Ipsen delivers strong results in 2025, driven by solid execution across all therapeutic areas, and provides 2026 guidance

On February 12, 2026 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-care biopharmaceutical company, reported its financial results for the full year (FY) 2025 and for the fourth quarter of 2025.

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Extract of consolidated results4 for FY25 and FY24

FY 2025 FY 2024 % change
€m €m Actual CER
Total Sales 3,675.9 3,400.6 8.1 % 10.9 %
Core Operating Income 1,294.1 1,109.4 16.7 %
Core operating margin 35.2 % 32.6 % +2.6pts
Core Consolidated Net Profit 1,009.1 857.8 17.6 %
Core earnings per share (fully diluted) €12.09 €10.27 17.8 %
IFRS Operating Income 625.9 496.7 26.0 %
IFRS operating margin 17.0 % 14.6 % +2.4pts
IFRS Consolidated Net Profit 444.5 347.3 28.0 %
IFRS earnings per share (fully diluted) €5.32 €4.15 28.3 %
Free Cash Flow 1,000.6 774.4 29.2 %
Closing net cash/(debt) 559.9 160.3 n/a

"In 2025, Ipsen delivered strong sales and profit growth," said David Loew, Chief Executive Officer, Ipsen. "We continued to execute across all three therapeutic areas, with a notable performance from Iqirvo. We have advanced multiple pipeline programs and further strengthened our innovation engine through targeted business development, including the acquisition of Imcheck Therapeutics. We also achieved promising proof-of-concept for IPN10200, our first-in-class differentiated long-acting recombinant molecule.

We are expecting another year of double-digit sales growth for 2026, supported by accelerated performance across the entire portfolio and a better outlook for Somatuline given the production challenges faced by generic competition. We anticipate five regulatory and clinical milestones this year and to further deliver on our external innovation strategy."

Full-year 2026 guidance and mid-term outlook
Ipsen has set for FY 2026 the following financial guidance:

Total sales growth greater than 13.0%, at constant currency. Based on the average level of exchange rates in January 2026, an adverse effect on total sales of around 2% of currencies is expected
Core operating margin greater than 35.0% of total sales, which includes additional R&D expenses from anticipated early and mid-stage external-innovation opportunities
Guidance on total sales and core operating margin is assuming accelerated sales growth of the portfolio excluding Somatuline and the growth of Somatuline sales due to generic lanreotide challenges. It excludes any impact from potential late-stage (Phase III clinical development or later) business development transactions.

As part of its ongoing review of long-term assumptions including competitive intensity and product lifecycle considerations, Ipsen no longer expects to achieve the €500m peak sales for Onivyde and Tazverik.

Based on higher expected Somatuline sales due to continued generic lanreotide production challenges and the performance of the broader portfolio, Ipsen is highly confident on its 2027 mid-term outlook to exceed the total-sales average growth5 of at least 7% per year for the period 2023-27 and core operating margin in 2027 of at least 32%6 of total sales.

Pipeline progress
During 2025, Ipsen achieved a number of important regulatory and clinical milestones across its portfolio, reflecting continued advancement of its pipeline across the three therapeutic areas.

In the first quarter of 2025, the regulatory filing for tovorafenib, an oral, type II RAF-kinase inhibitor for pediatric low-grade glioma, was accepted for review by the European Medicines Agency (EMA).

In May 2025, Ipsen presented Phase II data from the ELMWOOD study of Iqirvo (elafibranor) at the European Association for the Study of the Liver (EASL) Congress, demonstrating a favorable safety profile and dose-dependent efficacy over 12 weeks in people living with primary sclerosing cholangitis, a condition with high unmet medical need.

In July 2025, the European Commission approved Cabometyx (cabozantinib) for the treatment of previously treated advanced neuroendocrine tumors (NETs), based on positive results from the Phase III CABINET trial.

