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Wednesday, June 25, 2025

‘Pickaxe Mountain,’ Iran’s secret underground fortress, may be stashing uranium stockpiles

 A hidden fortress under construction in Iran — known as “Pickaxe Mountain” — may potentially be housing any uranium stockpiles that Tehran managed to smuggle out before the US bombed its nuclear sites.

The deeply buried installation, which is just minutes from the Natanz nuclear facility — one of the three sites struck over the weekend — has been quietly reinforced in recent years.

Multiple reports have suggested that Pickaxe could be the perfect hiding place for uranium — as speculation mounted that Iran may have been able to remove its cache before the attacks unfolded over the weekend.

A hidden fortress under construction in Iran, known as “Pickaxe Mountain,” may potentially be housing any uranium stockpiles.Google Earth
A satellite image of the Natanz uranium enrichment site construction area in Iran.DigitalGlobe/Getty Images

Open-source satellite images taken Thursday and Friday showed lines of cargo-style trucks outside Fordow, arousing suspicion that the theocratic regime could have moved its stockpile of enriched uranium.

Almost 900 pounds of uranium enriched to 60% purity has been unaccounted for since the Israeli airstrikes began on June 13.

Meanwhile, Iran has been cagey about the Pickaxe Mountain site after satellite imagery emerged earlier this year showing a new deeply buried tunnel and security perimeter close to the existing Natanz site.

A graphic of the Natanz nuclear facility.Tam Nguyen / NYPost Design
A Google Earth image of the hidden fortress.Google Earth

The director general of the UN’s International Atomic Energy Agency asked Tehran in April about what was going on there — but got a blunt response.

“Since it is obvious it is in a place where numerous and important activities related to the program are taking place, we’re asking them, what is this for? They are telling us, it’s none of your business,” Rafael Grossi, the director general, said at the time.

He added that it “cannot be excluded” that the tunnels would store undeclared material, but said he didn’t want to speculate on intentions.

Images released by US defense contractor Maxar Technologies showed more than a dozen trucks lined up outside Iran’s Fordow nuclear facility just days before the US carried out its large-scale airstrikes.Satellite image ©2025 Maxar Technologies/AFP via Getty Images

“I’ve been raising this issue repeatedly, and I will continue to do so,” Grossi said.

It wasn’t immediately clear if Pickaxe suffered any damage during the latest strikes that targeted Natanz, as well as the Fordow and Isfahan nuclear facilities.

President Trump, for his part, has insisted Iran wouldn’t have been able to remove any uranium being enriched at the sites before the attacks.

The deeply buried installation is just minutes from the Natanz nuclear facility.DigitalGlobe/Getty Images
“They didn’t have a chance to get anything out because we acted fast,” Trump said Wednesday.

“It would have taken two weeks, maybe. But it’s very hard to remove that kind of material, very hard and very dangerous for them to remove it.”

Trump also has insisted his attacks “obliterated” Iran’s nuclear program, and the White House has dismissed a leaked preliminary intelligence assessment suggesting Tehran could salvage it within months.

https://nypost.com/2025/06/25/world-news/inside-pickaxe-mountain-irans-underground-fortress-that-may-be-stashing-uranium/

Nuvalent chases after Nuvation in ROS1 lung cancer

 Nuvalent has said it is on course to file for approval of its ROS1 inhibitor zidesamtinib as a lung cancer treatment, although rival Nuvation Bio has beaten it to market.

Cambridge, Massachusetts-based Nuvalent has reported the results of its phase 1/2 ARROS-1 trial of zidesamtinib in previously treated patients with ROS1-mutated non-small cell lung cancer (NSCLC), saying the study is "aligned" with the FDA's position on regulatory submissions for this type of cancer.

It now plans to submit the drug via a rolling submission next month, with the aim of completing the filing in the third quarter, as it chases after Nuvation and its recently FDA-approved rival Ibtrozi (taletrectinib).

Like Ibtrozi, zidesamtinib has been held up as a next-generation ROS1 inhibitor that could improve on other drugs in the class, like Pfizer's first-to-market Xalkori (crizotinib), Roche's Rozlytrek (entrectinib), and Bristol Myers Squibb's Augtyro (repotrectinib).

