Tonix Pharmaceuticals Holding Corp (NASDAQ:TNXP) is one of the top long-term biotechnology stocks to buy. On October 17, Tonix Pharmaceuticals (NASDAQ:TNXP) presented encouraging preclinical data for its investigational mpox and smallpox vaccine candidate, TNX-801, at the World Vaccine Congress Europe 2025. Tonix Pharmaceuticals Holding Corp (TNXP) Showcases Promising TNX-801 Vaccine Data The live, attenuated horsepox-based vaccine elicited strong immune responses, provided long-term protection, and demo ...

Avalo Therapeutics, Inc. (NASDAQ:AVTX) is one of the top long-term biotechnology stocks to buy. On October 17, Piper Sandler analyst Yasmeen Rahimi reaffirmed her Buy rating on Avalo Therapeutics Inc. (NASDAQ:AVTX), maintaining a price target of $48, which implies a substantial upside potential of 167.86% from the stock’s current trading levels. Piper Sandler Maintains Bullish $48 Price Target on Avalo Therapeutics (AVTX) The buy stance underscores confidence in Avalo’s strategic direction and pipeline p ...

Core Insights - Telitacicept has shown significant improvement in quality of life for patients with generalized myasthenia gravis (gMG), with 100% of patients achieving a ≥2-point improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) after 48 weeks [1][2] - The drug demonstrated sustained efficacy and a favorable safety profile, suggesting it may have a global best-in-disease profile for gMG [1][2] Study Results - In the 48-week open-label extension (OLE) study, patients on telitacicept achieved a mean reduction of -7.5 points in MG-ADL, while those who crossed over from placebo achieved a -6.3 point reduction [6] - At week 48, 96.2% of continuous telitacicept patients and 90.2% of crossover patients reached a ≥3-point improvement in MG-ADL [6] - The mean change in Quantitative Myasthenia Gravis (QMG) was -9.8 for continuous patients and -9.3 for crossover patients, with 94.2% and 90.2% achieving a ≥5-point improvement, respectively [6] Mechanism of Action - Telitacicept is a recombinant fusion protein that selectively inhibits BLyS (BAFF) and APRIL, two cytokines crucial for B cell and plasma cell survival, thereby reducing autoreactive B cells and autoantibody production [5] Regulatory Status - Telitacicept is already approved in China for systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and generalized myasthenia gravis (gMG) [7] - A global Phase 3 clinical trial for gMG is currently ongoing across 14 countries, aiming for potential approval in the United States, Europe, and Japan [7] Disease Context - Generalized myasthenia gravis (gMG) is a rare autoimmune neuromuscular disorder affecting approximately 90,000 people in the United States, 140,000 in Europe, and 29,000 in Japan, characterized by muscle weakness due to autoantibodies [8]

Accessibility StatementSkip Navigation On this news, Jasper's stock price fell $3.73 per share, or 55.1%, to close at $3.04 per share on July 7, 2025. The court-appointed lead plaintiff is the investor with the largest financial interest in the relief sought by the class who is adequate and typical of class members who directs and oversees the litigation on behalf of the putative class. Any member of the putative class may move the Court to serve as lead plaintiff through counsel of their choice, or may cho ...

