CCycle Pharmaceuticals develops and sells medicines that improve existing drugs for rare genetic diseases. It focuses on repurposing, reformulating, and reintroducing generic medications to treat rare metabolic, immunological, and neurological conditions (such as HT-1, PKU, MS). Its products are delivered as ready-to-use therapies in the United States, aided by the Cycle Vita patient support program that helps with education, insurance coordination, and affordability to ensure patients can stay on treatment. Unlike some peers that chase new molecular entities, Cycle builds value by optimizing existing drugs to fit patient needs, aiming for reliable cash flow, profitability, and the ability to fund acquisitions and growth. The company also operates a social mission to provide free medicines in developing countries. Overall, its goal is to improve quality of life for people with rare diseases while expanding access and maintaining sustainable operations.
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Company Size
201-500
Company Stage
Debt Financing
Total Funding
$25M
Headquarters
Cambridge, United Kingdom
Founded
2012
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Xeris files KEVEYIS suits. Barclays lifts target for Xeris Biopharma Holdings stock. Published on 10/18/2026 at 13:35 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS Second-quarter revenue reached USD 92.10 million on June 30, 2026. Xeris Biopharma Holdings stock is valued at USD 1.9 billion as of October 16, 2026. Catalysts and financial markers. * Xeris filed two KEVEYIS patent lawsuits on October 13, 2026, citing U.S. Patent No. 12,758,502. * Second-quarter revenue reached USD 92.10 million for the period ended June 30, 2026, while net loss was USD 31.10 million. * Barclays raised its Xeris target from USD 12.00 to USD 14.00 on October 6, 2026. Xeris Biopharma Holdings (ISIN US98422E1038) filed two KEVEYIS patent infringement lawsuits on October 13, 2026, after receiving U.S. Patent No. 12,758,502. The move adds an intellectual-property defense to a portfolio story shaped by commercial growth, upcoming clinical data and analyst target increases. Discover more Read Company News Track Stock Market Invest in Stocks Patent action adds product defense. According to the SEC filing dated October 13, 2026, Xeris Pharmaceuticals filed the cases in the United States District Court for the District of New Jersey against Torrent Pharma, Cycle Pharmaceuticals, Lemed Pharmacy and Rising Pharma affiliates. The complaints allege infringement involving generic dichlorphenamide products and seek injunctions, damages and legal costs. What does the portfolio show? The latest reported quarter ended June 30, 2026, with revenue of USD 92.10 million and a net loss of USD 31.10 million, according to Yahoo Finance. Revenue exceeded the cited USD 90.12 million consensus estimate by USD 1.98 million, but adjusted expectations were not met because reported loss per share was USD 0.18 against a projected USD 0.01 profit. The chronology is clear: Xeris reported second-quarter revenue of USD 92.10 million on August 6, 2026; it granted equity awards covering 352,170 shares to 60 new employees on October 1, 2026, according to Business Wire; and it filed the two KEVEYIS cases on October 13, 2026. Analysts raise the valuation bar. Barclays raised its Xeris price target from USD 12.00 to USD 14.00 on October 6, 2026, while keeping an Overweight rating, as reported by Markets Insider. The target change puts greater emphasis on whether Recorlev growth, Gvoke adoption and the XP-8121 pipeline can support the commercial valuation. Two dates shape the next test. Discover more Open Bank Account Xeris is scheduled to present hypothyroidism data at the American Thyroid Association Annual Meeting on November 6, 2026, according to the Xeris Biopharma release. A separate market calendar lists November 5, 2026 as the next quarterly reporting date, giving investors two closely timed events for assessing execution. Market value and trading dates. Xeris had a USD 1.9 billion market capitalization and a USD 5.25 to USD 11.33 52-week range as of October 16, 2026. Its Nasdaq Global Select Market listing places the patent dispute, quarterly figures and upcoming data presentation in the same valuation frame. The further course