GH

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

Retrieved on: 
Tuesday, 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.

Guardant Health Reports Third Quarter 2023 Financial Results and Increases Revenue Guidance

Retrieved on: 
Monday, November 6, 2023
Biotechnology, Health, Oncology, ASPS, ESMO, Medicare, EBITDA, European Society for Medical Oncology, Net, GAAP, Acquisition, Helmy Eltoukhy, Cancer, Lung, Growth, PEGASUS, GH, Marketing, Partnership, Webcast, MRD, Depreciation, European Society of Clinical Microbiology and Infectious Diseases, Forecasting, Video game, Medical imaging, Pharmaceutical industry, Bank, Insurance, Shield

Precision oncology gross margin was 60% in the third quarter of 2023, as compared to 61% in the prior year period.

Key Points: 
  • Precision oncology gross margin was 60% in the third quarter of 2023, as compared to 61% in the prior year period.
  • Operating expenses were $199.0 million for the third quarter of 2023, as compared to $221.5 million for the corresponding prior year period.
  • Guardant Health now expects full year 2023 revenue to be in the range of $553 to $556 million, representing growth of 23% to 24% compared to full year 2022.
  • Guardant Health will host a conference call to discuss the third quarter and full year 2023 financial results after market close on Monday, November 6, 2023 at 1:30 pm Pacific Time / 4:30 pm Eastern Time.

Guardant Health to Participate in Upcoming November Investor Conferences

Retrieved on: 
Friday, November 3, 2023
Biotechnology, Medical Devices, Health, Health Technology, Oncology, Fireside chats, Conference, GH, Piper Sandler Companies, Cryptocurrency

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company will participate in the following investor conferences:

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company will participate in the following investor conferences:
    Jefferies 14th Annual Global Healthcare Conference in London, UK
    Presentation on Thursday, November 16 at 9:00 a.m. Greenwich Mean Time
    Piper Sandler 35th Annual Healthcare Conference in New York, NY
    Fireside Chat on Tuesday, November 28 at 9:30 a.m. Eastern Time
    Interested parties may access live and archived webcasts of the sessions on the “Investors” section of the company website at: www.guardanthealth.com .

Guardant Health, Flatiron Health Announce Integration of Guardant Genomic Profiling Tests Into OncoEMR® Platform

Retrieved on: 
Tuesday, October 31, 2023
Technology, Genetics, Health Technology, Software, Practice Management, Biotechnology, Health, Data Management, Oncology, Artificial Intelligence, Flatiron, MPH, Physician, Clinical Oncology, Research, Helmy Eltoukhy, Multimedia, GH, Recurrence, EMR, Cancer, Patient, Molecule, Medical imaging, Nursing, MD

“Genomic profiling provides critical data that helps oncologists make timely and informed decisions about personalized treatment plans for their patients,” said Chris Freeman, Guardant Health chief commercial officer.

Key Points: 
  • “Genomic profiling provides critical data that helps oncologists make timely and informed decisions about personalized treatment plans for their patients,” said Chris Freeman, Guardant Health chief commercial officer.
  • Guardant Health and Flatiron Health plan to roll the integration out to the entire OncoEMR network over the next several months.
  • Practices in the network will have access to Guardant Health’s entire portfolio of advanced blood and tissue tests for early- and advanced-stage cancer through the Molecular Profiling Integration.
  • “By offering integrated test ordering and reporting for Guardant Health’s genomic profiling tests within OncoEMR, we are enabling oncologists with the tools they need to further expand possibilities at the point of care," said James Hamrick, MD, MPH, Vice President, Clinical Oncology at Flatiron Health.

First results from PEGASUS trial reported at ESMO show promise for use of liquid biopsy to guide adjuvant treatment of colon cancer

Retrieved on: 
Monday, October 23, 2023
Science, Other Science, Biometrics, Oncology, Health, Medical Devices, Genetics, Clinical Trials, Patient, Cohort (statistics), Liquid biopsy, III, Congress, MD, Doctor of Philosophy, Circulating tumor DNA, Helmy Eltoukhy, PEGASUS, GH, Biology, Recurrence, MRD, Cancer, ISS, Toxicity, Neoplasm, Rollcage Stage II, DNA, Pharmaceutical industry, Medical imaging

One of the first prospective studies using liquid biopsy, the PEGASUS trial includes 135 patients recruited from 11 cancer centers in Italy and Spain.

