BridgeBio gets EU nod for ATTR cardiomyopathy drug

 The European Commission has approved BridgeBio's acoramidis for life-threatening heart disorder transthyretin amyloidosis cardiomyopathy (ATTR-CM), setting up a market clash with Pfizer.

The oral drug – which has been cleared under the Beyonttra trade name – can be used to treat cardiomyopathy in wild-type or variant ATTR patients and will be launched by European marketing partner Bayer in the second half of this year.

The EU is the second market for the drug after the US, where it was approved under the Attruby brand name last November, on the back of clinical data showing that it was able to reduce cardiovascular death and cardiovascular-related hospitalisation in adults with ATTR-CM, a progressive disease that leads to heart failure and death.

It is expected to be a major competitor to Pfizer's blockbuster Vyndamax/Vyndaqel/Vynmac franchise – based on tafamidis – which has been approved for ATTR-CM since 2019 and is also used to treat polyneuropathy associated with ATTR (ATTR-PN). Last year, sales of the Vyndaqel family grew 65% to $5.45 billion.

Both acoramidis and tafamidis are transthyretin (TTR) stabilisers, designed to block the formation of amyloid fibrils in tissues and organs that are a hallmark of ATTR and responsible for symptoms.

According to BridgeBio, its drug has shown the most rapid benefit in ATTR-CM of any therapy tested in phase 3 trials and is the only one with a label specifying near-complete stabilisation (≥90%) of TTR, although, Pfizer disputes that interpretation claiming its drug has shown similar levels in trials.

Early signs from the US market have been positive, with the Palo Alto, California-based company reporting that 430 prescriptions for Attruby had been written before the end of 2024.

The drug had a US list price at launch of around $244,000 per year based on the recommended dose of two 356mg tablets taken twice daily, which was a discount on the $268,000 annual cost of the Vyndaqel range.

BridgeBio now stands to receive a $75 million milestone payment from Bayer as a result of the EU approval and will book royalties on sales by Bayer at a rate in the low-30s percentage or higher.

The company is also anticipating approval of acoramidis in the first half of this year in Japan, where it is licensed to AstraZeneca.

Another rival in the ATTR-CM market could be on the way, as Alnylam is waiting to hear from the FDA whether its gene-silencing therapy vitrusiran – already approved as Amvuttra for ATTR-PN – will get its US label extended to include ATTR-CM. That decision is due by 23rd March.

https://pharmaphorum.com/news/bridgebio-gets-eu-nod-attr-cardiomyopathy-drug

Acting NASA chief says DOGE plans to examine space agency's spending

 NASA's acting administrator Janet Petro on Wednesday said Elon Musk's government efficiency panel plans to examine the space agency's spending and that any concerns about conflicts of interest would be reviewed by NASA's legal team.

"We are going to have DOGE come. They're going to look - similarly what they've done in other agencies - at our payments and what money has gone out," Petro, who was previously the head of NASA's Kennedy Space Center, told reporters at a conference in Washington.

https://www.marketscreener.com/news/latest/Acting-NASA-chief-says-DOGE-plans-to-examine-space-agency-s-spending-49040236/

SpaceX To Switch Capsules To Bring 2 Stranded Astronauts Back To Earth Sooner

 by Rudy Blalock via The Epoch Times,

NASA said Tuesday they have revised their strategy in order to expedite the homecoming of two astronauts stranded on the International Space Station (ISS), the space agency said on Feb. 11.

Astronauts Suni Williams and Butch Wilmore, who have been aboard the space station for eight months, are now slated to return to Earth in mid-March—two weeks earlier than the previously anticipated late March or April timeframe, according to NASA.

The change in plans involves SpaceX altering its capsule assignments for upcoming missions.

“Human spaceflight is full of unexpected challenges,” Steve Stich, NASA’s commercial crew program manager, said in a statement released by the agency.

