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September 03, 2024 09:00 ET | Source: Longeveron

Longeveron® Announces Positive Type C Meeting with U.S. FDA Regarding Pathway to BLA for Lomecel-B™ in Hypoplastic Left Heart Syndrome (HLHS)

Longeveron announces positive Type C meeting with FDA, clarifying regulatory pathway to BLA submission for Lomecel-B for hypoplastic left heart syndrome.
August 14, 2024 16:05 ET | Source: Longeveron

Longeveron® Announces Second Quarter 2024 Financial Results and Provides Business Update

Longeveron reports Q2 2024 financial results and provides business update. Phase 2b clinical trial in HLHS achieves 70% enrollment.
June 11, 2024 09:00 ET | Source: Longeveron

Longeveron® Announces Completion of Successful Investigator Meeting for On-going Phase 2b Clinical Trial Evaluating Lomecel-B™ as a Potential Treatment for HLHS, a Rare Pediatric Cardiac Disease

Investigator meeting for ELPIS II, the on-going Phase 2b clinical trial evaluating Lomecel-B as a potential adjunct treatment for HLHS.
May 14, 2024 16:05 ET | Source: Longeveron

Longeveron Announces First Quarter 2024 Financial Results and Provides Business Update

Longeveron announces 2024 Q1 financial results and business update. Phase 2b study in rare pediatric disease HLHS on track to complete enrollment in 2024.
March 02, 2022 08:37 ET | Source: Hillstream BioPharma Inc.

Hillstream BioPharma R&D Day Highlights Ferroptosis, the Non-Genetic Novel, Emerging Mechanism of Action, Targeting Drug Resistant and Devastating Cancers

HSB-1216’s active moiety in clinical pilot study produced a 71% response rate in TNBC and epithelial carcinomasHSB-1216 was recently granted Orphan Drug Designation to treat Uveal Melanoma by the...
September 15, 2021 16:01 ET | Source: Crinetics Pharmaceuticals, Inc.

Crinetics Pharmaceuticals’ Oral SST5 Agonist CRN04777 Demonstrated Pharmacologic Proof-of-Concept with Strong Dose-dependent Suppression of Insulin Secretion in Phase 1 Single Ascending Dose Study

CRN04777 Phase 1 Program Progressing to Multiple Ascending Dose Cohorts to Advance Development as a Treatment for Congenital Hyperinsulinisms Demonstrated Dose-dependent Reductions in...
November 06, 2020 08:31 ET | Source: Crinetics Pharmaceuticals, Inc.

Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update

Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of oral paltusotine for the treatment of acromegaly CRN04777 received Rare Pediatric Disease Designation for the...
October 29, 2020 08:00 ET | Source: Cerecin

Cerecin Announces Orphan Drug Designation from U.S. FDA for Tricaprilin in the Treatment of Infantile Spasms

SINGAPORE AND DENVER, COLORADO, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Cerecin, a biopharmaceutical company focused on discovering and developing brain therapeutics, announced today that the U.S. Food...
October 08, 2020 04:48 ET | Source: Cerecin

U.S. FDA Grants Rare Pediatric Disease Designation to Cerecin’s Investigational Drug Tricaprilin for the Treatment of Infantile Spasms

SINGAPORE AND DENVER, COLORADO , Oct. 08, 2020 (GLOBE NEWSWIRE) -- Cerecin, a biopharmaceutical company focused on discovering and developing brain therapeutics, announced that the U.S. Food and...