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Monday, December 1, 2025

'OpenAI: All impacted services fully recovered'

 OpenAI Inc. stated on Monday that all of its services are operational again after a short disruption, particularly with ChatGPT.

"All impacted services have now fully recovered," the company said.

Previously, OpenAI said its users could have "experienced various conversation errors and connectivity issues." They were resolved after the company investigated the problem and applied the mitigation.

https://breakingthenews.net/Article/OpenAI:-All-impacted-services-fully-recovered/65276403

'Ukraine Offers to Replace Growth-Linked Warrants With Bonds'

 


Ukraine started a process to exchange securities linked to economic growth into bonds as it seeks to restructure the terms of $3.2 billion debt after another round of talks with a group of private creditors.

The government in Kyiv offered to replace the so-called GDP warrants with bonds and cash and expects to close the deal by the end of the year, according to a statement on Monday. The east European nation is looking for ways to preserve financial resources for defending itself against Russia’s full-scale invasion and potential post-war reconstruction.

https://www.bloomberg.com/news/articles/2025-12-01/ukraine-starts-push-to-replace-growth-linked-warrants-with-bonds

FDA Delays Decision on Ascendis’ Dwarfism Drug by Three Months

 

If approved, Ascendis’ TransCon CNP would become the second therapy for achondroplasia, challenging BioMarin’s Voxzogo.

The FDA has pushed the deadline out three months for its final decision on Ascendis Pharma’s achondroplasia treatment TransCon CNP.

The delay comes after Ascendis in early November filed additional information regarding a post-marketing requirement for TransCon CNP. The FDA considered this a “major amendment,” according to a news release last Wednesday, necessitating the review extension. The agency’s original target action date was Nov. 30, but Ascendis now expects the verdict to come on or before Feb. 28, 2026.

In a statement, Ascendis CEO Jan Mikkelsen said that the company has addressed “all outstanding requests from the FDA.” Ascendis will continue to work with the regulator to bring TransCon CNP to patients who need it “as soon as possible,” Mikkelsen added

Achondroplasia is a genetic disease characterized by impaired bone development. The condition affects 15,000 to 40,000 newborns and qualifies as a rare disease, though it is known as the most common cause of dwarfism. TransCon CNP, also called navepegritide, specifically addresses the achondroplasia subtype caused by overactivity of the FGFR3 gene which, aside from compromising bone growth, also manifests with neurological, muscular and cardiorespiratory issues.

Ascendis’ treatment gives patients the C-type natriuretic peptide (CNP), in turn counteracting the effects of mutated FGFR3 and helping to stimulate bone growth. Data from the Phase II ACcomplisH study published in The Lancet in November 2023, showed that TransCon CNP improved growth rates in patients with achondroplasia.

The regulatory delay for TransCon CNP should give some breathing room to BioMarin, which owns Voxzogo, the only FDA-approved treatment for achondroplasia. That drug, approved in November 2021addresses the same disease pathway as TransCon CNP: it mimics the action of CNP and targets FGFR3 signaling, facilitating bone growth.

BioMarin is increasingly wary of the incoming competition from TransCon CNP, alongside other investigational achondroplasia therapies on the horizon, including BridgeBio’s infigratinib. During its third-quarter earnings call in October, the company revealed that it will abandon its previously announced goal of hitting $4 billion in revenue in 2027, with CFO Brian Mueller specifically citing the “impact of potential Voxzogo” competition.

https://www.biospace.com/fda/fda-delays-decision-on-ascendis-dwarfism-drug-by-three-months

Texas attorney general investigates Shein over labor practices, product safety

 Attorney General Ken Paxton is investigating global fast-fashion retailer Shein US Services LLC Corporation and its affiliates (“Shein”) for potential violations of Texas law related to unethical labor practices and the sale of unsafe consumer products. 

“Safe, non-toxic material and products are another key ingredient to the Make America Healthy Again movement. Any company that cuts corners on labor standards or product safety, especially those operating in foreign nations like China, will be held accountable,” said Attorney General Paxton. “Texans deserve to know that the companies they buy from are ethical, safe, transparent, and not exploiting workers or selling harmful products. I will not allow cheap, dangerous, foreign goods to flood America and jeopardize our health.” 

Shein generated more than $30 billion in global revenue in 2023. The company operates primarily online, offering a vast range of clothing, accessories, and home decor products. Although the company promotes itself as a responsible and innovative retailer, numerous reports have raised serious concerns about its reliance on forced labor, the use of unsafe product materials, and deceptive marketing practices. 

