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

VIEWPOINTS

Funds Raised: David Domzalski Discusses the Closing of VYNE Therapeutics’ Private Placement

Shots: David Domzalski, President & Chief Executive Officer at VYNE Therapeutics, in an invigorating conversation with PharmaShots The PIPE transaction generated $88M ensuring a steady cash flow through the end of 2025 and multiple anticipated clinical catalysts across VYNE’s BET inhibitor platform David believes the financing will be instrumental in the advancement of VYN201, into…

BySaurabh ChaubeyJanuary 29, 2024

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2023

Shots: The Fourth quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. Starting with the latest acquisitions, BMS acquired Mirati Therapeutics for ~$5.8B and AbbVie acquired ImmunoGen for $10.1B The Fourth quarter of the year also showcases multiple clinical trial results from Regeneron’s Two-Year…

BySenior EditorJanuary 16, 2024

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

Funds Raised: David Domzalski Discusses the Closing of VYNE Therapeutics’ Private Placement

PharmaShots’ Key Highlights of Fourth Quarter 2023

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