Latest news with #REZPEG
Medscape
30-07-2025
- Health
- Medscape
FDA Puts Alopecia Treatment on Fast Track
The FDA has granted a 'Fast Track' designation to rezpegaldesleukin (REZPEG) as a treatment for severe-to-very severe alopecia areata, according to a press release from the manufacturer, Nektar Therapeutics. The indication applies to adults and children aged 12 years or older weighing at least 40 kg. REZPEG is a novel biologic that targets 'the interleukin-2 receptor complex in the body to stimulate proliferation of inhibitory immune cells known as regulatory T cells,' according to the company. The Fast Track designation was created to help bring important new treatments to patients as soon as possible and is granted to investigational therapies that may address unmet medical needs for serious conditions, according to the press release. REZPEG is being evaluated in the ongoing Rezolve AA phase 2b study in patients with alopecia areata. In the study, 90 patients with severe-to-very severe alopecia areata (defined as scalp involvement of 50% or more) who were not previously treated with a JAK inhibitor or another biologic were randomized to two different doses of REZPEG or placebo. It will be a self-administered injection, the company said. The primary efficacy endpoint is the mean percent change in the Severity of Alopecia Tool (SALT) score at the end of the 36-week induction period, according to the company. Secondary endpoints include the proportion of participants with reductions in SALT scores of 50% or more at 36 weeks and other timepoints, as well as the mean percent improvement in SALT score at multiple timepoints and the proportion of patients achieving an absolute SALT score ≤ 20. Data from the trial are scheduled to be reported in December 2025, according to the company. The designation follows a previous Fast Track designation for the product as a treatment for moderate-to-severe atopic dermatitis in February.
Yahoo
13-03-2025
- Business
- Yahoo
Nektar Therapeutics (NKTR) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial ...
Cash and Investments: $269.1 million at the end of 2024. Revenue: $29.2 million for Q4 2024; $98.4 million for the full year 2024. R&D Expenses: $28.7 million for Q4 2024; $120.9 million for the full year 2024. G&A Expenses: $17.1 million for Q4 2024; $76.8 million for the full year 2024. Net Income: $7.3 million for Q4 2024; net loss of $119 million for the full year 2024. Earnings Per Share: $0.03 basic and diluted for Q4 2024; $0.58 basic and diluted loss per share for the full year 2024. Gain from Sale: $40.4 million gain from the sale of the Huntsville manufacturing facility. 2025 Revenue Guidance: Expected between $40 million and $50 million. 2025 R&D Expense Guidance: Expected between $110 million and $120 million. 2025 G&A Expense Guidance: Expected between $60 million and $65 million. Cash Runway: Expected to extend into Q4 2026. Warning! GuruFocus has detected 8 Warning Signs with NKTR. Release Date: March 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nektar Therapeutics (NASDAQ:NKTR) completed enrollment for its Phase IIB studies in atopic dermatitis and alopecia areata on schedule, demonstrating strong interest from patients and physicians. The company has a strong financial position with a cash runway extending into the fourth quarter of 2026, ending 2024 with $269 million in cash and investments. REZPEG, Nektar's lead autoimmune pipeline program, has shown potential as a novel treatment option with a unique immunomodulating mechanism, offering hope for more durable treatment options. Nektar Therapeutics (NASDAQ:NKTR) has expanded its pre-clinical pipeline in immunology and inflammation, advancing its TNFR2 agonist antibody program, NKTR-0165, with plans for an IND submission in the second half of 2025. The company has formed a clinical trial agreement with TrialNet to investigate REZPEG in type 1 diabetes, highlighting its commitment to addressing unmet needs in autoimmune diseases. Nektar Therapeutics (NASDAQ:NKTR) reported a net loss of $119 million for the full year 2024, indicating ongoing financial challenges. The company's revenue for 2024 was $98.4 million, which may not be sufficient to offset its R&D and G&A expenses. There is uncertainty regarding the efficacy of REZPEG in its Phase IIb trials, with the company aiming to replicate promising Phase Ib results. The competitive landscape for atopic dermatitis and alopecia areata treatments is highly competitive, posing challenges for market penetration. The company's reliance on forward-looking statements introduces risks and uncertainties that could impact future performance and outcomes. Q: How are you thinking about dose response across the three dose arms in the atopic dermatitis study? A: Jonathan Zalevsky, Chief Research and Development Officer, explained that they addressed dose response with three different cohorts evaluating both dose level and regimen. Two cohorts evaluated the 24 microgram per kilogram dose, one twice a month and the other once a month, to model the pharmacodynamic profile of Tregs. The third cohort used an 18 microgram per kilogram dose twice a month, chosen to be higher than the 12 microgram per kilogram used in Phase Ib, which showed lower efficacy. Q: What efficacy bar on EASI or IGA would be commercially viable for advancing REZPEG into pivotal development? A: Jonathan Zalevsky noted that they are looking to replicate the Phase Ib results, which showed a dramatic separation from placebo and an 83% change from baseline. They also consider efficacy in the range of Dupixent, the current standard of care, as a successful outcome. The novel mechanism of REZPEG, which has shown a remittive effect, is expected to be appreciated in the underserved market. Q: What is the scope of data planned for the top line Phase II atopic dermatitis results release, and what secondary endpoints should be looked for? A: Jonathan Zalevsky mentioned that the focus will be on the 16-week induction data to provide a directional understanding of the drug's performance. The greatest impact in the first-line setting would be achieved through efficacy, and they aim to replicate the marked results from Phase Ib. The novel mechanism of REZPEG, offering durable responses and low-frequency dosing, is expected to impact the market significantly. Q: Can you provide updates on the timing or expectations for the interim PFS results from the JAVELIN Bladder Medley study? A: Jonathan Zalevsky stated that the results are expected in the middle of the year, as it is an event-driven analysis. The goal is to improve PFS and potentially OS compared to single-agent BAVENCIO in the post-chemo setting. The study is designed to test the combination of NKTR-255 plus BAVENCIO versus BAVENCIO alone. Q: How do you expect the patient baseline in the Phase II atopic dermatitis trial to impact the placebo arm? A: Jonathan Zalevsky hopes for baseline EASI scores in the range of 25 to 30, which have been linked with lower placebo responses and better studies. They implemented several prospective features, such as limiting the US footprint and focusing on experienced dermatologists, to protect the study from high placebo response rates. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
13-03-2025
- Business
- Yahoo
Nektar Therapeutics (NKTR) Q4 2024 Earnings Call Highlights: Strategic Advances Amid Financial ...
