Month: January 2025

Three blockbuster-potential assets in late-stage clinical trials and four pivotal readouts expected in 2025; anticipate four commercial assets by 2028 Study 1 of Essential3 program for ulixacaltamide in essential tremor (ET) on track for Q1 2025 interim analysis; NDA filing for ulixacaltamide expected in 2025 Enrollment in EMBOLD study of relutrigine cohort 2 is on track; targeting NDA filing in 2026 Vormatrigine ENERGY program advancing with read-outs of RADIANT in first half of 2025 and POWER1 by year-end 2025 UCB has exercised its option to license KCNT1 small molecule candidate for global development and commercialization Cash and investments ~ $470 million at the end of 2024 support runway into 2028 BOSTON, Jan. 12, 2025 (GLOBE NEWSWIRE) — Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical...

NEW HAVEN, Conn. and UTRECHT, The Netherlands and CAMBRIDGE, Mass., Jan. 12, 2025 (GLOBE NEWSWIRE) — Biohaven Ltd. (NYSE: BHVN) and Merus N.V. (Nasdaq:MRUS), today announced a research collaboration and license agreement to co-develop three novel bispecific antibody drug conjugates (ADCs), leveraging Merus’ leading Biclonics® technology platform, and Biohaven’s next-generation ADC conjugation and payload platform technologies. Under the terms of the agreement, Biohaven is responsible for the preclinical ADC generation of three Merus bispecific antibodies under mutually agreed research plans. The agreement includes two Merus bispecific programs generated using the Biclonics® platform, and one program under preclinical research by Merus. Each program is subject to mutual agreement for advancement to further development, with the...

— CB-010 GALLOP Phase 1 trial initiated in lupus — — CB-012 AMpLify Phase 1 trial in r/r AML completes dose level 3 with no DLTs; enrolling patients at dose level 4 — — CB-010 ANTLER 2L LBCL and CB-011 CaMMouflage r/r MM Phase 1 clinical data expected in H1 2025 — — Sri Ryali appointed chief financial officer — — Caribou to present at 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, at 10:30 am PST — BERKELEY, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) — Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, today announced initiation of the GALLOP Phase 1 clinical trial evaluating CB-010 in patients with lupus nephritis (LN) and extrarenal lupus (ERL). In addition, Caribou highlighted successful...

Oral Presentation Presented at ASH 2024 Showed Iopofosine I 131 Achieved an 83.6% ORR and Exceeded Primary and Secondary Efficacy Endpoints in Phase 2 CLOVER-WaM Study for Relapsed/Refractory Waldenstrom’s Macroglobulinemia Plans to Advance Iopofosine I 131 Internally, Through Strategic Partnerships and Other Approaches; Finalizing Confirmatory Study and Pathway for US FDA Accelerated Approval and EMA Prime Marketing Authorization Advancing Radiotherapeutic Assets including Alpha- and Auger-emitting Radioconjugates into Phase 1/2a Solid Tumor Studies FLORHAM PARK, N.J., Jan. 12, 2025 (GLOBE NEWSWIRE) — Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announces plans to highlight the...

– Ascendis positioned to drive rapid revenue growth COPENHAGEN, Denmark, Jan. 12, 2025 (GLOBE NEWSWIRE) — Ascendis Pharma A/S (Nasdaq: ASND) today provided a business and strategic roadmap update, including planned 2025 key corporate milestones. Ascendis President and CEO Jan Mikkelsen will present this update tomorrow, January 13, during the 43rd Annual J.P. Morgan Healthcare Conference. “Ascendis is well-positioned for rapid revenue growth with the launch of our first two Endocrinology Rare Disease medicines, SKYTROFA and YORVIPATH, and, following our pre-NDA meeting, planned filings for our third, TransCon CNP for achondroplasia,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “Our expanding TransCon technology platform and partnerships demonstrate that our business model built on fast, successful...

MELBOURNE, Australia and INDIANAPOLIS, Jan. 13, 2025 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces it has entered into an asset purchase agreement with antibody engineering company ImaginAb, Inc. (ImaginAb) to acquire a pipeline of next-generation therapeutic candidates, proprietary novel biologics technology platform, and a protein engineering and discovery research facility to enhance existing innovation capabilities. This transaction adds a pipeline of early-stage drug candidates against high-value targets including DLL31 and integrin αvβ62, as well as several other novel targets in discovery stage. These next generation drug candidates fit synergistically with Telix’s therapeutics pipeline, enabling expansion to future therapy areas with unmet clinical need. The...

2024 Total Revenue of $528M, Representing Significant Growth of 32% Year-Over-Year1 Strong and Growing Demand for Galafold® and Pombiliti® + Opfolda® Total Revenue Growth of 17-24% at CER Expected in 2025 >3,000 People Treated with an Amicus Therapy Today2 PRINCETON, N.J., Jan. 12, 2025 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today provided its preliminary and unaudited 2024 revenue, corporate updates, and full-year 2025 outlook. Bradley Campbell, President and Chief Executive Officer of Amicus Therapeutics, Inc., said, “For Amicus, 2024 was a remarkable year in which we set out high expectations and met or exceeded each of them. Amicus delivered significant revenue growth of 32% in addition...

MONACO, Jan. 12, 2025 (GLOBE NEWSWIRE) — Scorpio Tankers Inc. (NYSE: STNG) (“Scorpio Tankers” or the “Company”) through its Norwegian investment banks, will arrange a series of fixed income investor calls commencing on January 13, 2025. A five-year USD denominated senior unsecured bond issue may follow, subject to inter alia market conditions. The net proceeds from the contemplated bond issue are intended to be used for the refinancing of the Company’s existing 7.0% senior unsecured notes due June 30, 2025 which have an outstanding principal balance of USD 70.6 million, and for general corporate purposes. The senior unsecured bonds, if issued, will be offered in the United States or its territories only to persons reasonably believed to be qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933,...

New agreement enables both companies to fuel a broad and innovative pipeline of 212Pb-Radio-DARPin candidates, bringing the total number of programs up to ten Expanded partnership highlights the parties’ emerging leadership in targeted alpha therapies (TAT), leveraging Orano Med’s expertise in the development of 212Pb-based TAT and vast proprietary supply of 212Pb and Molecular Partners’ unique Radio-DARPins as an ideal vector for radiopharmaceuticals Most advanced 212Pb-Radio-DARPin, DLL3-targeted MP0712, starts clinical trials in 2025ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., and PARIS, Jan. 12, 2025 (GLOBE NEWSWIRE) — Ad hoc announcement pursuant to Art. 53 LR – Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics,...

Radio-DARPin MP0712 against DLL3, in co-development with Orano Med, to enter first-in-human study in 2025 Mesothelin named as second target in Radio-DARPin pipeline, program to be co-developed with Orano Med Orano Med partnership on Radio-DARPins now expanded to 10 programs MP0533 clinical data show improved response rate and depth in cohort 8 with steeper step-up and more frequent dosing; additional dose densification planned in cohort 9, updates expected in 2025 CD3 Switch-DARPin research proof-of-concept of conditional T cell activation and CD2 co-stimulation shown in solid tumors, further data in Q2 2025ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., Jan. 12, 2025 (GLOBE NEWSWIRE) — Ad hoc announcement pursuant to Art. 53 LR Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a...