Year: 2021

WAKIX®(pitolisant) Net Revenue of $80.7 Million for Third Quarter 2021 Increase of 77% vs. the Same Period in 2020 Average Number of Patients on WAKIX Increased to ~3,500 Announced Inclusion of WAKIX in American Academy of Sleep Medicine’s (AASM) Updated Clinical Practice Guideline Conference Call and Webcast to be Held Today at 8:30 a.m. ET  PLYMOUTH MEETING, Pa., Nov. 09, 2021 (GLOBE NEWSWIRE) — Harmony Biosciences Holdings, Inc. (“Harmony” or the “Company”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today reported financial results and business updates for the quarter ended September 30, 2021. “The company continues to execute on optimizing the performance of WAKIX, demonstrated by another solid quarter of sequential...

NEW YORK, Nov. 09, 2021 (GLOBE NEWSWIRE) — Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of rare primary and metastatic cancers of the liver, today reported business highlights and financial results for the third quarter ended September 30, 2021. Recent Business Highlights During and since the third quarter Delcath:Entered a debt facility with Avenue Venture Opportunities Fund, L.P. providing up to $20 million with an initial $15 million funded at closing, Submitted to and received approval from the FDA for an expanded access protocol for the use of HEPZATO™ Kit (melphalan hydrochloride for injection/hepatic delivery system) in the treatment of patients with liver dominant metastatic ocular melanoma, Updated guidance of the Class 2 resubmission of the NDA to mid-year from the...

PRINCETON, N.J., Nov. 09, 2021 (GLOBE NEWSWIRE) — Oyster Point Pharma, Inc. (Nasdaq: OYST), a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases, today announced multiple scientific presentations at the American Academy of Ophthalmology (AAO) Annual Meeting 2021 being held in New Orleans, LA November 12th – 15th, 2021. “The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons whose mission is to empower lives by serving as an advocate for patients and the public, leading ophthalmic education, and advancing the profession of ophthalmology.” said Marian Macsai, MD Chief Medical Officer of Oyster Point Pharma. “We are pleased to share a number of data presentations...

NESS ZIONA, Israel, Nov. 09, 2021 (GLOBE NEWSWIRE) — Sol-Gel Technologies, Ltd. (Nasdaq: SLGL), a dermatology company focused on identifying, developing and commercializing branded and generic topical drug products for the treatment of skin diseases, today announced that the Company will participate in the Jefferies London Healthcare Conference, taking place in-person on November 16th and 17th, 2021.Jefferies London Healthcare Conference Presentation Information:Format Live presentation and 1-on-1 in person meetingsSpeaker: Dr. Alon Seri-Levy, Chief Executive OfficerDate: Tuesday, November 16th 2021Time: 8:00-8:35 AM GMTTo Listen To listen to the presentation, click here. A replay will be archived for 30 days at this link (or go to www.sol-gel.com to access within the Investors/Events and Presentations section).About...

BETHLEHEM, Pa., Nov. 09, 2021 (GLOBE NEWSWIRE) — OraSure Technologies, Inc. (NASDAQ: OSUR), a global leader in point-of-care and home diagnostic testing and sample collection technologies, announced today that after almost 21 years of service to the Company, Jack E. Jerrett is retiring as the Company’s Senior Vice President, General Counsel, Chief Compliance Officer and Secretary, effective as of December 31, 2021. Agnieszka M. Gallagher, who most recently served as the Chief Ethics and Compliance Officer at Alnylam Pharmaceuticals has been hired by the Company to fill Jack’s roles as the new General Counsel, Chief Compliance Officer and Secretary. “Jack has been a stalwart and extremely dedicated member of OraSure’s executive leadership team for over two decades and his countless contributions to the Company’s growth and development...

ROBIT PLC          STOCK EXCHANGE RELEASE          9 NOVEMBER 2021 AT 2.00 P.M.            ROBIT PLC’S FINANCIAL INFORMATION AND ANNUAL GENERAL MEETING IN 2022 Robit Plc will publish its financial statement release, half-year financial report as well as financial reviews of January–March and January–September in 2022 as follows: 15.02.2022          Financial statement release for financial period ending on 31 December 202127.04.2022          Financial review for January–March 202209.08.2022          Half-year financial report for January–June 202226.10.2022          Financial review for January–September 2022 Robit observes a 30-day period of silence before publishing financial reports. During the silent period, Robit will not comment on the company’s financial position or prospects and shall not meet with representatives of the capital...

Mock patient in trial site therapy roomMock patient in psilocybin therapy trial therapy roomTrial site therapy roomTrial site therapy roomLargest randomised, controlled, double-blind psilocybin therapy study ever completedshows rapid and sustained response for patients receiving a single dose of COMP360 psilocybin with psychological support COMPASS management team to host an investor conference call today at 1.00pm UK (8.00am ET)London, UK – 9 November 2021             COMPASS Pathways plc (Nasdaq: CMPS) (“COMPASS”), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that its groundbreaking phase IIb clinical trial of COMP360 psilocybin therapy for treatment-resistant depression has achieved its primary endpoint for...