Structure Therapeutics (GPCR) stock and Metsera (MTSR) stock soar as Eli Lilly (LLY) reports promising Phase 3 results for its oral GLP-1
https://seekingalpha.com/news/4432338-lilly-stock-gains-rally-structure-metsera
Thursday, April 17, 2025
FSU shooting: Six injured, one critically; man arrested; campus locked down
At least one shooter injured six people on Florida State University's Tallahassee campus Thursday, as law enforcement continues to evacuate buildings and nearby businesses and schools were placed on lockdown. No deaths have yet been confirmed by officials.
Paige Miller, an FSU freshman, was in the restroom outside her classroom at the Moore building next to the Student Union when she heard four loud bangs.“I thought it was the roof collapsing honestly, and then suddenly three girls come running in and one of them was crying," she said. "One of the girls looks over at my stall and tells me to call the police because there’s an active shooter.”She called 911. With no lock on the restroom door, they held it shut for 20 minutes until police arrived. When she came outside, she saw one person on the ground surrounded by officers.
Miller assumed he was a shooter but wasn’t sure. Miller also heard police say they were looking for a shotgun. She saw what appeared to be two injured people on the ground by the Student Union.“We saw them when they were still on the grass,” she said. “I think they moved a couple to the pavement.” She said law enforcement was swarming everywhere: “It was terrifying.”
Various social media posts and news reports have differing numbers of injured and deaths but law enforcement as of 2 p.m. had not confirmed any deaths from Thursday's shooting.
Tallahassee Memorial HealthCare spokesperson Stephanie Derzypolski earlier told the Democrat TMH ER staff was treating received six patients, one in critical condition and the others in serious condition.
"All Florida State athletics home events through Sunday, April 20, have been canceled," the university posted on X. "Further updates on events scheduled for next week will be communicated when available."
Sam Swartz and Sean Gulledg said they were in the basement of the FSU student union when the shooting started. “Everyone started freaking out,” Swartz said. He said they heard maybe 10 gunshots while they were working on a group project.
The group of eight cornered themselves in a hallway and started to barricade the opening with trash cans and plywood. “I remember learning to do the best you can to make them take time because they don’t want to do anything that takes time, they’re just trying to get as many people,” Swartz said.
The whole event took maybe 10 minutes, Gulledg added, “but it felt a lot longer.”
Students heard law enforcement officers going up and down hallways telling everyone to come out with their hands up. Everyone was patted down and checked before evacuating.
Gulledg, a resident assistant, said they train for these types of situations, but never thought they’d ever have to use them. “I trusted the training,” he said.
Trump Says US to Sign Ukraine Minerals Deal Next Thursday
President Donald Trump said the US and Ukraine would sign a deal on critical minerals next Thursday, in a step expected to keep Kyiv in good favor as the White House seeks to broker a quick ceasefire deal with Russia.
“We have a minerals deal which I guess is going to be signed on Thursday,” Trump said while meeting with Italian Prime Minster Giorgia Meloni in the Oval Office. “And I assume they’re going to live up to the deal.”
US Supreme Court to hear Trump bid to enforce birthright citizenship order
The U.S. Supreme Court said on Thursday it will hear arguments over Donald Trump's bid to broadly enforce his executive order to restrict automatic birthright citizenship.
The justices did not immediately act on a request by Trump's administration to narrow the scope of three nationwide injunctions issued by federal judges in Washington state, Massachusetts and Maryland that halted his January 20 order while the matter is litigated.
The court will hear arguments in the case on May 15.
Trump's order, signed on his first day back in office, directed federal agencies to refuse to recognize the citizenship of children born in the United States who do not have at least one parent who is an American citizen or lawful permanent resident.
In a series of lawsuits, plaintiffs including 22 Democratic state attorneys general, immigrant rights advocates and some expectant mothers argued that Trump's order violates a right enshrined in the U.S. Constitution's 14th Amendment that provides that anyone born in the United States is a citizen.
The 14th Amendment's citizenship clause states that all "persons born or naturalized in the United States, and subject to the jurisdiction thereof, are citizens of the United States and of the state wherein they reside."
The administration contends that the 14th Amendment, long understood to confer citizenship to virtually anyone born in the United States, does not extend to immigrants who are in the country illegally or even to immigrants whose presence is lawful but temporary, such as university students or those on work visas.
The birthright citizenship order "reflects the original meaning, historical understanding and proper scope of the Citizenship Clause," wrote U.S. Solicitor General John Sauer, representing the administration.
Sauer said that universal birthright citizenship encourages illegal immigration and "birth tourism" in which people travel to the United States to give birth to secure citizenship for their children.
