WESTLAKE VILLAGE

Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, April 5, 2024

WESTLAKE VILLAGE, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 58,500 restricted stock units of Arcutis’ common stock to four newly hired employees.

Key Points: 
  • WESTLAKE VILLAGE, Calif., April 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 58,500 restricted stock units of Arcutis’ common stock to four newly hired employees.
  • These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of April 1, 2024, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The restricted stock units vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to the employee being continuously employed by Arcutis as of such vesting dates.

MannKind Repays Certain Debt Obligations

Retrieved on: 
Wednesday, April 3, 2024

On April 1, 2024, MannKind made a payment to the lenders under the Loan Agreement of approximately $31.6 million, including a contractually obligated exit fee of $2.8 million and a prepayment fee of approximately $0.3 million, in full satisfaction of all of the Company’s debt obligations under the Loan Agreement, which would have matured on August 1, 2025.

Key Points: 
  • On April 1, 2024, MannKind made a payment to the lenders under the Loan Agreement of approximately $31.6 million, including a contractually obligated exit fee of $2.8 million and a prepayment fee of approximately $0.3 million, in full satisfaction of all of the Company’s debt obligations under the Loan Agreement, which would have matured on August 1, 2025.
  • In connection with the repayment of outstanding indebtedness by MannKind, all liens, mortgages and security interests in any assets or property securing the obligations under the Loan Agreement were automatically terminated and released and MannKind and its subsidiaries were automatically released from all guarantees.
  • Upon receipt of this consideration, all indebtedness under the Note was satisfied in full and all obligations under the Note were automatically terminated.
  • “Repaying the MidCap loan agreement eliminates our most expensive debt going forward and releases our assets from their security interests,” said Michael Castagna, PharmD, Chief Executive Officer of MannKind Corporation.

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

Retrieved on: 
Monday, April 1, 2024

WESTLAKE VILLAGE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2023 financial results and business updates.

Key Points: 
  • – $23.2 million in cash, cash equivalents and short-term investments –
    WESTLAKE VILLAGE, Calif., April 01, 2024 (GLOBE NEWSWIRE) -- Genelux Corporation (NASDAQ: GNLX), a late clinical-stage immuno-oncology company, reported fourth quarter and full year 2023 financial results and business updates.
  • Currently, 21 sites have been activated to enroll patients with additional sites identified and in various stages of activation ( NCT05281471 ).
  • Genelux and our partner Newsoara co-sponsor the trial, which is being conducted by Newsoara in greater China.
  • Cash, cash equivalents and short-term investments were $23.2 million as of December 31, 2023 compared to $0.4 million on December 31, 2022.

Arcutis to Present at the 23rd Annual Needham Virtual Healthcare Conference

Retrieved on: 
Thursday, March 28, 2024

WESTLAKE VILLAGE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in the 23rd Annual Needham Virtual Healthcare Conference, taking place April 8-11, 2024.

Key Points: 
  • WESTLAKE VILLAGE, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that Arcutis management will participate in the 23rd Annual Needham Virtual Healthcare Conference, taking place April 8-11, 2024.
  • Details for the company’s participation are as follows:
    The webcast for this conference may be accessed at the “ Events ” section of the Company’s website.
  • A replay of the webcast will be available on the Arcutis website for 180 days following the conference.

MannKind Announces CFO Transition

Retrieved on: 
Tuesday, March 26, 2024

Mr. Binder plans to remain at MannKind through the end of the year as Executive Vice President, Special Projects.

Key Points: 
  • Mr. Binder plans to remain at MannKind through the end of the year as Executive Vice President, Special Projects.
  • “We are excited to have Chris join us at such a pivotal time as our new CFO,” said Michael Castagna, PharmD., Chief Executive Officer for MannKind Corporation.
  • We are pleased that Steve will remain with MannKind for the rest of 2024, allowing for an optimal transition with Chris.”
    “I look forward to working with Chris and remain totally committed to MannKind’s continued success,” said Steve Binder, Chief Financial Officer.
  • His earlier career also included senior financial roles at InterMune, Inc., Dynavax Technologies Corporation and MannKind.

Arcutis Promotes Todd Tucker to Chief Human Resources Officer

Retrieved on: 
Monday, March 11, 2024

WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the promotion of Todd Tucker to senior vice president and Chief Human Resources Officer (CHRO), effective immediately.

