VERTEX PHARMACEUTICALS INCORPORATED


Associated tags: Biotechnology, Health, Pharmaceutical, Vertex Pharmaceuticals, Pharmaceutical industry, Vertex, Genetics, Clinical Trials, VRTX, Science, Research, Patient

Vertex Announces Advancements of Suzetrigine (VX-548) in Acute and Neuropathic Pain

Retrieved on: 
Thursday, April 18, 2024
Health, FDA, Neurology, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, VRTX, Pain, Pregabalin, Safety, NDA, Food, New Drug Application, DPN, Sciatica, Fast track (FDA), Week, Patient, Medicine, Neuropathic pain, LSR, Vertex, Vertex Pharmaceuticals, Pharmaceutical industry

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced important advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced important advancements across its suzetrigine pain program, which has the potential to be the first new class of medicine for acute and neuropathic pain in more than two decades.
  • Following the positive Phase 3 results in acute pain announced in January 2024, the Food and Drug Administration (FDA) has granted a rolling New Drug Application (NDA) submission for suzetrigine in moderate-to-severe acute pain.
  • Suzetrigine was previously granted FDA Fast Track and Breakthrough Therapy designations in moderate-to-severe acute pain.
  • The company intends to advance its next generation NaV1.8 pain signal inhibitor VX-993 oral formulation into Phase 2 acute pain and peripheral neuropathic pain studies later this year.

Vertex Enters Into Agreement to Acquire Alpine Immune Sciences

Retrieved on: 
Wednesday, April 10, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Slate, Glomerulonephritis, FASN, Lazard, Lupus nephritis, Kidney, Immunotherapy, BAFF, Centerview Partners, Immunoglobulin A, Autoimmune disease, Hart–Scott–Rodino Antitrust Improvements Act, Patient, Multimedia, Vertex Pharmaceuticals, Pharmaceutical industry

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a biotechnology company focused on discovering and developing innovative, protein-based immunotherapies, today announced that the companies have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share or approximately $4.9 billion in cash.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Alpine Immune Sciences, Inc. (Nasdaq: ALPN), a biotechnology company focused on discovering and developing innovative, protein-based immunotherapies, today announced that the companies have entered into a definitive agreement under which Vertex will acquire Alpine for $65 per share or approximately $4.9 billion in cash.
  • The transaction was unanimously approved by both the Vertex and Alpine Boards of Directors and is anticipated to close later this quarter.
  • A subsidiary of Vertex will commence a cash tender offer to purchase all outstanding shares of Alpine common stock.
  • For Alpine, Centerview Partners is acting as exclusive financial advisor and Fenwick & West LLP as legal counsel.

Vertex to Announce First Quarter 2024 Financial Results on May 6

Retrieved on: 
Tuesday, April 9, 2024
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, International, Webcast, Vertex Pharmaceuticals, Vertex, VRTX

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2024 financial results on Monday, May 6, 2024 after the financial markets close.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) will report its first quarter 2024 financial results on Monday, May 6, 2024 after the financial markets close.
  • The company will host a conference call and webcast at 4:30 p.m.
  • To access the call, please dial (833) 630-2124 (U.S.) or +1 (412) 317-0651 (International) and reference the “Vertex Pharmaceuticals First Quarter 2024 Earnings Call.”
    The conference call will be webcast live and a link to the webcast can be accessed through Vertex's website at www.vrtx.com in the "Investors" section.
  • To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast.

Vertex Advances Inaxaplin (VX-147) into Phase 3 Portion of Adaptive Phase 2/3 Clinical Trial for the Treatment of APOL1-Mediated Kidney Disease

Retrieved on: 
Monday, April 1, 2024
Biotechnology, Other Health, Health, Pharmaceutical, Clinical Trials, BTD, Orphan drug, APOL1, RPD, Disease, Patient, Apolipoprotein L1, FSGS, Standard of care, EMA, UPCR, European Medicines Agency, Vertex Pharmaceuticals, Clinical trial, Vertex, Proteinuria, Food, FDA, IDMC, VRTX, Pharmaceutical industry

The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.

Key Points: 
  • The clinical trial is designed to assess the impact of inaxaplin on kidney function and proteinuria for people living with proteinuric kidney disease mediated by two variants in the APOL1 gene, known as AMKD.
  • In addition, the trial has been expanded to include adolescents with AMKD ages 10 to 17 years.
  • The IDMC also recommended enrolling adolescents with AMKD ages 10 to 17 years in the Phase 3 portion of the study.
  • The European Medicines Agency (EMA) has also granted inaxaplin Priority Medicines (PRIME) and Orphan Drug designations for AMKD.

