Earnings summaries and quarterly performance for Emmaus Life Sciences.
Research analysts covering Emmaus Life Sciences.
Recent press releases and 8-K filings for EMMA.
Ascentage Pharma Receives China CDE Clearance for BTK Degrader APG-3288
EMMA
New Projects/Investments
- Ascentage Pharma's novel next-generation Bruton's tyrosine kinase (BTK)-targeted protein degrader, APG-3288, has received investigational new drug (IND) application clearance from the China Center for Drug Evaluation (CDE), shortly after receiving clearance from the U.S. Food and Drug Administration (FDA).
- APG-3288 is poised to enter a multicenter, open-label Phase I clinical study to evaluate its safety, tolerability, pharmacokinetic (PK) profile, and preliminary efficacy in patients with relapsed/refractory hematologic malignancies.
- This drug candidate is designed to overcome resistance to existing BTK inhibitors by inducing rapid, potent, and sustained degradation of both wild-type BTK and multiple BTK mutants.
- The IND clearance further strengthens Ascentage Pharma’s pipeline in hematologic malignancies, complementing its two already approved products in China, Olverembatinib and Lisaftoclax.
1 day ago
Zevra Therapeutics Presents New Data on MIPLYFFA® for Niemann-Pick Disease Type C
EMMA
Product Launch
New Projects/Investments
- Zevra Therapeutics announced the presentation of four posters highlighting positive new data on MIPLYFFA® (arimoclomol) for the treatment of Niemann-Pick Disease Type C (NPC) at the 22nd Annual WORLD Symposium™.
- Four years of real-world data from the U.S. Early Access Program demonstrated that arimoclomol was well tolerated and stabilized disease progression in NPC patients, including adults.
- A post hoc efficacy analysis of the randomized, placebo-controlled NPC002 trial showed that MIPLYFFA combined with miglustat significantly slowed disease progression as early as three months after treatment initiation, with sustained and increasing benefit through 12 months.
- MIPLYFFA was approved by the U.S. FDA on September 20, 2024, and Zevra has submitted a Marketing Authorization Application to the European Medicines Agency for its evaluation.
3 days ago
Elevar Therapeutics: FDA Accepts Resubmission for Liver Cancer Treatment
EMMA
Product Launch
New Projects/Investments
- Elevar Therapeutics announced the U.S. Food and Drug Administration (FDA) accepted the resubmission of a New Drug Application (NDA) for its investigational drug rivoceranib in combination with camrelizumab.
- This combination is intended as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC).
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of July 23, 2026, for the review.
- The resubmission fully addresses concerns raised in the FDA's Complete Response Letter issued on March 20, 2025.
- In the global Phase 3 CARES-310 study, the combination therapy achieved a median overall survival of 23.8 months in patients with uHCC, representing the longest overall survival reported to date among first-line treatments for uHCC.
8 days ago
Corcept's ROSELLA Trial Achieves Primary Overall Survival Endpoint for Relacorilant
EMMA
Product Launch
New Projects/Investments
- Corcept's Phase 3 ROSELLA trial for relacorilant in platinum-resistant ovarian cancer met its primary endpoint of overall survival.
- The trial demonstrated a 35% reduction in the risk of death for patients treated with relacorilant plus nab-paclitaxel, with a 4.1-month increase in median overall survival (16.0 months vs. 11.9 months) compared to nab-paclitaxel alone.
- The study also achieved its primary endpoint for progression-free survival, showing a 30% reduction in the risk of disease progression.
- The New Drug Application (NDA) for relacorilant is under review by the U.S. FDA with a PDUFA target action date of July 11, 2026, and a Marketing Authorization Application (MAA) is under review by the EMA.
Jan 23, 2026, 2:35 AM
Azafaros Announces Nizubaglustat Presentations at WORLD Symposium 2026
EMMA
New Projects/Investments
- Azafaros announced five scientific presentations on its lead asset, nizubaglustat, at the WORLD Symposium™ 2026, highlighting its therapeutic potential in Lysosomal Storage Disorders.
- Nizubaglustat is currently undergoing two global Phase 3 studies for Niemann-Pick type C disease and GM1/GM2 gangliosidoses, which are actively recruiting.
- Preliminary clinical efficacy and safety data from a Phase II study of nizubaglustat will be presented on February 5 at the symposium.
- The drug has received Rare Pediatric Disease Designations, Orphan Drug Designations, and Fast Track Designation from the US FDA, along with Orphan Medicinal Product Designation from the EMA.
