Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots: The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks. Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…

ByRidhi RastogiJanuary 15, 2025

NEWS

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

Shots: The first patient was dosed with iadademstat (ORY-1001) + venetoclax + azacitidine combination to treat AML naïve patients (n=45) under the P-I trial to evaluate the safety, tolerability, preliminary efficacy & optimal dose. Trial will be managed & funded by NCI under CRADA In addition, the combination is being evaluated to treat 1L…

ByDipanshu DixitJanuary 14, 2025

NEWS

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

Shots: The P-III (QUANTI; N=808) trials of gadoquatrane (0.04mmol Gd/kg body wt.) comprised of QUANTI CNS for CNS disorders like brain tumors, brain metastasis & multiple sclerosis; QUANTI OBR for other body regions like head & neck, thorax, abdomen & pelvis as well as QUANTI Pediatric study for children (birth to 18yrs.) Study assessed…

ByRidhi RastogiJanuary 13, 2025

WEEKLY SNAPSHOT

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

Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Oryzon Reports Dosing of the First Patient with Iadademstat + Venetoclax + Azacitidine in P-I Trial to Treat 1L Acute Myeloid Leukemia (AML)

Bayer Reports Topline Data from P-III (QUANTI) Trials of Gadoquatrane for its Use in MRI

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

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