Vertex Announces FDA Clearance of Investigational New Drug Application for VX-407 for the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)

Retrieved on: 
Thursday, March 21, 2024
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, FDA, Clinical Trials, Death, Autosome, VRTX, Growth, Disease, PC1, Patient, Kidney failure, Kidney transplantation, Polycystic kidney disease, IND, Vertex Pharmaceuticals, PKD1, Vertex, ADPKD, Dialysis, Cystic fibrosis, Food, Pharmaceutical industry

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) for VX-407, an investigational first-in-class small molecule corrector that targets the underlying cause of autosomal dominant polycystic kidney disease (ADPKD) in patients with a subset of PKD1 genetic variants.
  • ADPKD is the most common inherited kidney disease, with an estimated 250,000 people in the U.S. and Europe living with ADPKD; however, there are no treatments currently available that address the underlying causal biology of the disease.
  • ADPKD is a life-shortening genetic kidney disease characterized by the growth of numerous kidney-enlarging cysts that impair kidney function and can ultimately lead to kidney failure, requiring dialysis or kidney transplantation, and premature death.
  • The majority of ADPKD cases are caused by variants in the PKD1 gene, which encodes the polycystin 1 (PC1) protein.

Vertex Receives CHMP Positive Opinion for KALYDECO® for the Treatment of Infants With Cystic Fibrosis Ages 1 Month and Older

Retrieved on: 
Friday, February 23, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, Committee, Cystic fibrosis, VRTX, Vertex, European, Vertex Pharmaceuticals, CHMP, CFTR, Disease, Medication

Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KALYDECO® (ivacaftor) for the treatment of infants with cystic fibrosis (CF) ages 1 month to less than 4 months old who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

Key Points: 
  • Vertex Pharmaceuticals (Nasdaq: VRTX) today announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the label expansion of KALYDECO® (ivacaftor) for the treatment of infants with cystic fibrosis (CF) ages 1 month to less than 4 months old who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: R117H, G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.
  • “Cystic fibrosis is a chronic, progressive disease that is present from birth, which is why it is important to treat the underlying cause of this disease as early as possible to potentially slow disease progression,” said Fosca De Iorio, Vice President, International Medical Affairs at Vertex.
  • “If the label expansion for KALYDECO is approved, this would allow eligible infants with CF to receive a treatment that targets the underlying cause of their disease at the very start of their lives.”
    In the European Union, KALYDECO® is already approved for the treatment of people with CF ages 4 months old and above with specific mutations in the CFTR gene.

Vertex to Participate in Upcoming Investor Conferences

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, Pharmaceutical, Genetics, Health, VRTX, News, Conference, Global Research, Vertex Pharmaceuticals

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Charles Wagner, Executive Vice President and Chief Financial Officer, and David Altshuler, M.D., Ph.D., Executive Vice President, Global Research, and Chief Scientific Officer, will participate in two upcoming investor conferences:

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that Charles Wagner, Executive Vice President and Chief Financial Officer, and David Altshuler, M.D., Ph.D., Executive Vice President, Global Research, and Chief Scientific Officer, will participate in two upcoming investor conferences:
    TD Cowen 44th Annual Health Care Conference on Tuesday, March 5, 2024 at 10:30 a.m.
  • Leerink Partners Global Biopharma Conference on Monday, March 11, 2024 at 4:00 p.m.
  • A live webcast of management's remarks will be available through the Vertex website, www.vrtx.com in the "Investors" section under the "News and Events" page.
  • A replay of the conference webcast will be archived on the company's website.

European Commission Approves First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™ (exagamglogene autotemcel), for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia

Retrieved on: 
Tuesday, February 13, 2024
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hospital, European Commission, CRISPR, Volatile organic compound, Hematology, Gene, HSC, VRTX, TDT, SCD, European, Civil service commission, Haematopoietic system, Patient, Sickle cell disease, Bambino, Catholic higher education, Pediatrics, Vertex Pharmaceuticals, Pharmaceutical industry

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy.

Key Points: 
  • Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the European Commission has granted conditional marketing authorization to CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy.
  • CASGEVY is the only genetic therapy approved for SCD and TDT patients in the European Union (EU) and with this approval, there are now more than 8,000 patients potentially eligible for treatment.
  • Through this work, Vertex has secured early access for eligible TDT patients in France ahead of the national reimbursement process.
  • Vertex continues to engage with hospitals experienced in stem cell transplantation to establish a network of independently operated authorized treatment centers (ATCs) for the administration of CASGEVY.