JAK1

Sierra Oncology Announces Submission of New Drug Application for Momelotinib to US Food & Drug Administration

Retrieved on: 
Friday, June 17, 2022

The NDA submission is based on the results from several Phase 2 and Phase 3 studies, including the recently completed MOMENTUM study.

Key Points: 
  • The NDA submission is based on the results from several Phase 2 and Phase 3 studies, including the recently completed MOMENTUM study.
  • As with all new drug applications, the company expects the FDA to respond as to whether this submission is accepted within 60 days.
  • Assuming the submission is accepted and a subsequent approval is granted, commercial launch of momelotinib is anticipated in 2023.
  • Sierra Oncology is a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer.

CTI BioPharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, May 27, 2022

The equity awards were approved on May 27, 2022, in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The equity awards were approved on May 27, 2022, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The employees received options to purchase an aggregate of 94,000 shares of CTI BioPharma common stock.
  • One-fourth of the options will vest on each anniversary of the employee's Grant Date, subject to the employee's continued employment with CTI BioPharma on such vesting dates.
  • VONJO is a trademark of CTI BioPharma Corp.

Dizal Announces New Data from the Phase I/II Study of Golidocitnib in Refractory or Relapsed Peripheral T Cell Lymphoma Selected for Oral Presentation at 2022 EHA Annual Meeting

Retrieved on: 
Friday, May 13, 2022

Patients with PTCL face an extremely high risk of disease relapse even if they achieved tumor remission following 1L conventional therapy.

Key Points: 
  • Patients with PTCL face an extremely high risk of disease relapse even if they achieved tumor remission following 1L conventional therapy.
  • The agent is currently being studied in the global pivotal clinical trial for the treatment of r/r PTCL.
  • Earlier results of this study were first presented on 22 June 2021 during an oral session at the 2021 International Conference on Malignant Lymphoma (ICML) Annual Meeting.
  • "We are thrilled to share the updated results from the phase I/II study of golidocitnib in patients with r/r PTCL at 2022EHA."

CTI BioPharma Announces Presentation at the 2022 American Society of Clinical Oncology Annual Meeting

Retrieved on: 
Tuesday, May 10, 2022

SEATTLE, May 10, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced one poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2021.

Key Points: 
  • SEATTLE, May 10, 2022 /PRNewswire/ -- CTI BioPharma Corp. (Nasdaq: CTIC) today announced one poster presentation from the Company's pacritinib program at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago and virtually, June 3-7, 2021.
  • Pacritinib exhibits inhibitory activity against additional cellular kinases (such as CSF1R and IRAK1), the clinical relevance of which is unknown.
  • CTI is conducting the Phase 3 PACIFICA study of VONJO in patients with myelofibrosis and severe thrombocytopenia as a post-marketing requirement.
  • VONJOTM is a trademark of CTI BioPharma Corp.

Arcutis Announces First Quarter 2022 Financial Results and Provides Business Update

Retrieved on: 
Thursday, May 5, 2022

Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022.

Key Points: 
  • Topline data from each of INTEGUMENT-1 and INTEGUMENT-2, in subjects six years of age or older, are anticipated by the end of 2022.
  • In April 2022, Arcutis announced the completion of enrollment of the sole pivotal Phase 3 trial (ARRECTOR) for the treatment of scalp and body psoriasis, with topline data anticipated late in the third quarter or early in the fourth quarter of 2022.
  • Research and development (R&D) expenses for the quarter ended March31, 2022 were $40.6 million compared to $21.6 million for the corresponding period in 2021.
  • General and administrative (G&A) expenses for the quarter ended March31, 2022 were $22.0 million compared to $14.5 million for the corresponding period in 2021.

CTI BioPharma to Report First Quarter 2022 Financial Results on May 12, 2022

Retrieved on: 
Thursday, April 28, 2022

SEATTLE, April 28, 2022 /PRNewswire/ --CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) today announced that management plans to report its first quarter 2022 financial results on Thursday, May 12, 2022, after the close of the U.S. financial markets.

