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New national action plan targets gaps at the intersection of mental health and criminal justice.

FOR IMMEDIATE RELEASE

OTTAWA, ON – The Mental Health Commission of Canada (the Commission) today released “Finding New Pathways: An action plan for criminal justice and mental health in Canada”. The plan provides an evidence-based roadmap to address systemic gaps in care, coordination, and community supports, recognizing the impact of mental health on the criminal justice system.

Many are working to improve outcomes but needs remain high and progress is uneven. This action plan is a practical pan-Canadian reference point that seeks to contribute to the mental health and wellbeing of all individuals who interact with the criminal justice and forensic mental health systems, including those who work within them.

Developed through a rigorous five-year process, the action plan was shaped by input from national subject matter experts, research, and the lived and living experiences of justice-involved individuals and system workers. The action plan comes at a critical time, as individuals experiencing mental health challenges currently comprise roughly three-quarters of all federally incarcerated people in Canada.

“Meaningful and sustainable transformation is within reach for Canada,” said Lili-Anna Pereša, President and CEO of the Mental Health Commission of Canada. “While these transformative changes cannot be implemented overnight or by one group alone, this action plan serves as a starting point. It centralizes evidence-based approaches designed to break the cycle of recidivism and prioritize prevention, diversion, end-to-end supports and continuity of care.” The action plan stands on three strategic pillars:

  • Care, not criminalization: Ensuring all people in Canada have access to supports that help prevent involvement with the criminal justice system, and prioritizing diversion for those with mental illnesses.
  • Care during criminal justice involvement: Providing access to high-quality, trauma-informed, and culturally safe health and social supports for those within the system.
  • Care after criminal justice involvement: continuity of care and seamless integration into community-based mental health
    and substance use services upon release.

“Finding New Pathways” identifies 68 specific recommendations across individual, community, institutional, systemic, and societal levels. It pays particular attention to priority populations, including people from First Nations, Inuit, and Métis, and African, Caribbean, and Black, and other equity-deserving groups who are currently overrepresented in the justice system and face distinct mental health needs.

The action plan further highlights the critical importance of supporting the psychological health and safety of workers within the criminal justice and forensic mental health systems, noting that public safety personnel are significantly more likely to experience symptoms consistent with mental disorders than the general population.

Howard Sapers, current executive director of the Canadian Civil Liberties Association, former Correctional Investigator of Canada, and project advisor for the action plan, emphasized the necessity of these reforms: “ or too long, Canada’s criminal justice system has been asked to shoulder responsibilities it was never designed to carry. The over representation of people with mental health needs in police encounters, courts, and correctional facilities is a predictable consequence of systemic gaps in care, coordination, and community supports. The Mental Health Commission of Canada’s National Action Plan offers something we have been missing for years: a coherent, evidence-based roadmap that prioritizes health, human rights, and dignity.”.

Media Contact:

For English requests, please contact Josie Sabatino at jsabatino@summa.ca; 250-649-6856.

For French requests, please contact Carlene Variyan, cvariyan@summa.ca; 613-601-7456.

About the Mental Health Commission of Canada

The Commission is a national organization committed to recognizing and contributing to a new and equitable relationship with First Peoples, with its head office located on the unceded traditional territory of the Algonquin Anishinaabe Nation in Ottawa.

As an independent, not-for-profit with charitable status, the Commission collaborates with leading experts and organizations nationally and internationally, including with people with lived and living experience, to develop national guidelines, standards and strategies, promote innovation and best practices, reduce stigma, increase mental health literacy, develop and deliver training through our Opening Minds division and support all levels of government to improve mental health outcomes for everyone living in Canada.   

The post New national action plan targets gaps at the intersection of mental health and criminal justice. appeared first on Mental Health Commission of Canada.

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Microbiome Therapy Could Help Drug-Resistant Melanoma Patients

Microbiotica, a microbiome-focused biotech based in Cambridge in the U.K., has achieved good Phase Ib results in a trial of its microbiome therapy for patients with advanced melanoma skin cancer.

