Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Precipio launches HemeScreen AML

Precipio (NASDAQ:PRPO) launched its HemeScreen acute myeloid leukemia (AML) panel, which tests for the presence of mutations in certain genes to help develop a treatment plan for patients. The company noted that AML...

September 22, 2020

Developments

Crinetics gets FDA rare pediatric disease designation for congenital hyperinsulinism

The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) CRN04777 rare pediatric disease designation for the treatment of congenital hyperinsulinism. Congenital hyperinsulinism occurs when infants are born with life...

September 21, 2020

Developments

FDA clears Acutus’ AcQMap catheter

The FDA cleared Acutus Medical’s (NASDAQ:AFIB) AcQMap, a 3D mapping and navigation catheter designed to be inserted into the left and right atrium. In addition to cardiac activation mapping, the AcQMap catheter can...

September 17, 2020

Developments

Zynerba Pharma Zygel gets FDA orphan drug designation for 22q deletion syndrome

Zynerba Pharma’s (NASDAQ:ZYNE) Zygel was granted FDA orphan drug designation for the treatment of 22q11.2 deletion syndrome. Also known as DiGeorge syndrome, 22q11.2 deletion syndrome is caused by a deletion of a small...

September 17, 2020

Developments

Hepion CRV431 shows positive activity against SARS-CoV-2 in NIAID study

Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 demonstrated positive activity against SARS-CoV-2 in a preclinical study conducted at the National Institute of Allergy and Infectious Diseases (NIAID). Conducted under...

September 17, 2020

Developments

Arrowhead reports positive interim results from Phase 2 alpha-1 liver disease trial

Arrowhead Pharma (NASDAQ:ARWR) reported positive 24-week data from its Phase 2 clinical study of ARO-AAT for the treatment of alpha-1 antitrypsin deficiency (AATD)-associated liver disease. ARO-ATT is a subcutaneously...

September 16, 2020

Developments

IntelGenx’s two oral psychedelic film deals featured on FiercePharma

FiercePharma featured IntelGenx (TSXV:IGX; OTCQX:IGXT) and its two recent deals for the development of psychedelic oral films. In July and August, the company signed feasibility agreements with Cybin Corp. and ATAI Life...

September 16, 2020

Developments

Aerpio completes enrollment in Phase 2 glaucoma trial

Aerpio Pharma (NASDAQ:ARPO) completed enrollment in its Phase 2 trial evaluating razuprotafib for the treatment of elevated intraocular pressure (IOP). The study enrolled some 195 patients with elevated IOP associated...

September 15, 2020

Developments

Kiniksa mavrilimumab gets FDA orphan drug designation for giant cell arteritis

Kiniksa Pharma’s (NASDAQ:KNSA) mavrilimumab received FDA orphan drug designation for the treatment of giant cell arteritis (GCA). GCA is a chronic inflammatory disease of medium-to-large arteries, which can result in...

September 15, 2020

Developments

Titan Pharma Probuphine commercialization partner inks European distribution agreement

Titan Pharmaceuticals’ (NASDAQ:TTNP) Probuphine commercialization partner, Molteni, signed an exclusive European distribution agreement with Accord Healthcare Europe for the commercialization of Sixmo, the brand name...

September 15, 2020

Developments

Frequency Therapeutics reports positive results from hearing loss study

Frequency Therapeutics (NASDAQ:FREQ) reported results from its Phase 2a clinical study of FX-322 for the treatment of sensorineural hearing loss (SNHL). The study follows a Phase 1/2 trial that demonstrated...

September 14, 2020

Developments

AVITA enrolls first patient in pivotal vitiligo trial

AVITA Therapeutics (NASDAQ:RCEL) initiated a pivotal study evaluating its RECELL system for the treatment of vitiligo, an autoimmune disease that causes loss of color or pigmentation in the skin. The study will assess...

September 14, 2020

Developments

Hepion CRV431 featured on The Bio Report podcast

The Bio Report podcast featured Hepion Pharmaceuticals’ (NASDAQ:HEPA) CRV431 for the treatment of non-alcoholic steatohepatitis (NASH), and potentially, COVID-19. “We’ve kicked off our Phase 2 trial in NASH...

September 11, 2020

Developments

VBL Therapeutics enrolls first patients in Phase 2 metastatic colorectal cancer trial

VBL Therapeutics (NASDAQ:VBLT) enrolled the first two patients in its Phase 2 trial evaluating VB-111, in combination with nivolumab, for the treatment of metastatic colorectal cancer. VB-111 is an adenovirus that...

September 10, 2020

Developments

Satsuma Pharma STS101 fails Phase 3 migraine trial

Satsuma Pharmaceuticals (NASDAQ:STSA) reported disappointing topline results from its Phase 3 trial of STS101 for the acute treatment of migraine. STS101 is a drug-device combination of dihydroergotamine mesylate (DHE)...

September 10, 2020

Developments

Precision BioSciences gets FDA fast track designation for second allogeneic CAR-T cell therapy

Precision BioSciences’ (NASDAQ:DTIL) allogeneic chimeric antigen receptor (CAR-T) cell therapy, PBCAR269A, received FDA fast track designation for the treatment of relapsed/refractory multiple myeloma. PBCAR269A...

September 9, 2020

Developments

Spero Therapeutics reports positive topline results from Phase 3 UTI and acute pyelonephritis trial

Spero Therapeutics (NASDAQ:SPRO) reported topline results from its Phase 3 ADAPT-PO trial evaluating tebipenem HBr for the treatment of complicated urinary tract infection (UTI) and acute pyelonephritis. Hospitalized...

September 8, 2020

Developments

Strongbridge Biopharma reports positive topline data from Phase 3 Cushing’s syndrome trial

Strongbridge Biopharma (NASDAQ:SBBP) reported topline data from its Phase 3 LOGICS trial evaluating RECORLEV for the treatment of endogenous Cushing’s syndrome. The study enrolled 44 patients to supplement the long-term...

September 8, 2020

Developments

Hepion completes dosing in Phase 1b multiple ascending dose study of CRV431

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that dosing has now been completed in all subjects enrolled in the Phase 1b multiple ascending dose (MAD) study of CRV431. The open-label MAD study was designed to assess...

September 1, 2020

Developments

Durect presents data from Phase 2a alcoholic hepatitis trial

Durect (NASDAQ:DRRX) reported data from its Phase 2a trial evaluating DUR-928 for the treatment of alcoholic hepatitis at the liver congress. The dose escalation trial evaluated doses of 30 mg, 90 mg, or 150 mg of DUR...

August 27, 2020

Developments

Applied Molecular Transport doses first patient in Phase 2 ulcerative colitis trial

Applied Molecular Transport (NASDAQ:AMTI) initiated its Phase 2a trial evaluating AMT-101 for the treatment of ulcerative colitis. The trial will enrol some 100 patients with moderate-to-severely active ulcerative...

August 27, 2020

Developments

IntelGenx, Exeltis expand RIZAPORT commercialization pact to include the EU

IntelGenx (TSXV:IGX; OTCQB:IGXT) granted its partner, Exeltis Healthcare, an exclusive license to manufacture and commercialize RIZAPORT in the EU. Under the accord, Exeltis will pay IntelGenx royalties on net RIZAPORT...

August 27, 2020

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