Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Advicenne submits registration application to FDA for Sibnayal in dRTA

Advicenne (Euronext Growth Paris: FR0013296746—ALDVI) has announced the submission of a registration application to the FDA for Sibnayal—a fixed-dose combination of potassium citrate and potassium bicarbonate—for the...

November 5, 2025

Developments

Surmodics reports outcomes from registry evaluating Pounce in limb ischemia

Surmodics (NASDAQ: SRDX) has announced outcomes from an analysis of 160 real-world patients with symptomatic infrainguinal limb ischemia in the PROWL registry study evaluating its Pounce thrombectomy platform. The...

November 5, 2025

Developments

Wellgistics enters LOI to acquire Kare RX digital hub

Wellgistics Health (NASDAQ: WGRX) has announced that it has entered into a non-binding letter of intent (LOI) to acquire Kare RX—an AI-based digital hub—from closely held Kare PharmaTech. According to Wellgistics, Kare...

November 5, 2025

Developments

GeoVax connects IDSA COVID-19 guidance to GEO-CM04S1 clinical data

GeoVax Labs (NASDAQ: GOVX) has highlighted that its recent Phase 2 findings for GEO-CM04S1 aligns with Infectious Diseases Society of America (IDSA) guidelines prioritizing vaccination for immunocompromised individuals...

October 29, 2025

Developments

APO grants new patent for Moleculin’s Annamycin

Moleculin Biotech (NASDAQ: MBRX) has announced that the Australian Patent Office (APO) has granted a patent with claims covering certain preliposomal Annamycin lyophilizates with improved stability and high purity...

October 29, 2025

Developments

PharmaJet’s Tropis ID selected for Pakistan’s polio campaign

Closely held PharmaJet has announced that its WHO prequalified Tropis ID Needle-free Injection System will be used exclusively in Pakistan’s latest polio immunization campaign to deliver vaccines to 1.8 million children...

October 24, 2025

Developments

CorMedix receives innovative technology designation for DefenCath

CorMedix (NASDAQ: CRMD) has announced that its DefenCath antimicrobial catheter lock solution (CLS) has received innovative technology designation from closely held Vizient—a heathcare performance improvement company...

October 23, 2025

Developments

MAIA details exceptional survival in third-line NSCLC at ESMO

MAIA Biotechnology (NYSE American: MAIA) has announced highlights from a presentation at the European Society for Medical Oncology (ESMO) Congress 2025 held in Berlin, Germany, showcasing its ongoing Phase 2 and Phase 3...

October 23, 2025

Developments

Three peer-reviewed studies reveal Nexalin’s DIFS potential in AD

Nexalin Technology (NASDAQ: NXL) has announced that three independently published, peer-reviewed clinical studies collectively demonstrate the ability of its proprietary 15 mA Gen-2 Nexalin DIFS technology to improve...

October 21, 2025

Developments

Tenon receives FDA 510(k) clearance for joint fusion system

Tenon Medical (NASDAQ:TNON) has announced that the FDA has granted 510(k) clearance for its SImmetry+ SI Joint Fusion System indicated for sacroiliac (SI) joint fusion for conditions including sacroiliac joint...

October 21, 2025

Developments

USPTO publishes patent application for Clearmind’s MEAI for binge behavior disorders

Clearmind Medicine (NASDAQ: CMND; FSE: CWY0) has announced the publication of a patent application by the USPTO for its innovative combination therapy of 5-methoxy-2-aminoindane (MEAI) and N-Acylethanolamines, such as...

October 20, 2025

Developments

Profound congratulates Busch Center for 500th TULSA procedure achieved

Profound Medical (NASDAQ: PROF; TSX: PRN) has unveiled new, real-world data from the internationally recognized Busch Center—marking the completion of 500 TULSA Procedures. This milestone highlights the versatility and...

October 16, 2025

Developments

Sunshine launches generic statin

Sunshine Biopharma (NASDAQ: SBFM) has announced that its wholly owned Canadian subsidiary, Nora Pharma, has launched Pravastatin—a generic prescription version of the drug Pravachol. Pravastatin is a statin medication...

October 16, 2025

Developments

Theravance launches education campaign for nOH associated with MSA

Theravance Biopharma (NASDAQ: TBPH) has announced the launch of Power in the Periphery—a new disease education campaign to raise awareness and deepen scientific understanding of the pathophysiology underlying neurogenic...

October 16, 2025

Developments

First patient dosed in Adicet’s trial of ADI-001 in RA

Adicet Bio (NASDAQ: ACET) has announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory rheumatoid arthritis (RA). The company’s Phase 1 study is designed...

October 16, 2025

Developments

CervoMed reports new data from trial showing potential of neflamapimod for DLB

CervoMed (NASDAQ: CRVO) has announced additional data from its Phase 2b RewinD-LB trial, demonstrating neflamapimod’s potential as a treatment for dementia with Lewy bodies (DLB). According to CervoMed, FDA feedback on...

October 8, 2025

Developments

USPTO grants Aquestive two patents for Anaphylm

Aquestive Therapeutics (NASDAQ: AQST) has announced that the USPTO has issued two additional patents extending protection into 2037 for Anaphylm, a novel epinephrine prodrug sublingual film. According to Aquestive, if...

October 8, 2025

Developments

Profound sees record revenues in Q3-2025; up 84-87% YoY with higher gross margin

Profound Medical (NASDAQ: PROF; TSX: PRN) announced that it anticipates total revenues for the third quarter of 2025 to be in the approximate range of $5.2 million to $5.3 million, representing YoY revenue growth of...

October 7, 2025

Developments

PharmaJet initiates development of needle-free injection pens for home use

Closely held PharmaJet has announced that it is expanding its needle-free injection portfolio with the development of a suite of proprietary, needle-free, self-injector pens. The single-use and reusable needle-free...

October 7, 2025

Developments

FDA grants ALTO fast track designation for treatment of CIAS

Alto Neuroscience (NYSE: ANRO) announced that the FDA has granted its novel small molecule PDE4 inhibitor, ALTO-101, fast track designation for the treatment of cognitive impairment associated with schizophrenia (CIAS)...

October 6, 2025

Developments

Aspire files omnibus patent application with USPTO for drug delivery platform

Aspire Biopharma Holdings (NASDAQ: ASBP) has announced the filing of an omnibus patent application with the USPTO for its sublingual drug delivery technology. According to Aspire, the technology is designed to enhance...

October 6, 2025

Developments

First patient dosed in Perspective’s study of PSV359 in FAP-a positive solid tumors

Perspective Therapeutics (NYSE American: CATX) has announced that the first patient has been dosed in the second cohort of a Phase 1/2a dose-finding trial to determine the safety and preliminary anti-tumor activity of...

October 2, 2025

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