The therapy, currently known as MB097, is designed to be given to patients who have not previously responded to immunotherapy in addition to a checkpoint inhibitor pembrolizumab. MB097 was developed to reverse the drug resistance seen in these patients and is based on research looking into the gut microbiome of melanoma patients who do respond to this kind of immunotherapy.

The primary endpoint of the trial, which included 41 patients from the U.K., France, Italy, and Spain, who had previously shown resistance to anti-PD-1 drugs, was safety and tolerability of MB097. Several secondary endpoints including response rate, duration of response, and overall survival were also included. The therapy, which contains nine beneficial strains of gut bacteria, met both its primary and secondary endpoints in the study, according to the company, although precise details will be released at a scientific conference later this year.

“There is increasing evidence that the microbiome plays a crucial role in patients’ response to immune checkpoint inhibitors. Clinical benefit has been reported with fecal microbiota transplantations, while MB097 capsules taken orally each day affords an easy and reproducible way of modifying the microbiome,” said the national coordinating investigator for the study, Pippa Corrie, MD, PhD, a clinician and researcher from Cambridge University Hospitals NHS Foundation Trust, in a press statement.

“The MELODY-1 study results show that MB097 is well tolerated, with encouraging early signs of efficacy in a very difficult to treat metastatic melanoma patient population with primary resistance to anti-PD-1 based immunotherapy, in whom there is a significant unmet need.”

Up to half of all advanced melanoma patients fail to respond to anti-PD-1 immunotherapy, leaving them with very few options. A growing body of research, including a 2021 study showing fecal transplant can overcome resistance to anti-PD-1 immunotherapy, shows that the gut microbiome plays an important role in whether a patient’s immune system mounts an effective anti-tumor response when given these therapies.

The make-up of MB097 is based on detailed research looking at strains of bacteria linked to effective response to immunotherapy. Preclinical work showed that the bacteria in the therapy directly activate cytotoxic T cells and counter immunosuppressive tumor macrophages. If larger controlled trials confirm these initial results MB097 could become a standard add-on to immunotherapy.

Microbiotica has another clinical program in ulcerative colitis, which also reported good results earlier this year in another Phase Ib trial. In total, 63% of those in the treatment group achieved clinical disease remission versus 30% in the placebo group and all were also taking standard therapy for the autoimmune disease.

The company now plans to move both its programs to larger controlled studies with a view to moving closer to market approval with both therapies.

The post Microbiome Therapy Could Help Drug-Resistant Melanoma Patients appeared first on Inside Precision Medicine.

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StockWatch: Regenxbio Tumbles Despite Positive Pivotal Data for DMD Gene Therapy Candidate

Regenxbio (NASDAQ: RGNX) shares nosedived 43% over two days late last week, reaching 52-week lows on consecutive days, despite generating positive pivotal Phase III data for its Duchenne muscular dystrophy (DMD) gene therapy candidate RGX-202.

While the data was encouraging enough to enable discussion of Regenxbio bringing a second DMD gene therapy to the market, investors and analysts concluded it was not encouraging enough to pose a competitive threat to the developer of the first marketed DMD gene therapy, Sarepta Therapeutics (NASDAQ: SRPT), or to Solid Biosciences (NASDAQ), whose DMD gene therapy candidate SGT-003 is in Phase III as well as Phase I/II trials.

Even worse, investors were jolted by Regenxbio’s disclosure that the FDA had recommended the company conduct a randomized controlled trial (RCT) to assess RGX-202 in DMD during talks with agency officials. Regenxbio sought to reassure investors in its first-quarter earnings press release by noting past FDA guidance that externally controlled trials “may be adequate for demonstrating substantial evidence of effectiveness, especially when the treatment effect is sufficiently large enough to overcome limitations of externally controlled trials.”

Regenxbio plans to discuss its data with FDA officials at a future meeting. The agency has offered to review the RGX-202 data and alternative proposals, according to the company.

“RGX-202 pivotal data point to potential entry of second DMD gene theory, but a possibility of RCT requirement makes market entry timing unclear,” Kostas Biliouris, PhD, a managing director on the biotechnology research team of Oppenheimer & Co., wrote in a research note.