In September 2025, positive Phase II data from the LANTIC trial in aesthetics were reported, demonstrating a differentiated, long-acting clinical profile for IPN10200. During the year, Ipsen also initiated a Phase II study of IPN10200 in cervical dystonia, representing the fourth clinical study in the development plan of the global long-acting recombinant molecule across therapeutic and aesthetic indications.

In December 2025, Ipsen announced that the pivotal Phase II FALKON trial of fidrisertib in fibrodysplasia ossificans progressiva (FOP) did not meet its primary endpoint and that the study was subsequently closed; fidrisertib was generally well-tolerated, with no safety concerns identified.

In addition, Ipsen initiated multiple Phase I oncology studies across IPN01195, a RAF inhibitor, the antibody-drug conjugate IPN60300 and the T-cell activator IPN01203, further strengthening its targeted oncology pipeline.

External innovation
In December 2025, Ipsen expanded its immuno-oncology portfolio with the acquisition of ImCheck Therapeutics, a biotechnology company developing next-generation immuno-oncology therapies including IPN60340 (ICT01), a first-in-class monoclonal antibody targeting BTN3A, currently in Phase I/II development, with a Phase IIb/III study planned to start in 2026. IPN60340 has the potential to be a new standard of care in combination in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults.

Interim data orally presented at the annual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 from the Phase I/II EVICTION trial showed treatment with ICT01 in combination with venetoclax and azacitidine (Ven-Aza) achieved very encouraging high responses. In this single-arm trial, treatment response nearly doubled relative to those seen in historical standard-of-care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard-of-care (Ven-Aza). In January 2026, Ipsen also announced that IPN60340 received U.S. FDA Breakthrough Therapy Designation in first-line unfit acute myeloid leukemia.

In December 2025, Ipsen further strengthened its oncology and early-stage pipeline through two additional targeted business development and research collaborations. Ipsen entered into an exclusive licensing agreement with Simcere Zaiming for rights outside Greater China to SIM0613, an antibody–drug conjugate (ADC) targeting LRRC15. Ipsen also announced a new research collaboration and option agreement with the Université de Montréal and IRICoR, encompassing two discovery-stage programs focused on novel inhibition of pathways complementary to the MAP kinase pathway.

2026 Upcoming Milestones
Ipsen anticipates several key milestones across its portfolio in 2026, including:

Tovorafenib (FIREFLY-1) – European regulatory decision for pediatric low-grade glioma
Bylvay (BOLD) – Readout of pivotal Phase III in biliary atresia
Iqirvo (ELSPIRE) – Readout of pivotal Phase III in primary biliary cholangitis
Dysport (BEOND) – Readout of pivotal Phase III trials in chronic and episodic migraine
IPN10200 (LANTIC) – Readout of Phase II in lateral canthal lines and forehead lines
These milestones reinforce Ipsen’s commitment to advancing innovative therapies and expanding treatment options for patients worldwide.

Full data from the Phase II LANTIC study of IPN10200, which demonstrated a positive first-in-class, differentiated long-acting clinical profile enabling the initiation of Phase III, are expected to be presented in the first half of 2026 at an upcoming congress.

Galderma arbitration
In January 2026, the Arbitral Tribunal of the International Chamber of Commerce (ICC) issued a final decision in favor of Ipsen, dismissing the claim brought by Galderma in connection with Ipsen’s termination of the R&D agreement. The Tribunal confirmed Ipsen’s full rights to its clinical-stage toxin programs in the aesthetics field, including IPN10200. Ipsen continues to assess all options to maximize the value of its long-acting program.

Environmental, Social and Governance
Ipsen took important steps in 2025 to deliver its ambitious sustainability strategy, continuing to embed sustainability across its operations and decision-making. From reducing its environmental footprint to advancing patient access and strengthening its workplace culture, Ipsen reinforced its commitment to delivering progress for patients, employees, communities, and the planet.

