U.S. FDA

Genmab Announces Financial Results for the First Quarter of 2024

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목요일, 5월 2, 2024
USD, FDA, Pfizer, EDT, Priority review, AbbVie, Food, Risk, Annual report, Johnson & Johnson, DKK, Janssen, U.S. FDA, Risk management, Environment, Rituximab, Follicular lymphoma, Novartis, PDUFA, ADC, Patient, Acquisition, Interim, Lenalidomide, Daratumumab, Priority, BST, Pharmaceutical industry

Genmab is maintaining its 2024 financial guidance published on February 14, 2024.

Key Points: 
  • Genmab is maintaining its 2024 financial guidance published on February 14, 2024.
  • We expect to update our guidance no later than in connection with our second quarter 2024 earnings.
  • Genmab will hold a conference call to discuss the results for the first quarter of 2024 today, Thursday, May 2, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT.
  • Actual results or performance may differ materially from any future results or performance expressed or implied by such statements.

Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

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목요일, 4월 25, 2024
FDA, Annual, Pharmacy, NMPA, Private, Partnership, CDE, PDUFA, CEPS, European Medicines Agency, News, Annual report, Intangibles, DMD, U.S. FDA, Catalyst Pharmaceuticals, Tax, CHF, MHRA, Duchenne muscular dystrophy, Quality of life, Leber's hereditary optic neuropathy, Vamorolone, BST, Public, EMA, Marketing, File, Sale, Medication, Treasury, NDA, Health care, Duchenne, Bond, Patient, Bank statement, AGM, Growth, Cryptocurrency

As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.

Key Points: 
  • As permitted by SIX Exchange Regulation, the Company will publish the full 2023 Annual Report in May.
  • Financially, Santhera reported a 2023 revenue of CHF 103.4 million and net income of CHF 54.8 million, driven by the Catalyst licensing deal.
  • After closing of the transaction in July 2023, Santhera received an upfront payment of USD 90 million (USD 75 million in cash and USD 15 million equity investment).
  • SIX Exchange Regulation has permitted Santhera to publish its 2023 Annual Report by May 31, 2024, at the latest.

Eloxx Pharmaceuticals Provides ELX-02 and ZKN-013 Program Updates

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화요일, 4월 16, 2024
FDA, Genetics, Drug discovery, ADPKD, Mutation, IPS, Food, Prevalence, Proteinuria, Organoid, OTC, Kidney, Gene, Orphan, RNA, Partnership, UPCR, Almirall, U.S. FDA, FAP, IND, RDEB, Disease, SAD, Patient, Biopsy, Clinical trial, Polycystic kidney disease, ODD, Food and Drug Administration, PKD, Pharmaceutical industry

WATERTOWN, Mass., April 16, 2024 (GLOBE NEWSWIRE) -- Eloxx Pharmaceuticals, Inc. (OTC: ELOX), a leader in ribosomal RNA-targeted genetic therapies for rare diseases, today provided program updates for ELX-02 and ZKN-013, including Orphan Drug Designation (ODD) for ELX-02.

Key Points: 
  • Eloxx has significantly advanced the development of ELX-02 for the treatment of Alport syndrome with Nonsense Mutations (NMAS).
  • “The recent ELX-02 program updates, including Orphan Drug Designation for ELX-02 for the treatment of Alport Syndrome highlights the significant unmet medical needs of Alport Syndrome patients with Nonsense Mutations,” said Sumit Aggarwal, President and Chief Executive Officer of Eloxx.
  • The designation was based on a review of the prevalence of NMAS and the data from the Proof-of-concept Phase 2 Study that Eloxx announced top-line results for in 2023.
  • In March 2024, Eloxx announced an exclusive license agreement with Almirall to develop and commercialize ZKN-013 in orphan indications including RDEB and FAP with nonsense mutations.

Establishment Labs Announces Appointment of Jeff Ehrhardt as General Manager of North America

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수요일, 5월 1, 2024
Health, Medical Devices, Consumer, Women, Surgery, Health Technology, General Health, Xavier University, FDA, University, ESTA, American Cyanamid, Woman, Regenerative medicine, Breast augmentation, Johnson & Johnson, U.S. FDA, Science, Marketing, MBA, PMA, Organization

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced today that Jeff Ehrhardt has joined the company as General Manager of North America.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced today that Jeff Ehrhardt has joined the company as General Manager of North America.
  • “Jeff is the ideal person to introduce Motiva to the United States,” said Juan José Chacón-Quirós, CEO and Founder of Establishment Labs.
  • Mr. Ehrhardt was most recently General Manager for Plastic Surgery & Regenerative Medicine at Allergan Aesthetics.
  • "Joining Establishment Labs is in many ways the culmination of the last 25 years of my career,” said Jeff Ehrhardt.

Ocugen, Inc. Announces Positive Scientific Advice from the European Medicines Agency Related to the Approval Pathway for OCU400—Modifier Gene Therapy for Broad Retinitis Pigmentosa Indication

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수요일, 4월 10, 2024
FDA, RP, Retinitis pigmentosa, Safety, Marketing, MAA, CHMP, Vaccine, U.S. FDA, Arm, IND, Patient, EMA, Committee, RHO, BLA, Clinical trial, Leber congenital amaurosis, European Medicines Agency

EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.

