CDMO

Avid Bioservices Announces Receipt of Deficiency Notice from Nasdaq Regarding Late Form 10-Q

Retrieved on: 
Wednesday, March 20, 2024
CDMO, Rule, Notice, Classification, Security (finance), Bank statement, Debt-to-GDP ratio, Calendar, Cryptocurrency

The Rule requires listed companies to timely file all required periodic reports with the Securities and Exchange Commission (the “SEC”).

Key Points: 
  • The Rule requires listed companies to timely file all required periodic reports with the Securities and Exchange Commission (the “SEC”).
  • Under Nasdaq rules, the company has 60 calendar days from the receipt of the Notice, or until May 20, 2024, to submit a plan to regain compliance with the Rule.
  • The company intends to file the Form 10-Q as promptly as reasonably practicable.
  • If the company does not file the Form 10-Q by May 20, 2024, the company intends to timely submit a plan to regain compliance with the Rule.

Scorpius Holdings Awarded Contract in Excess of $1 Million with NIH-Funded Researcher at a Major University

Retrieved on: 
Tuesday, March 19, 2024
Annual report, Attention, CDMO, CHO, CGMP, NIH, Traction, Pharmaceutical industry

DURHAM, N.C., March 19, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it has been awarded a contract in excess of $1 million with an NIH-funded researcher at a major university.

Key Points: 
  • DURHAM, N.C., March 19, 2024 (GLOBE NEWSWIRE) -- Scorpius Holdings, Inc (NYSE American: SCPX), an integrated contract development and manufacturing organization (CDMO), today announced that it has been awarded a contract in excess of $1 million with an NIH-funded researcher at a major university.
  • The program involves process optimization and development of a therapeutic antibody, which Scorpius will manufacture for preclinical studies.
  • Following process optimization and development, the Company expects to expand the scope of the agreement to include Phase 1 clinical manufacturing.
  • Jeff Wolf, CEO of Scorpius, stated, "Scorpius is excited to begin work with another nationally renowned university.

INVESTIGATION ALERT: Edelson Lechtzin LLP Announces an Investigation into Avid Bioservices, Inc. (NASDAQ: CDMO) and Encourages Investors with Substantial Losses or Witnesses with Relevant Information to Contact the Firm

Retrieved on: 
Monday, March 18, 2024
Failure, CDMO, Biotechnology, Acceleration, News, LLP, Bank statement, Note, Debt-to-GDP ratio, Security (finance)

If you have information that could assist in the Avid Bioservices Investigation or if you are an Avid Bioservices investor who suffered a loss and would like to learn more, you can provide your information HERE .

Key Points: 
  • If you have information that could assist in the Avid Bioservices Investigation or if you are an Avid Bioservices investor who suffered a loss and would like to learn more, you can provide your information HERE .
  • THE COMPANY: Avid Bioservices is a contract development and manufacturing organization based in Tustin, California.
  • They provide process development and manufacturing services to the biotechnology and biopharmaceutical industries, including clinical and commercial drug substance manufacturing, bulk packaging, release and stability testing, and regulatory submission and support.
  • On this news, the price of Avid Bioservices stock fell over 28% in intraday trading on March 7, 2024.

Grace Expands Contract Development & Manufacturing Organization Services in South Haven, MI

Retrieved on: 
Monday, March 18, 2024
Grace, Royal, CGMP, CDMO, Active ingredient, Good manufacturing practice, Research, William Russell Grace, CDM, API, Fine chemical

COLUMBIA, Md., March 18, 2024 (GLOBE NEWSWIRE) -- W. R. Grace & Co. (Grace), a leading global specialty chemicals company, today announced the opening of its expanded fine chemical contract development and manufacturing (CDM) facility in South Haven, MI.

