reports
ImprimisRx Announces Leadership Changes
ImprimisRx Announces Leadership Changes Frank Mullery Appointed Chief Executive Officer of ImprimisRx Bridseida Cruz Appointed Head of Quality of ImprimisRx NASHVILLE, Tenn., Oct. 06, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced leadership changes at its wholly-owned subsidiary, ImprimisRx. Frank Mullery has been appointed as Chief Executive Officer and Bridseida Cruz has been appointed as Head of Quality of ImprimisRx. Mr. Mullery is a senior executive with over 20 years of leadership ex...
Harrow to Acquire Melt Pharmaceuticals
Harrow to Acquire Melt Pharmaceuticals NASHVILLE, Tenn., Sept. 26, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has entered into an agreement to acquire Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company pioneering non-opioid, non-IV therapies for sedation for medical procedures in the hospital, outpatient, and in-office settings. The closing of this acquisition is subject to customary closing conditions, including approval by Melt stockholders, excluding Harrow and ...
Harrow Launches Harrow Access for All (HAFA)
Harrow Launches Harrow Access for All (HAFA) HAFA to Expand Harrow’s Innovative Market Access Model Across Ophthalmic Portfolio Program will be available in late 2025 through the HarrowAccess.com Portal NASHVILLE, Tenn., Sept. 25, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the launch of Harrow Access for All (“HAFA”), expanding Harrow’s commitment to make it easier and more affordable for patients to access Harrow’s full range of branded, generic, and compounded ophthalmic medications. H...
Capricor Therapeutics Provides Regulatory Update on Deramiocel Program...
Capricor Therapeutics Provides Regulatory Update on Deramiocel Program for Duchenne Muscular Dystrophy Following Type A Meeting FDA and Capricor aligned on endpoints for HOPE-3 pivotal trialHOPE-3 pivotal trial completed; topline data expected mid-Q4 2025 to support BLA resubmissionCompany preparing to resubmit CRL response under the current BLAConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, Sept. 25, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today annou...
Harrow Announces Agenda and Speakers for Investor & Analyst Day
Harrow Announces Agenda and Speakers for Investor & Analyst Day NASHVILLE, Tenn., Sept. 15, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced the agenda for its upcoming Investor & Analyst Day on Friday, September 26, from 11:30 a.m. ET to 3 p.m. ET in New York. The event will also be webcast live and instructions for accessing the webcast are below. Harrow’s Investor & Analyst Day will include a comprehensive overview of Harrow’s business, featuring presentations from the Company’s leadership t...
Capricor Therapeutics Responds to FDA Posting of Complete Response Let...
Capricor Therapeutics Responds to FDA Posting of Complete Response Letter (CRL) for Deramiocel SAN DIEGO, Sept. 09, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today issued a statement regarding the U.S. Food and Drug Administration’s (FDA) public posting of its Complete Response Letter (CRL) for the Biologics License Application (BLA) for Deramiocel, the Company’s investigational cell therapy for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). The Com...
Harrow Announces Offering of $250.0 Million Senior Unsecured Notes Due...
Harrow Announces Offering of $250.0 Million Senior Unsecured Notes Due 2030 Announces Commitment for New $40 Million Revolving Credit Facility Issues Conditional Notice of Redemption of 11.875% Senior Notes due 2027 NASHVILLE, Tenn., Sept. 08, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, today announced that it has commenced a private offering (the “Offering”) of $250.0 million aggregate principal amount of senior unsecured notes due 2030 (the “2030 Notes”), subject to market and certain other conditi...
Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinic...
Capricor Therapeutics Announces First Subjects Dosed in Phase 1 Clinical Trial of Novel Exosome-Based Vaccine First-in-human trial of Capricor’s StealthX™ vaccine initiated under HHS’s Project NextGenTrial conducted and funded by the National Institute of Allergy and Infectious Diseases (NIAID) SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome-based va...
Capricor Therapeutics Reports Second Quarter 2025 Financial Results an...
Capricor Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update Type A meeting with U.S. FDA scheduled to discuss Deramiocel BLA and path toward potential approvalCapricor seeks to resubmit its BLA based on its existing dataset, with HOPE-3 data (expected in Q4 2025) potentially serving as supportive and confirmatory evidence, pending regulatory guidanceAll 483 observations noted in the Pre-License Inspection have been resolved and accepted by the FDAFDA clears IND for StealthX™ exosome-based vaccine; NIAID has initiated the Phase 1 clinical trial Cash bala...