of trading is shown by the continuously updated real-time quote of Xeris Biopharma Holdings stock. Xeris Biopharma Holdings stock at a glance. * Company: Xeris Biopharma Holdings, Inc. * ISIN: US98422E1038 * Ticker: XERS * Primary exchange: Nasdaq Global Select Market * Market capitalization: USD 1.9 billion (as of October 16, 2026) * 52-week range: USD 5.25-11.33 (as of October 16, 2026) * Sector / Industry: Health care / biotechnology Sponsored Ad Discover more NASDAQ stock quotes Track Biotech Find Specialists Xeris Pharmaceuticals stock: new analysis - 22 October. Fresh Xeris Pharmaceuticals information released. What's the impact for investors? Our latest independent report examines recent figures and market trends. Disclaimer regarding our articles: This is not investment advice, nor is it a recommendation to buy or sell. Information regarding prices, companies, and markets is provided without guarantee; changes may occur at any time. Stock market transactions can result in significant losses. Our articles are created and reviewed, in whole or in part, automatically with the assistance of AI. en | US98422E1038 | XERS | boerse | 70353577 | bgmi
Cycle Pharmaceuticals selects Forma Life Sciences to establish U.S. Commercial supply for fda-approved CAVHANZA(TM)(nilotinib) Orally Disintegrating Tablets. * 2 hrs ago Cycle Pharmaceuticals ("Cycle"), a global pharmaceutical company focused on rare diseases, and Forma Life Sciences, Inc. ("Forma"), a U.S. contract development and manufacturing organization, today announced a commercial manufacturing agreement for CAVHANZA(TM)(nilotinib) orally disintegrating tablets. CAVHANZA is an FDA-approved treatment for adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Under the agreement, Forma will manufacture CAVHANZA at its facilities in Irvine, California, establishing a U.S. commercial supply as Cycle prepares to introduce the product to the U.S. market. TUV leader Jim Allister MP reacts as three dead in Ballymena. "Establishing U.S. manufacturing for CAVHANZA is an important step in our preparations to bring this differentiated treatment to patients," said Catherine Wainwright, Chief Operations & Regulatory Officer at Cycle Pharmaceuticals. "We are pleased to work with Forma and draw on its experience in complex oral drug product manufacturing as we prepare to introduce CAVHANZA in the United States." CAVHANZA was developed to address important administration challenges associated with conventional nilotinib products. CAVHANZA can be administered with proton pump inhibitors and H[2] receptor antagonists without timing restrictions.[1] This addresses a known treatment challenge in Ph+ CML, where 47% of patients are prescribed PPIs at some point after diagnosis, potentially affecting treatment bioavailability.[2] Clinical studies also demonstrated no food effect, allowing CAVHANZA to be taken without regard to mealtimes.[1] Additionally, as an orally disintegrating tablet, CAVHANZA can be taken with or without water - potentially providing an option to patients who have difficulty swallowing tablets.[1] Forma will manufacture CAVHANZA using ElectroNanoSpray(TM), a proprietary, non-thermal particle engineering technology developed by Flex Pharma, LLC and designed to produce highly uniform amorphous drug particles. Forma has supported the product through its progression toward commercial manufacturing and will provide ongoing manufacturing services under the new agreement with Cycle. "We are proud to support Cycle as it prepares to introduce CAVHANZA in the United States," said Armand Amin, President of Forma Life Sciences. "Our team is excited to bring its experience in complex oral drug products and commercial manufacturing to this important launch." The agreement builds on Cycle's preparations for the U.S. commercialization of CAVHANZA and Forma's continued investment in domestic development and commercial manufacturing capabilities. Forma supports pharmaceutical and biotechnology companies across formulation development, analytical services, clinical manufacturing and commercial supply, including programs using 505(b)(2) regulatory pathways. About Forma Life Sciences Forma Life Sciences is a U.S. contract development and manufacturing organization specializing in formulation development, analytical services