The extended stay of Williams and Wilmore stems from a series of setbacks that began in June 2024. Initially, the pair was scheduled to return after a brief June 5 test flight aboard Boeing’s Starliner capsule. 

However, the Starliner experienced major issues during the flight, including helium leaks and problems with its reaction control thrusters, as it approached the ISS.

The issues led to NASA’s decision to return the Starliner to Earth without crew members, leaving Williams and Wilmore safe but stranded on the ISS.

“Spaceflight is risky, even at its safest and most routine. A test flight, by nature, is neither safe, nor routine,” NASA Administrator Bill Nelson stated at the time.

The situation was further complicated when SpaceX and NASA said they would delay the launch of the replacement astronaut crew to late March 2025 due to necessary preparations for flight of a new capsule, which would have extended Williams and Wilmore’s mission even further without the revisions now in place.

With additional work still needed on the new capsule, NASA has now opted for an older SpaceX capsule for the next crew launch, to bring Williams and Wilmore home earlier, weather permitting on March 12. This capsule had previously been assigned to a private mission organized by Axiom Space, featuring astronauts from Poland, Hungary, and India. As a result of NASA’s decision, the Axiom mission has been postponed to a later date, potentially still within the spring season.

Returning with Williams and Wilmore are NASA astronaut Nick Hague and Roscosmos cosmonaut Aleksandr Gorbunov, who were selected to join the pair on the ISS in September 2024, where they have been preparing for their return mission together.

The replacement crew to take over duties at the ISS after a week-long handover period will include two NASA astronauts, as well as one astronaut from the Japan Aerospace Exploration Agency and one Roscosmos cosmonaut.

This latest adjustment comes just two weeks after NASA announced it was working “expeditiously” to bring Williams and Wilmore back as soon as possible. The announcement followed a request by President Donald Trump for SpaceX CEO Elon Musk to speed up the astronauts’ return.

https://www.zerohedge.com/technology/spacex-switch-capsules-bring-2-stranded-astronauts-back-earth-sooner

Trump says he expects to meet with Putin in Saudi Arabia

 President Trump said Wednesday he expects to meet in person with Russian President Vladimir Putin multiple times, suggesting they are likely to meet first in Saudi Arabia.

“We ultimately expect to meet,” Trump told reporters in the Oval Office. “In fact, we expect that he’ll come here, and I’ll go there, and we’re going to meet also, probably in Saudi Arabia. The first time we’ll meet in Saudi Arabia.”

The timing of when the meetings would happen were not yet clear but Trump said it would be “not in the too distant future.”

Trump’s comments came hours after he spoke with Putin on the phone and as his administration pressed forward with plans to negotiate an end to the war in Ukraine.

White House press secretary Karoline Leavitt told reporters earlier Wednesday she was not aware of any preconditions that would have to be met for a meeting to take place.

The meeting would mark a major shift in U.S. relations with Russia. 

Former President Biden held an in-person summit with Putin in June 2021, nearly four years ago, but had not spoken with Putin directly since February 2022, just before Russian forces invaded Ukraine. Biden in a March 2022 speech declared Putin “cannot remain in power,” remarks the White House later tried to walk back.

Trump spoke with Putin earlier Wednesday. It was the first publicly disclosed call between the two leaders since Trump took office.

The two leaders discussed several topics, Trump said, but focused mainly on efforts to negotiate an end to the war in Ukraine. Trump spoke to Ukrainian President Volodymyr Zelensky following his conversation with Putin.

Vice President Vance is expected to meet with Zelensky this week during a trip to Europe for the Munich Security Conference. Treasury Secretary Scott Bessent was also dispatched to Ukraine to meet with Zelensky as the U.S. pursues a deal for more access to Ukraine’s critical minerals.

Leavitt was asked Wednesday whether the administration views Russia as an adversary or a partner.

