Faruqi & Faruqi, LLP Securities Litigation Partner James (Josh) Wilson Encourages Investors Who Suffered Losses In Inovio To Contact Him Directly To Discuss Their Options If you purchased or acquired securities in Inovio between October 10, 2023 and December 26, 2025 and would like to discuss your legal rights, call Faruqi & Faruqi partner Josh Wilson directly at 877-247-4292 or 212-983-9330 (Ext. 1310). [You may also click here for additional information] NEW YORK, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Faruqi ...

Financial Data and Key Metrics Changes - Insmed reported a strong performance in 2025, with revenue guidance for BRINSUPRI set at a minimum of $1 billion for 2026, reflecting confidence in market access and early launch performance [9][10] - The company anticipates total revenue in 2026 to be more than double that of 2025, driven by both BRINSUPRI and ARIKAYCE [10][37] - As of the end of 2025, Insmed had approximately $1.4 billion in cash, cash equivalents, and marketable securities, positioning the company well for future investments [40][41] Business Line Data and Key Metrics Changes - BRINSUPRI achieved $144.6 million in net revenue in its first full quarter, exceeding expectations and indicating a strong launch trajectory [12] - ARIKAYCE experienced significant growth, particularly in Japan with a 40% increase compared to 2024, contributing over a quarter of its global revenues [31] - The cost of product revenues for Q4 2025 was $44.2 million, or 16.8% of revenues, reflecting improved gross margin due to BRINSUPRI's contributions [45] Market Data and Key Metrics Changes - The total addressable market for BRINSUPRI in the U.S. is estimated at 500,000 diagnosed patients with non-CF bronchiectasis, with significant potential for expansion as more patients are identified [13][18] - The company is actively working to identify additional patients with undiagnosed bronchiectasis among the 32 million diagnosed with COPD or asthma in the U.S. [17][20] Company Strategy and Development Direction - Insmed aims to expand its leadership in bronchiectasis and NTM, with plans to accelerate the U.S. launch of BRINSUPRI while continuing to grow ARIKAYCE [7][8] - The company is pursuing additional DPP1 inhibitors for respiratory diseases, indicating a strategy to broaden its therapeutic offerings [48] - Insmed is focused on educating physicians about bronchiectasis to enhance patient identification and treatment [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow positivity without needing to raise additional capital, although they may seek capital for strategic opportunities [11][43] - The positive early feedback from physicians and patients regarding BRINSUPRI is expected to drive increased prescribing behavior in the coming quarters [23][81] - Management highlighted the importance of market access dynamics, noting that over 90% of targeted patient lives have access to BRINSUPRI reimbursement [25][28] Other Important Information - The company received orphan drug designation for TPIP for the treatment of pulmonary arterial hypertension, which could enhance its market position [32] - Insmed is evaluating several business development opportunities to expand its pipeline and support future growth [11][76] Q&A Session Summary Question: Expansion of BRINSUPRI's Total Addressable Market - Management acknowledged the potential for expanding BRINSUPRI's market by identifying patients with COPD or asthma who may have undiagnosed bronchiectasis [47] Question: Guidance for BRINSUPRI and Patient Behavior - Management provided insights into patient compliance and prescription dynamics, indicating strong metrics that support their revenue guidance [51][52] Question: Trends in Prescription and Business Development - Management confirmed strong initial performance and expressed confidence in the ongoing launch, while also discussing potential business development opportunities [54][57] Question: Depth of Prescribing and Education Efforts - Management noted that many physicians are initially prescribing BRINSUPRI to one patient, with expectations that positive experiences will lead to increased prescribing [78][81] Question: Ex-U.S. Contribution to Revenue Guidance - Management indicated that contributions from ex-U.S. markets for BRINSUPRI in 2026 will be minimal, with a focus on U.S. sales [71][72]

Madrigal Pharmaceuticals (NasdaqGS:MDGL) Q4 2025 Earnings call February 19, 2026 08:00 AM ET Company ParticipantsBill Sibold - CEODavid Soergel - CMOMardi Dier - CFOTina Ventura - Chief Investor Relations OfficerYasmeen Rahimi - 5-star analyst and MdConference Call ParticipantsAlex Thompson - AnalystEllie Merle - Senior Biotech Equity Research AnalystJay Olson - Md and Senior Biotechnology AnalystJonathan Wolleben - Md and Senior Research AnalystManoj Garg - AnalystMichael DiFiore - Equity Research AnalystP ...

