Latest news with #shortbowelsyndrome
Associated Press
2 days ago
- Business
- Associated Press
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutide Glepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial Program The Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/S Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statements This press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Contacts Adam Lange (Investors) Vice President, Investor Relations [email protected] Neshat Ahmadi (Investors) Investor Relations Manager [email protected] Anna Krassowska, PhD (Investors and Media) Vice President, Investor Relations & Corporate Communications [email protected]
Yahoo
2 days ago
- Business
- Yahoo
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutideGlepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial ProgramThe Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/SZealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statementsThis press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. ContactsAdam Lange (Investors)Vice President, Investor Relationsalange@ Neshat Ahmadi (Investors)Investor Relations Managerneahmadi@ Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate Communicationsakrassowska@
Yahoo
2 days ago
- Business
- Yahoo
Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome
Press release – No. 10 / 2025 Zealand Pharma submits Marketing Authorization Application to the European Medicines Agency for glepaglutide in short bowel syndrome Copenhagen, Denmark, June 2, 2025 – Zealand Pharma A/S (Nasdaq: ZEAL) ('Zealand') (CVR-no. 20045078), a biotechnology company focused on the discovery and development of innovative peptide-based medicines, today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for glepaglutide, a long-acting GLP-2 analog, for the treatment of adult patients with short bowel syndrome (SBS). The submission of the MAA to the EMA for glepaglutide administered twice weekly for the treatment of SBS is based on results from a pivotal Phase 3 trial (EASE-1), supported by interim results from two ongoing long-term extension trials (EASE-2 and EASE-3) and results from a mechanistic trial (EASE-4). 'We are pleased to bring our potential best-in-class GLP-2 analog, glepaglutide, one step closer to patients in Europe living with short bowel syndrome with intestinal failure, who urgently need more effective and more convenient treatment options,' said David Kendall, MD, Chief Medical Officer of Zealand Pharma. 'We believe that glepaglutide, administered twice weekly, offers meaningful potential to reduce both the burden of parenteral support and the inconvenience of daily dosing required with the only currently available GLP-2 therapy. Looking ahead, we expect to initiate the EASE-5 Phase 3 trial in the second half of the year to obtain further confirmatory safety and efficacy data on the twice weekly dosing regimen, supporting regulatory submission in the U.S.' About glepaglutideGlepaglutide is a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome (SBS). Glepaglutide is developed as a liquid product in an autoinjector designed for subcutaneous administration by twice weekly dosing, aimed to reduce, or eliminate, the need for parenteral support in people living with SBS. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS. About the EASE Clinical Trial ProgramThe Phase 3 program, named EASE, is designed to evaluate the potential for glepaglutide to reduce or eliminate the need for parenteral support in SBS patients with intestinal failure. EASE-1 (NCT03690206) was a randomized, double-blind Phase 3 trial that enrolled a total of 106 SBS patients with intestinal failure who were dependent on parenteral support for at least three days per week. Patients were evenly randomized to receive treatment with 10 mg glepaglutide administered either once or twice weekly, or placebo. The primary endpoint in the trial was the absolute change in weekly parenteral support volume from baseline at 24 weeks. At 24 weeks, glepaglutide administered twice weekly significantly reduced the total weekly volume of PS by 5.13 liters/week, compared to a reduction of 2.85 liters/week in the placebo group (p=0.0039). When administered once weekly, glepaglutide treatment resulted in a reduction in weekly PS of 3.13 liters/week, however this did not achieve statistical significance. A total of 9 patients treated with glepaglutide were completely weaned off PS (achieving enteral autonomy), while no placebo-treated patients were able to discontinue PS. For patients treated with glepaglutide twice weekly, 14% of patients (n=5) achieved enteral autonomy. In total, 102 of 106 participating patients completed EASE-1, of which 96 continued into the ongoing two-year, long-term safety and efficacy extension trial, EASE-2. EASE-2 (NCT03905707) is a randomized, double-blind trial in which SBS patients continued their randomly assigned treatment from EASE-1 with glepaglutide 10 mg once- or twice-weekly. Patients who received placebo in EASE-1 were re-randomized to treatment with either glepaglutide 10 mg once- or twice-weekly. In an interim analysis conducted after at least six months of treatment, clinical response to glepaglutide across the key efficacy endpoints was generally maintained or showed continued improvement, including additional patients on both doses weaning off PS. Patients who complete EASE-2 are eligible to participate in EASE-3 (NCT04881825), evaluating glepaglutide administered once weekly using an autoinjector. An interim analysis of EASE-3, conducted with the first 57 patients rolled over from EASE 2, showed that the reduction in prescribed PS was generally maintained. EASE-4 (NCT04991311) was a Phase 3b trial to assess mechanistic effects of glepaglutide on intestinal fluid and energy uptake. The trial provides evidence of the pharmacodynamic effects of glepaglutide in improving intestinal absorption. In the second half of 2025, Zealand Pharma expects to initiate EASE-5, a single Phase 3 clinical trial that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. About Zealand Pharma A/SZealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology company focused on the discovery and development of peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market and three candidates are in late-stage development. The company has development partnerships with a number of pharma companies as well as commercial partnerships for its marketed products. Zealand was founded in 1998 and is headquartered in Copenhagen, Denmark, with a presence in the United States. For more information about Zealand's business and activities, please visit Forward looking statementsThis press release contains 'forward-looking statements', as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'forecast,' 'goal,' 'intend,' 'may,' 'plan,' 'possible,' 'potential,' 'will,' 'would' and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. ContactsAdam Lange (Investors)Vice President, Investor Relationsalange@ Neshat Ahmadi (Investors)Investor Relations Managerneahmadi@ Anna Krassowska, PhD (Investors and Media)Vice President, Investor Relations & Corporate Communicationsakrassowska@