Ipsen made good progress across multiple environmental targets, including:

54% reduction in Scopes 1 & 2 greenhouse gas emissions (vs. a 2019 baseline)
16% reduction in Scope 3, fully in line with our 2030 targets (vs. a 2019 baseline)
100% of Ipsen’s global electricity now comes from renewable sources
55% of the company fleet now comprised of electric vehicles as of 2025 through the Fleet for Future Project
Ipsen received an A rating from CDP for our best-practice environmental actions and transparency, and for demonstrating our comprehensive understanding of environmental dependencies, risks, and opportunities.

Ipsen is proud to be one of the first biopharmaceutical companies to achieve full gender parity within the Executive Leadership Team, and with women now representing 53% of the Global Leadership Team.

Consolidated financial statements
The Board of Directors approved the consolidated financial statements on 11 February 2026. The consolidated financial statements have been audited, and the Statutory Auditors’ report is in the process of being published. Ipsen’s comprehensive audited financial statements will be available on ipsen.com in due course, under the Reports and Accounts tab in the Investor Relations section.

Conference call
A conference call and webcast for investors and analysts will begin today at 2pm CET. Participants can access the webcast here. Analysts can join the call and ask questions by registering here.

(Press release, Ipsen, FEB 12, 2026, View Source [SID1234662640])

INOVIO to Participate in Upcoming Scientific and Investor Conferences

On February 12, 2026 INOVIO (NASDAQ:INO), a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-associated diseases, cancer and infectious diseases, reported that it will participate in the following scientific and investor conferences:

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American Association for Cancer Research Immuno-Oncology Conference (Los Angeles, CA)
Date: Wednesday, February 18
Time: 7:30-10 PM PT, Poster Session A
Poster Presentation: Treatment of RRP with DNA immunotherapy INO-3107 induces activation and enrichment of pro-inflammatory CD4+ T cell responses in blood and airways of patients with clinical response

Oppenheimer 36th Annual Healthcare Life Sciences Conference (Virtual)
Date: Wednesday, February 25
Time: 12:40 -1:10 PM ET
Format: Fireside Chat
Webcast: https://event.summitcast.com/view/CTtthLh2Bi2D9aYoKpvtEv/degYsHNqjq4UMJYMr4minN

Festival of Biologics (San Diego, CA)
Date: Wednesday, March 4
Time: 3:10 PM PT
Presentation: Safety and Pharmacokinetics of SARS-CoV-2 DNA-Encoded Monoclonal Antibodies (DMAbs) in Healthy Adults: A Phase 1 Trial

Citizens Life Sciences Conference (Miami Beach, FL)
Date: Tuesday, March 10
Time: 1:40 – 2:05 PM ET
Format: Fireside Chat
Webcast: https://event.summitcast.com/view/BuMiPNPtyHKimMF6k4AFMd/j7XuLLN6VFvrBMcQmqB55w

Available abstracts will be shared on INOVIO’s website following presentations. Replay of the investor events will be available for 90 days at the links above and on the INOVIO events page. Members of INOVIO’s management team will also be conducting one-on-one meetings with investors during the investor conferences.

(Press release, Inovio, FEB 12, 2026, View Source [SID1234662639])

GENFIT to receive US$20M milestone after Ipsen’s Iqirvo® exceeds the US$200M threshold in its first full year of net sales

On February 12, 2026 GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported that the strong commercial performance of Iqirvo in its first full year on the primary biliary cholangitis (PBC) market has triggered a US$20M milestone payment from Ipsen under the companies’ licensing agreement.

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The commercial success of Iqirvo in 2025 underscores the strength of our partnership with Ipsen and exceeded our initial expectations with first-year net sales reaching US$208M. This performance activated a US$20M milestone payment ahead of plan, reinforcing GENFIT’s financial position. This momentum also led to the receipt of an additional €30M tranche under GENFIT’s royalty‑financing agreement with HCRx, enhancing financial flexibility in a non-dilutive way.

In parallel, Ipsen confirmed the initiation of the first and only global Phase 3 clinical trial in primary sclerosing cholangitis (PSC), addressing a significant unmet medical need, as no approved therapies currently exist for this severe and progressive disease. PSC represents a substantial untapped market opportunity, comparable in size to second line PBC. Should Iqirvo ultimately receive regulatory approval for this indication, GENFIT would be eligible for additional milestone payments as well as additional double‑digit royalties.

