Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

AnaptysBio imsidolimab gets FDA orphan drug designation for pustular psoriasis

The FDA granted AnaptysBio’s (NASDAQ:ANAB) imsidolimab orphan drug designation for the treatment of generalized pustular psoriasis (GPP). GPP is a rare, chronic, life-threatening disease characterized by the development...

July 8, 2020

Developments

Ziopharm doses first patient in Phase 1/2 pediatric brain tumor trial

Ziopharm Oncology (NASDAQ:ZIOP) dosed the first patient in its Phase 1/2 trial evaluating controlled IL-12 for the treatment of diffuse intrinsic pontine glioma (DIPG). Ziopharm’s controlled IL-12 is a gene therapy...

July 8, 2020

Developments

Outlook Therapeutics completes enrollment in pivotal retinal disease trial

Outlook Therapeutics (NASDAQ:OTLK) completed patient enrollment in its pivotal clinical trial evaluating LYTENAVA, an ophthalmic formulation of bevacizumab, for use in retinal indications. Formerly known as ONS-5010...

July 7, 2020

Developments

IntelGenx in feasibility pact with Cybin for fast-acting, orally-dissolving psilocybin film

IntelGenx (TSXV:IGX; OTCQB:IGXT) inked a feasibility agreement with Cybin for the development of an orally-dissolving film for the delivery of pharmaceutical-grade psilocybin. Cybin is Canada’s premier mushroom...

July 7, 2020

Developments

Hepion Pharma posts preclinical data supporting two-pronged approach treating COVID-19 with CRV431

Hepion Pharmaceuticals (NASDAQ:HEPA) reported that its anti-fibrotic drug candidate, CRV431, was efficacious in two distinct preclinical research models related to COVID-19 disease. CRV431 demonstrated strong anti...

July 7, 2020

Developments

Soliton files 510(k) for RAP device approval to reduce cellulite

Soliton (NASDAQ:SOLY) filed for 510(k) premarket clearance with the FDA of its second generation Rapid Acoustic Pulse (RAP) device for the reduction in the appearance of cellulite. The 510(k) filing is based on results...

July 1, 2020

Developments

Luminal BioSciences provides guidance on milestones; begins collecting plasma from COVID-19 recovered donors

Liminal BioSciences (NASDAQ, TSX:LMNL) provided a guidance update on the timing of certain expected key milestones for 2020. The company withdrew guidance in May because of the COVID-19 pandemic. In a statement, Kenneth...

July 1, 2020

Developments

Hepion advances to final dosing level in ongoing Phase 1 study of CRV431

Hepion Pharmaceuticals (NASDAQ:HEPA) advanced to the final dose level of CRV431 in its ongoing Phase 1 multiple ascending dose trial. The clinical trial management team determined the 300 mg dosing level to be safe and...

June 29, 2020

Developments

Iterum Therapeutics reports mixed topline results from Phase 3 sulopenem trial

Iterum Therapeutics (NASDAQ:ITRM) reported mixed topline results from its clinical trial assessing sulopenem, an anti-infective compound, in combination with probenecid for the treatment of uncomplicated urinary tract...

June 29, 2020

Developments

Kiniksa Pharma reports positive Phase 3 rilonacept data in pericarditis

Kiniksa Pharmaceuticals’ (NASDAQ:KNSA) rilonacept met its primary and major secondary efficacy endpoints in a Phase 3 recurrent pericarditis trial. The trial met its primary endpoint of time to pericarditis recurrence...

June 29, 2020

Developments

Orthofix FIREBIRD SI fusion system gets FDA clearance for low back pain

Orthofix Medical (NASDAQ:OFIX) received FDA clearance for its FIREBIRD SI fusion system and has treated its first patients for low back pain. The system is designed to compress and stabilize the sacroiliac (SI) joint...

June 29, 2020

Developments

Chiasma MYCAPSSA gets FDA approval for acromegaly

The FDA approved Chiasma’s (NASDAQ:CHMA) MYCAPSSA for the treatment of acromegaly, a rare, chronic disease characterized by the overproduction of growth hormone and insulin-like growth factor-1 hormone. MYCAPSSA...

June 26, 2020

Developments

Imara granted FDA orphan drug designation for the treatment of beta-thalassemia

The FDA granted Imara’s (NASDAQ:IMRA) IMR-687 orphan drug designation for the treatment of beta-thalassemia. Beta-thalassemia is a blood disorder characterized by reduced levels of hemoglobin. IMR-687 is small molecule...

June 24, 2020

Developments

Titan Pharma and Indegene sign Probuphine co-promotion partnership

Titan Pharmaceuticals (NASDAQ:TTNP) signed a co-promotion partnership with Indegene to establish multichannel digital marketing programs across the U.S. and engage health care providers (HCPs) who are eligible to...

June 24, 2020

Developments

Kane Biotech receives new funding from CanExport SMEs program

Kane Biotech (TSX-V:KNE; OTCQB:KNIBF) has been approved for up to $54,750 in funding from the Government of Canada’s CanExport small and medium-sized enterprises (SMEs) program. The program provides direct...

June 24, 2020

Developments

Hepion Pharma CRV431 shows efficacy in kidney fibrosis

Hepion Pharmaceuticals (NASDAQ:HEPA) CRV431 demonstrated antifibrotic activity in an experimental model of renal fibrosis. The study, which was conducted by SMC Laboratories in Tokyo, Japan, evaluated CRV431 in the...

June 22, 2020

Developments

Ziopharm completes enrollment of Phase 2 glioblastoma trial

Ziopharm Oncology (NASDAQ:ZIOP) completed enrollment of 36 subjects in its Phase 2 trial evaluating controlled IL-12, in combination with PD-1 inhibitor cemiplimab, for the treatment of recurrent or progressive...

June 22, 2020

Developments

Stereotaxis to be added to the Russell 2000 and Russell 3000 indexes

Stereotaxis (NYSE: STXS) will be added to the Russell 2000 and Russell 3000 indexes after the close on June 26, as part of the Russell indexes annual reconstitution. “This is another step forward in our effort to...

June 22, 2020

Developments

uniQure doses first patients in Phase 1/2 Huntington’s disease gene therapy trial

uniQure (NASDAQ:QURE) dosed the first two patients in its Phase 1/2 trial evaluating AMT-130 for the treatment of Huntington’s disease (HD). HD is an inherited neurodegenerative disorder where production and aggregation...

June 19, 2020

Developments

Ovid Therapeutics OV101 granted FDA rare pediatric disease designation

Ovid Therapeutics’ (NASDAQ:OVID) OV101 received FDA rare pediatric disease designation for the treatment of Angelman syndrome. Angelman syndrome is a rare genetic disorder that affects the brain’s ability to correctly...

June 19, 2020

Developments

Kane Biotech DispersinB program receives $2.7-million U.S. Department of Defense award

Kane Biotech (TSX-V:KNE; OTCQB:KNIBF) received the U.S. DoD’s Medical Technology Enterprise Consortium (MTEC) Research Project Award for DispersinB. The non-dilutive $2.7-million award will fund continued clinical...

June 18, 2020

Developments

Xeris Pharma posts positive topline data from Phase 2 T1D study

Xeris Pharmaceuticals (NASDAQ:XERS) reported positive topline results from its Phase 2 study of XP-3924, a pramlintide-insulin co-formulation, in adults with Type 1 diabetes (T1D). The trial enrolled 18 adults with T1D...

June 18, 2020

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