Day: January 12, 2025

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...

New biomarkers on track for commercial launch in January 2025 Preliminary financial results indicate record full-year revenue and AVISE CTD trailing twelve-month ASP, with improvements to adjusted EBITDA and cash burn CARLSBAD, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) — Exagen Inc. (Nasdaq: XGN), a leading provider of autoimmune testing, today announced it has received conditional approval from the New York State Department of Health for its new systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) biomarker assays, with a planned commercial launch in January 2025.  The company also announced preliminary unaudited select financial results for the fourth quarter and full year ended December 31, 2024, in line with prior financial guidance. New AVISE CTD Biomarkers The company’s new SLE and RA biomarkers will be incorporated...

Orbit Phase 3 study of setrusumab in osteogenesis imperfecta continuing to planned second interim analysis, expected in mid-2025 Alvelestat, for Alpha-1 Antitrypsin Deficiency-associated Lung Disease, receives positive EMA opinion on European Orphan Designation Application; European Commission expected to issue final decision in first quarter 2025 LONDON, Jan. 12, 2025 (GLOBE NEWSWIRE) — Mereo BioPharma Group plc (NASDAQ: MREO) (“Mereo” or the “Company”), a clinical-stage biopharmaceutical company focused on rare diseases, today provided an update on its lead clinical programs, setrusumab, a monoclonal antibody in Phase 3 clinical development for the treatment of Osteogenesis Imperfecta (OI) through a partnership with Ultragenyx Pharmaceutical, Inc. (Ultragenyx) and alvelestat, an oral neutrophil elastase inhibitor being studied...

Preliminary 2024 total revenue of $555 million to $560 million, exceeding top end of guidance, including Crysvita® revenue of $405 million to $410 million, and Dojolvi® revenue of $87 million to $89 million 2025 expected total revenue guidance of $640 million to $670 million UX143 (setrusumab) Phase 3 Orbit study for osteogenesis imperfecta progressing to second interim analysis in mid-2025 GTX-102 Phase 3 Aspire study for Angelman syndrome expected to complete enrollment in second half of 2025 NOVATO, Calif., Jan. 12, 2025 (GLOBE NEWSWIRE) — Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultrarare genetic diseases, today reported preliminary unaudited 2024 revenue results, cash and investments at year end 2024,...