Regulation of tobacco by the U.S. Food and Drug Administration

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023

CRANFORD, N.J. and NEW YORK, N.Y., Oct. 24, 2023 (GLOBE NEWSWIRE) -- Citius Pharmaceuticals, Inc. (“Citius Pharma” or the “Company”) (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition (“TenX”) (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma’s wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024.

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. (“Citius Oncology”).
  • Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.
  • “We are very pleased to announce the proposed merger with Citius Oncology,” said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • In the transaction, all shares of Citius Pharma’s wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Elevar Therapeutics Names Brian Cunningham Vice President of Sales and Kenneth Rankin Vice President of Market Access, Strengthening Commercial Leadership in Buildup to Launch

Retrieved on: 
Monday, October 23, 2023

"The additions of Brian Cunningham and Kenneth Rankin come at an important and exciting time for Elevar, as we position the company for a potential commercial launch in the coming year,” said Elevar Chief Commercial Officer Paul Friel.

Key Points: 
  • "The additions of Brian Cunningham and Kenneth Rankin come at an important and exciting time for Elevar, as we position the company for a potential commercial launch in the coming year,” said Elevar Chief Commercial Officer Paul Friel.
  • “Both possess a wealth of sales and management acumen, and a great understanding of the road ahead for our company.
  • Cunningham joins Elevar from global oncology company Novocure, where he served as the national sales and operations lead for its Central Nervous System Cancers Franchise.
  • He was previously vice president of sales for rare commercial services at Dohmen Life Science Services, and director of Eisai Inc.’s government payer team.

Marizyme CEO Delivers Business Update

Retrieved on: 
Monday, October 23, 2023

JUPITER, FL, Oct. 23, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - Marizyme, Inc. ("Marizyme" or the "Company") (OTCQB: MRZM), today provided the following business update to the stockholders and the investing public from the Company’s Chief Executive Officer, David Barthel:

Key Points: 
  • JUPITER, FL, Oct. 23, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire - Marizyme, Inc. ("Marizyme" or the "Company") (OTCQB: MRZM), today provided the following business update to the stockholders and the investing public from the Company’s Chief Executive Officer, David Barthel:
    “I am very pleased to bring you an update on the Company’s FDA Clearance for DuraGraft™ as well as Marizyme’s business priorities for 2024.
  • Here are our 2024 business priorities:
    DuraGraft™ U.S. commercialization including engagement of hospital integrated networks and utilization with a small direct sales force.
  • "I will continue to provide further updates on our business developments and plans in the months to come.
  • “I want to thank everyone involved in Marizyme for their support and commitment to the Company.

OrthoPediatrics Corp. Launches Pediatric Nailing Platform | Tibia

Retrieved on: 
Thursday, October 19, 2023

WARSAW, Ind., Oct. 19, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, announced today it has released the new Pediatric Nailing Platform TIBIA system and successfully completed the first cases in its limited launch.

Key Points: 
  • WARSAW, Ind., Oct. 19, 2023 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, announced today it has released the new Pediatric Nailing Platform TIBIA system and successfully completed the first cases in its limited launch.
  • Part of the Trauma & Deformity Correction suite of products, PNP Tibia represents another pediatric-focused solution for treating patients with fractures and deformities in the lower extremities.
  • It expands the Company’s offering to 52 unique systems designed specifically to help treat the needs of pediatric patients.
  • The PNP Tibia System features rigid cannulated nails, ranging in diameters from 7mm-12mm, and includes specialized instrumentation to facilitate multiple surgical techniques.

Vaxcyte Announces FDA Clearance of Investigational New Drug Application for VAX-31 for the Prevention of Invasive Pneumococcal Disease in Adults

Retrieved on: 
Thursday, October 19, 2023

SAN CARLOS, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s adult Investigational New Drug (IND) application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD). Vaxcyte expects to initiate the VAX-31 Phase 1/2 clinical study in adults in the fourth quarter of this year and announce topline safety, tolerability and immunogenicity results in the second half of 2024.

Key Points: 
  • -- VAX-31 is a 31-Valent Pneumococcal Conjugate Vaccine Designed to Provide Coverage for Approximately 95% of Disease Currently Circulating in the U.S.
  • Adult Population --
    SAN CARLOS, Calif., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s adult Investigational New Drug (IND) application for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD).
  • Vaxcyte expects to initiate the VAX-31 Phase 1/2 clinical study in adults in the fourth quarter of this year and announce topline safety, tolerability and immunogenicity results in the second half of 2024.
  • This is important given IPD contributes to high-case fatality rates, antibacterial resistance and meningitis, all of which are particularly concerning in the older adult population.”