An 1898 U.S. Supreme Court ruling in a case called United States v. Wong Kim Ark long has been interpreted as guaranteeing that children born in the United States to non-citizen parents are entitled to American citizenship.
Trump's Justice Department has argued that the court's ruling in that case was narrower, applying to children whose parents had a "permanent domicile and residence in the United States."
The administration has used the legal battle over birthright citizenship to press the Supreme Court to tackle nationwide, or "universal," injunctions that federal judges have issued impeding aspects of Trump's various executive orders to reshape national policy.
Universal injunctions can prevent the government from enforcing a policy against anyone, instead of just the individual plaintiffs who sued to challenge the policy.
Proponents have said they are an efficient check on presidential overreach, and have stymied actions deemed unlawful by presidents of both parties. Critics have said they exceed the authority of district judges and politicize the judiciary.
Sauer said in a written filing that a "small subset of federal district courts tars the entire judiciary with the appearance of political activism," issuing 28 nationwide injunctions against Trump's administration in February and March.
The plaintiffs criticized the administration's focus on the scope of the lower court orders instead of their conclusions that Trump's conflicts with the Constitution.
Washington state called on the Supreme Court to reject the government's "myopic" request given that Trump's order is "flagrantly unconstitutional," the state, which sued along with three other Democratic-led states, said in a filing.
"Recognizing that the citizenship stripping order is impossible to defend on the merits, the federal government frames its application as an opportunity to address the permissibility of nationwide injunctions," the state added.
In asking the court to enforce Trump's order except against individual plaintiffs who challenged it, Sauer said the states do not have the requisite legal standing to assert the individuals' rights under the citizenship clause.
In the Washington state lawsuit, brought by the Democratic-led states of Washington, Arizona, Illinois and Oregon and several pregnant women - Seattle-based U.S. District Judge John Coughenour issued his injunction on February 6 against Trump's order.
During one hearing in the case, Coughenour, an appointee of Republican former President Ronald Reagan, called Trump's order "blatantly unconstitutional."
The San Francisco-based 9th U.S. Circuit Court of Appeals on February 19 refused to put the judge's injunction on hold.
https://www.yahoo.com/news/us-supreme-court-hear-trump-181332595.html
FAA Announces (More) Drone Tests In New Jersey
by Janice Hisle via The Epoch Times,
Transportation Secretary Sean Duffy is telling people there is no cause for concern over the large numbers of drones flying across New Jersey skies.
According to the Federal Aviation Administration (FAA), which is under Duffy’s purview, more tests are planned later this year in at least three other states—New Mexico, North Dakota, and Mississippi.
Duffy said in an April 15 video posted on social media that the drone flights, like those that caused public alarm in late 2024, are authorized.
Specifically, the FAA is conducting “drone-detection testing” in Cape May, New Jersey, through April 25. The FAA said it began the tests on April 14.
Duffy said more than 100 “commercial, off-the-shelf drones,” large and small, are being used. The FAA alerted local authorities and invited their participation.
“The FAA is doing this to ensure we can properly detect drones in our airspace and make sure they don’t interfere with aircraft navigation systems,” Duffy said.
“This is about protecting our national security and American safety.”
Because drone flights may interfere with aircraft navigation, “operating drones around airplanes, helicopters, and airports is dangerous and illegal,” the FAA said. Yet the agency still receives more than 100 drone-sighting reports near airports each month.
Officials said the FAA test drones are being flown over the water near the Cape May Ferry Terminal during daytime hours on weekdays only.
“The public should not fly recreational drones near this area during the test period,” it said.
Similar research has been done at airports during the past few years, but the FAA expanded these investigations to off-airport locations, including some in Alaska.
Duffy pledged he would “continue to provide you, the American people, with this kind of candid, behind-the-scenes updates.”
“You deserve a government that’s always going to be transparent about what we say and what we do,” he said.
Before Duffy became transportation secretary in January, he was a New Jersey resident. Thus, he knew from personal experience that concerns about the drones festered as citizens clamored for further explanation.
“The public was deeply worried about the lack of clear information—communities, kids, families, seeing drones flying over their homes,” he said.
To prevent such undue concerns, Duffy said, the FAA has adopted a “radical transparency” approach to ensure that people are better informed.
In December 2024, White House national security adviser John Kirby said there was “no evidence that the reported drone sightings pose a national-security threat or a public-safety threat.” Authorities were inundated with at least 5,000 reports of mystery drone sightings across several states.
Questions lingered after President Donald Trump took office in January. He instructed his staff to release more information.
