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. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

Articles

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

New CDC data show fewer kindergartners are fully vaccinated as exemption rates increased during the 2024-2025 school year.

CDC: Kindergarten vaccination decreases, exemptions increase 

A look back at the FDA submissions and regulatory decisions in the pediatric health care space from July 2025.

FDA news in pediatrics: July 2025

Take a quick look at everything you may have missed last month, including the top FDA approvals and latest clinical updates.

Top 5 pediatric health headlines you missed in July 2025

The FDA approved concizumab-mtci (Alhemo; Novo Nordisk) for hemophilia A/B without inhibitors, offering once-daily subcutaneous prophylaxis that significantly reduces bleeding rates.

FDA approves concizumab-mtci for hemophilia A/B without inhibitors in patients 12 years and older

Contemporary Pediatrics connects pediatricians with peer-reviewed articles, guideline updates, and practice strategies for real-world clinical application.

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Elizabeth Reichert, PhD, pediatric and adolescent psychologist, Stanford Medicine Children’s Health; co-director, Stanford Parenting Center.

Elizabeth Reichert, PhD, shared practical tips for pediatricians to help families monitor teen media use and recognize early signs of anxiety.

Elizabeth Reichert, PhD, talks media exposure and mental health

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

On July 29, 2025, the FDA granted fast track designation to the investigational therapy rezpegaldesleukin (Rezpeg; Nektar Therapeutics) for the treatment of severe to very severe alopecia areata (AA) in adults and pediatric patients 12 years or older with a weight of at least 40 kg.

Rezpegaldesleukin is a biologic candidate designed to target the IL-2 receptor complex to stimulate proliferation of regulatory T cells (Tregs), which may help restore immune tolerance in autoimmune conditions such as AA. Nektar noted that results from multiple trials showed the therapy safely and dose-dependently increased Treg populations. 

"We are pleased that rezpegaldesleukin has been granted fast track designation for the treatment of alopecia areata, adding to its fast track designation in atopic dermatitis," said Jonathan Zalevsky, PhD, senior vice president and chief research and development officer at Nektar. "Alopecia areata is a chronic, systemic, immune-mediated inflammatory disease, and there is an urgent need for novel mechanistic approaches that could treat the underlying pathogenesis of this disorder."

The FDA’s fast track designation is intended to facilitate the development of treatments for serious conditions that address an unmet medical need. With this designation, rezpegaldesleukin becomes eligible for more frequent meetings with the FDA, written communications on clinical trial design, and potential rolling and priority review. 

Phase 2b Rezolve AA study of rezpegaldesleukin 

The phase 2b Rezolve AA trial (NCT06340360) was initiated in March 2024 and enrolled approximately 90 patients across 30 sites worldwide, including in Poland (62%), Canada (24%), and the United States (14%).

Participants were randomly assigned to receive 1 of 2 dose regimens of rezpegaldesleukin or placebo over a 36-week induction period. Patients were eligible for the study if they had a diagnosis of severe to very severe AA, defined as 50% or greater scalp involvement based on the Severity of Alopecia Tool (SALT) score at both screening and random assignment. Individuals with diffuse alopecia or an unstable disease course in the previous 6 months were excluded.

The study's primary end point is the mean percent change in SALT score at week 36. Secondary outcomes include the proportion of patients achieving 50% or more reduction in SALT score, mean SALT improvement at other time points, and the proportion of patients reaching SALT-20 (defined as an absolute SALT score of 20 or less).

"We remain on track to announce top-line data in December from our ongoing Rezolve AA phase 2b study for rezpegaldesleukin in alopecia areata, and we look forward to the opportunity to collaborate quickly with the agency on a potential registrational program following the completion of phase 2," added Zalevsky. 

February 2025 fast track designation for atopic dermatitis

previously received fast track designation

moderate to severe atopic dermatitis (AD)

 in patients 12 years or older whose condition is not adequately controlled with topical therapies or where such therapies are not advisable.

