Month: June 2025

Amneal holds exclusive U.S. commercialization rights; BLA filing expected in Q4 2025 Poised to be among the first wave of biosimilars in the $3.9 billion U.S. omalizumab market and an important growth driver for Amneal BRIDGEWATER, N.J., June 25, 2025 (GLOBE NEWSWIRE) — Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today highlighted positive topline results from a confirmatory clinical efficacy and safety clinical trial evaluating ADL-018, a proposed biosimilar to XOLAIR® (omalizumab), developed by Kashiv BioSciences, LLC. The randomized, double-blind, multicenter study was conducted by Kashiv to assess the efficacy, safety, and immunogenicity of ADL-018 compared to XOLAIR® in patients with Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite treatment...

Combination cohort initiated following successful review of monotherapy cohort Over 100 participants dosed to-date in monotherapy cohort Priority are Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer Data update on schedule for later this year  NORWOOD, Mass., June 25, 2025 (GLOBE NEWSWIRE) — Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company focused on oncology and obesity, today announced the dosing of the first participant in the PD-1 combination arm of its Phase 1 study investigating CRB-701 in solid tumors (the Phase 1 Western study). Participants in this arm of the study are being randomized to the 2.7 mg/kg and 3.6 mg/kg cohorts in combination with Keytruda® (pembrolizumab). “We are very pleased to reach this important milestone and with such an encouraging...

BOSTON, June 25, 2025 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that three late-breaking abstracts have been accepted for presentation at The Endocrine Society’s Annual Meeting (ENDO 2025) taking place July 12-15 in San Francisco, CA. In a live oral presentation, Susan Phillips, M.D., Pediatric Endocrinology, University of California San Diego/Rady Children’s Hospital, San Diego, will present data from Rhythm’s pivotal Phase 3 TRANSCEND trial evaluating setmelanotide in the largest randomized, placebo-controlled trial in acquired hypothalamic obesity to date.Efficacy and Safety of Setmelanotide in Acquired Hypothalamic Obesity: Results from a Double-Blind,...

Non-dilutive funding extends Ovid’s operational runway; Immedica assumes certain ganaxolone IP costs NEW YORK and STOCKHOLM, Sweden, June 25, 2025 (GLOBE NEWSWIRE) — Ovid Therapeutics Inc. (Nasdaq: OVID), a biopharmaceutical company dedicated to developing small molecule medicines for brain conditions with significant unmet need, today announced that it has entered into a definitive agreement with Immedica Pharma AB (‘Immedica’), a leading global rare disease company, for the sale of its future royalties related to sales of ganaxolone outside of China. Under the terms of the agreement, Immedica will pay $7 million in cash to acquire 100% of the royalty rights held by Ovid, further strengthening Immedica’s focus on ganaxolone by acquiring control of additional intellectual property rights. This transaction provides a non-dilutive...

To discuss the unmet medical need in Borderline Personality Disorder (BPD) and the design of vafidemstat’s Phase III PORTICO-2 trial in BPD MADRID and CAMBRIDGE, Mass., June 25, 2025 (GLOBE NEWSWIRE) — Oryzon Genomics, S.A. (ISIN Code: ES0167733015, ORY), a clinical-stage biopharmaceutical company and a European leader in epigenetics, announced today that it will host a virtual KOL event on Wednesday, July 9, 2025 at 12:00 pm ET. The event, moderated by Michael Ropacki, PhD and Oryzon’s CMO for CNS, will feature insights from leading experts:Alan F. Schatzberg, MD, MS(Hon) – Stanford University School of Medicine Emil F. Coccaro, MD – The Ohio State University College of Medicine Eric Hollander, MD – Albert Einstein College of Medicine Sarah Fineberg, MD, PhD – Yale University School of MedicineThe event...

RICHMOND, Va., June 25, 2025 (GLOBE NEWSWIRE) — ARKO Corp. (Nasdaq: ARKO), a Fortune 500 company and one of the largest convenience store operators in the United States, proudly announces the opening of its first food-focused remodeled store in Ashland, Virginia, located at 10030 Sliding Hill Rd. This milestone location also marks the debut of fas craves, ARKO’s innovative new food brand that will be a key feature of future store remodels across its nationwide network. This flagship location is the first of eight initial sites—six remodels and two new-to-industry builds—launched as part of a pilot program focused on delivering a relevant and delicious menu of hot and cold grab-n-go items. The new concept debuts a crave-worthy prepared food and dispensed beverage concept designed for today’s on-the-go consumer. Whether it’s a quick...

NEW YORK, June 25, 2025 (GLOBE NEWSWIRE) — Getty Realty Corp. (NYSE: GTY), a net lease REIT focused on convenience and automotive retail real estate, will release its financial results for the second quarter ended June 30, 2025 after the market closes on Wednesday, July 23, 2025. Getty Realty Corp. will host a conference call and webcast on Thursday, July 24, 2025, at 8:30 a.m. EDT. To participate in the call, please dial 1-877-423-9813, or 1-201-689-8573 for international participants, ten minutes before the scheduled start. Participants may also access the call via live webcast by visiting the investors section of the Company’s website at ir.gettyrealty.com. If you cannot participate in the live event, a replay will be available on Thursday, July 24, 2025, beginning at 11:30 a.m. EDT through 11:59 p.m. EDT, Thursday, August...

Submission Seeks Approval of GTx-104 in the Treatment of Patients with aneurysmal Subarachnoid Hemorrhage (aSAH) Comprehensive Data Package Includes Positive Results from Phase 3 STRIVE-ON Safety Trial of GTx-104 Submission Has the Potential to Trigger Exercise of up to $7.6 million in Gross Proceeds from 2023 Financing Warrants Tied to FDA Acceptance of NDA for Review PRINCETON, N.J., June 25, 2025 (GLOBE NEWSWIRE) — Grace Therapeutics, Inc. (Nasdaq: GRCE) (Grace Therapeutics or the Company), a late-stage, biopharma company advancing GTx-104, a clinical-stage, novel, injectable formulation of nimodipine being developed for IV infusion to address significant unmet medical needs in aneurysmal subarachnoid hemorrhage (aSAH) patients, today announced the submission to the U.S. Food and Drug Administration (FDA) of the Company’s...

As shoppers shift to AI search, brands must optimize their data or risk missing opportunities to drive traffic and sales AUSTIN, Texas, June 25, 2025 (GLOBE NEWSWIRE) — BigCommerce (Nasdaq: BIGC), a leading open SaaS ecommerce platform for B2C and B2B businesses, and Feedonomics, a leading data feed management solution, today announced their customers now have access to cutting-edge AI-powered search engine Perplexity to optimize visibility and relevance for brands in AI search results. In the shift from traditional SEO to AI search, it is critical that merchants ensure their products can be syndicated to the right marketplaces and advertising channels or owned channels so they can be found in order to drive traffic and sales. Historical data scraping is inefficient and often inaccurate for large language models. Feedonomics now...