On Jan. 28, the ninth day of Trump’s second presidency, White House press secretary Karoline Leavitt told reporters that the FAA had authorized “large numbers” of drones to fly over New Jersey for research and various other reasons.”
https://www.zerohedge.com/technology/faa-announces-more-drone-tests-new-jersey
ACIP Considers Single-Dose HPV Vaccination
At its meeting on Tuesday, the CDC's Advisory Committee on Immunization Practices (ACIP) considered whether the U.S. should move to single-dose human papillomavirus (HPV) vaccination instead of the currently recommended schedule.
At present, the U.S. recommends two doses of HPV vaccine if they are started before age 15, and three doses if they are started at age 15 or older, and for people who are immunocompromised. Routine vaccination starts at age 11 or 12 -- though it can be started at age 9 -- while catch-up vaccination is recommended through age 26. Shared clinical decision making is advised for those 27 to 45.
However, global HPV vaccination schedules have shifted in recent years, with the World Health Organization recommending in 2022 a two-dose schedule for those 9 and older, with an option for a one-dose schedule for those between 9 and 20. The U.K. and Australia have adopted this schedule, too.
"As of now ... in some age groups, 67 countries have adopted one-dose and 77 countries have adopted two-dose HPV vaccination schedules," Oliver Brooks, MD, chief medical officer at Watts Healthcare Corporation in Los Angeles, said during his presentation.
The HPV vaccination working group noted that the KEN SHE trial, published in NEJM Evidence in 2022, showed that among Kenyan women ages 15 to 20, single-dose HPV vaccination had 98% efficacy against HPV 16 and 18, according to the trial's protocol chair Ruanne Barnabas, MBChB, DPhil, chief of the division of infectious diseases at Massachusetts General Hospital in Boston.
The trial's endpoint was incident persistent vaccine type-specific cervical infection among participants who were HPV naive at vaccination. In the nonavalent group -- the HPV vaccine used in the U.S. -- there was just one case of cumulative incidence of HPV over 3 years compared with 72 cases in the control group. Barnabas also noted that the trial found "no evidence of waning of this protection."
Workgroup co-lead Lauri Markowitz, MD, from CDC's National Center for Immunization and Respiratory Diseases, said the next ACIP meeting in June will have data from the ESCUDDO randomized control trial out of Costa Rica, which evaluated non-inferiority of one versus two doses of HPV vaccine.
Another major discussion centered on whether to change the wording of the HPV vaccine age recommendation.
The current language is that "CDC recommends two doses of HPV vaccine at ages 11-12 years" but "HPV vaccination can be started at age 9 years." The workgroup is considering modifying this language to "HPV vaccination is routinely recommended at age 9 to 12 years," which may allow for more flexibility. The American Academy of Pediatrics has already adopted this language.
Charlotte Moser, MS, co-director of the Vaccine Education Center at Children's Hospital of Philadelphia, noted that this change is fundamentally about communications. She asked the workgroup to consider how changing the wording on this recommendation may impact parental pushback because already some "parents aren't comfortable with the fact that it prevents against a sexually transmitted disease" and thus "we could be doing ourselves a disservice in the larger scope of HPV uptake."
Advisors did not vote on any of these issues, and a final vote is expected at the next meeting in June.
Georgina Amaral, MD, an ob/gyn with UTHealth Houston specializing in adolescents and teens, who is not on the panel, said many ob/gyns are hoping the evidence will support a reduced dose schedule and changed language.
"The most important thing with any of the vaccination schedules is that the vaccine is given before any potential exposure," Amaral said. "We've known long before the vaccine was available that conditions like cervical cancer and HPV-related diseases tend to [disproportionately] affect the most vulnerable populations."
She said fewer doses mean easier logistics for families and easier buy-in on getting vaccinated. It also makes it harder for patients to slip through the cracks and miss vaccination. Plus, the HPV vaccine is known to sting, and having fewer injections would make this experience easier on patients.
"Most people are excited and hopeful if we can make this better for patients and families," Amaral said. "I would be thrilled if we get enough efficacy data to make that just a little bit more streamlined."
Honing Indications for Endocrine Therapy in ER-Low Early Breast Cancer
- More than 40% of Americans with estrogen receptor (ER)-low early breast cancer did not receive endocrine therapy, analysis of a national database showed.
- Omitting endocrine therapy in ER-low breast cancer was associated with a 23% relative increase in the risk of death in 3 years, driven by patients with 6-10% ER expression.
- Patients with residual disease after neoadjuvant chemotherapy also had significantly worse survival without endocrine therapy.
Omission of endocrine therapy in estrogen receptor (ER)-low early breast cancer had a significant association with worse survival, particularly in patients with residual disease after neoadjuvant chemotherapy (NAC), a large retrospective analysis showed.
