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NewAmsterdam Pharma to Present at the Guggenheim Emerging Outlook: Biotech Summit
Globenewswire· 2026-02-04 13:00
Core Insights - NewAmsterdam Pharma is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medicines for patients at risk of cardiovascular disease with elevated low-density lipoprotein cholesterol [1] Company Overview - NewAmsterdam Pharma aims to improve patient care in populations with metabolic diseases where existing therapies are inadequate or poorly tolerated [3] - The company is investigating obicetrapib, an oral, low-dose, once-daily CETP inhibitor, in multiple phase 3 trials as a LDL-C lowering therapy [3] - Obicetrapib is being studied both alone and in fixed-dose combinations with ezetimibe, intended as an adjunct to statin therapy for patients with elevated LDL-C [3]
Akebia Therapeutics to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-04 13:00
Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [3]. Event Participation - Members of Akebia's executive team will participate in a Fireside Chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 12 at 9:30 AM EST [1]. - The Emerging Outlook: Biotech Summit will be held from February 11-12 in New York City [2]. Webcast Information - A webcast of the presentation will be available in the "Investors" section of Akebia's website following the conference [2].
Verastem Oncology Provides Preliminary Fourth Quarter and 2025 Revenue and Business Updates and Outlines 2026 Strategic Priorities for Novel Portfolio Targeting RAS/MAPK Pathway-Driven Cancers
Businesswire· 2026-02-04 12:30
Core Insights - Verastem Oncology has reported preliminary, unaudited net product revenues for AVMAPKI FAKZYNJA CO-PACK, amounting to approximately $17.5 million for Q4 2025 and $30.9 million for the full year 2025, reflecting the product's launch period from May to December 2025 [6][2] - The company is focused on maximizing the commercial launch of AVMAPKI FAKZYNJA CO-PACK and advancing its clinical pipeline targeting RAS/MAPK pathway-driven cancers in 2026 [4][2] Financial Update - The expected net product revenues for AVMAPKI FAKZYNJA CO-PACK are approximately $17.5 million for Q4 2025 and $30.9 million for the full year 2025 [6] - As of January 25, 2026, the company has netted $29.4 million from exercised cash warrants, with total cash, cash equivalents, and investments amounting to $205 million as of December 31, 2025 [6] - The company anticipates that the LGSOC commercial launch and development program will be self-sustaining by the second half of 2026 [6] 2026 Priorities - The company aims to maximize the adoption of AVMAPKI FAKZYNJA CO-PACK in the U.S. as the treatment of choice for KRAS-mutated recurrent low-grade serous ovarian cancer [7] - Key clinical trials include the ongoing RAMP 301 Phase 3 trial, which is fully enrolled and aims to confirm the initial indication for AVMAPKI FAKZYNJA CO-PACK [4][14] - The company plans to report topline results from the RAMP 301 trial in mid-2027 [7] Clinical Development - The ongoing RAMP 201J Phase 2 trial in Japan has shown a confirmed overall response rate (ORR) of 38% among 16 efficacy-evaluable patients, with a 57% ORR in KRAS-mutated patients [4] - The company is also advancing VS-7375, an investigational oral KRAS G12D inhibitor, with ongoing Phase 1/2 trials in various solid tumors [21][12] Product Information - AVMAPKI FAKZYNJA CO-PACK is the first FDA-approved treatment for adults with KRAS-mutated recurrent low-grade serous ovarian cancer who have received prior systemic therapy [15][14] - The combination therapy is designed to inhibit critical signaling pathways in cancer, specifically targeting the RAS/MAPK pathway [11][23]
Nature Medicine Publishes Results from the Pivotal DEVOTE Study of High-Dose Regimen of Nusinersen in Spinal Muscular Atrophy
Globenewswire· 2026-02-04 12:30
Core Insights - Biogen announced the publication of results from the Phase 2/3 DEVOTE study in Nature Medicine, evaluating a high-dose regimen of nusinersen for spinal muscular atrophy (SMA) [1][2] - The high-dose regimen includes a loading dose of 50 mg/5 mL and a maintenance dose of 28 mg/5 mL, which is more rapid and higher than the previously approved 12 mg regimen [1][6] - The study demonstrated safety and effectiveness across a broad range of SMA patients, showing significant improvements in motor function and other health domains [2][3] Study Details - DEVOTE enrolled 139 participants of various ages and SMA types, with treatment-naïve infants showing statistically significant improvements in motor function compared to a matched sham group [2][3] - The pivotal cohort (Part B) reported a mean difference of 26.19 points in motor function (CHOP-INTEND) between the high-dose regimen and sham group (p<0.0001) [2] - In the open-label Part C, participants transitioning from the 12 mg regimen to the high-dose regimen experienced mean increases of 1.8 points on the Hammersmith Functional Motor Scale – Expanded (HFMSE) [3] Safety Profile - The safety profile of the high-dose regimen was consistent with the known safety profile of the 12 mg regimen, with common adverse events including pneumonia and respiratory failure [4] - In the Part B infantile-onset cohort, the most common adverse events (≥15% of participants) were pneumonia, respiratory failure, pyrexia, COVID-19, and upper respiratory tract infection [4] Regulatory Status - The high-dose regimen of nusinersen is approved in the European Union and Japan, and is currently under review by the U.S. FDA with a PDUFA action date of April 3, 2026 [5][7]
Zenas BioPharma to Present at the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-04 12:05
Core Insights - Zenas BioPharma, Inc. is a clinical-stage global biopharmaceutical company focused on developing transformative therapies for autoimmune diseases [3] - The company will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026 [1] Company Overview - Zenas aims to lead in the development and commercialization of therapies for autoimmune diseases, leveraging an experienced leadership team and a disciplined product candidate acquisition strategy [3] - The company is advancing two late-stage product candidates: obexelimab and orelabrutinib [3] - Obexelimab is a bifunctional monoclonal antibody targeting CD19 and FcγRIIb, designed to inhibit pathogenic B cells without depleting them [3] - Orelabrutinib is a selective CNS-penetrant oral small molecule BTK inhibitor that targets pathogenic B cells in both peripheral and central nervous systems [3] - Zenas also has earlier stage programs, including ZB021, an oral IL-17AA/AF inhibitor, and ZB022, a brain-penetrant TYK2 inhibitor [3]
