P-value

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

Retrieved on: 
Thursday, March 28, 2024
Cream, Dysmenorrhea, Patient, History, Bacteria, G&A, Vaginal discharge, IND, Bayer, Human development, Investment, Diclofenac, NSAID, Menstruation, Research, Hormone, Bacterial vaginosis, P-value, Webcast, SAN, NIH, Trial of the century, Pleasure, Woman, Breast cancer, Safety, Pharmacokinetics, Food, Development, Menopause, Nonsteroidal anti-inflammatory drug, HR, ARPA, VVA, Tamoxifen, FDA, Attention, CRADA, Female, Dyspareunia, Ecosystem, NICHD, Bangladesh Technical Education Board

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.

TFF Pharmaceuticals Announces Update on Clinical Programs

Retrieved on: 
Wednesday, March 20, 2024
Health, TFF, P-value, Acceleration, Partnership, Patient, IPA, EAP, KOL, Mortality, Clinical research associate, Microsoft Access, Calendar, Potential, Safety, Voriconazole, Pharmaceutical industry

FORT WORTH, Texas, March 20, 2024 (GLOBE NEWSWIRE) -- TFF Pharmaceuticals, Inc. (NASDAQ: TFFP) (“the Company”), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, is announcing data updates and strategic prioritization of its clinical programs. Based on positive data from the ongoing Phase 2 study of TFF TAC, the potential to address a significant unmet need in lung transplant medicine, and substantial market opportunity, the Company has made the decision to prioritize the TFF TAC program and focus resources on the acceleration of its clinical pathway towards registration.

Key Points: 
  • “However, after a rigorous assessment of our pipeline, including the significant capital and resources required to progress both clinical development programs, we will focus our clinical development efforts and financial resources on TFF TAC.
  • In summary, for TFF TAC, eight out of eight patients have successfully transitioned from oral Tacrolimus to TFF TAC in the Phase 2 study.
  • TFF TAC continues to demonstrate favorable safety results with no mortality or discontinuations due to adverse events.
  • The Company will host a conference call on Wednesday, March 27, 2024, at 4:30 PM Eastern Time, to discuss updated clinical data for the TFF TAC and TFF VORI.

Spruce Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Wednesday, March 13, 2024
Biotechnology, Pharmaceutical, Health, Research, A4, GC, Congenital adrenal hyperplasia, Administration, PCOS, P-value, GCS, Patient, Cash, Șaeș, Spruce, Outline, CAH, Clinical trial, Safety, Hyperandrogenism, Polycystic ovary syndrome, ULN, Research and development, Food, FDA, Pharmaceutical industry

(Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2023 and provided corporate updates.

Key Points: 
  • (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet medical need, today reported financial results for the year ended December 31, 2023 and provided corporate updates.
  • “We are grateful to all the patients, families, study team and investigators who supported the CAHmelia-203 clinical trial,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, Spruce Biosciences.
  • Non-cash stock-based compensation expense for the year ended December 31, 2023 was $4.6 million compared to $3.6 million in 2022.
  • Net Loss: Net loss for the year ended December 31, 2023 was $47.9 million compared to $46.2 million in 2022.

Applied Therapeutics Reports Fourth Quarter and Year-end 2023 Financial Results

Retrieved on: 
Wednesday, March 6, 2024
Janus, Sorbitol, Marketing, EMA, Doctor of Philosophy, New Drug Application, MAA, Interim analysis, P-value, FDA, Food, Growth, Treatment, INSPIRE, Priority review, PDUFA, Chairperson, Therapy, CHMP, European Medicines Agency, Patient, Private placement, PRV, NDA, Ageing, Pharmaceutical industry

The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.

Key Points: 
  • The FDA also noted that it is planning to hold an advisory committee meeting to discuss the application.
  • Govorestat was previously granted Pediatric Rare Disease designation and will qualify for a Priority Review Voucher (PRV) upon approval.
  • The Company expects a decision by the EMA in the fourth quarter of 2024.
  • Full study results will be presented at an upcoming medical conference, along with results of the Diabetic Peripheral Neuropathy sub-study, which are still being analyzed.