According to Nektar, rezpegaldesleukin showed rapid improvement in disease outcomes during a 12-week induction phase and continued benefits lasting 36 weeks after treatment cessation. Early data presented at the 2023 European Academy of Dermatology and Venereology Congress demonstrated significant improvements in Eczema Area and Severity Index (EASI) scores and body surface area affected (

The ongoing phase 2b REZOLVE-AD study (NCT06136741) has enrolled 398 patients with moderate to severe AD. Patients are randomly assigned to 1 of 3 induction doses or placebo for 16 weeks. Those who meet an EASI threshold are then randomly assigned again to a maintenance regimen administered once monthly or once every 3 months.

Nektar Therapeutics receives fast track designation for rezpegaldesleukin for the treatment of severe-to-very severe alopecia areata. Press release. Nektar Therapeutics. July 29, 2025. Accessed July 29, 2025. https://ir.nektar.com/news-releases/news-release-details/nektar-therapeutics-receives-fast-track-designation-0 

Fitch J. FDA grants rezpegaldesleukin fast track to treat moderate, severe atopic dermatitis. 

. February 10, 2025. Accessed July 29, 2025. https://www.contemporarypediatrics.com/view/fda-grants-rezpegaldesleukin-fast-track-to-treat-moderate-severe-atopic-dermatitis

Nektar Therapeutics remains on track to announce top-line phase 2 data in December. 

News

FDA grants fast track designation to rezpegaldesleukin for severe alopecia areata in patients 12 years and older

On July 28, 2025, the FDA approved PTC Therapeutics' sepiapterin (Sephience) to treat adult and pediatric patients with phenylketonuria (PKU), including all age groups and the full spectrum of disease subtypes, according to a press release from PTC. Additionally, the approval includes broad labeling to treat hyperphenylalaninemia (HPA) in patients 1 month or older with sepiapterin-responsive PKU.

WATCH: Experts react to the FDA approval of sepiapterin to treat PKU

"We are excited to have reached this important milestone for those affected by PKU," Matthew B. Klein, MD, CEO of PTC, said a press release. "The broad labeling reflects the potential of [sepiapterin] to meet the significant unmet need of patients [with] PKU. The [sepiapterin] clinical data, along with our expertise in launching rare disease therapies, positions [sepiapterin] to become the future standard of care. Our experienced customer-facing teams are ready to bring this therapy to children and adults with PKU in the United States as quickly as possible." 

“Without treatment, individuals with PKU would have very high blood Phe levels, and high blood Phe levels are a toxin to the brain, so that results in neurocognitive deficits and mood disorders," Suzanne Hollander, MS, RD, LDN, a metabolic dietitian at Boston Children’s Hospital 

PKU is typically diagnosed shortly after birth through newborn screening, and treatment begins immediately. The goal is to keep blood Phe levels under 360 µmol/L. 

In March, PTC announced new data from the phase 3 APHENITY trial, which ultimately led to approval from the FDA.

According to the company, key findings included the following

Over 97% of participants in the Phe tolerance protocol of the APHENITY open-label extension study demonstrate the ability to liberalize their diet while on sepiapterin treatment, with a mean increase in protein intake of 126%. 

A total of 66% of participants in the Phe tolerance substudy reached or exceeded the age-adjusted recommended daily allowance of protein intake for an individual without PKU while maintaining control of blood Phe levels.

Genetic variant analysis of participants in the APHENITY study demonstrates that over 70% had a genotype-phenotype value consistent with classical PKU. 

"From a dietary standpoint, the study was really exciting because we did a Phe tolerance assessment,” said Hollander. “For individuals who had their Phe level lowered with the medication to less than 360 [μmol/L], they were able to participate in a portion of the study where we systematically monitored their Phe levels and then increased their dietary or natural protein. Overall, participants saw a 126% increase in natural protein intake and a 50% reduction in their use of medical formula, a meaningful outcome given the burden the formula places on children and families."

WATCH: PKU and the pediatrician with Suzanne Hollander, MS, RD, LDN

"The approval marks an exciting milestone for the PKU community," Catherine Warren, executive director of National PKU Alliance, said a statement. "This progress brings renewed hope, and we are eager to see the positive impact this new treatment option will have on advancing care and potentially improving quality of life for individuals of all ages and PKU subtypes who respond to this therapy."