If the FDA does not insist on an RCT, RGX-202 could gain accelerated approval in 2027, Biliouris noted. Otherwise, the gene therapy is looking at not reaching the market for at least three additional years.

“Completing an RCT study as a precursor to filing or a precursor to approval means that it’s very unlikely that any new gene therapy would be approved until 2030. And I think that scenario is really untenable for the [DMD] community,” Simpson said. “It’s the opposite of regulatory flexibility.”

These regulatory and competitive concerns sent investors scrambling to sell Regenxbio shares late last week. The shares tumbled 38% from $10.04 to $6.24 Thursday, then slid another 8% Friday, sinking to $5.72 at the closing bell.

Positive microdystrophin expression

Regenxbio’s stock woes came despite the company announcing positive results from its pivotal Phase III portion of the Phase I/II/III AFFINITY DUCHENNE® trial (NCT05693142) of RGX-202. The company said the trial met its primary endpoint as 93% of participants (28 of 30) reached at least 10% microdystrophin expression at Week 12. A 31st participant refused a muscle biopsy and, as a result, did not have a Week 12 biopsy available for evaluation.

Microdystrophin expression averaged 71.1% across all participants, and 41.6% in older boys, aged >8 years, with 80% of participants achieving >40% microdystrophin expression, Regenxbio said.

“High unmet need remains for Duchenne patients as current options face limitations related to efficacy, safety, and access. The untreated Duchenne population continues to grow in the United States and globally. Physicians and patients need new next-generation options,” Curran M. Simpson, president and CEO, told analysts on the company’s first quarter earnings call.

Regenxbio acknowledged two reports of treatment-related serious adverse events (~6.5% of treated patients): An 8-year-old patient developed subacute myocarditis, while a 10-year-old patient showed a case of asymptomatic liver injury.

“Both were easily managed and resolved within weeks without sequelae,” Simpson told analysts.

Biliouris acknowledged RGX-202’s positive microdystrophin but said it will not likely have a material impact on Sarepta and its marketed DMD gene therapy Elevidys® (delandistrogene moxeparvovec-rokl).

Limited likelihood

“RGX-202’s functional benefit remains unclear without RCT data, limiting the likelihood of AA [accelerated approval] given an already fully approved DMD gene therapy,” Biliouris said.

He added that RGX-202’s safety profile could deteriorate once the gene therapy reaches the market and is being administered to patients, as happened with Elevidys after some 800 had been treated with the therapy, prompting Sarepta to halt shipments of Elevidys for non-ambulatory patients and pause a Phase III trial.

The halt—plus a label update limiting Elevidys use to ambulatory patients—explains why the gene therapy’s net product revenue plunged 73% year-over-year in Q1, to $102 million from $375 million. Elevidys generated $898.7 million in 2025 revenue—it ranks second on GEN’s just published A-List of Top 10 Best-Selling Gene Therapies—which was 9.5% above 2024’s $820.8 million.

The Q1 sales decline has sent Sarepta’s stock into decline: From $23.06 on May 6, before releasing Q1 results after that day’s closing bell, Sarepta shares have slumped 22.5%, to $17.88 on Friday.

Elevidys sparked a showdown with the FDA last summer when the agency briefly demanded Sarepta also pause Elevidys shipments to ambulant patients following the second patient death tied to Elevidys, then reversed itself after, according to news reports, pleas to Congress, the FDA, and President Donald Trump by conservative leaders and DMD patient advocates—who launched a Change.org petition that garnered 1,900 signatures.

Competitive advantage

Despite the slumping sales and resulting stock decline, Biliouris noted that Sarepta and Elevidys have a significant competitive advantage over challengers: A 3-1/2 year first to market advantage, with statistically significant functional benefits reported from randomized trials, as well as what the analyst called “compelling” three-year positive topline follow-up data from ambulatory DMD patients in the 52-patient active arm in Part 1 of Sarepta’s EMBARK trial (Study SRP-9001-301, NCT05096221).

