CMC

AXSOME ALERT: Bragar Eagel & Squire, P.C. is Investigating Axsome Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, April 12, 2024
FDA, News, NDA, Food, Myenteric plexus, P.C, Chemistry, CMC, Symantec Endpoint Protection, Migraine, CRL, Therapy, Telephone, Pharmaceutical industry

Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Axsome have breached their fiduciary duties to the company.
  • Axsome is a biopharmaceutical company that engages in the development of novel therapies for central nervous system disorders in the United States.
  • However, unbeknownst to investors, the Company’s preparation and eventual submission of the AXS-07 NDA was plagued with chemistry, manufacturing, and control (“CMC”) issues.
  • Then, on April 25, 2022, Axsome disclosed in a filing with the U.S. Securities and Exchange Commission that, “[o]n April 22, 2022, Axsome .

Bicycle Therapeutics Reports Recent Business Progress and First Quarter 2024 Financial Results

Retrieved on: 
Thursday, May 2, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Natural killer T cell, Citizenship, Bicycle, Cancer, Safety, BTC, Abstract, Conference, Research, Webcast, ASCO, Therapy, CMC, Society, MUC, AACR, Annual general meeting, Teva Pharmaceuticals, AstraZeneca, Pharmaceutical industry

Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported recent business progress and financial results for the first quarter ended March 31, 2024.

Key Points: 
  • Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported recent business progress and financial results for the first quarter ended March 31, 2024.
  • Bicycle Therapeutics will present two abstracts highlighting the company’s clinical progress in developing Bicycle Toxin Conjugates® (BTC® molecules) as differentiated cancer therapies.
  • Continued progress across research and development (R&D) pipeline, with numerous clinical data readouts and program updates expected in 2H 2024.
  • Bicycle Therapeutics management will participate in a fireside chat at the Citizens JMP Life Sciences Conference on May 13, 2024, at 9 a.m.

Exelon Reports First Quarter 2024 Results

Retrieved on: 
Thursday, May 2, 2024
Utilities, Energy, Sale, Table, ACE, Corporation, Weather, ROE, Safety, BGE, Natural gas, Electricity, DPL, SMBC, Carbon, Growth, PHI, Pepco, CMC, Commonwealth Edison, EPS, ICC, PECO, Series, GAAP, Incidence, Bank

Exelon Corporation (Nasdaq: EXC) today reported its financial results for the first quarter of 2024.

Key Points: 
  • Exelon Corporation (Nasdaq: EXC) today reported its financial results for the first quarter of 2024.
  • Exelon's GAAP Net Income for the first quarter of 2024 decreased to $0.66 per share from $0.67 per share in the first quarter of 2023.
  • Adjusted (non-GAAP) Operating Earnings for the first quarter of 2024 decreased to $0.68 per share from $0.70 per share in the first quarter of 2023.
  • ComEd's first quarter of 2024 GAAP Net Income decreased to $193 million from $241 million in the first quarter of 2023.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

Retrieved on: 
Thursday, May 2, 2024
Class Action Lawsuit, Professional Services, Legal, Suite, FDA, CRL, Telephone, CMC, News, Symantec Endpoint Protection

Law Offices of Howard G. Smith announces an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • Law Offices of Howard G. Smith announces an investigation on behalf of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) investors concerning the Company’s possible violations of federal securities laws.
  • If you purchased Abeona securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847 or by email to [email protected] , or visit our website at www.howardsmithlaw.com .
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
  • View source version on businesswire.com: https://www.businesswire.com/news/home/20240501940982/en/

The Law Offices of Frank R. Cruz Announces Investigation of Abeona Therapeutics Inc. (ABEO) on Behalf of Investors

Retrieved on: 
Tuesday, April 30, 2024
Professional Services, Class Action Lawsuit, Suite, FDA, Law, CRL, CMC, News, Symantec Endpoint Protection

The Law Offices of Frank R. Cruz announces an investigation of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) on behalf of investors concerning the Company’s possible violations of federal securities laws.

Key Points: 
  • The Law Offices of Frank R. Cruz announces an investigation of Abeona Therapeutics Inc. (“Abeona” or the “Company”) (NASDAQ: ABEO ) on behalf of investors concerning the Company’s possible violations of federal securities laws.
  • If you are a shareholder who suffered a loss, click here to participate.
  • If you inquire by email please include your mailing address, telephone number, and number of shares purchased.
  • This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

Macomics Unveils its Lead First-in-Class Anti-Pan-LILRB Monoclonal Antibody Programme with Positive Pre-clinical Data Presented at AACR 2024

Retrieved on: 
Thursday, April 11, 2024
Neoplasm, Cancer, Inflammation, CRISPR, Poster, AACR2, IND, Drug discovery, Disease, CRISPR interference, Patient, CMC, Fibrosis, Macrophage, LILRB1, AACR, MHC, LILRB2, Cell potency, NK, Pharmaceutical industry

MACO-355 is a novel, non-ligand blocking, pan-LILR targeting antibody capable of mediating macrophage reprogramming under immune suppressive conditions.

