Chemical compounds

Incyte Announces Updated Data for Ruxolitinib Cream Accepted for Presentation at the 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference

Saturday, June 12, 2021 - 10:01pm

Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.

Key Points: 
  • Incyte (Nasdaq:INCY) today announced that multiple abstracts highlighting updated data for ruxolitinib cream, an investigational topical JAK1/JAK2 inhibitor, in patients with atopic dermatitis (AD) will be presented at the upcoming 2021 Revolutionizing Atopic Dermatitis (RAD) Virtual Conference, held on June 13, 2021.
  • We are pleased to be sharing new data from our Phase 3 TRuE-AD program at the RAD Virtual Conference.
  • These data provide additional insights on the potential role ruxolitinib cream could play as a treatment option for patients living with atopic dermatitis.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V).

New Phase 3 Study Results Show IMBRUVICA® (ibrutinib)-Based Combination Regimen as an All-Oral Fixed-Duration Treatment Demonstrated Superior Progression-Free Survival in Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia

Saturday, June 12, 2021 - 8:00am

Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.

Key Points: 
  • Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.
  • Waldenstrms macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients.
  • Fixed-Duration Ibrutinib Plus Venetoclax (I+V) Versus Chlorambucil Plus Obinutuzumab (Clb+O) for First-Line Treatment of Chronic Lymphocytic Leukemia (CLL): Primary Analysis of the Phase 3 GLOW Study.
  • Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL: 5 years of follow-up from the phase 3 RESONATE-2 study Leukemia.

Biotin Water® Hair, Skin, & Nails Makes Its Way To Publix Supermarkets

Friday, June 11, 2021 - 1:44pm

ROME, Ga., June 11, 2021 /PRNewswire/ --2T Water, LLC, the maker of Biotin Water Hair, Skin, and Nails announced today that Biotin Water will be sold at Publix Supermarkets across the southeast region of the United States starting June 2021.

Key Points: 
  • ROME, Ga., June 11, 2021 /PRNewswire/ --2T Water, LLC, the maker of Biotin Water Hair, Skin, and Nails announced today that Biotin Water will be sold at Publix Supermarkets across the southeast region of the United States starting June 2021.
  • 2T Water, LLC owns the exclusive rights to distribute Biotin Water Hair, Skin, and Nails which is the first biotin infused beverage that delivers 300 mcg per 16oz with zinc and folic acid included in the proprietary formula.
  • Biotin Water Hair, Skin, and Nails is formulated to ensure the body is properly hydrated while enjoying the many benefits of B7, often considered the most overlooked vitamin.
  • This new introduction of Biotin Water gives consumers more locations throughout the southeast to purchase Biotin Water in a great grocery chain.

Marinus Pharmaceuticals to Present at Multiple Upcoming Investor Conferences

Friday, June 11, 2021 - 12:30pm

Vice President, Clinical Development

Key Points: 
  • Vice President, Clinical Development
    Speakers: Scott Braunstein, M.D., Chief Executive Officer and Joe Hulihan, M.D., Chief Medical Officer
    All of the above public webcasts may be accessed through the Events & Presentations page of the Investors & Media section of the Marinus website, www.marinuspharma.com .
  • Marinus Pharmaceuticals, Inc. is a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders.
  • Ganaxolone is a positive allosteric modulator of GABAA receptors that acts on a well-characterized target in the brain known to have anti-seizure, antidepressant and anti-anxiety effects.
  • The company has initiated a Phase 3 trial in refractory status epilepticus.

Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis

Friday, June 11, 2021 - 12:30pm

Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).

Key Points: 
  • Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for ruxolitinib cream for the treatment of atopic dermatitis (AD).
  • The FDA extended the PDUFA action date to allow time to review additional analyses of previously submitted data provided by Incyte in response to the FDAs information request.
  • Ruxolitinib cream is a proprietary formulation of Incytes selective JAK1/JAK2 inhibitor ruxolitinib that has been designed for topical application.
  • Ruxolitinib cream is currently in Phase 3 development for the treatment of adolescents and adults with atopic dermatitis (TRuE-AD) and vitiligo (TRuE-V).

