Entries by clickgiant

BI Analyst Briefing: What’s New in Skin and Auto-Immune Disorders?

November 2, 2021 at 10:00 AM ET (sign up here) Please join us to review recent and upcoming clinical and regulatory developments in skin and auto-immune disease. Bloomberg Intelligence analyst Michael Shah, and Senior Principal of inThought Research Amanda Weyerbacher, PhD, will be joined by dermatologist Steven R. Feldman, MD, PhD and rheumatologist Christopher Ritchlin […]

BI Analyst Briefing: ASCO Highlights Review

June 9 at 11am – 12:30pm ET (sign up here) Please join us for a review of key data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Bloomberg Intelligence analysts Marc Engelsgjerd, MD, and Sam Fazeli, PhD, and inThought Research analyst Matt Presby, PhD, will be joined by expert speakers Patrick Forde, MBBCh, […]

Reata Submits NDA for Bardoxolone in Alport Syndrome

March 1, 2021 Impact: High Reata has submitted an NDA to the FDA for bardoxolone methyl for the treatment of chronic kidney disease caused by Alport Syndrome. Reata has requested priority review for the application. The submission was based on the results of the phase 2/3 CARDINAL study which demonstrated statistically significant improvement in  kidney […]

Prothena Reports Q4 2020 & Full Year Earnings

February 14, 2021 Impact: High During its Q4 2021 earnings call, Prothena gave an update on its prasinezumab clinical program for Parkinson’s disease. During the clinical overview, Prothena highlighted that prasinezumab specifically targets the C-terminus of alpha-synuclein and is the “first antibody to show significant slowing of motor progression and improvements in imaging biomarkers.” The company stated that preclinical studies […]

BCMA Bispecific Earnings Roundup: Pfizer’s Elranatamab Granted FDA Fast Track Designation While Amgen’s Pavurutamab Trial is Paused Due to Safety

February 3, 2021 Impact: High Both Pfizer and Amgen provided updates on its BCMA bispecific programs in Q4/FY 2020 earnings calls on February 2. Pfizer’s BCMAxCD3 bispecific, elranatamab (PF-06863135), received FDA Fast Track designation in late January for the treatment of multiple myeloma patients who are refractory to at least one proteasome inhibitor, one immunomodulatory drug […]

Affimed’s AFM13 in Combination with Keytruda Demonstrates Promising Early Stage Results for Patients with r/r Hodgkin Lymphoma

November 19, 2020 Impact: High Results for Affimed’s AFM13 (CD30/CD16A ICE; Innate Cell Engager) in combination with Keytruda (pembrolizumab) in a phase 1b study for r/r Hodgkin Lymphoma patients have been published in the journal Blood. Key efficacy data included (n=30): ORR (Objective Response Rate): 88% (CR rate: 46%) at the recommended dose level Investigators deemed […]

Oramed Initiates Two Phase 2 Studies in T2D Patients with NASH

November 10, 2020 Impact: Moderate Oramed is planning two new phase 2 studies to evaluate the efficacy and safety of its oral insulin candidate, ORMD-0801 in T2DM patients with NASH. The studies are due to start in November 2020. The first study is a double-blind study that will randomize 36 subjects in a 2:1 ratio to […]

Krystal Biotech Presents Positive Pre-Clinical Data of KB301 for Aesthetic Indications at ASDS 2020; Phase 1 Recruiting for KB301 Injections to Treat Deep Wrinkles and Acne Scars

October 8, 2020 Impact: Moderate Krystal Biotech announced the presentation of preclinical data supporting the ongoing development of KB301. Data will be presented at the American Society for Dermatologic Surgery (ASDS) 2020 Virtual Meeting to be held October 9-11, 2020. KB301 is an investigational therapy designed to restore collagen homeostasis locally via directed expression of […]