Harrow Announces Second-Quarter 2025 Financial Results
Harrow Announces Second-Quarter 2025 Financial Results Second-Quarter 2025 and Recent Selected Highlights: Total revenues of $63.7 million, a 30% increase over $48.9 million recorded in the prior-year periodGAAP net income of $5.0 millionAdjusted EBITDA of $17.0 millionCash and cash equivalents of $53.0 million as of June 30, 2025 NASHVILLE, Tenn., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading provider of ophthalmic disease management solutions in North America, announced results for the second quarter ended June 30, 2025. The Company also posted its second quar...
Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA
Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA – Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 08, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel, the Company’s lead cel...
Capricor Therapeutics to Present Second Quarter 2025 Financial Results...
Capricor Therapeutics to Present Second Quarter 2025 Financial Results and Recent Corporate Update on August 13 – Company to Host Conference Call on August 13, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that it will release its financial results for the second quarter ended June 30, 2025, after the market close on Wednesday, August 13, 2025. Management will then host a webcast and conference call at 4:30 p.m....
Harrow to Present at H.C. Wainwright 5th Annual Ophthalmology Conferen...
Harrow to Present at H.C. Wainwright 5th Annual Ophthalmology Conference NASHVILLE, Tenn., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that management will participate in H.C. Wainwright’s 5th Annual Ophthalmology Conference on Wednesday, August 13, 2025, being held virtually. Harrow’s Chief Executive Officer, Mark L. Baum, and Chief Financial Officer, Andrew Boll, will participate in a fireside chat on Wednesday, August 13 at 8:30 a.m. Eastern time. In addition, Mark will participate in a panel discuss...
Harrow To Report Second Quarter 2025 Financial Results After Market C...
Harrow To Report Second Quarter 2025 Financial Results After Market Close on August 11, 2025 Company to Host Conference Call to Discuss Results at 8:00 a.m. Eastern Time on August 12, 2025 NASHVILLE, Tenn., July 29, 2025 (GLOBE NEWSWIRE) -- Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that it will report its financial results for the second quarter ended June 30, 2025, on Monday, August 11, 2025, after the market close. The Company will also post its second quarter Letter to Stockholders to the “Investors” section of its website, . Har...
Capricor Therapeutics and Parent Project Muscular Dystrophy to Host We...
Capricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar to Review Latest Developments in the Deramiocel Program for the Treatment of Duchenne Muscular Dystrophy – Webinar to be held on Tuesday, July 29, 2025, at 1:00 p.m. ET – SAN DIEGO, July 28, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it will host a webinar in collaboration with Parent Project Muscular Dystrophy (PPMD) to review the current status of Capricor’s Biologics License Application ...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in Q3 2025 to continue pursuing the indication for the treatment of cardiomyopathy associated with Duchenne muscular dystrophyFDA advised Capricor to request a meeting to determine next steps toward potential approvalConference call and webcast scheduled for today at 8:30 a.m. ET SAN DIEGO, July 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company dev...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for...
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy FDA has indicated that an Advisory Committee meeting is not required at this timeIn-person late-cycle review meeting scheduled for mid-July Biologics License Application (BLA) remains under Priority Review with PDUFA target action date of August 31, 2025Four-year data presented at PPMD 2025 Conference demonstrate sustained cardiac function SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for r...
Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-...
Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-Label Extension Study of Deramiocel in Duchenne Muscular Dystrophy Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow with extended treatment (PUL v2.0)Deramiocel’s long-term safety profile remains favorableResults presented at PPMD’s 2025 Annual Conference SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive fou...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Mus...
Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseasesCapricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-base...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenn...
Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program U.S. FDA successfully completed Pre-License Inspection; Company expects facility will meet all requirements to support licensureAdvisory Committee meeting scheduled for July 30, 2025Mid-cycle meeting recently completed with no significant issues or major deficiencies; late-cycle meeting planned for mid-JulyBiologics License Application remains under priority review with PDUFA target action date of August 31, 2025 SAN DIEGO, June 11, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: CAPR), a biotechnolog...
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