Ibtrozi has approval as a first-line alternative to the established drugs, however, while the ARROS-1 data will only allow Nuvalent to seek approval in patients previously treated with ROS1 drugs, at least initially, although, the company has also reported encouraging preliminary data this morning in a treatment-naïve population.

In the study, there was a 44% objective response rate (ORR) among 117 pre-treated patients – around half of whom had received at least two earlier therapies – after treatment with zidesamtinib. In 78% of responders, the cancer was still being held at bay after 12 months, falling to 62% at 18 months.

The ORR rose to 51% in a subgroup of patients who had received prior treatment with just one ROS1 therapy, with an estimated durability of response of 93% at both the 12- and 18-month landmarks.

Nuvalent has also reported the first data from another study in ROS1 inhibitor-untreated patients, who may have had prior chemotherapy, revealing an ORR of 89% in 35 subjects that is in the same ballpark as was seen with Ibtrozi in the TRUST-1 and TRUST-2 trials that underpinned its approval.

The company said it "continues to engage with the FDA on potential opportunities for line-agnostic expansion."

It is estimated that approximately 2% of the million or so people around the world who are diagnosed with NSCLC each year have ROS1-positive disease, which has a tendency to progress quickly and spread to other parts of the body, particularly the brain.

Meanwhile, Nuvalent has also given an update on its ALK inhibitor neladalkib, saying that the startup of its ALKAZAR trial comparing the drug to Alecensa (alectinib) as a front-line treatment for ALK-positive NSCLC is gathering pace and enrolment is due to start in the latter half of 2025.

https://pharmaphorum.com/news/nuvalent-chases-after-nuvation-ros1-lung-cancer

ACIP Meeting Information

 

  • The ACIP holds three regular meetings each year to review scientific data and vote on vaccine recommendations. Additional meetings may be held as needed.
  • Meetings are open to the public via live webcast.
  • This page provides information on upcoming and past ACIP meetings.

Public comment

Public engagement and input are vital to ACIP's work. Members of the public are invited to submit comments to ACIP in two ways: (1) written comments submitted via regulations.gov, and/or (2) oral public comment at ACIP meetings.

How to submit a written public comment

Any member of the public can submit a written public comment to ACIP. The docket, identified by Docket No. CDC-2025-0024, will be opened to receive written comments on June 9, 2025. Written comments must be received by June 20, 2025, using the Federal eRulemaking Portal. Follow the instructions for submitting comments. All submissions received must include the agency name and Docket Number.

All relevant comments received will be posted without change to https://www.regulations.gov, including any personal information provided. For access to the docket or to read background documents or comments received, go to https://www.regulations.gov.

How to request to make an oral public comment

The June 25-26, 2025 ACIP meeting will be a virtual meeting and will include time for oral public comment for members of the public. All individuals interested in making an oral public comment are strongly encouraged to submit a request starting June 9, 2025,to no later than 11:59 p.m., EDT, June 20, 2025, as there will be no opportunity to register for oral public comment later than June 20th.

If the number of persons requesting to speak is greater than can be reasonably accommodated during the scheduled time, CDC will conduct a lottery to determine the speakers for the scheduled public comment session. CDC staff will notify individuals regarding their request to speak by email by June 23, 2025. To accommodate the significant interest in participation in the oral public comment session of ACIP meetings, each speaker will be limited to 3 minutes, and each speaker may only speak once per meeting.

Requests to make an oral public comment are closed.

https://www.cdc.gov/acip/meetings/index.html

Hoth-Silo jv for GDNF therapy licensed from U.S. Veterans Affairs targets obesity, fatty liver disease



Hoth Therapeutics (NASDAQ: HOTH) and Silo Pharma (NASDAQ: SILO) have formed a 50/50 joint venture to develop and commercialize a novel obesity treatment licensed from the U.S. Department of Veterans Affairs. The therapy is based on Glial Cell Line-Derived Neurotrophic Factor (GDNF), targeting obesity and non-alcoholic fatty liver disease (NAFLD).