Beyond Iqirvo, GENFIT continues to advance its oncology program. The ongoing Phase 1b study in cholangiocarcinoma (CCA), evaluating GNS561 in combination with a MEK inhibitor, is progressing in line with expectations. As communicated in December 2025, early positive activity was observed in the first evaluable patients at Week 6. Enrollment for a the next escalated-dose cohort has now been completed, with no dose-limiting toxicities (DLTs) reported to date. Recruitment for the following one will now proceed, consistent with the predefined dose‑escalation process. Multi-cohort readouts on safety, tolerability and activity along with the determination of the recommended Phase 2 doses remain expected by the end of the first half of 2026.

Pascal Prigent, CEO of GENFIT declared: "We are pleased with Ipsen’s continued success with Iqirvo. Net sales have surpassed US$200M in 2025 and this remarkable performance has allowed us to get the first commercial milestone a year earlier than anticipated. We believe that this commercial trajectory has the potential to be transformative for our business model. We are also pleased with the progress of our GNS561 program, with a new cohort fully recruited. This program might bring significant hope for patients with a devastating disease, and we are eagerly awaiting new data. As we are also anticipating the first ACLF patients to be included in a phase 2 evaluating G1090N in the second half of the year we believe 2026 will be a landmark year for GENFIT."

GENFIT will publish its 4Q25 revenue and cash position on February 26, 2026.

(Press release, Genfit, FEB 12, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-receive-us20m-milestone-after-ipsens-iqirvor-exceeds [SID1234662638])

CRISPR Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results

On February 12, 2026 CRISPR Therapeutics (Nasdaq: CRSP) reported financial results for the fourth quarter and full year ended December 31, 2025.

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"As we close out the fourth quarter, CRISPR Therapeutics continues to make steady progress across a broad and increasingly mature pipeline," said Samarth Kulkarni, Ph.D., Chairman and Chief Executive Officer of CRISPR Therapeutics. "We made meaningful advances across multiple clinical and preclinical programs, including encouraging data from zugo-cel in autoimmune disease and oncology, continued global uptake of CASGEVY, and important developments across our in vivo liver editing portfolio, and momentum in our siRNA collaboration with Sirius Therapeutics. At the same time, we continue to strengthen our platform capabilities to support long-term value creation. Together, these developments reflect continued execution across the portfolio."

Recent Highlights and Outlook

Hemoglobinopathies and CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY is approved in the U.S., EU, Great Britain, Canada, Switzerland, the Kingdom of Saudi Arabia (KSA), the Kingdom of Bahrain, Qatar, the United Arab Emirates (UAE), and Kuwait for patients 12 years and older with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT).
CASGEVY generated fourth quarter 2025 revenue of $54 million and full year 2025 revenue of $116 million, reflecting continued growth in treated patients. 64 patients received infusions of CASGEVY during the year, including 30 in the fourth quarter. Globally, 147 people with SCD or TDT initiated the treatment process with their first cell collection during the year.
Patient initiations and first cell collections increased nearly three-fold in 2025 compared to 2024, with continued momentum going into 2026.
Access to CASGEVY continued to expand across key markets. As of year-end, approximately 90% of patients in the U.S. have reimbursed access to CASGEVY. CASGEVY is also reimbursed in the U.K., Italy, Austria, Denmark, Luxembourg, KSA, the Kingdom of Bahrain, the UAE, and Kuwait. Most recently, in January, Vertex secured reimbursed access for eligible patients with SCD in Scotland, consistent with the prior reimbursement agreement reached in 2025 for patients with TDT.
At the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2025, positive pediatric data from the pivotal studies in children ages 5-11 years with SCD or TDT were presented and featured in the "Best of ASH (Free ASH Whitepaper)" program. Global regulatory submissions in this age group are expected to begin in the first half of 2026. The U.S. Food and Drug Administration (FDA) awarded a Commissioner’s National Priority Voucher for this pediatric submission, supporting an expedited review once submissions are complete.
CRISPR Therapeutics continues to advance its in vivo hematopoietic stem cell editing approach utilizing lipid nanoparticle (LNP)-mediated delivery through preclinical studies. This initiative has the potential to expand the addressable patient populations for SCD and TDT.