Yahoo
5 days ago
- General
- Yahoo
‘Still being considered': DHS says reports of Bakersfield girl being deported are false
BAKERSFIELD, Calif. (KGET) — Sofia is a fighter and so is her community. The four-year-old Bakersfield girl has short bowel syndrome and must be connected to a feeding system for more than half of the day. Her mom Deysi Vargas brought her to the United States legally to receive life-saving treatment. After two years of treatment and recovery, her mom says their humanitarian parole has been unexpectedly terminated. On Wednesday, Sofia's attorneys begged the Department of Homeland Security to reconsider the family's immigration status. In support, California Senators Alex Padilla and Adam Schiff signed a letter alongside 36 Democratic Congress members urging DHS Secretary Kristi Noem to reconsider Sofia and Deysi's legal status. The letter said, 'Without action, Sofia will die.' In a statement, the Department of Homeland Security said, 'Any reporting that Vargas and her family are actively being deported is false. This family applied with USCIS for humanitarian parole on May 14, 2025, and the application is still being considered.' Sofia's attorneys say the family has been told to leave the country immediately after reapplying for parole. 'We did our best to give them the benefit of the doubt and let them know we think they made an error,' said Gina Amato Lough, Directing Attorney for Public Counsel. 'We have not heard anything back. We subsequently filed for new applications for humanitarian parole, and similarly have not received a response.' Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Washington Post
5 days ago
- General
- Washington Post
Democrats urge DHS to allow 4-year-old to stay in U.S. for lifesaving care
Deysi Vargas's 4-year-old daughter sleeps tethered to a special intravenous feeding system — a machine that pumps nutrients through a tube into her tiny body throughout the night. Four times each day, Vargas sets up a second, portable feeding system that delivers additional nutrients through a tube into her stomach. This delicate routine keeps the girl, who has short bowel syndrome — a condition in which the body cannot absorb enough nutrients from food — alive, Vargas said. But the 28-year-old mother, who hails from Oaxaca, Mexico, now fears it could end at any moment. Last month, the Department of Homeland Security revoked the family's humanitarian parole, warning them in a letter: 'It is time for you to leave the United States.' Without continued access to her treatment at Children's Hospital Los Angeles, her attorneys and doctor warn, the girl could die within days. The decision, which was first reported by the Los Angeles Times, has triggered national outrage and urgent pleas from lawmakers. On Thursday, 38 Democratic members of Congress — including California Sens. Alex Padilla and Adam Schiff, and prominent progressives like Reps. Luz Rivas, Alexandria Ocasio-Cortez, Pramila Jayapal and Ted Lieu — sent a letter to Homeland Security Secretary Kristi L. Noem urging her to reverse the decision. 'It is our duty to protect the sick, vulnerable, and defenseless,' the lawmakers wrote. The family entered the United States legally in 2023 through an appointment secured through the Biden administration's CBP One app, said their attorney, Gina Amato Lough. On July 30, 2023, Vargas, her husband and daughter were granted humanitarian parole — which allows individuals to temporarily live in the country for urgent humanitarian reasons — for two years, she said. As one of his first acts in office, President Donald Trump on Jan. 20 signed an executive order to restrict eligibility for parole, a status that allows migrants to live in the United States for limited periods of time. The Biden administration had expanded its use to help limit illegal border crossings. By contrast, Trump said parole should be 'exercised on only a case-by-case basis ... and in all circumstances only when an individual alien demonstrates urgent humanitarian reasons or a significant public benefit derived from their particular continued presence.' In their letter, the lawmakers made the case that the family met the stricter criteria. 'We believe this family's situation clearly meets the need for humanitarian aid and urge you and this Administration to reconsider its decision,' they wrote. One of the Democrats who signed the letter, Rep. Greg Casar of Texas, also posted on X about the situation: 'Trump wants to deport a four-year-old who could die from a life-threatening medical condition if her treatment is interrupted. How does this cruelty make us a stronger nation?' It's unclear whether DHS plans to respond to the lawmakers' letter. In a statement to The Washington Post, a senior DHS official said, 'Any reporting that Vargas and her family are actively being deported are FALSE. This family applied with USCIS for humanitarian parole on May 14, 2025, and the application is still being considered.' Although the family has not been actively targeted for deportation — meaning, they have not received a final removal order or been placed in proceedings — they received three letters stating that their humanitarian parole, which had originally been granted through July 2025, had been revoked, said Amato Lough. The only reason they filed a new application for humanitarian parole on May 14, she noted, was because their status was terminated 'prematurely.' The filing came just one day after Vargas received notice that her work authorization had also been canceled. Amato Lough added that on Wednesday, U.S. Citizenship and Immigration Services contacted the family for the first time to begin scheduling biometrics appointments.
