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Second Rare Pediatric Disease (RPD) Designation for QRX003FDA Previously Granted RPD Designation for QRX003 in Netherton SyndromeIf a New Drug Application (NDA) for QRX003 Is Approved for Peeling Skin Syndrome, Quoin May Receive a Freely Tradable Priority Review Voucher (PRV)Quoin Expects to Initiate Phase 2 Study in 2H 2026; Study Plans to Enroll up to 12 Pediatric and Adult Peeling Skin Patients in the U.S. and EuropeThere are Currently No Approved Treatments for Peeling Skin Syndrome ASHBURN, Va., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the Company’s lead asset, QRX003, for the treatment of Peeling Skin Syndrome (PSS).

The designation reinforces the potential of QRX003 as a therapeutic candidate for a profoundly underserved pediatric population. This is the second RPD designation granted for QRX003, following the previously granted RPD designation for Netherton Syndrome.

The FDA’s Rare Pediatric Disease Designation program is intended to encourage the development of new therapies for serious and life-threatening diseases that primarily affect individuals under 18 years of age. If a New Drug Application (NDA) for QRX003 is approved, Quoin may qualify to receive a Priority Review Voucher (PRV), which can be redeemed to receive priority review for another marketing application or may be sold or transferred.

“We are very pleased to announce the receipt of Rare Pediatric Disease Designation for QRX003 for Peeling Skin Syndrome. This designation means that Quoin could potentially receive two PRVs, which, given the current trading value of PRVs, could have an aggregate non-dilutive cash value in excess of $300 million,” said Dr. Michael Myers, Chief Executive Officer of Quoin Pharmaceuticals. “With the IND cleared by FDA, the Quoin team is preparing to initiate the Phase 2 clinical study before the end of this year with plans to enroll up to 12 pediatric and adult Peeling Skin patients in the U.S. and Europe. This will be the first formal study ever conducted in the U.S. for this disease under an open IND.”

About Peeling Skin Syndrome (PSS)
Generalized inflammatory peeling skin syndrome (PSS) is a rare autosomal recessive genodermatosis caused by loss-of-function disease-causing variants of the corneodesmosin gene (CDSN), resulting in excessive shedding of the superficial layers of the epidermis. Patients generally suffer from a variety of conditions including severe pain and chronic pruritus (itch). There is currently no approved treatment for PSS.

About Quoin Pharmaceuticals Ltd.
Quoin Pharmaceuticals Ltd. is a late clinical-stage specialty pharmaceutical company focused on developing and commercializing therapeutic products that treat rare and orphan diseases. We are committed to addressing unmet medical needs for patients, their families, communities, and care teams. Quoin's innovative pipeline is focused on two key platform products, QRX003 and QRX009, that collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas and others. For more information, visit: www.quoinpharma.com or LinkedIn for updates.

Cautionary Note Regarding Forward Looking Statements
The Company cautions that statements in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as “expect,” “intend,” “plan,” “anticipate,” “believe,” “look forward to,” and “will,” among others. All statements that reflect the Company’s expectations, assumptions, projections, beliefs, or opinions about the future, other than statements of historical fact, are forward-looking statements, including, without limitation, statements relating to: the potential of QRX003 as a therapeutic candidate for Peeling Skin Syndrome and a profoundly underserved pediatric population, Quoin’s eligibility to receive Priority Review Vouchers upon approval of a New Drug Application for QRX003, including the potential to receive two PRVs with an aggregate non-dilutive cash value in excess of $300 million; the initiation of a Phase 2 clinical study for Peeling Skin Syndrome before the end of 2026 with plans to enroll up to 12 pediatric and adult patients in the U.S. and Europe; and Quoin’s belief that its products in development collectively have the potential to target a broad number of rare and orphan indications, including Netherton Syndrome, Peeling Skin Syndrome, Palmoplantar Keratoderma, Pachyonychia Congenita, Gorlin Syndrome and Tuberous Sclerosis Complex, Microcystic Lymphatic Malformations, Venous Malformations, Angiofibromas and others.  Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties including, but not limited to, the Company’s ability to pursue its regulatory strategy; the Company’s ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements; the Company’s ability to complete clinical trials on time and achieve desired results and benefits as expected; and other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025 and in other filings the Company has made and may make with the SEC in the future. One should not place undue reliance on these forward-looking statements, which speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as may be required by law.

For further information, contact:

Quoin Pharmaceuticals Ltd.
Michael Myers, Ph.D., CEO
[email protected]

Investor Relations
PCG Advisory
Jeff Ramson
[email protected]
(646) 863-6341

Rapid7 (RPD - Free Report) came out with quarterly earnings of $0.44 per share, beating the Zacks Consensus Estimate of $0.35 per share. This compares to earnings of $0.58 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of +25.71%. A quarter ago, it was expected that this cybersecurity company would post earnings of $0.3 per share when it actually produced earnings of $0.36, delivering a surprise of +20%.

Over the last four quarters, the company has surpassed consensus EPS estimates four times.

