Core Viewpoint - Nektar Therapeutics has announced the pricing of an upsized public offering of $400 million, which includes common stock and pre-funded warrants, aimed at supporting its clinical development and general corporate purposes [1][2] Group 1: Offering Details - Nektar is offering 6,603,449 shares of common stock at a price of $58.00 per share and 293,103 pre-funded warrants at a price of $57.9999 each, leading to expected gross proceeds of approximately $400 million before expenses [1] - The underwriters have a 30-day option to purchase an additional 1,034,482 shares at the public offering price [1] - The offering is expected to close on February 13, 2026, subject to customary conditions [1] Group 2: Use of Proceeds - The net proceeds from the offering will be used for general corporate purposes, including research and development, clinical development (notably Phase 3 trials for rezpegaldesleukin), and manufacturing costs [1] Group 3: Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing innovative treatments for autoimmune and chronic inflammatory diseases [1] - The lead product candidate, rezpegaldesleukin, is being evaluated in multiple clinical trials for conditions such as atopic dermatitis, alopecia areata, and Type 1 diabetes mellitus [1] - Nektar's pipeline includes additional candidates like NKTR-0165, NKTR-0166, and NKTR-422, as well as NKTR-255, which is designed to enhance the immune system's ability to combat cancer [1]

Table of Contents As filed with the Securities and Exchange Commission on February 11, 2026 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. (Exact name of Registrant as specified in its charter) Delaware 2834 82-5024477 (State or Other Jurisdiction of Incorporation or Organization) Primary Standard Industrial Classification Code Number 2929 N Commerce Parkway Miramar, FL 33025 (9 ...

enGene (NasdaqCM:ENGN) 2026 Conference February 11, 2026 02:30 PM ET Company ParticipantsRon Cooper - CEOConference Call ParticipantsMichael Schmidt - Senior Biotech AnalystMichael SchmidtWelcome to this next Fireside Chat. My name is Michael Schmidt, Senior Biotech Analyst with Guggenheim, and with us today we have Ron Cooper, CEO of enGene Therapeutics. Ron, welcome. Thanks for joining us.Ron CooperWell, thanks for the invitation. Great to be here.Michael SchmidtSo Ron, you're in the non-muscle invasive b ...

Cancer has quietly become the pharmaceutical industry’s most lucrative disease area. In 2024 alone, global cancer drug sales exceeded $200 billion, making oncology the single largest revenue category in biopharma, well ahead of even the fast-growing obesity drug market. Yet behind the blockbuster numbers and steady stream of approvals, a more troubling reality is emerging. Many of today’s most profitable cancer drugs do not meaningfully extend patients’ lives. A recent Bloomberg investigation underscored th ...

An updated edition of the December 17, 2025, article.The global oncology market is entering a phase of accelerated transformation, driven by rising cancer incidence, demographic shifts and rapid scientific progress. The American Cancer Society estimates that the United States will see about 2.1 million new cancer diagnoses and more than 626,000 cancer-related deaths in 2026. Globally, lifestyle-related risk factors and demographic shifts continue to increase cancer prevalence, supporting sustained growth in ...

Core Insights - AIM ImmunoTech Inc. reported positive data from the ongoing Phase 2 clinical study of Ampligen combined with AstraZeneca's Imfinzi for treating metastatic pancreatic cancer, showing median survival of 19.7 months compared to 8.6 months with standard care [1][2] - The study aims to assess the clinical benefit rate, overall survival, progression-free survival, immune monitoring, and quality of life for patients [2][3] Group 1: Clinical Study Details - The DURIPANC study is an exploratory, open-label trial expected to enroll up to 25 subjects, with 18 patients already enrolled [3] - The study has shown promising results in progression-free survival and overall survival, with no significant toxicity reported, indicating a favorable safety profile [3][4] - The combination therapy appears to enhance the body's immune response, suggesting a coordinated activation of both innate and adaptive immune systems [5] Group 2: Market Potential and Intellectual Property - AIM holds a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, extending protection until August 9, 2039 [7] - The company has received orphan drug designations in pancreatic cancer from both the U.S. and EU, providing market exclusivity post-commercial approval [7][8] - AIM believes that advancing Ampligen to Phase 3 clinical trials could present significant financial opportunities for the company and its shareholders [5][8]

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026 Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ( ...

Clinical progress, pipeline expansion, and operational momentum underpin leadership continuity as the Company advances into 2026 and beyond SEATTLE, WA / ACCESS Newswire / February 3, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIRâ"¢ and ADAPTIR-FLEXâ"¢ platform technologies, today announced executive leadership transitions to support the Company's continued execution, drive achievement of l ...

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $3.9 billion, reflecting a 3% year-over-year increase, driven by higher collaboration revenue and strong sales growth of Dupixent, EYLEA HD, and Libtayo [40][41] - Diluted net income per share was $11.44, with net income of $1.2 billion [40] - Regeneron's share of collaboration profits from Sanofi grew 42% year-over-year, primarily due to Dupixent [41] Business Line Data and Key Metrics Changes - Global net product sales for Dupixent reached $4.9 billion in Q4 2025, a 32% increase year-over-year [7] - Libtayo's global net sales were $425 million in Q4 2025, up 13% year-over-year [37] - EYLEA HD net product sales in the U.S. were $506 million in Q4 2025, representing a 66% increase [9] Market Data and Key Metrics Changes - Dupixent is now approved in eight indications, with over 1.4 million patients on therapy globally, indicating significant market penetration potential [7] - EYLEA HD has become a growing proportion of Regeneron's total anti-VEGF franchise, contributing nearly half of total net sales [33] - Libtayo is recognized as the leading immunotherapy for advanced non-melanoma skin cancers, with strong demand growth across all approved indications [37] Company Strategy and Development Direction - Regeneron anticipates at least four FDA approvals in 2026, including three for new molecular entities and one for the EYLEA HD prefilled syringe [11] - The company plans to initiate 18 additional phase 3 studies, targeting approximately 35,000 patients over multiple years [13] - Regeneron aims to continue capital deployment for share repurchases, dividends, and complementary business development to drive long-term shareholder value [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching an agreement with the U.S. government to reduce drug costs while ensuring access to innovative treatments [11] - The company highlighted the importance of its innovative pipeline, with multiple pivotal readouts and regulatory milestones expected in 2026 [30] - Management emphasized the competitive advantages of Dupixent, including its efficacy and safety profile compared to other immunomodulators [59] Other Important Information - Regeneron generated $4.1 billion in free cash flow in 2025 and returned $3.8 billion to shareholders, primarily through share repurchases [44][45] - The company initiated a quarterly dividend, providing additional flexibility to return capital to shareholders [45] Q&A Session Summary Question: Update on Libtayo plus fianlimab readouts - Management indicated that the best estimate for advanced melanoma readout is in the first half of the year, with adjuvant timing also expected in the same timeframe [52] Question: Dupixent IP and future potential - Management refrained from providing additional comments but acknowledged Sanofi's commentary on extending the IP runway [55] Question: Frontline metastatic melanoma data and hazard ratio - Management stated that the study is powered to achieve a primary endpoint similar to the current standard of care, with hopes for better outcomes [63] Question: Broader R&D strategy and focus areas - Management confirmed a commitment to a balanced approach across therapeutic areas, driven by genetics to identify new drug opportunities [70] Question: Development of a new version of Dupixent - Management discussed the potential of a "souped-up" version of Dupixent that may offer longer-lasting effects and other advantages, with plans to move it forward in clinical development [76]