Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

FDA clears Soliton RAP technology for cellulite improvement

The FDA cleared Soliton’s (NASDAQ:SOLY) Rapid Acoustic Pulse (RAP) technology for the short-term improvement in the appearance of cellulite. Soliton’s rapid-pulsed technology safely and comfortably breaks apart the...

February 1, 2021

Developments

Titan Pharma posts positive early study results for JT-09 ProNeura program

Titan Pharmaceuticals (NASDAQ:TTNP) announced that studies of its kappa opioid agonist peptide, JT-09, has demonstrated high potency and specificity for the human kappa-opioid receptor (KOR). JT-09 is being developed...

February 1, 2021

Developments

Kardium raises $115-million financing round

Closely-held Kardium raised $115-million in a new financing round led by Fidelity Management & Research, together with follow-on participation by funds and accounts advised by T. Rowe Price Associates. The new...

January 25, 2021

Developments

FDA approves Aurinia’s LUPKYNIS for lupus nephritis

The FDA approved Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) LUPKYNIS(voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis. LUPKYNIS is...

January 25, 2021

Developments

Soricimed approach to COVID-19 being validated by other researchers

Researchers at Rush University Medical Center in Chicago are developing a new peptide treatment to prevent COVID-19 symptoms that supports the approach being taken by closely-held Soricimed Biopharma. The peptide...

January 25, 2021

Developments

Think Research to acquire MDBriefCase Group

Think Research (TSXV:THNK) agreed to acquire closely-held MDBriefCase Group, a portfolio company of Persistence Capital Partners, for $25.3-million, mostly in stock. The transaction, which is expected to close in the...

January 20, 2021

Developments

Sernova’s Cell Pouch shows sustained clinical benefit in Type 1 diabetes

Sernova (TSXV:SVA; OTC:SEOVF; FSE:PSH) reported additional positive preliminary safety and efficacy data for its Cell Pouch transplanted with insulin producing cells in patients with Type 1 diabetes. Data presented at...

January 15, 2021

Developments

Neuronetics Q4 preliminary revenue tops guidance

Neuronetics (NASDAQ:STIM) reported preliminary unaudited revenue for the fourth quarter of 2020 between $15-million and $15.5-million, compared with previous guidance of $13-million and $13.5-million. “During the...

January 13, 2021

Developments

Diabeloop, SFC Fluidics in U.S. development pact for Type 1 diabetes

Diabeloop and SFC Fluidics agreed to develop a Type 1 diabetes system that integrates SFC’s alternate controller-enabled (ACE) insulin pod into Diabeloop’s automated insulin delivery solution in the U.S. The new...

January 11, 2021

Developments

iBio’s FastPharming featured in Genetic Engineering & Biotechnology News

iBio’s (NYSE American:IBIO) plant-based FastPharming System and customized FastGlycaneering tools were featured in an article in Genetic Engineering & Biotechnology. Sylvain Marcel, Ph.D., VP of protein expression...

January 11, 2021

Developments

Soricimed Biopharma, Orano Med in radiotherapeutics pact to treat solid tumors

Closely-held Soricimed Biopharma and Orano Med, a nuclear biotech company based in Piano, TX entered an agreement to develop a novel peptide receptor radionuclide therapy (PRRT) to treat solid tumor cancers. The...

January 7, 2021

Developments

IntelGenx receives first purchase order for CBD filmstrips from Heritage Cannabis

IntelGenx (TSXV:IGX; OTCQB:IGXT) executed of a definitive supply agreement with Heritage Cannabis Holdings (CSE:CANN; OTCQX:HERTF) to manufacture and supply filmstrip products containing 10 mg of cannabidiol (CBD) using...

January 7, 2021

Developments

Profound Medical Q4 preliminary revenue beats consensus estimates

Profound Medical (NASDAQ:PROF; TSX:PRN) preliminary revenue for the fourth quarter of 2020 of $3.7-million beat the Street estimate of $2.7-million, despite the pandemic surge. “We believe strong TULSA-PRO adoption and...

January 6, 2021

Developments

aTyr Pharma posts positive topline results from Phase 2 COVID-19 study

aTyr Pharma (NASDAQ:LIFE) announced positive topline results from its Phase 2 clinical trial of its lead therapeutic candidate, ATYR1923, in hospitalized COVID-19 patients with severe respiratory complications who do...

