Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Synlogic initiates pivotal study for phenylketonuria

Synlogic (NASDAQ:SYBX) initiated Synpheny-3, a global, Phase 3 study evaluating the efficacy and safety of SYNB1934 as a potential treatment for phenylketonuria (PKU), a rare inherited disorder that causes an amino...

June 5, 2023

Developments

Jazz, Zymeworks present positive pivotal data in BTC

Jazz Pharmaceuticals (NASDAQ:JAZZ) and Zymeworks (NASDAQ:ZYME) presented positive pivotal trial data, including new data on progression-free survival (PFS), from the Phase 2b HERIZON-BTC-01 trial of the bispecific...

June 5, 2023

Developments

AMA unveils new CPT Category 1 codes for Profound Medical’s TULSA-PRO

Profound Medical (NASDAQ:PROF; TSX:PRN) announced that, with sponsorship and support from multiple physician specialty societies, it has received from the American Medical Association (AMA) three new Current Procedural...

June 2, 2023

Developments

Vistagen presents Phase 3 data for SAD

Vistagen (NASDAQ:VTGN) presented positive safety and exploratory efficacy data at the American Society for Clinical Psychopharmacology annual meeting in Miami from its large Phase 3 open-label study of fasedienol nasal...

June 1, 2023

Developments

Ionis posts late-stage clinical progress in HAE

Ionis Pharmaceuticals (NASDAQ:IONS) reported positive clinical progress with donidalorsen, its late-stage investigational prophylactic therapy for hereditary angioedema (HAE). Topline two-year open-label extension (OLE)...

June 1, 2023

Developments

Glyscend posts positive topline Phase 2a results for Type 2 diabetes and obesity

Closely-held Glyscend Therapeutics reported that Phase 1 and Phase 2a clinical trials demonstrated that the novel mechanism of its lead candidate, GLY-200, offers significant and clinically relevant reductions in...

May 31, 2023

Developments

IntelGenx unveils short-term commercial objectives

IntelGenx (TSX:IGX; OTCQB:IGXT) unveiled a plan focussed on near-term revenue generation. “There is no question in my mind that IntelGenx has great science, services, assets, and people,”Dwight Gorham, the company’s...

May 31, 2023

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

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