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Tuesday, June 17, 2025

Novavax stock slips as Citi issues Sell rating

 Novavax (NVAX) stock dropped after Citi issued a Sell rating, citing concerns over its respiratory vaccine-focused pipeline.

https://seekingalpha.com/news/4459116-novavax-stock-slips-citi-issues-sell-rating

UBS upgrades Alkermes stock rating on orexin treatment potential

 UBS upgraded Alkermes (NASDAQ:ALKS) from Neutral to Buy on Tuesday, raising its price target to $42.00 from $33.00. The upgrade reflects UBS’s growing confidence in the company’s orexin receptor drug candidate ALKS-2680 for narcolepsy and idiopathic hypersomnia treatment. 

UBS analyst commentary indicates that a recent physician survey strengthened the firm’s outlook on ALKS-2680’s market positioning. The drug candidate appears well-positioned to potentially establish itself as an attractive treatment option in sleep disorders, according to the research note.

The current stock valuation prices in approximately $1.2 billion in 2030 estimated sales, compared to UBS’s base case projection of $1.8 billion. This base case includes $350 million specifically for ALKS-2680, with the remainder attributed to Alkermes’ existing business portfolio. With a market capitalization of $4.85 billion and a P/E ratio of 15.08,

UBS notes that three key mid/late-stage orexin clinical trial results are expected in the second half of the year from Alkermes, Takeda, and Centessa Pharmaceuticals. These upcoming data readouts could generate broader market excitement for the entire orexin drug class.

The price target increase represents a 27% upside from the previous $33.00 target, signaling UBS’s more bullish stance on Alkermes’ growth prospects in the sleep disorder treatment market. 

https://www.investing.com/news/analyst-ratings/ubs-upgrades-alkermes-stock-rating-on-orexin-treatment-potential-93CH-4098594

Supreme Court Gets First Chance to Weigh in on Donald Trump's Tariffs



Two small toy companies have petitioned the U.S. Supreme Court to overturn President Donald Trump's global tariffs, arguing that he exceeded his authority under the International Emergency Economic Powers Act (IEEPA).

The Supreme Court's decision on whether to hear the case could have significant implications for the scope of executive power in trade policy.

Trump's tariffs led to global market turmoil, particularly after the president rolled out hefty tariffs targeting almost every U.S. trading partner on April 2, which he dubbed "liberation day." The president has since backtracked on the initial announcement, but the U.S. tariff policy remains in flux.

Tuesday's petition comes from an earlier case in which a federal judge sided with two Chicago-based toy companies and ruled that Trump overstepped his powers when invoking the IEEPA to impose tariffs. The Trump administration appealed the ruling, which was limited to the two toy companies, after which the plaintiffs went to the U.S. Supreme Court.

"In light of the tariffs' massive impact on virtually every business and consumer across the nation, and the unremitting whiplash caused by the unfettered tariffing power the president claims, challenges to the IEEPA tariffs cannot await the normal appellate process [even on an expedited timeline]," the family owned toy companies, Learning Resources Inc. and hand2mind Inc., said in their petition to the high court.

"There is ample reason for this Court to grant certiorari before judgment now so this case can be briefed over the summer and argued as soon as possible."

Trump's global tariffs were also blocked by the U.S. Court of International Trade (USCIT) in a separate case last month, but a federal appeals court quickly stayed the ruling, allowing the tariffs to remain in place while legal proceedings play out.

The USCIT's three-judge panel said in its summary judgment: "The question in the two cases before the court is whether the International Emergency Economic Powers Act of 1977 ['IEEPA'] delegates these powers to the President in the form of authority to impose unlimited tariffs on goods from nearly every country in the world."

https://www.newsweek.com/supreme-court-gets-first-chance-weigh-donald-trump-tariffs-2086898

China continues to stockpile oil

 China’s crude oil stockpiles likely grew at an elevated rate for the third consecutive month in May, which could allow Beijing to purchase lower volumes over the next weeks amid the spike in oil prices due to the Israel-Iran conflict.   

