Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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

Developments

Sweden Orphan Biovitrium to acquire CTI BioPharma

Sweden Orphan Biovitrium (STO:SOBI) entered into a definitive agreement to acquire CTI BioPharma (NASDAQ:CTIC) for $9.10 a share in cash, representing an implied equity value of approximately $1.7-billion. The...

May 10, 2023

Developments

Theralase updates Phase 2 bladder cancer study

Theralase Technologies (TSXV:TLT; OTCQB:TLTFF) updated recently reported interim clinical data from a Phase 2 clinical study of patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle Invasive Bladder...

May 10, 2023

Developments

Omeq Medical receives FDA approval for epidural injections smart device

Closely-held Omeq Medical, a portfolio company of Israel’s The Trendlines Group (SGX:42T;TCQX:TRNLY), received regulatory clearance from the FDA for its EpiFinder device, which assists physicians to accurately position...

May 9, 2023

Developments

Acasti submits Phase 3 safety protocol; implements strategic realignment

Acasti Pharma (NASDAQ:ACST) submitted to the FDA the full protocol of its GTX-104 for a Phase 3 safety study of a rare disease, aneurysmal subarachnoid hemorrhage, and implementation of a strategic realignment plan to...

May 8, 2023

Developments

Visus posts positive Phase 3 results in presbyopia

Visus Therapeutics reported that the BRIO-I Phase 3 clinical trial met its primary and secondary endpoints, evaluating the safety and efficacy of BRIMOCHOL PF, a preservative-free ophthalmic solution for the treatment...

May 5, 2023

Developments

FibroGen flunks Phase 3 anemia study

FibroGen’s (NASDAQ:FGEN) Phase 3 MATTERHORN study of roxadustat for treatment of anemia in patients with transfusion-dependent lower-risk myelodysplastic syndromes (MDS) did not meet its primary efficacy endpoint. The...

May 5, 2023

Developments

MindBio Therapeutics lists on CSE

MindBio Therapeutics (CSE:MBIO) has listed its common shares on the Canadian Securities Exchange under the ticker symbol, MBIO. MindBio is the only company in the world to have clinical trials approved for LSD take-home...

May 5, 2023

Developments

Three finalists announced for Bloom Burton Award

The finalists for the 2023 Bloom Burton Award are: Stephen Dilly, former president and CEO, Sierra Oncology Ian Mortimer, president and CEO, Xenon Pharmaceuticals Dave Wessinger, co-founder and CEO, and Mike Wessinger...

May 4, 2023

Developments

SAB presents positive Phase 1, 2a data in influenza

SAB Biotherapeutics (NASDAQ:SABS) presented positive safety and efficacy data from Phase 1 and 2a clinical trials of its influenza immunotherapy, SAB-176, at the AVG conference, which is hosted by the International...

May 4, 2023

Developments

Immunic posts positive Phase 1b results in celiac disease

Immunic (NASDAQ:IMUX) announced positive results from the part C portion of its Phase 1 clinical trial of IMU-856 in patients with celiac disease. The company believes that this data set provides initial clinical proof...

May 4, 2023

Developments

Magenta, Dianthus in merger agreement

Magenta Therapeutics (NASDAQ:MGTA) and closely-held Dianthus Therapeutics entered into a definitive merger agreement to combine the companies in an all-stock transaction that is expected to close in the third quarter of...

May 3, 2023

Developments

NeuroSense posts positive preliminary PD biomarker data

NeuroSense Therapeutics (NASDAQ:NRSN) reported positive preliminary results from a novel biomarker study conducted to evaluate the potential of its combination platform therapy for the treatment of Parkinson’s...

May 2, 2023

Stereotaxis, Abbott collaborate in cardiac mapping and robotics

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

FDA eases partial clinical hold on Avidity dosing

IntelGenx receives amended Health Canada license for third-party testing

Dermavant posts positive results in second Phase 3 for atopic dermatitis

Chinook, Ionis partner to develop antisense therapy for CKD

Oramed partner in China moving oral insulin to regulatory approval

POINT invests in alpha-emitting Isotope maker

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

Review committee recommends Addex continue epilepsy study

Sweden Orphan Biovitrium to acquire CTI BioPharma

Theralase updates Phase 2 bladder cancer study

Omeq Medical receives FDA approval for epidural injections smart device

Acasti submits Phase 3 safety protocol; implements strategic realignment

Visus posts positive Phase 3 results in presbyopia

FibroGen flunks Phase 3 anemia study

MindBio Therapeutics lists on CSE

Three finalists announced for Bloom Burton Award

SAB presents positive Phase 1, 2a data in influenza

Immunic posts positive Phase 1b results in celiac disease

Magenta, Dianthus in merger agreement

NeuroSense posts positive preliminary PD biomarker data

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