JAK

EQS-News: MorphoSys AG Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Wednesday, April 10, 2024
Novartis, ASH, Tafasitamab, Webcast, Purchasing, EZH1, EDT, Acquisition, Standard of care, BET, Business analyst, EZH2, Ruxolitinib, Exposition, Society, Safety, Anemia, GMT, MorphoSys, JAK, Annual general meeting, Pharmaceutical industry

“Now, in 2024, we are pleased that Novartis is committing to the future of our promising pipeline.

Key Points: 
  • “Now, in 2024, we are pleased that Novartis is committing to the future of our promising pipeline.
  • With its ample resources, additional scientific expertise and global footprint, Novartis can help accelerate pelabresib's potential worldwide.
  • Total revenues for the fourth quarter 2023 were € 59.0 million compared to € 81.6 million for the same period in 2022.
  • The decrease resulted first and foremost from prior year revenues stemming from the execution of an out-licensing agreement with Novartis.

Biora Therapeutics Achieves Positive Interim Results for Clinical Trial of BT-600, Advancing NaviCap™ Platform Development

Retrieved on: 
Thursday, April 4, 2024
Toxicity, TNF, Absorption, Ulcerative colitis, Plasma, Tmax, SAN, Patient, UC, MD, Cmax, IBD, Clinical trial, Therapy, Safety, Pharmacokinetics, SAD, JAK, Pharmaceutical industry

SAN DIEGO, April 04, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today shared additional positive interim results from the single-ascending dose (SAD) clinical trial of BT-600, which is a drug-device combination consisting of the orally administered NaviCap™ device that delivers a proprietary liquid formulation of tofacitinib to the colon. BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC). The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.

Key Points: 
  • BT-600 is being developed for the potential treatment of patients with ulcerative colitis (UC).
  • The SAD portion of the phase 1 randomized, double-blind, placebo-controlled clinical trial tested the tolerability and pharmacokinetics of BT-600 at 5 mg and 10 mg doses of tofacitinib, compared to placebo, in healthy adult participants.
  • We believe this could lead to better outcomes for patients suffering from UC.”
    According to the interim clinical data, all pharmacokinetic endpoints were met in all study participants.
  • The mean time to reach maximum concentration (Tmax) was 8–10 hours following administration of BT-600, versus 0.5-1.0 hours for conventional oral tofacitinib.

Roivant Announces Positive NEPTUNE Study Results for Brepocitinib in NIU, as well as Board Authorization for up to $1.5 Billion Share Repurchase Program, Including Repurchase of Entire Sumitomo Pharma Stake for $648 Million

Retrieved on: 
Tuesday, April 2, 2024
Disease, Macular edema, NIU, Paratriathlon, Arm, Rule, Safety, Risk, Webcast, Inflammation, Patient, NEPTUNE, EDT, Master of Science, Haze, Prednisone, Visual acuity, Therapy, Sumitomo Pharma, Calendar, Share repurchase, JAK, Visual impairment, Physician, Hand, Pediatrics, Pharmaceutical industry

We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma.

Key Points: 
  • We are also pleased to announce our authorized share repurchase program, and our agreed repurchase of all shares owned by Sumitomo Pharma.
  • The NEPTUNE study enrolled 26 subjects with active NIU who were randomized 2:1 to brepocitinib 45 mg once daily or brepocitinib 15 mg once daily.
  • All week 24 secondary efficacy endpoints, including haze grades, visual acuity, and macular thickness, were also positive and dose responsive.
  • The presentation and webcast details are also available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events.

Disc Medicine Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 21, 2024
Well, Research, Administration, Development, ASH, EPP, MF, Patient, NTD, Trial of the century, Ruxolitinib, IRON, Anemia, Porphyria, JAK

“The past year has been truly remarkable for Disc and marks another important chapter in our company’s story.

Key Points: 
  • “The past year has been truly remarkable for Disc and marks another important chapter in our company’s story.
  • During 2023, we provided the first evidence of the therapeutic potential of our programs, with positive read-outs in patients for both bitopertin and DISC-0974.
  • The increase was primarily due to the completion of a registered direct offering in February 2023 and a publicly marketed follow-on offering in June 2023.
  • The increase was primarily due to higher operating costs in the current period to support the continued advancement of our pipeline.

