offerings to the public.

Several governments are considering how to mitigate the dangers of the emerging technology, which has experienced a boom in investment and consumer popularity in recent months after the release of OpenAI's ChatGPT.

In April, the Cyberspace Administration of China (CAC) said that China supports AI innovation and application and encourages use of safe and reliable software, tools and data resources, but content generated by generative AI had to be in line with the country's core socialist values.

Providers will be responsible for the legitimacy of data used to train generative AI products and measures should be taken to prevent discrimination when designing algorithms and training data, it said.

https://www.marketscreener.com/quote/stock/TESLA-INC-6344549/news/Elon-Musk-says-China-will-initiate-AI-regulations-44042715/