China is estimated to have stockpiled a lot of crude in the early months of the year, Reuters columnist Clyde Russell has calculated. The high inventories could potentially allow Chinese refiners to reduce crude buying later this year, which would weigh on oil prices and perceived demand in China. 

Since China doesn’t report oil inventories, Russell has calculated the rate of stockpiling or stock draws based on official Chinese data of imports, domestic production, and refinery processing rates. 

These calculations showed that China likely stockpiled 1.4 million barrels per day (bpd) in May, as this is the available crude from imports and domestic production that wasn’t used by refineries last month.  

The likely inventory build in May is the third consecutive month in which China has added more than 1 million bpd to its strategic and commercial crude stockpiles. 

Amid heavy seasonal maintenance, crude oil processing at China’s refineries dipped by 1.8% in May from a year earlier, to the lowest level in nine months

Chinese refiners processed a total of about 13.92 million bpd of crude oil last month, according to data from the National Bureau of Statistics. Throughput slumped to the lowest level since August last year as several major state-run and private refiners underwent scheduled maintenance ahead of the peak driving season.  

China accelerated crude oil imports in March and April, but the increased purchases this spring weren’t necessarily a sign of recovering fuel demand in the world’s biggest crude importer. It’s more likely that Chinese refiners were aggressively stockpiling cheaper crude amid uncertainties about sanctioned barrels going forward. 

This stockpiling could come in handy for China as it could allow it to reduce crude buying at prices with the war premium attached. 

https://oilprice.com/Latest-Energy-News/World-News/China-Continues-to-Stockpile-Crude-Oil.html

G7 leaders sign joint statements on critical minerals, AI

 Group of Seven nations gathered for a summit have agreed six joint statements on subjects such as critical minerals, artificial intelligence and wildfires, host nation Canada said on Tuesday.

The other topics they agreed statements on were quantum computing, migrant smuggling and transnational repression. Prime Minister Mark Carney is due to issue a separate chair's statement later.

https://www.yahoo.com/news/g7-leaders-sign-joint-statements-201055169.html

Ventyx’s Parkinson’s Pill ‘Promising’ Results in Mid-Stage Study, Path to Other Neuro Diseases

 

Jefferies analysts said on Tuesday that Ventyx could leverage its mid-stage data for VTX3232 to position the oral drug candidate as a treatment for other neurodegenerative diseases, including Alzheimer’s.

Ventyx Biosciences’ oral drug candidate VTX3232 can durably knock down its target biomarker in patients with Parkinson’s disease, an outcome that analysts at Jefferies said could support studies in other neurodegenerative diseases.

“Today’s data supports advancing to a larger Phase II study in Parkinson’s and perhaps Alzheimer’s, too,” the analysts wrote in a Tuesday note to investors, contending that Ventyx could also leverage these results in potential business development talks with pharma companies.

Tuesday’s data come from a small Phase IIa study which gave a daily 40-mg oral dose of VTX3232 to 10 patients with early-stage, idiopathic Parkinson’s disease. Treatment lasted for 28 days. Results showed that the drug was present at high levels in both the patients’ plasma and the cerebrospinal fluid (CSF). According to Jefferies, this supports its once-daily dosing profile.

VTX3232 treatment also reduced levels of its target biomarker, an immune protein called NLRP3, as well as downstream signaling molecules such as IL-6, hsCRP and SAA. Ventyx said patients showed notable improvements in motor and non-motor symptoms, with significant gains across the different domains of the MDS-Unified Parkinson’s Disease Rating Scale.

The biotech was quick to point out, however, that the study was open-label and had no placebo control. Patients were also on active symptomatic treatment.

Jefferies said that VTX3232 showed a “clean and safe profile.” Ventyx’s announcement noted that all side effects were mild or moderate in severity and were deemed unrelated to VTX3232. There were no serious adverse events documented.