Key Points: 
  • One of the first prospective studies using liquid biopsy, the PEGASUS trial includes 135 patients recruited from 11 cancer centers in Italy and Spain.
  • Initial results show that 34% of patients with a positive liquid biopsy result after surgery had the cancer return, while only 10% of patients with a negative result experienced a relapse.
  • Approximately 40% of patients converted from ctDNA-positive to ctDNA-negative after treatment, suggesting treatment efficacy of chemotherapy for some patients.
  • “A shift from the current paradigm of one-size-fits-all chemotherapy toward a new paradigm of tailored therapies is not the only expected impact of the PEGASUS trial.

Guardant Health to Report Third Quarter 2023 Financial Results on November 6, 2023

Retrieved on: 
Monday, October 16, 2023
Biotechnology, Medical Devices, Health, Health Technology, Oncology, GH, Webcast, Communications satellite, Broadcasting

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company will report financial results for the third quarter of 2023 after market close on Monday, November 6, 2023.

Key Points: 
  • Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the company will report financial results for the third quarter of 2023 after market close on Monday, November 6, 2023.
  • Company management will be webcasting a corresponding conference call beginning at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time.
  • Live audio of the webcast will be available on the “Investors” section of the company website at: www.guardanthealth.com .
  • The webcast will be archived and available for replay after the event.

TalkShopLive and Good Housekeeping Partner for GH's First-Ever Week of Live Shopping Events

Retrieved on: 
Monday, October 9, 2023
Partnership, Dolly, Family, Red Table Talk, Housekeeping, Good Housekeeping, GM, LIVE, Digital, Rock, Entrepreneurship, Good, Rock & Roll Hall of Fame Covers EP, Rock Star, GMO, GH, Friends, Landon, Content delivery network, News, Cookbook, Dance, Social media, Paris Hilton, Holiday, Music, Flour, Hotel

NEW YORK, Oct. 9, 2023 /PRNewswire/ -- TalkShopLive announced today a new partnership with Good Housekeeping that allows the leading live commerce platform to power the first-ever Good Housekeeping Live Shopping Week, where you can score exclusive deals on gift-worthy products from some high-profile celebs and influencers. From October 9 through October 14, top talent will host live shows that will appear on GoodHousekeeping.com, TalkShop.Live as well as various social media channels associated with the talent and their brands.

Key Points: 
  • NEW YORK, Oct. 9, 2023 /PRNewswire/ -- TalkShopLive announced today a new partnership with Good Housekeeping that allows the leading live commerce platform to power the first-ever Good Housekeeping Live Shopping Week, where you can score exclusive deals on gift-worthy products from some high-profile celebs and influencers.
  • Plus, you don't want to miss the very special surprise that Good Housekeeping has in store for her!
  • "Our partnership with Good Housekeeping is the ultimate example of how TalkShopLive and publishers can collaborate to create engaging, entertaining content that meets commerce," says TalkShopLive Co-Founder and CEO, Bryan Moore.
  • I can't wait for our audience to tune in live for our first-ever shopping week and experience everything this iconic lineup of talent has to offer."

Lumos Pharma Announces New Data and Analysis of 15 Subjects from OraGrowtH212 Trial Presented at the 2023 ESPE Annual Meeting

Retrieved on: 
Tuesday, September 26, 2023
IGFBP3, LUMO, Comparable, Time zone, Growth hormone, Serum, IGF, ESPE, Endocrine Society, Doctor of Philosophy, GH, Deconvolution, PEM, 2010 Formula Renault 3.5 Series, MD, Growth, Ageing, Patient, European Society for Paediatric Infectious Diseases, Poster, SD, AHV, Pharmaceutical industry, The Hague

“The presented results add to the growing body of evidence supporting the physiologic mechanism of action for LUM-201, as well as its potential as a treatment for moderate PGHD.