13 of the Top 20 Biopharmas Standardize Globally on Veeva Link Key People
Prnewswire· 2026-02-04 12:03
Core Insights - Veeva Systems announced that 13 of the top 20 biopharmaceutical companies have adopted Veeva Link Key People to enhance customer engagement and support AI initiatives globally [1] - The adoption of Link Key People has led to the addition of 38 new customers, with three of the top 20 biopharmas making it their global standard in the past year [1] Customer Engagement and AI Integration - Access to Veeva Link Key People strengthens data-driven decision-making, enhances targeting, and fosters engaging healthcare professional (HCP) interactions, ultimately benefiting patient healthcare [2] - The data from Link Key People has become integral to Bayer's data strategy, enriching AI-driven platforms and providing actionable business insights for long-term patient benefits [2] Value Delivery and Innovations - Link Key People provides valuable insights for medical and commercial teams, while analytics teams utilize Link data to enhance their AI models [3] - Recent innovations, including AI-powered summaries and personalized notifications, improve customer interactions and reveal new engagement opportunities [3] - The Link Direct Data API offers high-speed access to Veeva's data, further enhancing data accessibility for teams [3] Industry Impact and Strategic Relationships - The increasing use of Link Key People among top biopharmas and emerging biotechs is expected to advance engagement across the industry, leveraging deep Key Opinion Leader (KOL) data for strategic relationships [4] Veeva Data Cloud Integration - Link Key People is part of Veeva Data Cloud, which includes Veeva OpenData, Veeva HCP 360, and Veeva Compass, utilizing Veeva's Common Data Architecture to connect data and software [5] Company Overview - Veeva Systems provides industry cloud solutions for life sciences, serving over 1,500 customers, from large biopharmaceutical companies to emerging biotechs, with a commitment to innovation and customer success [6]
Maze Therapeutics to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-04 12:00
SOUTH SAN FRANCISCO, Calif., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company developing small molecule precision medicines for patients with kidney and metabolic diseases, today announced that Jason Coloma, Ph.D., chief executive officer of Maze Therapeutics, will present at the Guggenheim Emerging Outlook: Biotech Summit 2026 on Wednesday, February 11, 2026 at 3:00 p.m. ET. A live webcast of the event will be available in the Investors se ...
Aclaris Therapeutics to Participate in Two February Healthcare Conferences
Globenewswire· 2026-02-04 12:00
Core Viewpoint - Aclaris Therapeutics, Inc. is actively participating in two healthcare conferences in February 2026, showcasing its commitment to addressing immuno-inflammatory diseases through innovative product candidates [1][4]. Company Overview - Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel product candidates for patients with immuno-inflammatory diseases who currently lack satisfactory treatment options [3]. - The company boasts a multi-stage portfolio of product candidates supported by a robust research and development engine [3]. Upcoming Events - On February 12, 2026, at 2:30 PM EST, Aclaris' CEO Dr. Neal Walker and senior leadership will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York, NY [4]. - On February 26, 2026, at 8:40 AM EST, Aclaris' President and COO Hugh Davis, Ph.D. will deliver a corporate presentation during the virtual Oppenheimer 36th Annual Healthcare Life Sciences Conference [4].
C4 Therapeutics to Participate in the Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-04 12:00
Core Insights - C4 Therapeutics, Inc. (C4T) is participating in the Guggenheim Emerging Outlook: Biotech Summit 2026, scheduled for February 11-12, 2026, in New York, NY [1] - The company focuses on advancing targeted protein degradation (TPD) science to develop innovative medicines that can transform patient lives [3] Event Details - The fireside chat will take place on February 11, 2026, at 11:30 AM ET, with a live webcast available on the company's website [2] - An archived replay of the webcast will be accessible for approximately 90 days following the event [2] Company Overview - C4 Therapeutics is a clinical-stage biopharmaceutical company that aims to create a new generation of medicines through targeted protein degradation [3] - The company is advancing targeted oncology programs and utilizing its TORPEDO platform to design and optimize small-molecule medicines for challenging diseases [3] - C4T's degrader medicines are intended to leverage the body's natural protein recycling system to degrade disease-causing proteins, potentially addressing drug resistance and improving patient outcomes [3]
Neumora Therapeutics to Participate in Guggenheim Emerging Outlook: Biotech Summit 2026
Globenewswire· 2026-02-04 12:00
Core Insights - Neumora Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for brain diseases through novel mechanisms of action [3] - The company will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 on February 11, 2026, at 4:00 p.m. ET [1] - A live webcast of the event will be available on the company's website, with a replay accessible for up to 30 days [2] Company Overview - Neumora's therapeutic pipeline includes seven neuroscience programs targeting underserved neuropsychiatric disorders and neurodegenerative diseases [3] - The company aims to redefine neuroscience drug development by utilizing an integrated suite of translational, clinical, and computational tools to enable precision medicine [3] - Neumora's mission is to improve treatment outcomes and quality of life for patients suffering from brain diseases [3]