That data showed significant improvements in North Star Ambulatory Assessment (NSAA), Time to Rise (TTR), and 10-meter walk/run (10MWR).

“Even if RGNX secures AA, we expect minimal impact given the large DMD market size (can accommodate multiple companies) and potential Elevidys monopoly in the non-ambulatory market,” projected for 2027 and later, Biliouris wrote.

According to Sarepta, Duchenne affects approximately 1 in 3,500 to 5,000 males born worldwide—some 300,000 people worldwide, according to research and patient care group Cure Duchenne. In the United States, about 15,000 young men and a few young women live with DMD, according to Parent Project Muscular Dystrophy estimates. A 2019 study found that most people with DMD become non-ambulatory around ages 10–12 and need assisted ventilation at around 20 years of age.

Andrew Tsai, equity analyst with Jefferies, said Sarepta’s three-year data, including muscle MRI data, has only begun to be promoted by the company this year. Since it can take six months to go from “start form” initiating the treatment process to infusion with Elevidys, Tsai reasoned, “we expect momentum to rebuild progressively/steadily in Q3/Q4, restoring confidence in the ambulatory DMD oppty.”

Some ~80% of ambulatory DMD patients remain untreated, Tsai noted, while Sarepta told investors in its Q1 earnings presentation that more than 1,300 patients have been treated with Elevidys in commercial settings or clinical trials as of May 5.

“While Elevidys’ safety perception has changed, we think marketing efforts on muscle MRI data, long-term three-year EMBARK data, and no deaths in ambulatory DMD could entice patients/caregivers and physicians to adopt Elevidys more, widening the moat,” Tsai wrote.

Maury Raycroft, PhD, a colleague of Tsai and equity analyst with Jefferies, wrote that Regenxbio’s data “reinforces microdystrophin as a surrogate, which is constructive for SLDB [Solid Biosciences].”

Playing to strengths

However, Raycroft added that Regenxbio’s safety events (notwithstanding immunosuppression) and limited regulatory clarity absent a pivotal RCT “play into SLDB’s strengths,” such as its use of a steroid-only prophylactic immunomodulation regimen (no safety issues to date) and its ongoing Phase III IMPACT DUCHENNE trial (NCT07160634), which is an RCT, thus a derisking factor from a regulatory standpoint.

“We believe RGNX is relying on and will require reg[ulatory] flexibility, which incorporates add’l risk and limitations, especially w/ FDA leadership in flux,” Raycroft wrote. “We caught up w/ SLDB, who also pointed out that RGNX could run into challenges to run an RCT given their immunosuppressive regimen.”

That regimen consisted of sirolimus, eculizumab, and steroids that included prednisone, researchers from Regenxbio and clinical partners reported in a poster presented at the International Congress of the World Muscle Society, held October 7–11, 2025, in Vienna.

On May 7, Solid announced it had dosed the first patient in the IMPACT DUCHENNE trial in Australia, at the Children’s Hospital at Westmead. The multi-country, placebo-controlled, randomized, double-blind trial has a pre-specified primary endpoint of change from baseline at 18 months in time to rise from supine (TTR) velocity, based on a Type C meeting with the FDA.

“With the initiation of a randomized, placebo-controlled clinical trial, we are reinforcing our conviction in SGT-003 and our long-standing commitment to generating well-controlled, high-quality data,” Gabriel Brooks, MD, Solid’s chief medical officer, said in a statement.

Solid shares dipped 2% on news of the dosing, from $7.20 to $7.07. Since then, the shares have yo-oed, climbing 9% to $7.72 on May 12 but sliding 10% since then, to $6.92 on Friday.

In its Phase I/II INSPIRE DUCHENNE study (NCT06138639), SGT-003 has also been administered to 46 patients, with approximately 30 participants dosed as of year-end 2025, Solid said.

“Families living with Duchenne continue to face difficult treatment decisions in a setting of significant unmet medical need,” Brooks added. “Solid remains focused on helping inform the Duchenne community of potential additional treatment options through the responsible and rigorous clinical evaluation of SGT-003.”

uniQure, Replimune gain as Makary exits FDA

Two gene therapy developers saw their stocks enjoy significant gains after Martin A. Makary, MD, resigned as FDA commissioner.

