Entries by clickgiant

Roche Presents GENERATION-HD1 Trial Data And Post-Hoc Subgroup Analysis

HIGH IMPACT – During Roche’s HDSA presentation, the company discussed GENERATION-HD1 trial data and post-hoc analysis in subgroups of patients. The call was led by Peter McColgan (Roche) and Lauren Boak (Roche). The speaker mentioned that there were over 700 participants listening in to the talk. The GENERATION HD-1 study is a randomized, multi-center double-blind […]

Poseida finally pulls plug on autologous BCMA CAR-T program

HIGH IMPACT – Poseida announced in its Q3 press release that it will end its P-BCMA-101 autologous CAR-T program and prioritize its allogeneic CAR-T P-BCMA-ALLO1. “While we believe the P-BCMA-101 autologous program has competitive advantages and would be approvable, one long-term strategic benefit of that program has been to inform our highly-differentiated allogeneic approach. With […]

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

HIGH IMPACT – 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 function as […]

Prothena Reports Q4 2020 & Full Year Earnings

HIGH IMPACT – During its Q4 2020 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 […]

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

HIGH IMPACT – 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 and one […]

TOXINS 2021: Ipsen to Present New Analysis of Phase 3 Data Demonstrating the long-duration of Dysport in Five Therapeutic Indications

MODERATE IMPACT Ipsen will present 26 abstracts at TOXINS 2021. A key presentation titled AbobotulinumtoxinA: Evidence for Long Duration of Response from 5 Patient Populations demonstrates long-duration of Dysport. Data from the long-term open-label extension study indicated that repeat cycles of Dysport resulted in at least 12 weeks duration for a large proportion of study patients for […]

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 […]