MV TELEGRAPH

Sopa Pictures | Light Rocket | Getty Images

shares of Modern fell on Monday as Wall Street munched over new trial results on the personalized cancer vaccine it is developing note.

Merck shares were essentially flat.

The experimental mRNA vaccine, when combined with Merck’s blockbuster drug Keytruda, reduces the risk of skin cancer-melanoma recurrence by 44% compared to Keytruda alone, the companies said on Sunday in their first detailed presentation of results from a key Phase 2 Study.

Almost 80% of participants who received both the vaccine and Keytruda remained cancer-free at 18 months, compared with 62% of participants who received only Keytruda, the companies said. They added that the vaccine’s side effects were generally mild, with fatigue being the most common.

These results, presented at a meeting of the American Association for Cancer Research in Florida, add to initial results on the treatment combination published in December.

The results suggest that the vaccine, when combined with Keytruda, “could be a novel means of potentially prolonging the lives of patients with high-risk melanoma,” said Dr. Kyle Holen, director of development, therapeutics and oncology at Moderna, in a press release. Moderna and Merck said they will initiate a Phase 3 trial in 2023 and will “rapidly expand” their research to look at the treatment’s effect on additional tumor types, including an important type of lung cancer.

Wall Street greeted the news with a mixture of cautious optimism and doubt.

Analysts from SVB Securities said the results suggest the personalized cancer vaccine shows promise. But they also wrote in a Sunday note that the treatment’s path to approval is new and untested, adding that the company doesn’t see accelerated approval as an option.

The Food and Drug Administration’s Accelerated Approval designation is intended to allow faster approval of medicines for serious conditions that address an unmet medical need.

A Monday note from Wolfe Research analyst Tim Anderson said many Moderna and Merck stakeholders remain “cautiously optimistic at best” about the possibilities of the cancer vaccine-Keytruda combination.

He said expectations for the treatment combination were quite high at the start of the weekend, but noted there are still many skeptics about cancer vaccines due to a “long history of failures in this area”.

Wells Fargo analyst Mohit Bansal also said he expressed “cautious optimism” about the treatment combination. In a Sunday note, Bansal pointed to “trial imbalances” that may have led to more favorable outcomes for the personalized cancer vaccine.

He said these imbalances warrant waiting for more data on the treatment.

A US district judge in Washington state said Thursday access to the abortion pill mifepristone was unaffected by a federal appeals court ruling that imposed restrictions on the drug this week.

Judge Thomas Rice of the state’s US Eastern District last Friday ordered the Food and Drug Administration to gain access to mifepristone in 17 states and the District of Columbia, which requested protection of the drug in those jurisdictions.

Rice reiterated in a court order Thursday that the FDA cannot reverse access to the drug, despite a decision this week by the US 5th Circuit Court of Appeals that imposed restrictions on how the drug is dispensed and used by patients.

“No judge in Texas or the 5th Circuit can overrule a decision of a federal judge in Washington state,” Washington State Attorney General Bob Ferguson told CNBC on Thursday. Ferguson led the lawsuit to protect access in the 17 states and the district.

Rice’s Thursday order underscores the chaotic legal landscape that has emerged after dueling court decisions over the drug’s legal status. The U.S. Supreme Court appears poised to rule on the future of mifepristone — and possibly soon.

Rice’s order applies to Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington and the District of Columbia.

Rice’s order maintains FDA’s current regulatory framework in those jurisdictions. These include sending the abortion pill by mail, allowing pharmacies to dispense it if they are certified to do so, and administering mifepristone up to 10 weeks’ gestation.

“We have a crystal clear ruling, and we expect the FDA will respect it,” Ferguson said earlier Thursday.

Rice’s decision last Friday came just 20 minutes after US District Judge Matthew Kacsmaryk of the US Northern District of Texas unilaterally stayed the FDA’s more than two-decade-old approval of mifepristone and all subsequent regulatory actions the agency has taken since has taken.

The Justice Department appealed Kacsmaryk’s decision to the 5th Circuit Court of Appeals on Monday.

A three-judge panel Wednesday voted 2-1 to block Kacsmaryk’s attempt to suspend the FDA’s approval of mifepristone. But it also imposed tighter restrictions on the drug, limiting access.

Judges Kurt Engelhardt and Andrew Oldham, appointed by former President Donald Trump, voted to temporarily block mail delivery of the abortion pill and reintroduce visits to the doctor to obtain the drug. The decision also shortened the period that mifepristone can be administered down to the seventh week of pregnancy. The 5th circle will hold oral hearings in the case at the earliest possible date.

The DOJ earlier this week asked Rice to clarify what legal obligations the government has under his order by Friday, as it sees “significant” tensions with Kacsmaryk’s decision. Rice said Thursday that Kacsmaryk’s order and the 5th Circuit Court ruling will not affect access to mifepristone in the 17 states and DC

“I don’t see a world where the FDA decides for Washington and the states that have joined our coalition that they are going to withdraw access in the way the 5th Circuit envisions,” Ferguson said earlier Thursday.