Makary’s resignation on May 12 capped nearly a week of speculation that he was about to exit the agency after a turbulent 13-month tenure. That tenure was marked in part by the elimination of 3,500 FDA positions as part of the Elon Musk-led Department of Government Efficiency (DOGE)-directed federal job cuts—as well as more frequent rejections of biologics license applications (BLAs) for new therapies, particularly gene therapies in rare disease indications.

Those rejections were carried out by the agency’s Center for Biologics Evaluation and Research (CBER) during the two tenures of Vinayak (Vinay) Prasad, MD, as Center director. Prasad resigned the first time in August 2025 after less than three months at the CBER helm, after he led the FDA’s confrontation with Sarepta over patient deaths tied to Elevidys (see Regenxbio item, above). The second resignation was announced in March and took effect on April 30, after he led the FDA’s hardline stance and public criticism against uniQure (NASDAQ: QURE)’s Huntington’s disease (HD) gene therapy candidate AMT-130.

While uniQure stock roller-coastered after Prasad’s second resignation, the stock jumped 21% in the four trading days between May 8, when an unnamed-source report about Makary being fired first surfaced in The Wall Street Journal, and May 13, the day after he resigned. uniQure rose 14.5% from $24.15 to $27.66 the day of the WSJ report, plateaued on May 10, dipping two cents to $27.64, then resumed their climb, rising 5% to $29.10 the following day before inching up another 0.2% to $29.17 on Wednesday.

An even bigger winner among stocks, however, was Replimune Group (NASDAQ: REPL). The developer of oncolytic immunotherapies saw its shares rocket 59% after news surfaced of Makary exiting the FDA.

Replimune has found itself in the FDA’s crosshairs over its biologics license application (BLA) for its lead product candidate RP1 (vusolimogene oderparepvec) in combination with nivolumab to treat advanced melanoma, instead issuing two complete response letters (CRLs)—one in April 2025, the other last month.

On April 10, the FDA rejected Replimune’s BLA for a second time, issuing a complete response letter (CRL) contending that the data set upon which the agency’s breakthrough therapy designation was awarded was not sufficient to allow for RP1 approval—an assertion Replimune vehemently rejects.

Replimune responded to the second BLA by criticizing the FDA for an inconsistent review process, saying the agency contradicted earlier guidance to the company and assessed the resubmitted BLA through a different review team that replaced the team that previously interacted with the company.

Replimune also defended the combination therapy’s data in the Phase II IGNYTE trial (NCT03767348)—a 34% response rate with a median duration of 24.8 months and a favorable safety profile, the basis of the combo’s breakthrough therapy designation.

Following the first news report of a Makary firing in the works, Replimune shares jumped 22% from $3.34 to $4.07. After slipping 8% to $3.74 the following trading day (May 11), Replimune rose 9% to $4.09 the following day after Makary resigned—then vaulted 30% to $5.30 on Wednesday.

“Broadly, we see multiple options for experienced leaders who could help stabilize the Agency following the many leadership transitions, and believe the tendency toward the administration’s “Right to Try” could draw a next leader who is more permissive on drug approvals near-term positive on the space,” Brian Abrahams, MD, head of global healthcare research with RBC Capital Markets, wrote in a research note.

Abrahams put forward six possible permanent successors to Makary:

  • Kyle Diamantas, current interim FDA commissioner; previously FDA deputy commissioner for human foods and senior counselor to Health and Human Services Secretary Robert F. Kennedy Jr.
  • Stephen Hahn, MD, CEO of Nucleus RadioPharma and a former FDA commissioner in President Donald Trump’s first administration (December 2019–January 2021).
  • Brett Giroir, MD, CEO of Altesa Biosciences; previously assistant secretary for health in Trump’s first term and an acting FDA commissioner (2019).
  • Sara Brenner, MD, HHS senior counselor for public health as of April 16; previously FDA principal deputy commissioner and acting FDA commissioner (January–April 2025).
  • Houman Hemmati, MD, PhD, a board-certified ophthalmologist and co-founder of Optigo Biotherapeutics, who is under consideration for CBER director.
  • Richard Pazdur, MD, a 26-year FDA veteran who retired in December 2025 after serving three weeks as CDER director (November–December 2025); previously founding director, FDA Oncology Center of Excellence (2017–2025).

