Inhalable insulin

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.

MannKind Corporation Reports 2023 Third Quarter Financial Results

Retrieved on: 
Tuesday, November 7, 2023

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Nov. 07, 2023 (GLOBE NEWSWIRE) --  MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended September 30, 2023.

Key Points: 
  • V-Go net revenue for the nine months ended September 30, 2023 increased $6.9 million, compared to the same period in 2022.
  • Royalties related to Tyvaso DPI, launched in the late second quarter of 2022 by UT, reached $51.0 million in the nine months ended September 30, 2023 due to an increase in patient demand.
  • R&D expenses for the nine months ended September 30, 2023 were $22.0 million compared to $12.6 million for the same period in 2022.
  • We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

Akston Biosciences Receives 2023 Most Innovative Award at Animal Health Summit

Retrieved on: 
Thursday, August 31, 2023

Akston Biosciences Corporation, which invents, develops and manufactures breakthrough protein therapeutics for Companion Animal Health, received the 2023 Innovation Award at the just-concluded Animal Health Summit in Kansas City , MO.

Key Points: 
  • Akston Biosciences Corporation, which invents, develops and manufactures breakthrough protein therapeutics for Companion Animal Health, received the 2023 Innovation Award at the just-concluded Animal Health Summit in Kansas City , MO.
  • Akston was selected from a highly competitive field of Animal Health companies that participated in the “Emerging Company Presentations,” The Selection Committee stated it was the most qualified group of applicants since the program's inception in 2009.
  • Of the 51 companies that applied, the committee chose 14 companies to present at the Summit and compete for the Innovation Award.
  • “We are honored to receive the 2023 Most Innovative Award,” said Todd Zion, Ph.D., president and CEO of Akston.

Akston Biosciences CEO to Present at the 2023 Animal Health Summit in Kansas City

Retrieved on: 
Monday, August 28, 2023

Akston Biosciences Corporation, which invents, develops and manufactures breakthrough protein therapeutics for Companion Animal Health, announced today that President & CEO Todd Zion, Ph.D., will present at the 2023 Animal Health Summit in Kansas City , MO on August 28, 2023.

Key Points: 
  • Akston Biosciences Corporation, which invents, develops and manufactures breakthrough protein therapeutics for Companion Animal Health, announced today that President & CEO Todd Zion, Ph.D., will present at the 2023 Animal Health Summit in Kansas City , MO on August 28, 2023.
  • Akston’s most advanced candidates are AKS-321d and AKS-425c , groundbreaking once-a-week insulins to treat canine and feline diabetes.
  • Both are licensed to and are being developed in partnership with Dechra Pharmaceuticals, Plc, a global veterinary pharmaceuticals company.
  • “We believe that protein therapeutics are poised to revolutionize Companion Animal Health, just as they did for human health 20 years ago,” said Dr. Zion.

Akston Biosciences to Focus on Strong Animal Health Pipeline

Retrieved on: 
Thursday, August 17, 2023

Akston Biosciences Corporation announced today that it will focus on inventing, developing, and manufacturing breakthrough protein therapeutics for Companion Animal Health, utilizing its versatile Ambifect™ Fc-fusion platform and its Beverly, Massachusetts cGMP biologics manufacturing facility.

Key Points: 
  • Akston Biosciences Corporation announced today that it will focus on inventing, developing, and manufacturing breakthrough protein therapeutics for Companion Animal Health, utilizing its versatile Ambifect™ Fc-fusion platform and its Beverly, Massachusetts cGMP biologics manufacturing facility.
  • Akston is spinning off its infectious disease vaccine and human Type 1 Diabetes prevention lines of business into two wholly-owned subsidiaries: Vakston, Inc. and Diamune Therapeutics, Inc.
    Akston’s most advanced Animal Health candidates, AKS-321d and AKS-425c , are once-a-week insulins designed to treat canine and feline diabetes.
  • Both are licensed to and are being developed in partnership with Dechra Pharmaceuticals, Plc, a global veterinary pharmaceuticals company.
  • “As with human health 20 years ago, protein therapeutics are now poised to revolutionize companion Animal Health,” said Todd Zion, Ph.D., President & CEO of Akston Biosciences.

