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Akero's Efruxifermin Shows Promise in Reversing Cirrhosis Due to MASH in Phase 2b Trial

Akero Therapeutics' Efruxifermin (EFX) demonstrated statistically significant cirrhosis reversal in patients with MASH in a Phase 2b trial.
In patients with baseline and week 96 biopsies, 39% treated with 50mg EFX showed cirrhosis reversal without worsening MASH, compared to 15% with placebo.

aTyr Pharma's Efzofitimod Shows Continued Promise in Phase 3 Pulmonary Sarcoidosis Trial

aTyr Pharma's efzofitimod maintains a positive safety profile in the Phase 3 EFZO-FIT™ study for pulmonary sarcoidosis, according to an independent DSMB review.
The EFZO-FIT™ trial, involving 268 patients, assesses efzofitimod's efficacy in reducing corticosteroid use and improving lung function in pulmonary sarcoidosis.

Vyepti (Eptinezumab) Shows Positive Phase III Results in Asian Migraine Patients

Lundbeck's Vyepti (eptinezumab) met the primary endpoint in the SUNRISE Phase III trial, demonstrating statistically significant reductions in monthly migraine days compared to placebo.
The SUNRISE trial confirmed Vyepti's efficacy across all key secondary endpoints, with the treatment generally well-tolerated among chronic migraine patients in Asia.

Ensitrelvir Shows Promise as Post-Exposure Prophylaxis for COVID-19 in Phase 3 Trial

Shionogi's ensitrelvir significantly reduced symptomatic SARS-CoV-2 infection in individuals exposed to household contacts with COVID-19, meeting the primary endpoint in a Phase 3 trial.
The SCORPIO-PEP study involved approximately 2,400 participants and demonstrated that once-daily ensitrelvir was well-tolerated with no new safety concerns identified.

Fabhalta Demonstrates Sustained Efficacy in Phase 3 Trial for C3 Glomerulopathy

Novartis' Fabhalta (iptacopan) shows clinically meaningful proteinuria reduction in C3 glomerulopathy (C3G) patients over 12 months in the Phase 3 APPEAR-C3G study.
The study demonstrated a statistically significant 35.1% reduction in proteinuria at six months compared to placebo, with sustained effects observed throughout the trial.

Glaukos' Epioxa Shows Positive Phase 3 Results for Keratoconus Treatment

Glaukos' Epioxa met its primary efficacy endpoint in a Phase 3 trial, showing a statistically significant improvement in maximum corneal curvature (Kmax) at 12 months compared to placebo.
The company plans to submit a New Drug Application (NDA) to the FDA by the end of the year, based on this trial and a previous Phase 3 study.

MeiraGTx's AAV-GAD Gene Therapy Shows Promise in Parkinson's Disease Phase I/II Trial

MeiraGTx's AAV-GAD gene therapy met its primary endpoint, demonstrating safety and tolerability in a Phase I/II trial for Parkinson's disease.
The high-dose group showed a statistically significant 18-point improvement in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score.

Nxera Pharma Partners with Shionogi for Quviviq Distribution in Japan Following Approval for Insomnia

Nxera Pharma has entered a commercial partnership with Shionogi for the distribution and sales of Quviviq in Japan, succeeding a prior agreement with Mochida Pharmaceutical.
Quviviq, a dual orexin receptor antagonist, received approval in Japan for treating adult insomnia, marking a significant advancement in addressing sleep disorders.

Merck's Gardasil 9 Shows Positive Phase 3 Results in Japanese Males

Merck's Gardasil 9 demonstrated efficacy in preventing HPV-related anogenital persistent infection in Japanese males aged 16-26 in a Phase 3 trial.
The trial met its primary endpoint, showing a reduction in the combined incidence of anogenital persistent infection caused by 9 HPV types compared to placebo.

Akero Therapeutics Doses First Patient in Phase 3 SYNCHRONY Outcomes Trial for MASH Cirrhosis

Akero Therapeutics has dosed the first patient in its Phase 3 SYNCHRONY Outcomes trial evaluating Efruxifermin (EFX) for compensated cirrhosis (F4) due to MASH.
The SYNCHRONY program includes two other ongoing trials: SYNCHRONY Histology (pre-cirrhotic MASH, F2-F3) and SYNCHRONY Real-World (non-invasively diagnosed MASLD/MASH, F1-F4).

Reference News

[1]
Viatris seeks Japan's MHLW approval for Effexor SR capsules to treat generalized anxiety disorder
pharmabiz.com · Apr 22, 2025
[2]
Viatris Files Supplemental New Drug Applications to Japan's Ministry of Health, Labor and ...
newsroom.viatris.com · Apr 21, 2025
[3]
Positive Top-line Results from Phase 3 Study of Effexor in Japanese Adults with Generalized Anxiety Disorder
drugs.com · Apr 9, 2025

Viatris announces positive Phase 3 results for EFFEXOR in treating GAD in Japanese adults, showing superiority over plac...

[4]
Viatris Announces Positive Top-line Results from Phase 3 Study of EFFEXOR® in Japanese ...
biospace.com · Oct 9, 2024

EFFEXOR® met primary and secondary efficacy endpoints in a Phase 3 study for GAD in Japanese adults, showing superior an...

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