Workflow
rezpegaldesleukin
icon
Search documents
医药生物行业周报:和铂医药HBM4003 BD落地,携手偏向性IL-2共启Treg治疗新局-20260224
Guohai Securities· 2026-02-24 11:01
Investment Rating - The report maintains a "Recommended" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The pharmaceutical sector has shown a decline of 0.81% in the past week, ranking 21st among 31 primary sub-industries, while the Shanghai and Shenzhen 300 index increased by 0.36% [11][34] - Recent developments include a partnership between Heptares Therapeutics and Solstice Oncology, granting exclusive rights for HBM4003 outside Greater China, with a total upfront payment exceeding $105 million [5][12] - The report highlights the promising clinical data for HBM4003 in treating metastatic colorectal cancer, showing an objective response rate (ORR) of 34.8% and a disease control rate (DCR) of 60.9% [5][12] - Nektar Therapeutics announced positive results from the REZOLVE-AD study for moderate to severe atopic dermatitis, demonstrating sustained efficacy with the new Treg-targeting agent Rezpeg [16][19] Summary by Sections Recent Performance - The pharmaceutical sector's performance over the past month shows a decline of 0.81%, with specific sub-sectors like traditional Chinese medicine and medical devices experiencing significant drops [34] Market Dynamics - Year-to-date, the pharmaceutical sector has outperformed the Shanghai and Shenzhen 300 index by 1.79 percentage points, with a total return of 2.44% [34] Valuation - As of February 13, 2026, the pharmaceutical sector's valuation stands at 33.2 times PE, representing a 30% premium over the overall A-share market (excluding financials) [37] Key Companies to Watch - The report emphasizes companies such as Aidi Pharmaceutical, WuXi Biologics, and Innovent Biologics as key players to monitor in the current market environment [5][39]
Nektar Therapeutics Announces Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a Tumor Necrosis Factor Receptor 2 (TNFR2) Antibody, in Multiple Sclerosis
Prnewswire· 2026-02-17 12:00
Nektar Therapeutics Announces Research Collaboration with UCSF and Dr. Stephen Hauser for NKTR-0165, a Tumor Necrosis Factor Receptor 2 (TNFR2) Antibody, in Multiple Sclerosis [Accessibility Statement] Skip NavigationSAN FRANCISCO, Feb. 17, 2026 /PRNewswire/ -- Nektar Therapeutics (Nasdaq: NKTR) today announced an academic research collaboration with the University of California, San Francisco (UCSF) and Stephen L. Hauser, M.D., Robert A. Fishman Distinguished Professor of Neurology and Director of the UCSF ...
Why Is Nektar Therapeutics Stock Gaining Wednesday?
Benzinga· 2026-02-11 12:35
Core Insights - Nektar Therapeutics' stock experienced a significant surge following the release of long-term data indicating that its experimental eczema therapy provides sustained and deepening disease control over one year, enhancing its competitive position in the atopic dermatitis market [1] Group 1: Clinical Data and Efficacy - The 36-week blinded maintenance period of the 52-week REZOLVE-AD study showed that the dosing regimens resulted in sustained disease control, with notable improvements in Eczema Area Severity Index (EASI) scores and Itch Numerical Rating Scale (NRS) responses [2][3] - A significant proportion of patients achieved new EASI-75, EASI-90, Itch NRS, and validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) responses at Week 52, indicating enhanced disease control with prolonged therapy and less frequent dosing [4] - Monthly maintenance dosing increased EASI-100 response from 4% to 22%, while quarterly dosing increased it from 9% to 18% among re-randomized patients [5] Group 2: Analyst Upgrades and Market Position - William Blair upgraded Nektar Therapeutics to Outperform, citing the deepening of response and durability of the therapy as key factors [6] - The analyst noted that approximately 20% of patients achieved complete disease clearance (EASI-100) after re-randomization, with about 30% achieving this among those who had a prior response [6] - EASI-75 and EASI-90 scores showed remarkable similarity, with quarterly dosing maintaining a higher response rate compared to competitor datasets [7] Group 3: Financial Developments - Nektar Therapeutics initiated a public offering to raise $300 million through equity [8] - The stock closed at $56.00, reflecting a 51.07% increase in regular trading, and continued to rise to $59.10 in early trading [8]
Nektar Therapeutics (NKTR) Discusses 36-Week Maintenance Results From Phase 2b REZOLVE-AD Study in Atopic Dermatitis Transcript
Seeking Alpha· 2026-02-10 21:24
Core Viewpoint - The conference call is focused on discussing the maintenance data of REZOLVE-AD, a treatment for atopic dermatitis, with insights from industry experts [1]. Group 1: Company Overview - Nektar Therapeutics is hosting an analyst and investor event to present findings related to REZOLVE-AD [1]. - Key executives participating in the call include Howard Robin (President and CEO), Dr. Jonathan Zalevsky (Chief Research and Development Officer), and Dr. Mary Tagliaferri (Chief Medical Officer) [2]. Group 2: Future Outlook - The company plans to make forward-looking statements regarding the therapeutic potential and future development plans for rezpegaldesleukin, as well as the timing for future clinical data presentations [3]. - These forward-looking statements are subject to uncertainties and risks that may affect actual results [4].