The technology, protected under U.S. Patent No. 10,052,362, aims to address a $100B+ market with potential applications for type 2 diabetes and central obesity. The partnership combines the VA's clinical infrastructure, Hoth's regulatory expertise, and Silo's translational capabilities to develop this first-in-class treatment targeting the neuroinflammatory root of obesity.

https://www.stocktitan.net/news/HOTH/hoth-therapeutics-hoth-and-silo-pharma-nasdaq-silo-today-announced-9wumkyqaag4d.html

Kymera suffers Sanofi setback but secures $750M Gilead deal

 Kymera Therapeutics sweetened news of a setback Wednesday, revealing that Sanofi is pulling back from its lead IRAK4 degrader alongside details of the selection of a follow-up prospect and a $750 million deal with Gilead Sciences. 

Sanofi took its original lead IRAK4 degrader, which is called SAR444656 or KT-474, into phase 2 trials in atopic dermatitis and hidradenitis suppurativa in 2023. The studies were scheduled to wrap up next year, but the Big Pharma has rethought its plans before reaching the milestones. Rather than advancing KT-474, Sanofi has decided to prioritize the preclinical IRAK4 degrader KT-485, according to a June 25 press release from Kymera.

In the release, Kymera said the new candidate showed increased selectivity and potency with a favorable safety profile in preclinical testing. The biotech expects KT-485 to enter the clinic next year, five years after it started a phase 1 trial of KT-474. 

Sanofi will pay a milestone when KT-485 starts clinical development. The fee is part of a total package that is worth up to $975 million in potential clinical, regulatory and commercial milestones. Last month, Kymera said it was eligible to receive up to $1 billion in development and regulatory milestones, plus up to $400 million tied to commercial successes, as part of the Sanofi deal.

Kymera shared news of changes to the Sanofi collaboration minutes after disclosing an oncology deal with Gilead. The Big Biotech has committed up to $85 million in upfront and potential option exercise payments for a chance to license a CDK2-directed molecular glue degrader. The idea is to remove the protein from cells, taking out a tumor growth driver without causing the side effects associated with CDK2 inhibitors.

Companies including AstraZeneca, Incyte and Pfizer have CDK2 inhibitors in clinical trials, reflecting the potential for medicines that inhibit the protein to address resistance mechanisms to CDK4/6 inhibitors in breast cancer. First-generation candidates had tolerability problems, potentially because they hit other proteins as well as CDK2.

Advocates of molecular glue degraders argue the modality could avoid the dose-limiting toxicities seen in some CDK2 inhibitor trials by more selectively targeting the protein. Monte Rosa Therapeutics shared preclinical data on its CDK2-directed molecular glue degrader late last year. 

Kymera will lead all research activities for the Gilead-partnered CDK2 program. Gilead has an option to exclusively license the program in exchange for a financial package that could total $750 million plus royalties.

https://www.fiercebiotech.com/biotech/kymera-suffers-sanofi-setback-secures-750m-gilead-deal

More people staying on a GLP-1 for weight loss after one year

 GLP-1 weight loss drugs like Wegovy and Zepbound see rising adherence rates, but long-term use remains low.

https://seekingalpha.com/news/4462239-more-people-staying-glp-1-weight-loss-after-one-year

Powell reaffirms Fed has no issues with banks conducting crypto activities



Federal Reserve Chair Jerome Powell reaffirmed that the central bank does not object to U.S. banks providing services to cryptocurrency companies or participating in crypto-related activities, so long as they follow established risk management and consumer protection standards.


Powell made the statement during his semiannual monetary policy report testimony before the House Financial Services Committee on June 24, reinforcing recent steps by federal regulators to remove barriers that have long restricted crypto’s access to traditional banking.

The Federal Reserve Board formally removed “reputational risk” from its bank supervision framework on June 23, ordering examiners to strike the subjective standard from examination manuals and focus instead on measurable financial exposures.

The decision aligns the Fed with the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency, which made similar revisions earlier this year. Together, the three regulators oversee every federally insured depository institution in the United States.

The coordinated policy shift eliminates a broad and often opaque reason that examiners have used to deny banking services to crypto firms or prevent banks from offering services like Bitcoin trading or custody.

Under the updated guidance, Fed staff will be retrained to implement the changes uniformly across all supervised institutions and will coordinate with peer agencies to ensure consistent oversight.