“If Makary’s ouster indeed stemmed from political disagreements (vapes, abortion), the next Commissioner could harbor more ideological views—which could compromise perceived Agency credibility—and just by virtue of having another change, this would likely exacerbate the mixed messages companies have been receiving around FDA’s bar for their drugs, one of the key regulatory challenges the sector has faced,” Abrahams cautioned.

Leaders and laggards

  • Innate Pharma (Euronext Paris: IPH) shares jumped 35% from €1.23 ($1.42) to €1.66 ($1.92) on Wednesday after the Marseille, France-based developer of cancer drugs based on innate immunity and antibody engineering reported first-quarter results that beat analyst expectations. Innate finished Q1 with earnings per share of -0.1522, vs. the consensus forecast of -0.1616, on revenue of €2.6 million ($3.022 million) that was more than double (117% above) the €1.2 million ($1.395 million) reported in Q1 2025, thanks to partial or entire recognition of the proceeds received under collaboration agreements with AstraZeneca (NYSE, London Stock Exchange, and NASDAQ Stockholm: AZN) and Sanofi (Euronext Paris: SAN). Innate’s American depositary shares (ADSs) (NASDAQ: IPHA) rocketed 64% from $1.32 to $2.17 Wednesday.
  • Reviva Pharmaceuticals Holdings (NASDAQ: RVPH) shares plummeted 56% from 80 cents to 35 cents on Wednesday after the central nervous system (CNS), inflammatory, and cardiometabolic disease drug developer disclosed in a regulatory filing that the Nasdaq Hearings Panel had delisted the company’s stock, suspending it from trading on the exchange as of Thursday. Reviva said its shares will instead begin trading that day on the OTCQB Venture Market under its existing symbol. The Panel told Reviva that it failed to comply with Nasdaq’s minimum bid price of $1 per share required for continued listing on the Nasdaq Capital Market. Reviva disclosed the delisting the same day it reported first quarter results: The company narrowed its quarterly net loss year-over-year, finished Q1 with a net loss of approximately $3.2 million ($0.46 per share) vs. approximately $6.4 million ($2.61 per share) in the year-ago quarter.

The post StockWatch: Regenxbio Tumbles Despite Positive Pivotal Data for DMD Gene Therapy Candidate appeared first on GEN – Genetic Engineering and Biotechnology News.

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Animal skin disease confirmed in clusters of European men who have sex with men

Researchers in France and Spain have diagnosed a number of men who have sex with other men with dermatophilosis, a skin disease that normally infects livestock, even though the cases had no known exposure to affected animals. Cases have also been detected in Germany, one of the researchers told STAT. 

The clusters of infections are in some ways reminiscent of the emergence of mpox in 2022 in networks of gay men and other men who have sex with men. But people who have diagnosed some of these dermatophilosis cases describe a disease that is much milder in presentation. 

Read the rest…

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STAT+: French regulator fines Novo and Lilly over weight loss ad campaigns

As competition mounts in the red-hot market for weight loss drugs, France’s medicines regulator fined Novo Nordisk approximately $2 million for running “misleading” advertisements for its Wegovy and Saxenda medications.

At the same time, the National Agency for Medicines and Health Products Safety also fined Eli Lilly roughly $127,000 over advertising for its Mounjaro obesity treatment that purportedly amounted to indirect promotion of a medicine for which a prescription is required.

The penalties reflect increasing concern among regulators that weight loss medicines may be misused and, as result, promotions run by pharmaceutical companies are being closely scrutinized. Two years ago, the regulator issued a bulletin on the risks associated with the drugs, especially inappropriate use.