Key Points: 
  • COLUMBIA, Md., March 18, 2024 (GLOBE NEWSWIRE) -- W. R. Grace & Co. (Grace), a leading global specialty chemicals company, today announced the opening of its expanded fine chemical contract development and manufacturing (CDM) facility in South Haven, MI.
  • Grace executives and local community leaders joined more than 200 employees at the site for a ribbon cutting to mark completion of the 21-month project .
  • “The newly expanded South Haven facility cements our position as a leading North American contract development and manufacturing organization (CDMO) and a leading employer in the community,” said Ed Sparks, Chief Executive Officer, Grace.
  • The site integrates with Grace’s Tyrone, PA, facility to offer customers flexibility in meeting pharmaceutical and nutraceutical production needs with a U.S.-based supply chain.

SHAREHOLDER UPDATE: Halper Sadeh LLC Investigates HRT, NGM, SCTL

Retrieved on: 
Saturday, March 16, 2024
CDMO, HireRight, NGM, Column, Sale, Fraud, Advertising, General Atlantic, Society, LP, Security (finance)

If you are a HireRight shareholder, click here to learn more about your rights and options .

Key Points: 
  • If you are a HireRight shareholder, click here to learn more about your rights and options .
  • Halper Sadeh LLC may seek increased consideration for shareholders, additional disclosures and information concerning the proposed transaction, or other relief and benefits on behalf of shareholders.
  • Please call Daniel Sadeh or Zachary Halper at (212) 763-0060 or email [email protected] or [email protected] .
  • Halper Sadeh LLC represents investors all over the world who have fallen victim to securities fraud and corporate misconduct.

Avid Bioservices (CDMO) Falls Further After Disclosing Intent to Restate Financial Statements Due to Misclassification of $146 Million of 2026 Notes as Long-Term Liabilities – Hagens Berman

Retrieved on: 
Thursday, March 14, 2024
SAN, Bank statement, CDMO, Hagens Berman, Note, Sale, Person, Cryptocurrency

12, 2024 after the CDMO announced the need to restate its financial performance over several quarters in 2022 and 2023.

Key Points: 
  • 12, 2024 after the CDMO announced the need to restate its financial performance over several quarters in 2022 and 2023.
  • The company blamed the misreporting on its misclassification of certain notes as long term liabilities and its failures to record additional interest expenses payable to note holders.
  • The debt in question are $143.8 million of 1.250% exchangeable senior notes due 2026 (“2026 Notes”) that Avid privately placed with qualified institutional investors in Mar.
  • In addition, the indenture governing the 2026 Notes required Avid to remove the legend by Mar.

Pluri Selected as CDMO by Remedy Cell for Cell-Derived Cell-Free Drug Manufacturing

Retrieved on: 
Thursday, March 14, 2024
CDMO, Biotechnology, Plural, Cell, Survival, WCB, Partnership, Stem cell, Idiopathic pulmonary fibrosis, GMP, IPF, PLUR, Idiopathic disease, Cell bank, Pharmaceutical industry

HAIFA, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or "the Company"), a leading biotechnology company that transforms cells into solutions, today announced that its CDMO division (PluriCDMO™) has signed a manufacturing agreement with Remedy Cell Ltd, an innovative, biopharmaceutical company developing stem cell-derived, cell-free therapeutics for complex fibrotic conditions.

Key Points: 
  • HAIFA, Israel, March 14, 2024 (GLOBE NEWSWIRE) -- Pluri Inc. (Nasdaq:PLUR) (TASE:PLUR) ("Pluri" or "the Company"), a leading biotechnology company that transforms cells into solutions, today announced that its CDMO division (PluriCDMO™) has signed a manufacturing agreement with Remedy Cell Ltd, an innovative, biopharmaceutical company developing stem cell-derived, cell-free therapeutics for complex fibrotic conditions.
  • PluriCDMO™ will support Remedy Cell’s production team in the manufacturing of a clinical-grade Working Cell Bank (WCB) and GMP batches of Remedy Cell’s drug candidate RC-0315, derived from mesenchymal stem cells, towards the launch of their Phase Ib clinical trial for the treatment of Idiopathic Pulmonary Fibrosis (IPF), a lethal, complex, progressive interstitial lung disorder with a median survival of 3.8 years.
  • Remedy Cell CEO, Ayelet Dilion-Mashiah, said, “This is an exciting time at Remedy Cell as we initiate the early stages of clinical development of our novel drug candidate, RC-0315, for IPF, a condition with significant unmet treatment needs.
  • We are delighted that Remedy Cell has chosen PluriCDMO™ to assist with their clinical manufacturing, and we eagerly anticipate the establishment of a robust, long-term partnership grounded in excellence and collaboration."

