Month: March 2025

Positive Results with Zervimesine (CT1812) in Phase 2 SHIMMER Dementia with Lewy Bodies (DLB) Phase 2 SHINE Data Show Dramatic Slowing of Cognitive Decline with Zervimesine in a Key Pre-specified Alzheimer’s Disease Subgroup 2025 Objective: Advance Zervimesine into Late-stage Trials for DLB and Alzheimer’s Disease Management will Review Results at 8:00 a.m. ET on Live Webcast and Conference Call PURCHASE, N.Y., March 20, 2025 (GLOBE NEWSWIRE) — Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical stage company developing product candidates that treat neurodegenerative disorders, (the “Company” or “Cognition”), today reported financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update. Data readouts in 2024 from the Company’s Phase 2 studies in mild-to-moderate Alzheimer’s disease...

Phase 1 MAD dosing completed for SION-451 and final MAD cohort of SION-719 planned; Interim data in healthy volunteers show potential to provide clinically meaningful benefit to CF patients. Topline data anticipated in first half of 2025 On track to initiate NBD1 Phase 2a proof-of-concept trial in combination with SOC in CF patients and combination MAD trials of an NBD1 stabilizer with a complementary modulator in healthy volunteers in the second half of 2025, with topline data for both anticipated in mid-2026 Completed upsized IPO with gross proceeds of approximately $219 million, extending runway into 2028 WALTHAM, Mass., March 20, 2025 (GLOBE NEWSWIRE) — Sionna Therapeutics, Inc. (Nasdaq: SION), a clinical-stage biopharmaceutical company on a mission to revolutionize the current treatment paradigm for cystic fibrosis (CF) by...

Full-Year Sales of $467.0 million, Net Income of $3.1 million, $0.05 EPS, Adjusted EBITDA of $19.9 million CANTON, Mass., March 20, 2025 (GLOBE NEWSWIRE) — Destination XL Group, Inc. (NASDAQ: DXLG), the largest integrated commerce specialty retailer of Big + Tall men’s clothing and shoes, today reported financial results for the fourth quarter and fiscal year 2024. Fourth Quarter HighlightsTotal sales for the 13-week fourth quarter were $119.2 million, down 13.1% from $137.1 million for the 14-week fourth quarter of fiscal 2023. Comparable sales for the fourth quarter decreased 8.7% as compared to the fourth quarter of fiscal 2023. Net loss for the fourth quarter was $(1.3) million, or $(0.02) per diluted share, as compared to net income of $5.2 million, or $0.08 per diluted share, for the fourth quarter of fiscal 2023. Adjusted...

$7.3 million in total neffy® (epinephrine nasal spray) U.S. net product revenue in 2024 since launch in late September 2024 neffy 1 mg approved by U.S. FDA for children aged four and older and weighing 15 kilograms to < 30 kilograms (33 lbs. to < 66 lbs.), expanding the reach of neffy to approximately 2 million younger, school-aged children at risk of a severe allergic reaction $314.0 million in cash, cash equivalents, and short-term investments at year-end 2024, supporting an increased investment in commercialization in 2025 while maintaining an operating runway of at least three years Company to host conference call today, March 20, 2025 at 5:30 a.m. PT / 8:30 a.m. ET SAN DIEGO, March 20, 2025 (GLOBE NEWSWIRE) —  ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical company dedicated to empowering at-risk patients and...

Topline data from Phase 2 LOTUS Trial of AVTX-009 for the treatment of hidradenitis suppurativa expected in 2026 Appointed Jennifer Riley as Chief Strategy Officer Cash on hand of approximately $135 million as of December 31, 2024 expected to provide runway into at least 2027WAYNE, Pa. and ROCKVILLE, Md., March 20, 2025 (GLOBE NEWSWIRE) — Avalo Therapeutics, Inc. (Nasdaq: AVTX), a clinical stage biotechnology company focused on the treatment of immune dysregulation, today announced business updates and year-end financial results for 2024. “2024 was a transformational year for Avalo, and I am proud of the accomplishments the team has made in a short amount of time,” said Dr. Garry Neil, Chief Executive Officer and Chairman of the Board. “In March 2024, we acquired AVTX-009, a promising monoclonal antibody targeting interleukin-1β....

AUCATZYL® (obecabtagene autoleucel) U.S. commercial launch progressing on track with 33 authorized treatment centers as of March 19, 2025, following US FDA approval on November 8, 2024 Obe-cel MHRA and EMA marketing authorizations expected in H2 2025 Initial six patients dosed in Phase 1 dose confirmation trial in Systemic Lupus Erythematosus (SLE) Company to provide clinical development program updates, including plans for expansion in autoimmune diseases, at R&D investor event to be held on April 23rd Conference call to be held today at 08:30 am EDT/12:30 pm GMT: conference call participants should pre-register using the link at the bottom of this press releaseLONDON, March 20, 2025 (GLOBE NEWSWIRE) — Autolus Therapeutics plc (Nasdaq: AUTL), a commercial-stage biopharmaceutical company developing, manufacturing and delivering...

Results of the MRT-6160 Phase 1 SAD/MAD study demonstrate deep VAV1 degradation of greater than 90%, significant T and B cell functional inhibition as well as significant inhibition of cytokine release from T and B cells following ex-vivo stimulation, and favorable safety/tolerability profile; data support clear path to Phase 2 studies and broad potential applications in immune-mediated diseases Phase 1/2 study of MRT-2359 demonstrates encouraging signals of clinical response in castration-resistant prostate cancer (CRPC) patients resistant to AR therapy, including confirmed RECIST response; CRPC cohort will be focus moving forward with additional Phase 1/2 results expected in H2 2025; deprioritizing further expansion arms in SCLC, NSCLC and NE tumors MRT-8102, a NEK7-directed molecular glue degrader targeting diseases driven by IL-1β...

Strategic transformation ongoing, positioning the Company as a focused leader in immunology and inflammatory diseases Highly differentiated, potentially curative immunotherapy for celiac disease (VTP-1000) in the clinic, with first data expected in third quarter of 2025 Proprietary SNAP-TI platform promoting antigen-specific immune tolerance is anticipated to drive multiple future pipeline and partnership opportunities Strategic prioritization of resources expected to provide a cash runway into 2027OXFORD, United Kingdom and GERMANTOWN, Md., March 20, 2025 (GLOBE NEWSWIRE) — Barinthus Biotherapeutics plc (NASDAQ: BRNS) (“Barinthus Bio,” or the “Company”), an immunology and inflammation (I&I) company focused on developing therapies that promote immune tolerance with curative potential, today announced its financial results...