Transgender hormone therapy

Lumos Pharma Announces New Analyses of Phase 2 OraGrowtH212 Trial Presented at ENDO 2024

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Dienstag, Juni 4, 2024
ENDO, Patient, Serum, Functional, Doctor of Philosophy, Clinical trial, Growth, GHD, M6, Endocrine Society, IQR, Political moderate, Functional principal component analysis, FPCA, Therapy, LUMO, FDA, Growth hormone, D1, Poster, Transgender hormone therapy, Pattern, AHV, Pulse

AUSTIN, Texas, June 04, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced today details of new analyses of data from its Phase 2 OraGrowtH212 clinical trial presented in two posters at the 2024 Annual Meeting of the Endocrine Society (ENDO) , held in Boston, MA, June 1-4, 2024.

Key Points: 
  • AUSTIN, Texas, June 04, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced today details of new analyses of data from its Phase 2 OraGrowtH212 clinical trial presented in two posters at the 2024 Annual Meeting of the Endocrine Society (ENDO) , held in Boston, MA, June 1-4, 2024.
  • The posters were presented in parallel sessions on Monday June 3, 2024.
  • “The new analyses of data from our OraGrowtH212 Trial further characterized LUM-201’s unique ability to augment the natural pulsatile secretion of growth hormone, producing comparable growth to injectable rhGH with significantly less exposure to circulating growth hormone,” said John C. McKew, PhD, President and Chief Scientific Officer of Lumos Pharma.
  • At baseline GH secretion was 0.19 ±0.09 μg/kg/12-hrs; pulsatile GH was 1.17 ±0.66 μg/kg/12-hrs; and total GH was 1.35 ±0.66 μg/kg/12-hrs.

Lumos Pharma Announces Positive End-of-Phase 2 Meeting with FDA and Reports First Quarter 2024 Financial Results

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Dienstag, Mai 14, 2024
Patient, Investment, Transgender hormone therapy, LUMO, Clinical trial, FDA, Conference, Growth hormone, AHV, Research, Therapy, Pharmaceutical industry

AUSTIN, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical stage biopharmaceutical company focused on therapeutics for rare diseases, today announced the outcome from its End-of-Phase 2 meeting with the FDA, provided a clinical programs update, and reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • "We are pleased to announce that, earlier this quarter, we had a very productive End-of-Phase 2 meeting with the FDA," said Rick Hawkins, Chairman and CEO of Lumos Pharma.
  • We expect to finalize design details with the FDA in the third quarter and to be in position to initiate this trial before the end of this year.
  • "In addition to our encouraging engagement with the FDA, we are also very pleased to share updated data from our Phase 2 OraGrowtH trials.
  • Financial Results for Quarter Ended March 31, 2024
    Cash Position – Lumos Pharma ended the quarter on March 31, 2024, with cash, cash equivalents, and short-term investments totaling $23.2 million, as compared to $36.1 million on December 31, 2023.

Lumos Pharma Announces Abstracts Accepted for Presentation at Upcoming Medical Meetings

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Donnerstag, April 18, 2024
Congress, European Society of Endocrinology, Growth hormone, PES, LUMO, Abstract, MD, Doctor of Philosophy, GRS, ECE, Transgender hormone therapy, GHS, Growth

AUSTIN, Texas, April 18, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, announced today that abstracts reviewing data from its Phase 2 OraGrowtH210 and OraGrowtH212 Trials will be presented at several upcoming medical meetings in the US and Europe.

