FDA - Spark Newswire

2 minute read

Palatin Announces Completion Of End-Of-Phase 2 Meeting With FDA On PL9643 For Dry Eye Disease; Co. And FDA Reached Agreement On All Ket Elements Of Phase 3 Program

Today, 4:04 PM

Palatin Technologies, Inc. ("Palatin") (NYSE:PTN) a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin peptide receptor system, today

PTN

4 minute read

Orchard Therapeutics Announces Regulatory And Clinical Updates For Lead Gene Therapy Programs

By Bill Haddad

Today, 4:04 PM

Expected clinical package for OTL-200 BLA for MLD using data from existing patients clarified with FDA Guidance obtained on design of OTL-203 global registrational trial for MPS-IH Enrollment goal met in OTL-201

ORTX

1 minute read

Chiasma Files Mycapssa European Application For Acromegaly

By Vandana Singh

Today, 4:04 PM

Chiasma Inc (NASDAQ:CHMA) submitted a marketing application to the European Medicines Agency seeking approval of Mycapssa (oral octreotide capsules) as maintenance…

CHMA

1 minute read

Synthetic Biologics Says Patient Dosing And Observation Has Been Completed In Phase 1 Study Of SYN-020

By Bill Haddad

Today, 4:04 PM

Synthetic Biologics, Inc. (NYSE:SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet

SYN

3 minute read

DiaMedica Therapeutics Announces Interim Results From Phase 2 REDUX Study In CKD; Says Results ‘Affirm Biological Activity, Safety and Tolerability of DM199’ And Indicate ‘Statistically and Clinically Significant Reduction in UACR’

By Bill Haddad

Today, 4:04 PM

Results Affirm Biological Activity, Safety and Tolerability of DM199 Consistent with Porcine KLK1 Product in Asia Early Data Indicate Statistically and Clinically Significant Reduction in UACR seen in IgA Nephropathy

DMAC

1 minute read

Ra Medical Systems Says Enrollment In DABRA Clinical Trial Is Now At 62 Subjects

By Bill Haddad

Today, 4:04 PM

Ra Medical Systems, Inc. (NYSE:RMED), a medical device company focused on commercializing excimer laser systems to treat vascular and dermatological diseases, announces progress with finalizing the next-generation

RMED

4 minute read

Cerevel Therapeutics Announces Topline Results For CVL-231 In Phase 1b Clinical Trial In Patients With Schizophrenia; Says Both Doses Demonstrated Clinically Meaningful And Statistically Significant In PANSS Total Score

By Bill Haddad

Today, 4:04 PM

Both doses of CVL-231 demonstrated a clinically meaningful and statistically significant improvement in PANSS Total score at 6 weeks and were overall well-tolerated compared with placebo 30 mg of CVL-231

CERE

2 minute read

Iovance Biotherapeutics Announces Clinical Data For LN-145 ; Showed 21.4% Overall Response Rate In Relapsed/Refractory Metastatic Non-Small Cell Lung Cancer Patients Following One Or More Prior Systemic Therapies Including Immunotherapy

By Bill Haddad

Today, 4:04 PM

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced clinical data for its tumor infiltrating lymphocyte (TIL)

IOVA

1 minute read

Entera Bio Shares Spike Higher Following Co. Press Release Highlighting Upcoming Jun. 30 Conference Call To Discuss ‘Phase 2 Results for EB613 Positioned to be the First Oral Bone-Building Agent for the Treatment of Osteoporosis’

By Benzinga Newsdesk

Today, 4:04 PM

Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced it will conduct a conference call to discuss results from its successfully completed Phase 2

ENTX

2 minute read

Anavex Life Sciences Stock Rallies: Technical Levels To Watch

By Tyler Bundy

Today, 4:04 PM

Anavex Life Sciences Corp. (NASDAQ: AVXL) shares traded higher Monday after the company announced ANAVEX2-73, the company’s main pipeline drug, improved both primary cognitive and secondary MDS-UPDRS efficacy endpoints with significant biomarker correlation in placebo-controlled Phase 2 clinical trial

AVXL