The Biden administration is appealing the 5th Circuit Court decision to the Supreme Court. US Attorney General Merrick Garland said Thursday the DOJ “strongly disagrees” with the appeals court and will seek emergency relief from the Supreme Court to “protect Americans’ access to safe and effective reproductive care.”

Glenn Cohen, a former DOJ attorney, said the FDA had an even stronger case for the court to step in after Rice upheld its order to maintain access in response to the government’s request for clarification.

“The need to go to the Supreme Court in the meantime is becoming more compelling — and the FDA has a stronger case for a judicial review since two courts are telling it to do conflicting things,” said Cohen, a health law expert Harvard Law School CNBC in an email ahead of Rice’s clarification on Thursday.

In this photo illustration, packs of mifepristone tablets are on display at a family planning clinic in Rockville, Maryland on April 13, 2023.

Anna Moneymaker | Getty Images

The Biden administration and abortion pill distributor Danco Laboratories on Friday asked the Supreme Court to block an order threatening access to that drug, mifepristone, in an escalation of a legal battle that could make it harder to settle to undergo the process nationwide.

The U.S. 5th Circuit Court of Appeals late Wednesday blocked U.S. District Judge Matthew Kacsmaryk’s order to stay the Food and Drug Administration’s approval of mifepristone.

But the appeals court voted 2-1 to temporarily reinstate restrictions on mifepristone, which will severely limit access to the drug even in states where abortion is legal.

“If enacted, the lower court orders would upend the regulatory system for mifepristone, with far-reaching implications for the pharmaceutical industry, women who need access to the drug, and the FDA’s ability to implement its statutory authority ‘ US Attorney General Elizabeth Prelogar said.

The attorney general said this is the first time a court has overturned the terms of an FDA drug approval because of a disagreement over the agency’s judgment on safety. She emphasized that mifepristone has been on the market for more than 20 years.

Mifepristone, used in combination with another drug called misoprostol, is the most common method of abortion in the United States, accounting for about half of all abortions. Misoprostol, which is used as a standalone abortion drug in other parts of the world, is unaffected by the lower court’s rulings.

The Justice Department has said in previous filings that the ruling restricting access to mifepristone is scheduled to take effect at 12:00 a.m. CT Saturday.

Implications for access to abortion

Court of Appeal judges temporarily blocked mail delivery of mifepristone, reinstated doctor visits for patients and shortened the length of time patients can take the pill from 10 weeks earlier to the seventh week of pregnancy. Judges Kurt Engelhardt and Andrew Oldham, appointed by ex-President Donald Trump, voted in favor of the restrictions.

Prelogar said the lower court rulings would immediately mislabel all doses of mifepristone because its labeling would not match the original FDA approval. The generic version of mifepristone, made by a second company called GenBioPro, would also no longer be approved by the FDA at all, Prelogar said.

CNBC Health & Science

Read CNBC’s latest global health coverage:

Although the 5th Circuit maintained the FDA’s approval of mifepristone, attorneys for Danco said the company will not be able to market mifepristone unless the agency takes a series of regulatory actions to implement the Court of Appeals’ order.

“The direct consequence of the Fifth Circuit’s decision is that the FDA must obtain a comprehensive set of approvals in order to implement the Fifth Circuit’s retraction. Without these approvals, Danco cannot legally market and distribute mifepristone,” wrote Jessica Ellsworth, the company’s attorney.

The Justice Department said realigning mifepristone’s labeling could take months. The delay could deny women access to a drug the FDA has approved as a safe and effective alternative to surgical abortions, the Biden administration said.

DOJ criticizes court decisions

The Justice Department harshly criticized Kacsmaryk’s order and the Court of Appeal’s ruling. Kacsmaryk ruled against the FDA based on “a flimsy allegation” by the anti-abortionists who filed the lawsuit, the government said.

The Justice Department criticized the Court of Appeals for forcing the FDA to review virtually every action the agency had taken against mifepristone since it was originally approved in 2000 — with just 48 hours before Kacsmaryk’s ruling was due to go into effect.

“The course of this litigation has been troubling at every level,” Attorney General Prelogar wrote.

“This court should fully uphold the district court’s opinion and uphold the long-established status quo pending the completion of due appellate review,” she said.

Conflicting court decisions

The national legal landscape surrounding mifepristone has become confusing over the past week after Kacsmaryk of the US North District of Texas and Judge Thomas Rice of the US East District of Washington issued conflicting orders last Friday. The Supreme Court is likely to rule on the drug’s legal status.

While Kacsmaryk issued a sweeping order against mifepristone, Rice barred the FDA from taking any action restricting the drug’s availability in 17 states and the District of Columbia. Rice reiterated Thursday that Texas and the 5th District orders restricting access to mifepristone do not apply in states that have filed lawsuits in Washington state to protect the drug.

The Justice Department said the FDA risks contempt in those states if it allows mifepristone to be marketed in a manner consistent with the 5th Federal Court order.

Danco’s attorneys said the conflicting judgments created an “unsustainable limbo” for the company, providers, women and the healthcare system as they “try to navigate these uncharted waters.”

Rice’s order applies to Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Oregon, Rhode Island, Vermont, Hawaii, Maine, Maryland, Minnesota, Pennsylvania, Washington and Washington, DC