The investigation will determine whether Shein’s supply chain and manufacturing practices violate Texas law by using toxic or hazardous materials, misleading consumers about product safety, and misleading consumers about ethical sourcing. The investigation will also examine the company’s data collection and privacy practices, which may pose risks to millions of American consumers. 

https://texasattorneygeneral.gov/news/releases/attorney-general-ken-paxton-investigates-global-fast-fashion-giant-shein-unethical-labor-practices

NATO Mulls 'Preemptive Strike' Against Russia's Hybrid Warfare, Claims 'More Aggression' Needed

 At a moment Washington under President Trump is busy issuing rare calls for restraint, de-escalation, and to enact a peace deal in Ukraine, a top NATO commander says the conflict needs more aggression by the Western military alliance directly against Russia.

Admiral Giuseppe Cavo Dragone, chair of NATO’s Military Committee, has told Financial Times as part of a fresh report that NATO is currently mulling more proactive measures in response to Russia’s escalating hybrid warfare. The report cites an alleged rise in Russian-backed cyberattacks, sabotage operations and airspace violations over Europe - which NATO could mirror and more, as any potential "pre-emptive strike" on Russian targets would be justified.

Adm. Giuseppe Cavo Dragone, via ANSA English

"We are studying everything… On cyber, we are kind of reactive," Dragone said"Being more aggressive or being proactive instead of reactive is something that we are thinking about."

That's when he explained his view that a "pre-emptive strike" could under certain circumstances and context be classified as a defensive action. "It is further away from our normal way of thinking and behavior," he conceded.

"Being more aggressive compared with the [aggressiveness] of our counterpart could be an option" - but he said that the questions that remain are: "legal framework, jurisdictional framework, who is going to do this?"

Multiple diplomats and officials from Eastern European and Baltic states are calling for this more proactive stance, or a less merely 'reactive' approach, to make Moscow feel real pain.

"If all we do is continue being reactive, we just invite Russia to keep trying, keep hurting us," one Baltic diplomat was quoted in the FT as complaining.

"Hybrid warfare is asymmetric – it costs them little, and us a lot. We need to be more inventive," the diplomat said.

And yet, there already have been years of covert sabotage operations in place, aimed at Russia and overseen by the West. These efforts, some which long ago were exposed in mainstream publications, are a large reason of why there's been constant escalation of the Ukraine war. 

This has in turn resulted in escalation of nuclear rhetoric and threats between Russia and the West. But the temperature needs to be drastically turned down, but these latest comments by the chair of NATO's Military Committee will only do the opposite.

Young men are continuing to pay the price on the battlefield, even as a peace process slowly and painfully plays out. Reuters has belatedly admitted and documented the immense losses suffered by Ukraine's military:

Pavlo Broshkov had high hopes when he joined the Ukrainian army in March as a fresh-faced recruit eager to defend his country and earn a bumper bonus to buy a home for his wife and baby daughter.

Three months later, the 20-year-old lay broken and prone on the battlefield, his dreams in tatters.

Broshkov is among hundreds of 18 to 24-year-olds who have volunteered to fight on the front lines this yearlured by generous pay and perks in a national youth recruitment drive designed to breathe fresh life into Ukraine's aged and exhausted armed forces of about one million.

Meanwhile, EU nations are finding any way possible to keep up the conflict instead of finding true compromise...

The Kremlin has hit back against the aforementioned remarks of Adm. Dragone, with Kremlin spokesperson Maria Zakharova calling Dragone's remarks "an extremely irresponsible step, indicating the readiness of the alliance to continue to move toward escalation."

https://www.zerohedge.com/geopolitical/nato-mulls-preemptive-strike-against-russias-hybrid-warfare-claims-more-aggression

PTC Therapeutics downgraded at RBC as Sephience sales priced in

 

  • RBC Capital Markets has downgraded PTC Therapeutics (PTCT) to sector perform from outperform, saying that its current share price already factors in sales from hyperphenylalaninemia treatment Sephience (sepiapterin).
  • The firm, however, increased its price target to $91 from $82 (~6% upside based on Nov. 28 close).
  • Analyst Brian Abrahams said that although Sephience has done well since its launch earlier this years, shares are up ~75% in the last three months. 
  • "While we could see some additional momentum for shares, particularly if they beat on 4QE, which now looks more likely to us, with Sephience at a $7.5B market cap, now reflecting ~4x peak adjusted sales, we see less room for significant additional appreciation," he noted.
  • Abrahams added that a proprietary survey of 15 physicians who treat patients with sepiapterin-responsive phenylketonuria (PKU) found that two-thirds of them have patients on the treatment, with ~20% of their total patients on Sephience.

Crispr Therapeutics pares loss amid takeover speculation

  • Crispr Therapeutics (CRSP) pared a loss amid some takeover speculation.
  • There's speculation that a takeover bid for Crispr (CRSP) could be moving along as the potential buyer has hired an adviser to help with a bid, according to traders, who cited a Betaville "uncooked" alert that was circulating on Monday. People following the matter have heard talk that the potential bidder may have hired law firm Skadden for a takeover. 
  • The latest update comes after Betaville last month said a US-based biopharma with a market cap of $100-$200 billion  may be interested in bidding for Crispr (CRSP).