Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA approves Eiger’s Zokinvy for progeria

The FDA approved Eiger BioPharmaceuticals’ (NASDAQ:EIGR) Zokinvy for the treatment of Hutchinson-Gilford progeria syndrome and progeroid laminopathies. Progeria is an extremely rare and fatal disease caused by a...

November 23, 2020

Developments

Seelos Therapeutics SLS-005 gets FDA orphan drug designation for ALS

Seelos Therapeutics’ (NASDAQ:SEEL) SLS-005 (trehalose) received FDA orphan drug designation for the treatment of amyotrophic lateral sclerosis (ALS). Trehalose is a low molecular weight disaccharide that crosses the...

November 19, 2020

Developments

Kintara Therapeutics reports interim data from two Phase 2 trials of VAL-083

Kintara Therapeutics (NASDAQ:KTRA) reported interim data from two Phase 2 trials evaluating VAL-083 for the treatment of glioblastoma multiforme (GBM). In the first Phase 2 study, newly diagnosed patients receiving VAL...

November 19, 2020

Developments

Selecta gets FDA rare pediatric disease designation for methylmalonic acidemia gene therapy

Selecta Biosciences’ (NASDAQ:SELB) MMA-101 received FDA orphan drug designation for the treatment of methylmalonic acidemia (MMA). MMA is caused by a mutation in the methylmalonyl-CoA mutase gene, which results in the...

November 19, 2020

Developments

DSMB approves continuation of Hepion’s Phase 2a NASH trial

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that an independent data safety monitoring board (DSMB) approved the continuation of the company’s Phase 2a ‘AMBITION’ clinical trial to the next dose level cohort. After...

November 18, 2020

Developments

Kazia presents positive interim data from Phase 2 glioblastoma trial

At the Society for Neuro-Oncology annual meeting, Kazia Therapeutics (NASDAQ:KZIA) presented positive interim data from its Phase 2 trial evaluating paxalisib for the treatment of diffuse intrinsic pontine glioma...

November 18, 2020

Developments

Milestone Pharma enrolls first patient in Phase 3 etripamil trial

Milestone Pharmaceuticals (NASDAQ:MIST) enrolled the first patient in its Phase 3 RAPID trial evaluating etripamil for the treatment of paroxysmal supraventricular tachycardia (PSVT). PSVT is characterized by...

November 18, 2020

Developments

Chiasma reports positive topline results from Phase 3 acromegaly trial

Chiasma (NASDAQ:CHMA) reported positive topline results from its Phase 3 trial evaluating MYCAPSSA for the treatment of acromegaly. Designed to support a planned marketing authorization application in the EU, the non...

November 18, 2020

Developments

Synthetic Biologics engages AGP to explore strategic alternatives

Synthetic Biologics (NYSE American:SYN) engaged Alliance Global Partners as an advisor to help the company evaluate strategic alternatives. The company is considering a variety of options, including an acquisition...

November 17, 2020

Developments

BrainStorm NurOwn flunks Phase 3 ALS trial

BrainStorm Cell Therapeutics’ (NASDAQ:BCLI) NurOwn failed to meet its primary and secondary endpoints in a Phase 3 amyotrophic lateral sclerosis (ALS) trial. NurOwn consists of mesenchymal stromal cells (MSCs) that have...

November 17, 2020

Developments

PharmaJet partners with Diomics to detect SARS-CoV-2 immune response

Closely-held PharmaJet’s needle-free injection system will be used to deliver Diomics’ Diocheck SARS-CoV-2 visual immune response indicator. Diomics’ immune response indicator will be injected under the skin using...

November 17, 2020

Developments

Adamis Pharma gets second CRL for ZIMHI

Adamis Pharmaceuticals (NASDAQ:ADMP) received a second complete response letter (CRL) from the FDA regarding its ZIMHI high dose naloxone injection product for the treatment of opioid overdose. The FDA issued its first...

November 16, 2020

Developments

Cytokinetics reports mixed results from Phase 3 heart failure trial

Cytokinetics (NASDAQ:CYTK) reported primary results from its Phase 3 GALACTIC-HF trial evaluating omecamtiv mecarbil for the treatment of heart failure. Omecamtiv mecarbil is a novel selective cardiac myosin activator...

November 13, 2020

Developments

Esperion presents positive Phase 3 NEXLETOL data

Esperion (NASDAQ: ESPR) presented positive pooled results from four Phase 3 NEXLETOL trials at the virtual American Heart Association scientific sessions. NEXLETOL, or bempedoic acid, is a non-statin, low-density...

November 13, 2020

Developments

Albireo Pharma presents positive Phase 3 odevixibat data

Albireo Pharma (NASDAQ:ALBO) presented positive results from two Phase 3 trials of odevixibat at the American Association for the Study of Liver Diseases meeting. Odevixibat is an ileal bile acid transport inhibitor...

November 13, 2020

Developments

Annexon initiates Phase 2 Huntington’s disease trial

Annexon (NASDAQ:ANNX) launched a Phase 2 trial evaluating ANX005 for the treatment of Huntington’s disease. ANX005 is a monoclonal antibody designed to inhibit the complement protein, C1q. “Huntington’s disease is a...

November 13, 2020

Developments

Hepion to present positive CRV431 findings at liver conference

Hepion Pharmaceuticals (NASDAQ:HEPA) will present positive findings from an expanded study of CRV431 at The Liver Meeting Digital Experience 2020 on Nov. 13. The poster presentation will review a study in which...

November 12, 2020

Developments

Surface Oncology gets FDA fast track designation for hepatocellular carcinoma

Surface Oncology’s (NASDAQ:SURF) SRF388 received FDA fast track designation for the treatment of hepatocellular carcinoma in patients who have previously been treated with standard therapies. SRF388 is a fully human...

November 11, 2020

Developments

Lineage Cell Therapeutics completes enrollment in Phase 1/2a dry AMD trial

Lineage Cell Therapeutics (NASDAQ:LCTX) completed enrollment in its Phase 1/2a trial evaluating OpRegen for the treatment of dry age-related macular degeneration (AMD) with geographic atrophy. OpRegen is injected into...

November 11, 2020

Developments

IntelGenx receives U.S. patent for novel oral film dosage technology

IntelGenx (TSXV:IGX; OTCQB:IGXT) received a patent from the U.S. Patent and Trademark Office, covering a novel oral film dosage technology platform for modulating the absorption profile of a sublingually- or buccally...

November 11, 2020

Developments

Five Prime bemarituzumab meets all efficacy endpoints in Phase 2 gastric cancer trial

Five Prime Therapeutics (NASDAQ:FPRX) reported positive topline results from its Phase 2 trial evaluating bemarituzumab, in combination with chemotherapy, in patients with fibroblast growth factor receptor 2b-positive...

November 10, 2020

Developments

Lumos Pharma initiates Phase 2b pediatric growth hormone deficiency study

Lumos Pharma (NASDAQ:LUMO) launched a Phase 2b trial evaluating LUM-201 for the treatment of pediatric growth hormone deficiency (PGHD). PGHD is typically caused by the pituitary gland’s inability to make sufficient...

November 10, 2020

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