Core Insights - United Therapeutics reported revenue of $799.5 million for the quarter ended September 2025, reflecting a year-over-year increase of 6.8% [1] - The company's EPS was $7.16, up from $6.39 in the same quarter last year, indicating a positive earnings performance [1] - Revenue fell short of the Zacks Consensus Estimate of $817.8 million, resulting in a surprise of -2.24%, while EPS exceeded expectations by 3.92% [1] Revenue Breakdown - U.S. revenues were $774.8 million, compared to an estimated $810.22 million, marking an 8% increase year-over-year [4] - Revenues from the Rest-of-World segment were $24.7 million, below the estimated $33.09 million, representing a decline of 21.8% year-over-year [4] - Tyvaso generated $470.1 million in U.S. revenue, falling short of the $507.8 million estimate, while Unituxin brought in $46.5 million, below the $62.24 million estimate [4] - Adcirca revenues were $9.7 million, exceeding the $5.49 million estimate, with a significant year-over-year increase of 38.6% [4] - Orenitram revenues reached $131.1 million, slightly above the $124.02 million estimate, reflecting a 15.8% year-over-year increase [4] - Tyvaso DPI revenues were $336.2 million, surpassing the $322.54 million estimate, with a year-over-year growth of 22.4% [4] - Other products generated $6.9 million, exceeding the $5.35 million estimate, with a year-over-year increase of 25.5% [4] Stock Performance - Over the past month, United Therapeutics shares have returned -0.9%, contrasting with the Zacks S&P 500 composite's increase of 3.8% [3] - The stock currently holds a Zacks Rank 3 (Hold), suggesting it may perform in line with the broader market in the near term [3]

Analysts on Wall Street project that Insmed (INSM) will announce quarterly loss of -$1.32 per share in its forthcoming report, representing a decline of 3.9% year over year. Revenues are projected to reach $114.65 million, increasing 22.7% from the same quarter last year.The current level reflects a downward revision of 0.6% in the consensus EPS estimate for the quarter over the past 30 days. This demonstrates how the analysts covering the stock have collectively reappraised their initial projections over t ...

Core Insights - Gilead Sciences, Inc. (GILD) is set to report its Q3 2025 results on October 30, with sales and earnings estimates of $7.46 billion and $2.15 per share respectively [1][7] - Earnings estimates for 2025 and 2026 have seen slight declines, with 2025 dropping from $8.09 to $8.07 and 2026 from $8.53 to $8.50 over the past month [1][2] Financial Performance - GILD has a strong earnings surprise history, beating estimates in three of the last four quarters with an average surprise of 11.04% [4][5] - The earnings estimate for Q3 2025 is $2.15 per share, consistent over the past 30 days, while the earnings surprise prediction is currently at -1.34% [8][2] Product Performance - The HIV portfolio, particularly Biktarvy and Descovy, continues to drive top-line growth, with Q3 sales estimates of $3.6 billion for Biktarvy and $629 million for Descovy [9][10] - The recent FDA approval of lenacapavir (Yeztugo) is expected to enhance Gilead's HIV franchise, with projected growth in HIV sales of approximately 3% in 2025 [11][22] Market Dynamics - Gilead's liver disease portfolio, including Livdelzi, is expected to perform well despite some challenges in hepatitis C virus sales [12][14] - Cell Therapy product sales are anticipated to decline due to competitive pressures, with estimates of $476 million for Q3 [15][23] Stock Performance - GILD shares have increased by 27.7% year-to-date, outperforming the industry average of 10.8% [18][19] - The current price/earnings ratio for GILD is 13.98x, higher than its historical mean but lower than the large-cap pharma industry average of 15.57x [21] Strategic Outlook - Gilead's ongoing innovation in the HIV sector and strategic acquisitions are viewed positively, although the Cell Therapy segment faces challenges [22][26] - The company is collaborating with Merck to evaluate a new HIV treatment, with updates expected in 2026 [27]

