Friday, May 8, 2026
Doctor vacationing on hantavirus cruise forced to treat patients after ship’s medic sickened
A doctor traveling as a passenger on the MV Hondius cruise ship has revealed how he stepped in to treat hantavirus patients after the ship’s medic was one of those sickened by the outbreak that has killed at least three people.
“I sort of fell into the role of becoming the ship doctor,” Stephen Kornfeld told CNN Thursday of his unexpected work role after the cruise ship’s primary doctor was sickened.
“I knew one of the passengers was getting ill. This is at the end of April, and I just reached out if I could assist the doc, make sure he felt he had adequate coverage,” he said of his initial offer of help, before they knew they were dealing with a spreading, deadly virus.
“And I was told the doctor was also sick. So over 12 to 24 hours, it became clear that there were a number of people sick and that they were getting sicker.”
Kornfeld, an oncologist in Bend, Oregon, said three people started to get ill around the same time — but didn’t realize their illnesses were hantavirus until last week, weeks after the first death on April 11, which at the time was assumed to be natural causes.
“Early on, we didn’t know it was hantavirus until May 2, May 3,” he said.
A Dutchman, 70, died on board the ship on April 11 and his wife, 69, died two weeks later after leaving the cruise and trying to fly out of South Africa.
Before the widow left, she showed “a lot of confusion, a lot of weakness,” but her symptoms were “non-specific,” Kornfeld said.
The unidentified ship’s doctor suffered from a “lot of fever, fatigue, and flushing” before he was removed and taken to intensive care in Johannesburg, according to Kornfeld.
“At the time, neither one of them looked critically ill. But the fear with hantavirus is you can go from seriously ill to critically ill very quickly,” he said.
Kornfeld, an avid bird watcher, told KTVZ-TV he masked up and worked 18 hours a day with limited resources as he treated sick passengers – when he should’ve been enjoying the excursion.
He noted how the ability to treat critically ill patients on the MV Hondius was “non-existent.”
“You kind of get into that doctor work mode,” he said. “You’re just trying to do the best you can in the circumstances with somewhat limited resources on a cruise.
“I was able to find some better protective gear. I showered a lot. I washed my clothes a lot. I felt vulnerable, but I didn’t feel super vulnerable.”
Kornfeld is one of 17 Americans on board the ship — and his representative, Janelle Bynum (D-Or.), has claimed passengers have “not received any guidance on returning home safely or disembarking the ship.”
“The seventeen Americans on board, including my constituent, are being abandoned by their government,” she claimed on X. “They have no guidance and no support to ensure their safe return home.”
The ship is currently en route to the Canary Islands, where it is due to dock Saturday.
Meanwhile, the US Centers for Disease Control and Prevention has classified the hantavirus outbreak as a “Level 3” threat and activated its emergency operations centers, sources told ABC News Thursday.
The designation is the lowest level of emergency activation, signifying that the risk to the general public remains low — in line with information given by the World Health Organization.
The CDC is actively monitoring the situation, including by activating the emergency centers. It means that epidemiologists, scientists, and physicians may be reassigned to monitor and assist with the disease response.
Artiva prices financing after positive AlloNK autoimmune data and FDA alignment on single Phase 3
Artiva prices $300M underwritten common stock and pre-funded warrant offering at $11.52 after positive AlloNK autoimmune data and FDA alignment on single Phase 3 trial
- Initial AlloNK data showed 71% ACR50 response in refractory rheumatoid arthritis patients, indicating substantial clinical activity.
- AlloNK clinical results were positive across multiple autoimmune diseases beyond rheumatoid arthritis in early evaluations.
- FDA alignment achieved on a single Phase 3 registrational trial design for AlloNK in autoimmune diseases.
- Reported fiscal Q1 2026 non-GAAP EPS $-0.95 (-14% YoY) on revenue $0, missing EPS but beating revenue estimates.
