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ACELYRIN, INC. Announces Positive Top-line Results from Its Global Phase 2b/3 Clinical Trial of Izokibep in Psoriatic Arthritis

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星期一, 三月 11, 2024

LOS ANGELES, March 11, 2024 (GLOBE NEWSWIRE) -- ACELYRIN, INC. (Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance. Results from the 160 mg weekly (QW) and every other week (Q2W) arms showed improved magnitude of responses on higher hurdle endpoints such as ACR70, PASI100, and Minimal Disease Activity relative to the Phase 2 80 mg Q2W dose. This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.

Key Points:

(Nasdaq: SLRN), a late-stage clinical biopharma company focused on accelerating the development and delivery of transformative medicines in immunology, today announced its global Phase 2b/3 clinical trial of izokibep in psoriatic arthritis (PsA) met the primary endpoint of ACR50 at week 16 with high statistical significance.
This is notable given a higher baseline disease burden in the Phase 2b/3 trial population relative to the Phase 2 trial.
Izokibep was well-tolerated with a favorable safety profile consistent with previous experience and the IL-17A class, without evidence of the safety liabilities observed with targeting IL-17A&F.
This reinforces our enthusiasm for developing izokibep as an important potential new medicine for patients.”

ViiV Healthcare presents phase I clinical trial findings of a cabotegravir long-acting injectable investigational formulation allowing at least four months between doses

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星期一, 三月 4, 2024

ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.

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ViiV Healthcare is conducting a registrational study of CAB-ULA in 2024 to further evaluate its use for the prevention of HIV in adults.
Future areas of study will include its potential use in combination with other medicines as a complete, ultra long-acting HIV treatment regimen.
ViiV Healthcare is a pioneer and leader in the development of long-acting HIV medicine, having already brought innovations through injectable therapies to the HIV community.
Based on these combined findings, ViiV Healthcare is no longer pursuing CAB 200 SC + rHuPH20 for ultra long-acting dosing.

Salubris Biotherapeutics Presents Positive Initial Data from Phase 1b/2 Clinical Trial of JK08 at the European Society for Medical Oncology Annual Congress 2023

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星期一, 十月 23, 2023

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Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced that positive initial data from the first-in-human study evaluating JK08 in adults with solid tumors were presented in a poster session during the European Society of Medical Oncology Annual Congress 2023.

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Salubris Biotherapeutics, Inc. (SalubrisBio), a clinical-stage biotechnology company dedicated to discovering and developing novel complex biologic therapeutics, today announced that positive initial data from the first-in-human study evaluating JK08 in adults with solid tumors were presented in a poster session during the European Society of Medical Oncology Annual Congress 2023.
The presentation included safety data from 32 patients with relapsed or refractory solid tumors who received subcutaneous JK08 monotherapy once weekly in this Phase 1b/2 dose escalation study.
At the dose levels evaluated to date, JK08 has been well tolerated, demonstrating preliminary disease stability and anticipated modulation of target immune cell populations in heavily pre-treated patients.
SalubrisBio plans to report additional data from this study at future medical meetings.

argenx Announces Positive CHMP Opinion for Subcutaneous Efgartigimod for Generalized Myasthenia Gravis

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星期五, 九月 15, 2023

SC efgartigimod is formulated with Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.

Key Points:

SC efgartigimod is formulated with Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous delivery of biologics.
“Generalized myasthenia gravis is a complex and devastating disease that is debilitating for people who live with it, making routine movements exhausting and challenging to perform,” said Prof. dr. Jan De Bleecker, Ghent University Hospital and Ghent University.
The positive CHMP opinion is a scientific recommendation for marketing authorization, serving as a basis for the EC’s final decision on argenx’s application for SC efgartigimod.
The decision will apply to all 27 European Union Member States, and also to Iceland, Norway and Liechtenstein.

Perspective Therapeutics Reports Second Quarter Fiscal 2023 Results and Recent Business Highlights

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星期五, 八月 11, 2023

RICHLAND, Wash. and CORALVILLE, Iowa, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy powering expanding treatment options for multiple cancers, reports second quarter financial results for the period ended June 30, 2023 and recent business highlights.

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RICHLAND, Wash. and CORALVILLE, Iowa, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Perspective, Therapeutics, Inc. (“Perspective” or “the Company”) (NYSE AMERICAN: CATX), a precision oncology company developing alpha-particle therapies and complementary diagnostic imaging agents and an innovator in seed brachytherapy powering expanding treatment options for multiple cancers, reports second quarter financial results for the period ended June 30, 2023 and recent business highlights.
With a strong team in place, we’re focused on securing new business and re-gaining old business.
For the first half of fiscal 2023 ended June 30, 2023, revenue decreased 23% to $4.2 million versus $5.4 million in the prior year comparable period.
Prostate brachytherapy represented 42% of total revenue for the first six months of fiscal 2023 compared to 73% for the first six months of fiscal 2022.