Rapid7, which belongs to the Zacks Internet - Software industry, posted revenues of $210.88 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 1.34%. This compares to year-ago revenues of $214.19 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Rapid7 shares have lost about 23.9% since the beginning of the year versus the S&P 500's gain of 13.3%.

What's Next for Rapid7?While Rapid7 has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Rapid7 was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.43 on $210.24 million in revenues for the coming quarter and $1.56 on $838.94 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Internet - Software is currently in the top 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

eGain (EGAN - Free Report) , another stock in the same industry, has yet to report results for the quarter ended June 2026.

This maker of customer engagement software is expected to post quarterly earnings of $0.04 per share in its upcoming report, which represents a year-over-year change of -55.6%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days.

eGain's revenues are expected to be $21.65 million, down 6.8% from the year-ago quarter.

Regulatory recognition in the United States and Europe supports the development of NB4168, a novel small molecule candidate for a rare pediatric disease with no approved treatments

LOS ANGELES--(BUSINESS WIRE)--Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that the U.S. Food & Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicotinamide riboside (NR) exposure than conventional NR while maintaining a differentiated pharmacokinetic and safety profile. In addition, the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to NB4168 for the treatment of A-T, providing regulatory recognition in the European Union and further supporting the Company's plans to advance the program globally.

Niagen Bioscience Receives Exclusive U.S. FDA Rare Pediatric Disease (RPD) Designation and European Medicines Agency Orphan Medicinal Product Designation (OMPD) for NB4168 for the Treatment of Ataxia Telangiectasia (A-T)

Share The FDA granted RPD Designation based on its determination that A-T is a serious and life-threatening disease that primarily affects individuals from birth through adolescence and meets the statutory definition of a rare disease. The EMA's Committee for Orphan Medicinal Products similarly concluded that NB4168 met the criteria for orphan designation for the treatment of A-T. Together, these regulatory designations recognize the significant unmet medical need in A-T and provide development incentives intended to support and accelerate the advancement of promising therapies for rare diseases.

NB4168 is the first investigational therapeutic candidate to emerge from Niagen Bioscience's recently announced wholly owned subsidiary focused on developing therapies for rare genetic diseases and age-related disorders, NAD Pharmaceuticals Corp. NB4168 is designed to have significantly higher bioavailability and increase NAD+, a coenzyme essential for DNA repair, mitochondrial function, cellular energy production, and stress responses—biological pathways disrupted in A-T. As A-T is categorized as a rare genetic premature aging disease, NB4168 may translate to other age-related diseases.

“Receiving RPD Designation from the U.S. FDA and OMPD from the EMA represents meaningful regulatory validation of NB4168 and our strategy to develop therapies for patients with serious rare diseases,” said Rob Fried, CEO of Niagen Bioscience. “These milestones strengthen our path toward clinical development and reinforce the opportunity to extend our leadership in NAD+ science into regulated medicines.”

About Ataxia Telangiectasia (A-T)

A-T is a rare genetic disease caused by mutations in the ATM gene. The disease typically presents in early childhood and is characterized by progressive loss of motor coordination, impaired immune function, increased susceptibility to infections, pulmonary complications, a substantially elevated risk of cancer, and premature aging. Children living with A-T often experience worsening neurological disability over time, with many requiring wheelchair assistance as the disease progresses. There are currently no FDA-approved therapies for A-T, and treatment is largely limited to supportive care. A-T impacts roughly 1 in 40,000 people in the U.S. (Riboldi et al., 2023; Teive et al., 2015) and 1 in 150,000 people in Europe (Bhatt et al., 2015).

About the U.S. FDA RPD and EMA OMPD

The FDA's RPD Designation is intended to encourage the development of therapies for serious and life-threatening diseases that primarily affect children. The designation provides certain regulatory and development incentives intended to support the advancement of promising therapies for rare pediatric conditions.

The EMA's OMPD is granted to therapies intended to diagnose, prevent, or treat life-threatening or chronically debilitating rare diseases affecting fewer than five in 10,000 people in the European Union. Orphan designation provides access to regulatory support and other development incentives designed to facilitate treatment development for rare diseases.

About NB4168

NB4168 is a distinct, proprietary small molecule designed for oral pharmaceutical development. It is not commercially available as a supplement or approved drug and has robust coverage by Niagen Bioscience's patent portfolio, including a composition-of-matter patent. After oral administration, NB4168 is designed to deliver significantly increased doses of NR to the bloodstream. NR enters cells directly, where it is converted through the nicotinamide riboside kinase pathway into NAD+. Because NAD+ supports DNA repair, mitochondrial function and cellular resilience, increasing intracellular NAD+ may represent a novel therapeutic approach for rare genetic diseases such as A-T in which these biological pathways are impaired.

The compound was designed to build upon Niagen Bioscience's extensive expertise in NR and NAD+ biology. The Company is currently advancing preclinical development activities and plans to submit an Investigational New Drug (IND) application to the FDA in anticipation of initiating human clinical studies, representing another step in Niagen Bioscience's strategy to translate decades of NAD+ science into proprietary medicines for serious rare genetic diseases.

