By MATTHEW PERRONE, Associated Press

WASHINGTON (AP) — Shares of Sarepta Therapeutics plunged Monday after the biotech drugmaker reported a second death in connection with its gene therapy for muscular dystrophy.

Sarepta reported the death over the weekend and provided additional details about its response, which includes pausing shipments of the therapy, Elevidys, for older patients who are no longer able to walk. The one-time treatment is approved for children with a genetic variant of Duchenne’s muscular dystrophy, which causes weakness, loss of mobility and early death in males.

Elevidys is the first gene therapy approved in the U.S. for the rare muscle-wasting condition, but it has faced scrutiny since its accelerated approval in 2023.

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The second death, like an earlier one reported in March, occurred in a teenage boy who suffered a fatal case of acute liver injury, a known side effect of the therapy. Older patients receive a larger dose of the therapy.

Sarepta said it would pause a study in those patients and assemble an expert panel to recommend new safety protocols for taking the drug. Those changes are expected to include increased use of immune-system suppressing drugs, company executives said Monday. The liver injury associated with the therapy is thought to be connected to the immune system’s response.

Sarepta said it was cooperating with the Food and Drug Administration, which would have to sign off on any changes to the product’s use.

Elevidys received expedited approval despite concerns from some FDA scientists about its effectiveness in treating Duchenne’s.

The FDA granted full approval last year and expanded the therapy’s use to patients 4 years and older, regardless of whether they are still able to walk. Previously it was only available for younger patients who were still walking.

Shares of the Cambridge, Massachusetts-based company fell more than 42% to close at about $21 in trading.

Wall Street analysts speculated that FDA officials, including new vaccine chief Dr. Vinay Prasad, might impose more restrictions on the drug or even block its use. Prasad has been highly critical of the therapy since its approval under the agency’s previous leadership.

“Now with two deaths reported in this segment of the market, it seems incrementally more possible that the FDA could step in and remove the therapy from the market in non-ambulatory patients,” said Leerink Partners analyst Joseph Schwartz, in a Sunday research note.

Elevidys uses a disabled virus to insert a replacement gene for producing dystrophin into patient cells. It costs $3.2 million for a one-time infusion.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

Israel’s attack on Iran opens the next phase of the Great Middle Eastern War that began on Oct. 7, 2023. Over the past 20 months, that war has played out on fronts across the region and has drawn in actors from around the globe.

There is much we don’t yet know about what has happened, let alone what will happen. But it is clear that Iran has suffered significant damage to its leadership, its military and industrial capabilities, and perhaps its nuclear program. The endgame of this conflict and the future of the region will be profoundly shaped by how a wounded Iran responds.

There are four basic possibilities. Their consequences range from a bigger, bloodier Middle Eastern mess to a potentially surprising diplomatic denouement: a far stronger nuclear deal than President Donald Trump could have gotten just a few days ago.

First, Iran could go nasty but narrow, striking back against Israel but avoiding U.S. bases or other regional targets. Drone, missile or terrorist attacks against Israel (some of which are already underway) would offer a measure of vengeance. But this strategy would seek to avoid triggering a larger, riskier conflict with Washington.

The problem is that America is already involved in this conflict: Trump has pledged to help Israel defend itself. A narrow response could thus look pathetic if Tehran’s remaining weapons can’t penetrate Israel’s multi-layered (and multi-nation) air and missile defense. And even if Iran draws blood, Israel will just keep coming, as these opening strikes were the beginning of a larger military campaign.

If Iran needs to make a bigger statement, it could go big and broad. In addition to hitting Israel, it could strike U.S. personnel, facilities and partners from Iraq to the Persian Gulf. It could also activate its proxies — the Houthis, Iraqi Shia militias, and what remains of Hezbollah — in a bid to set the region on fire.

