공시 • May 06
Vertex Pharmaceuticals Incorporated Reaffirms Earnings Guidance for Full Year 2026 Vertex Pharmaceuticals Incorporated reaffirmed earnings guidance for full year 2026. Vertex’s total revenue guidance of $12.95 billion to $13.1 billion includes expectations for continued growth in CF, including the ongoing U.S. rollout and ex-U.S. launches of ALYFTREK, as well as $500 million or more in revenue from non-CF products, including increased patient infusions of CASGEVY through Vertex’s global ATC network and growth in prescriptions and revenue from the second year of the launch of JOURNAVX. 공시 • Apr 07
Vertex Pharmaceuticals Incorporated to Report Q1, 2026 Results on May 04, 2026 Vertex Pharmaceuticals Incorporated announced that they will report Q1, 2026 results at 4:00 PM, US Eastern Standard Time on May 04, 2026 공시 • Apr 06
Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026 Vertex Pharmaceuticals Incorporated, Annual General Meeting, May 13, 2026. 공시 • Mar 10
Vertex Pharmaceuticals Incorporated Announces Positive Interim Analysis Results for Povetacicept in Rainier Phase 3 Trial Vertex Pharmaceuticals Incorporated announced positive data from a pre-specified Week 36 interim analysis of the ongoing Phase 3 RAINIER trial of povetacicept, an engineered fusion protein and dual inhibitor of the BAFF (B cell activating factor) and APRIL (a proliferation inducing ligand) cytokines, in immunoglobulin A nephropathy (IgAN). The trial met its primary objective. In the interim analysis population, patients treated with povetacicept achieved a 52.0% reduction from baseline in urine protein to creatinine ratio (UPCR) at Week 36, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P<0.0001). For the first secondary endpoint, povetacicept treatment led to a 77.4% reduction from baseline in serum Gd-IgA1, resulting in a statistically significant and clinically meaningful reduction of 79.3% (P<0.0001). Povetacicept was generally safe and well tolerated. RAINIER is a global Phase 3 randomized, double-blind, placebo-controlled pivotal trial of povetacicept 80 mg administered subcutaneously every four weeks versus placebo on top of standard of care. A total of 605 patients were randomized in the trial, N=557 are in the main cohort, of which N=199 are in the interim analysis population, and N=48 patients are in an exploratory cohort. These patients are representative of real world IgAN patients at risk of kidney disease progression. The median time from diagnosis of IgAN to randomization in the main cohort was approximately 3.8 years and the trial patients had high rates of background supportive care, with 97.8% of patients on angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARBs), and 67.7% of patients on sodium-glucose co-transporter 2(SGLT2) inhibitors, the latter representing the highest percentage in recently completed IgAN trials. For the interim analysis, the trial’s primary endpoint is percent change from baseline in 24-hour UPCR, and the two alpha-controlled secondary endpoints are percent change from baseline in serum Gd-IgA1 and the proportion of patients to achieve hematuria resolution, all at Week 36. Exploratory endpoints for this interim analysis included the proportion of patients with 24-hour UPCR. Povetacicept was generally safe and well tolerated. The data below reflect 557 patients in the main cohort with a mean duration of treatment of 33.7 weeks for the povetacicept cohort and 33.4 weeks for placebo. Adverse Events Occurring During the Treatment Period in the Safety Population: Placebo N=185 n (%) Patients with any adverse event during the treatment emergent period 145 (78.4), Povetacicept N=372 n (%) Patients with any adverse event during the treatment emergent period 279 (75.0). Adverse events occurring in =10% of patients in either group: Upper respiratory tract infection 21 (11.4) for placebo, 68 (18.3) for povetacicept; Nasopharyngitis 23 (12.4) for placebo, 36 (9.7) for povetacicept; Injection site reactions 4 (2.2) for placebo, 54 (14.5) for povetacicept. Injection site reactions (ISR) were identified using a pre-specified set of Preferred Terms (including, for example, injection site reaction and