PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below: Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis Read More: Oculis PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential…

BySenior EditorJanuary 10, 2025

NEWS

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

Shots: The P-III (OASIS 4) study assessed elinzanetant (oral, QD) vs PBO for 52wks. to treat mod. to sev. VMS caused by endocrine therapy in women (n=474) & for another 2yrs. for those with or at high risk of HR+ breast cancer The study achieved its 1EP of VMS severity reduction at 4 &…

ByRidhi RastogiJanuary 10, 2025

NEWS

MaaT Pharma Reports Topline Data from the Pivotal P-III (ARES) Trial of MaaT013 for Acute Graft-Versus-Host Disease

Shots: The P-III (ARES) trial assesses MaaT013 as a 3L treatment of acute GI-aGvHD in patients (n=66) refractory to steroids & ruxolitinib across the EU Trial achieved its 1EP, depicting 62% GI-ORR at D28 (38% CR & 20% VGPR); 64% ORR in all evaluable organs (36% CR & 18% VGPR); 54% survival at 12mos.…

BySenior EditorJanuary 9, 2025

NEWS

PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)

Shots: PharmaEssentia has reported topline data from a P-III (SURPASS-ET) study assessing P1101 (n=91) vs anagrelide (n=83) in patients (N=174) as a 2L treatment of ET for 12mos. with the US FDA filing for label extension to ET is expected by YE’25 The study achieved its 1EP of durable hematologic response at 9 &…

BySenior EditorJanuary 8, 2025

NEWS

Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis

Shots: The P-II (ACUITY) study assessed safety, tolerability & efficacy of OCS-05 (2 or 3mg/kg/day, IV, QD) vs PBO for 5 days in acute optic neuritis patients (n=36), on steroid in EU. 33/36 received treatment and included in the pre-specified modified ITT analysis. Its IND is approved in the US to begin trial 1EP…

BySenior EditorJanuary 6, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (December 30th, 2024 – January 03rd, 2025)

This week PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Biosimilars, Animal Health & Biotech. Check out our full report below: Novartis Reports Data from P-III (STEER) Study of Onasemnogene Abeparvovec to Treat Children and Young Adults with Spinal Muscular Atrophy (SMA) Read More: Novartis CARsgen Therapeutics Reports Topline Results from P-II…

BySenior EditorJanuary 3, 2025

NEWS

Hanx Biopharmaceuticals Reports the First Patient Dosing with HX044 in P-I Clinical Evaluation

Shots: Hanx Biopharmaceuticals has dosed the first patient with HX044 under its P-I clinical evaluation for treating solid tumors The dose escalation & expansion P-I/IIa (HX044-I-01) trial will assess safety, tolerability, PK profile & initial efficacy of HX044 for the treatment of advanced solid tumor malignancies HX044 is a first-in-class bispecific antibody and…

BySenior EditorJanuary 3, 2025

NEWS

Xgene Pharmaceutical Reports Results from P-IIb Trial of XG005 for Post-Surgical Pain

Shots: The P-IIb trial is evaluating XG005 (1250mg or 750mg, BID, oral) vs PBO in patients (n=450) for managing acute pain after bunionectomy Results showed reduced pain intensity over 72hrs. post-surgery, with mild pain (<4 NRS) in high dose group vs severe pain (>7 NRS) in PBO; delayed rescue medication use of up to…

BySenior EditorJanuary 2, 2025

NEWS

ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma

Shots: The patient enrollment in confirmatory P-III (LOTIS-5) study assessing Zynlonta + rituximab for treating 2L+ r/r DLBCL has been completed. Zynlonta was previously approved in 2021 under accelerated pathway for the same The study aims to convert accelerated approval & support label expansion to 2L+ with rituximab. Part 1 enrolled 20 patients for…

BySenior EditorJanuary 1, 2025

VIEWPOINTS

Macrophage Checkpoint Therapy: Roy Maute from Pheast Therapeutics in a Riveting Conversation with PharmaShots

Shots: Recently Pheast Therapeutics shared the preclinical data for PHST001, an anti-CD24 macrophage checkpoint inhibitor at the 20th Annual PEGS Boston Summit Today, at PharmaShots, we had a dialogue exchange with Roy Maute, Cofounder and CEO of Pheast Therapeutics Pheast Therapeutics currently plans to initiate a clinical trial in H1’25 Saurabh: Can you walk me…

BySaurabh ChaubeyJune 26, 2024

PharmaShots Weekly Snapshots (January 06, 2025 – January 10, 2025)

Bayer Reports Topline Data from P-III (OASIS 4) Study of Elinzanetant to Treat Vasomotor Symptoms (VMS) Associated with Breast Cancer Therapies

MaaT Pharma Reports Topline Data from the Pivotal P-III (ARES) Trial of MaaT013 for Acute Graft-Versus-Host Disease

PharmaEssentia Reports Topline Data from P-III (SURPASS-ET) Trial of Ropeginterferon Alfa-2b-Njft (P1101) in Essential Thrombocythemia (ET)

Oculis Reports Results from P-II (ACUITY) Study of OCS-05 for Treating Acute Optic Neuritis

PharmaShots Weekly Snapshots (December 30th, 2024 – January 03rd, 2025)

Hanx Biopharmaceuticals Reports the First Patient Dosing with HX044 in P-I Clinical Evaluation

Xgene Pharmaceutical Reports Results from P-IIb Trial of XG005 for Post-Surgical Pain

ADC Therapeutics Reports Enrollment Completion in P-III (LOTIS-5) Study of Zynlonta Plus Rituximab for 2L+ Diffuse Large B-Cell Lymphoma

Macrophage Checkpoint Therapy: Roy Maute from Pheast Therapeutics in a Riveting Conversation with PharmaShots

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