In Vivo Liver Editing

CRISPR Therapeutics continues to advance a diversified portfolio of in vivo gene editing programs leveraging its proprietary LNP delivery platform.

The Company continues to advance CTX310, targeting angiopoietin-related protein 3 (ANGPTL3), in Phase 1b clinical trials, prioritizing development in severe hypertriglyceridemia (sHTG) and refractory hypercholesterolemia. The Company expects to provide an update in the second half of 2026.
Building on insights from CTX320, the Company is advancing its next-generation LPA program, CTX321. CTX321 incorporates an updated guide RNA that demonstrates approximately two-fold greater potency in preclinical testing while utilizing the same LNP delivery system. CTX321 is currently in IND/CTA-enabling studies, with an Lp(a) program update expected in 2026.
CRISPR Therapeutics continues to advance several preclinical in vivo gene editing candidates, including:

CTX460, targeting SERPINA1 for the treatment of alpha-1 antitrypsin deficiency (AATD), is the first investigational candidate to emerge from the Company’s SyNTase editing platform. The Company expects to initiate a clinical trial for CTX460 in mid-2026.
CTX340, targeting angiotensinogen (AGT) for refractory hypertension, is currently in IND/CTA-enabling studies. The Company expects to initiate a clinical trial for CTX340 in the first half of 2026.

siRNA-based Programs

CRISPR Therapeutics’ small interfering RNA (siRNA)-based portfolio includes clinical-stage programs in cardiovascular and thromboembolic diseases, developed in collaboration with Sirius Therapeutics.

CTX611 (SRSD107), a long-acting siRNA targeting Factor XI (FXI), is in an ongoing Phase 2 clinical trial in patients undergoing total knee arthroplasty (TKA). The Company expects to provide an update in the second half of 2026.
The program has the potential to target a range of thromboembolic and clotting-related indications and represents a multi-billion-dollar market opportunity, including atrial fibrillation (AF), venous thromboembolism (VTE), ischemic stroke, cancer-associated thrombosis (CAT), thrombosis in chronic kidney disease (CKD), peripheral vascular disease (PVD), chronic coronary artery disease (CAD). CRISPR Therapeutics is expected to lead global Phase 3 development of CTX611 with Sirius Therapeutics responsible for development activities in greater China.
CRISPR Therapeutics has the option to nominate up to two siRNA targets for research and development and expects to provide an update in 2026. For each target, CRISPR Therapeutics will fund research and retain opt-in rights to lead clinical development and commercialization. Sirius will be eligible to receive milestone payments and contingent payments, as well as tiered royalties.

Autoimmune Disease and Immuno-Oncology

Zugocabtagene geleucel (zugo-cel; formerly CTX112) continues to advance in both autoimmune disease and hematologic malignancies.

In autoimmune disease, Phase 1 clinical trials of zugo-cel are ongoing across multiple indications, including systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and inflammatory myositis and a second Phase 1 trial in immune thrombocytopenia purpura (ITP) and warm autoimmune hemolytic anemia (wAIHA), with continued progress across studies. The Company expects to provide updates in the second half of 2026.
In immuno-oncology, the Phase 1/2 clinical trial of zugo-cel in B-cell malignancies is ongoing. The Company expects to provide updates in the second half of 2026. Zugo-cel is also being evaluated in combination with pirtobrutinib in aggressive B-cell lymphomas under an existing collaboration with Lilly.
CRISPR Therapeutics continues to leverage its proprietary lipid nanoparticle (LNP) delivery platform, mRNA, and conjugation capabilities to advance its in vivo CAR-T platform with potential applications in autoimmune disease and oncology.
CRISPR Therapeutics’ autoimmune disease and immuno-oncology platforms are supported by a wholly-owned, GMP manufacturing facility located in Framingham, Massachusetts, which provides end-to-end production capabilities for its cell therapy portfolio and supports both clinical and future commercial supply.