Key Points: 
  • EMA provided this opinion based on safety and tolerability of OCU400 demonstrated in the Phase 1/2 study.
  • In each arm, participants will be randomized 2:1 to the treatment group (2.5 x 1010 vg/eye of OCU400) and untreated control group, respectively.
  • The positive scientific advice from EMA is in alignment with U.S. FDA clearance of the IND amendment to initiate the Phase 3 liMeliGhT clinical trial of OCU400.
  • OCU400 is the first gene therapy to enter Phase 3 with a broad RP indication.

Edwards Lifesciences Reports First Quarter Results

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목요일, 4월 25, 2024
Managed Care, Biotechnology, Health, Cardiology, Acumen, Mortality, FDA, Critical care, Investment, Pulmonary artery catheter, Research, Trial of the century, Aortic stenosis, Growth, Ultra, U.S. FDA, ICU, TAVR, Patient, PROGRESS, EPS, Hospital, PASCAL, Quality of life, M3, Heart failure, Pharmaceutical industry

Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended March 31, 2024.

Key Points: 
  • Edwards Lifesciences (NYSE: EW) today reported financial results for the quarter ended March 31, 2024.
  • Surgical Structural Heart sales for the quarter were $266 million, which grew 7%, or 8% on a constant currency basis.
  • For the quarter, the adjusted gross profit margin was 76.0%, compared to 77.5% in the same period last year.
  • For the second quarter of 2024, the company projects total sales to be between $1.62 and $1.70 billion, and adjusted EPS of $0.67 to $0.71.

Allurion Closes $48 Million Convertible Senior Secured Note Financing with RTW Investments

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수요일, 4월 17, 2024
Biotechnology, Pharmaceutical, Managed Care, General Health, Health, Health Technology, Fitness & Nutrition, Other Health, Partnership, U.S. FDA, Growth, Obesity, Partner (business rank), RTW, Investment

Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated to ending obesity, today announced the closing of a $48 million convertible senior secured note financing with certain entities managed by RTW Investments, LP (“RTW”).

Key Points: 
  • Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated to ending obesity, today announced the closing of a $48 million convertible senior secured note financing with certain entities managed by RTW Investments, LP (“RTW”).
  • "RTW’s investment underscores our shared belief in the long-term potential of the Allurion Program,” said Dr. Shantanu Gaur, Founder and CEO of Allurion.
  • The investment furthers our long-term partnership with RTW and provides us additional flexibility to achieve our long-term goals,” Dr. Gaur continued.
  • “We are pleased to strengthen our relationship with Allurion as it continues its mission to end obesity around the world.

Establishment Labs Announces Participation in The Aesthetic Meeting 2024

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수요일, 4월 17, 2024
Medical Devices, Health, Consumer, Surgery, Women, Health Technology, FDA, ESTA, Aesthetics, U.S. FDA, Motiva, Clinical trial, PMA, Medical director, Labs

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in The Aesthetic Meeting 2024, which is being held May 2-5 in Vancouver, BC Canada.

Key Points: 
  • Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, today announced its participation in The Aesthetic Meeting 2024, which is being held May 2-5 in Vancouver, BC Canada.
  • At the meeting, Dr. Caroline Glicksman, the Medical Director and an Investigator in the Motiva US IDE Study, will present an update on the clinical trial after completion of four-year follow-up.
  • The presentation, Motiva US Core Clinical Study Update, is part of an investigator research update session scheduled for approximately 6:30 p.m. PT on May 2.
  • Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States.

Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

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수요일, 4월 3, 2024
Ovarian cancer, BofA Securities, PIN, U.S. FDA, Shearman, Webcast, Patient, Fast Track, Goldman Sachs, Morgan Stanley, LLP, Acquisition, Cancer, Spacecraft, Cooley LLP, DKK, Shearman & Sterling, ADC, USD, Law, Food, Pharmaceutical industry

Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).

Key Points: 
  • Genmab will acquire ProfoundBio for USD 1.8 billion in cash, payable at closing (subject to adjustment for ProfoundBio’s closing net debt and transaction expenses).
  • The transaction will further broaden Genmab’s mid- to late-stage clinical pipeline and strengthen and complement Genmab’s already validated suite of proprietary technology platforms.
  • The addition of Rina-S to Genmab’s portfolio will enable Genmab to deepen its presence in the gynecologic oncology space and establish a firm foundation in solid tumors.
  • Based on the data from the ongoing Phase 1/2 clinical trial Genmab intends to broaden the development plans for Rina-S within ovarian cancer and other FRα-expressing solid tumors.

AEON Biopharma Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
금요일, 3월 29, 2024
AEON, Steps, U.S. FDA, LTD, Headache, Patient, Migraine, Investment, Alembic Pharmaceuticals, Safety, FDA, Food, Pharmaceutical industry

IRVINE, Calif., March 29, 2024 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON, AEON WS), a clinical-stage biopharmaceutical company focused on developing a proprietary botulinum toxin complex for the treatment of multiple debilitating medical conditions, announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • We are now well-positioned to plan for the initiation of our pivotal Phase 3 program,” commented Marc Forth, AEON’s President and Chief Executive Officer.
  • “Recently, we announced plans to conduct an interim analysis of our ongoing Phase 2 study of ABP-450 as a preventive treatment for chronic migraine, which completed enrollment in December 2023.
  • On track to announce topline results from the Phase 2 study of ABP-450 as a preventive treatment for chronic migraine in the third quarter of 2024.
  • Episodic Migraine Program Next Steps – The Company is continuing to plan for the initiation of its proposed pivotal Phase 3 program for ABP-450.