Year: 2023

Successful End-of-Phase 2 Meeting with FDA for Oral APX3330; Agreement on Phase 3 Registration Endpoint RYZUMVI™ Approved by FDA; Ocuphire Received $10 million Regulatory Milestone Payment VEGA-2 Phase 3 Presbyopia Trial Met Primary Endpoint; Viatris Expected to Continue Phase 3 Development in 1H 2024 George Magrath, M.D., M.B.A., M.S. Named as CEO; Conference Call Scheduled for December 5th, 2023, at 10 AM ET FARMINGTON HILLS, Mich., Nov. 13, 2023 (GLOBE NEWSWIRE) — Ocuphire Pharma, Inc. (Nasdaq: OCUP), a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing small-molecule therapies for the treatment of retinal and refractive eye disorders, today announced financial results for the third quarter ended September 30, 2023 and provided a corporate update. “We achieved important regulatory...

NORCROSS, Ga., Nov. 13, 2023 (GLOBE NEWSWIRE) — Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the three months ended September 30, 2023. These results are included in the Company’s Quarterly Report on Form 10-Q, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov. Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said: “Recently, two significant events occurred that we believe demonstrate confidence in our ongoing mission to bring to market a therapy for NASH cirrhosis patients where none currently exists. First, in late September 2023, our Board Chairman, Richard E. Uihlein, exercised 2,236,204 common stock purchase...

Transformative capital raise of $88.2 million from leading healthcare investors provides funding for BET inhibitor programs through the end of 2025 Phase 2b preparatory activities progressing for VYN201 in nonsegmental vitiligo following positive Phase 1b results On track for VYN202 IND submission by year-end 2023, with plans to begin Phase 1a trial in Q1 2024 BRIDGEWATER, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a clinical-stage biopharmaceutical company focused on developing proprietary, innovative and differentiated therapies for the treatment of immuno-inflammatory conditions, today announced financial results for the three and nine months ended September 30, 2023 and provided a business update. “We have made substantial progress in advancing our business in recent...

Topline data results from the pivotal STRIDE study are expected in December 2023 IRVINE, Calif., Nov. 13, 2023 (GLOBE NEWSWIRE) — Reneo Pharmaceuticals, Inc. (Nasdaq: RPHM), a clinical-stage pharmaceutical company focused on the development and commercialization of therapies for patients with rare genetic mitochondrial diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a business update. “We are looking forward to sharing topline results of our pivotal STRIDE study in December,” said Gregory J. Flesher, President and CEO of Reneo Pharmaceuticals. “In addition, we continue to be encouraged by the high participation rate in our STRIDE AHEAD open-label extension study, and are happy to announce enrollment of our first patient with PMM due to nuclear DNA defect in this ongoing trial....

MIGDAL HAEMEK, Israel, Nov. 13, 2023 (GLOBE NEWSWIRE) — Tower Semiconductor (NASDAQ: TSEM & TASE: TSEM) reports today its results for the third quarter ended September 30, 2023. HighlightsEntered into a capacity corridor agreement with Intel, enabling Tower additional high-volume 12-inch capacity. Third quarter 2023 revenue of $358 million, as compared to $357 million for the second quarter of 2023. Net Profit for the third quarter of 2023 of $342 million, including $290 million net profit from the merger contract termination fee received from Intel.Mr. Russell Ellwanger, Chief Executive Officer of Tower Semiconductor, stated: “This past period has been most significant putting in place (1) added capacity, capable to drive substantial revenue growth at accretive margins across the board; (2) additional premier end and...

Phase 1 clinical trial of APG777, a fully optimized, subcutaneous, extended half-life anti-IL-13 antibody, initiated ahead of schedule with initial PK and safety data from healthy volunteers expected mid-2024; on track to begin Phase 2 in moderate-to-severe atopic dermatitis in 2024 Announcing our finalized nomination of development candidate for APG808, a potentially best-in-class, femtomolar affinity, subcutaneous extended half-life antibody targeting IL-4Rα, a target with clinical validation across eight Type 2 allergic diseases in 4Q 2023 Well-capitalized with $422.9 million in cash following upsized IPO supporting operating runway into 4Q 2026 SAN FRANCISCO and WALTHAM, Mass., Nov. 13, 2023 (GLOBE NEWSWIRE) — Apogee Therapeutics, Inc. (Nasdaq: APGE), a clinical-stage biotechnology company advancing differentiated biologics...

Abeona’s first-ever U.S. Biologics License Application (BLA) submission completed in September 2023 FDA decision on priority review and acceptance of BLA for pz-cel (prademagene zamikeracel, formerly known as EB-101) in recessive dystrophic epidermolysis bullosa (RDEB) expected by late-November 2023 Initiated commercial readiness activities for potential U.S. launch of pz-cel CLEVELAND, Nov. 13, 2023 (GLOBE NEWSWIRE) — Abeona Therapeutics Inc. (Nasdaq: ABEO) today reported financial results for the third quarter of 2023 and provided corporate updates. “In the third quarter, we made substantial progress in our evolution from a late-stage clinical development company to one with significant commercial opportunity,” said Vish Seshadri, Chief Executive Officer of Abeona. “With the completion of Abeona’s first-ever U.S. BLA submission,...

Dosed first patient in Phase 1b/2 clinical trial in the US evaluating FasTCAR-T GC012F for the treatment of relapsed/refractory multiple myeloma (RRMM) Expect to commence Phase 1/2 clinical trial in China evaluating GC012F for the treatment of RRMM in the fourth quarter 2023 Presented longer-term follow-up data from an ongoing Phase 1 investigator-initiated trial (IIT) evaluating GC012F as a frontline treatment for patients with transplant-eligible, high-risk, newly diagnosed multiple myeloma (NDMM); updated data to be reported as an oral presentation at the 65ᵗʰ American Society of Hematology Annual Meeting & Exposition (ASH 2023) On track to submit IND filings for planned Phase 1 clinical trials in the US and China of GC012F in refractory systemic lupus erythematosus (rSLE) in 2023 Anticipate to release data from the ongoing investigator-initiated...

Announced a definitive agreement to be acquired by Lilly for a purchase price of $12.50 per share in cash (an aggregate of approximately $1.4 billion); transaction expected to close near the end of 2023 INDIANAPOLIS, Nov. 13, 2023 (GLOBE NEWSWIRE) — POINT Biopharma Global Inc. (NASDAQ: PNT) (the “Company” or “POINT”), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, today announced financial results for the third quarter ended September 30, 2023, and provided a business update. “The founding mission of our company is to accelerate the discovery, development and global access to radiopharmaceuticals,” said Joe McCann, Ph.D., CEO of POINT Biopharma. “I view Lilly’s agreement to acquire POINT as validation of the uniqueness of our team, infrastructure and pipeline. Together,...