Bergenbio Presents Encouraging Updated Preliminary Data From Phase Ii Study In Relapsed Aml Patients At Eha Virtual Meeting

Friday, June 11, 2021 - 8:38am

An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.

Key Points: 
  • An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.
  • The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
  • Ongoing dialogue continues with the FDA and EMA regulatory agenciesto align on a pathway for apivotalregistration trial for the combination ofbemcentinibandLDAC in relapsed elderly AML patients unfit for intensive chemotherapy.
  • Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.

Bergenbio Presents Encouraging Updated Preliminary Data From Phase Ii Study In Relapsed Aml Patients At Eha Virtual Meeting

Friday, June 11, 2021 - 8:35am

An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.

Key Points: 
  • An update will be provided from an expansion cohort of 27 relapsed/refractory AML patients, who were assessed to explore safety and efficacy together with translational analysis.
  • The data indicate that the combination of bemcentinib, a once-daily oral AXL-inhibitor and LDAC is efficacious and well tolerated in the elderly and unfit relapsed AML population.
  • Ongoing dialogue continues with the FDA and EMA regulatory agenciesto align on a pathway for apivotalregistration trial for the combination ofbemcentinibandLDAC in relapsed elderly AML patients unfit for intensive chemotherapy.
  • Data from a Phase II in human clinical trial has shown that treatment with AXL inhibitor bemcentinib increased the rate ventilator free survival in hospitalised COVID-19 patients.

European Hematology Association - ALPINE Study Reveals Superior Safety and Efficacy of Zanubrutinib Compared with Ibrutinib

Friday, June 11, 2021 - 8:00am

Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.

Key Points: 
  • Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.
  • The activity and tolerability of zanubrutinib have been demonstrated in patients with CLL/SLL in early phase clinical trials.
  • The ALPINE study solidifies the findings of these pivotal trials by a head-to-head comparison of the safety and efficacy of zanubrutinib and ibrutinib in 415 patients with relapsed/refractory CLL/SLL.
  • In summary, zanubrutinib showed more selective inhibition of BTK resulting in improved efficacy and safety compared with ibrutinib.

European Hematology Association - ALPINE Study Reveals Superior Safety and Efficacy of Zanubrutinib Compared with Ibrutinib

Friday, June 11, 2021 - 8:00am

Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.

Key Points: 
  • Zanubrutinib is a next-generation BTK inhibitor that is designed for potent and sustained inhibition of BTK while minimizing the off-target effects of first-generation inhibitors such as ibrutinib.
  • The activity and tolerability of zanubrutinib have been demonstrated in patients with CLL/SLL in early phase clinical trials.
  • The ALPINE study solidifies the findings of these pivotal trials by a head-to-head comparison of the safety and efficacy of zanubrutinib and ibrutinib in 415 patients with relapsed/refractory CLL/SLL.
  • In summary, zanubrutinib showed more selective inhibition of BTK resulting in improved efficacy and safety compared with ibrutinib.

X4 Pharmaceuticals Announces Presentation of Positive Data from Ongoing Phase 1b Clinical Trial of Mavorixafor in Waldenström’s Macroglobulinemia at EHA 2021

Friday, June 11, 2021 - 8:00am

We are very pleased to present this exciting first look at the data from our ongoing Phase 1b trial in double-mutation Waldenstrms patients, said Diego Cadavid, M.D., Chief Medical Officer of X4 Pharmaceuticals.

Key Points: 
  • We are very pleased to present this exciting first look at the data from our ongoing Phase 1b trial in double-mutation Waldenstrms patients, said Diego Cadavid, M.D., Chief Medical Officer of X4 Pharmaceuticals.
  • We look forward to presenting longer-term data and an expanded data set from this trial later in the year.
  • Mavorixafor exposures tracked with sustained and dose-dependent increases in white blood cell counts, confirming target engagement and mavorixafor mechanism of action.
  • The e-poster (EP784) entitled: Preliminary Clinical Data From a Phase 1b Study of Mavorixafor and Ibrutinib in Patients With Waldenstrms Macroglobulinemia With MYD88 and CXCR4 Mutations is now available on the X4 corporate website .