CHMP opinion now expected in 1Q 2025 No Major Objections outstanding; continue to expect Germany launch in 2Q 2025 Dec. 09, 2024 -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) cancelled the Oral Explanation regarding the Company’s Marketing Authorization Application for beremagene geperpavec-svdt (B-VEC) for the treatment of dystr

The combination of acimtamig with AlloNK® demonstrated an overall response rate of 86% and complete response of 55% in 22 heavily pretreated patients with R/R cHL, who have exhausted all standard of care treatments The combination showed a well-manageable safety profile with no unexpected safety signals Dec. 08, 2024 -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today

ASH: rilzabrutinib demonstrated significant patient benefit in the first positive phase 3 study of a BTK inhibitor in ITP Pivotal phase 3 data show rapid and durable platelet response, reduced bleeding and need for rescue response, and improved physical fatigue and quality of life measures in patients with persistent or chronic ITP Results underscore the safety and efficacy of rilzabrutinib and its potential as the first BTK inhibitor in ITP Rilzabrutinib is currently under regulatory review in

Exploratory long-term follow-up analysis of the phase III POLARIX study indicated a positive trend in overall survival in favour of Polivy in combination with R-CHP for people with first-line diffuse large B-cell lymphoma (DLBCL)1 Patients treated with Polivy in combination with R-CHP required fewer subsequent treatments, potentially reducing burdens on patients and healthcare systems1 These encouraging five-year results continue to highlight the potential of this Polivy combination to improve o

Ntrust-2 open to enroll patients with systemic sclerosis, myositis and ANCA-associated vasculitis across three parallel cohorts Investigator-Sponsored Trial (IST) expands the development of NKX019 to neuromuscular autoimmune disease myasthenia gravis Patient dosing initiated and enrollment open in Ntrust-1 and IST of NKX019 in systemic lupus erythematosus Clinical data from Ntrust-1 and Ntrust-2 planned for 2025 Dec. 05, 2024 -- Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developin

Petosemtamab in combination with pembrolizumab in 1L r/m PD-L1 expressing HNSCC ongoing with clinical data update planned for 2025 Petosemtamab in mCRC evaluation expanded to include 1L and 3L+; initial clinical data planned for 2025 – Conference Call on Saturday, December 7th at 9:00 a.m. ET Dec. 07, 2024 -- Merus N.V. (Nasdaq: MRUS) (Merus, the Company, we, or our), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®), to

Data from the ongoing Phase 1/2 ATALANTA-1 study in a heavily pretreated R/R NHL patient population demonstrate high antitumor activity and an encouraging safety profile in all NHL subtypes studied. 96% of patients received an infusion of fresh, fit, stem-like, early memory CD19 CAR T-cell therapy with a median vein-to-vein time of seven days, avoiding the need for cryopreservation and bridging therapy. These data reinforce the potential of Galapagos’ decentralized cell therapy manufacturing pla

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients Dec. 05, 2024 -- Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that the U.S. FDA has granted RMAT designation to the combination thera

Dec. 04, 2024 -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced it has reached full planned enrollment of 5,000 subjects in the Phase 2b NAVIGATE trial across clinical sites in the US and UK. The trial is designed to evaluate the efficacy and safety of CD388, the company’s DF

TARA-002 demonstrates 72% six-month landmark complete response rate and 70% complete response rate at any time across BCG exposures 100% six-month landmark complete response rate and 80% complete response rate at any time observed in BCG-Unresponsive patients 64% six-month landmark complete response rate and 67% complete response rate at any time observed in BCG-Naïve patients 80% reinduction salvage rate and compelling durability observed with 100% of patients maintaining a complete response fr