January 5, 2021

Developments

Hepion Pharma posts positive Phase 2a low dose data for CRV431 in advanced NASH

Hepion Pharmaceuticals (NASDAQ:HEPA) reported positive top line data from the low dose cohort in its Phase 2a AMBITION clinical trial of 75 mg CRV431, an oral, once-daily novel cyclophilin inhibitor, for the treatment...

December 30, 2020

Developments

DSMB recommends continuation of Hepion Pharma Phase 2a AMBITION trial in NASH

An independent data safety monitoring board (DSMB) has approved continuation of Hepion Pharmaceuticals’ (NASDAQ:HEPA) Phase 2a AMBITION clinical trial for the treatment of advanced non-alcoholic steatohepatitis (NASH)...

December 29, 2020

Developments

FDA accepts Hepion Pharma IND for CRV431 to treat COVID-19

The FDA accepted an IND application from Hepion Pharmaceuticals (NASDAQ:HEPA) for the use of CRV431, a novel cyclophilin inhibitor, for the treatment of COVID-19. Hepion is developing CRV431 as part of its artificial...

December 22, 2020

Developments

Profound Medical in pact with GE Healthcare to expand access to TULSA-PRO

Profound Medical (NASDAQ:PROF; TSX:PRN) and GE Healthcare agreed to a non-exclusive, worldwide license that will enable Profound to interface its TULSA-PRO system with certain GE Healthcare MRI scanners. The...

December 21, 2020

Developments

Albireo initiates Phase 3 Alagille syndrome trial

Albireo Pharma (NASDAQ:ALBO) launched a Phase 3 trial evaluating odevixibat for the treatment of Alagille syndrome, a rare genetic disorder that affects multiple parts of the body. Most Alagille patients present with...

December 17, 2020

Developments

Aldeyra initiates 3 Phase 2 trials of ADX-629

Aldeyra Therapeutics (NASDAQ:ALDX) launched three Phase 2 trials evaluating ADX-629 for the treatment of COVID-19, atopic asthma, and psoriasis. ADX-629 is an orally administered RASP inhibitor designed to modulate the...

December 17, 2020

Developments

Soricimed to investigate SOR-C13 to treat COVID-19

Closely-held Soricimed Biopharma, benefiting from funding support from the National Research Council of Canada Industrial Research Assistance Program, will investigate the potential therapeutic role its cancer drug...

December 17, 2020

Developments

vTv Therapeutics azeliragon fails Phase 2 AD and T2D trial

vTv Therapeutics’ (NASDAQ:VTVT) Phase 2 trial of azeliragon in patients with Alzheimer’s disease (AD) and Type 2 diabetes (T2D) failed to meet its primary endpoint. The trial enrolled 43 patients who were randomized to...

December 16, 2020

FDA clears Soliton RAP technology for cellulite improvement

Titan Pharma posts positive early study results for JT-09 ProNeura program

Kardium raises $115-million financing round

FDA approves Aurinia’s LUPKYNIS for lupus nephritis

Soricimed approach to COVID-19 being validated by other researchers

Think Research to acquire MDBriefCase Group

Sernova’s Cell Pouch shows sustained clinical benefit in Type 1 diabetes

Neuronetics Q4 preliminary revenue tops guidance

Diabeloop, SFC Fluidics in U.S. development pact for Type 1 diabetes

iBio’s FastPharming featured in Genetic Engineering & Biotechnology News

Soricimed Biopharma, Orano Med in radiotherapeutics pact to treat solid tumors

IntelGenx receives first purchase order for CBD filmstrips from Heritage Cannabis

Profound Medical Q4 preliminary revenue beats consensus estimates

aTyr Pharma posts positive topline results from Phase 2 COVID-19 study

Hepion Pharma posts positive Phase 2a low dose data for CRV431 in advanced NASH

DSMB recommends continuation of Hepion Pharma Phase 2a AMBITION trial in NASH

FDA accepts Hepion Pharma IND for CRV431 to treat COVID-19

Profound Medical in pact with GE Healthcare to expand access to TULSA-PRO

Albireo initiates Phase 3 Alagille syndrome trial

Aldeyra initiates 3 Phase 2 trials of ADX-629

Soricimed to investigate SOR-C13 to treat COVID-19

vTv Therapeutics azeliragon fails Phase 2 AD and T2D trial

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