“A-T is characterized by defects in DNA damage repair, mitochondrial dysfunction and chronic cellular stress, all biological processes that rely on adequate NAD+ availability,” said Vilhelm Bohr, M.D., Ph.D., D.Sc., formerly at the National Institute on Aging, NIH, and currently a Professor (AFL) in Molecular Aging at the University of Copenhagen. “The absence of effective treatment options underscores the urgent need for new therapeutic approaches. It is encouraging to see scientific advances in NAD+ biology translated into investigational medicines such as NB4168, as this intervention has implications for similar accelerated aging diseases.”

Niagen Bioscience, Inc. is a publicly traded bioscience company focused on NAD+ science and healthy aging research. The Company's product portfolio includes its flagship patented NR ingredient, Niagen®, Tru Niagen®, Niagen™ Plus and a pharmaceutical development effort focused on proprietary NAD+ precursors. Niagen Bioscience maintains a portfolio of over 50 patents protecting NR and other NAD+ precursors.

For additional information on the Pharmaceutical Program for rare genetic diseases and age-related disorders and NB4168, visit www.niagenbioscience.com/nad-pharmaceuticals.

About Niagen Bioscience

Niagen Bioscience, Inc. (NASDAQ: NAGE) is the global authority in NAD+ (nicotinamide adenine dinucleotide) science and healthy-aging research. As a trusted pioneer of NAD+ discoveries, Niagen Bioscience™ is dedicated to advancing healthspan through precision science and innovative NAD+-boosting solutions.

The Niagen Bioscience team, composed of world-renowned scientists, works with independent investigators from esteemed universities and research institutions around the globe to uncover the full potential of NAD+. A vital coenzyme found in every cell of the human body, NAD+ declines with age and exposure to everyday lifestyle stressors. NAD+ depletion is a key contributor to age-related changes in health and vitality.

Distinguished by state-of-the-art laboratories, rigorous scientific and quality protocols, and collaborations with leading research institutions worldwide, Niagen Bioscience sets the gold standard for research, quality, and innovation. There’s a better way to age.

At the heart of its clinically proven product portfolio is Niagen® (patented nicotinamide riboside, or NR), the most efficient, well-researched, and high-quality NAD+ booster available. Niagen powers the Company’s consumer supplement, Tru Niagen®, the number one NAD+ boosting oral supplement in the United States† (available at www.truniagen.com), and Niagen™ Plus, featuring pharmaceutical-grade intravenous (IV) and injectable Niagen products (www.niagenplus.com). Pharmaceutical-grade Niagen IV and injections are compounded and distributed by U.S. FDA-registered 503B outsourcing facilities and are available exclusively at clinics with a prescription. NAD Pharmaceuticals Corp., the Company’s wholly owned subsidiary focused on developing therapies for rare genetic diseases and age-related disorders, is conducting research on NB4168, a differentiated molecule.

Niagen Bioscience’s robust patent portfolio protects NR and other NAD+ precursors. Niagen Bioscience maintains a website at www.niagenbioscience.com, where copies of press releases, news, and financial information are regularly published.

†Based on revenue per largest U.S. e-commerce marketplace (Jan. 2025 – Dec. 2025)

Forward-Looking Statements

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects,” “anticipates,” “intends” “estimates,” “plans,” “potential,” “possible,” “probable,” “believes,” “seeks,” “may,” “will,” “should,” “could,” “predicts,” “projects,” “continue,” “would” or the negative of such terms or other similar expressions.

Forward-looking statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those described. These risks and uncertainties include, but are not limited to, statements regarding Niagen Bioscience's NB4168 pharmaceutical development program; planned preclinical, IND-enabling and clinical development activities; the potential timing of an IND submission or first-in-human study; the potential bioavailability, exposure, safety, tolerability, efficacy, pharmacodynamic or clinical profile of NB4168; and the Company's ability to translate its NAD+ platform into pharmaceutical products; inflationary conditions and adverse economic conditions; our history of operating losses; the growth and profitability of our product sales; our ability to maintain and grow sales, marketing and distribution capabilities; changing consumer perceptions of our products; our reliance on a single or limited number of third-party suppliers; risks of conducting business in China; including unanticipated developments in and risks related to the Company’s ability to secure adequate quantities of pharmaceutical-grade Niagen in a timely manner; the Company’s ability to obtain appropriate contracts and arrangements with U.S. FDA-registered 503B outsourcing facilities required to compound and distribute pharmaceutical-grade Niagen to clinics; the Company’s ability to remain on the U.S. FDA Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Category 1 list; the Company’s ability to maintain and enforce the Company’s existing intellectual property and obtain new patents; whether the potential benefits of NRC can be further supported; further research and development and the results of clinical trials possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical trials; determinations made by the FDA and other governmental authorities, including with respect to products seeking to compete in our market; mislabeling or other misleading marketing practices by competitors; economic and market instability, including as a result of tariffs or trade conflicts; and the risks and uncertainties associated with our business and financial condition in general, described in our filings with the Securities and Exchange Commission (SEC), including, without limitation, our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q as filed with the SEC.

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and actual results may differ materially from those suggested by these forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement and Niagen Bioscience undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.