U.S. FDA

Genmab to Broaden and Strengthen Oncology Portfolio with Acquisition of ProfoundBio

Retrieved on: 
Wednesday, April 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: 
Friday, March 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.

Emergent BioSolutions Continues to Broaden Access, Awareness and Availability of NARCAN® Nasal Spray to Help Save Lives from the Ongoing Opioid Crisis

Retrieved on: 
Thursday, March 28, 2024
FSA, U.S. FDA, Arm, Heroin, Risk, Education, Pharmacy, School, Naloxone, Policy, EBS, Flexible, House, Drug, OTC, CDC, Restaurant, Medicaid, National Safety Council, AED, HSA, FDA, Emergent BioSolutions, NSC, Medicine, Fentanyl, Pharmaceutical industry

Emergent and other stakeholders in the fight must continue raising awareness about the availability of products like NARCAN® Nasal Spray, reducing stigma and further improving access for all Americans.

Key Points: 
  • Emergent and other stakeholders in the fight must continue raising awareness about the availability of products like NARCAN® Nasal Spray, reducing stigma and further improving access for all Americans.
  • Since the OTC launch, NARCAN® Nasal Spray can be purchased at more than 32,000 mass drug, grocery, online retailers and e-commerce sites.
  • Emergent is working with retail partners to make it easy to find and access, however each retailer ultimately determines in-store product placement.
  • “That’s why we remain committed to increasing awareness of NARCAN® Nasal Spray availability.

Invivyd Reports Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, March 28, 2024
Hook effect, Administration, U.S. FDA, Pre-exposure prophylaxis, Risk, COVID-19, Ageing, SARS-CoV-2, Research and development, Clinical trial, Vaccination, Immunodeficiency, Food, FDA, Vaccine

“We made remarkable progress throughout 2023 and in recent months.

Key Points: 
  • “We made remarkable progress throughout 2023 and in recent months.
  • Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2.
  • Cash Position: Cash and cash equivalents were $200.6 million as of December 31, 2023.
  • Basic and diluted net loss per share was $1.81 for the year ended December 31, 2023, compared to $2.23 for the year ended December 31, 2022.

United States Food & Drug Administration (FDA) Notifies Mesoblast that Available Clinical Data from Phase 3 Trial Appear Sufficient to Support BLA Submission for Remestemcel-L in Children with Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD)

Retrieved on: 
Tuesday, March 26, 2024
Patient, MESO, Mesoblast, U.S. FDA, MSB, FDA, BLA, Inflammation

NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

Key Points: 
  • NEW YORK, March 25, 2024 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that U.S. FDA has informed the company that following additional consideration the available clinical data from its Phase 3 study MSB-GVHD001 appears sufficient to support submission of the proposed Biologics License Application (BLA) for remestemcel-L for treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).
  • “We thank the agency for their collaborative approach.
  • The responses and guidance from FDA are clear and provide us with a high level of confidence to refile our BLA for remestemcel-L in children with SR-aGVHD,” said Mesoblast CEO Dr. Silviu Itescu.
  • Mesoblast intends to file the resubmission during the next quarter, seeking to address all remaining product characterization issues.

Aprea Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, March 26, 2024
Ovarian cancer, Cyclin, IND, Therapy, Anemia, Research, University, Cell cycle, MD Anderson Cancer Center, PLK1, DDR, Investigational New Drug, Safety, Pharmacokinetics, Synthetic lethality, WEE1, U.S. FDA, Mutation, Acceleration, Part, HERG, ATR, KOL, Acquisition, Cancer, AACR, Research and development, Poster, FDA, Cyclin E, Toxicity, Aplastic anemia, Administration, Conference, APRE, PLK3, PLK2, Division, Data, Cardiotoxicity, Pharmaceutical industry

DOYLESTOWN, Pa., March 26, 2024 (GLOBE NEWSWIRE) -- Aprea Therapeutics, Inc. (Nasdaq: APRE) (“Aprea”, or the “Company”), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • “Aprea had a very productive 2023 with significant progress across our diversified pipeline of synthetic lethality-based cancer therapeutics.
  • An update from Part 1 of the trial was featured in a poster presentation at the AACR-NCI-EORTC International Conference in October 2023.
  • Select Financial Results for the Fourth Quarter ended December 31, 2023
    As of December 31, 2023, Aprea reported cash and cash equivalents of $21.6 million.
  • Research and Development (R&D) expenses were $2.0 million for the quarter ended December 31, 2023, compared to $0.5 million for the fourth quarter of 2022.