Financial Data and Key Metrics Changes - United Therapeutics reported record total revenues of $800 million for Q3 2025, representing a 7% growth from Q3 2024 [8] - The company is guiding for a $4 billion revenue run rate by 2027, indicating strong future growth expectations [7][33] Business Line Data and Key Metrics Changes - Continued year-over-year growth in Tyvaso and Orenitram sales, driven by patient demand and effective commercial strategy [8] - Tyvaso sales demonstrated double-digit revenue growth, with no material impact from the launch of Eutrepia [8] - The launch of Tyvaso DPI 80 g cartridges is expected to enhance patient convenience and dosing flexibility [9][49] Market Data and Key Metrics Changes - The company is experiencing strong patient shipments and an increase in the number of prescribers, indicating robust market demand [36] - The TETON 2 study results are anticipated to broaden the therapeutic reach into respiratory diseases, potentially accelerating growth [11] Company Strategy and Development Direction - United Therapeutics is focused on expanding its product portfolio for pulmonary fibrosis and pulmonary hypertension, with significant investments in clinical trials [6][7] - The company is actively engaged in business development and anticipates partnerships with major pharmaceutical companies due to its strong data in pulmonary disease [7][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth profile of Tyvaso and the potential for increased diagnoses of IPF patients following the TETON 2 results [17][18] - The company is optimistic about the synergy between ralinepag and treprostinil, which could enhance treatment options for patients [23][24] Other Important Information - The Remunity Pro pump was launched to improve the experience of parenteral therapy for patients [11] - The company is preparing for upcoming conferences to discuss its product pipeline and business activities [4] Q&A Session Summary Question: Are you seeing an uptick in diagnoses of IPF patients due to TETON 2 results? - Management noted that while physicians are discussing more aggressive screening for pulmonary hypertension in IPF patients, it is still too early to confirm an uptick in diagnoses [15][18] Question: What is the market opportunity for ralinepag? - Management highlighted that ralinepag is exceeding expectations, with strong enrollment in the outcomes trial and best-in-class results for six-minute walk distances [21][22] Question: Can you elaborate on potential partnerships related to Tyvaso IPF data? - Management indicated that skepticism about the drug's efficacy in pulmonary fibrosis is changing, and they are open to partnerships to expand the drug's reach globally [26][30] Question: What are the commercial dynamics for Tyvaso recently? - Management reported strong patient shipments and prescriber growth, with no significant impact from Eutrepia's launch, expecting continued growth in both PAH and PH-ILD [32][36] Question: What is the status of the TETON PPF enrollment and regulatory path? - Management confirmed that enrollment is about halfway through and they are working with the FDA to expedite the regulatory review process [41][43] Question: What are the launch plans for the new 80 g cartridge for Tyvaso DPI? - Management stated that the 80 g cartridge will launch within 30 to 60 days, aimed at enhancing patient convenience and dosing [49]

Financial Data and Key Metrics Changes - United Therapeutics reported record total revenues of $800 million for Q3 2025, representing a 7% growth from Q3 2024 [8] - The company is guiding for a $4 billion revenue run rate by 2027, indicating strong future growth expectations [7][33] Business Line Data and Key Metrics Changes - Continued year-over-year growth in Tyvaso and Orenitram sales, with Tyvaso showing double-digit revenue growth [8] - The launch of Tyvaso DPI is driving a shift in dosing behavior, with an increase in average dosing from nine breaths per treatment to twelve breaths equivalent [9] - New Tyvaso DPI 80-microgram cartridges will soon be launched, allowing patients to take 15 nebulized breaths in one single breath, enhancing convenience [9][49] Market Data and Key Metrics Changes - The company is experiencing no material impact from the launch of Eutrepia, with expectations of continued growth in both PAH and PH-ILD markets [34][36] - The TETON 2 study demonstrated unprecedented treatment benefits for inhaled treprostinil in patients with idiopathic pulmonary fibrosis, potentially broadening the therapeutic reach [11][22] Company Strategy and Development Direction - United Therapeutics is actively engaged in business development and anticipates partnerships with major pharmaceutical companies due to its strong data in pulmonary disease [7][22] - The company emphasizes its public benefit status, focusing on patient care while also considering shareholder interests [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth profile of Tyvaso, supported by favorable coverage decisions from major payers [11] - The company is optimistic about the potential for ralinepag, highlighting its long patent life and the possibility of combination therapies [22][24] Other Important Information - The Remunity Pro pump was launched to enhance the experience of parenteral therapy, designed based on feedback from healthcare providers and patients [12] - The company is preparing for upcoming conferences to present its scientific and commercial advancements [4] Q&A Session Summary Question: Are you seeing an uptick in diagnoses of IPF patients due to TETON 2 results? - Management noted that while physicians are discussing more aggressive screening for pulmonary hypertension in IPF patients, it is still too early to confirm any direct uptick in diagnoses [15][18] Question: Can you elaborate on the market opportunity for ralinepag? - Management highlighted that ralinepag is exceeding expectations, with strong enrollment in the outcomes trial and best-in-class results for six-minute walk distances [21][22] Question: What are the partnership expectations related to Tyvaso IPF data? - Management indicated that skepticism about the drug's efficacy in pulmonary fibrosis is changing, and they are open to partnerships to expand the drug's reach globally [26][30] Question: Can you discuss the commercial dynamics for Tyvaso recently? - Management reported strong patient shipments and prescriber growth, with no material impact from Eutrepia's launch, expecting continued growth in both PAH and PH-ILD [32][36] Question: What is the status of the 80 micrograms cartridge for Tyvaso DPI? - Management confirmed that the new cartridge will launch within 30-60 days, aimed at enhancing patient convenience and dosing flexibility [49]

