Healthcare Industry Developments | BioTuesdays by Kilmer Lucas IR

Developments

Kazia gets FDA rare pediatric disease designation for paxalisib

Kazia Therapeutics (NASDAQ:KZIA) received FDA rare pediatric disease designation for paxalisib for the treatment of diffuse intrinsic pontine glioma (DIPG). Paxalisib is currently in a Phase 1 trial for DIPG. Positive...

August 7, 2020

Developments

Clovis enrolls first patient in Phase 2 portion of gynecologic cancer trial

Clovis Oncology (NASDAQ:CLVS) enrolled the first patient in the Phase 2 portion of its LIO-1 trial evaluating lucitanib for the treatment of gynecologic cancers. The trial is designed to evaluate the safety and efficacy...

August 6, 2020

Developments

FDA clears Surmodics’ Sublime dilatation catheter

Surmodics (NASDAQ:SRDX) received FDA 510(k) clearance for its Sublime radial access dilatation catheter. The company noted that at 250 cm, the Sublime catheter has the longest working length of currently available...

August 6, 2020

Developments

MediciNova reports positive results from Phase 2 alcohol use disorder trial

MediciNova (NASDAQ:MNOV) reported positive results from its Phase 2 trial evaluating ibudilast for the treatment of alcohol use disorder (AUD). Ibudilast has been marketed in Japan and Korea since 1989 to treat post...

August 6, 2020

Developments

Endologix gets CE Mark for ALTO abdominal stent graft system

Endologix (NASDAQ:ELGX) received a CE Mark for its ALTO abdominal stent graft system. ALTO is an endovascular aneurysm repair device designed to increase patient applicability and technical success rate, and improve...

August 5, 2020

Developments

Axsome AXS-12 gets FDA breakthrough therapy designation for narcolepsy

The FDA granted Axsome Therapeutics’ (NASDAQ:AXSM) AXS-12 breakthrough therapy designation for the treatment of cataplexy in patients with narcolepsy. Narcolepsy is a neurological condition characterized by excessive...

August 5, 2020

Developments

DBV Technologies gets FDA complete response letter for Viaskin Peanut

The FDA issued DBV Technologies (NASDAQ:DBVT) a complete response letter (CRL) regarding the company’s BLA for Viaskin Peanut, and epicutaneous patch to treat peanut allergies in children. The FDA identified concerns...

August 5, 2020

Developments

Eloxx Pharma ELX-02 granted FDA orphan drug designation for cystic fibrosis

Eloxx Pharmaceuticals’ (NASDAQ:ELOX) ELX-02 received FDA orphan drug designation for the treatment of cystic fibrosis (CF). ELX-02 is a small molecule designed to restore production of CF transmembrane conductance...

August 5, 2020

Developments

Hepion doses first patient with CRV431 in Phase 2 NASH study

Hepion Pharmaceuticals (NASDAQ:HEPA) dosed the first patient in its Phase 2 trial assessing CRV431 for the treatment of non-alcoholic steatohepatitis (NASH). The Phase 2a study, called AMBITION, is designed to assess...

August 5, 2020

Developments

Marinus gets FDA rare pediatric disease designation for ganaxolone

Marinus Pharmaceuticals (NASDAQ:MRNS) received FDA rare pediatric disease designation for ganaxolone for the treatment of CDKL5 deficiency disorder (CDD). CDD is a rare refractive form of pediatric epilepsy caused by a...

July 31, 2020

Developments

Titan Pharma and Indegene provide details of new Probuphine co-promotion partnership

Titan Pharmaceuticals’ (NASDAQ:TTNP) CEO, Sunil Bhonsle, and Indegene VP of co-commercialization, Jamie Peck, provided additional information on their recently established Probuphine co-promotion partnership. In an...

July 29, 2020

Developments

Krystal Biotech initiates Phase 3 dystrophic epidermolysis bullosa trial

Krystal Biotech (NASDAQ:KRYS) initiated a Phase 3 clinical trial evaluating beremagene geperpavec (B-VEC) for the treatment of dystrophic epidermolysis bullosa (DEB). DEB is a rare and severe monogenic skin disease with...

July 29, 2020

Developments

Regulus gets FDA orphan drug designation for polycystic kidney disease

Regulus Therapeutics’ (NASDAQ:RGLS) RGLS4236 received FDA orphan drug designation for the treatment of autosomal dominant polycystic kidney disease (ADPKD). ADPKD is caused by mutations in the PKD1 or PKD2 genes, and is...

July 29, 2020

Developments

Nabriva XENLETA gets European approval for community-acquired pneumonia

The EMA approved Nabriva Therapeutics’ (NASDAQ:NBRV) XENLETA for the treatment of community-acquired pneumonia. The approval is based on efficacy data from two Phase 3 clinical trials, both of which established XENLETA...

July 28, 2020

Developments

Protara gets FDA rare pediatric disease designation for lymphatic malformation

Protara Therapeutics’ (NASDAQ:TARA) TARA-002 received FDA rare pediatric disease designation for the treatment of lymphatic malformation. Lymphatic malformations are rare, typically congenital and result in the failure...

July 28, 2020

Developments

Celsion randomizes first patients in Phase 1/2 ovarian cancer study

Celsion (NASDAQ:CLSN) randomized the first two patients in the Phase 2 portion of its Phase 1/2 study evaluating GEN-1 for the treatment of advanced ovarian cancer. GEN-1 is an interleukin-12 DNA plasmid vector...

July 27, 2020

Developments

Immunic reports first patients enrolled in Phase 2 COVID-19 trial

The first patients have been enrolled in an investigator-sponsored Phase 2 study evaluating Immunic Therapeutics‘ (NASDAQ:IMUX) IMU-838 for the treatment of COVID-19. IMU-838 is a selective immune modulator that...

July 27, 2020

Developments

PolarityTE reports positive topline data from diabetic foot ulcer trial

PolarityTE (NASDAQ:PTE) reported positive topline results from its trial evaluating SkinTE for the treatment of diabetic foot ulcers. SkinTE is a human cellular and tissue-based product derived from a patient’s own skin...

July 24, 2020

Developments

miRagen cobomarsen gets FDA orphan drug designation for T-cell lymphoma

miRagen Therapeutics’ (NASDAQ:MGEN) cobomarsen was granted FDA orphan drug designation for the treatment of T-cell lymphoma. Cobomarsen, an inhibitor of microRNA-155, is being evaluated in a Phase 1 and Phase 2 trial...

July 24, 2020

Developments

AxoGen completes target enrollment in Phase 3 nerve graft study

AxoGen (NASDAQ:AXGN) completed target enrollment of 220 subjects in its Phase 3 RECON study evaluating its Avance nerve graft in digital nerve injuries. The study will compare AxoGen’s Avance nerve graft with...

July 22, 2020

Developments

FDA accepts Aurinia NDA for voclosporin; agrees to priority review

The FDA accepted for priority review Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) NDA for voclosporin for the treatment of lupus nephritis (LN). The NDA for voclosporin is based on the Phase 3 AURORA and Phase 2 AURA...

July 22, 2020

Developments

9 Meters doses first patients in Phase 1b/2a short bowel syndrome trial

9 Meters Biopharma (NASDAQ:NMTR) dosed the first patients in its Phase 1b/2a clinical trial evaluating NM-002 for the treatment of short bowel syndrome. Short bowel syndrome is a rare, life-threatening disease caused by...

July 21, 2020

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