Financial Data and Key Metrics Changes - Insmed reported a strong performance in 2025, with revenue guidance for BRINSUPRI of at least $1 billion in 2026, reflecting confidence in market access and early launch performance [7][8][28] - The company anticipates total revenue in 2026 to be more than double that of 2025, indicating significant growth potential [8][28] - Cash position at the end of 2025 was approximately $1.4 billion, with a cash burn in Q4 including $70 million of one-time items [31][32] Business Line Data and Key Metrics Changes - BRINSUPRI launched with $144.6 million in net revenue in its first full quarter, exceeding expectations [9] - ARIKAYCE showed strong growth, particularly in Japan with a 40% increase compared to 2024, contributing over a quarter of its global revenues [23] - The company is pursuing four Phase III clinical programs for TPIP, which received orphan drug designation for pulmonary arterial hypertension [24][25] Market Data and Key Metrics Changes - The total addressable market for BRINSUPRI in the U.S. is estimated at 500,000 diagnosed patients with non-CF bronchiectasis, with significant room for expansion as only 11,550 new patients started treatment in 2025 [10][11] - The company is focusing on identifying undiagnosed bronchiectasis patients among the 32 million diagnosed with COPD or asthma, which could significantly increase the patient base for BRINSUPRI [14][15][16] Company Strategy and Development Direction - Insmed aims to expand its leadership in bronchiectasis and NTM, with plans to accelerate the U.S. launch of BRINSUPRI while continuing to grow ARIKAYCE [6][7] - The company is also exploring additional DPP-1 inhibitors for respiratory diseases and other indications, indicating a broader strategy for pipeline expansion [38] - Insmed is actively working on outreach and education initiatives to identify potential patients who could benefit from BRINSUPRI [15][17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow positivity without needing to raise additional capital, although they may seek capital for business development opportunities [8][33] - Positive early feedback from physicians and patients regarding BRINSUPRI is expected to drive additional prescribing behavior [19][70] - The market access landscape for BRINSUPRI is progressing well, with over 90% of targeted patient lives having access to reimbursement [20][21] Other Important Information - The gross-to-net guidance for BRINSUPRI in 2026 is expected to be in the mid-20s to low 30s percentage range, reflecting good visibility into payer contracting [30][31] - The company is evaluating several business development opportunities to expand its pipeline and support future growth [8][33] Q&A Session Summary Question: Plans to develop other DPP-1 inhibitors within respiratory disease - Insmed intends to bring other DPP-1 inhibitors forward, including INS1033 for rheumatoid arthritis and inflammatory bowel disease, and is also advancing other DPP-1s for respiratory conditions [38] Question: Guidance for BRINSUPRI and patient behavior dynamics - Management is seeing positive metrics across various patient behavior indicators, which supports their confidence in achieving at least $1 billion in revenue for BRINSUPRI [41][42] Question: Trends in scrip data and interest in business development - The launch is performing strongly, and while management does not track Symphony data, they are confident in the trajectory based on internal metrics [45][46] Question: Depth of prescribing and physician behavior - Many physicians are initially prescribing BRINSUPRI to one or two patients, and positive experiences are expected to lead to increased prescribing [68][70] Question: Ex-U.S. contribution to BRINSUPRI guidance - Ex-U.S. contributions for BRINSUPRI in 2026 are expected to be very small, with the majority of revenue coming from the U.S. market [61] Question: Additional capital for business development - Insmed sees a clear path to cash flow positivity based on existing programs, with business development being a separate consideration for potential capital sourcing [63][65]

