AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

Shots: AL-S Pharma has reported the global P-II (AP-101-02) trial data assessing AP-101 (IV, Q3W) vs PBO in 73 pts with sporadic ALS (n=52) & SOD1 mutations (n=21) for 24wks., followed by 24wk. OLE phase, where all pts received AP-101, & 16wk. safety follow-up Trial met its 1EP for safety & tolerability, with AP-101 showing…

ByRidhi RastogiMarch 19, 2026

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Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Shots: Ascendis Pharma has reported the P-II (New InsiGHTS) trial data assessing TransCon hGH (lonapegsomatropin, QW) vs somatropin (QD) in 49 prepubertal children (1-10yrs.) with Turner syndrome At Wk. 52, TransCon hGH showed improved annualized height velocity (AHV) with LS mean AHV of 9.05 vs 9.04 cm/year, irrespective of starting dose, with mean dose of…

ByRidhi RastogiMarch 18, 2026

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Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Shots: Pfizer has reported P-II (FOURLIGHT-1) trial data assessing atirmociclib + fulvestrant vs fulvestrant or everolimus plus exemestane in 264 pts with HR+, HER2- advanced or metastatic breast cancer who had received prior CDK 4/6 inhibitor-based treatment Trial met its 1EP, showing improved PFS as assessed by the investigator, with benefit consistent across all subgroups. OS…

ByRidhi RastogiMarch 17, 2026

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Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Shots: The P-III (ADorable‑1) study data assessed Ebglyss vs PBO in 363 pediatric pts (≥6mos.) with mod. to sev. AD; Topical corticosteroids were required for 2 wks. pre-randomization through Wk. 16, with tapering or discontinuation allowed once pts achieved IGA ≤2 At Wk. 16, the trial met it 1EP & key 2EPs, with 63% vs…

ByRidhi RastogiMarch 17, 2026

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Sana Biotechnology Reports Clinical Data on UP421 in Type 1 Diabetes

Shots: Sana has reported 14mos. follow-up data from a FIH study of UP421, a hypoimmune-engineered allogeneic islet cell therapy, transplanted into a patient with Type 1 Diabetes without immunosuppression Results showed sustained survival & function of pancreatic β cells. At 14mos., fasting & MMTT C-peptide levels matched the first 6mos. & exceeded in mos. 9-12,…

ByRidhi RastogiMarch 16, 2026

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Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Shots: Bayer has reported the P-III (FIND-CKD) trial data assessing Kerendia (finerenone; 10 or 20mg) vs PBO, both in addition to SoC, in >1,500 adults with non-diabetic chronic kidney disease Trial met its 1EP, showing a statistically significant improvement in eGFR slope, defined as the mean annual change in eGFR from baseline to Month 32; data…

ByRidhi RastogiMarch 16, 2026

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Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Shots: OLE study assessed repinatrabit (JNT-517) in adolescents with PKU. Early time-point data remain embargoed to preserve parent-study blinding, with additional randomized-period results to be presented later First cohort receiving repinatrabit (75mg, PO, BID) showed a 67% mean reduction in Phe from baseline (Day 56/OLE Month 1), with responses seen in all pts, incl. prior…

ByRidhi RastogiMarch 13, 2026

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Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency

Shots: Ultragenyx has reported the P-III (Enh3ance) study data assessing DTX301 AAV8 gene therapy vs PBO for the treatment of ornithine transcarbamylase (OTC) deficiency DTX301 reduced 24hr. plasma ammonia by 18% vs PBO at Wk. 36, with ammonia levels maintained in the normal range, despite a 27% mean decrease in scavenger drugs & ~13% increase…

ByRidhi RastogiMarch 13, 2026

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Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia

Shots: Aplagon has dosed the first patient with APAC (IV) in its P-IIa (HEALING) trial in Finland for peripheral arterial occlusive disease (PAOD), leading to chronic limb-threatening ischemia (CLTI) Trial will evaluate APAC in ~42 CTLI pts across 4 cohorts to assess safety, efficacy, & effects on thrombo-inflammatory biomarkers. Additionally, an associated PET imaging study with…

ByRidhi RastogiMarch 12, 2026

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Pfizer Reports Topline P-II Trial Data on Tilrekimig in Moderate to Severe Atopic Dermatitis

Shots: The P-II trial consists of 4 overlapping stages: Stage 1 (vs PBO) for tilrekimig & ompekimig; Stage 2 (dose-ranging) & Stage 3 (ongoing) evaluated tilrekimig, with Stage 3 involving biologic-experienced adults; Stage 4 is an ongoing ompekimig dose-ranging study Trial met its 1EP with more pts achieving EASI-75 at Wk. 16; PBO-adjusted rates were…

ByRidhi RastogiMarch 10, 2026

AL-S Pharma Reports the P-II (AP-101-02) Trial Data on AP-101 for Amyotrophic Lateral Sclerosis (ALS)

Ascendis Pharma Reports Topline P-II (New InsiGHTS) Trial Data on TransCon hGH in Turner Syndrome

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Eli Lilly Reports P-III (ADorable 1) Trial Data on Ebglyss (Lebrikizumab-lbkz) in Atopic Dermatitis (AD)

Sana Biotechnology Reports Clinical Data on UP421 in Type 1 Diabetes

Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Otsuka Pharmaceutical Reports OLE Study Data on Repinatrabit in Phenylketonuria

Ultragenyx Reports the P-III (Enh3ance) Trial for DTX301 AAV8 Gene Therapy in OTC Deficiency

Aplagon Doses First Patient in P-IIa (HEALING) Trial of APAC for Peripheral Arterial Occlusive Disease/Chronic Limb Threatening Ischemia

Pfizer Reports Topline P-II Trial Data on Tilrekimig in Moderate to Severe Atopic Dermatitis

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