Financial Data and Key Metrics Changes - United Therapeutics reported record total revenues of $800 million for Q3 2025, representing a 7% growth from Q3 2024 [8] - The company is guiding for a revenue run rate of $4 billion by 2027 [6] Business Line Data and Key Metrics Changes - Continued year-over-year growth in Tyvaso and Orenitram sales, with Tyvaso showing double-digit revenue growth [8] - The launch of Tyvaso DPI is driving a meaningful shift in treprostinil dosing behavior, with an increase in average dosing from nine breaths per treatment to twelve breaths [9] - The introduction of new Tyvaso DPI 80 microgram cartridges is expected to enhance patient convenience and dosing flexibility [10] Market Data and Key Metrics Changes - The company has secured multiple favorable coverage decisions with major payers, validating Tyvaso DPI's market position [11] - The TETON 2 study demonstrated unprecedented treatment benefits for inhaled treprostinil in patients with idiopathic pulmonary fibrosis (IPF), potentially broadening the therapeutic reach [11] Company Strategy and Development Direction - United Therapeutics is actively engaged in business development and anticipates partnerships with major pharmaceutical companies due to its strong data in pulmonary disease [6] - The company is focusing on expanding its product portfolio in pulmonary fibrosis, which presents a larger market opportunity compared to pulmonary hypertension [60] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth profile of Tyvaso, expecting continued growth in both pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD) [42] - The management is optimistic about the potential for ralinepag, highlighting its long patent life and synergy with other treatments [28] Other Important Information - The company is preparing for upcoming conferences to present its pipeline and engage with investors [3][4] - The Remunity Pro pump was launched to enhance the experience of parenteral therapy for patients [11] Q&A Session Summary Question: Are you seeing an uptick in diagnoses of IPF patients due to TETON 2 results? - Management noted that physicians are more aggressive in screening for pulmonary hypertension in IPF patients, but it is too early to quantify any direct impact on sales [15][17] Question: What is the market opportunity for ralinepag? - Ralinepag is exceeding expectations, with strong enrollment in its outcomes trial and best-in-class results in six-minute walk distances [26][28] Question: Can you clarify the guidance for a $4 billion run rate by 2027? - Management confirmed the expectation to reach $1 billion in quarterly revenue by 2027, driven by strong IPF results [38][40] Question: What are the commercial dynamics for Tyvaso? - Management indicated no material impact from the launch of Eutrepia, with continued strong growth in patient shipments and prescriber metrics [41][42] Question: What is the status of the TETON PPF enrollment and regulatory path? - Enrollment is about halfway through, and the company is meeting with the FDA to discuss expediting the regulatory review process [50][51] Question: What are the launch plans for the new 80 microgram cartridge for Tyvaso DPI? - The new cartridge is expected to launch within 30 to 60 days, aimed at enhancing patient convenience and dosing [58][60]