Financial Data and Key Metrics Changes - Insmed reported a strong performance in 2025, with revenue guidance for BRINSUPRI of at least $1 billion in 2026, reflecting confidence in market access and early launch performance [5][6][25] - The company anticipates total revenue in 2026 to be more than double that of 2025, indicating a significant growth trajectory [6][25] - As of the end of 2025, Insmed had approximately $1.4 billion in cash, cash equivalents, and marketable securities, positioning the company well for future investments [29][31] Business Line Data and Key Metrics Changes - BRINSUPRI launched in the U.S. with net revenue of $144.6 million in its first full quarter, exceeding expectations [7][20] - ARIKAYCE showed strong growth, particularly in Japan with a 40% increase compared to 2024, contributing significantly to global revenues [21][25] - The company is pursuing additional DPP1 inhibitors for respiratory diseases, indicating a strategy to expand its product portfolio [35] Market Data and Key Metrics Changes - The total addressable market for BRINSUPRI in the U.S. is estimated at 500,000 diagnosed patients with non-CF bronchiectasis, with significant potential for expansion as more patients are identified [8][10] - The company is actively working to identify additional patients with undiagnosed bronchiectasis among those with COPD and asthma, which could significantly increase the patient base for BRINSUPRI [12][13] Company Strategy and Development Direction - Insmed aims to accelerate the U.S. launch of BRINSUPRI while continuing to grow ARIKAYCE, focusing on expanding its clinical pipeline in respiratory, inflammation, immunology, and neurology [4][5] - The company is committed to pursuing first or best-in-class therapies within its target therapeutic areas, indicating a proactive approach to pipeline development [5][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving cash flow positivity without needing to raise additional capital, although they may seek capital for strategic opportunities [6][31] - The positive early feedback from physicians and patients regarding BRINSUPRI is expected to drive further prescribing behavior, enhancing the launch's momentum [17][66] Other Important Information - The gross-to-net guidance for BRINSUPRI in 2026 is expected to be in the mid-20s to low 30s percentage range, reflecting favorable payer contracting dynamics [27][28] - The company is evaluating several business development opportunities to support pipeline expansion and value creation [6][31] Q&A Session Summary Question: Plans to develop other DPP1 inhibitors - Insmed intends to bring other DPP1s forward, including INS1033 for rheumatoid arthritis and inflammatory bowel disease, and is also advancing DPP1s for respiratory conditions [35] Question: Guidance for BRINSUPRI and patient behavior - Management is seeing metrics at or above targets, contributing to confidence in achieving at least $1 billion in revenue for BRINSUPRI [39] Question: Trends in scrip data and interest in business development - Management noted strong initial performance and is open to pursuing first or best-in-class compounds for business development [42][45] Question: Depth of prescribing and physician behavior - Physicians are initially prescribing BRINSUPRI to one or two patients, with expectations that positive experiences will lead to increased prescribing [66] Question: Ex-U.S. contribution to BRINSUPRI guidance - Ex-U.S. contributions for BRINSUPRI in 2026 are expected to be very small, with a focus on U.S. market dynamics [58]

Madrigal Pharmaceuticals (NasdaqGS:MDGL) Q4 2025 Earnings call February 19, 2026 08:00 AM ET Speaker10Good morning, and thank you for standing by. Welcome to Madrigal Pharmaceuticals' fourth quarter and full year 2025 earnings conference call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations ...

Shareholders that lost money on Vistagen Therapeutics, Inc.(VTGN) Urged to Join Class Action - Contact The Gross Law Firm to Learn More [Accessibility Statement] Skip NavigationNEW YORK, Feb. 19, 2026 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Vistagen Therapeutics, Inc. (NASDAQ: VTGN).Shareholders who purchased shares of VTGN during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff i ...

Cassava Sciences said on Thursday the U.S. Department of Justice had ended its probe into the company regarding allegations of research misconduct for its experimental Alzheimer's drug simufilam. ...

SOUTH SAN FRANCISCO, Calif., Feb. 19, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. ("ALX Oncology”; Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced that ALX Oncology leadership will participate in the Wells Fargo Executive Biotech Summit, TD Cowen 46th Annual Health Care Conference, and UBS Biotech Summit. The details of the meetings are as follows: Wells Fargo Executive Biotech Summit F ...

Core Insights - ALX Oncology Holdings Inc. plans to report its fourth quarter and full year 2025 financial results on February 27, 2026, before market open [1] - The company will host a teleconference to discuss the financial results [1] Financial Results Webcast Information - The webcast is scheduled for February 27, 2026, at 5:30 AM PT / 8:30 AM ET [2] - Access to the conference call can be obtained by dialing 1-877-407-0755 or +1-201-389-0913 [2] Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment [4] - The lead candidate, evorpacept, is being evaluated in multiple clinical trials across various cancer indications [4] - The second candidate, ALX2004, is an EGFR-targeted antibody-drug conjugate currently in a Phase 1 trial for EGFR-expressing solid tumors [4]