Key Points: 
  • AUSTIN, Texas, April 18, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a biopharmaceutical company advancing an oral therapeutic candidate for Pediatric Growth Hormone Deficiency (PGHD) through Phase 2 clinical trials, announced today that abstracts reviewing data from its Phase 2 OraGrowtH210 and OraGrowtH212 Trials will be presented at several upcoming medical meetings in the US and Europe.
  • Pediatric Endocrine Society ( PES ) Annual Meeting, held May 2-5, 2024, in Chicago, IL
    Abstract, OraGrowtH210 Trial (Phase 2): Oral LUM-201 Shows Similar Annualized Height Velocity to Daily rhGH in Moderate Pediatric Growth Hormone Deficiency (PGHD) with a 1.6mg/kg/day Dose and a Promising Investigational Safety Record, Andrew Dauber, MD, et al, to be presented in a poster session, Friday, May 3rd, 12:15-1:45 PM CT
    The 10th International Congress of the Growth Hormone Research Society ( GRS ), held May 10-11, 2024, in Stockholm, Sweden
    Abstract, Approaching the reality of restoring GH secretion and growth with the investigative oral growth hormone secretagogue (GHS) LUM-201 in moderate Pediatric Growth Hormone Deficiency (PGHD), Peter Clayton, MD, PhD, et al, to be presented in an oral session, Friday, May 10th, 12:00-1:00 PM CET
    European Congress of Endocrinology ( ECE ) 2024, held May 11-14, 2024, in Stockholm, Sweden
    Abstract, Approaching the reality of restoring GH secretion and growth with the investigative oral growth hormone secretagogue (GHS) LUM-201 in moderate Pediatric Growth Hormone Deficiency (PGHD), Peter Clayton, MD, PhD, et al, to be presented in an oral session, Sunday, May 12th, 4:20-6:00 PM CET
    “We are excited to share additional data analyses from our Phase 2 OraGrowtH Trials with the global endocrine community at these key medical meetings,” said Rick Hawkins, Lumos Pharma’s Chairman and CEO.
  • “Our Phase 2 data to date have demonstrated that, by augmenting the natural pulsatile secretion of growth hormone, our oral therapeutic candidate, LUM-201, produces comparable growth to injectable rhGH with significantly less exposure to circulating GH.
  • We believe this information will continue to resonate throughout the endocrine community and that oral LUM-201 could create a paradigm shift in the way PGHD and other growth hormone disorders are treated.”

Lumos Pharma Reports Full Year 2023 Financial Results and Provides Clinical Development Update

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Donnerstag, März 7, 2024
Research, CMO, Transgender hormone therapy, PIN, AHV, Investment, FDA, Endocrinology, LUMO, Webcast, Patient, Clinical trial, Initiation, Travel

AUSTIN, Texas, March 07, 2024 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a late-stage biopharmaceutical company advancing an oral therapeutic candidate for moderate Pediatric Growth Hormone Deficiency (PGHD), today announced financial results for the year ended December 31, 2023 and provided an update on clinical and regulatory activity.

Key Points: 
  • We expect to be in position to initiate this registrational trial in the fourth quarter, pending positive feedback from the FDA.
  • Financial Results for the Year Ended December 31, 2023
    Cash Position – Lumos Pharma ended the year on December 31, 2023, with cash, cash equivalents, and short-term investments totaling $36.1 million compared to $67.4 million on December 31, 2022.
  • Cash on hand as of December 31, 2023, is expected to support operations through the third quarter of 2024.
  • ET today to discuss its financial results and to give an update on clinical programs.

Ascendis Pharma Introduces Vision 2030

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Sonntag, Januar 7, 2024
Growth hormone, Vision 2030, Patient, Endocrine gland, Hypoparathyroidism, Conference, Achondroplasia, Turner syndrome, FDA, GHD, PDUFA, Globalization, Investigational New Drug, New Drug Application, Transgender hormone therapy, J. P. Morgan, Ophthalmology, CNP, HNSCC, Growth, CTA, Pharmaceutical industry

COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.

Key Points: 
  • COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030.
  • Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference.
  • Topline results from Phase 2 trial in Turner syndrome expected in the fourth quarter of 2024.
  • The Company’s slides from the J.P. Morgan presentation will be available on the same Investor Relations website at https://investors.ascendispharma.com .

Lumos Pharma Promotes Pisit “Duke” Pitukcheewanont, MD to Chief Medical Officer

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Donnerstag, Januar 4, 2024
Research, CMO, MD, Education, Medical education, University, Human Growth Foundation, Transgender hormone therapy, Helsinki University Central Hospital, Clinical Pediatrics, LUMO, University of Southern California, Publication, Therapy, Senior, Pharmaceutical industry

Duke has extensive experience in clinical development and medical affairs related to the advancement of novel therapeutics for growth disorders.

