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 FDA Rejects Telix Pharmaceuticals' Glioma Imaging Agent Submission

FDA Rejects Telix Pharmaceuticals' Glioma Imaging Agent Submission

April 28, 2025 05:36 PM AEST | By Team Kalkine Media

Highlights:,Telix Pharmaceuticals faces a setback as the FDA declines approval for its glioma imaging agent.,The regulatory body requests additional c...

 Cochlear Ltd (ASX:COH) Share Price Analysis in 2025

Cochlear Ltd (ASX:COH) Share Price Analysis in 2025

April 28, 2025 05:21 PM AEST | By Team Kalkine Media

Highlights:,Cochlear Ltd’s share price has decreased by approximately 7.5% since the start of 2025.,The company continues to lead in the global hearin...

 Radiopharm Theranostics (ASX:RAD) Advances Brain Metastasis Imaging with Promising Phase 2b Trial

Radiopharm Theranostics (ASX:RAD) Advances Brain Metastasis Imaging...

April 28, 2025 03:45 PM AEST | By Team Kalkine Media

Highlights,Radiopharm Theranostics initiates Phase 2b trial for brain metastasis imaging.,18F-RAD101 targets fatty acid synthase for enhanced diagnost...

 EMVision dispatches its bedside brain scanning device to Mayo Clinic for evaluation at a second testing location.

EMVision dispatches its bedside brain scanning device to Mayo Clinic...

April 28, 2025 01:31 PM AEST | By Team Kalkine Media

Highlights:,EMVision (ASX:EMV) enhances emergency care with bedside brain imaging technology.,Portable brain scanner aims to support first responders...

 TrivarX Approved for US Trial to Use Heart Rate in Identifying Depression in Veterans

TrivarX Approved for US Trial to Use Heart Rate in Identifying Depre...

April 28, 2025 01:30 PM AEST | By Team Kalkine Media

Highlights:,TrivarX (ASX:TRI) initiates a trial using heart rate data to detect depression in US veterans.,The trial proceeds through collaboration wi...

 Pharmaceutical Sector: Telix Pharmaceuticals Addresses FDA Data Requirements for Imaging Agent

Pharmaceutical Sector: Telix Pharmaceuticals Addresses FDA Data Requ...

April 28, 2025 01:30 PM AEST | By Team Kalkine Media

Highlights:,Telix Pharmaceuticals faced an FDA request for additional data on TLX101-CDx.,TLX101-CDx holds Orphan Drug and Fast Track designations for...

 ResMed (ASX:RMD): Why Healthcare Shares Continue to Win Investor Confidence

ResMed (ASX:RMD): Why Healthcare Shares Continue to Win Investor Con...

April 28, 2025 12:49 PM AEST | By Team Kalkine Media

Highlights,ResMed (RMD),operates,a global healthcare business with expanding digital health capabilities.,Healthcare sector’s 'sticky' revenue offers...

 Setback for Telix Pharmaceuticals (ASX:TLX) as FDA Requests Additional Data for Brain Cancer Imaging Agent

Setback for Telix Pharmaceuticals (ASX:TLX) as FDA Requests Addition...

April 28, 2025 12:48 PM AEST | By Team Kalkine Media

Highlights,FDA issues complete response letter for TLX101-CDx application,No safety concerns raised for investigational brain cancer imaging agent,Tel...

 FDA Setback Hits Telix Pharmaceuticals' Imaging Agent Ambitions

FDA Setback Hits Telix Pharmaceuticals' Imaging Agent Ambitions

April 28, 2025 12:44 PM AEST | By Team Kalkine Media

Highlights,Telix,Pharmaceuticals faces FDA roadblock for glioma imaging agent,Additional,clinical data,required,for TLX101-CDx approval,Company's fina...

 Recce Pharmaceuticals Strengthens Biodefense Strategy with New US Army Research Agreement

Recce Pharmaceuticals Strengthens Biodefense Strategy with New US Ar...

April 28, 2025 11:55 AM AEST | By Team Kalkine Media

Highlights,Recce Pharmaceuticals advances partnership with US Army.,R327 to be tested against deadly pathogens under high biocontainment.,Collaboratio...

