Obesity Drug Player Fractyl Health Files For $100M IPO

 Fractyl Health, developing procedural and gene therapies for type 2 diabetes and obesity, filed an S-1 filing with the SEC on Thursday to raise up to $100 million in an initial public offering.

Fractyl Health is a metabolic therapeutics company focused on new approaches for metabolic diseases, including type 2 diabetes and obesity. 

Its lead candidate, the Revita DMR System, is an outpatient procedural therapy designed to modify duodenal dysfunction. 

Revita is approved for patients with inadequately controlled type 2 diabetes in Europe. 

The company is enrolling a pivotal study of Revita in patients with inadequately controlled type 2 diabetes, with topline data expected in 4Q24. It plans to evaluate Revita in a clinical study for weight maintenance, expecting to submit an IDE and comparable documents to the FDA in the first half of 2024. 

Fractyl is also developing Rejuva, an adeno-associated virus-delivered pancreatic gene therapy platform, and it plans to nominate its first candidate in the 1Q24.

The company was founded in 2010 and plans to list on the Nasdaq under the symbol GUTS. 

As the gold rush in obesity meds shows no sign of slowing, Fractyl Health's filing comes on the heels of diabetes and obesity-focused biotech Carmot Therapeutics, which announced earlier this month that it would be acquired by Roche Holdings AG RHHBY, shortly after filing for an IPO in late November.

In October, Fractyl Health presented data showing that a single dose of Rejuva could reduce body fat by 24.8% in a mouse model of type 2 diabetes, compared to 18.4% in animals given daily doses of Novo Nordisk A/S NVO semaglutide available as Wegvoy and Ozempic.

The company is currently working on lead optimization and IND-enabling toxicology studies and is targeting 2024 for its first human studies.

https://www.benzinga.com/general/biotech/23/12/36262799/weight-loss-drug-gold-rush-gets-larger-as-new-player-fractyl-health-files-for-100m-ipo

Tourmaline Bio added to the NASDAQ Biotechnology Index

 Tourmaline Bio, Inc. (“Tourmaline”) (Nasdaq: TRML), a late-stage clinical biotechnology company developing transformative medicines to dramatically improve the lives of patients with life-altering immune and inflammatory diseases, today announced that Tourmaline has been added to the NASDAQ Biotechnology Index (Nasdaq: NBI), effective prior to market open, Monday, December 18, 2023.

https://www.globenewswire.com/news-release/2023/12/15/2797271/0/en/Tourmaline-Bio-added-to-the-NASDAQ-Biotechnology-Index.html

Stefanik files complaint against federal judge who ruled in Jan. 6, Trump cases

 Rep. Elise Stefanik (R-N.Y.) on Friday requested an ethics investigation into a federal judge who has ruled in cases linked to Jan. 6 rioters and former President Trump — and who is currently overseeing Trump ally Rudy Giuliani’s defamation trial.

Stefanik claimed that U.S. District Judge Beryl Howell engaged in “judicial misconduct” during a speech she gave last month after accepting an award at a Women’s White Collar Defense Association gala. Stefanik called it a “highly inappropriate political speech.”

In the speech, Howell discussed the impact of “big lies” in connection with the Jan. 6, 2021, Capitol attack and quoted historian Heather Cox Richardson’s book “Democracy Awakening” that “big lies are springboards for authoritarians.” The judge did not mention Trump by name.

“We are having a very surprising and downright troubling moment in this country when the very importance of facts is dismissed or ignored,” Howell said in the speech. 

Rep. Elise Stefanik (R-N.Y.) speaks with Rep. Jim Jordan (R-Ohio) in the House Chamber following the second vote for Speaker of the House on Wednesday, October 18, 2023. (Greg Nash)

A staunch Trump ally, Stefanik criticized the comments as “unbecoming of a federal judge” and suggested a connection between Howell’s comment on authoritarianism and Trump’s 2024 presidential campaign.