Altria Group, Inc. Announces Retirement of Director Nabil Y. Sakkab From Board of Directors

Retrieved on: 
Wednesday, October 25, 2023

Nabil Y. Sakkab, a director of Altria Group, Inc. (“Altria”) since 2008, will retire from service on our Board of Directors following the completion of his current term.

Key Points: 
  • Nabil Y. Sakkab, a director of Altria Group, Inc. (“Altria”) since 2008, will retire from service on our Board of Directors following the completion of his current term.
  • Consequently, Mr. Sakkab will not stand for re-election to the Board of Directors at Altria’s 2024 Annual Meeting of Shareholders, which Altria anticipates holding on May 16, 2024.
  • "Nabil's contributions have significantly benefited Altria over the past 15 years," said Kathryn McQuade, Altria’s independent Chair of the Board.
  • "We thank him for his long and distinguished service and wish him the very best upon his retirement."

Evofem Biosciences Announces Preliminary Results for the Third Quarter of 2023

Retrieved on: 
Tuesday, October 24, 2023

SAN DIEGO, Oct. 24, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFMD) ("Evofem") today announced preliminary results for the third quarter of 2023, including sequential growth in net product sales of its hormone-free prescription contraceptive gel, Phexxi® (lactic acid, citric acid and potassium bitartrate) and the positive impact of ongoing cost containment initiatives.

Key Points: 
  • Phexxi net product sales expected to be $5.0 to $5.2 million for the third quarter of 2023.
  • Selling and marketing expenses were more than 75% lower and total operating expenses were more than 65% lower in the third quarter of 2023 than the third quarter of 2022.
  • Reduced loss from operations by more than 80% in the third quarter of 2023 as compared to the third quarter of 2022.
  • The Company expects to report full unaudited results for the three- and nine- months ended September 30, 2023, in mid-November.

Citius Pharmaceuticals Executes Definitive Agreement to Merge Wholly Owned Subsidiary with TenX Keane Acquisition to Form Publicly Listed Citius Oncology, Inc.

Retrieved on: 
Tuesday, October 24, 2023

CRANFORD, N.J. and NEW YORK, Oct. 24, 2023 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company developing and commercializing first-in-class critical care products, and TenX Keane Acquisition ("TenX") (NASDAQ: TENKU), a publicly traded special purpose acquisition company (SPAC), today announced that they have entered into a definitive agreement, dated October 23, 2023, for a proposed merger of TenX and Citius Pharma's wholly owned oncology subsidiary that will continue as a public company listed on the Nasdaq exchange. The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology"). Upon closing, pursuant to the terms of the merger agreement, Citius Pharma would receive 67.5 million shares in Citius Oncology at $10 per share and retain majority ownership of approximately 90%. The transaction has been approved by the Board of Directors of both companies and is expected to close in the first half of 2024. 

Key Points: 
  • The newly combined public company will be named Citius Oncology, Inc. ("Citius Oncology").
  • "We are very pleased to announce the proposed merger with Citius Oncology," said Mr. Xiaofeng Yuan, Chairman and CEO of TenX.
  • Pursuant to the proposed agreement, TenX will acquire Citius Pharma's wholly owned subsidiary via a merger, with the newly combined publicly traded company to be named Citius Oncology, Inc.
  • In the transaction, all shares of Citius Pharma's wholly owned subsidiary would be converted into the right to receive common stock of Citius Oncology.

Milestone Pharmaceuticals Announces Submission of New Drug Application to the U.S. FDA for Etripamil

Retrieved on: 
Tuesday, October 24, 2023

The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.

Key Points: 
  • The primary analysis and supportive assessments from the pivotal RAPID Phase 3 clinical trial were recently published in The Lancet.
  • The FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review.
  • If accepted, Milestone Pharmaceuticals expects a standard review of 10 months of the company's NDA.
  • Milestone continues to advance commercial preparations to support the anticipated launch of etripamil with the proposed trade name, CARDAMYST™.

Intellia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application to Initiate a Pivotal Phase 3 Trial of NTLA-2001 for the Treatment of Transthyretin (ATTR) Amyloidosis with Cardiomyopathy

Retrieved on: 
Wednesday, October 18, 2023

The global Phase 3 study of NTLA-2001, an in vivo CRISPR-based gene editing candidate, is expected to initiate by year-end 2023.

Key Points: 
  • The global Phase 3 study of NTLA-2001, an in vivo CRISPR-based gene editing candidate, is expected to initiate by year-end 2023.
  • “The FDA clearance of the NTLA-2001 IND application allows us to initiate a pivotal Phase 3 trial in the United States, marking the first in vivo CRISPR-based candidate to begin late-stage clinical development.
  • “We are thrilled to further advance NTLA-2001 and our pipeline of investigational gene editing therapies as we embark on a new era in medicine.
  • We look forward to sharing additional information about the Phase 3 study at our upcoming quarterly earnings webcast, being held on Thursday, November 9.”