 Telix Faces Regulatory Setback as FDA Requests More Data on Brain Cancer Imaging Agent

Telix Faces Regulatory Setback as FDA Requests More Data on Brain Ca...

April 28, 2025 11:54 AM AEST | By Team Kalkine Media

Highlights,Telix,faces regulatory setback on brain cancer imaging agent,FDA requests more clinical evidence for approval,Company plans swift resubmiss...

 SomnoMed Limited (ASX:SOM): A Comprehensive Look at Recent Performance

SomnoMed Limited (ASX:SOM): A Comprehensive Look at Recent Performan...

April 26, 2025 12:30 PM AEST | By Team Kalkine Media

Highlights:,SomnoMed shares have seen a notable decline in recent weeks.,Despite recent challenges, the company has exhibited strong year-over-year gr...

 Determining the Intrinsic Value of Alcidion Group Limited (ASX:ALC)

Determining the Intrinsic Value of Alcidion Group Limited (ASX:ALC)

April 25, 2025 10:32 PM AEST | By Team Kalkine Media

Highlights:,Alcidion Group's share price closely reflects its estimated equity valuation derived from discounted cash flow modelling,The company maint...

 Micro-X Insider Stock Buyers Recover Some Losses This Week

Micro-X Insider Stock Buyers Recover Some Losses This Week

April 25, 2025 12:30 PM AEST | By Team Kalkine Media

Highlights:,Micro-X insiders hold a significant stake in the company, with a substantial portion of shares owned by those directly involved.,A notewor...

 Recce Pharmaceuticals Prepares for Pivotal Trials with A$15.8 Million Funding Injection

Recce Pharmaceuticals Prepares for Pivotal Trials with A$15.8 Millio...

April 24, 2025 07:00 PM AEST | By Team Kalkine Media

Highlights,Recce Pharmaceuticals secures A$15.8 million for pivotal Phase 3 trials.,Key focus on diabetic foot infections and skin infections across A...

 ResMed’s (ASX:RMD) Robust Growth Driven by Demand for Sleep Apnoea Solutions

ResMed’s (ASX:RMD) Robust Growth Driven by Demand for Sleep Apnoea S...

April 24, 2025 06:44 PM AEST | By Team Kalkine Media

Highlights,ResMed delivers strong double-digit EPS growth.,Robust demand for sleep apnoea devices drives revenue.,New home-based diagnostic test expan...

 ASX Healthcare Focus: Exploring Cochlear Ltd (ASX:COH) Amid Sector Trends

ASX Healthcare Focus: Exploring Cochlear Ltd (ASX:COH) Amid Sector T...

April 24, 2025 06:26 PM AEST | By Team Kalkine Media

Highlights:,Cochlear Ltd has recorded a share price decline since the beginning of the year,The company manufactures hearing implants and operates in...

 ResMed (ASX:RMD) Reports Strong FY25 Q3 Performance Driving Share Price Surge

ResMed (ASX:RMD) Reports Strong FY25 Q3 Performance Driving Share Pr...

April 24, 2025 06:17 PM AEST | By Team Kalkine Media

Highlights:,ResMed’s revenue increased driven by performance across all major markets and product segments,Net profit recorded double-digit growth sup...

 Telix Pharmaceuticals: A Rapidly Growing Force in Cancer Treatment

Telix Pharmaceuticals: A Rapidly Growing Force in Cancer Treatment

April 24, 2025 06:12 PM AEST | By Team Kalkine Media

Highlights:,Telix Pharmaceuticals has experienced rapid revenue growth, reaching over one billion dollars in sales.,The company specializes in radioth...

 Botanix's SODFRA Sales Surge in Q1, Boosting Confidence in Expansion Strategy

Botanix's SODFRA Sales Surge in Q1, Boosting Confidence in Expansion...

April 24, 2025 06:12 PM AEST | By Team Kalkine Media

Highlights,Q1 revenue from SODFRA doubles between Feb and Mar,$40M raised via institutional placement,Expansion plans supported by strong cash reserve...

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