“Judge Howell’s speech is plainly inappropriate, consisting of partisan statements, election interference and improper extrajudicial statements while criminal cases are pending — all barred by Canon 2B,” Stefanik wrote, referencing a judicial ethics guide.

Howell was chief judge of the federal court in Washington, D.C., for seven years; she passed the baton to Judge James Boasberg, who became chief judge in March. While in that role, Howell oversaw the grand jury that heard evidence and later indicted Trump in his federal 2020 election subversion case.

Stefanik said in a statement to The Hill that she filed her complaint against Howell because “election interference by judges destroys public confidence in the federal judiciary, tears apart the fabric of our Republic and is illegal.” 

The judge is overseeing a defamation case brought by two former Georgia election workers against Giuliani, Trump’s former lawyer, after he accused them of 2020 election fraud. A jury began deliberating on the case Thursday.

A spokesperson for the court declined to comment on the matter. 

Howell is not the only judge linked to Trump and his allies that Stefanik has targeted with an ethics inquiry request. She filed a complaint last month against Judge Arthur Engoron, who is overseeing Trump’s New York civil fraud trial, claiming he has shown “inappropriate bias and judicial intemperance” toward Trump.

https://thehill.com/regulation/court-battles/4362060-elise-stefanik-complaint-federal-judge-trump-cases/

Gasoline Prices Sink to Lowest Since 2021 on Soft Demand, Supply Boost

 

The cheapest gasoline in 2 1/2 years is set to drive spending for US consumers this holiday shopping season.

A gallon of regular gasoline now costs $3.087, down more than 10 cents from a year ago and the lowest since late-June 2021, according to data from the American Automobile Association. Fuel prices have steadily declined since the summer driving season ended in September, largely tracking losses in oil as well as reflecting soft seasonal demand and growing supplies.

https://www.bloomberg.com/news/articles/2023-12-15/gasoline-prices-sink-to-lowest-since-june-2021-in-boon-to-us-consumers

Palestinian Americans sue Biden administration over relatives stuck in Gaza

 Two Palestinian American families have sued the Biden administration, claiming the government has not done as much to evacuate their U.S. relatives stuck in Gaza as it did for Israeli dual nationals.

In the days after Hamas' Oct. 7 assault in southern Israel, the U.S. government organized charter flights from Tel Aviv to Europe to help Americans leave Israel after many airlines canceled service to the country.

The State Department says it has helped around 1,300 U.S. Palestinians leave Gaza and escape Israel's retaliatory bombardment - in part by coordinating their exit to neighboring Egypt with Israeli and Egyptian authorities.

But the United States has not taken steps to organize dedicated flights or otherwise help secure the exit of an estimated 900 U.S. citizens, residents and family members who remain trapped in Gaza, the American families suing the government say.

They say this violates their constitutional rights.

"There is more that the U.S. government can do and they are choosing not to do it for Palestinians," Yasmeen Elagha, who has family stuck in Gaza and helped organize the lawsuit, said in an interview.

The State Department declined to comment on pending litigation but a spokesperson said the department is working to get more Americans and family members out of Gaza. The White House referred questions on the lawsuit to the Justice Department, which did not immediately comment.

Hamas militants killed 1,200 people in Israeli border communities with Gaza and took 240 hostage during its Oct. 7 assault, according to Israeli tallies.

Since then, Israeli bombardment has killed nearly 19,000 Palestinians, according to Gaza health officials. According to U.N. estimates, up to 85% of the 2.3 million people in the densely populated enclave have been displaced from their homes.

The lawsuit, filed on Wednesday in U.S. District Court in Indianapolis, accuses the federal government of failing to protect U.S. citizens in an active war zone and denying equal protection to Palestinian Americans, a right under the U.S. Constitution.

The suit seeks to force the government to begin evacuation efforts and secure the safety of its citizens "on equal terms to other noncombatants in the same war zone."

Two of the plaintiffs in the lawsuit are Elagha's cousins, Borak Alagha and Hashem Alagha, U.S. citizens who were studying engineering in the Palestinian coastal enclave.