Regenerative Medicine

CRISPR Therapeutics continues to advance its regenerative medicine portfolio, including its efforts in diabetes. The Company is advancing CTX213, a deviceless beta cell replacement product candidate consisting of unencapsulated precursor islet cells derived from edited induced pluripotent stem cells (iPSCs), for the treatment of Type 1 diabetes. CTX213 has demonstrated compelling preclinical efficacy via direct administration and is progressing towards the clinic. The Company expects to provide additional updates as development progresses.

Upcoming Events

The Company will present at the upcoming events:

Citi’s 2026 Virtual Oncology Leadership Summit

Date: Wednesday, February 18, 2026

Time: 10:45 a.m. ET

TD Cowen 46th Annual Health Care Conference

Date: Monday, March 2, 2026

Time: 11:10 a.m. ET

Leerink Partners Global Healthcare Conference

Date: Wednesday, March 11, 2026

Time: 1:00 p.m. ET

Fourth Quarter and Full Year 2025 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $1,975.8 million as of December 31, 2025, compared to $1,903.8 million as of December 31, 2024. The increase in cash was primarily driven by proceeds from the issuance of common shares, option exercise activity and interest income, offset by operating expenses.
R&D Expenses: R&D expenses were $83.5 million for the fourth quarter of 2025, compared to $71.7 million for the fourth quarter of 2024. The increase in R&D expense was primarily driven by an increase in licensing fees.
G&A Expenses: General and administrative expenses were $18.4 million for the fourth quarter of 2025, compared to $18.1 million for the fourth quarter of 2024.
Collaboration Expense: Collaboration expense, net, was $53.7 million for the fourth quarter of 2025, compared to $10.4 million for the same period in 2024. In 2024, we exercised our option to defer specified costs under the CASGEVY program in excess of the deferral limit of $110.3 million under the amended collaboration agreement with Vertex. The year-over-year increase in collaboration expense reflects the absence of a comparable deferral in 2025.
Net Loss: Net loss was $130.6 million for the fourth quarter of 2025, compared to a net loss of $37.3 million for the fourth quarter of 2024.

About CASGEVY (exagamglogene autotemcel [exa-cel])

CASGEVY is a non-viral, ex vivo CRISPR/Cas9 gene-edited cell therapy for eligible patients with SCD or TDT, in which a patient’s own hematopoietic stem and progenitor cells are edited at the erythroid specific enhancer region of the BCL11A gene. This edit results in the production of high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is the form of the oxygen-carrying hemoglobin that is naturally present during fetal development, which then switches to the adult form of hemoglobin after birth. CASGEVY has been shown to reduce or eliminate VOCs for patients with SCD and transfusion requirements for patients with TDT. CASGEVY is approved for eligible SCD and TDT patients 12 years and older by multiple regulatory bodies around the world.

(Press release, CRISPR Therapeutics, FEB 12, 2026, View Source [SID1234662637])

CORMEDIX TO PARTICIPATE IN UPCOMING INVESTOR CONFERENCES

On February 12, 2026 CorMedix Therapeutics (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, reported that senior management will be presenting and participating in investor meetings at upcoming investor conferences taking place in March.

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Leerink Partners Global Healthcare Conference
Date: March 10, 2026
Time: 1:00pm Eastern
Format: Fireside Chat
Webcast: Link to webcast

Citizens Life Sciences Conference
Date: March 11, 2026
Time: 9:35am Eastern
Format: Fireside Chat
Webcast: Link to webcast

Barclays 28th Annual Global Healthcare Conference
Date: March 12, 2026
Format: One-on-one investor meetings

(Press release, CorMedix, FEB 12, 2026, View Source [SID1234662636])