Equillium Reports on Fourth Quarter and Full Year 2023 Financial Results and Corporate and Clinical Highlights

Retrieved on: 
Monday, March 25, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Itolizumab, Organic acid, Harvard Medical School, Exercise, Alopecia areata, ASN, Partnership, Patient, Gastrointestinal tract, ACR, IL-9, Acquisition, G&A, MPA, Dermatology, Investment, MPH, Therapy, Eosinophilic esophagitis, Retirement, Inflammatory bowel disease, Lupus nephritis, JAK, Pharmaceutical industry

Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights.

Key Points: 
  • Equillium , Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the fourth quarter and full year 2023, as well as corporate and clinical highlights.
  • Research and development (R&D) expenses for the fourth quarter of 2023 were $9.2 million, compared with $8.5 million for the same period in 2022.
  • General and administrative (G&A) expenses for the fourth quarter of 2023 were $3.2 million, compared with $5.2 million for the same period in 2022.
  • Net cash used in operating activities in the fourth quarter was $5.7 million.

BenevolentAI Announces Positive Topline Safety and Pharmacokinetic Data from the Phase Ia Clinical Study of BEN-8744 in Healthy Volunteers

Retrieved on: 
Monday, March 25, 2024
Professional Services, Health, Finance, Clinical Trials, Research, Science, Pharmaceutical, PDE10, Phases of clinical research, Ulcerative colitis, Brain, IL6, Disease, Tumor necrosis factor, Central nervous system, IL8, Benevolence, Patient, CNS, CGMP, UC, Camp, Șaeș, Trial of the century, BAI, Cytokine, Drug development, Safety, Inflammatory bowel disease, Euronext Amsterdam, Steroid, JAK, Pharmaceutical industry

BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.

Key Points: 
  • BenevolentAI (“BenevolentAI” or the “Company”) (Euronext Amsterdam: BAI), a leader in applying advanced AI to accelerate biopharma drug discovery, today announces positive safety data from its Phase Ia, first-in-human, clinical study of BEN-8744 in healthy volunteers.
  • As a result, BenevolentAI’s scientists designed BEN-8744 to be not only a potent PDE10 inhibitor, but also a peripherally-restricted molecule, i.e.
  • The Phase Ia study results support this profile, showing no evidence of CNS-associated adverse events at any dose level.
  • It is anticipated that the full results from this study will be presented in a peer-reviewed forum at a later date.

Shaperon Enrolls Its First Patient in Phase 2 U.S. Clinical Trial for Atopic Dermatitis Therapy 'Nugel'

Retrieved on: 
Monday, March 18, 2024
Health, Health Technology, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Growth, Atopic dermatitis, Inflammation, Patient, EASI, Technology transfer, PDE4, IND, Patent, FDA, Steroid, JAK, Pharmaceutical industry

Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis.

Key Points: 
  • Shaperon, Inc. (Kosdaq: 378800), a biotechnology company developing innovative immune drugs, announced the enrollment of the first patient in the Phase 2 clinical trial for Nugel, its therapy for Atopic Dermatitis.
  • Employing a rigorous double-blind, placebo-controlled methodology, the trial is anticipated to conclude by the first half of 2026.
  • Market research forecasts indicate a robust growth of over 8.7%, projecting the global atopic dermatitis market to reach $19.1 billion by 2030.
  • Nugel represents a paradigm shift in atopic dermatitis therapy as the world's first inflammation control drug targeting 'GPCR19' action.

Global Irritable Bowel Disease (IBD) Market Analysis Report 2024: Increasing Prevalence of Crohn's Disease, and Ulcerative Colitis Driving the $21 Billion Market - Forecasts to 2029 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 12, 2024
General Health, Pharmaceutical, Health, Corticosteroid, TNF, Injection (medicine), Growth, Prevalence, Porter's five forces analysis, Incidence, SWOT, Disease, Research, IBD, Market, Medicine, Crohn's disease, Route of administration, Ulcerative colitis, USD, Administration, JAK, Irritable bowel syndrome, Pharmaceutical industry

The Global Irritable Bowel Disease market showcased growth at a CAGR of 2.60% during 2019-2022.

