- Spark Newswire

1 minute read

Vaxcyte Concludes Enrolment In Mid-Stage Pneumococcal Disease Study

Today, 4:23 AM

Vaxcyte (NASDAQ: PCVX) completed patient enrollment in the Phase 2 portion of the ongoing Phase 1/2 proof-of-concept study evaluating VAX-24 in healthy adults 50 to 64 years of age.

PCVX

1 minute read

Rhythm Shares Climb Following Positive Interim Results From Mid-Stage Obesity Study

By Ragothaman Srinivasan

Today, 4:23 AM

Rhythm Pharmaceuticals (NASDAQ: RYTM) announced positive interim results from a Phase 2 clinical trial evaluating setmelanotide for the treatment of severe obesity and hyperphagia in people living with hypothalamic obesity.

RYTM

1 minute read

Aethlon Medical Secures FDA Clearance For Amendment In Initial-Stage COVID-19 Study

By Ragothaman Srinivasan

Today, 4:23 AM

The U.S. Food and Drug Administration (FDA) has approved an amendment to the protocol of the ongoing clinical trial investigating Aethlon Medical’s (NASDAQ: AEMD) lead therapy Aethlon Hemopurifier for patients with severe COVID-19.

AEMD

1 minute read

Horizon Therapeutics Receives FDA Approval For Uncontrolled Gout Candidate

By Ragothaman Srinivasan

Today, 4:23 AM

The U.S. Food and Drug Administration (FDA) has approved Horizon Therapeutics’ (NASDAQ: HZNP) supplemental Biologics License Application (sBLA) for expanding the labeling to include KRYSTEXXA (pegloticase) injection co-administered with methotrexate, in patients with uncontrolled gout.

HZNP

1 minute read

InflaRx’s Stock Gains Following FDA Fast Track Status To Skin Disease Drug

By Ragothaman Srinivasan

Today, 4:23 AM

The US Food and Drug Administration (FDA) granted a Fast Track designation to InflaRx’s (NASDAQ: IFRX) lead candidate Vilobelimab for the treatment of ulcerative Pyoderma Gangrenosum (PG).

IFRX

1 minute read

Corcept Therapeutics Commences Late-Stage Ovarian Cancer Study

By Ragothaman Srinivasan

Today, 4:23 AM

Corcept Therapeutics (NASDAQ: CORT) has initiated pivotal Phase 3 clinical trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer.

CORT

1 minute read

Lexicon Shares Jump 20 Percent Following Positive Results From Mid-Stage Diabetic Neuropathy Study

By Ragothaman Srinivasan

Today, 4:23 AM

Lexicon Pharmaceuticals (NASDAQ: LXRX) reported positive topline results from the Phase 2 proof-of-concept study of its lead candidate LX9211 in painful diabetic neuropathy. The RELIEF-DPN-1 is the first of two Phase 2 proof-of-concept study designed to evaluate LX9211 in patients with neuropathic pain.

LXRX

1 minute read

U.S. FDA Accepts Regeneron’s Diabetic Retinopathy Candidate Submission For Review

By Ragothaman Srinivasan

Today, 4:23 AM

The U.S. Food and Drug Administration (FDA) has accepted Regeneron Pharmaceuticals’ (NASDAQ: REGN) supplemental Biologics License Application (sBLA) of EYLEA (aflibercept) Injection for review in patients with diabetic retinopathy (DR).

REGN

1 minute read

Icosavax Shares Plummet Following Interim Results From Initial-Stage RSV Vaccine Study

By Ragothaman Srinivasan

Today, 4:23 AM

Icosavax (NASDAQ: ICVX) announced interim results from its Phase 1/1b clinical trial of IVX-121, respiratory syncytial virus (RSV) F antigen, in young and older adults. The Phase 1/1b clinical trial is designed to evaluate the safety and immunogenicity of three dose levels of IVX-121.

ICVX

1 minute read

Jazz Pharmaceuticals’ Late-Stage Multiple Sclerosis Study Misses Primary Endpoint

By Ragothaman Srinivasan

Today, 4:23 AM

Jazz Pharmaceuticals (NASDAQ: JAZZ) announced top-line results from the Phase 3 clinical trial investigating nabiximols oromucosal spray (JZP378) on clinical measures of spasticity in individuals with multiple sclerosis (MS).

JAZZ