Among women with ER expression of 1-10%, omitting endocrine therapy was associated with a 23% increased risk of death in 3 years (HR 1.23, 95% CI 1.04-1.46). Patients with ER expression of 6-10% accounted for most of the excess risk. In a subgroup analysis of patients who received NAC, overall survival (OS) was significantly worse in those who had residual disease and did not receive endocrine therapy.
The study provided data relevant to an unresolved controversy in managing early breast cancer, reported Matthew Goetz, MD, of the Mayo Clinic in Rochester, Minnesota, and coauthors in the Journal of Clinical Oncology.
"We saw that over 40% of oncologists and patients omit endocrine therapy [in ER-low disease]," Goetz told MedPage Today. "I think that points to the controversy. No one really knows quite what to do."
"What we can say from our study is that it looks like not everybody is going to benefit from endocrine therapy," he added. "What we have to do as a community is identify those patients who are most likely to get the benefit from endocrine therapy."
The 10,000+ patients included in the analysis had high-risk early breast cancer; about 70% received NAC and/or adjuvant chemotherapy in accordance with current clinical guidelines.
The study suggested that patients who do not attain a complete response (residual disease) are most likely to benefit from endocrine therapy: in the subgroup of patients who received NAC, omission of endocrine therapy did not significantly affect OS in patients who achieved a pathologic complete response (HR 1.06, 95% CI 0.62-1.80) but was associated with worse OS among patients who had residual disease after NAC (HR 1.26, 95% CI 1.00-1.57, P=0.046).
"The reason is probably pretty simple," said Goetz. "If you have residual disease, you're likely to have enrichment of tumor cells that are ER positive. We didn't look at that but other people have in the past. So one of our recommendations would be to retest the tumor that remains in the breast after chemotherapy. You could have a tumor that starts out 1-10% [ER expression] and you eliminate the ER clones with chemotherapy, and what remains are surviving cancer cells that are estrogen receptor positive, tumor cells that obviously would benefit from endocrine therapy."
Standard of care for early ER-positive breast cancer includes 5-10 years of adjuvant endocrine therapy, which has been shown to reduce recurrence, decrease breast cancer mortality, and improve OS, independent of response to chemotherapy. Omission and decreased adherence to endocrine therapy are associated with worse survival, Goetz and coauthors noted.
ER-low tumors (1-10% expression) have histologic characteristics and response to NAC similar to those of ER-negative breast cancer, which has led guideline authors to classify ER-low breast cancer as a separate entity from ER-positive tumors. However, the benefits of endocrine therapy in ER-low breast cancer have remained unproven, the authors continued.
In their present study, an effort to provide information to assist decision making, Goetz and colleagues queried the National Cancer Database for patients with high-risk stage I-III, ER-low breast cancer from 2018 to 2020. The search identified 10,362 patients, of whom 7,018 received chemotherapy.
This cohort had a median age of 55 at breast cancer diagnosis and 73% were white. Tumors were largely PR-negative (73%), HER2-negative (65%), grade 3 (74%), and of invasive ductal histology (92%).
Overall, 42% of patients did not receive endocrine therapy. Omission of endocrine therapy was associated with progesterone receptor-negative status, HER2 negativity, higher histologic grade, Ki-67 values ≥20, and NAC. During a median follow-up of 3 years, 586 patients died.
Omission of endocrine therapy did not significantly affect the risk of death among patients with ER expression of 1-5% (HR 1.15, 95% CI 0.91-1.45) but had a significant association with mortality risk in patients with ER expression of 6-10% (HR 1.42, 95% CI 1.00-2.02, P=0.048).
"Further research is needed to identify the biological subtypes of ER-low BCs [breast cancers] that are most likely to benefit from ET [endocrine therapy]," the authors concluded. "Until then, patients with ER-low BC should be counseled regarding the potential benefit of ET."
Disclosures
The study was supported by the National Cancer Institute.
Goetz disclosed relationships with Lilly, AstraZeneca, Blueprint Medicines, Genzyme, ARC Therapeutics, RNA Diagnostics, Seagen, Engage Health Media, Novartis, Sermonix Pharmaceuticals, BioTheryX, Laekna, Tersera, BeiGene, bioTheranostics, Puma Biotechnology, eChinaHealth, Intellisphere, Context Therapeutics, Atossa Therapeutics, Biovica, Eagle Pharmaceuticals, Loxo, Pfizer, and SimBioSys.
Primary Source
Journal of Clinical Oncology
Source Reference: Choong GM, et al "Endocrine therapy omission in estrogen receptor-low (1%-10%) early-stage breast cancer" J Clin Oncol 2025; DOI: 10.1200/JCO-24.02263.
https://www.medpagetoday.com/hematologyoncology/breastcancer/115154
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