Nektar Therapeutics (NasdaqCM:NKTR) Update / briefing Transcript
2026-02-10 14:02
Nektar Therapeutics (NasdaqCM:NKTR) Conference Call Summary Company Overview - **Company**: Nektar Therapeutics - **Focus**: Development of Rezpegaldesleukin (ResPEG) for the treatment of atopic dermatitis and other conditions Key Points from the Conference Call Industry and Product Insights - **Therapeutic Area**: Atopic dermatitis, with a focus on patients with comorbid asthma, which represents 25% of the overall population [3][12] - **Mechanism of Action**: ResPEG utilizes a novel TREG mechanism to promote immune resolution, differentiating it from traditional cytokine-blocking therapies [8][9] - **Clinical Trials**: Phase 2b Resolve AD study results were discussed, highlighting the efficacy and safety of ResPEG over a 36-week maintenance period [3][15] Clinical Data Highlights - **Efficacy Results**: - 74% of patients on the 24 microgram per kilogram monthly regimen maintained their EASI-75 response at week 52 [22] - 80% of patients on the monthly dosing regimen maintained an EZ90 response, compared to 78% on the quarterly regimen [23] - New responders were identified, with 41% and 40% of non-responders converting to vIGA responders at the end of 52 weeks for monthly and quarterly regimens, respectively [29] - A five-fold increase in patients achieving complete disease clearance (EASI-100) was observed, with 30% of patients achieving this by the end of 52 weeks [31] Safety Profile - **Adverse Events**: - Discontinuation due to adverse events was low at 3.5%, with no new safety signals identified [32] - Injection site reactions (ISRs) were the most common adverse events, with a frequency of 0.7% leading to treatment discontinuation [32][70] - The incidence of ISRs decreased during the maintenance phase compared to induction [33] Future Development Plans - **Phase 3 Trials**: Plans to initiate Phase 3 trials in Q2 2026, targeting a BLA submission in 2029 [5][36] - **Patient Population**: Trials will include biologic-naïve patients and those who have received prior biologics or JAK inhibitors [37] Competitive Landscape - **Comparison with Dupilumab**: ResPEG's maintenance efficacy was shown to be comparable or superior to Dupilumab, particularly in maintaining vIGA responses [25][26] - **Market Positioning**: ResPEG is positioned as a first-line treatment option, especially for patients with comorbid asthma, which is a significant differentiator from other therapies [44][52] Expert Opinions - **Clinical Adoption**: Experts expressed optimism about using ResPEG as a first-line treatment due to its efficacy and safety profile, particularly for difficult-to-treat patients [42][48] Upcoming Milestones - **Data Presentations**: Additional data from the Resolve AD study and other ongoing studies are expected to be presented at medical meetings in the coming year [38] Conclusion Nektar Therapeutics is advancing its clinical development of ResPEG for atopic dermatitis, demonstrating promising efficacy and safety data. The upcoming Phase 3 trials and the potential for a BLA submission in 2029 position the company favorably in the competitive landscape of dermatological therapies.