Key Points: 
  • SEATTLE, April 28, 2022 /PRNewswire/ --CTI BioPharma Corp. (CTI BioPharma) (NASDAQ: CTIC) today announced that management plans to report its first quarter 2022 financial results on Thursday, May 12, 2022, after the close of the U.S. financial markets.
  • Following the announcement, members of the management team will host a conference call and webcast to discuss the results and provide a general corporate update at 4:30 p.m.
  • To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 7291915.
  • A live audio webcast of the event may also be accessed through the "Investors" section of CTI's website at www.ctibiopharma.com .

Advanced Immunological and Clinical Trials for Treating Ovarian Cancer Accelerating

Retrieved on: 
Monday, April 25, 2022

Cancer remains undetected until the mutation spreads to the stomach and pelvis, a very advanced stage of ovarian cancer, which is fatal.

Key Points: 
  • Cancer remains undetected until the mutation spreads to the stomach and pelvis, a very advanced stage of ovarian cancer, which is fatal.
  • A report from Market Data Forecast projected that the size of the global ovarian cancer market is predicted to register a CAGR of 10.1% from 2022 to 2027 and that the increased prevalence of ovarian cancer worldwide are majorly accelerating the growth rate of the global ovarian cancer market.
  • Some of the other important reasons driving the growth of the ovarian cancer market are rising ovarian cancer prevalence, the launch of new medications and therapies, increased healthcare expenditure, and increased government funding.
  • Several ovarian cancer treatments are now in clinical trials and are likely to hit the market in the near future.

Advanced Immunological and Clinical Trials for Treating Ovarian Cancer Accelerating

Retrieved on: 
Monday, April 25, 2022

Cancer remains undetected until the mutation spreads to the stomach and pelvis, a very advanced stage of ovarian cancer, which is fatal.

Key Points: 
  • Cancer remains undetected until the mutation spreads to the stomach and pelvis, a very advanced stage of ovarian cancer, which is fatal.
  • A report from Market Data Forecast projected that the size of the global ovarian cancer market is predicted to register a CAGR of 10.1% from 2022 to 2027 and that the increased prevalence of ovarian cancer worldwide are majorly accelerating the growth rate of the global ovarian cancer market.
  • Some of the other important reasons driving the growth of the ovarian cancer market are rising ovarian cancer prevalence, the launch of new medications and therapies, increased healthcare expenditure, and increased government funding.
  • Several ovarian cancer treatments are now in clinical trials and are likely to hit the market in the near future.

Asana BioSciences Announces Dosing of First Patient in Phase 1 Trial of ASN004, a Novel 5T4-Antibody-Drug-Conjugate

Retrieved on: 
Friday, April 8, 2022

ASN004 incorporates a novel single-chain Fv-Fc antibody linked to a clinically validated Auristatin F hydroxypropylamide cytotoxic payload, and drug to antibody ratio (DAR) of approximately 10-12.

Key Points: 
  • ASN004 incorporates a novel single-chain Fv-Fc antibody linked to a clinically validated Auristatin F hydroxypropylamide cytotoxic payload, and drug to antibody ratio (DAR) of approximately 10-12.
  • In preclinical cancer models, a single dose of ASN004 achieved complete and durable tumor regression leading to tumor-free survivors.
  • Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.
  • In a Phase 1b study in atopic dermatitis patients, topical application of ASN008 showed rapid onset of pruritus relief (NCT03798561).

Arcutis Highlights Growth Opportunities at Investor Day in Advance of 2022 Catalysts

Retrieved on: 
Monday, March 28, 2022

This year will be transformational for Arcutis.

Key Points: 
  • This year will be transformational for Arcutis.
  • An archived replay of the webcast will be available on the Arcutis website following the event.
  • For more information, visit www.arcutis.com or follow Arcutis on LinkedIn and Twitter .
  • We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.