Jan 22, 2026, 6:00 AM
IntraBio Announces Positive Pivotal Trial Results for Levacetylleucine in Ataxia-Telangiectasia
EMMA
Product Launch
New Projects/Investments
- IntraBio announced positive topline results from its pivotal Phase III IB1001-303 clinical trial for levacetylleucine in treating Ataxia-Telangiectasia (A-T).
- The trial successfully achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful -1.88 point improvement in the Scale for the Assessment and Rating of Ataxia (SARA) score compared to placebo, and also met key secondary endpoints.
- Levacetylleucine was found to be safe and well-tolerated, and IntraBio plans to immediately advance regulatory submissions to the US FDA, European Medicines Agency (EMA), and other global authorities for this neurodegenerative disease with no approved treatments.
Jan 21, 2026, 1:00 PM
Nouscom Publishes Positive NOUS-209 Clinical Trial Results in Nature Medicine
EMMA
Product Launch
New Projects/Investments
- Nouscom announced the publication of Phase 1b/2 clinical trial results for its investigational cancer immunotherapy, NOUS-209, in Nature Medicine on January 16, 2026.
- The trial, conducted in Lynch Syndrome (LS) carriers, demonstrated a favorable safety profile with no serious treatment-related adverse events, and potent and durable immunogenicity.
- Key findings included functional anti-cancer activity and clinical evidence of efficacy, with a reduced frequency of MSI precancer lesions and no new advanced adenomas detected one year post-treatment.
- These results support advancing NOUS-209 into an FDA- and EMA-aligned registration-enabling clinical trial for cancer interception in LS carriers.
Jan 16, 2026, 10:00 AM
Ascentage Pharma Outlines 2025 Achievements and 2026 Global Innovation Strategy
EMMA
New Projects/Investments
Guidance Update
Revenue Acceleration/Inflection
- Ascentage Pharma presented its 2025 milestone achievements and 2026 global innovation strategy at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026.
- The company's dual-engine growth is driven by two commercialized hematology products, Olverembatinib and Lisaftoclax, which achieved significant progress in 2025 and are main growth drivers for 2026, with a strong China market presence and multiple global registrational Phase III trials underway.
- The next-generation BTK protein degrader APG-3288 received Investigational New Drug (IND) clearance from the U.S. FDA, propelling the expansion of its global innovative pipeline.
- The outlook for 2026 includes advancing multiple global registrational Phase III studies, continued growth in commercial sales, broader patient accessibility, and the inclusion of Lisaftoclax in China's National Reimbursement Drug List (NRDL) coverage.
Jan 15, 2026, 1:25 AM
Actuate Reports Positive Phase 2 Data for Elraglusib in Metastatic Pancreatic Cancer
EMMA
New Projects/Investments
- Actuate Therapeutics announced positive follow-up data from its randomized controlled Phase 2 trial (Actuate 1801-Part 3B) for elraglusib combined with gemcitabine/nab-paclitaxel (GnP) in metastatic pancreatic cancer.
- The study met its primary endpoint, demonstrating statistically significant improved overall survival and reducing the risk of death by 38% compared to chemotherapy alone.
- Key efficacy findings include a median overall survival of 10.1 months for the elraglusib/GnP arm versus 7.2 months for GnP alone, a doubled 12-month survival rate (44.4% vs. 22.3%), and a fivefold increase in the 24-month survival rate (12.9% vs. 2.6%).
- The safety and tolerability profile of elraglusib was consistent with previously reported data, with no new safety signals identified.
Jan 12, 2026, 1:45 PM
Benitec Biopharma Announces Positive Long-Term Clinical Study Results for BB-301
EMMA
New Projects/Investments
Guidance Update
- Benitec Biopharma Inc. announced that Patient 1 of Cohort 1 in the BB-301 Phase 1b/2a clinical study completed the 24-month post-treatment assessment, demonstrating robust, disease-modifying outcomes with deepening improvements in post-swallow pharyngeal residue and total dysphagic symptom burden.
- All four patients enrolled in Cohort 1 completed the 12-month statistical follow-up period and were formal Responders to BB-301, showing durable response to the treatment.
- At the 24-month follow-up, Patient 1 showed a 60% improvement in Normalized Residue Ratio Scale-Valleculae (NRRSv) and a 78% improvement in Sydney Swallow Questionnaire (SSQ) total score compared to pre-treatment, indicating deepening improvements in swallowing efficiency and reduced dysphagic symptom burden.
- Benitec Biopharma plans to engage with the U.S. Food and Drug Administration (FDA) in mid-2026 to confirm the BB-301 pivotal study design.
Jan 11, 2026, 1:00 PM
Ask Fintool AI Agent
Get instant answers from SEC filings, earnings calls & more