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

Retrieved on: 
Tuesday, February 27, 2024
Licensure, Investment, Growth, Exercise, Tolerability, Immunization, Host, Trial of the century, Ageing, PCV20, PCV, P-value, Safety, BLA, Success, Phase 10, Genetically modified bacteria, Net, G&A, CMC, SAN, Research and development, ID, OPA, Conference, The Lancet, Biologics license application, Breakthrough therapy, Advisory Committee, PCV15, POC, FDA, End, Food, Breakthrough, Element, Fireside chats, Administration, IPD

-- Significant Progress in Establishing Global Commercial Manufacturing Capacity for Vaxcyte's PCV Candidates, Including Expanded Collaboration with Lonza --

Key Points: 
  • ET / 1:30 p.m. PT --
    SAN CARLOS, Calif., Feb. 27, 2024 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • Additionally, as part of ongoing Chemistry, Manufacturing and Controls (CMC)-focused discussions, Vaxcyte received encouraging input from the FDA regarding the VAX-24 adult licensure requirements.
  • The six-month safety data from both studies showed safety and tolerability results for VAX-24 similar to PCV20 at all doses studied.
  • Vaxcyte will host a conference call and webcast to discuss this announcement today, February 27, 2024, at 4:30 p.m.

C4 Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Recent Business Highlights

Retrieved on: 
Thursday, February 22, 2024
BRAF, PD, Research, International Myeloma Foundation, Sale, Lung cancer, Workforce, Poster, Melanoma, P-value, Clinical trial, ATM, BCMA, Therapy, CCCC, Roche, Completeness, CRC, AACR, Conference, Colorectal cancer, Merck, NHL, Research and development, Cancer, Dexamethasone, Administration, Patient, Finance, Biogen, Pharmaceutical industry

WATERTOWN, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation science, today reported financial results for the year ended December 31, 2023, as well as recent business updates.

Key Points: 
  • As of February 2024, three escalation cohorts are complete and dose escalation continues with a fourth dose level currently enrolling.
  • In December 2023, C4T and Merck entered into a license and research collaboration to discover and develop degrader antibody conjugates.
  • Net loss per share for the year ended December 31, 2023 was $2.67, compared to $2.62 for the year ended December 31, 2022.
  • Cash Position and Financial Guidance: Cash, cash equivalents and marketable securities as of December 31, 2023 were $281.7 million, compared to $337.1 million as of December 31, 2022.

Vaxcyte Reports First Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Monday, May 8, 2023
Exercise, OPA, Research and development, P-value, Solar eclipse of March 31, 2090, Investment, IPD, Safety, Pneumococcal conjugate vaccine, Ageing, G&A, Element, Breakthrough therapy, Genetically modified bacteria, PCV20, Safety data sheet, Administration, SAN, Peterborough, Growth, R, PCV, STS, FDA, General Administration of Sport of China, Immunization, IND, Vaccine, Pharmaceutical industry, Cryptocurrency, PCV15, Infant

-- $949.9 Million in Cash, Cash Equivalents and Investments as of March 31, 2023, Excluding Net Proceeds of $545.1 Million from Recent Public Offering --

Key Points: 
  • VAX-24, the Company’s lead, broad-spectrum 24-valent pneumococcal conjugate vaccine (PCV) candidate, is being studied for the prevention of IPD.
  • Submission of the adult IND application to the FDA and announcement of subsequent FDA clearance in the second half of 2023.
  • The March 31, 2023 amount excludes the $545.1 million in estimated net proceeds from the follow-on offering completed in April 2023.
  • Net Loss: For the three months ended March 31, 2023, net loss was $60.5 million, compared to $39.0 million for the same period in 2022.

Alpha Cognition Announces Second Quarter 2022 Results and Provides Corporate Update

Retrieved on: 
Thursday, August 25, 2022
Biotechnology, Pharmaceutical, Health, Neurology, Inflammation, Partnership, COVID-19, TBI, NDA, Tablet, Research, Technology, Second, Survival, Amyotrophic lateral sclerosis, Central nervous system, Spinal muscular atrophy, Cognition, Toxicity, Disease, Burn, R, Gemstone, USD, Depreciation, Advertising, ACOG, TSX, Alzheimer's disease, Growth hacking, Rivastigmine, OTC Markets Group, Neurodegeneration, Donepezil, Company, FDA, Memantine, Met, News, Failure, Transaction, TSX Venture Exchange, Terminology, Potential, Growth, Industry, Discovery, Acquisition, Capsule, ALS, Patient, P-value, Income, Pharmaceutical industry, Renewable energy, Medical device, Dietary supplement, Online gambling, Cryptocurrency, Tutoring, G&A

Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (Alpha Cognition, or the Company), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, today reported financial results and provided a corporate update for the second quarter ended June 30, 2022.