Nektar to Hold Conference Call to Discuss Topline Results from the 36-Week Maintenance Period for its REZOLVE-AD Phase 2b Study of Rezpegaldesleukin in Atopic Dermatitis on February 10, 2026
Prnewswire· 2026-02-09 21:15
Core Insights - Nektar Therapeutics will host an investor call and live webcast to discuss topline results from the 36-week maintenance period of the Phase 2b REZOLVE-AD clinical trial for rezpegaldesleukin, targeting moderate-to-severe atopic dermatitis on February 10, 2026 [1] Company Overview - Nektar Therapeutics is a clinical-stage biotechnology company focused on developing treatments for autoimmune and chronic inflammatory diseases [3] - The lead product candidate, rezpegaldesleukin (REZPEG or NKTR-358), is a first-in-class regulatory T cell stimulator being evaluated in two Phase 2b clinical trials: one for atopic dermatitis and another for alopecia areata, along with a Phase 2 trial for Type 1 diabetes mellitus [3] - Nektar's pipeline includes a preclinical bivalent tumor necrosis factor receptor type II (TNFR2) antibody, bispecific programs NKTR-0165 and NKTR-0166, and a modified hematopoietic colony stimulating factor (CSF) protein, NKTR-422 [3] - The company is also evaluating NKTR-255, an investigational IL-15 receptor agonist aimed at enhancing the immune system's ability to combat cancer, in several ongoing clinical trials [3]
5 Small Drug Stocks to Buy as Industry Recovery Picks Up
ZACKS· 2026-01-07 14:46
Industry Overview - The drug and biotech sector has shown recovery after a sluggish first half, supported by drug pricing agreements with the Trump administration and renewed M&A activity [1][4] - Innovation in areas such as obesity treatments, gene therapy, inflammation, and neuroscience continues to drive growth, despite challenges like pipeline setbacks and regulatory uncertainty [2][3] Market Performance - The Zacks Medical-Drugs industry has underperformed compared to the Zacks Medical sector and the S&P 500 over the past year, with a collective rise of 1.2% compared to 3.4% and 18.9% respectively [13] - The industry currently holds a Zacks Industry Rank of 90, placing it in the top 37% of 244 Zacks industries, indicating potential for outperformance [12] Valuation Metrics - The industry is trading at a trailing 12-month price-to-sales (P/S) ratio of 2.25, lower than the S&P 500's 6.03 and the Zacks Medical sector's 2.61 [16] Key Companies and Their Prospects - **Ironwood Pharmaceuticals**: Developing apraglutide for short bowel syndrome, with a significant rise in stock price by 178.9% in the past three months and a consensus estimate for 2026 earnings increasing from $0.40 to $0.47 [20][22] - **Rigel Pharmaceuticals**: Sales of Tavalisse rose by approximately 54% in the first nine months of 2025, with a stock increase of 46.7% and a consensus estimate for 2026 earnings rising from $3.70 to $4.30 [24][27] - **Soleno Therapeutics**: Launched Vykat XR for Prader-Willi syndrome, generating around $99 million in sales since April, with a stock decline of 25.7% but a rising consensus estimate for 2026 earnings from $3.10 to $3.59 [29][30] - **Marker Therapeutics**: Focused on next-generation T cell therapies, with a stock increase of 75.5% and a narrowing consensus estimate for 2026 loss per share from $4.92 to $1.86 [33][34] - **Nektar Therapeutics**: Developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with a stock decline of 26.0% but a narrowing consensus estimate for 2026 loss per share from $12.17 to $10.81 [36][38]
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Nektar Therapeutics - NKTR
Globenewswire· 2025-12-30 17:40
Core Viewpoint - Pomerantz LLP is investigating claims on behalf of investors of Nektar Therapeutics regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1]. Group 1: Company Performance - On December 16, 2025, Nektar announced topline results from the Phase 2b REZOLVE-AA trial of its investigational drug rezpegaldesleukin, which failed to reach statistical significance due to the inclusion of four ineligible patients [3]. - Following the announcement of the trial results, Nektar's stock price dropped by $4.14 per share, or 7.77%, closing at $49.16 per share on the same day [4]. Group 2: Legal Investigation - Pomerantz LLP, a firm known for its work in corporate and securities class litigation, is leading the investigation into Nektar's business practices and potential fraud [5].
