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Vor Bio Enters into Exclusive Global License Agreement with RemeGen for Late-Stage Autoimmune Asset
Globenewswire· 2025-06-25 20:45
Core Insights - Vor Bio has secured exclusive global rights (excluding Greater China) to develop and commercialize telitacicept, a dual-target recombinant fusion protein for autoimmune diseases [1][6] - RemeGen has received an initial payment of $125 million, which includes a $45 million upfront payment and $80 million in warrants, along with potential milestones exceeding $4 billion and tiered royalties [1][5] - Jean-Paul Kress, MD, has been appointed as the new CEO and Chairman of Vor Bio, bringing extensive experience in clinical development and commercialization [3][4] Company Developments - Vor Bio is focused on advancing telitacicept through Phase 3 clinical development to address serious autoantibody-driven conditions globally [7] - RemeGen is conducting a global Phase 3 clinical trial for telitacicept, with initial results expected in the first half of 2027 [2][6] - The strategic out-licensing of telitacicept's ex-China rights is aimed at maximizing its clinical and commercial potential on a global scale [5] Product Information - Telitacicept targets key immune pathways by inhibiting BlyS (BAFF) and APRIL, which are critical for B cell survival, thereby reducing autoreactive B cells and autoantibody production [2][5] - In a Phase 3 trial in China for generalized myasthenia gravis, telitacicept showed a 4.8-point improvement in the MG-ADL scale compared to placebo at 24 weeks [5]
Forte Biosciences (FBRX) Earnings Call Presentation
2025-06-23 12:34
FORTE BIOSCIENCES CLINICAL STAGE FB-102 3 FB102 CELIAC DISEASE PHASE 1B RESULTS JUNE 2025 1 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 2 Certain statements contained in this presentation regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities and Exchange Act of 1934, as amended, and the Private Securities Litigation Act of 1995, known as the PSLRA. These include statements regarding management's intention, plans, beliefs, ...
NAYA Biosciences (INVO) Earnings Call Presentation
2025-06-23 11:45
A Portfolio Company Corporate Presentation February 2025 1 This Presentation is not an Offer or a Representation. This Presentation does not constitute an offer, or a solicitation of an offer, to buy orsell any securities, investment or otherspecific product, or a solicitation of any vote or approval, norshall there be any sale ofsecurities, investment or otherspecific product in any jurisdiction in which such offer,solicitation orsale would be unlawful priorto registration or qualification underthe securit ...
Labcorp Stock Climbs 25.6% This Year: What's Driving the Surge?
ZACKS· 2025-06-18 13:31
Core Insights - Labcorp (LH) shares have increased by 25.6% over the past year, outperforming the industry's decline of 16.2% and the S&P 500's gain of 9.1% [1][9] Company Strategy and Growth - Labcorp is focusing on major growth opportunities that are expected to grow faster than other therapeutic areas, supported by a solid pipeline of potential acquisitions [2] - The company is expanding its capabilities in oncology, women's health, autoimmune diseases, and neurology through strategic partnerships and acquisitions [4] - Labcorp has enhanced its testing capabilities for neurodegenerative diseases and launched new solutions in precision oncology, indicating a strong commitment to innovation [5][6] Financial Performance - As of March-end, Labcorp reported cash and cash equivalents of $369 million with zero short-term debt, and a dividend payout ratio of 40.4% after distributing $62 million in dividends [12] - The Zacks Consensus Estimate projects Labcorp's earnings per share (EPS) to increase by 10.2% in 2025 and 9.5% in 2026, with revenues expected to grow by 6.9% to $13.90 billion in 2025 [14] Operational Efficiency - The LaunchPad initiative achieved annual savings of $100-$125 million in 2024, focusing on margin expansion through various operational optimizations [11]
PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy
Globenewswire· 2025-06-13 15:47
PolTREG Establishes U.S. Subsidiary Immuthera to Advance International Development Strategy PolTREG established Immuthera (https://immuthera.bio/) in Delaware to expand its presence in the U.S. market. A Pre-IND application was submitted to the FDA.The Paediatric Committee (PDCO) of the European Medicines Agency issued a positive opinion on PolTREG’s Pediatric Investigation Plan (PIP) for PTG-007 in pre-symptomatic type 1 diabetes (Stage 1). Gdańsk, Poland – 13 JUNE 2025 – PolTREG S.A. (Warsaw Stock Exch ...
Vera Therapeutics(VERA) - 2025 FY - Earnings Call Transcript
2025-06-11 20:15
Vera Therapeutics (VERA) FY 2025 Conference June 11, 2025 03:15 PM ET Speaker0 Okay. Good afternoon. We'll continue with the next session. I'm Paul Choi, and I cover the SpidCap biotech sector here at Goldman Sachs. It's my pleasure to have Vera Therapeutics here on stage with us. To my immediate left is CEO, Marshall Fortis, and to my far left, Chief Medical Officer Rob Brenner. Maybe what we'll do is let Marshall kick it off with maybe some high level comments or an introduction of Avera, just kind of wha ...
AnaptysBio (ANAB) FY Conference Transcript
2025-06-11 13:40
AnaptysBio (ANAB) FY Conference June 11, 2025 08:40 AM ET Speaker0 All right. Good morning. And it's my pleasure to introduce Dan Vega, President and CEO of Adaptive Bio as our next speaker. Dan, welcome. It's the time for me to host you at the Goldman Sachs Conference. Conference. So thank you for being here. Before we kick off with the Q and A, I'm going to turn it to you for a quick opening remark. Speaker1 Perfect. Well, thanks for having me here today. It's my pleasure to be here. We have a lot going o ...