Sepiapterin is to be used in conjunction with a Phe-restricted diet, with the aim of liberalization to allow for an increase in protein.

"[Sepiapterin and a Phe-restricted diet will go] hand in hand. The approach has always centered on diet, with pharmacologic management as an adjunct to hopefully help liberalize diet," Timothy Tramontana, MD, medical and biochemical geneticist at Cleveland Clinic Foundation, told 

. "That approach has helped a number of people through the use of sapropterin and now with sepiapterin. The hope is to expand the number of patients who may be able to liberalize their diet and increase their protein intake. That is our goal for most of our patients: to help them live a more normal life in terms of intake. It may never be 100% protein unrestricted, but the hope is to liberalize it enough to allow increased intake," said Tramontana.

PTC Therapeutics announces FDA approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria (PKU). Press release. PTC Therapeutics. July 28, 2025. Accessed July 28, 2025. https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-announces-fda-approval-sephiencetm-sepiapterin

PTC Therapeutics announces FDA target regulatory action date for sepiapterin and Lancet publication of phase 3 trial results. Press release. PTC Therapeutics. October 14, 2024. Accessed July 25, 2025. https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-announces-fda-target-regulatory-action-date

Fitch J. PKU and sepiapterin data with Suzanne Hollander, MS, RD, LDN. 

. May 7, 2025. Accessed July 25, 2025. https://www.contemporarypediatrics.com/view/pku-and-sepiapterin-data-with-suzanne-hollander-ms-rd-ldn

PTC Therapeutics presents new sepiapterin data from ongoing studies. Press release. PTC Therapeutics. March 20, 2025. Accessed July 25, 2025. https://ir.ptcbio.com/news-releases/news-release-details/ptc-therapeutics-presents-new-sepiapterin-data-ongoing-studies

“Without treatment, individuals with PKU would have very high blood Phe levels...so that results in neurocognitive deficits and mood disorders," Suzanne Hollander, MS, RD, LDN, said.

FDA approves sepiapterin to treat phenylketonuria in adult, pediatric patients

A previously healthy 10-year-old girl presented to the primary care pediatric office with complaints of new onset headaches that were localized to the left side of her forehead and the left side of her face, sometimes additionally radiating to the back of her eye but not the eye itself. Accompanying the headache was redness of the conjunctiva that occurred only to the affected side of headache and only during the episode. The patient denied tearing/drainage from the eye with no visual complaints.

She had been experiencing this for 1 month prior to coming into the clinic, at first occurring once a week but then increasing to twice a day without any known triggers or pattern of timing; however, she noted that episodes began to occur more often later in the day. The patient described the headache as “pressure-like,” episodes that occurred for 1 to 2 hours with high severity. She has used acetaminophen/ibuprofen for relief of episodes but at times relieved without any medication. There was no reported family history of migraines or headache disorders. 

The patient was referred to neurology with high suspicion for a trigeminal autonomic cephalgia (TAC), such as short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) or short-lasting unilateral neuralgiform with cranial autonomic symptoms (SUNA). Pediatric neurology confirmed the clinical diagnosis of SUNCT given unilateral localization with repeated episodes of over 20 attacks with cranial autonomic symptoms. 

Short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT).

Headaches are the most common neurological issue across both the pediatric and adult populations.

 Headaches have major psychosocial impacts on various aspects of life and can largely negatively impact life.

 Short-lasting unilateral neuralgiform headache attacks (SUNHA) are a specific type of headache that is moderate to severe in severity, occurring from seconds to minutes, at least once a day, located strictly unilaterally.

Two subtypes of SUNHA are described: short-lasting unilateral neuralgiform headache attacks with conjunctival injection and tearing (SUNCT) and short-lasting unilateral neuralgiform headache attacks with cranial autonomic symptoms (SUNA). For years, SUNA and its subtypes were solely discussed in the adult population; however, recent cases have been reported in the pediatric population.

The patient described the headache as “pressure-like,” episodes that occurred for 1 to 2 hours with high severity.

Elizabeth Reichert, PhD

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