Cash and Investments: $269.1 million at the end of 2024. Revenue: $29.2 million for Q4 2024; $98.4 million for the full year 2024. R&D Expenses: $28.7 million for Q4 2024; $120.9 million for the full year 2024. G&A Expenses: $17.1 million for Q4 2024; $76.8 million for the full year 2024. Net Income: $7.3 million for Q4 2024; net loss of $119 million for the full year 2024. Earnings Per Share: $0.03 basic and diluted for Q4 2024; $0.58 basic and diluted loss per share for the full year 2024. Gain from Sale: $40.4 million gain from the sale of the Huntsville manufacturing facility. 2025 Revenue Guidance: Expected between $40 million and $50 million. 2025 R&D Expense Guidance: Expected between $110 million and $120 million. 2025 G&A Expense Guidance: Expected between $60 million and $65 million. Cash Runway: Expected to extend into Q4 2026. Warning! GuruFocus has detected 8 Warning Signs with NKTR. Release Date: March 12, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Nektar Therapeutics (NASDAQ:NKTR) completed enrollment for its Phase IIB studies in atopic dermatitis and alopecia areata on schedule, demonstrating strong interest from patients and physicians. The company has a strong financial position with a cash runway extending into the fourth quarter of 2026, ending 2024 with $269 million in cash and investments. REZPEG, Nektar's lead autoimmune pipeline program, has shown potential as a novel treatment option with a unique immunomodulating mechanism, offering hope for more durable treatment options. Nektar Therapeutics (NASDAQ:NKTR) has expanded its pre-clinical pipeline in immunology and inflammation, advancing its TNFR2 agonist antibody program, NKTR-0165, with plans for an IND submission in the second half of 2025. The company has formed a clinical trial agreement with TrialNet to investigate REZPEG in type 1 diabetes, highlighting its commitment to addressing unmet needs in autoimmune diseases. Nektar Therapeutics (NASDAQ:NKTR) reported a net loss of $119 million for the full year 2024, indicating ongoing financial challenges. The company's revenue for 2024 was $98.4 million, which may not be sufficient to offset its R&D and G&A expenses. There is uncertainty regarding the efficacy of REZPEG in its Phase IIb trials, with the company aiming to replicate promising Phase Ib results. The competitive landscape for atopic dermatitis and alopecia areata treatments is highly competitive, posing challenges for market penetration. The company's reliance on forward-looking statements introduces risks and uncertainties that could impact future performance and outcomes. Q: How are you thinking about dose response across the three dose arms in the atopic dermatitis study? A: Jonathan Zalevsky, Chief Research and Development Officer, explained that they addressed dose response with three different cohorts evaluating both dose level and regimen. Two cohorts evaluated the 24 microgram per kilogram dose, one twice a month and the other once a month, to model the pharmacodynamic profile of Tregs. The third cohort used an 18 microgram per kilogram dose twice a month, chosen to be higher than the 12 microgram per kilogram used in Phase Ib, which showed lower efficacy. Q: What efficacy bar on EASI or IGA would be commercially viable for advancing REZPEG into pivotal development? A: Jonathan Zalevsky noted that they are looking to replicate the Phase Ib results, which showed a dramatic separation from placebo and an 83% change from baseline. They also consider efficacy in the range of Dupixent, the current standard of care, as a successful outcome. The novel mechanism of REZPEG, which has shown a remittive effect, is expected to be appreciated in the underserved market. Q: What is the scope of data planned for the top line Phase II atopic dermatitis results release, and what secondary endpoints should be looked for? A: Jonathan Zalevsky mentioned that the focus will be on the 16-week induction data to provide a directional understanding of the drug's performance. The greatest impact in the first-line setting would be achieved through efficacy, and they aim to replicate the marked results from Phase Ib. The novel mechanism of REZPEG, offering durable responses and low-frequency dosing, is expected to impact the market significantly. Q: Can you provide updates on the timing or expectations for the interim PFS results from the JAVELIN Bladder Medley study? A: Jonathan Zalevsky stated that the results are expected in the middle of the year, as it is an event-driven analysis. The goal is to improve PFS and potentially OS compared to single-agent BAVENCIO in the post-chemo setting. The study is designed to test the combination of NKTR-255 plus BAVENCIO versus BAVENCIO alone. Q: How do you expect the patient baseline in the Phase II atopic dermatitis trial to impact the placebo arm? A: Jonathan Zalevsky hopes for baseline EASI scores in the range of 25 to 30, which have been linked with lower placebo responses and better studies. They implemented several prospective features, such as limiting the US footprint and focusing on experienced dermatologists, to protect the study from high placebo response rates. For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus. Sign in to access your portfolio