and commercial manufacturing of oral solid dosage products. The company supports pharmaceutical and biotechnology companies from development through commercial supply, with expertise in spray drying, hot melt extrusion, particle engineering technologies and complex oral solid dosage manufacturing. About Cycle Pharmaceuticals Cycle Pharmaceuticals was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease community. Cycle focuses on rare genetic conditions in metabolic, immunology, urology, and oncology. In neurology, Mycarrollcountynews focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Detroit, Michigan. About CAVHANZA CAVHANZA(TM) is an FDA-approved nilotinib orally disintegrating tablet for the treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia. CAVHANZA provides greater administration flexibility, including use with proton pump inhibitors or H[2] receptor antagonists without timing restrictions, and can be taken without regard to meals. CAVHANZA will be commercialized in the United States by Cycle Pharmaceuticals. Warning: QT Prolongation and Sudden Deaths Nilotinib prolongs the QT interval. Monitor for hypokalemia or hypomagnesemia and correct deficiencies. Obtain ECGs to monitor the QTc at baseline on day 7, and periodically thereafter, and following any dose adjustments. Sudden deaths have been reported. Avoid use in patients with hypokalemia, hypomagnesemia or long QT syndrome. Avoid concomitant drug use with QT-prolonging drugs and strong CYP3A4 inhibitors. Indications CAVHANZA (nilotinib) is a kinase inhibitor indicated for the treatment of: Adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Adults with CP Ph+ CML or accelerated phase (AP) Ph+ CML resistant to or intolerant to prior therapy. Contraindications CAVHANZA is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome. Important Safety Information Warnings and Precautions: * Substitution between nilotinib products requires dose conversion to avoid medication errors. * Monitor for myelosuppression; manage with dose adjustments or interruptions. * Cardiovascular and arterial occlusive events have been reported; assess and monitor cardiovascular risk. * Pancreatitis risk: monitor serum lipase; interrupt dosing if abdominal symptoms occur with lipase elevations. * Hepatotoxicity has been reported, with higher risk in pediatrics. Monitor liver function tests regularly. * Correct and monitor electrolyte abnormalities throughout treatment. * Tumor lysis syndrome has been reported; ensure hydration and correct uric acid before initiating treatment. * Serious hemorrhage may occur; advise patients to report signs and symptoms of bleeding. * Monitor for fluid retention and manage accordingly. * Growth retardation has been reported in pediatric patients. Monitor growth and development. * Can cause fetal harm; advise use of effective contraception during and 14 days after treatment. * Monitor BCR-ABL transcript levels in patients discontinuing treatment and manage loss of response appropriately. Adverse Reactions: Common non-hematologic adverse reactions include rash, pruritus, headache, nausea, fatigue, alopecia, myalgia, abdominal pain, constipation, diarrhea and vomiting. Hematologic adverse reactions include thrombocytopenia, neutropenia, and anemia. Serious adverse reactions include QT prolongation, sudden deaths, febrile neutropenia, and intracranial hemorrhage. Postmarketing reports include thrombotic microangiopathy, facial paralysis, and osteonecrosis. Drug Interactions: Avoid concomitant use with strong CYP3A inhibitors or inducers. Dose reduction is recommended if strong CYP3A inhibitors cannot be avoided. Avoid drugs that prolong the QT interval, including anti-arrhythmics. Use in Specific Populations: Pregnancy: CAVHANZA can cause fetal harm when administered to a pregnant woman. Lactation: Breastfeeding is not recommended during treatment with CAVHANZA and for 14 days after the last dose. Pediatric use: CAVHANZA is not approved for use in pediatric patients. Monitor growth and development if used. Due to Novartis Pharmaceuticals Corporation's marketing exclusivity rights, this drug product is not labeled with that pediatric information. Geriatric use: No major differences for safety were observed in patients >=65 years taking CAVHANZA. For more detailed