FDA Grants Orphan Status to Experimental Drug for Newborn Brain Injury

The FDA has just granted orphan drug designation* to NNZ-2591 (ercanetide), an experimental drug from Australia’s Neuren Pharmaceuticals, for neonatal hypoxic-ischemic encephalopathy (HIE). NNZ-2591 is an oral solution that, as stated in the Neuren Pharmaceuticals website “is meant to mimic a natural brain molecule that regulates the growth factor IGF-1 and calms inflammation…. NNZ-2591 exert[s] diverse effects which can help to control or normalize abnormal biological processes in the brain. This means that the target is to have a broad impact on the condition rather than aiming to treat one symptom.”

Illustrated side view of the human brain and skull with glowing blue outlines

HIE is a brain injury caused when a baby’s brain is starved of oxygen or blood flow during birth. It is rare, striking about 1 to 1.7 of every 1,000 US births, according to US studies in the American Journal of Obstetrics & Gynecology and Pediatric Neurology. Given its rarity, it is unsurprising, but unfortunate, that no drug is currently approved to treat HIE. The standard treatment protocol is cooling the baby for about 72 hours. Even so, it is reported that 40 – 45 percent of survivors have significant impairment by age two. The hope is that this new medicinal treatment can calm immediate acute injury and prevent lasting damage.

“We now look forward to discussing the development path with the FDA and preparing the IND [Investigational New Drug] application [in the 2027] for a clinical study in HIE, a devastating condition with serious need,” said Neuren CEO Jon Pilcher.

* “The FDA has authority to grant orphan drug designation to a drug or biological product to prevent, diagnose or treat a rare disease or condition. Orphan drug designation qualifies sponsors for incentives including: tax credits for qualified clinical trials, exemption from user fees, potential seven years of market exclusivity after approval.” (fda.gov)

** “Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.” (fda.gov)

Gut Toxin Wrecks the Premature Brain Without Touching It

Necrotizing enterocolitis (NEC) destroys the intestines of premature babies, and survivors often face lasting brain damage. National Institute of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development director Diana Bianchi has stated, “It is estimated that one infant in the United States dies almost every day from NEC.”

Newborn baby wrapped in a blanket inside a neonatal incubator

On October 28, 2026, the NLM indexed a report that describes the condition as “the most devastating gastrointestinal emergency in preterm infants, frequently causing mortality and long-term neurodevelopmental impairment.” First published by Nature, the study connected to the report finally names the culprit for that condition that has puzzled doctors for decades: Delta toxin, made by certain strains of the common gut bacterium Clostridium perfringens.

In this study, stool from infants with severe or fatal NEC was loaded with Delta-toxin-carrying strains. In mice, the toxin alone reproduced the disease, with no other stressors required. Delta toxin hunts macrophages, the immune system’s cleanup cells, and makes them rupture within an hour. The resulting inflammatory flood pries open the blood-brain barrier. While the toxin never reaches the brain itself, brain injury “is probably driven by systemic inflammation rather than direct brain toxin accumulation,” the authors write. Furthermore, the NLM-report concludes that, “these findings suggest that a subset of NEC is a specific-toxin-mediated disorder and validates the Delta toxin-CD9 axis as a therapeutic target for this subset.”

CT Senator Murphy Recovering After Stroke

Senator Chris Murphy (CT) is recovering at Johns Hopkins Hospital in Baltimore after a stroke Oct. 31. “He is awake and alert, and we are optimistic he will make a full recovery,” said Allison Herwitt, his chief of staff.

Speaker addressing an audience at a United States Senate public forum

Reportedly, Murphy felt arm numbness while at his son’s hockey game and was taken to a local hospital. At 53, Murphy is relatively young for a stroke, as statistics have determined that the median age to have a stroke is 71. Survivors can face fatigue, depression and repeat-stroke risk. Whether and when he returns is a medical call; Yale neurologist Adam Jasne said some patients leave the hospital “back to 100 percent normal” while others have lasting deficits.

Murphy’s term runs through January 2031, and he has been mentioned as a 2028 presidential prospect. Other politicians are continuing their terms in office following this same medical emergency: current Senators John Fetterman, Ben Ray Luján and Chris Van Hollen had strokes in 2022. Whether or not Murphy’s personal trauma will affect his support for the stroke community remains uncertain. Previously, Murphy backed Pediatric Stroke Awareness Month resolutions.

As of now, the stroke type and return date are undisclosed.

Saturday Halloween: Keep the Fun, Protect the Brain

Crossing guard standing at a neighborhood crosswalk on an autumn evening

Tomorrow, October 31, is both Halloween and Saturday, a weekend night. Because of this coalescence, some towns have moved trick-or-treating earlier, giving kids more daylight. However, when daylight fades, AAA and other organizations warn of possible danger, as costumed children will share dark streets with weekend drivers, partygoers and e-bike riders.

The risk is real. A 2018 study of 42 years of crash data, indexed by the National Highway Traffic Safety Administration, found pedestrian deaths rose 43% on Halloween evening, peaking around 6 p.m. Children ages 4 to 8 faced tenfold risk, and alcohol didn’t explain it.