Key Points: 
  • WESTLAKE VILLAGE, Calif., March 11, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage company focused on developing meaningful innovations in immuno-dermatology, today announced the promotion of Todd Tucker to senior vice president and Chief Human Resources Officer (CHRO), effective immediately.
  • Mr. Tucker joined Arcutis in July 2020 as executive director and head of human resources and was promoted to vice president of human resources in March 2022.
  • Prior to joining Arcutis, he held leadership roles in human resources and employee management at multiple pharmaceutical companies including Atara Biotherapeutics, Sienna Biopharmaceuticals, and Kythera.
  • Prior, he functioned as senior director and head of human resources at Sienna Biotherapeutics, where he established and led the human resources function as the company transitioned from a private to a publicly traded company.

INHALE-3 Study’s Initial Meal Challenge Results Comparing Afrezza® Head-To-Head With Multiple Daily Injections (MDI) and Insulin Pumps

Retrieved on: 
Monday, March 11, 2024

INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.

Key Points: 
  • INHALE-3 is a Phase 4 U.S. clinical trial evaluating inhaled insulin (plus basal) vs. standard of care.
  • “In this large, randomized trial utilizing more appropriate dose conversion, we are excited to see meal challenge results support the safety and efficacy of inhaled insulin from the start.”
    INHALE-3 is a 17-week randomized controlled trial with a 13-week extension.
  • Subjects utilizing inhaled insulin received a higher initial conversion dose than in the current label.
  • For the meal challenge, the inhaled insulin group took an inhaled insulin dose immediately prior to a standardized meal (a 240 calorie nutritional shake) whereas those using usual care used RAA 5-15 minutes prior to the meal.

Arcutis Presents Late-Breaking Data From INTEGUMENT-PED Phase 3 Trial of Roflumilast Cream 0.05% in Atopic Dermatitis in Children Ages 2 to 5 at the American Academy of Dermatology Annual Meeting

Retrieved on: 
Sunday, March 10, 2024

In the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P

Key Points: 
  • In the study, 39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in EASI (EASI-75) at Week 4 compared to 20.6% treated with vehicle (P
  • “For the pediatric patient population, tradeoffs between efficacy, tolerability, and safety are critical aspects of atopic dermatitis treatment decisions.
  • The data reinforces the well-established efficacy, safety, and tolerability profile of roflumilast cream in atopic dermatitis across the INTEGUMENT program.
  • “Roflumilast cream 0.05% was also shown to be well-tolerated in young children as demonstrated by both investigator and patient-reported outcomes.

New Research Reveals Genomic Profile of Seborrheic Dermatitis and Answers Key Questions on Immune Response and Skin Barrier Dysfunction

Retrieved on: 
Saturday, March 9, 2024

“We are excited to have successfully employed noninvasive tape-stripping techniques developed from studying these diseases to study an understudied and undertreated inflammatory skin disease, seborrheic dermatitis.

Key Points: 
  • “We are excited to have successfully employed noninvasive tape-stripping techniques developed from studying these diseases to study an understudied and undertreated inflammatory skin disease, seborrheic dermatitis.
  • These findings will help establish the groundwork for greater understanding of this very common condition.”
    “The pathophysiology of seborrheic dermatitis has been poorly understood.
  • In addition, the skin barrier disruption observed in seborrheic dermatitis has unique molecular underpinnings, primarily in the tight junction of the epithelial skin cells and lipid metabolism pathways.
  • These data demonstrate that seborrheic dermatitis is an immune disease with a uniquely polarized profile distinct from atopic dermatitis and plaque psoriasis.

Arcutis Biotherapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Tuesday, March 5, 2024

WESTLAKE VILLAGE, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 12,000 restricted stock units of Arcutis’ common stock to two newly hired employees.

Key Points: 
  • WESTLAKE VILLAGE, Calif., March 05, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported the grant of an aggregate of 12,000 restricted stock units of Arcutis’ common stock to two newly hired employees.
  • These awards were approved by the Compensation Committee of Arcutis’ Board of Directors and granted under the Arcutis Biotherapeutics, Inc. 2022 Inducement Plan, with a grant date of March 4, 2024, as an inducement material to the new employees entering into employment with Arcutis, in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The restricted stock units vest over four years, with 25 percent vesting on each annual anniversary of the vesting commencement date, subject to the employee being continuously employed by Arcutis as of such vesting dates.