Ginkgo Bioworks (NYSE:DNA) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Company ParticipantsDaniel Marshall - Senior Manager of Communications and OwnershipJason Kelly - Co-Founder and CEOSteve Cohen - CFODaniel MarshallGood evening. I'm Daniel Marshall, Senior Manager of Communications and Ownership. I'm joined by Jason Kelly, our co-founder and CEO, and Steve Cohen, our CFO. Thanks as always for joining us. We're looking forward to updating you on our progress. As a reminder, during the presentatio ...

Ginkgo Bioworks (NYSE:DNA) Q4 2025 Earnings call February 26, 2026 04:30 PM ET Speaker0Good evening. I'm Daniel Marshall, Senior Manager of Communications and Ownership. I'm joined by Jason Kelly, our co-founder and CEO, and Steve Cohen, our CFO. Thanks as always for joining us. We're looking forward to updating you on our progress. As a reminder, during the presentation today, we will be making forward-looking statements which involve risks and uncertainties. Please refer to our filings with the SEC to lea ...

Schrödinger (NasdaqGS:SDGR) Q4 2025 Earnings call February 25, 2026 04:30 PM ET Company ParticipantsConor MacKay - Equity Research AssociateJaren Madden - Chief Corporate Affairs Officer and Head of Investor RelationsKaren Akinsanya - President, Head of Therapeutics R&D, and Partnerships Chief Strategy OfficerRamy Farid - CEORichie Jain - CFONone - Company RepresentativeNone - Company RepresentativeNone - Company RepresentativeNone - Company RepresentativeConference Call ParticipantsBrendan Smith - Director ...

(This release updates the release that posted earlier on February 25, 2026 to update the sub headlines.) NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expecte ...

NDA for rusfertide submitted to the US Food and Drug Administration (FDA), with potential approval and launch this year Company expects to opt-out of the 50:50 profit and loss sharing arrangement for rusfertide with Takeda during a 90-day window expected to open in Q2 U.S. regulatory decision for ICOTYDETM (icotrokinra) anticipated in 2026 with potential launch this year PN-881 Phase 1 completion expected by mid- 2026 NEWARK, CALIFORNIA / ACCESS Newswire / February 25, 2026 / Protagonist Therapeutics (Nasda ...

Keros Therapeutics Conference Call Summary Company Overview - **Company**: Keros Therapeutics (NasdaqGM: KROS) - **Industry**: Biopharmaceuticals - **Focus**: Discovery, development, and commercialization of treatments for disorders linked to dysfunctional signaling of the TGF-beta superfamily of proteins, targeting pathways critical for blood cell growth, repair, and maintenance across various tissues [1][3] Core Products and Development - **Lead Candidate**: KER-065 (Rinvatercept) - **Indications**: Developed for neuromuscular diseases, specifically Duchenne muscular dystrophy (DMD) and amyotrophic lateral sclerosis (ALS) [2][4] - **Mechanism**: A modified activin receptor ligand trap designed to inhibit TGF-beta ligands, promoting muscle regeneration, increasing muscle size and strength, and reducing fibrosis and inflammation [5][11] - **Partnered Drug**: Elritercept - **Indications**: Developed for treating ineffective hematopoiesis in myelodysplastic syndromes (MDS) and myelofibrosis (MF) [2][21] - **Partnership**: Global license agreement with Takeda, including an upfront payment of $200 million and potential milestones exceeding $1.1 billion [21] Clinical Insights - **Duchenne Muscular Dystrophy (DMD)** - **Prevalence**: Approximately 1 in 3,500 male births [8] - **Current Treatments**: Glucocorticoids (short-term benefits), exon skippers (limited benefit), gene therapy (declining efficacy) [10] - **Potential of KER-065**: Increases muscle mass, decreases fat mass, improves bone mineral density, and reduces negative effects of glucocorticoids [11][14] - **Amyotrophic Lateral Sclerosis (ALS)** - **Patient Population**: Approximately 30,000 patients in the U.S. [16] - **Mechanism of Action**: Aims to preserve muscle function and quality of life by promoting muscle regeneration and potentially counteracting muscle atrophy [19] Financial Overview - **Current Financial Position**: As of the third quarter, Keros reported $383 million in cash, providing a runway into the first half of 2028 [24][25] - **Investment in Trials**: Funds allocated for phase 2 trials and advancing preclinical assets into clinical development [25] Upcoming Milestones - **DMD Trial**: Expected to start in the current quarter [24] - **ALS Trial**: Engagement with regulators planned for the second half of the year [24] - **Elritercept Phase 3 RENEW Trial**: Ongoing, with Takeda committed to starting frontline treatment in the 2025 fiscal year [26] Additional Insights - **Research and Development**: Keros has a proprietary library of modified activin receptor II ligand traps and is exploring a broad range of indications, including neurodegenerative diseases and obesity [22][23] - **Clinical Data**: Phase 1 study of KER-065 showed it was well tolerated with no serious adverse events, indicating a favorable safety profile compared to earlier molecules [13][14] This summary encapsulates the key points from the Keros Therapeutics conference call, highlighting the company's focus, product pipeline, clinical insights, financial status, and future milestones.