Adults face a different danger: NHTSA reports that, from 2019 to 2024, there were 201 alcohol-related deaths on Halloween night. A weekend party night may raise those stakes.

October is also National Pedestrian Safety Month, designated by the U.S. Department of Transportation. “During National Pedestrian Safety Month, I want to remind drivers about the importance of following the speed limit, paying attention to the road ahead, and keeping an eye out for pedestrians,” Ohio Gov. Mike DeWine said October 9.

For protection, the government reminds trick-or-treaters to use reflective tape, flashlights, face paint instead of masks, and helmets when on wheels. For their part, drivers need to slow down and plan sober rides. As the government-affiliated North Jersey Transportation Planning Authority (NJTPA) states, “Halloween is a night for costumes, celebrations, and spending time with friends and family. A little extra caution can help keep the focus on the fun.”

Texas Teaches Designated Doctors to See What Brain Scans Miss

Four roofing workers in helmets and harnesses on a residential roof

A roofer hits his head; they get a clean brain scan; months later, they can’t even retain a short grocery list in their mind. In Texas, doctors are now legally mandated to determine if such issues are the results of a brain injury, depression or something else.

In October 2026, the Texas Division of Workers’ Compensation tackled the issue in a six-part online case study related to non-musculoskeletal traumatic brain injury. Designated doctors were taught to rate impairment, using the AMA Guides to the Evaluation of Permanent Impairment (Fourth Edition, 1993), by performing a physical exam that covers all areas and functions of the brain. Doctors were told to use neuropsychological testing, structured memory, attention and effort test to objectively determine whether TBI residuals exist or if there is an alternate explanation. (Questionnaires like the oft-used PHQ-9, a nine-question depression screen, can result in exaggerated symptoms, and lack built-in checks which can have legal ramifications.)

Other states, including California, train their independent medical examiners in impairment rating, so Texas’s dedicated TBI module is unique. Its stress on objective evidence echoes federal concussion guidance from agencies like the CDC and VA.

Unlikely DOW-NCAA Alliance Rewriting Concussion Science

Military Health System’s Around the MHS video, released on Oct. 21, 2026, opens with the seemingly unlikely pairing of college sports and the Department of War. The video’s news peg was a September meeting on a CARE-SALTOS (Concussion Assessment, Research and Education – Service Academy Longitudinal Mild TBI Outcomes Study) that will follow participants for up to 10 years.

This partnership, though, is over a decade old, begun when the NCAA and the Department of Defense announced a $30 million Grand Alliance at a White House concussion summit in 2014. NCAA chief medical officer Brian Hainline described athletes and service members alike as “young, ambitious, bright risk takers.”

The alliance funded the $7 million launch of the Mind Matters Challenge in 2014, “two concurrent challenges. One, an educational program challenge, aimed at young adults, seek[ing] to identify entities that have the expertise and capability to create compelling and impactful educational materials.” The second challenge focused on research, specifically research on young athletes and service members. The $23 million CARE Consortium (Concussion Assessment, Research and Education Consortium), enrolled more than 53,000 athletes and cadets from 26 schools and four service academies, making it “the largest concussion database of its kind.” One important CARE finding is that recovery is better measured over 28 days than over the old benchmark of 14 days.

Colorado’s Brain Injury Help Desk for Kids

Colorado Department of Education seal reading “Excellence in Education” and “Est. 1876”

Colorado Department of Education (CDE) just launched its brain-injury support office hours in the State, holding its first virtual session of the 2026-2027 school year on Thursday, October 22. The five Zoom sessions that are currently scheduled are open to anyone wanting to learn, ask questions or share issues related to brain injury.

In addition to this new endeavor, the CDE hosts Colorado Kids with Brain Injury that’s “website serves as a resource for educators, related service providers, community partners, families, and anyone seeking information, tools, and guidance to support Colorado students with brain injuries..” The CDE also manages Colorado’s youth brain injury program, through a 2011 agreement with the State’s brain injury agency MINDSOURCE, and in 2016 adopted BrainSTEPS, a school-consulting initiative modeled on that created by Pennsylvania’s health department in 2007. By fiscal 2024, MINDSOURCE’s legislative report reported 31 BrainSTEPS teams, with 265 members serving districts enrolling 75 percent of students, and 549 staff had completed concussion “Return to Learn” training.

(Most states have a specialized state department, agency or programs to oversee brain injuries, rather than relying on a federal Department of Brain Injury.)

OSU Experts Issue First Brain Injury Guidelines for First Responders

Emergency responders review a map beside police, fire, and ambulance vehicles

Police officers, firefighters and paramedics take blows to the head on the job far too often. Acknowledging this, The Journal of Head Trauma Rehabilitation published the first guidelines to follow for police officers, firefighters, corrections officers, EMTs, and others, in relation to workplace policy, prevention, recognition, diagnosis, mental-health monitoring and return to duty. These guidelines were assembled by 52 experts at The Ohio State University, a public research university, recognizes, “While addressing injury prevention, treatment and return to duty, the recommendations also recognize that better outcomes will require education, supportive reporting practices and organizational cultures that enable first responders to identify injuries and access appropriate care,” and made their findings public on October 16, 2026.