Key Points: 
  • Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (Alpha Cognition, or the Company), a biopharmaceutical company committed to developing novel therapies with the potential to transform the lives of people with debilitating neurodegenerative disorders, today reported financial results and provided a corporate update for the second quarter ended June 30, 2022.
  • "The Company released positive topline data from the ALPHA-1062 pivotal trial during the second quarter of 2022 which allows for the preparation of an NDA filing for the product.
  • The Company is seeking additional capital to fund this study initiation and will commence the study within a quarter to securing the required funding.
  • R&D expenses increased in 2022 primarily due to the additional costs associated with advancing ALPHA-1062 and ALPHA-0602 clinical and preclinical studies.

UNITY Biotechnology, Inc. Reports Second Quarter 2022 Financial Results and Business Updates

Retrieved on: 
Friday, August 12, 2022
U.S. Securities and Exchange Commission, Risk, CST, Vasculitis, Injection, P-value, Inflammation, GLOBE, Population, UNITY, DME, Research, Eye, Unity Biotechnology, Company, Twitter, SAN, Biotechnology, TEK tyrosine kinase, Therapy, Endophthalmitis, Ageing, AMD, Safety, Central retinal vein occlusion, NASDAQ, Intention, Lists of diseases, VEGF, Operating cost, Cellular senescence, UBX, LinkedIn, Blood, Retina, Pharmaceutical industry, Dentistry, Patient

SOUTH SAN FRANCISCO, Calif., Aug. 12, 2022 (GLOBE NEWSWIRE) -- UNITY Biotechnology, Inc. (UNITY) [NASDAQ:UBX], a biotechnology company developing therapeutics to slow, halt, or reverse diseases of aging, today reported financial results for the second quarter ended June 30, 2022.“We are thrilled with the recent data announced in our BEHOLD Study in patients with DME and are grateful for the support and enthusiasm from our physician community and other stakeholders,” said Anirvan Ghosh, Ph.D., chief executive officer of UNITY. “The sustained and significant improvement in visual acuity after a single injection of UBX1325 is very impressive, and , if approved, could provide an attractive treatment option for patients who currently can only hope to maintain their vision at the cost of frequent injections with current standard of care. We look forward to sharing our 24-week data in BEHOLD as we continue to investigate UBX1325, along with 16-week data in ENVISION, our study in wet age-related macular degeneration.”

Key Points: 
  • Based on pre-defined proof-of-concept criteria of alpha=0.15, the study demonstrated a statistically significant treatment effect for both BCVA and CST at both timepoints.
  • UNITY believes that current cash, cash equivalents, and marketable securities are sufficient to fund operations through the first quarter of 2023.
  • Cash used in operations during the first and second quarters of 2022 was $29.8 million compared to $28.5 million for the first and second quarters of 2021.
  • Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make.

Decibel Therapeutics Reports Second Quarter 2022 Financial Results and Corporate Update

Retrieved on: 
Wednesday, August 10, 2022
Regulation of food and dietary supplements by the U.S. Food and Drug Administration, U.S. Securities and Exchange Commission, Ear, Gene, Private Securities Litigation Reform Act, P-value, GLOBE, Disease, SEC, Cancer, Clinical trial, Sale, Cisplatin, Director, Hearing, Interim analysis, Achievement, Board, Research, Security (finance), Therapy, COVID-19, Company, Genetic distance, Twitter, CTA, Program, Regeneron Pharmaceuticals, GJB2, Hearing loss, Ototoxicity, Congenital hearing loss, Development, Medicine, Administration, Food, Terminology, Pharmaceutical industry, IND, Decibel, Patient

BOSTON, Aug. 10, 2022 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the second quarter ended June 30, 2022 and provided a corporate update.

Key Points: 
  • We believe these positive data showcase the integrated capabilities that Decibel has implemented to develop innovative therapeutics for conditions of the inner ear.
  • Decibel is developing DB-OTO in collaboration with Regeneron Pharmaceuticals and retains global commercial rights to the product candidate.
  • Second Quarter 2022 Financial Results:
    Cash Position: As of June 30, 2022, cash, cash equivalents and available-for-sale securities were $125.6 million, compared to $162.3 million as of December 31, 2021.
  • However, while Decibel may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.