Category - Developments

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

Category - Developments

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