Funded by the Department of Defense, the 28 recommendations borrow from those in place for the military and in sports. They advise testing brain function prior to injury, pulling off duty those with a suspected head injury, checking their mental health, and easing them back to work. Seemingly to somewhat counter OSU’s new rules, the University of Pennsylvania reported in September 2026 that after reporting a brain injury, first responders often, “have to go on desk duty. [They] are taken out of [their] job. There are huge [negative] implications.” The OSU report states that many first responders do not report on their suspected injury due to perception of weakness; perhaps it is fear of being removed from their primary duties.

The Fungus in the Dust That Can Reach Your Brain

Two hikers on a rocky trail overlooking forested canyons and distant mountains

A fungus hiding in Western dirt is sickening Americans at record pace, various publications reported in the past few months. A 2026 CDC study found that, in Arizona’s cooler northern plateaus, infections now run 6.6 times higher than in 2005–2007. In a study published in June 2025, available in the PubMed database, “a nationwide* total of 273,000 incident symptomatic coccidioidomycosis cases were estimated in 2019.” California recorded nearly 12,500 Valley fever cases in 2024, which reportedly is its highest ever. Federal modelers estimate up to 360,000 Americans get sick each year from fungus.

While infections typically affect the lungs, when spores reach the brain, they cause meningitis. As described by the CDC, meningitis is inflammation of the lining of the brain and spinal cord. Among patients hospitalized for Valley fever, 63.6% needed procedures like brain shunts. In one study, half developed hydrocephalus, a buildup of brain fluid, and 39% suffered strokes.

Scanning electron micrograph of fungal spores and branching hyphae, with 10 µm scale bar

“Too many patients are misdiagnosed and left without answers while their condition worsens,” said Congressman Vince Fong (CA) in September 2026. As always, the most important step is to protect yourself, so this misdiagnosis cannot occur. Protect yourself. While avoidance of dusty areas is optimal, it is not always possible. The Occupational Safety and Health Administration, along with the CDC and various state governments, recommend wearing an N95 mask when in dusty outdoor environments, and when digging is involved. Ideally, stay fully indoors during dust storms. Also, be cautious about domestic or international travel: in 2023, a fungal meningitis outbreak tied to Mexican cosmetic-surgery clinics killed 12 of 24 US patients. See a doctor about any cough or headache that lingers.

*The number of Valley fever incidents are not recorded in every state, but of those who do, California, Arizona and the rest of the Southwest seem to have the greatest number of cases.

Senate Passes Brain Injury Program Renewal; House Is Next

Thirty years ago, Congress first passed the Traumatic Brain Injury Act, “to amend the Public Health Service Act to provide for the conduct of expanded studies and the establishment of innovative programs with respect to traumatic brain injury.” The federal program it created has now been without authorization since the end of fiscal year 2024.* On September 29, the Senate passed S.5600, Dennis John Benigno Traumatic Brain Injury Program Reauthorization Act of 2026, by voice vote the same day it was introduced, to possibly fix this financing lapse.

The bill is sponsored by Sen. Alan Armstrong (OK), who was appointed to the Senate following the resignation of Markwayne Mullin, who now serves as the head of the Department of Homeland Security. S.5600 is very similar to Mullin-sponsored S.2898 in content and title, although with date adjustments. However, Dennis John Benigno Traumatic Brain Injury Program Reauthorization Act of 2025 never got past the Senate Health committee (HELP), to which it was referred to on September 18, 2025. (The last action on S.2898 was a star print on October 8, 2025.)

Co-sponsors of S.5600 include Senator Andy Kim (NJ), friend and colleague of Representative Bill Pascrell, Jr. (NJ), a fervent advocate for those with brain injury. The federal traumatic brain injury program is named in honor of a teen from Pascrell’s northern New Jersey district who prompted his advocacy. The 2026 bill’s other cosponsors include John Cornyn (TX) and Catherine Cortez Masto (NV).

S.5600 renews CDC prevention and surveillance work and two Administration for Community Living grant programs through fiscal 2031. It also names the CDC surveillance program after Pascrell, who passed away in 2024. The Bill Pascrell, Jr., National Program for Traumatic Brain Injury Surveillance and Registries handles nationwide tracking, research, and support infrastructure. New provisions add tribal eligibility, track high-risk groups such as public safety officers and domestic-violence survivors, and order a study of long-term effects, including dementia.

The current hurdle is the House, which passed its own version, H.R.1493, in July. That bill runs only through FY2030, so the chambers must reconcile their differences.

Pascrell’s successor, Representative Nellie Pou, acknowledges the importance: “We must get a TBI renewal across the finish line this year.”

*Without federal authorization, Congress can and has still funded programs. However, without a law guarantee of financial funding, it must be newly argued each fiscal year.