Zai Lab and argenx Report Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

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星期一, 七月 17, 2023

The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.

Key Points:

The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.
Detailed data from ADHERE will be presented at an upcoming medical meeting.
“Currently, intravenous immunoglobulin (IVIg), plasma exchange (PLEX), and glucocorticoids are the main treatments used during the induction and maintenance phases.
Zai Lab has an exclusive license agreement with argenx for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China.

argenx Reports Positive Topline Data from ADHERE Study of VYVGART Hytrulo in Patients with Chronic Inflammatory Demyelinating Polyneuropathy

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星期一, 七月 17, 2023

The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.

Key Points:

The study met its primary endpoint (p=0.000039), demonstrating a significantly lower risk of relapse with VYVGART Hytrulo compared to placebo.
The positive ADHERE data show that VYVGART Hytrulo may represent a new patient-forward treatment option that can prevent symptom deterioration while minimizing side effects and treatment burden,” commented Jeffrey Allen, M.D., Associate Professor, Department of Neurology, University of Minnesota.
“With ADHERE, argenx has set a new standard for innovative CIDP studies that more broadly inform the neuromuscular community.
A webcast of the live call and replay may be accessed on the Investors section of the argenx website.

Zai Lab Announces Acceptance by China’s NMPA of the BLA for Efgartigimod Alfa Injection (Subcutaneous Injection) for Patients with Generalized Myasthenia Gravis

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星期一, 七月 10, 2023

SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG).

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SHANGHAI, China and CAMBRIDGE, Mass., July 10, 2023 (GLOBE NEWSWIRE) -- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for efgartigimod alfa injection (subcutaneous (SC) injection, 1000mg (5.6ml)/vial) for the treatment of adult patients with generalized myasthenia gravis (gMG).
“We are pleased to have the NMPA’s acceptance of the BLA for efgartigimod alfa injection for subcutaneous use.
Patients treated with efgartigimod SC achieved mean total IgG reduction of 66.4% from baseline at day 29, compared to 62.2% reduction with efgartigimod IV.
It was generally well-tolerated; the most frequent adverse event being injection site reactions (ISRs), commonly observed with biologics administered subcutaneously.

Chinook Therapeutics to Present Updated Data from Zigakibart (BION-1301) Phase 1/2 Trial in Patients with IgA Nephropathy (IgAN) at the 60th European Renal Association (ERA) Congress

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星期一, 六月 12, 2023

Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).

Key Points:

Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).
Key highlights from the presentation include the following:
Patients in Cohort 1 initially received a 450mg intravenous (IV) dose of zigakibart every two weeks.
Cohort 1 enrolled 10 patients, of which two patients withdrew from the study for reasons unrelated to study drug, and eight patients continued receiving treatment.
Of all 40 patients enrolled in both Cohorts 1 and 2:
There were no anti-drug antibodies observed in any patients.

Travere Therapeutics Announces Positive Topline Results from Cohort 6 in the Phase 1/2 COMPOSE Study of Pegtibatinase in Classical Homocystinuria

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星期三, 五月 31, 2023

SAN DIEGO, May 31, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced positive results from cohort 6 in the placebo-controlled Phase 1/2 COMPOSE Study of pegtibatinase, a novel investigational enzyme replacement therapy being evaluated for the treatment of classical homocystinuria (HCU). In this cohort, five patients were randomized in a blinded fashion to receive 2.5 mg/kg of lyophilized pegtibatinase or placebo twice weekly (BIW), with four patients assigned to the treatment group. In this highest dose cohort to date, treatment with pegtibatinase resulted in rapid and sustained reductions in total homocysteine (tHcy), with a 67.1% mean relative reduction in tHcy from baseline, as well as maintenance of mean tHcy below the clinically meaningful threshold of 100 μM, over weeks 6 to 12. To date in the study, pegtibatinase has been generally well-tolerated.

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ET
SAN DIEGO, May 31, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced positive results from cohort 6 in the placebo-controlled Phase 1/2 COMPOSE Study of pegtibatinase, a novel investigational enzyme replacement therapy being evaluated for the treatment of classical homocystinuria (HCU).
The Company plans to present additional detailed study results at an upcoming medical meeting or in a peer-reviewed publication.
ET to discuss the topline results from cohort 6 in the Phase 1/2 COMPOSE Study.
Following the live webcast, an archived version of the call will be available for 30 days on the Company’s website.