Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Cerecor enrolls first patient in COVID-19 trial

Cerecor (NASDAQ:CERC) enrolled the first patient in its a proof-of-concept trial evaluating CERC-002 in patients with COVID-19 cytokine storm-induced acute respiratory distress syndrome (ARDS). CERC-002 is a...

July 21, 2020

Developments

Lexicon sotagliflozin meets primary endpoint in four Phase 3 studies

Lexicon Pharmaceuticals (NASDAQ:LXRX) reported topline data from four Phase 3 studies, each of which demonstrated that sotagliflozin significantly reduced A1C levels in patients with Type 2 diabetes (T2D). Sotagliflozin...

July 21, 2020

Developments

BioXcel BXCL501 meets primary and secondary endpoints in two Phase 3 trials

BioXcel Therapeutics’ (NASDAQ:BTAI) BXCL501, a dexmedetomidine sublingual thin film, met its primary and secondary endpoints in two Phase 3 trials in patients with schizophrenia and bipolar disorders. In the SERENITY I...

July 20, 2020

Developments

IntelGenx and Tilray amend exclusivity of cannabis-infused VersaFilm accord

IntelGenx (TSXV:IGX; OTCQB:IGXT) and Tilray (NASDAQ:TLRY) amended the exclusivity terms of their November 2018 license, development and supply agreement to allow for IntelGenx’s co-development and commercialization of...

July 20, 2020

Developments

Denovo Biopharma DB102 gets FDA fast track designation for glioblastoma

Closely-held Denovo Biopharma’s DB102 received FDA fast track designation for the treatment of patients with newly-diagnosed glioblastoma. DB102, or enzastaurin, is a small molecule, serine/threonine kinase inhibitor...

July 17, 2020

Developments

PhaseBio doses first COVID-19 patient in Phase 2 trial

PhaseBio Pharmaceuticals (NASDAQ:PHAS) dosed the first patient in its potentially pivotal Phase 2 trial evaluating PB1046 for the treatment of high-risk, hospitalized COVID-19 patients. PB1046 is a long-acting analog of...

July 17, 2020

Developments

Liminal BioSciences acquires Fairhaven Pharmaceuticals

Liminal BioSciences (NASDAQ, TSX:LMNL) acquired closely-held Fairhaven Pharmaceuticals for $8-million (Canadian) in common shares. Fairhaven’s assets include a preclinical research program of small molecule...

July 17, 2020

Developments

AC Immune initiates second dosing group in Phase 1b/2a Alzheimer’s disease vaccine trial

AC Immune (NASDAQ:ACIU) initiated the second highest dosing group in a Phase 1b/2a clinical trial evaluating its anti-phospho-tau vaccine in patients with early Alzheimer’s disease (AD). The vaccine, called ACI-35...

July 16, 2020

Developments

Imagin Medical to test i/Blue Imaging System on anatomical bladder models

Imagin Medical (CSE:IME; OTCQB:IMEXF; Frankfurt & Stuttgart Symbol:DPD2) will use anatomical bladder models to confirm the i/Blue Imaging System’s simultaneous white and blue light image display. The anatomical...

July 15, 2020

Developments

Rigel Pharma fostamatinib being evaluated in COVID-19 pneumonia trial

Rigel Pharmaceuticals’ (NASDAQ:RIGL) fostamatinib is being evaluated in an investigator-sponsored study for the treatment of COVID-19 pneumonia. Fostamatinib, an oral spleen tyrosine kinase (SYK) inhibitor, is approved...

July 14, 2020

Developments

Histogen completes enrollment in Phase 1b/2a alopecia trial

Histogen (NASDAQ:HSTO) completed patient enrollment in its Phase 1b/2a clinical trial evaluating HST 001 for the treatment of androgenic alopecia in men. The trial enrolled 36 subjects with male pattern hair loss who...

July 14, 2020

Developments

Verrica Pharma gets complete response letter for molluscum contagiosum drug

The FDA issued Verrica Pharmaceuticals (NASDAQ:VRCA) a complete response letter (CRL) regarding the company’s NDA for VP-102. VP-102 is a topical cantharidin solution designed to treat molluscum contagiosum, a viral...

July 14, 2020

Developments

Akebia vadadustat being evaluated for COVID-19-related acute respiratory distress syndrome

Akebia Therapeutics’ (NASDAQ:AKBA) vadadustat is being evaluated in an investigator-sponsored study as a potential therapy to prevent and lessen the severity of COVID-19-related acute respiratory distress syndrome...

July 14, 2020

Developments

Albireo Pharma enrolls first patient in Phase 3 biliary atresia trial

Albireo Pharma (NASDAQ:ALBO) enrolled the first patient in its Phase 3 BOLD clinical trial of odevixibat for the treatment of biliary atresia. Odevixibat is an inhibitor of the ileal bile acid transporter and is...

July 14, 2020

Developments

BioSig subsidiary begins enrollment in Phase 2 COVID-19 trial

ViralClear Pharmaceuticals, a subsidiary of BioSig Technologies (NASDAQ: BSGM), began enrolling patients in its Phase 2 clinical trial of merimepodib for the treatment of COVID-19. Merimepodib is an orally...

July 13, 2020

Developments

Bellerophon treats first COVID-19 patient in Phase 3 INOpulse study

Bellerophon Therapeutics (NASDAQ:BLPH) treated the first patient in its Phase 3 study evaluating INOpulse, a pulsed nitric oxide system, for the treatment of COVID-19. The study will enroll up to 500 patients requiring...

July 13, 2020

Developments

FDA authorizes emergency use of electroCore’s vagus nerve stimulation in COVID-19 patients

The FDA has issued an emergency use authorization for electroCore’s (NASDAQ:ECOR) gammaCore Sapphire CV non-invasive vagus nerve stimulation (nVNS) to treat adult patients with known or suspected COVID-19. The FDA has...

July 13, 2020

Developments

Adverum randomizes first patient in Phase 2 diabetic macular edema study

Adverum Biotechnologies (NASDAQ:ADVM) randomized the first patient in its INFINITY clinical trial evaluating ADVM-022 for the treatment of diabetic macular edema (DME). ADVM-022 is a one-time intravitreal gene therapy...

July 13, 2020

Developments

Tonix Pharmaceuticals meets target enrollment in Phase 3 fibromyalgia study

Tonix Pharmaceuticals (NASDAQ:TNXP) met its target enrollment of 470 patients in its Phase 3 study of TNX-102 SL for the management of fibromyalgia. TNX-102 SL is a non-opioid analgesic, administered daily at bedtime...

July 10, 2020

Developments Markets

Mayo Clinic listed on TULSA center locator page, indicating Profound Medical’s first sale to a teaching hospital

The Mayo Clinic has just been listed as a new TULSA-PRO site, representing the first sale of the system to a teaching hospital by the technology’s developer, Profound Medical Profound Medical (TSX:PRN; NASDAQ:PROF)...

July 9, 2020

Developments

FDA approves Osmotica Pharma’s Upneeq for blepharoptosis

The FDA approved Osmotica Pharmaceuticals’ (NASDAQ:OSMT) Upneeq for the treatment of acquired blepharoptosis, an abnormal drooping of the upper eyelid that can limit field of vision. Acquired blepharoptosis is often...

July 9, 2020

Developments

Crinetics Pharma’s paltusotine gets FDA orphan drug designation for acromegaly

The FDA granted Crinetics Pharmaceuticals’ (NASDAQ:CRNX) paltusotine orphan drug designation for the treatment of acromegaly, a disease usually caused by a benign growth hormone-secreting tumor in the brain’s pituitary...

July 8, 2020

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