Ultragenyx to Participate at Investor Conferences in November

On November 20, 2023 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultrarare genetic diseases, reported that management, will participating in two upcoming investor conferences (Press release, Ultragenyx Pharmaceutical, NOV 20, 2023, View Source [SID1234637862]).

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6th Annual Evercore ISI HealthCONx (Miami, FL)

Tuesday, November 28, 2023, management will host 1×1 meetings.

Piper Sandler 35th Annual Healthcare Conference (New York City, NY)

Wednesday, November 29, 2023, at 10:00am, Emil Kakkis, M.D., Ph.D., CEO and President, will participate in a fireside chat and host 1×1 meetings.
The live and archived webcast of the fireside chat will be accessible from the company’s website at View Source

Tvardi Therapeutics to Present at the 35th Annual Piper Sandler Healthcare Conference

On November 20, 2023 Tvardi Therapeutics, Inc. ("Tvardi"), a privately held, clinical-stage biopharmaceutical company focused on the development of STAT3 inhibitors, reported that the management team will present at the 35th Annual Piper Sandler Healthcare Conference on Tuesday, November 28, 2023, and will participate in one-on-one meetings with investors throughout the day, in New York, NY (Press release, Tvardi Therapeutics, NOV 20, 2023, View Source [SID1234637861]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Presentation Details:
Date: Tuesday, November 28, 2023
Time: 10:10 a.m.-10:30 a.m. EST
Location: Lotte New York Palace, 455 Madison Ave, New York, NY 10022

TRACON Pharmaceuticals Announces License of Product Development Platform for $3.0 Million Upfront Payment

On November 20, 2023 TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, reported that it has licensed its proprietary PDP of CRO-independent clinical research to a clinical stage biotech company for a $3.0 million upfront payment (Press release, Tracon Pharmaceuticals, NOV 20, 2023, View Source [SID1234637860]).

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"We are excited to announce the first license of our PDP to a company that recognizes the value of internalizing its clinical operations to reap the benefits of CRO-independent clinical trial implementation that we enjoy at TRACON," said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer. "We are now in a position to widely license our PDP to allow clinical stage biotechnology and pharmaceutical companies to transform their clinical operations with the expectation of potentially dramatic cost reductions and shorter clinical trial timelines."

Under the terms of the Agreement, TRACON granted a non-exclusive and non-transferable license of its PDP to the clinical stage biotech company for the design, conduct and administration of clinical trials and related research and development activities, including activities relating to regulatory filings, submissions and approvals. A licensee can integrate TRACON’s configuration documentation with a widely-used software package, enabling validation and qualification of the software package, in conjunction with TRACON’s standard operation procedure documents, policies, work instructions, and clinical operation templates.

Tempest to Present at the 35th Annual Piper Sandler Healthcare Conference

On November 20, 2023 Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage oncology company developing first-in-classi therapeutics that combine both targeted and immune-mediated mechanisms, reported that management will participate in a fireside chat at the 35th Annual Piper Sandler Healthcare Conference on Tuesday, November 28, 2023 at 3:00 p.m. ET (Press release, Tempest Therapeutics, NOV 20, 2023, View Source [SID1234637856]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live or archived recording of the discussion, please visit the investor section of the Tempest website at View Source

Novartis showcases significant data updates from Kisqali®, iptacopan and Scemblix® at SABCS and ASH

On November 20, 2023 Novartis reported that it will present data from over 100 trials across its breast cancer and hematology portfolios at the 2023 San Antonio Breast Cancer Symposium (SABCS) and the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition (Press release, Novartis, NOV 20, 2023, https://www.novartis.com/news/media-releases/novartis-showcases-significant-data-updates-from-kisqali-iptacopan-and-scemblix-sabcs-and-ash [SID1234637853]). The new data will highlight the latest advances across our breast cancer and hematology portfolios and pipeline, such as the Phase III NATALEE trial and Phase III APPLY-PNH trial.

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"We’re developing new therapies across a range of cancers and blood disorders as well as evaluating the potential of our priority medicines in earlier stages of disease," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "Among the new findings we will present at SABCS and ASH (Free ASH Whitepaper) this year are additional follow-up Kisqali data from NATALEE, adding to the body of evidence of ribociclib in early breast cancer, as well as new 48-week data from the Phase III APPLY-PNH trial for iptacopan."