information, please refer to the full Prescribing Information at https://cyclepharma.com/nilotinib-pi/ To report SUSPECTED ADVERSE REACTIONS, contact Cycle Pharmaceuticals at 1-855-831-5413, or the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. References: * CAVHANZA(TM)(nilotinib) Orally Disintegrating Tablets. Prescribing Information. Flex Pharma. * Larfors, G. et al. (2023). Despite warnings, co-medication with proton pump inhibitors and dasatinib is common in chronic myeloid leukemia, but XS004, a novel oral dasatinib formulation, provides reduced pH-dependence, minimizing undesirable drug-drug interactions. European journal of haematology, [online]. doi: https://doi.org/10.1111/ejh.14059. CAVHANZA(TM) and ElectroNanoSpray(TM) are trademarks of Flex Pharma, LLC. Media gallery
Cycle Pharmaceuticals has announced FDA approval of CAVHANZA, an orally disintegrating nilotinib formulation for treating Philadelphia chromosome-positive chronic myeloid leukaemia. The treatment addresses a significant challenge in CML therapy, as 25% of patients are co-prescribed proton pump inhibitors or H₂ antagonists that can compromise treatment efficacy. CAVHANZA's formulation enables maintained bioavailability when used with acid-reducing agents without timing restrictions, a first in the nilotinib market. Clinical trials showed no food effect, allowing flexible dosing regardless of meals. The orally disintegrating tablets support patients with swallowing difficulties and can be taken with or without water. Developed through a partnership between Cycle and Flex Pharma using ElectroNanoSpray technology, CAVHANZA represents Cycle's tenth product and second CML treatment option.
Cycle Pharmaceuticals completes acquisition of Applied Therapeutics. Cycle Group Holdings Limited ("Cycle") is delighted to announce it has completed the acquisition of NASDAQ-listed Applied Therapeutics, Inc. (NASDAQ: APLT; "Applied"), a clinical-stage biopharmaceutical company. Applied's lead drug candidate, govorestat, is a novel central nervous system (CNS) penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS rare metabolic diseases, including Classic Galactosemia, Charcot-Marie-Tooth Sorbitol Dehydrogenase Deficiency (CMT-SORD) and phosphomannomutase 2 congenital disorder of glycosylation (PMM2-CDG), for which there are currently no FDA approved treatment options available. "Cycle was founded with a commitment to support patients living with rare metabolic diseases. From our beginnings with NITYR(R), we have grown to offer three therapies for this community. With Applied Therapeutics now a part of the Cycle group, we can look to expand further in this area. Our focus remains the same: to bring meaningful, reliable treatments to the patients and families who need them most." says James Harrison, CEO of Cycle. The transaction is to be funded from cash on hand. For Cycle, Goodwin Procter LLP acted as legal counsel. For Applied, Aquilo Partners, L.P. provided a fairness opinion, and Ropes & Gray LLP acted as legal counsel. About Cycle Pharmaceuticals Cycle was founded in 2012 with the sole aim of delivering drug treatments and product support to the underserved rare disease community. Cycle focuses on rare genetic conditions in metabolic, immunology, urology, and oncology. In neurology, Pharmaceutical Tech focus on multiple sclerosis. Cycle is headquartered in Cambridge, UK and has offices in Detroit, Michigan, Boston, Massachusetts and High Point, North Carolina. For more information, please visit www.cyclepharma.com and follow Pharmaceutical Tech on X, LinkedIn and Facebook. Contacts FOR FURTHER INFORMATION PLEASE CONTACT [email protected] Cycle Pharmaceuticals Ltd Tel: +44 1223 354 118
Applied Therapeutic’s lead drug candidate, govorestat, is a novel central nervous system penetrant Aldose Reductase Inhibitor for the treatment of CNS rare metabolic diseases NEW YORK, Dec. 11, 2025 (GLOBE NEWSWIRE) -- Applied Therapeutics, Inc. (Nasdaq: APLT; “Applied”), a clinical-stage
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Industries
Company Size
201-500
Company Stage
Debt Financing
Total Funding
$25M
Headquarters
Cambridge, United Kingdom
Founded
2012
Find jobs on Simplify and start your career today
Don't see your dream role? Check out thousands of other roles on Simplify.Browse all jobs