Key Points: 
  • MACO-355 is a novel, non-ligand blocking, pan-LILR targeting antibody capable of mediating macrophage reprogramming under immune suppressive conditions.
  • This new mode of action results in increased antibody activity as measured by macrophage reprogramming (cytokine release) and T cell activation.
  • The antibody also induces tumour cell phagocytosis and NK cell tumour kill independent of the ligand status of the tumour cells, unlike ligand blocking antibodies.
  • Data presented also showed that it reverts M2 (TGFβ/IL-10/IL-4) macrophage mediated suppression of T cell activity in vitro and slows tumour growth in vivo.

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

Retrieved on: 
Wednesday, April 10, 2024
Abele, AAAAI, FDA, Citizenship, Research, Healthcare Improvement Scotland, Trial of the century, SMC, IND, Record, Intellectual property, National Congress, American Academy, Attack, Food, ACAAI, Conference, Hereditary angioedema, MHRA, HAE, Therapy, Network, EOP, Book, PRO, Chemistry, CMC, G&A, Investigational New Drug, Doctor of Philosophy, Medication, Research and development, American College, Mass meeting, Health care, Administration, Bank statement, Annual general meeting, Heredity, Pharmaceutical industry

Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.

Key Points: 
  • Pharvaris is currently enrolling in RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule (PHVS416) for the on-demand treatment of HAE attacks.
  • Effective April 15, 2024, David Nassif, J.D., will join Pharvaris as Chief Financial Officer and will be responsible for refining and implementing Pharvaris’ corporate financial strategy and activities including financial reporting and operations.
  • Loss for the fourth quarter of 2023 was €32.7 million, resulting in basic and diluted loss per share of €0.74.
  • Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board.

Synedgen Completes IND-Enabling Studies for Two Parallel Programs for Lead Asset MIIST305

Retrieved on: 
Thursday, April 25, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Mortality, FDA, Ulcerative colitis, Radiation, Drug discovery, Safety, MD, Trial of the century, Doctor of Philosophy, IND, Disease, Patient, Chemistry, CMC, GLP, Physician, Good laboratory practice, Toxicology, UC, Pharmaceutical industry

Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced it has completed IND-enabling studies for its lead candidate, MIIST305.

Key Points: 
  • Synedgen, Inc., a biotechnology company targeting human glycobiology to treat gastrointestinal diseases, today announced it has completed IND-enabling studies for its lead candidate, MIIST305.
  • MIIST305 is being developed for two parallel programs, an indication for ulcerative colitis (UC) and a medical countermeasure for gastrointestinal acute radiation syndrome (GI-ARS).
  • Within a year, Synedgen plans to open an Investigational New Drug (IND) application for MIIST305 and initiate a Phase 1 clinical study to support both programs.
  • Synedgen was awarded a $4.4 million grant from the Congressionally Directed Medical Research Program (CDMRP) to fund some of MIIST305’s preclinical, IND-enabling studies.

Medincell Enters Into Strategic Co-development and Licensing Agreement with AbbVie to Develop Next-generation Long-acting Injectable Therapies

Retrieved on: 
Tuesday, April 16, 2024
Research, FDA, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, Other Science, Science, Partnership, CMC, Growth, AbbVie, Pharmaceutical industry

Medincell (Paris:MEDCL) today announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications.

Key Points: 
  • Medincell (Paris:MEDCL) today announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications.
  • Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies.
  • Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials.
  • AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization.

FIRST STANDALONE FOUR SEASONS BRANDED RESIDENCES IN FLORIDA TO OPEN IN MIAMI'S COCONUT GROVE

Retrieved on: 
Tuesday, April 23, 2024
CMC Group, Housekeeping, Fortification, School, Four Seasons Hotel Miami, Partnership, Collection, Water, Life, Miele, Yoga, Restaurant, Culture, Tree, CMC, Condo, Trust, Siesta Key (TV series), Sand, Quality of life, Florentine, Architecture, Hotel

MIAMI, April 23, 2024 /PRNewswire/ -- Real estate development firms CMC Group and Fort Partners, together with leading luxury hospitality and branded residential company Four Seasons, announce the highly anticipated Four Seasons Private Residences Coconut Grove. Set within one of Miami's most historic neighbourhoods and building on the success of Four Seasons residential portfolio in South Florida and around the globe, this groundbreaking development will be the first Four Seasons standalone offering in the state, delivering legendary service and experiences outside of a hotel or resort.

Key Points: 
  • Four Seasons Private Residences Coconut Grove will offer 70 homes ranging from two- to four-bedrooms and spanning up to 3,980 square feet (370 square metres).
  • "Fifteen years ago, CMC Group pioneered luxury living in the Grove with Grovenor House, and now with Four Seasons Coconut Grove, we're raising the bar yet again.
  • Homes at Four Seasons Private Residences Coconut Grove will feature nearly 11-foot (3.35 metre) ceilings throughout, complementing the spacious, open floor plans.
  • Four Seasons Private Residences Coconut Grove will reflect the neighbourhood's refined, serene atmosphere, steeped in culture and connectedness.