Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

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; Frankfurt:WF6) 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...

May 5, 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

Developments

Profound Medical’s TULSA procedure featured at AUA

Profound Medical’s (NASDAQ:PROF; TSX:PRN) TULSA procedure was featured in four presentations at the American Urological Association (AUA) annual meeting that reinforced its safety, efficacy and durability, further...

May 1, 2023

Developments

Kiora RP treatment seen restoring visual function in blind patients

Kiora Pharmaceuticals (NASDAQ:KPRX) presented preliminary results from an ongoing clinical trial, showing that its investigational drug, KIO-301, has the potential to restore light perception in patients who are blind...

April 28, 2023

Developments

Avidity posts positive Phase 1/2 topline data in myotonic dystrophy 1

Avidity Biosciences (NASDAQ:RNA) reported positive topline data from the Phase 1/2 MARINA clinical trial of AOC 1001 for the treatment of myotonic dystrophy type 1 (DM1), an underrecognized, progressive and often fatal...

April 28, 2023

Developments

SAB posts positive Phase 3 results in high-risk COVID-19 patients

SAB Biotherapeutics (NASDAQ:SABS) reported positive top-line results from the Phase 3 National Institutes of Health’s ACTIV-2 clinical trial that assessed SAB-185 in non-hospitalized people with COVID-19 who were at...

April 26, 2023

Developments

Morphic posts positive cohort data in ulcerative colitis

Morphic Therapeutic (NASDAQ:MORF) reported positive topline data from the main cohort of the open-label EMERALD-1 Phase 2a study of MORF-057, an oral small molecule inhibitor of the α4β7 integrin, in adults with...

April 25, 2023

Developments

Lyra restarts Phase 3 trial in chronic rhinosinusitis

Lyra Therapeutics (NASDAQ:LYRA) resumed screening and enrollment in ENLIGHTEN II, its second Phase 3 clinical trial of LYR-210 in patients with chronic rhinosinusitis (CRS). LYR-210 is a bioresorbable nasal implant...

April 25, 2023

Developments

Blue Water Vaccines changes name to Blue Water Biotech

Blue Water Vaccines changed its corporate name to Blue Water Biotech, following its recent acquisition of ENTADFI, an FDA-approved treatment for benign prostatic hyperplasia, which has begun Blue Water’s transition into...

April 25, 2023

Developments

Lantheus, POINT get FDA fast track for mCRPC

The FDA granted Lantheus Holdings (NASDAQ:LNTH) and POINT Biopharma (NASDAQ:PNT) fast track designation for 177Lu-PNT2002 for the treatment of metastatic castration resistant prostate cancer (mCRPC). PNT2002 is an...

April 24, 2023

Developments

Visus posts positive Phase 3 data to treat presbyopia

Visus Therapeutics reported positive topline results from its Phase 3 pivotal BRIO-I trial, demonstrating highly statistically significant improvements in near and distance binocular visual acuity at multiple...

April 20, 2023

Developments

MAIA Biotechnology reports preliminary Phase 2 survival data for NSCLC

MAIA Biotechnology (NYSEA:MAIA) announced preliminary survival data in the Part A safety lead-in of its ongoing Phase 2 trial, THIO-101, evaluating THIO in patients with advanced non-small cell lung cancer (NSCLC). The...

April 20, 2023

Developments

Cali initiates Phase 3 studies to decrease post-operative pain; cut opioid use

Cali Biosciences initiated Phase 3 studies of its core product, CPL-01, a long-acting ropivacaine, with dosing in hernia patients already begun and dosing in bunion patients scheduled to start next month. CPL-01 is an...

April 19, 2023

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