“This nation views Putin and Russia as a great competitor in the region, at times an adversary,” Leavitt said. “But as the president has said as well, he enjoys having good diplomatic relations with leaders around the world.”

https://thehill.com/homenews/administration/5141580-trump-putin-meet-saudi-arabia/

Education Department launches Title IX probes over trans athlete policies

 The Department of Education announced on Wednesday it is investigating two state athletic associations that say they will not abide by the Trump administration’s Title IX rules that forbid transgender girls and women from participating on sports teams that align with their gender identity.  

Local outlets have reported that both the Minnesota State High School League (MSHSL) and the California Interscholastic Federation (CIF) have said they will instead abide by state law and allow transgender athletes in women’s sports.  

“The Minnesota State High School League and the California Interscholastic Federation are free to engage in all the meaningless virtue-signaling that they want, but at the end of the day they must abide by federal law,” said Acting Assistant Education Secretary for Civil Rights Craig Trainor.  

The department’s Office of Civil Rights, Trainor said, will conduct investigations “to ensure that female athletes in these states are treated with the dignity, respect, and equality that the Trump Administration demands.” 

CIF said “has been notified of the investigation” but will not comment on it, while MSHSL did not immediately respond to The Hill’s request for comment.

Both groups put out the statements last week in support of transgender athletes.  

MSHSL said in a statement their policies are “determined by state law, through the Minnesota Human Rights Act and the Minnesota Constitution,” local outlet Fox 9 KMSP reported. 

Anti-discrimination laws in Minnesota include discrimination on the basis of gender identity.  

“Therefore, students in Minnesota are allowed to participate consistent with their gender identity. League Member Schools have done excellent work in respecting students and their individual situations as they determine their participation and eligibility within interscholastic sports,” the group said.  

CIF also said it would abide by state law that allows students to participate in school activities based on gender identity.  

“The CIF provides students with the opportunity to belong, connect, and compete in education-based experiences in compliance with California law [Education Code section 221.5. (f)] which permits students to participate in school programs and activities, including athletic teams and competitions, consistent with the student’s gender identity, irrespective of the gender listed on the student’s records,” a CIF statement said, Fox News reported.  

Earlier Wednesday, the Trump Education Department also called on sports organizations to strip transgender athletes of records and awards they had received in their sports.  

And the same day, a federal judge granted a request by two transgender high school athletes to add the Trump administration onto a lawsuit in New Hampshire that is challenging state law keeping them off teams that match their gender identity. 

The growing fight — and the Title IX shift from Biden policies that defended trans rights — come after Trump signed an executive order that said these individuals could not play on the teams that matched their gender identity. The president has also ordered the federal government to recognize only two sexes, male and female.

San José State University, the University of Pennsylvania (Penn) and the Massachusetts Interscholastic Athletic Association (MIAA) are also under investigation by the department for “apparent Title IX violations” for having transgender athletes on their women’s sports teams.  

“We are putting every school receiving taxpayer dollars on notice: If you let men take over women’s sports teams or invade your locker rooms, you will be investigated for violations of Title IX and risk your federal funding,” Trump said. 

https://thehill.com/homenews/education/5141630-education-department-title-ix-trans-athlete-trump/

Ascendis Repurchase Program & Net Settlement of Certain RSUs

 – Expected use of approximately $25 million in first quarter of 2025 intended to preserve approximately 200,000 ADSs held as treasury shares

https://www.globenewswire.com/news-release/2025/02/12/3025408/0/en/Ascendis-Pharma-A-S-Announces-Share-Repurchase-Program-Net-Settlement-of-Certain-RSUs.html

'Arcutis takeover interest'

 Arcutis Biotherapeutics (NASDAQ:ARQT) rose 12% amid some takeover speculation.

The biotech is speculated to have attracted some takeover interest, according to traders, who cited a Betaville "uncooked" alert that circulated on Wednesday. An unidentified European company is said to be interested.

https://seekingalpha.com/news/4407170-arcutis-biotherapeutics-jumps-amid-takeover-speculation