Key Points: 
  • Duke has extensive experience in clinical development and medical affairs related to the advancement of novel therapeutics for growth disorders.
  • In his role as Lumos Pharma’s CMO, Dr. Duke is expected to significantly bolster the advancement of our clinical programs.”
    “I am honored to assume the role of Chief Medical Officer of Lumos Pharma,” Dr. Pitukcheewanont stated.
  • Dr. Pitukcheewanont initially joined Lumos Pharma in May 2022 as Vice President of Global Clinical Development and Medical Affairs.
  • Before joining Lumos Pharma, Dr. Pitukcheewanont served in key roles as the Vice President of Medical Affairs and Vice President of Global Medical Ambassador and Medical Education at Ascendis Pharma.

GenSci Launches Global Innovation Hub in Shanghai

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Sonntag, Dezember 24, 2023
Science, Woman, Research, Health, Transgender hormone therapy, Obesity, Allergy, Puberty, Investment, Body image, ADC, Fine chemical

SHANGHAI, Dec. 23, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), hosted a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th. This facility is on track to be fully operational by 2027, with a capacity to accommodate 2,000 R&D professionals.

Key Points: 
  • SHANGHAI, Dec. 23, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), hosted a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th.
  • Since its founding in 1997, GenSci has introduced several groundbreaking therapies, including the GenSci Recombinant Human Growth Hormone, GenSci Heng Recombinant Human Follicle-Stimulating Hormone and Jinfuning Recombinant Human Granulocyte-Stimulating Factor Gel.
  • GenSci has ramped up its R&D investments to address the unmet health needs of women and children.
  • "GenSci has built a globally innovative and competitive R&D product pipeline," Dr. Jin Lei, Chief Scientist and General Manager of GenSci declared.

GenSci Launches Global Innovation Hub in Shanghai

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Samstag, Dezember 23, 2023
Quality of life, LBP, Science, Government, Hearing loss, Menopause, Health, Shandong University, Transgender hormone therapy, Obesity, Allergy, Zhangjiang, Precocious puberty, Multimedia, Shanghai Jiao Tong University, Body image, Zhejiang University, Life, Pregnancy, Recombinant, Near-sightedness, Outline, Prize, AI, Puberty, Child, Patient, Drug resistance, University, Research, Hospital, Incidence, Intelligence, Pediatrics, Growth, Investment, Vaginitis, Gynaecology, ADC, Medical device

SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th. With an increasing focus on women`s and children`s health, the Chinese government has been intensifying efforts to improve healthcare services for these demographics, embedding their care within the wider framework of the country's economic and social development policies. The establishment of the R&D center sets the stage for GenSci to further advance the convergence of industry, academia, research and the medical community. By leveraging cutting-edge R&D capabilities and the application of artificial intelligence technologies, GenSci is well-positioned to provide premium health solutions for women and children. The initiative aligns with GenSci's commitment to harnessing science and technology to protect and enhance the health of these vulnerable groups.

Key Points: 
  • SHANGHAI, Dec. 22, 2023 /PRNewswire/ -- Changchun GeneScience Pharmaceutical ("GenSci"), a subsidiary of Changchun High-Tech Industries (Group), held a groundbreaking ceremony for its new global headquarters and research & development (R&D) center at Shanghai Zhangjiang International Medical Park on December 15th.
  • Integrating AI technology, GenSci covers the entire drug innovation process, from initial design and screening to process development and formulation.
  • GenSci has formed enduring and robust partnerships with nearly 20 prominent universities, including Shanghai Jiao Tong University and Zhejiang University.
  • The groundbreaking of GenSci's global innovation hub and R&D center enpowers the company to fully utilize its expertise in gynecology and pediatrics.