Continue to STAT+ to read the full story…

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Inexpensive seafloor-hopping submersibles could stoke deep-sea science—and mining

Smack dab between Australia and South America, the US National Oceanic and Atmospheric Administration (NOAA) research vessel Rainier is currently on a mission to map more than 8,000 square nautical miles of the Pacific seafloor in search of critical mineral deposits. But it isn’t doing it alone; for a month starting this week, it will deploy two oblong neon submersibles as the project’s special agents, sending them nearly 6,000 meters down to hop along the seafloor. 

The submersibles, built by the young company Orpheus Ocean, are designed to explore just this environment: a squelchy substrate that teems with life of all kinds, from tiny microbes to worms and snails, along with egg-size “nodules” of metals—such as copper, cobalt, nickel, and manganese—that are crucial for technologies worldwide.  

Scientists and companies have long sought to probe the deep sea and bring such treasures to the surface. Orpheus, which spun off from the Woods Hole Oceanographic Institution (WHOI) in 2024, could be well positioned to make those possibilities a lot more economical. The company has designed its vehicles on a simple philosophy: “deep for cheap,” says Jake Russell, Orpheus’s cofounder and CEO, who is a chemist by training. The vehicles cost a couple of hundred thousand dollars each to build, whereas existing options can range from $5 million to $10 million. And unlike most autonomous ocean vehicles, they can push into the seafloor and capture cores of sediment—and the creatures within. 

Orpheus’s engineers have been tinkering with their deep-sea designs for years, much of the work taking place at WHOI and in collaboration with NOAA and the National Aeronautics and Space Administration. Its prototype vehicles were rated capable of diving to 11,000 meters—the deepest part of the Mariana Trench. They’ve completed two commercial deployments, but this new expedition marks the submersibles’ biggest test yet: operating over large ranges for multiple weeks and with multiple instruments at play. Using Rainier as their home base on the ocean’s surface, the vehicles will swim out for 10 kilometers at a time, taking one high-resolution image every second and up to eight physical samples from the seafloor apiece.

If all goes well, the test could help establish the vehicles as a tool for government agencies, scientists, and companies that hope to probe the vastly understudied deep sea and the resources it holds. And while they’re not the only option on the market, Orpheus hopes their size and low building cost will soon make them one of the most accessible. 

At present, to reach these depths scientists must wait for time on a limited and expensive set of submersibles owned by government agencies and research institutes. That formula lends itself better to capturing snapshots of the deep sea than it does to probing its interconnected ecological and biogeochemical systems. “A lot of this region that we’re surveying … has really never been explored in any kind of detail,” says Russell. “Anything we see is going to be new to NOAA and new to science.”

A sediment specialist

The Orpheus subs are classified as autonomous underwater vehicles (AUVs), which operate on a mix of preprogrammed commands and live decision-making and without being tethered to a ship. But unlike traditional AUVs engineered for long-distance, high-speed gliding, these submersibles are short and stout with little legs—better for making soft landings on the seafloor and then pushing into the mud to suck out sediment cores for scientists. When they do land, the submersibles can lift off the surface, thrust a few feet, and settle once more in a “hopping” fashion.

Their bodies are made mostly of a buoyant material known as syntactic foam, with the important electronics encased in a thick sphere of glass. The same kind of foam, which is interspersed with hollow microspheres of glass to prevent it from collapsing under high pressures, went to the deep in the vehicle that carried the filmmaker James Cameron to the Mariana Trench in 2012; he even donated leftover material for use in earlier Orpheus prototypes. 

At less than two meters in length and under 600 pounds (270 kilograms), Russell says the Orpheus robots are the smallest—and correspondingly the least expensive—ocean vehicles on the market capable of descending to 6,000 meters. They’re designed to populate future fleets of robotic explorers.

The approach stems from a fundamental challenge, says Victoria Orphan, a geobiologist at the California Institute of Technology, who has previously worked with an Orpheus vehicle on a science campaign: “Anytime you do things in the deep ocean, you always run this risk, when you put something over the side [of a ship], that it might not come back.” With existing fleets of large, expensive vessels operated by groups like NOAA, WHOI, and the Monterey Bay Aquarium Research Institute (MBARI), losing a vehicle can be disastrous, not least because scientists must already compete for their limited time.

