Transgender hormone therapy

Southern Scripts Launches New Solution to Address High-Cost Medications

Retrieved on: 
Tuesday, April 26, 2022

NATCHITOCHES, La., April 26, 2022 /PRNewswire/ -- Southern Scripts, a leading pharmacy benefit manager (PBM) highly regarded for its transparent pricing, announced today that it has launched RxCompass, a new solution designed to support U.S. companies and their employees with mitigating the high costs of specialty medications.

Key Points: 
  • Southern Scripts created RxCompass to alleviate this pain point for companies and their employees.
  • Employers can implement RxCompass as a fully integrated solution with Southern Scripts' PBM services.
  • Southern Scripts is a leading transparent pharmacy benefit manager.
  • Southern Scripts offers a unique pass-through and transparent model that generates both meaningful savings and optimal health outcomes for its customers.

Lumos Pharma Reaches 50% Randomization Milestone in Phase 2 OraGrowtH210 Trial Evaluating Oral LUM-201 in PGHD

Retrieved on: 
Monday, April 11, 2022

AUSTIN, Texas, April 11, 2022 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced this morning achievement of the 50% randomization milestone for our Phase 2 OraGrowtH210 Trial evaluating orally administered LUM-201 in pediatric growth hormone deficiency (PGHD). Interim data from both the OraGrowtH210 and OraGrowtH212 Trials are anticipated by the end of 2022.

Key Points: 
  • We are pleased to have reached an important milestone in our trials evaluating oral LUM-201 in PGHD despite the severe challenges posed by conditions from the Covid-19 pandemic worldwide, commented Rick Hawkins, CEO and Chairman of Lumos Pharma.
  • We believe the interim data should provide an early indication of efficacy and safety of oral LUM-201 versus standard of care in PGHD.
  • The complete set of 6-month, primary outcome data for OraGrowtH210 Trial is anticipated in the second half of 2023.
  • Lumos Pharmas lead therapeutic candidate is LUM-201, an oral growth hormone stimulating small molecule, currently being evaluated in a Phase 2 clinical trial, the OraGrowtH210 Trial, and a PK/PD trial, the OraGrowtH212 Trial, for the treatment of Pediatric Growth Hormone Deficiency (PGHD).

Lumos Pharma Reports Full Year 2021 Financial Results and Announces Plan to Perform Interim Analyses of OraGrowtH Trials

Retrieved on: 
Thursday, March 10, 2022

We are excited to announce that we plan to conduct interim analyses on two of our OraGrowtH Trials evaluating orally administered LUM-201 in PGHD, commented Rick Hawkins, Chairman and CEO of Lumos Pharma.

Key Points: 
  • We are excited to announce that we plan to conduct interim analyses on two of our OraGrowtH Trials evaluating orally administered LUM-201 in PGHD, commented Rick Hawkins, Chairman and CEO of Lumos Pharma.
  • No patients had been randomized to treatment in the clinical trial at any of our nine sites in Ukraine and Russia.
  • Financial Results for the Year Ended December 31, 2021
    Cash Position Lumos Pharma ended the year on December 31, 2021, with cash and cash equivalents totaling $94.8 million compared to $98.7million on December 31, 2020.
  • Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases.

Pfizer and OPKO’s Once-Weekly NGENLA™ (somatrogon) Injection Receives Marketing Authorization in European Union for Treatment of Pediatric Growth Hormone Deficiency

Retrieved on: 
Tuesday, February 15, 2022

We are pleased that the marketing authorization in the European Union will enable more children with growth hormone deficiency to benefit from once-weekly treatment.

Key Points: 
  • We are pleased that the marketing authorization in the European Union will enable more children with growth hormone deficiency to benefit from once-weekly treatment.
  • The marketing authorization of NGENLA is valid in all EU Member States as well as Iceland, Norway and Liechtenstein.
  • In this study, 224 prepubertal, treatment-nave children with growth hormone deficiency (GHD) were randomized 1:1 to receive NGENLA once-weekly or GENOTROPIN (somatropin) once-daily.
  • NGENLA (somatrogon) is a synthetic growth hormone that works by replacing the lack of growth hormone in the body.

Freeline Appoints Henning R. Stennicke, PhD, as Chief Scientific Officer to Lead Research and Discovery

Retrieved on: 
Thursday, February 3, 2022

He will be based in Stevenage, UK, and report to Michael Parini, Freelines Chief Executive Officer, as part of the executive leadership team.

Key Points: 
  • He will be based in Stevenage, UK, and report to Michael Parini, Freelines Chief Executive Officer, as part of the executive leadership team.
  • As CSO, Dr. Stennicke will lead the research and advancement of the Companys innovative science and platform technology.
  • I am energized by the world-class team and organization we continue to build at Freeline, and excited for Henning to continue the momentum of our talented research team.
  • Henning R. Stennicke brings 26 years of experience in scientific research and leadership, including 20 years in various leadership positions at Novo Nordisk.