Lumos Pharma Announces Topline Data from Phase 2 OraGrowtH210 and OraGrowtH212 Trials of LUM-201 in PGHD Met All Primary and Secondary Endpoints

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Dienstag, November 7, 2023
Research, ECG, PD, Injection, Injection (medicine), Comparable, Classification, AHV, Child, Transgender hormone therapy, PEM, KOL, University, Safety, Patient, LUMO, Unique, MD, Growth, Standard error, GH, Growth hormone, Coronavirus Scientific Advisory Board, FDA, Șaeș, Aes, Pediatric endocrinology, City of Hope National Medical Center, Mother, LSM, SDS, University of Chile, Political moderate, Silviculture, Vaccine, Pharmaceutical industry, Birth control, Wood drying, Online shopping, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO) today announced that topline results from its Phase 2 OraGrowtH210 dose-finding trial and its Phase 2 OraGrowtH212 Pharmacokinetic/Pharmacodynamic (PK/PD) trial met all primary and secondary endpoints. Data from the OraGrowtH210 Trial demonstrated annualized height velocity (AHV) on the 1.6 mg/kg dose of orally administered LUM-201 of 8.2 cm/yr at six months and 8.0 cm/yr at 12 months on treatment,* in line with historical data in moderate pediatric growth hormone deficiency (PGHD) patients and within the targeted 2 cm/yr margin of the comparator injectable recombinant growth hormone (rhGH) arm. Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program. Data from the OraGrowtH212 Trial confirmed that LUM-201’s unique pulsatile mechanism produces an increase in growth rates while restoring growth hormone secretion and IGF-1 to within normal ranges †, with levels substantially below those produced by exogenous injectable rhGH.†† Additionally, data from a small subset of 10 subjects combined 1.6 and 3.2 mg/kg dosage of LUM-201 in both OraGrowtH210 and OraGrowtH212 trials demonstrated the sustained effectiveness of AHV up to 24 months. Furthermore, the safety profile for LUM-201 remained clean throughout both Phase 2 studies, with no safety concerns identified in either of our Phase 2 trials conducted thus far.

Key Points: 
  • Data also provided preliminary validation of the predictive enrichment marker (PEM) strategy, with prespecified primary and secondary outcomes met, de-risking our patient selection for our Phase 3 program.
  • The OraGrowtH210 trial met its primary objective, with 6-month AHV data of 8.2 cm/yr supporting the 1.6 mg/kg as the optimal dose for a Phase 3 clinical trial.
  • Eighteen and 24-month growth data were available for 10 subjects from the OraGrowtH210 and OraGrowtH212 Trials who met AHV criteria per protocol at 12 months.
  • Every participant in the OraGrowtH212 Trial met the criteria for Patient PEM positivity, ensuring their potential responsiveness to LUM-201.

Lumos Pharma Reports Third Quarter 2023 Financial Results and Clinical Development Updates

Retrieved on: 
Dienstag, November 7, 2023
Research, Transgender hormone therapy, American Association of Clinical Endocrinologists, Event, Child, LUMO, Pediatric endocrinology, Therapy, City of Hope National Medical Center, Rare, IGFBP3, Mother, MD, Quarter, SDS, Endocrine Society, Clinical trial, PEM, KOL, Lumos, University, Serum, University of Chile, Political moderate, European Society of Gynaecological Oncology, Growth hormone, Investment, Consistency, AHV, Silviculture, Pharmaceutical industry, Birth control, Endocrinology

AUSTIN, Texas, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, today announced that topline results met primary and secondary endpoints for its Phase 2 Dose-Finding OraGrowtH210 Trial and Phase 2 Pharmacokinetic/Pharmacodynamic (PK/PD) OraGrowtH212 Trial evaluating oral LUM-201 for subjects with moderate pediatric growth hormone deficiency (PGHD) who screened PEM-positive utilizing Lumos Pharma’s predictive enrichment marker (PEM) strategy. Lumos also announced its financial results for the quarter ended September 30, 2023.

Key Points: 
  • Lumos also announced its financial results for the quarter ended September 30, 2023.
  • The Company expects cash use of approximately $9.0 to $10.0 million in the fourth quarter of 2023.
  • Net Loss – The net loss for the quarter ended September 30, 2023 was $8.3 million compared to a net loss of $7.3 million for the same period in 2022.
  • Lumos Pharma ended the third quarter 2023 with 7,914,582 shares outstanding.