Cabaletta Bio Announces Proposed Public Offering of Securities
Globenewswire· 2025-06-11 10:15
Core Viewpoint - Cabaletta Bio, Inc. has initiated an underwritten public offering of its common stock and accompanying warrants, aiming to raise capital for its clinical-stage biotechnology operations focused on autoimmune diseases [1][2]. Group 1: Offering Details - The public offering includes shares of common stock and pre-funded warrants, with an option for underwriters to purchase an additional 15% of the offering [1][2]. - The offering is expected to close around June 12, 2025, subject to market conditions and customary closing conditions [2]. Group 2: Company Overview - Cabaletta Bio is a clinical-stage biotechnology company dedicated to developing curative targeted cell therapies for autoimmune diseases [5]. - The company’s CABA™ platform employs two strategies to advance engineered T cell therapies, with a focus on the CARTA strategy and its lead investigational therapy, rese-cel [5]. - Rese-cel is currently being evaluated in the RESET™ clinical development program, which spans multiple therapeutic areas including rheumatology, neurology, and dermatology [5].
Cabaletta Bio Announces New Rese-cel Safety and Efficacy Data in Patients with Myositis, Lupus and Scleroderma to Be Presented at the EULAR 2025 Congress
Globenewswire· 2025-06-11 10:00
Core Insights - Cabaletta Bio, Inc. announced promising clinical data from its ongoing RESET clinical trials for autoimmune diseases, highlighting the potential of rese-cel to provide drug-free, symptom-free lives for patients [1][2][6] Clinical Trial Results - In the RESET-Myositis trial, 7 out of 8 patients achieved clinically meaningful total improvement scores (TIS) while off all immunomodulators and steroids, with 4 patients experiencing grade 1 cytokine release syndrome (CRS) [1][2][3] - All systemic lupus erythematosus (SLE) patients without nephropathy achieved remission as per DORIS criteria, with 7 out of 7 patients responding clinically while off immunomodulators and glucocorticoids [1][2] - Both patients in the RESET-SSc trial showed significant improvements in modified Rodnan Skin Score (mRSS) after discontinuing immunomodulatory drugs, with one patient meeting the revised Composite Response Index in Systemic Sclerosis (CRISS) criteria [1][8] Safety Profile - Among 18 patients with follow-up of 4 weeks or more, 94% experienced no CRS or only Grade 1 CRS, and 89% had no immune effector cell-associated neurotoxicity syndrome (ICANS) [1][2] - In the RESET-SLE trial, 2 out of 8 patients experienced grade 1 CRS, and one ICANS event was reported [3][8] Regulatory and Development Plans - Cabaletta plans to initiate enrollment in two registrational myositis cohorts in 2025 and has scheduled discussions with the FDA regarding registrational pathways for SLE/LN in 3Q25, scleroderma in 4Q25, and myasthenia gravis in 1H26 [1][9] - The RESET clinical trial program is accelerating, with 51 patients actively enrolled across over 65 clinical sites as of May 30, 2025 [1][2][6] Company Overview - Cabaletta Bio is focused on developing curative targeted cell therapies for autoimmune diseases, with rese-cel being a key investigational therapy designed to deplete CD19-positive B cells [5][6] - The company aims to change treatment paradigms for autoimmune diseases through its innovative CARTA platform, which includes multiple disease-specific clinical trials [5][6]
argenx Presents New Efgartigimod Data at EULAR 2025 Highlighting Positive Phase 2 Proof-of-Concept Results in Myositis and Sjogren’s Disease
Globenewswire· 2025-06-10 22:01
Core Insights - Argenx SE announced positive results from Phase 2 studies of VYVGART® (efgartigimod) for treating Sjogren's disease and idiopathic inflammatory myopathies, presented at EULAR 2025 [1][2][3] - The FDA granted efgartigimod Fast Track designation for primary Sjogren's disease treatment, indicating its potential for expedited development [2] Group 1: Efgartigimod in Myositis - The ALKIVIA Phase 2/3 study showed significant improvement in muscle strength and physical function in myositis patients treated with efgartigimod, with a mean Total Improvement Score (TIS) of 50.45 compared to 35.65 in the placebo group (P=0.0004) [4][5] - 79% of efgartigimod-treated patients achieved moderate improvement (TIS ≥40), while only 47% of placebo patients did [4] - Efgartigimod demonstrated a favorable safety profile, with similar rates of treatment-emergent adverse events between efgartigimod and placebo groups [5][11] Group 2: Efgartigimod in Sjogren's Disease - In the Phase 2 RHO study, 45.5% of efgartigimod-treated patients showed improved outcomes on the CRESS composite primary endpoint at Week 24, compared to 11.1% in the placebo group [9][10] - The median change in clinESSDAI total score was -7.0 for efgartigimod patients versus -4.0 for placebo [9] - Efgartigimod led to a ~60% reduction in IgG levels from Week 4 onwards, indicating its potential for disease biology modulation [10][12] Group 3: Ongoing Studies and Future Directions - The Phase 3 portion of the ALKIVIA study is ongoing to further evaluate efgartigimod's efficacy in myositis [6] - The Phase 3 UNITY trial is assessing efgartigimod's efficacy and safety in moderate to severe Sjogren's disease [11] - Argenx is committed to exploring new therapeutic areas in rheumatology, with ongoing studies in both myositis and Sjogren's disease [8][20]