The Zacks Analyst Blog Mineralys, Lyell, Insmed and Nektar
ZACKS· 2025-12-26 08:35
Industry Overview - The drug and biotech sector experienced a volatile performance in 2025, with a significant recovery in the last few months attributed to improved drug pricing policies and strong merger and acquisition activity [2] - The biotech sector has rallied 26% over the past six months, outperforming the S&P 500 index [2] Innovation and Regulatory Activity - Key growth areas in the industry include obesity, gene therapy, inflammation, and neuroscience, attracting investor interest [3] - The FDA approved 44 novel therapies as of December 22, 2025, indicating healthy regulatory activity [3] Company Highlights Mineralys Therapeutics - Mineralys is developing lorundrostat, an aldosterone synthase inhibitor for uncontrolled hypertension, chronic kidney disease, and obstructive sleep apnea [5] - The pivotal phase III Launch-HTN study and phase II Advance-HTN study met primary efficacy endpoints, showing favorable safety [6] - The company plans to submit a new drug application for lorundrostat in early 2026, with shares up 203.4% year-to-date [8][9] Lyell Immunopharma - Lyell focuses on next-generation CAR T-cell therapies, with its lead candidate ronde-cel for large B-cell lymphoma [11] - A pivotal phase III study for ronde-cel is expected to begin in early 2026, and the company has a strong cash position of approximately $320 million [14] - Shares have increased by 191.6% in 2025, with loss per share estimates narrowing from $12.68 to $9.70 [15] Insmed - Insmed markets Arikayce for refractory MAC lung disease, generating $314.5 million in sales in the first nine months of 2025, a 21% increase year-over-year [16] - The FDA approved Brinsupri for non-CF bronchiectasis, with sales of $28.1 million in Q3 2025 [17] - Despite a setback with the BiRCh study, the company is evaluating Brinsupri for hidradenitis suppurativa, with shares up 156% year-to-date [19][20] Nektar Therapeutics - Nektar is developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with positive data from phase IIb studies [21][22] - The company plans to advance rezpeg into phase III development in 2026, with shares soaring 218.8% year-to-date [24][25]
4 Drug, Biotech Stocks Rising More Than 50% in 2025 With Room to Grow
ZACKS· 2025-12-24 16:56
Industry Overview - The drug and biotech sector experienced a volatile performance in 2025, with a significant recovery in the last months attributed to improved drug pricing policies and strong M&A activity, leading to a 26% rally in the biotech sector over the past six months, outperforming the S&P 500 index [1] - Innovation is expected to drive growth in key areas such as obesity, gene therapy, inflammation, and neuroscience, with the FDA approving 44 novel therapies as of December 22, 2025, and strong M&A activity anticipated to continue into 2026 [2] Company Highlights Mineralys Therapeutics (MLYS) - MLYS's product candidate, lorundrostat, is in development for uncontrolled hypertension, chronic kidney disease, and obstructive sleep apnea, with pivotal studies showing positive results and plans for NDA submission in early 2026 [6][8] - MLYS shares surged 203.4% year-to-date, supported by favorable regulatory updates and strong clinical data [9] - The company has narrowed its loss per share estimates for 2026 from $3.06 to $2.50 [10] Lyell Immunopharma (LYEL) - LYEL focuses on next-generation CAR T-cell therapies, with its lead candidate, ronde-cel, in pivotal studies for large B-cell lymphoma, and a second pivotal study expected to begin in early 2026 [11][14] - LYEL shares increased by 191.6% year-to-date, bolstered by a strong cash position of approximately $320 million as of September 30, 2025 [16] - Loss per share estimates for 2026 have narrowed from $12.68 to $9.70 [17] Insmed (INSM) - INSM markets Arikayce for refractory MAC lung disease, generating $314.5 million in sales in the first nine months of 2025, a 21% increase year-over-year [18] - The FDA approved Brinsupri for non-CF bronchiectasis, with sales of $28.1 million in Q3 2025, although the company faced a setback with the failure of the BiRCh study [19][20] - INSM shares rose 156% year-to-date, with loss per share estimates for 2026 narrowing from $3.65 to $3.58 [22] Nektar Therapeutics (NKTR) - NKTR is developing rezpegaldesleukin for atopic dermatitis and alopecia areata, with positive data from phase IIb studies supporting its advancement into phase III development in 2026 [23][25] - NKTR shares skyrocketed 218.8% year-to-date, with loss per share estimates for 2026 narrowing from $12.82 to $10.81 [27]