ICU Medical beats, expands margins, reiterates guidance despite macro cost headwinds
ICU Medical beats Q1 estimates with non-GAAP EPS $1.97 (+15% YoY), expands margins and reiterates full-year guidance despite macro cost headwinds
- Consensus Q1 2026 EPS was $1.78, below reported non-GAAP EPS of $1.97, indicating an earnings beat.
- Q1 revenue $526M, +1% organic but -12% reported from IV Solutions JV deconsolidation.
- Adjusted EPS $1.97, up 15% YoY, with adjusted EBITDA flat at $99M amid tariff headwinds.
- Adjusted gross margin reached 41%, ahead of expectations, helped by mix shift to higher-margin businesses.
- Q1 2026 revenue of $520.6M compared with analyst forecast of $519.9M, a modest outperformance.
- Reported GAAP EPS of $1.20 for the first quarter 2026.
- Consumables grew 2% organic (5% reported); IV Systems grew 6% organic (8% reported, record pumps).
- Vital Care declined 14% organic (59% reported); management targeting flat to slightly down in the near term.
- Full-year revenue, EBITDA and EPS guidance reiterated; roughly $10M higher logistics costs largely offset elsewhere.
- Tariff expense was $10M in Q1 (~2% of revenue); 2026 outlook $40–50M unchanged but mix improves.
- FDA cleared new LifeShield software; Medfusion and CADD hardware clearances delayed by extra testing, not core design.
- Free cash flow was $28M in Q1; company targets improved 2026 FCF to near $150M and <2x leverage.
- Management tone confident; expects core segments to hit record 2026 revenue and further margin expansion from efficiencies.
- Main concern: macro and trade cost volatility and regulatory delays could affect pump and margin upside timing beyond 2026.
- Strong quarter, driven by core segment growth and mix-driven margin expansion offsetting macro and tariff pressures.
Co-Diagnostics JV leases turnkey molecular diagnostics manufacturing facility in Saudi Arabia
Co-Diagnostics' CoMira joint venture leases turnkey molecular diagnostics manufacturing facility in Saudi Arabia's Sudair Industrial City
- Facility lease advances Co-Diagnostics’ localized molecular diagnostics production strategy within the Kingdom of Saudi Arabia.
Ascendis retreats to rare endocrinology wheelhouse as cancer plans falter
Before discontinuing the asset, Ascendis Pharma was studying onvapegleukin alfa in advanced or metastatic solid tumors, demonstrating a three- to four-month overall survival advantage over historical controls.
Ascendis Pharma’s plans of expanding into cancer haven’t panned out, and the Danish biotech is now returning to its rare endocrinology roots.
Ascendis announced this strategy change Thursday alongside its Q1 earnings results, revealing that it will no longer invest in the development of onvapegleukin alfa, an IL-2 β/γ asset that was being tested in the Phase 1/2 IL-BELIEVE study, alone or in combination with other anti-cancer therapies, for advanced or metastatic solid tumors.
“Further internal oncology development does not align with our strategic focus,” Ascendis said by way of explaining onvapegleukin alfa’s discontinuation. The asset makes use of Ascendis’ TransCon technology, which allows for sustained and predictable release of a therapeutic agent, in turn enabling less frequent dosing but consistent drug exposure.
Before being axed, onvapegleukin alfa in IL-BELIEVE demonstrated a median overall survival of 10 months, Ascendis said Thursday, versus six to seven months in historical controls. The drug was “generally well-tolerated” in patients with late-stage platinum-resistant ovarian cancer.
While Ascendis is no longer putting money behind onvapegleukin alfa, the company said that it will “explore other ways to maximize the value of this asset.” There has been no word yet of what these alternatives might look like.
Onvapegleukin alfa still appears on Ascendis’ pipeline page, but the biotech lists no other cancer assets.
With cancer no longer a priority, Ascendis will return its focus to rare endocrinology portfolio. This includes its recently approved achondroplasia drug Yuviwel, indicated for children 2 years and older. The company is continuing to develop Yuviwel, with an ongoing study looking at its therapeutic value in infants. Enrollment for this trial is expected to wrap up in the third quarter, the company said.