That strategy has appeal as a way of restoring deterrence against dangerous enemies. It would remind the world that even a weakened Iran can cause real pain. But it would also cross the red line Trump has drawn against attacks on U.S. targets. So Iran could find itself fighting a bigger war against Israel and the U.S., fraught with existential dangers for an already battered regime.

The third possibility — nuclear breakout — could be just as dangerous. Depending on how much nuclear infrastructure is left — particularly the buried, hardened uranium enrichment facility at Fordow — Tehran could withdraw from the Non-Proliferation Treaty and make a desperate push for the bomb.

Iranian leaders might see this as their best option for salvation, given how badly Tehran’s conventional capabilities and proxy network has been degraded. If Iran did make it across the finish line, the result would be terrifying — a bloodied, vengeful terrorist state with the destructive power of nuclear arms.

The obvious risk is that Iran might never make it. A sprint for nuclear weapons would cross another Trump red line. It could bring U.S. intervention, with bunker-busting bombs that set back the Iranian program far more decisively than Israel could. So this scenario, too, seems likely to set off a larger regional war, probably ending in a devastating Iranian defeat.

That leaves the final option — one Trump is urging Tehran to take. Iran could wave the white flag and cut a nuclear deal, perhaps after a symbolic, face-saving retaliation. That deal would be far worse than anything Tehran might have hoped for a few days ago. It would be closer to the “Libya option” — the total dismantling of the nuclear program — than “Obama 2.0.”

The Iranian regime, which views the nuclear program as a guarantee of both its own survival and national security, would hate to take this path. But it might consider it, if other options lead to disaster. The Islamic Republic has made painful concessions before.

Ayatollah Ruhollah Khomeini settled the Iran-Iraq War in 1988 rather than risk U.S. intervention: Accepting peace, Khomeini acknowledged, was the cost of preserving the Islamic revolution. Tehran also drew in its horns, momentarily, after the U.S. overthrew Saddam Hussein in Iraq in 2003, and it looked like the ayatollahs might be next.

If Iran chooses this course, it would be a remarkable reversal: Less than two years ago, Israel was badly shaken and Tehran and its proxies seemed ascendant. It would be a triumph for a nuclear non-proliferation regime that has, lately, been under strain. It would be a diplomatic windfall for Trump, who didn’t want an Israeli strike but now might benefit from it. And it would be a reminder that force doesn’t always undercut diplomacy: It can, in fact, be indispensable to its success.

None of this is guaranteed, of course. A week from now, the Middle East could be consumed by a larger, more brutal war. But it is worth admiring the fact that Israel’s attack has left a terrible regime with only terrible options — and, perhaps, created a narrow path to a better outcome for the region and the world.

Hal Brands is a Bloomberg Opinion columnist and the Henry Kissinger Distinguished Professor at Johns Hopkins University’s School of Advanced International Studies.

HOUSTON — The day he turned 52 years old last December, LaTroy Hawkins hit submit on his final paper, the last thing standing between him and a college degree.

And last month, Hawkins, who is currently with the Twins on their road trip serving as an analyst on the television broadcast, donned a cap and gown as he walked across the stage and received his diploma, fulfilling a dream his mother and grandmother had for him and, he hopes, serving as an example to his family’s younger generation.

Drafted in the seventh round of the 1991 draft by the Twins, Hawkins forwent college as a teenager to begin a career in professional baseball. That career lasted 21 major league seasons, during which he appeared in more than 1,000 games.

But as Hawkins, who is currently works as a special assistant to baseball operations for the Twins and a television announcer, among his other jobs, got deeper into retirement, he started to feel the call to return to school.

“They always wanted to make sure I went back and did it. I didn’t have to,” Hawkins said. “I always told them, ‘If I ain’t have to, I’m not doing it.’ But then you get older. … I got bored. I’ve done a lot of things since I’ve retired. It’ll be 10 years this year, but this is probably the coolest thing I’ve done.”

