- Spark Newswire

1 minute read

Amylyx Pharmaceuticals Shares Shoot Up As FDA Extends Review Of NDA For Neurodegenerative Disease Candidate

Today, 5:01 PM

The U.S. Food and Drug Administration (FDA) has extended the review of New Drug Application (NDA) by three months, submitted by Amylyx Pharmaceuticals (NASDAQ: AMLX) for its lead drug candidate AMX0035 with regard to the treatment of patients with amyotrophic lateral sclerosis (ALS).

AMLX

1 minute read

Aeglea BioTherapeutics Shares Plummet Following Refusal To File Letter From FDA

By Ragothaman Srinivasan

Today, 5:01 PM

Aeglea BioTherapeutics, Inc. (NASDAQ: AGLE) announced the U.S. Food and Drug Administration (FDA) has refused to accept the company’s Biologics License Application (BLA) with a Refusal to File (RTF) letter.

AGLE

1 minute read

PDS Biotechnology Gains On FDA Fast Track Designation For Lead Candidate

By Ragothaman Srinivasan

Today, 5:01 PM

The U.S.

PDSB

1 minute read

FDA Accepts Regeneron, Sanofi’s Filing For Review In Skin Disease

By Ragothaman Srinivasan

Today, 5:01 PM

The U.S.

REGN

1 minute read

Moleculin Biotech Doses Healthy Volunteers For Covid-19 In Early-Stage Study Of WP1122

By Ragothaman Srinivasan

Today, 5:01 PM

Moleculin Biotech, Inc. (NASDAQ: MBRX) announced dosing of subjects in its Phase 1a clinical study of WP1122 in healthy volunteers for the treatment of COVID-19.

MBRX

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CytomX Therapeutics Initiates Dosing in Early-Stage Study Of Solid Tumor Settings

By Ragothaman Srinivasan

Today, 5:01 PM

CytomX Therapeutics, Inc. (NASDAQ: CTMX) initiated enrolment by dosing first patient in a Phase 1 dose-escalation study of CX-904 for patients with advanced solid tumors.

CTMX

1 minute read

Pharma Stock Shoots Up As FDA Accepts NDA For Neuromuscular Disorder Drug Under Priority Review

By Ragothaman Srinivasan

Today, 5:01 PM

Reata Pharmaceuticals (NASDAQ: RETA) announced that the U.S. Food and Drug Administration has accepted New Drug Application (NDA) for its lead drug candidate omaveloxolone for the treatment of patients with Friedreich's ataxia.

RETA

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FDA Accepts Review Of Phathom Pharmaceuticals’ NDA For Vonoprazan

By Ragothaman Srinivasan

Today, 5:01 PM

The Food and Drug Administration (FDA) has accepted for review Phathom Pharmaceuticals’ (NASDAQ: PHAT) New Drug Application (NDA) of its lead drug candidate Vonoprazan for the healing of all grades of erosive esophagitis (EE).

PHAT

1 minute read

Elevation Oncology Shares Gain On FDA Fast Track Designation For Seribantumab In Tumor-Agnostic Settings

By Ragothaman Srinivasan

Today, 5:01 PM

Elevation Oncology, Inc. (NASDAQ: ELEV) received Fast Track designation from the Food and Drug Administration (FDA) for Seribantumab in tumor-agnostic settings for the treatment of advanced solid tumors that harbor NRG1 gene fusions.

ELEV

1 minute read

Crinetics Pharmaceuticals Announces Positive Top-line Results From CRN04894 Early-Stage Trial

By Ragothaman Srinivasan

Today, 5:01 PM

Crinetics Pharmaceuticals Inc (NASDAQ: CRNX) revealed positive topline results from a first-in-human Phase 1 clinical study of CRN04894 for the treatment of patients with Cushing's disease.

CRNX