injection site erythema). All ISRs were non-serious and mild or moderate in severity. Serious AEs occurred in 4.3% (8 out of 185 patients) of the placebo group and 3.0% (11 out of 372 patients) of the povetacicept group. The same incidence of SAEs of infection (0.5%) occurred in both the placebo and povetacicept groups. The U.S. Food and Drug Administration (FDA) has granted rolling review of the Biologics License Application (BLA) for povetacicept in IgAN. Vertex has already submitted several modules and will complete the full BLA submission by the end of March for potential accelerated approval. Vertex is using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. Povetacicept is a dual inhibitor of the BAFF and APRIL cytokines, which promote B cell activation, differentiation and/or survival, and provides B cell control by inhibiting the ability of BAFF and APRIL to drive the pathogenesis of multiple autoimmune diseases. Due to its engineered TACI domain, povetacicept has demonstrated improved binding affinity, potency, pharmacokinetics, and/or tissue distribution compared to other APRIL, BAFF, and dual BAFF+APRIL inhibitors in preclinical studies. Povetacicept has received FDA Breakthrough Therapy Designation for the treatment of IgAN. Povetacicept is the only dual BAFF+APRIL inhibitor in pivotal trials for multiple kidney diseases. Expansion into additional indications for povetacicept is advancing with the ongoing Phase 2/3 OLYMPUS trial in primary membranous nephropathy (pMN) and the expected start of the ETNA Phase 2 trial in generalized myasthenia gravis (gMG) in the first half of 2026. Povetacicept is an investigational agent and has not been approved by health authorities. 공시 • Mar 05
Vertex Pharmaceuticals Incorporated Presents New Data on JOURNAVX for Effective Pain Management Following Aesthetic and Reconstructive Procedures Vertex Pharmaceuticals Incorporated announced data from a Phase 4 study of JOURNAVX (suzetrigine), a prescription non-opioid pain signal inhibitor for the treatment of moderate-to-severe acute pain, in adults, that demonstrated effective pain management and enabled opioid-free recovery after a broad range of plastic surgical procedures. These data showed that the majority of patients (90.9%) in the study were opioid free through the end of treatment (up to 14 days), demonstrating the potential for JOURNAVX as a core element of opioid-free multimodal treatment for moderate-to-severe acute pain after aesthetic and reconstructive procedures. In contrast, the literature shows opioid-free rates of less than 10% with multimodal treatment without JOURNAVX. These data will be presented at the American Academy of Pain Medicine (AAPM) PainConnect 2026 meeting, March 5-8, 2026, in Salt Lake City, UT. This Phase 4 open-label, multicenter, single-arm study evaluated JOURNAVX when administered preoperatively and postoperatively as part of multimodal therapy, most commonly with acetaminophen and ibuprofen, in a range of reconstructive and aesthetic plastic surgeries where patients typically experience moderate-to-severe pain and are typically treated with opioid therapy for at least 72 hours postoperatively. The study dosed 99 patients who underwent aesthetic and reconstructive surgeries, including reconstructive and aesthetic breast surgeries, liposuction or abdominoplasty with liposuction, or turbinoplasties. The primary endpoint was the proportion of patients who achieved excellent, very good or good on the Patient Global Assessment scale at the end of treatment. The study showed that 90.7% of patients (95% CI: 83.1%, 95.7%) rated the effectiveness of JOURNAVX as part of multimodal treatment as excellent, very good or good. 90.9% of patients did not require any rescue opioids after surgery through the end of treatment (up to 14 days). Of the nine patients who received rescue opioids, the average use was approximately 2 tablets over 2 days. JOURNAVX was generally safe and well tolerated with no serious adverse events related to JOURNAVX. Adverse events were mild or moderate in severity and consistent with the postoperative setting. These data will be presented on March 6, 2026 during the AAPM meeting. 
