Pharmacokinetics

Daré Bioscience Reports Full Year 2023 Financial Results and Provides Company Update

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Thursday, March 28, 2024
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SAN DIEGO, March 28, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today reported financial results for the year ended December 31, 2023 and provided a company update.

Key Points: 
  • In addition, we are excited about the increased attention that women’s health has received more broadly,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
  • In December 2023, Daré announced positive topline results from the Phase 1 study evaluating the pharmacokinetics (PK), safety, and exploratory efficacy of DARE-PDM1.
  • Financial Highlights for the Year Ended December 31, 2023 and 2024 Projections
    Cash and cash equivalents: $10.5 million at December 31, 2023.
  • Daré will host a conference call and live webcast today, March 28, 2024, at 4:30 p.m. Eastern Time to review financial results for the year ended December 31, 2023 and to provide a company update.

Renexxion Ireland Ltd. and Dr. Falk Pharma GmbH Announce FDA Clearance of the Investigational New Drug Application for Naronapride to Treat Gastroparesis and Subsequent Expansion of the Ongoing Phase 2b MOVE-IT Study to the United States

Retrieved on: 
Wednesday, March 27, 2024
FACC, Obesity, Gastroparesis, Metoclopramide, Diabetes, Patient, Volunteering, MD, IND, Nausea, European, Investigational New Drug, Safety, Pharmacokinetics, Phase, Conditional sentence, Vomiting, FDA, Bloating, Pharmaceutical industry

Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.

Key Points: 
  • Falk Pharma”), announce U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application for naronapride to treat patients with gastroparesis.
  • Renexxion and Dr. Falk Pharma will now expand patient enrollment for the ongoing global multi-center 320 patient placebo-controlled Phase 2b MOVE-IT study in gastroparesis to clinical sites in the United States (ClinicalTrials.gov ID: NCT05621811).
  • Furthermore, naronapride has already demonstrated dose-dependent accelerated gastric emptying in a GI transit study of healthy human volunteers.
  • We are aligned in our belief in the transformative power of naronapride to revolutionize treatment for gastroparesis patients and its ability to reshape the gastroparesis treatment landscape.”

Sagimet Biosciences Announces Completion of Phase 1 Hepatic Impairment Study with FASN Inhibitor Denifanstat

Retrieved on: 
Wednesday, March 27, 2024
Pharmacokinetics, Liver, SAN, FASN, Human, Safety, Pharmaceutical industry

SAN MATEO, Calif., March 27, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the completion of a Phase 1 hepatic impairment study with denifanstat, a selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).

Key Points: 
  • SAN MATEO, Calif., March 27, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced the completion of a Phase 1 hepatic impairment study with denifanstat, a selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH).
  • This study was designed to assess the safety and pharmacokinetics of denifanstat in subjects with hepatic impairment, a typical requirement of development programs in MASH.
  • The study population included 8 subjects in each category of mild, moderate or severe hepatic impairment, and 14 healthy subjects with normal hepatic function demographically matched to the subjects with hepatic impairment for age, body weight, and gender.
  • The pharmacokinetic results from this study are anticipated to support the planned Phase 3 program for denifanstat in MASH.

Immuneering Announces First Patient Dosed in its Phase 1/2a Trial of IMM-6-415 to Treat Advanced Solid Tumors with RAF or RAS Mutations

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Wednesday, March 27, 2024
Mutation, RAF, MAPK, Growth, Half-life, PD, Colorectal cancer, RAS, Patient, Neoplasm, Cancer, HRAS, DCI, Human, Binimetinib, AACR, NRAS, Safety, Cycle, Pharmacokinetics, Encorafenib, Pharmaceutical industry

CAMBRIDGE, Mass., March 27, 2024 (GLOBE NEWSWIRE) -- Immuneering Corporation (Nasdaq: IMRX), a clinical-stage oncology company seeking to develop and commercialize universal-RAS/RAF medicines for broad populations of cancer patients, today announced that the first patient has been dosed in its Phase 1/2a trial of IMM-6-415 to treat advanced solid tumors with RAF or RAS mutations.

Key Points: 
  • In animal studies, IMM-6-415 strongly inhibited the growth of tumors with RAF or RAS mutations, as both a monotherapy and in combinations.
  • “We are pleased to have dosed the first patient in our Phase 1/2a trial for IMM-6-415, our second product candidate to enter the clinic,” said Ben Zeskind, Chief Executive Officer, Immuneering Corporation.
  • We believe the shorter half-life of IMM-6-415 could provide a potential treatment option for a broad patient population with RAS or RAF mutations.
  • The trial will include solid tumor patients with any mutation in RAF, KRAS, NRAS, or HRAS who meet the enrollment criteria.