Ascendis is also planning a Phase 3 trial for Yuviwel in hypochondroplasia, set to start in the second half of 2026. Since its approval in March, Yuviwel has reached more than 60 patients.
In the first quarter, Ascendis made €247 million (roughly $290 million), more than double its €101 million (around $118.55 million) revenue during the same period last year. The hormone replacement therapy Yorvipath, indicated for hypoparathyroidism, accounted for much of this growth, Ascendis said Thursday. Sales of the product jumped to €197 million (approximately $231.4 million) in the most recent quarter, from €44.7 million (around $52.5 million) in the first quarter of 2025.
Biogen, Eisai hit with 3-month delay for starting SubQ Alzheimer’s therapy
The FDA’s extension will give reviewers more time to review a major amendment to Biogen and Eisai’s application for a subcutaneous induction formulation of Alzheimer’s therapy Leqembi. The new target action date is on Aug. 24.
Biogen and Eisai may have to wait three more months to learn the FDA’s verdict on their bid to start patients on an under-the-skin formulation of their anti-amyloid Alzheimer’s disease therapy.
As part of the ongoing drug review process, the FDA has requested additional information regarding the proposed use of subcutaneous Leqembi for treatment initiation, the pharma partners announced Friday. The regulator then deemed the companies’ submission as a major amendment to the application and pushed back the target action date.
The FDA’s original deadline for a decision was May 24. Now, Biogen and Eisai are expecting a verdict on or before August 24.
Analysts at RBC Capital Markets expect the impact of this delay to be “limited,” according to a Friday morning note to investors, given that with either decision date, reimbursements for the drug “would not have kicked in until 2027.”
The delay “pushes out a catalyst we believe the Street had been keying in on to provide visibility on medium-term Leqembi growth acceleration and adds incremental risk” to Biogen, RBC added, “but should still ultimately get resolved.”
Leqembi was first approved in January 2023 under the FDA’s accelerated pathway and in July that year became the first anti-amyloid antibody for Alzheimer’s to win the agency’s full approval. Leqembi is administered intravenously over one hour every two weeks.
In September 2025, the FDA cleared a new formulation of Leqembi, Leqembi Iqlik, that allowed the drug to be administered via an under-the-skin injection—a more convenient route of administration that also opened the option of at-home treatments. This approval, however, only applied to maintenance treatments. New patients would still have to undergo an 18-month induction period.
Biogen and Eisai are now proposing to use this subcutaneous formulation to initiate patients, completely eliminating the need for intravenous infusions. To back their application, the partners submitted data showing that Leqembi Iqlik, given weekly, achieved bioequivalent drug exposure to the intravenous version given once every two weeks, according to a January 2026 news release.
Both formulations of Leqembi had similar safety profiles, the companies added.
If approved, Leqembi Iqlik would be the first anti-amyloid therapy that offers patients at-home, subcutaneous dosing for the entirety of their treatment journey, Biogen and Eisai said in January. A nod would also allow them to better compete with Eli Lilly’s Kisunla on the convenience front.
An approval is “going to be extremely important,” Chris Viehbacher, Biogen’s CEO, said at the J.P. Morgan Healthcare Conference in January. Kisunla offers once-monthly infusion compared to Leqembi’s biweekly infusion. Kisunla’s convenience edge “is going to go away once we have a subcutaneous formulation,” Viehbacher said.
A subcutaneous, at-home treatment option also plays into Biogen’s strategy of catching patients who have finished treatment with Kisunla and are looking to transition to another Alzheimer’s therapy.
The first batch of Kisunla-treated patients are set to end their 18-month treatment period, Alisha Alaimo, Biogen’s head of North America, said during the company’s Q1 call on April 29. “Physicians are asking, what do we do? Patients in general, who are on either of the products, want to stay on product. There is a fear of coming off and having a decline in their cognition.”