Americans listed by the United States as wanting to leave Gaza at the Egyptian-controlled Rafah crossing must be approved by both Israel and Egypt.

The three Americans cited in the lawsuit have not been cleared to leave, said Elagha, who lives near Chicago.

Maria Kari, a lawyer with the Arab American Civil Rights League who represents the plaintiffs, said her organization filed about 40 lawsuits in the first month of the conflict on behalf of Palestinian dual nationals.

"We're simply asking the Biden administration to do something it already did for a class of citizens in the same war," she said.

https://www.marketscreener.com/news/latest/Palestinian-Americans-sue-Biden-administration-over-relatives-stuck-in-Gaza-45582121/

California's only nuclear plant gets state approval for 5-year extension

 California's utilities regulator on Thursday granted a five-year extension to operate Pacific Gas and Electric's Diablo Canyon power plant, the state's only nuclear facility, to avoid electricity shortages during extreme weather events.

The California Public Utilities Commission (CPUC) approved extended operations at the 2,240-megawatts Diablo Canyon plant's two reactor units until 2029 and 2030, from 2024 and 2025, respectively.

PG&E can now keep Diablo Canyon running while it awaits a renewed federal operating license, and it must also keep the terms of its $1.4 billion loan agreement with California, the CPUC said in its decision.

PG&E applied on Nov. 7 with the U.S. Nuclear Regulatory Commission for a license renewal, and had previously received approval to keep Diablo Canyon running during the relicensing period.

"Shortfalls could occur under climate-driven extreme events, including the extreme heat events California recently experienced in 2020 and 2022, and the risks are compounded if coincident wildfire risk reduced transmission capacity during peak events," it added.

Separately, the CPUC last month approved a 13% rate hike for PG&E, with most earmarked for wildfire mitigation.

The CPUC could not determine if Diablo Canyon's extension costs are "too high to justify" or "not cost-effective or imprudent," claiming it lacked sufficient information.

Critics of keeping open the plant, located next to the Pacific Ocean in San Luis Obispo County, say the region is vulnerable to earthquakes and that there is no permanent place for disposing of radioactive nuclear waste.

PG&E will be responsible for obtaining substitute capacity during outages, the CPUC said, adding that any excess charges collected in one year must be returned to customers over the next one.

In 2022, the Biden administration approved conditional funding of up to $1.1 billion to prevent the closure of Diablo Canyon, as part of its effort to fight climate change.

https://www.marketscreener.com/news/latest/California-s-only-nuclear-plant-gets-state-approval-for-5-year-extension-45582156/

'Mexican president urges Argentines to peacefully resist Milei'

 Mexico's leftist leader on Friday recommended that Argentines peacefully protest the new government of radical libertarian President Javier Milei, who took office last week promising deep budget cuts in a bid to tame triple-digit inflation.

President Andres Manuel Lopez Obrador, who has often criticized foreign calls to action against his own government's policies, told a press conference that Argentine citizens should embrace "peaceful civic resistance" and avoid any temptation to oppose Milei's policies with violence.

"What I will say to the Argentine people ... is don't be provoked, that non-violence is politically effective," said Lopez Obrador, who himself has pursued wide-ranging cuts to government spending that does not align with his priorities.

Milei's press office did not immediately repsond to a request for comment.

After Milei's triumph in a run-off election last month, Lopez Obrador dismissed the win as an "own goal", saying he was not in favor of "racist, classist governments."

His foreign ministry did, however, congratulate Milei, saying Mexico would seek constructive relations.

This week, Milei's economic chief rolled out an initial set of policies, including a sharp devaluation of the local peso currency plus major spending cuts, aimed at staving off hyperinflation and fixing his country's worst crisis in decades.

Milei's predecessor, center-left President Alberto Fernandez, had much warmer relations with Lopez Obrador.

https://www.marketscreener.com/news/latest/Mexican-president-urges-Argentines-to-peacefully-resist-Milei-45582167/