Month: March 2024

InflaRx will focus development activities and resources initially on selected indications in immuno-dermatology, with registrational-phase vilobelimab and potentially best-in-class oral C5aR inhibitor INF904INF904 development will be initially targeted at chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with initiation of a Phase IIa PK dose-ranging study expected by the end of 2024, with data availability anticipated in 2025InflaRx is considering partnership options for INF904 in additional areas of interest with a goal of unlocking its “pipeline-in-a-product” potential more broadlyOngoing Phase III trial with vilobelimab in pyoderma gangrenosum (PG) is expected to have an interim analysis in 2025Cash, cash equivalents and marketable securities of €98.4 million expected to fund operations at least...

Q2 GAAP revenues of $545.9 million, up 6.0% from Q2 2023. Organic Q2 ASV plus professional services of $2,209.5 million, up 5.4% year over year. Q2 GAAP operating margin of 33.3%, up approximately 50 bps year over year, and adjusted operating margin of 38.3%, up approximately 130 bps from the prior year. Q2 GAAP diluted EPS of $3.65, up 8.0% from the prior year, and adjusted diluted EPS of $4.22, up 11.1% year over year. Top-line growth expected at the lower end of the previously published guidance ranges for the fiscal year: ASV plus professional services growth of $110 – $150 million and GAAP revenues between $2,200 – $2,210 million.NORWALK, Conn., March 21, 2024 (GLOBE NEWSWIRE) — FactSet (“FactSet” or the “Company”) (NYSE:FDS) (NASDAQ:FDS), a global financial digital platform and enterprise solutions provider,...

 – Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with topline data expected for Advance-HTN trial in Q4 2024 and Launch-HTN trial in 2H 2025 – – Explore-CKD Phase 2 trial, a study for lorundrostat in hypertensive patients with stage 2-3b CKD on track for Q4 2024 to Q1 2025 topline data – – Conference call today at 8:30 a.m. ET – RADNOR, Pa., March 21, 2024 (GLOBE NEWSWIRE) — Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced financial results for the fourth quarter and full year ending December 31, 2023, and provided a corporate update. “Throughout 2023 we accomplished key milestones...

– On track to resubmit NDA for etripamil in PSVT early 2Q 2024 – Recent financing extends cash runway into 2026 – FDA reiterated prior guidance on regulatory pathway for AFib-RVR, End of Phase 2 Meeting expected mid-2024 MONTREAL and CHARLOTTE, N.C., March 21, 2024 (GLOBE NEWSWIRE) —  Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the fourth quarter and year ended December 31, 2023 and provided a regulatory and corporate update. “We look forward to resubmitting our NDA imminently. With the completion of our recent financing and potential future synthetic royalty payment, we believe we are well positioned to advance etripamil through potential approval and launch in PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “We’re excited...

Phase 1/2 study of KB-0742 is on track to clear 80mg four-days-on, three-days-off schedule in the third quarter of 2024; topline data from expansion cohort at this schedule expected in the first half of 2025 IND-enabling studies for KB-9558 expected to complete in 2024 with first-in-human study anticipated to commence in the first half of 2025 $175.0 million in cash, cash equivalents and investments as of December 31, 2023, providing expected cash runway into the second half of 2026 SAN MATEO, Calif. and CAMBRIDGE, Mass., March 21, 2024 (GLOBE NEWSWIRE) — Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, today reported recent business progress and fourth-quarter and full-year 2023 financial results. “In 2023, we made great progress across our portfolio and business. We demonstrated...

MANNHEIM, Germany, March 21, 2024 (GLOBE NEWSWIRE) — Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it will release full year 2023 results and corporate update on March 28, 2024. The Company will host a conference call at 8:30 a.m. EDT / 13:30 CET. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link https://register.vevent.com/register/BI43eadbb12f6143a5bdcb2c9549ef2e76, and you will be provided with dial-in details and a pin number. Note:...

Castellum, Inc. Announces 2023 Financial ResultsCastellum, Inc. (NYSE-American: CTM), a cybersecurity, electronic warfare, and software engineering services company focused on the federal government, announces its results for the year ended December 31, 2023; Revenue for 2023 was a record $45.2 million – http://castellumus.com/BETHESDA, Md., March 21, 2024 (GLOBE NEWSWIRE) — Castellum, Inc. (NYSE-American: CTM), a cybersecurity, electronic warfare, and software engineering services company focused on the federal government, announces its results for the year ended December 31, 2023. Revenue for 2023 was a record $45.2 million, up from $42.2 million in 2022. Net loss, including $6.9 million of non-cash charges for goodwill impairment due to the Company’s stock price was $17.9 million versus $15.0 million in 2022 when...

– Revenue for Fiscal 2024 increased 24.9% to a record $2.8 billion – – Record Fiscal 2024 EPS of $4.93, an increase of 9.8% – – Provides Fiscal 2025 Modeling Assumptions – WEST FARGO, N.D., March 21, 2024 (GLOBE NEWSWIRE) — Titan Machinery Inc. (Nasdaq: TITN), a leading network of full-service agricultural and construction equipment stores, today reported financial results for the fiscal fourth quarter and full year ended January 31, 2024. “We finished fiscal year 2024 with a strong performance that was driven by growth across all of our legacy operating segments and resulted in record revenue of $2.8 billion, consolidated pre-tax margin of 5.5%, and record earnings per share of $4.93,” stated Bryan Knutson, Titan Machinery’s President & Chief Executive Officer. “The fourth...

~ Achieved PEDMARK® Full-Year 2023 Net Product Sales of $21.3 Million, Including $9.7 Million in Net Product Sales in the Fourth Quarter of 2023 ~ ~ Entered Into Exclusive Licensing Agreement to Commercialize PEDMARQSI™ in Europe, Australia and New Zealand for Approximately $43 Million Upfront and Up to Approximately $230 Million in Additional Commercial and Regulatory Milestones, and Tiered Royalties Up to the Mid-Twenties ~ ~ Pro forma fourth quarter cash in excess of $55 million ~ ~ Management to Host Conference Call Today at 8:30 a.m. ET ~ RESEARCH TRIANGLE PARK, N.C., March 21, 2024 (GLOBE NEWSWIRE) — Fennec Pharmaceuticals Inc. (NASDAQ:FENC; TSX: FRX), a specialty pharmaceutical company, today reported its financial results for the fiscal year ended December 31, 2023 and provided a business update. “It was an exciting...