Ascendis Pharma A/S Receives Positive CHMP Opinion for TransCon™ hGH for Patients with Pediatric Growth Hormone Deficiency

Retrieved on: 
Friday, November 12, 2021

COPENHAGEN, Denmark, Nov. 12, 2021 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorization for Lonapegsomatropin Ascendis Pharma (TransCon hGH). TransCon hGH is a long-acting once-weekly, transiently pegylated somatropin that in the body releases somatropin (also called human growth hormone, or hGH), indicated for growth failure in children and adolescents aged from 3 years up to 18 years due to insufficient endogenous growth hormone secretion (growth hormone deficiency, or GHD). The European Commission final decision on the Company’s Marketing Authorisation Application (MAA) for TransCon hGH is expected within 67 days after the positive opinion, or by the end of January 2022.

Key Points: 
  • TransCon hGH is a once-weekly prodrug of somatropin designed to reduce the treatment burden for patients with growth hormone deficiency.
  • Final European Commission decision on TransCon hGH MAA for pediatric growth hormone deficiency expected within 67 days after positive opinion.
  • We are delighted to receive a positive CHMP opinion for once-weekly TransCon hGH, said Dana Pizzuti, M.D., Ascendis Pharmas Chief Medical Officer and Senior Vice President of Development Operations.
  • Ascendis, Ascendis Pharma, the Ascendis Pharma logo, the company logo, TransCon, and SKYTROFA are trademarks owned by the Ascendis Pharma Group.

I-Mab and Jumpcan Announce Strategic Commercial Partnership on Eftansomatropin Alfa

Retrieved on: 
Wednesday, November 10, 2021

The partnership brings together I-Mab's leadership in drug innovation and manufacturing with Jumpcan's commercial leadership in pediatric medicines in China with proven capabilities in market access and retail channels.

Key Points: 
  • The partnership brings together I-Mab's leadership in drug innovation and manufacturing with Jumpcan's commercial leadership in pediatric medicines in China with proven capabilities in market access and retail channels.
  • The deal creates a strong foundation for the future development and commercialization of eftansomatropin alfa and marks another significant milestone in I-Mab's commercial transformation following the announcement of its strategic collaboration with Sinopharm in October.
  • Under the collaboration agreement, I-Mab will continue to lead the ongoing registrational Phase 3 clinical trial of eftansomatropin alfa in pediatric growth hormone deficiency (PGHD).
  • "The strategic collaboration with Jumpcan is crucial for I-Mab as I believe the broad coverage and deep commercial experience of Jumpcan will accelerate the pre-launch and commercial launch readiness of eftansomatropin alfa to bring this differentiated therapy quickly to market and improve the lives of pediatric patients."

Lumos Pharma Reports Third Quarter 2021 Financial Results and Provides Clinical Updates

Retrieved on: 
Wednesday, November 3, 2021

AUSTIN, Texas, Nov. 03, 2021 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced financial results for the third quarter ending September 30, 2021 and provided an update on clinical programs.

Key Points: 
  • AUSTIN, Texas, Nov. 03, 2021 (GLOBE NEWSWIRE) -- Lumos Pharma, Inc. (NASDAQ:LUMO), a clinical-stage biopharmaceutical company focused on therapeutics for rare diseases, announced financial results for the third quarter ending September 30, 2021 and provided an update on clinical programs.
  • Lumos Pharma is in advanced discussions with key opinion leaders and our Clinical and Scientific Advisory Board to expand our LUM-201 pipeline.
  • Financial Results for the Quarter Ended September 30, 2021
    Cash Position Lumos Pharma ended the third quarter on September 30, 2021, with cash and cash equivalents totaling $100.7 million compared to $98.7 million on December 31, 2020.
  • Lumos Pharma, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of therapeutics for rare diseases.

Children's Growth Awareness Week Sept. 19-25 to focus on growth disorders

Retrieved on: 
Friday, August 13, 2021

During Growth Awareness Week, Sept. 19-25, The MAGIC Foundation (Major Aspects of Growth in Children) is working to draw attention to the issue of children's growth through its website, magicfoundation.org, and on its social media sites.

Key Points: 
  • During Growth Awareness Week, Sept. 19-25, The MAGIC Foundation (Major Aspects of Growth in Children) is working to draw attention to the issue of children's growth through its website, magicfoundation.org, and on its social media sites.
  • "We did not want others to face the unknown; we knew they needed information about growth and growth disorders to make their paths easier."
  • Today, MAGIC is the leading worldwide organization for growth disorders in children and adult endocrine disorders.
  • For additional information and to schedule an interview with parents of children impacted by growth disorders, please contact the MAGIC Foundation at 630-836-8200 or [email protected] .

Biote CEO Terry S. Weber to Present at Jefferies Healthcare Conference

Retrieved on: 
Wednesday, May 26, 2021

Biote Medical today announces that CEO Terry S. Weber will present at the Jefferies Virtual Healthcare Conference on June 3 at 9:30 a.m. Eastern time in Track 1.

Key Points: 
  • Biote Medical today announces that CEO Terry S. Weber will present at the Jefferies Virtual Healthcare Conference on June 3 at 9:30 a.m. Eastern time in Track 1.
  • The video presentation will be live streamed, and conference attendees can register via the Jefferies portal.
  • Biote is the leader in bioidentical hormone optimization therapy for men and women and commercializes supporting supplements scientifically formulated to complement hormone performance.
  • Under the leadership of Ms. Weber, Biote advocates for provider and patient access to bioidentical hormone replacement therapy (BHRT) and is committed to the highest standards of science, education, and research.