Key highlights of data accepted by SABCS include:

Medicine Abstract Title Abstract Number/ Presentation Details    
Kisqali (ribociclib)*   

Ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) as adjuvant treatment in patients with HR+/HER2− early breast cancer: final invasive disease–free survival (iDFS) analysis from the NATALEE trial

Abstract #GS03-03
Oral Presentation
Friday, December 8
8:15 – 11:15 AM CT
Kisqali (ribociclib)*   

    Invasive disease-free survival as a surrogate for overall survival in patients with hormone receptor−positive/human epidermal growth factor receptor 2−negative early breast cancer: a real-world analysis

Abstract #PO1-17-07
Poster Session
Wednesday, December 6
12:00 – 2:00 PM CT
Kisqali (ribociclib)*    Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study

Abstract #PO2-01-09
Poster Session
Wednesday, December 6
5:00 – 7:00 PM CT

Key highlights of data accepted by ASH (Free ASH Whitepaper) include: 

Medicine or Disease State Abstract Title    Abstract Number/ Presentation Details    
Iptacopan (LNP023)     

    Factor B Inhibition with Oral Iptacopan Monotherapy Demonstrates Sustained Long-Term Efficacy and Safety in Anti-C5-Treated Patients (pts) with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia: Final 48-Week Results from the Multicenter, Phase III APPLY-PNH Trial

Abstract #571
Oral Presentation
Sunday, December 10
4:30 PM PT
Iptacopan (LNP023)  Patient-Reported Improvements in Fatigue and Health-Related Quality of Life in the Phase 3 Studies APPLY-PNH and APPOINT-PNH Evaluating the Use of Iptacopan in C5 Inhibitor-Treated and Treatment-Naïve Patients with Paroxysmal Nocturnal Hemoglobinuria

Abstract #487
Oral Presentation
Sunday, December 10
9:30 AM PT
Iptacopan (LNP023)      Categorization of Hematological Responses to Oral Iptacopan Monotherapy in Anti-C5-Treated Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and Persistent Anemia in the Phase III APPLY-PNH Trial and Complement Inhibitor-Naïve Patients in the Phase III APPOINT-PNH Trial

Abstract #4084
Poster Presentation
Monday, December 11
6:00 – 8:00 PM PT 
Iptacopan (LNP023)  Clinical Breakthrough Hemolysis (BTH) during Monotherapy with the Oral Factor B Inhibitor Iptacopan Is Generally Not Severe and Managed without Treatment Discontinuation: 48-Week Data from the Phase III APPLY-PNH and APPOINT-PNH Trials in Paroxysmal Nocturnal Hemoglobinuria (PNH)

Abstract #1338
Poster Presentation
Saturday, December 9
5:30 – 7:30 PM PT
Scemblix (asciminib)   Sustained Efficacy and Safety with Asciminib (ASC) after Almost 4 Years of Median Follow-up from ASCEMBL, a Phase 3 Study of ASC vs Bosutinib (BOS) in Patients (Pts) with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) after ≥2 Prior Tyrosine Kinase Inhibitors (TKIs): An End of Study Treatment (EOS Tx) Update, Including Results from Switch Population

Abstract #4536
Poster Presentation
Monday, December 11
6:00 – 8:00 PM PT  
Scemblix (asciminib)   With up to 8 Years of Therapy, Asciminib (ASC) Monotherapy Demonstrated Continued Favorable Efficacy, Safety, and Tolerability in Patients (Pts) with Philadelphia Chromosome–Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP) without the T315I Mutation: Final Results from the Phase 1 X2101 Study

Abstract #450
Oral Presentation 
Sunday, December 10 
10:45 AM PT   
Sickle Cell Disease

Targeted Degradation of the Wiz Transcription Factor for Gamma Globin De-Repression

Abstract #2
Plenary Scientific Session
Sunday, December 10
2:00 – 4:00 PM PT

Kymriah  

(tisagenlecleucel)  Clinical Outcomes of Patients with Relapsed/Refractory Follicular Lymphoma Treated with Tisagenlecleucel: Phase 2 Elara 3-Year Follow-up

Abstract #601
Oral Presentation
Sunday, December 10
4:30 PM PT
Jakavi (ruxolitinib)   Ruxolitinib in Patients With Chronic Graft-Versus-Host Disease: 3-Year Final Analysis of Efficacy and Safety From the Phase III REACH3 study

Abstract #654
Oral Presentation
Sunday, December 10
5:45 PM PT  
Immune Thrombocytopenia (ITP) The lack of tolerable treatment options that can induce durable responses without fear of relapse after discontinuation represents a significant unmet need for patients (pts) with immune thrombocytopenia (ITP): Results from the ITP world impact survey (I-WISh) 2.0

Abstract #1212
Poster Presentation
Saturday, December 9
5:30 – 7:30 PM PT  

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