Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

BELLUS Health doses first patient in Phase 2b chronic cough trial

BELLUS Health (NASDAQ:BLU; TSX:BLU) dosed the first patient in its Phase 2b study evaluating BLU-5937 for the treatment of refractory chronic cough. The study, called SOOTHE, will evaluate three doses of BLU-5937 in...

December 8, 2020

Developments

electroCore reports positive topline results from migraine prevention study

electroCore (NASDAQ:ECOR) reported positive topline results from its PREMIUM II study evaluating gammaCore, a non-invasive vagus nerve stimulation (nVNS) device, for the prevention of migraines. The study was designed...

December 8, 2020

Developments

Precision BioSciences reports positive interim data from Phase 1/2a lymphoma, leukemia study

Precision BioSciences (NASDAQ:DTIL) reported positive interim results from its Phase 1/2a study evaluating PBCAR0191, an allogeneic chimeric antigen receptor (CAR-T) cell therapy, for the treatment of...

December 4, 2020

Developments

Taysha gets FDA rare pediatric and orphan drug designations for epilepsy

Taysha Gene Therapies’ (NASDAQ:TSHA) TSHA-103 received FDA rare pediatric and orphan drug designations for the treatment of SLC6A1-related epilepsy. SLC6A1-related epilepsy is caused by the loss of function of one copy...

December 3, 2020

Developments

Protagonist Therapeutics gets FDA fast track designation for polycythemia vera

Protagonist Therapeutics’ (NASDAQ:PTGX) PTG-300 received FDA fast track designation for the treatment of polycythemia vera, a rare disease characterized by the excessive production of red blood cells. PTG-300 is an...

December 2, 2020

Developments

Cara Therapeutics completes enrollment in Phase 2 pruritis trial

Cara Therapeutics (NASDAQ:CARA) completed enrollment in its Phase 2 KARE trial evaluating KORSUVA for the treatment of moderate-to-severe pruritus, or itchy skin, in atopic dermatitis patients. The trial enrolled 400...

December 2, 2020

Developments

Axsome reports positive results from Phase 2 treatment-resistant depression trial

Axsome Therapeutics (NASDAQ:AXSM) reported positive results from its Phase 2 COMET-TRD trial evaluating AXS-05 for the treatment resistant depression (TRD). The trial evaluated 70 patients who had ongoing symptoms of...

December 2, 2020

Developments

Catalyst Biosciences gets FDA fast track designation for hemophilia

Catalyst Biosciences’ (NASDAQ:CBIO) activated marzeptacog alfa, or MarzAA, received FDA fast track designation for the treatment of episodic bleeding in subjects with hemophilia A or B who have developed coagulation...

December 2, 2020

Developments

Hepion reports CRV431 may reduce risk of NASH-associated ischemic stroke

Hepion Pharmaceuticals (NASDAQ:HEPA) reported results from a translational research study in which its lead drug candidate, CRV431, decreased formation of procoagulant platelets. The company noted that patients with...

December 2, 2020

Developments

Aeglea BioTherapeutics gets FDA rare pediatric disease designation for homocystinuria

Aeglea BioTherapeutics’ (NASDAQ:AGLE) ACN00177 received FDA rare pediatric disease designation for the treatment homocystinuria. Homocystinuria is a serious metabolic disorder characterized by elevated plasma...

December 1, 2020

Developments

Bellerophon enrolls first patient in Phase 3 INOpulse study

Bellerophon Therapeutics (NASDAQ:BLPH) enrolled the first patient in its Phase 3 REBUILD study evaluating INOpulse, a pulsed nitric oxide system, for the treatment of fibrotic interstitial lung disease (fILD). The study...

December 1, 2020

Developments

Athira initiates dosing in Phase 2 Alzheimer’s disease study

Athira Pharma (NASDAQ:ATHA) initiated patient dosing in its ACT-AD Phase 2 trial evaluating ATH-1017 in patients with mild-to-moderate Alzheimer’s disease (AD). ATH-1017 is a small molecule designed to regenerate...

December 1, 2020

Developments

Moleculin Biotech gets FDA rare pediatric disease designation for three indications

Moleculin Biotech’s (NASDAQ:MBRX) WP1066 received FDA rare pediatric disease indication for the treatment of diffuse intrinsic pontine glioma (DIPG), medulloblastoma and atypical teratoid rhabdoid tumor. WP1066 is an...

December 1, 2020

Developments

Ovid Therapeutics’ OV101 fails Phase 3 Angelman syndrome trial

Ovid Therapeutics (NASDAQ: OVID) reported that its Phase 3 NEPTUNE trial evaluating OV101 for the treatment of Angelman syndrome failed to meet its primary endpoint. Angelman syndrome is a rare genetic disorder that...

December 1, 2020

Developments

Profound Medical gets FDA humanitarian device exemption approval for Sonalleve

Profound Medical’s (NASDAQ:PROF; TSX:PRN) Sonalleve received FDA humanitarian device exemption (HDE) approval for the treatment of osteoid osteoma. Osteoid osteoma is a non-cancerous bone tumor that occurs most often in...

November 30, 2020

Developments

Urovant Sciences vibegron fails Phase 2a IBS trial

Urovant Sciences (NASDAQ:UROV) reported disappointing topline results from its Phase 2b trial of vibegron for the treatment of abdominal pain due to irritable bowel syndrome (IBS) in women. The study failed to meet its...

November 25, 2020

Developments

KA Imaging launches subscription model for portable X-ray device

Closely-held KA Imaging introduced a new hardware subscription model to help U.S. and Canadian hospitals acquire Reveal 35C, the company’s portable X-ray device, during the pandemic. Reveal 35C is a portable, single...

November 24, 2020

Developments

FDA clears Neuronetics TouchStar protocol for major depressive disorder

The FDA cleared Neuronetics’ (NASDQ:STIM) TouchStar protocol for the treatment of major depressive disorder. TouchStar is a three-minute intermittent theta burst protocol administered using the company’s NeuroStar...

November 24, 2020

Developments

Capricor initiates dosing in Phase 2 COVID-19 trial

Capricor Therapeutics (NASDAQ:CAPR) dosed the first two patients in its Phase 2 trial evaluating CAP-1002 for the treatment of severe COVID-19. CAP-1002 is an intravenously delivered allogeneic cardiac cell therapy...

November 24, 2020

Developments

Oramed initiates Phase 3 oral insulin trials

Oramed Pharmaceuticals (NASDAQ, TASE:ORMP) began screening patients for its two Phase 3 trials evaluating ORMD-0801 for the treatment of Type 2 diabetes. The trials will enroll a total of 1,125 Type 2 diabetes patients...

November 24, 2020

Developments

PolyPid D-PLEX100 gets FDA breakthrough therapy designation

The FDA granted PolyPid’s (NASDAQ:PYPD) D-PLEX100 breakthrough therapy designation for the prevention of surgical site infections in patients undergoing colorectal surgery. D-PLEX100 is designed to provide prolonged...

November 24, 2020

Developments

FDA clears Orchard Therapeutics IND for OTL-200

The FDA cleared Orchard Therapeutics’ (NASDAQ:ORTX) IND for OTL-200, a stem cell-based gene therapy for the treatment of metachromatic leukodystrophy (MLD). MLD is caused by a mutation in the arylsulfatase-A gene, which...

November 23, 2020

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