Core Insights - Alvotech (NASDAQ:ALVO) announced strong initial results from a key clinical trial for AVT80, a potential biosimilar to Takeda's Entyvio, achieving all primary goals including matching Entyvio's pharmacokinetics [1][2] - The trial met all safety, tolerability, and immune response criteria, marking a significant milestone for the company's biosimilar development [2] - The potential approval of AVT80 targets a substantial market opportunity, with Entyvio's projected worldwide revenue reaching approximately $6.4 billion by 2025 [4] Company Overview - Alvotech specializes in the development, manufacturing, and commercialization of biosimilar medicines, aiming to provide affordable biologic alternatives globally [4] - The successful trial results allow the company to proceed towards regulatory submissions for AVT80 [2] Market Potential - Biosimilars like AVT80/AVT16 could significantly reduce costs for patients and payers once approved, tapping into a lucrative market [4]

Company Overview - Protagonist Therapeutics, Inc. (NASDAQ:PTGX) was founded on August 22, 2006, and is headquartered in Newark, California. The company focuses on developing peptide-based therapies targeting rare diseases, hematology, and immunology [4]. Recent Developments - H.C. Wainwright raised its price target on Protagonist Therapeutics to $117 from $80, reiterating a Buy rating based on the company's drug development track record and probability-of-success assumptions across multiple programs, including PN-8047 and obesity assets [1]. - A company director sold 20,000 shares valued at approximately $1.7 million, an event that investors are monitoring alongside ongoing pipeline developments [3]. - Protagonist Therapeutics reported two potential late-stage assets, Icotrokinra and Rusfertide, with New Drug Applications (NDAs) submitted for plaque psoriasis and polycythemia vera expected in 2025 [3]. Pipeline and Partnerships - The company anticipates multiple Phase 2 and Phase 3 readouts across immunology, hematology, and obesity indications [3]. - Existing partnerships with Johnson & Johnson and Takeda include milestone and royalty structures that support non-dilutive funding [3].

Core Viewpoint - Helus Pharma has appointed Michael Cola as CEO at a pivotal moment for the company, as it advances its next-generation mental health therapies and approaches critical clinical milestones [2][3]. Company Developments - Helus Pharma is progressing its clinical pipeline, with HLP004 Phase II data expected to be released this quarter and HLP003 Phase III topline data anticipated in Q4 2026 [2][6]. - The company has submitted over 350 patent applications globally and has received more than 100 patents, indicating a strong intellectual property portfolio [2]. - Helus Pharma is focused on addressing severe mental health disorders through differentiated projects and is transitioning from early clinical development to late-stage execution [2][6]. Leadership Appointment - Michael Cola brings over 30 years of experience in neuroscience, rare diseases, and specialty pharmaceuticals, making him a suitable leader for Helus [3][4]. - Cola's previous achievements include transforming Shire into a leader in the CNS field and significantly increasing its market value from $5 billion to $20 billion [4][5]. - Cola has also held leadership roles in various companies, contributing to successful clinical transitions and product launches [5][6]. Company Background - Helus Pharma, established in 2019, focuses on developing proprietary new serotonin agonists (NSAs) aimed at improving mental health recovery [8]. - The company is currently developing two proprietary NSAs: HLP003, in Phase III for major depressive disorder, and HLP004, in Phase II for generalized anxiety disorder [8]. - Helus Pharma aims to address the significant unmet treatment needs of patients with depression, anxiety, and other mental health disorders [8].

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--FDA Accepts New Drug Application and Grants Priority Review for Takeda's Oveporexton as a Potential First-in-Class Therapy for Narcolepsy Type 1. ...