Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

BioLight, Alexion to explore natural tears for diagnosis of retinal diseases

BioLight (TASE:BOLT) signed a research collaboration agreement with Alexion, a rare disease unit of AstraZeneca, to explore a potentially ground-breaking technology that utilizes natural tears for the potential...

May 30, 2023

Developments

Profound to reveal interim 5-year TACT follow-up data during June 6th webinar

Profound Medical (NASDAQ:PROF; TSX:PRN) will unveil interim five-year follow-up data from its TACT (TULSA-PRO ablation clinical trial) pivotal study at a live webinar event it is hosting on June 6 at 6 pm ET. The...

May 30, 2023

Developments

Hepion to highlight AI-POWR at medical conference

Hepion Pharmaceuticals (NASDAQ:HEPA) will outline the integration of its artificial intelligence and machine learning platform, AI-POWR, into all aspects of its clinical pharmacological programs at the 2023 Canadian...

May 25, 2023

Developments

Pyxis Oncology to acquire Apexigen

Pyxis Oncology (NASDAQ:PYXS) agreed to acquire Apexigen (NASDAQ:APGN) in an all-stock transaction for an implied value of 64 cents per Apexigen share. For each share of Apexigen, Pyxis Oncology will issue 0.1725 shares...

May 24, 2023

Developments

Wave Life flunks Phase 1b/2a study in ALS and dementia

Wave Life Sciences’ (NASDAQ:WVE) drug candidate, WVE-004, did not show clinical benefit, compared with placebo, in the Phase 1b/2a FOCUS-C9 study as an investigational treatment for C9orf72-associated amyotrophic...

May 23, 2023

Developments

T2 Biosystems exploring strategic alternatives

T2 BioSystems (NASDAQ:TTOO) initiated a process to explore a range of strategic alternatives focused on maximizing value and a restructuring plan, which includes a reduction in workforce. T2 has engaged an advisory firm...

May 23, 2023

Developments

MindBio gets ethics okay for take-home LSD-microdosing trial in MDD

MindBio Therapeutics (CSE:MBIO; Frankfurt:WF6) received ethics approval for a world’s first Phase 2a take-home LSD-microdosing clinical trial in patients with major depressive disorder (MDD) in New Zealand. The...

May 23, 2023

Developments

AVROBIO to sell cystinosis gene therapy program for $87.5-million

AVROBIO (NASDAQ:AVRO) agreed to sell its investigational hematopoietic stem cell (HSC) gene therapy program for the treatment of cystinosis to Novartis for $87.5-million. Cystinosis is a rare, multisystem genetic...

May 22, 2023

Developments

Hepion Phase 2 ALTITUDE-NASH trial achieves all endpoints, improvement in liver function and NASH biomarkers

Hepion Pharmaceuticals (NASDAQ:HEPA) reported positive topline results from its recently completed Phase 2 ALTITUDE-NASH clinical trial with lead drug candidate, rencofilstat. ALTITUDE-NASH met its primary endpoint by...

May 22, 2023

Developments

Centessa receives FDA fast track in hemophilia B

The FDA granted fast track designation to Centessa Pharmaceuticals’ (NASDAQ:CNTA) SerpinPC, an investigational novel inhibitor of activated protein C (APC) being developed for the treatment of hemophilia B, with or...

May 22, 2023

Developments

Hepion to release Phase 2 ALTITUDE-NASH results pre-market on May 22

Hepion Pharmaceuticals (NASDAQ:HEPA) expects to release topline results from the Phase 2 ALTITUDE-NASH clinical trial with its rencofilstat drug candidate before the market opens on Monday, May 22, 2023. The company...

May 19, 2023

Developments

HanAll BioPharma flunks Phase 3 dry eye disease trial

The Velos-3 pivotal trial of HanAll BioPharma’s (KRX:009420. KS) tanfanercept did not demonstrate statistical significance in either of the primary outcome measures of improvement in central corneal staining score or in...

May 19, 2023

Developments

Stereotaxis, Abbott collaborate in cardiac mapping and robotics

Stereotaxis (NYSE:STXS) and Abbott (NYSE:ABT) agreed to a global collaboration to integrate Abbott’s EnSite X EP System with its Robotic Magnetic Navigation systems. The combination brings together highly detailed real...

May 19, 2023

Developments

EyePoint to sell YUTIQ to Alimera Sciences for $82.5-million

EyePoint Pharmaceuticals (NASDAQ:EYPT) entered into a definitive agreement for the sale of YUTIQ (fluocinolone acetonide intravitreal implant) 0.18mg to Alimera Sciences (NASDAQ:ALIM). Under the accord, EyePoint...

May 18, 2023

Developments

FDA eases partial clinical hold on Avidity dosing

The FDA eased a partial clinical hold on AOC 1001, allowing Avidity Biosciences (NASDA:RNA) to double the number of participants in the MARINA open-label extension (MARINA-OLE) study receiving 4 mg/kg of AOC 1001. The...

May 17, 2023

Developments

IntelGenx receives amended Health Canada license for third-party testing

IntelGenx (TSX:IGX; OTCQB:IGXT) received an amended Drug Establishment License (DEL) from Health Canada, allowing the company to conduct third-party testing. Analytical testing of finished products and intermediates is...

May 17, 2023

Developments

Dermavant posts positive results in second Phase 3 for atopic dermatitis

Dermavant Sciences, a subsidiary of Roivant Sciences (NASDAQ:ROIV), reported positive results from ADORING 1, the second of two double-blind, randomized, vehicle-controlled Phase 3 studies to evaluate the efficacy and...

May 16, 2023

Developments

Chinook, Ionis partner to develop antisense therapy for CKD

Chinook Therapies (NASDAQ:KDNY) entered into a collaboration agreement with Ionis Pharmaceuticals for the discovery, development and commercialization of an antisense oligonucleotide (ASO) therapy for a rare, severe...

May 16, 2023

Developments

Oramed partner in China moving oral insulin to regulatory approval

Oramed Pharmaceuticals’ (NASDAQ, TASE:ORMP) strategic partner, Hefei Tianhui Biotechnology, successfully completed its Phase 3 trials of oral insulin in Type 2 diabetes patients in China under a differentiated study...

May 15, 2023

Developments

POINT invests in alpha-emitting Isotope maker

POINT Biopharma Global (NASDAQ:PNT) and IONETIX are collaborating to create Ionetix Alpha Corp., a new subsidiary of IONETIX, to focus on near-term, commercial-scale production of GMP-grade therapeutic isotopes, such as...

May 15, 2023

Developments

Last patient treated in Bellerophon Phase 3 trial in fibrotic lung disease

The last patient has completed blinded treatment in Bellerophon Therapeutics’ (NASDAQ:BLPH) Phase 3 REBUILD study of INOpulse, a proprietary pulsatile nitric oxide delivery system, for the treatment of fibrotic...

May 11, 2023

Developments

Review committee recommends Addex continue epilepsy study

An independent interim review committee (IRC), following review of unblinded data from Part 1 of patient Cohort 1, recommended Addex Therapeutics (SIX, NASDAQ:ADXN) continue with the ADX71149 Phase 2 epilepsy clinical...

May 10, 2023

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