Month: August 2025

Successful completion of strategic reorganization, reducing debt by $1.15 billion.In connection with emergence on 6/24/25, fiscal Q2 consists of a “Predecessor” period from 3/30/25 to 6/24/25, and a “Successor” period from 6/25/25 to 6/30/25 Combined End of Period Subscribers1 of 3.2 million; Combined End of Period Clinical Subscribers1 of 127 thousand Combined Revenues1 of $189 million, down 6% vs. prior year; Combined Clinical Revenues1 of $31 million, up 55% vs. prior year Predecessor Net Income1 of $1,191 million and Net Margin1 of 673% were impacted by Reorganization items; Successor Net Income1 of $1 million and Net Margin1 of 10%; Predecessor Adjusted EBITDA1,2 of $61 million and Adjusted Margin1,2 of 34%; Successor Adjusted EBITDA1,2 of $4 million and Adjusted Margin1,2 of 37% NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE)...

Reported positive KT-621 (STAT6) Phase 1 healthy volunteer data surpassing Kymera’s target product profile, and further validating its oral, dupilumab-like profile KT-621 BroADen Phase 1b trial in moderate to severe atopic dermatitis (AD) patients on track to report data in 4Q25 Doses selected for KT-621 Phase 2b trials in AD and asthma, which are on track to initiate in 4Q25 and 1Q26, respectively KT-579 (IRF5) IND-enabling studies ongoing, with Phase 1 clinical trial expected to start in early 2026 Company entered a strategic partnership with Gilead to develop novel oral molecular glue CDK2 degraders, with up to $750 million in potential total payments Well-capitalized with $1 billion in cash as of July 31, 2025, and runway into the second half of 2028 Company to hold video conference call and webcast today at 8:30 a.m. ET WATERTOWN,...

Positive 16-week data from APEX Phase 2 Part A met all primary and key secondary endpoints for APG777, a potentially best-in-class anti-IL-13 antibody, in moderate-to-severe atopic dermatitis APEX Part A testing every 3- or 6-month maintenance dosing, a significant improvement versus standard of care which is dosed every two weeks, is ongoing with 52-week readout anticipated in 1H 2026 Driven by strong enrollment, APEX Phase 2 Part B of APG777 readout accelerated to mid-2026 First patient dosed in Phase 1b head-to-head trial of APG279 (IL-13 + OX40L) vs. DUPIXENT in atopic dermatitis, with readout expected in 2H 2026 $621.2 million cash, cash equivalents and marketable securities supports runway into Q1 2028 SAN FRANCISCO and BOSTON, Aug. 11, 2025 (GLOBE NEWSWIRE) — Apogee Therapeutics, Inc., (Nasdaq: APGE), a clinical-stage...

Initiated a second potentially registrational study of IMVT-1402 in Graves’ disease (GD) and a potentially registrational study of IMVT-1402 in Sjögren’s disease (SjD), both in June 2025 All other clinical trials in previously announced six-indications remain on track with increased focus on clinical execution Remission data from the batoclimab proof-of-concept study in GD to be reported at the American Thyroid Association (ATA) Annual Meeting in September 2025 Current cash balance provides runway for announced indications through GD readout expected in 2027NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) — Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today reported corporate updates and financial results for the quarter ended June 30, 2025. Recent...

BASEL, Switzerland and LONDON and NEW YORK, Aug. 11, 2025 (GLOBE NEWSWIRE) — Roivant (Nasdaq: ROIV) today reported its financial results for the first quarter ended June 30, 2025, and provided a business update.Brepocitinib VALOR Phase 3 study in dermatomyositis (DM) remains on track for topline data readout in the second half of calendar year 2025, with last patient last visit completed in July; Roivant and Priovant hosted an investor event on brepocitinib in June to share details about the ongoing VALOR study, including pooled/blinded baseline data, clinical endpoints details and successful steroid tapering dataBrepocitinib program continues to advance with rapid enrollment in non-infectious uveitis (NIU) Phase 3 study and cutaneous sarcoidosis (CS) proof-of-concept trial, with readouts expected in the first half of calendar...

CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) net trade sales of approximately $439 million CARVYKTI® demonstrated positive long-term outcomes in CARTITUDE-1 study with one-third of patients remaining progression-free for ≥5 years Presented other important CARVYKTI® and new solid tumor data at ASCO Over 7,500 patients treated to date Cash and cash equivalents, and time deposits of $1.0 billion, as of June 30, 2025SOMERSET, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) — Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, today reported its second quarter 2025 unaudited financial results and key corporate highlights. “The groundbreaking five-year survival data from CARTITUDE-1, with one-third of patients remaining progression-free, reinforces CARVYKTI’s durability and potential to redefine the...

In the ongoing Phase 2/3 study of tovecimig (DLL4 x VEGF-A bispecific antibody) in patients with advanced biliary tract cancer, fewer deaths have been observed than originally projected. We believe this may suggest that tovecimig could be affecting overall survival in the patient population. As a result, the analysis of the secondary endpoints, including overall survival, is now expected in Q1 2026. In the ongoing Phase 1 dose-escalation study of CTX-8371 (PD-1 x PD-L1 bispecific antibody) in patients treated in the post-checkpoint inhibitor setting, two deep and confirmed partial responses have been observed to date. A patient with non-small cell lung cancer had a 100% reduction in target lesion tumor burden and a patient with triple-negative breast cancer had >90% reduction in total target lesion tumor burden. Cohort expansions including...

Reports Q2 2025 Revenues of $20.5M, Gross Margin of 56.4%, and Positive Cash Provided by Operations Third Quarter 2025 Guidance Reflects Improved Operations and Strong Financial Discipline New Credit Amendment Signed, Extending Refinance Deadline to December 5thHOLLISTON, Mass., Aug. 11, 2025 (GLOBE NEWSWIRE) — Harvard Bioscience, Inc. (Nasdaq: HBIO) (the “Company”) today announced financial results for the second quarter and six months ended June 30, 2025. “We made solid progress in the second quarter exceeding our revenue guidance. In my short time as CEO, I have already seen first-hand the dedication of our team. The fundamentals of the business remain intact with attractive margins and promising technologies serving high-growth markets,” said John Duke, President and CEO. “Our priorities are to grow our core business and...

– Total revenues of $301,000 for quarter, and $818,000 for first six months of 2025, from sales and collaborative research agreement – – 82 civilian hospitals now have VAC approval to purchase Symvess™ – – ECAT approval makes Symvess available to 35 Military Treatment Facilities and 160 U.S. Department of Veterans Affairs hospitals – – Conference call today at 8:00 am ET – DURHAM, N.C., Aug. 11, 2025 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced financial results for the second quarter ended June 30, 2025, and provided a business update. “During our second quarter of 2025, we continued to execute on our U.S. commercial launch...