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

Retrieved on: 
Monday, March 25, 2024
ODD, Research, Food and Drug Administration, U.S. FDA, Drug discovery, AML, International, Patient, Committee, SBIR, Female, Acute myeloid leukemia, Sale, INN, Marker, EMA, OTS, NIH, IND, Myelodysplastic syndrome, European Medicines Agency, Counsel, Therapy, MRD, Bone marrow, USAN, MDS, APOLLO, FDA, DLBCL, Press release, CD19, Pharmaceutical industry

Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.

Key Points: 
  • Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
  • Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023.
  • On June 26, 2023, Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately $19 million in cash.
  • Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million.

Emet Surgical Accepted into Innosphere Ventures Life Sciences Incubator Program

Retrieved on: 
Tuesday, April 9, 2024
Oncology, Medical Devices, Health, Surgery, Other Health, General Health, U.S. FDA, ROI, Entrepreneurship, Cancer, Surgeon, Ecosystem, Pathology, Orientation

Emet Surgical , developers of innovative tools to improve surgery outcomes, today announced its acceptance into the Innosphere Ventures Life Sciences Incubator for pioneering startups, a program of impact nonprofit Innosphere Ventures .

Key Points: 
  • Emet Surgical , developers of innovative tools to improve surgery outcomes, today announced its acceptance into the Innosphere Ventures Life Sciences Incubator for pioneering startups, a program of impact nonprofit Innosphere Ventures .
  • Innosphere’s incubation programs support the commercialization efforts of entrepreneurs, technical founders and university researchers who are launching and scaling high-tech startups.
  • The Innosphere Ventures Regional Life Sciences Incubator accelerates the success of founders building technology and science-based companies through its incubation programs, office and specialized wet laboratory facilities, and venture capital funds.
  • "Emet Surgical’s innovative approach to improving surgery outcomes, born out of firsthand experience and a commitment to addressing critical challenges in the field, exemplifies the spirit of entrepreneurship and innovation that defines our cohort,” said Kevin Noble, Life Sciences Program Director for Innosphere.

PureTech Launches Seaport Therapeutics with $100 Million Oversubscribed Series A and Announces Management Transitions

Retrieved on: 
Tuesday, April 9, 2024
Biotechnology, General Health, Health, Pharmaceutical, Clinical Trials, Depression, Eli Lilly, Major depressive disorder, Patient, Bristol Myers Squibb, PureTech Health, PRTC, Therapy, Creativity, Disorder, General counsel, CNS, Life, DSM-IV codes, Pleasure, Pharmacokinetics, Interim, Third Rock Ventures, U.S. FDA, Schizophrenia, KarXT, Teva Pharmaceuticals, ARCH Venture Partners, Merck, Anxiety, Merck & Co., Research and development, FDA, Lymphatic system, Hepatotoxicity, Sirna Therapeutics, Generalized anxiety disorder, Growth, Neuropsychiatry, Partner, Multimedia, Eli Lilly and Company, Probability, Liver, Medicine, Pharmaceutical industry

Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.

Key Points: 
  • Following the Series A financing, PureTech will hold equity ownership in Seaport of 61.5 percent on a diluted basis.
  • Under its license agreement with Karuna, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals.
  • Eric Elenko, Ph.D., a PureTech co-founder and current Chief Innovation Officer, has been promoted to the role of President of PureTech.
  • Daphne Zohar, the Chief Executive Officer of Seaport, is the founder and former CEO of PureTech Health where she also co-founded Karuna Therapeutics.

Seaport Therapeutics Launches with $100 Million Oversubscribed Series A Financing Round to Advance Novel Neuropsychiatric Medicines

Retrieved on: 
Tuesday, April 9, 2024
Mental Health, Health, Neurology, General Health, Pharmaceutical, Biotechnology, Generalized anxiety disorder, Depression, Eli Lilly, U.S. FDA, Schizophrenia, KarXT, Major depressive disorder, ARCH Venture Partners, Patient, CNS, Anxiety, Bristol Myers Squibb, PureTech Health, DSM-IV codes, Pleasure, Neuropsychiatry, Research and development, Therapy, Pharmacokinetics, Partner, Disorder, Third Rock Ventures, Probability, FDA, Lymphatic system, Hepatotoxicity, Liver, Medicine, Pharmaceutical industry

Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.

Key Points: 
  • Seaport Therapeutics , a clinical-stage biopharmaceutical company that is charting a proven path in neuropsychiatry, today announced the closing of a $100 million oversubscribed Series A financing round.
  • The round was co-led by ARCH Venture Partners and Sofinnova Investments along with Third Rock Ventures and Seaport founder PureTech Health.
  • Seaport is advancing a clinical-stage pipeline of novel neuropsychiatric medicines powered by its proprietary Glyph™ Technology Platform, which leverages the lymphatic system to create new medicines building on clinically validated mechanisms.
  • I am eager to support Seaport as an investor and board member as the team continues to advance its clinical-stage pipeline of novel therapeutics.”