Taken together, these findings support the continued clinical development of VTX3232 in Parkinson’s disease, for which the company is currently planning a double-blind and placebo-controlled Phase II study, Ventyx said on Tuesday. The biotech is also looking at the possibility of expanding beyond Parkinson’s and into other neurodegenerative diseases, including Alzheimer’s. The company is already testing VTX3232 in a Phase II trial for lowering inflammation in patients with cardiometabolic conditions and obesity, with data expected in the second half of 2025.

Ventyx CEO Raju Mohan on Tuesday said that the biotech has “initiated internal and external planning discussions” for the further development of VTX3232, though he did not specify whether these discussions were with potential industry partners or with regulators.

Jefferies believes Ventyx would be smart to look for a partner for VTX323. “Given the significant capital requirement, it makes sense to engage a Pharma partner to advance this program into larger [placebo]-controlled CNS studies,” its analysts wrote.

https://www.biospace.com/drug-development/ventyxs-parkinsons-pill-shows-promising-results-in-mid-stage-study-paving-path-to-other-neuro-diseases

FDA Rolls Out Commissioner’s Priority Voucher Program to Speed Drug Reviews

 

The program will bring together experts from across the FDA for a team-based review, rather than having an application move across numerous offices within the agency before getting a yay or nay.

The FDA launched a new priority review voucher program on Tuesday that it says could shorten the timeline for drug review from 10-12 months to 1-2 months. FDA chief Marty Makary said he modeled the new Commissioner’s National Priority Voucher (CNPV) program after his experience as a surgical oncologist.

“We often made multidisciplinary decisions with a team of doctors on major life-and-death questions for patients, incorporating the latest medical studies in a 1-day tumor board-style discussion. This voucher harnesses that model to deliver timely decisions for drug developers,” Makary said in a statement.

The CNPV program will bring together experts from across the FDA for a team-based review, rather than having an application move sequentially through offices within the agency before a decision is made. The experts will get together for a one-day “tumor board style” meeting, according to the press release.

The new vouchers will be offered to companies that are “aligned with U.S. national priorities,” the announcement states. These include addressing a health crisis in the U.S., delivering more innovative cures, addressing an unmet public health need and increasing domestic drug manufacturing as a national security issue. Besides the quick review, the drugs in the program could get an accelerated approval, meaning a therapy can be approved prior to completing a Phase III trial.

In the first year, just a handful of the vouchers will be available. The FDA explained that companies can use the vouchers toward a specific investigational new drug application, or they can be handed out as an undesignated voucher for a new drug “at the company’s discretion” so long as it aligns with the program.

“Using a common-sense approach, the national priority review program will allow companies to submit the lion’s share of the drug application before a clinical trial is complete so that we can reduce inefficiencies. The ultimate goal is to bring more cures and meaningful treatments to the American public,” Makary said.

The FDA offers a variety of vouchers to advance certain drugs, such as those for rare pediatric diseases, tropical diseases and medical countermeasures. These can be earned by companies and later sold, creating a marketplace and source of non-dilutive capital for smaller biotechs. The FDA clarified in an email to BioSpace that these vouchers will not be transferable but will be valid through changes in company ownership.

The previous administration under Joe Biden and former FDA chief Robert Califf took strides to advance the accelerated review program and ensure that companies have a confirmatory trial underway prior to submitting a request for a quick review.

Since taking over, Makary has proposed a new conditional approval pathway for rare diseases, although details remain slim. His new Center for Biologics Evaluation and Research chief Vinay Prasad has been critical in the past of the FDA’s use of accelerated approval but had pledged support for finding ways to speed rare disease drugs through the regulatory process.

But the agency has also slashed staff under this new administration, with Makary signaling this week that more cuts may be coming. In recent weeks, cracks began to show in the approval process as companies, including GSK and KalVista, reported delays.

https://www.biospace.com/policy/fda-rolls-out-commissioners-priority-voucher-program-to-speed-drug-reviews