Key Points: 
  • “The presented results add to the growing body of evidence supporting the physiologic mechanism of action for LUM-201, as well as its potential as a treatment for moderate PGHD.
  • The slides presented at ESPE are available on the Posters & Publications page under the Investors & Media section of Lumos Pharma’s website.
  • At baseline, subjects (10M:5F) were (mean ± SD) aged 7.9±1.4 years, with IGF-1 SDS -0.82±0.9, and peak GH 7.2±2.2 ng/mL (clonidine stimulation), consistent with moderate PGHD.
  • Deconvolution analysis was performed on serum GH measured every 10 minutes (0800 h to 2000 h).

Pancreatic Cancer Research Gains Momentum Amidst Soaring Young-Onset Cases

Retrieved on: 
Tuesday, September 26, 2023
Gastrointestinal cancer, MDT, Breakthrough therapy, MBA, GH, Congress, Incidence, Helmy Eltoukhy, Patient, JAMA Network Open, Health, NYSE, Polyp, News, Disease, Oncolytics Biotech, Research, Attention, Biologics license application, MRD, ONC, Pancreatic Cancer Action Network, Data, JD, TSX, FDA, Lancet, GI, Pancreatic cancer, Human, CAD, NSCLC, Biomarker, NRG1, Colorectal cancer, CR, United States Congress, ORR, Clinical trial, FOLFIRINOX, ASCO, American Society of Clinical Oncology, Physician, EUS, Annual general meeting, Poster, Recurrence, Society, FTD, Breast cancer, Pharmaceutical industry, Medical imaging, Meru Networks, Nvidia, Medtronic

VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA).

Key Points: 
  • This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now.
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN.

Pancreatic Cancer Research Gains Momentum Amidst Soaring Young-Onset Cases

Retrieved on: 
Tuesday, September 26, 2023
Gastrointestinal cancer, MDT, Breakthrough therapy, MBA, GH, Congress, Incidence, Helmy Eltoukhy, Patient, JAMA Network Open, Health, NYSE, Polyp, News, Disease, Oncolytics Biotech, Research, Attention, Biologics license application, MRD, ONC, Pancreatic Cancer Action Network, Data, JD, TSX, FDA, Lancet, GI, Pancreatic cancer, Human, CAD, NSCLC, Biomarker, NRG1, Colorectal cancer, CR, United States Congress, ORR, Clinical trial, FOLFIRINOX, ASCO, American Society of Clinical Oncology, Physician, EUS, Annual general meeting, Poster, Recurrence, Society, FTD, Breast cancer, Pharmaceutical industry, Medical imaging, Meru Networks, Nvidia, Medtronic

VANCOUVER, British Columbia, Sept. 26, 2023 /PRNewswire/ -- USA News Group - The seriousness of pancreatic cancer continues to grow, with increasing alarm since The Lancet published an analysis back in April 2023, showing a rising incidence of pancreatic cancer among individuals younger than 55 years. Another study published in JAMA Network Open showed that early-onset cancer in people younger than 50 rose over the last decade, with gastrointestinal cancers seeing the fastest increase. This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now. Among the ongoing efforts that are drawing more attention in the pancreatic cancer space have been the developments coming from Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Merus N.V. (NASDAQ: MRUS), Guardant Health, Inc. (NASDAQ: GH), Medtronic plc (NYSE: MDT), and even NVIDIA Corporation (NASDAQ: NVDA).

Key Points: 
  • This has led to increased calls from pancreatic cancer organizations such as Pancreatic Cancer Action Network (PanCAN) for more action in the space, including advocating that the US Congress invest more in cancer research funding now.
  • "By teaming up with PanCAN, we believe we may be able to expedite development and provide pancreatic cancer patients with a bespoke immunotherapeutic treatment option."
  • Pelareorep delivered the company a big win near the end of 2022, when the FDA rewarded it with a Fast Track Designation (FTD) for treating advanced or metastatic pancreatic cancer.
  • "With a five-year survival rate of 12%, pancreatic cancer patients cannot afford to wait for new treatment options," said Julie Fleshman, JD, MBA, President and CEO of PanCAN.