Key Points: 
  • The Global Irritable Bowel Disease market showcased growth at a CAGR of 2.60% during 2019-2022.
  • The increasing incidence and prevalence of Crohn's Disease, and Ulcerative Colitis are major drivers for the growth of the Market.
  • The report analyses the Irritable Bowel Disease Market by Drug Class (Corticosteroids, JAK inhibitors, TNF inhibitors, Other Drug Classes)
    The report analyses the Irritable Bowel Disease Market By Route of Administration (Injectable, Oral).
  • The report analyses the Irritable Bowel Disease Market by Indication (Crohn's Disease, Ulcerative Colitis).

Kymera Therapeutics Presents Preclinical Data for STAT6 and TYK2 First-In-Class, Oral Degrader Immunology Programs at the American Academy of Dermatology Annual Meeting

Retrieved on: 
Friday, March 8, 2024
Janus, Model, Spleen, STAT6, Doctor of Philosophy, Inflammation, Atopic dermatitis, Immunoglobulin E, Resource, JAK, Therapy, Inflammatory bowel disease, Protein, TYK2, TPD, Stem cell, Biology, Serum, Phase 1, American Academy, Pharmaceutical industry

WATERTOWN, Mass., March 08, 2024 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today announced that its preclinical data demonstrating the therapeutic potential of its potent and selective heterobifunctional degraders of STAT6 (KT-621) and TYK2 (KT-294) are being presented in the poster session at the American Academy of Dermatology’s Annual Meeting in San Diego, California. Kymera’s oral STAT6 and TYK2 degraders have the potential to address multiple immune-mediated diseases and overcome the limitations of existing technologies and agents. Today’s poster presentations mark the first time that data from a STAT6 targeted agent and a TYK2 degrader have been shared at a major medical meeting. Based on the results generated to date, Kymera intends to initiate Phase 1 testing for KT-621 and KT-294 in the in the second half of 2024 and the first half of 2025, respectively. Data from both Phase 1 trials are expected to be reported in 2025.

Key Points: 
  • Kymera’s oral STAT6 and TYK2 degraders have the potential to address multiple immune-mediated diseases and overcome the limitations of existing technologies and agents.
  • Today’s poster presentations mark the first time that data from a STAT6 targeted agent and a TYK2 degrader have been shared at a major medical meeting.
  • “Our differentiated strategy to targeted protein degradation has resulted in an industry-leading immunology pipeline of oral degrader medicines, each with the potential to treat multiple complex immuno-inflammatory diseases.
  • At low daily oral doses, preclinical studies with KT-621 demonstrated near full in vivo STAT6 degradation in disease-relevant tissues that was well-tolerated.

Charting New Paths: Non-TNF's Evolving in Rheumatoid Arthritis Market

Retrieved on: 
Friday, February 23, 2024
Therapy, Rheumatology, Rheumatoid arthritis, Physician, Rituximab, Adalimumab, JAK, Health, Patient, MOA, TNF, Research, Pharmaceutical industry

As demand for improved outcomes rises, it is vital for manufacturers to understand the top drivers catalyzing switching decisions in the well-established, yet continually evolving, RA landscape.

Key Points: 
  • As demand for improved outcomes rises, it is vital for manufacturers to understand the top drivers catalyzing switching decisions in the well-established, yet continually evolving, RA landscape.
  • Ongoing research from Spherix Global Insight’s Patient Chart Dynamix™: Rheumatoid Arthritis (US) service, marking its eighth year of tracking the US RA switch market, sheds light on these key treatment trends and leading opportunities for drug manufacturers.
  • While “TNF cycling” remains common, accounting for about one-third of all switches, this trend has been declining since 2017.
  • Brands that excel in these areas are well-positioned to capture market share and reshape treatment approaches.