Intellia Therapeutics has presented additional evidence supporting the possible long-term potential of its experimental one-time CRISPR gene-editing therapy in hereditary angioedema (HAE).The findings for lonvoguran ziclumeran (lonvo-z), presented this week at the American College of Allergy, Asthma & Immunology (ACAAI) conference, include follow-up extending several years and may reassure physicians about the treatment's long-term durability (see – Physician Views In-Depth: New HAE prophylactic

AstraZeneca secured another US approval for Imfinzi (durvalumab) in bladder cancer on Friday, with the FDA clearing the PD-L1 inhibitor together with Pfizer and Astellas' Padcev (enfortumab vedotin) for adults with muscle-invasive bladder cancer (MIBC) who are ineligible for or have refused cisplatin-based chemotherapy.Specifically, the combo is indicated for use as neoadjuvant treatment, followed by Imfinzi monotherapy after radical cystectomy.The decision was based on the Phase III VOLGA trial

Novo on Friday said that it submitted applications to the FDA and EMA seeking approval of etavopivat for the treatment of adolescents and adults living with sickle cell disease (SCD). The company suggested that decisions on the filings for the oral pyruvate kinase (PK) activator are expected in 2027."If approved, we are hopeful that etavopivat can provide a new disease-modifying treatment option for people living with sickle cell disease," remarked Martin Holst Lange, Novo's chief scientific off

Shares in Candel Therapeutics fell as much as 38% in pre-market trading Friday after the company disclosed a delay to its FDA filing for aglatimagene besadenovec (CAN-2409) in prostate cancer. The biotech is now targeting a submission for the viral-based immunotherapy in mid-2027, having previously guided for an application this year.Candel said that it remains "in ongoing dialogue" with the FDA regarding the submission of a biologics license application (BLA), but is facing a delay "due to time

Planned global Phase 3 LEGACY trial of tegoprubart in kidney transplantation remains on track to initiate in Q4 2026 FDA cleared the Company’s IND application for a planned registrational path study of tegoprubart in islet cell transplantation for patients with type 1 diabetes FDA Fast Track designation granted to tegoprubart for the prevention of rejection in kidney transplantation Cash, cash equivalents and short-term investments of $69.7 million with cash runway into Q2 2027 IRVINE, Calif., N

Delivering on the First of Four Distinct Value Drivers PRINCETON, N.J. , Nov. 12, 2026 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, today reported financial results for the third quarter ended September 30, 2026, recent business highlights, and provides a regulatory update. Third Quarter 2026 Financial Results Revenue was $9.7 million, an increase of 3

All participants showed cutaneous neurofibroma (cNF) reductions: All 15 evaluable participants had reductions in target cNF surface area, with a median best reduction of 41% across all doses and 46% at doses planned for Phase 2 cNF reductions deepened with continued treatment : The median reduction in target cNF surface area reached 49% at Cycle 12 among participants followed through 12 cycles and 71% at Cycle 15 in the 4mg cohort Favorable safety and tolerability profile: No treatment related

JAVENÉ, France , Nov. 13, 2026 /PRNewswire/ -- Thursday, November 12, HTL Biotechnology, a world leader in the development and production of pharmaceutical-grade biopolymers, inaugurated its new production unit, HTL8, dedicated to the manufacture of pharmaceutical-grade polynucleotides, at its Javené site (Ille-et-Vilaine). This €15 million investment marks a structuring step in the group's international development strategy and in the diversification of its biopolymer portfolio. It responds

COPENHAGEN, Denmark, November 13, 2026 – Bavarian Nordic A/S (OMX: BAVA) announced today its interim financial results and business progress for the third quarter and first nine months of 2026. Financial highlights Revenue in the third quarter was DKK 1,805 million, compared to DKK 1,795 million in the third quarter of 2025. Travel Health revenue increased by 22% (32% when adjusting for discontinued partnerships) to DKK 1,144 million, primarily driven by continued strong RabAvert/Rabipur sale

– Initiated Phase 2 clinical study of ABI-6250 in patients with chronic hepatitis delta virus infection – – Exercised 40% U.S. Profit-Share option for the HSV helicase primase inhibitor program – – Received first $75 million collaboration extension fee from Gilead; cash runway projected into 2029 – SOUTH SAN FRANCISCO, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company developing innovative therapeutics targeting serious viral and liver