In the fall of 2021, Hawkins decided to test it out, beginning at Collin College, a community college near his home in the Dallas-area. He was paying $64 dollars per credit hour, he said, so if he didn’t like it, he wasn’t too committed financially.

He attended one class in person because he wanted to have “the classroom experience” that he hadn’t had since high school. But primarily, he completed his coursework online as he maintained his other jobs. It was tough at the beginning, adapting to a totally different learning environment than the one he was in as a teenager.

“I was having my daughter help me put stuff in PDF files,” he said.

But once he was done with his general studies credits and transitioned into classes for his major, sociology, he said his “life experiences took over” and classes became easier and more enjoyable.

Hawkins eventually transferred to Southern New Hampshire University to complete his degree online, finishing in the winter and finally walking across the stage months later in May in front of a group of his loved ones, including his aunt, who surprised him at baggage claim when he landed out east.

There was another surprise waiting for him at graduation, too: The school president took a couple minutes to highlight him and his achievements in front of the class of graduates.

Completing his degree, he said, was especially important as he tried to set an example for the younger generation of his family — his daughter, Troi, his niece, who was in college at the same time as him, and his two young nephews.

“It’s one of those things where you start something and you’re trying to set examples, especially for people in your family for and other people you don’t know you’re impacting,” Hawkins said. “If I started, I’ve got to finish it.”

Now that he has his diploma, he’s often asked what comes next.

Turns out, the answer might be even more school — a friend of his is completing a Master of Science in Sports Leadership at Abilene Christian University, which has piqued his interest.

“I got my eye on that,” he said. “We’ll see.”

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By MIKE STOBBE, Associated Press

NEW YORK (AP) — All 17 experts recently dismissed from a government vaccine advisory panel published an essay Monday decrying “destabilizing decisions” made by U.S. Health Secretary Robert F. Kennedy Jr. that could lead to more preventable disease spread.

Kennedy last week announced he would “retire” the entire panel that guides U.S. vaccine policy. He also quietly removed Dr. Melinda Wharton — the veteran Centers for Disease Control and Prevention official who coordinated the committee’s meetings.

Two days later, he named eight new people to the influential panel. The list included a scientist who criticized COVID-19 vaccines, a leading critic of pandemic-era lockdowns and someone who worked with a group widely considered to be a leading source of vaccine misinformation.

“We are deeply concerned that these destabilizing decisions, made without clear rationale, may roll back the achievements of U.S. immunization policy, impact people’s access to lifesaving vaccines, and ultimately put U.S. families at risk of dangerous and preventable illnesses,” the 17 panelists wrote in the Journal of the American Medical Association.

The new committee is scheduled to meet next week. The agenda for that meeting has not yet been posted, but a recent federal notice said votes are expected on vaccinations against flu, COVID-19, HPV, RSV and meningococcal bacteria.

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The removal of Wharton and CDC immunization staff cuts will make it hard for a group of new outside advisers to quickly come up to speed and make fact-based decisions about what vaccines to recommend and not recommend to the public, the experts said.

“The termination of all members and its leadership in a single action undermines the committee’s capacity to operate effectively and efficiently, aside from raising questions about competence,” they wrote.

A spokeswoman for the U.S. Department of Health and Human Services did not respond to the JAMA commentary, but instead pointed to Kennedy’s previous comments on the committee.

Kennedy, a leading voice in the anti-vaccine movement before becoming the U.S. government’s top health official, has accused the committee of being too closely aligned with vaccine manufacturers and of rubber-stamping vaccines.

The Advisory Committee on Immunization Practices, created in 1964, makes recommendations to the CDC director on how vaccines that have been approved by the Food and Drug Administration should be used. CDC directors almost always approve those recommendations, which are widely heeded by doctors and guide vaccination programs.

ACIP policies require members to state past collaborations with vaccine companies and to recuse themselves from votes in which they had a conflict of interest, but Kennedy has dismissed those safeguards as weak.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.