In the spring of 2024, Orphan and her colleagues put an Orpheus sub through its paces during an expedition to study deep-sea methane seeps off the coast of Alaska’s Aleutian Islands. They hoped to use the vehicle to create maps of the area before the team sent down a human-crewed submersible called Alvin to study specific areas—and the microorganisms and animals that live there—in more detail. 

But as with any sort of new type of technology, “there’s always growing pains,” recalls Orphan. Frigid temperatures and steep topography added unseen challenges, and it took the full three weeks for the sub to get high-resolution photographs of the seeps. 

The setback didn’t dull Orphan’s excitement about the potential of these machines. “There’s a lot of real, unknown science right at that interface between the sediment and the ocean surface,” she says. “The Orpheus-type class of instrument, with the right kinds of sensors and samplers, could be a very enabling tool.”

Russell envisions pairing the vehicles with specially designed payloads that can sense the heat of chemical seeps and detect plumes of sediment, DNA shed from ocean life-forms, or the magnetic tug of buried cables. 

The vehicles are the “the best of both worlds,” says Andrew Sweetman, a deep-sea ecologist at the Scottish Association for Marine Science, who has not worked with Orpheus. While they can roam large areas like an AUV, they can also carry out precise sampling maneuvers like a remotely operated vehicle (ROV), a robot connected to a ship via cables that fulfills real-time human commands.

In addition to the low price tag, says Sweetman, the small size of the vessels means they don’t require a large research vessel to ferry them out to sea. That might make exploration more accessible for smaller or poorer countries without such ships, he says: “It will, in a way, help democratize deep-sea science.” He imagines using the sediment cores the submersibles gather to probe how seafloor-dwelling animals cycle nutrients—a crucial element of the ocean’s role as a carbon sink. 

The mining push 

As much as smaller, cheaper ocean vehicles have caught scientists’ eye, they have also piqued the interest of companies. Russell says inquiries come in weekly from businesses involved in deep-sea mining, defense, offshore wind, telecommunication, and oil and gas. He notes that Orpheus is merely a “service provider,” helping collect data where needed but not making decisions about how to use the seafloor. And he says that better data—such as information on the shape of the seafloor, the sediment quality, and the presence of life—also “raises the bars” that governments and regulators are only beginning to set.

But many scientists are far from eager about the growing push for seabed mining, which an executive order from President Donald Trump stoked further last week by mandating that the US government rapidly develop mineral exploration and processing. And earlier last month, the administration announced the creation of a new government office: the Marine Minerals Administration. 

the Orpheus from below with flare from its two lower lights
A view of an Orpheus vehicle from below.
ORPHEUS OCEAN

Given the current dearth of information on the deep sea, says Sweetman, “I think the push for deep-sea mining is happening way too fast.” And deep-sea communities are “probably the most stable environment on our planet,” adds Orphan. “The organisms that live there are really not adapted to a lot of disturbance, and it takes a really, really long time for them to recover, if at all.”

One mining method that governments and companies propose involves a machine that essentially operates like a giant bulldozer, trawling the seafloor, sucking up a trail of material, and leaving scar marks and sediment plumes in its wake. Brett Hobson, an ocean engineer at MBARI, says that Orpheus-like technology might enable companies to “take samples in a more surgical way, instead of just grossly scooping everything up off the seafloor and filtering through it.”

Hobson, who has run MBARI’s work on ocean vehicles for decades, also notes that Orpheus submersibles won’t be the only option available. Companies and government agencies—including those in Norway, France, Japan, China, and the UK—are developing similar deep-sea vehicles, he says: “What we really need [as] a society is just more of these systems out there.” 

As Orpheus’s neon vehicles plunge into the Pacific over the next few weeks, their readiness for future scientific and resource surveys should become clearer. Each time they dive, they will get a little bit more data—“just the smallest of postage stamps of our planet,” says Orphan. “There’s still so much to learn.”