Scorpius Holdings Accepted as a Member of the US Government’s BioMaP-Consortium

Retrieved on: 
Thursday, March 14, 2024
Annual report, CDMO, Development, Infection, Health, Biopharmaceutical, HHS, Human services, Pandemic, Pharmaceutical industry

The BioMap-Consortium has a $20 billion funding ceiling, through which it provides growth funding, as well as streamlined access to servicing government-funded manufacturing programs.

Key Points: 
  • The BioMap-Consortium has a $20 billion funding ceiling, through which it provides growth funding, as well as streamlined access to servicing government-funded manufacturing programs.
  • Scorpius offers a broad array of analytical testing, process development, and manufacturing services to pharmaceutical and biotech companies at its state-of-the-art facilities in San Antonio, TX.
  • With an experienced team and new, purpose-built U.S. facilities, Scorpius is dedicated to transparent collaboration and flexible, high-quality biologics biomanufacturing.
  • This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Microbix’s Clot-Buster Drug Project Advances

Retrieved on: 
Thursday, March 14, 2024
Drug, CDMO, Hope, TSX, OTCQX, Calendar, Pharmaceutical industry

The referenced CDMO agreement is for all actions necessary to resume production of Kinlytic Drug Substance at a scale sufficient for the Catheter Clearance market.

Key Points: 
  • The referenced CDMO agreement is for all actions necessary to resume production of Kinlytic Drug Substance at a scale sufficient for the Catheter Clearance market.
  • The CDMO has undertaken to complete this work over a timeframe specified by Sequel and in line with Microbix’s disclosed project objectives.
  • Anticipated future disclosures related to Kinlytic may include, among other matters, successful production of Drug Substance, contracting for manufacture of clinically-formulated drug (“Drug Product”), first production of Drug Product, and clinical, regulatory, or commercial milestones.
  • Cameron Groome, CEO and President of Microbix, commented, “We’re very pleased that a detailed agreement has been executed with a very well-qualified CDMO for the production of new Kinlytic Drug Substance.

3Daughters Announces Three New Appointments to Board of Directors

Retrieved on: 
Wednesday, March 13, 2024
Quotient, Thakeham, Alnylam Pharmaceuticals, CDMO, Birth, Labs, GSK plc, Pharmacy, University, Novartis, Dana–Farber Cancer Institute, IUD, University College London, Embryology, IND, MBA, Woman, Doctor of Philosophy, Intrauterine device, Therapy, Drug development, Allergan, Amersham plc, Takeda Oncology, Chief Justice of Hungary, Pharmacia, Birth control

Miles, Ph.D., and Sarah J. Stevens, Ph.D., to serve on the Company’s Board of Directors.

Key Points: 
  • Miles, Ph.D., and Sarah J. Stevens, Ph.D., to serve on the Company’s Board of Directors.
  • An IND for 3D-001 will be filed this year followed by a Phase 1 clinical trial.
  • Mary Beth Cicero, CEO of 3Daughters, expressed her enthusiasm about the new additions to the board: "We are incredibly excited to have the collective strengths of Michele, Sarah, and Vin on our Board of Directors.
  • With this first product, 3Daughters expects to disrupt the IUD market and establish a position as a major innovator in women's healthcare.