MannKind Corporation Reports 2023 Second Quarter Financial Results

Retrieved on: 
Monday, August 7, 2023

DANBURY, Conn. and WESTLAKE VILLAGE, Calif., Aug. 07, 2023 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today reported financial results for the quarter ended June 30, 2023.

Key Points: 
  • Royalties related to Tyvaso DPI, launched in the late second quarter of 2022 by UT, reached $30.7 million in the first half of 2023 based on strong patient demand.
  • Commercial product gross margin in the first half of 2023 was 70%, which was consistent with the same period in 2022.
  • R&D expenses for the first half of 2023 were $12.1 million compared to $8.4 million for the same period in 2022.
  • We believe that these non-GAAP financial measures, when considered together with our GAAP financial results, provide management and investors with an additional understanding of our business operating results, including underlying trends.

Arecor: Business Update

Retrieved on: 
Thursday, July 20, 2023

Cambridge, UK, 20 July 2023: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today provides a business update and announces that its interim results for the six months ended 30 June 2023 will be issued in mid-September.

Key Points: 
  • Cambridge, UK, 20 July 2023: Arecor Therapeutics plc (AIM: AREC), the biopharmaceutical group advancing today’s therapies to enable healthier lives, today provides a business update and announces that its interim results for the six months ended 30 June 2023 will be issued in mid-September.
  • Arecor is pleased to report strong progress across the business in the first half of 2023, with advances across its in-house and partnered programmes and continued success in the roll-out of Ogluo® in key territories.
  • Arecor looks forward to providing a full update on performance and outlook at the time of its interim results.
  • Later this year we expect key data for AT278 and anticipate further value inflection points within our licensed product portfolio.

Registration Now Open for American Diabetes Association 2023 Summer Camps

Retrieved on: 
Thursday, May 18, 2023

ARLINGTON, Va., May 18, 2023 /PRNewswire/ -- Registration is open for the American Diabetes Association® (ADA) 2023 summer camp season. The ADA runs 33 camps located in 20 states throughout the summer season, June through August. ADA camps provide a medically safe environment where children with diabetes and their families can partake in a fun-filled summer camp experience while learning how to better manage diabetes. ADA camps also serve as a connecting point for children to develop lifelong friendships that help improve their social skills, self-confidence, and independence.

Key Points: 
  • ARLINGTON, Va., May 18, 2023 /PRNewswire/ -- Registration is open for the American Diabetes Association® (ADA) 2023 summer camp season.
  • ADA camps provide a medically safe environment where children with diabetes and their families can partake in a fun-filled summer camp experience while learning how to better manage diabetes.
  • "ADA camps provide the support families need to understand how to manage and live well with diabetes.
  • Registration is also now open for the ADA 2023 fall camp and family retreat programs in Hawaii, Tennessee, Texas, and Washington.

Mannkind Corporation Reports 2023 First Quarter Financial Results

Retrieved on: 
Wednesday, May 10, 2023

Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022.

Key Points: 
  • Research and development expenses for the first quarter of 2023 were $5.6 million compared to $3.5 million for the same period in 2022.
  • Selling expenses for the first quarter of 2023 were $13.3 million compared to $12.7 million for the same period in 2022.
  • General and administrative expenses for the first quarter of 2023 were $10.5 million compared to $7.9 million for the same period in 2022.
  • Interest expense on financing liability was $2.4 million for the first quarter of 2023 and remained consistent with the same period in 2022.

MannKind Corporation Reports 2022 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Thursday, February 23, 2023

As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.

Key Points: 
  • As of December 31, 2022, $37.9 million of manufacturing revenue associated with Tyvaso DPI remains deferred and will be recognized as commercial product is sold to UT.
  • R&D expenses for 2022 were $19.7 million compared to $12.3 million for the prior year.
  • Selling expenses for 2022 were $53.8 million compared to $45.5 million for the prior year.
  • MannKind will host a conference call and presentation webcast to discuss these results today at 5:00 p.m. Eastern Time.