Biora Therapeutics Provides Corporate Update and Reports Fourth Quarter and Full-Year 2023 Financial Results

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Tuesday, March 26, 2024
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SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023.

Key Points: 
  • Results demonstrated targeted drug delivery and absorption in the colon, with 3-4 times lower drug levels in blood
    SAN DIEGO, March 26, 2024 (GLOBE NEWSWIRE) -- Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutic delivery, today provided a corporate update and reported financial results for the fourth quarter and year ended December 31, 2023.
  • “We are thrilled by the results from the single ascending dose (SAD) portion of our clinical trial for BT-600.
  • During 2023, Biora reduced its outstanding notes by more than $80 million, resulting in a 75% reduction in net debt.
  • Comparison of Full-Year Ended December 31, 2023 and 2022
    Operating expenses were $67.1 million for the year ended December 31, 2023, compared to $62.1 million for the year ended December 31, 2022.

Annexon Reports Fourth Quarter and Year-End 2023 Financial Results and Key Anticipated Milestones

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Tuesday, March 26, 2024
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BRISBANE, Calif., March 26, 2024 (GLOBE NEWSWIRE) -- Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported fourth quarter and full year 2023 financial results.

Key Points: 
  • Finally, we anticipate clinical proof-of-concept data from our novel oral inhibitor ANX1502 later in the year.
  • ANX005 in GBS: First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain.
  • ANX005 in GBS: Topline data from pivotal, randomized, placebo-controlled Phase 3 trial expected in the second quarter of 2024.
  • Cash and operating runway: Cash and cash equivalents and short-term investments were $259.7 million as of December 31, 2023.

Third Harmonic Bio Announces Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, March 26, 2024
Research, SAN, G&A, Inflammation, KIT, Safety, Pharmacokinetics, Medicine, Pharmaceutical industry

SAN FRANCISCO, March 26, 2024 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • SAN FRANCISCO, March 26, 2024 (GLOBE NEWSWIRE) -- Third Harmonic Bio, Inc. (Nasdaq: THRD), a biopharmaceutical company focused on advancing the next wave of medicine for inflammatory diseases, today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Third Harmonic Bio has a strong financial position with cash and cash equivalents totaling $269.1 million as of December 31, 2023, and continues to be managed in a capital efficient manner.
  • R&D expenses for the year ended December 31, 2023 decreased to $24.0 million, from $24.4 million for the same period in 2022.
  • G&A expenses for the year ended December 31, 2023 increased to $20.0 million, from $13.3 million for the same period in 2022.

Vigil Neuroscience Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
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WATERTOWN, Mass., March 26, 2024 (GLOBE NEWSWIRE) --  Vigil Neuroscience, Inc. (Nasdaq: VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided an update on recent progress.

Key Points: 
  • “Among our many recent milestones, the most significant for Vigil was the positive data readout from our ongoing Phase 2 IGNITE trial and ILLUMINATE Natural History Study.
  • We are also pleased to have enrolled 20 patients in our IGNITE trial, exceeding our target of 15 patients.
  • Cash Position: Cash, cash equivalents, and marketable securities were $117.9 million as of December 31, 2023, compared to $133.6 million as of September 30, 2023.
  • The increase year-over-year was primarily attributable to increases in headcount-related costs and professional service fees to support the Company’s growth.

Beam Therapeutics Announces Clearance of Clinical Trial Authorisation Application for BEAM-302 for the Treatment of Alpha-1 Antitrypsin Deficiency (AATD)

Retrieved on: 
Tuesday, March 26, 2024
Piz, AATD, Mutation, Biotechnology, Patient, Lung, CTA, AAT, Life expectancy, Safety, Pharmacokinetics, Liver, Medication, Pharmaceutical industry

CAMBRIDGE, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the clearance of its clinical trial authorisation (CTA) application by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with alpha-1 antitrypsin deficiency (AATD).

Key Points: 
  • CAMBRIDGE, Mass., March 26, 2024 (GLOBE NEWSWIRE) -- Beam Therapeutics Inc. (Nasdaq: BEAM), a biotechnology company developing precision genetic medicines through base editing, today announced the clearance of its clinical trial authorisation (CTA) application by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency for BEAM-302, an in vivo base editor, as a potential treatment for patients with alpha-1 antitrypsin deficiency (AATD).
  • “AATD is an inherited genetic condition that can cause serious lung and liver disease, which can lead to significant debility and reduced life expectancy for patients.
  • The study design includes a dose exploration portion followed by a dose expansion portion to identify the optimal dose to take forward in a pivotal study.
  • The company expects to initiate the Phase 1/2 trial of BEAM-302 in the UK in the first half of 2024.

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.