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 Rastogi1 day ago

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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 Rastogi3 days ago

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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 Rastogi3 days ago

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ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

Shots: The US FDA has granted FTDto ATX-01 for the treatment of Myotonic Dystrophy Type 1 (DM1) ATX-01 showed increased free MBNL, improved splicing abnormalities, & restored function in animal models, & is being evaluated in the P-I/IIa (ArthemiR) study ATX-01 is an RNA-based therapeutic designed to inhibit miR-23b, which results in increased MBNL protein…

ByRidhi RastogiMarch 11, 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

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BMS Reports P-II/III (SUCCESSOR-2) Trial Data on Mezigdomide Combination for R/R Multiple Myeloma

Shots: BMS has reported the P-II/III (SUCCESSOR-2) trial data assessing mezigdomide (PO) + carfilzomib & dexamethasone vs carfilzomib & dexamethasone alone in pts with r/r multiple myeloma The P-III portion showed improved PFS (1EP), with safety consistent with the known profile of the regimen & mezigdomide. The trial will continue to follow pts for survival…

ByRidhi RastogiMarch 10, 2026

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Roche and Zealand Pharma Report P-II (ZUPREME-1) Trial Data on Petrelintide in Obesity

Shots: The P-II trial assessed 5 doses of petrelintide (SC, QW) vs PBO for 42wks. in 493 overweight or obese pts (mean BMI of 37 kg/m²) with weight-related comorbidities Trial met its 1EP, with Q4W dose-escalated injections delivering significant weight loss across 5 arms after 28wks. & sustaining ~10.7% vs 1.7% mean reduction through Wk.…

ByRidhi RastogiMarch 6, 2026

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Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Shots: The P-II (COMPASSION-03/AK104-201) trial assessed cadonilimab in pts with recurrent or metastatic CC who have failed prior Pt-based CT, showing mOS of 17.5mos. in pts regardless of PD-L1 expression, with18 & 24mos. OS rates of 47.8% & 40.9%, respectively Updated data with 26.5mos. mFU showed that among 99 efficacy-evaluable pts achieving CR, mOS & PFS…

ByRidhi RastogiMarch 5, 2026

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Takeda and Protagonist Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of Rusfertide to Treat Polycythemia Vera

Shots: The US FDA has accepted NDA & granted priority review to rusfertide for the treatment of adults with polycythemia vera (PV), with PDUFA action date of Q3’26 NDA was backed by the 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study & THRIVE LTE…

ByRidhi RastogiMarch 2, 2026

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Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

Shots: The CHMP has recommended conditional approval of Ojemda monotx. for the treatment of pts (≥6mos.) with pLGG harbouring a BRAF fusion or rearrangement or BRAF V600 mutation, who have progressed after ≥1 prior systemic therapy Opinion was based on the ongoing P-II (FIREFLY-1) trial assessing Ojemda (QW, PO) in 137 relapsed or refractory BRAF-altered pLGG…

ByRidhi RastogiMarch 2, 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

ARTHEx Biotech’s ATX-01 Secures the US FDA Fast Track Designation for Myotonic Dystrophy Type 1

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

BMS Reports P-II/III (SUCCESSOR-2) Trial Data on Mezigdomide Combination for R/R Multiple Myeloma

Roche and Zealand Pharma Report P-II (ZUPREME-1) Trial Data on Petrelintide in Obesity

Akeso Presents P-II (COMPASSION-03) Trial Data on Cadonilimab for R/M Cervical Cancer at ESGO 2026

Takeda and Protagonist Therapeutics Report the US FDA’s NDA Acceptance with Priority Review of Rusfertide to Treat Polycythemia Vera

Ipsen Reports the CHMP Positive Opinion for Ojemda (Tovorafenib) for R/R BRAF-Altered Pediatric Low-Grade Glioma (pLGG)

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