Welcome to our dedicated page for Mannkind news (Ticker: MNKD), a resource for investors and traders seeking the latest updates and insights on Mannkind stock.
MannKind Corporation (MNKD) specializes in innovative inhaled therapies for diabetes and respiratory diseases, notably through its FDA-approved Afrezza® inhaled insulin. This page aggregates official announcements, clinical trial updates, and strategic partnership news critical for understanding the company's trajectory.
Investors and researchers will find curated press releases covering financial results, regulatory milestones, and technology licensing agreements. The collection emphasizes developments in MannKind's core platforms: the Technosphere® drug delivery system and iSPERSE™ formulation technology.
Content includes updates on pulmonary arterial hypertension treatments, diabetes management solutions, and global expansion initiatives. All materials maintain factual accuracy without speculative analysis, adhering to financial disclosure standards.
Bookmark this page for streamlined access to MNKD's latest business developments and scientific advancements. Verify time-sensitive details directly through company filings or official communications.
MannKind Corporation (Nasdaq: MNKD) presented two posters at the American Diabetes Association's virtual 81st Scientific Sessions from June 25-29, focusing on its inhaled insulin, Afrezza®. Poster 923-P details a Phase 2 clinical study demonstrating the pharmacokinetics and safety of Afrezza in pediatric patients with type 1 diabetes, showing no severe hypoglycemic events. Poster 722-P presents findings from a Levin study indicating that Afrezza helps reduce hyperglycemia in patients with uncontrolled type 2 diabetes, improving daytime time-in-range by 83.5%. MannKind is set to initiate a Phase 3 study in fall 2021.
MannKind Corporation (Nasdaq: MNKD) and United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™. This inhaled treatment addresses pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is set to conclude by October 2021, with no identified review issues thus far. This marks the second FDA review for a product developed using MannKind's Technosphere® technology, following the approved Afrezza®.
MannKind Corporation (Nasdaq: MNKD) announces the FDA's acceptance of the NDA for Tyvaso DPI™, intended for pulmonary arterial hypertension treatment. The priority review is expected to complete by October 2021, with no identified review issues so far. This advancement follows the company's collaboration with United Therapeutics to develop Tyvaso DPI, using MannKind’s Technosphere® technology. Additionally, MannKind is expanding its manufacturing facility in Connecticut, planning to hire over 100 employees to support the pre-launch inventory of Tyvaso DPI.
United Therapeutics Corporation (Nasdaq: UTHR) announced the FDA's acceptance for priority review of the New Drug Application (NDA) for Tyvaso DPI™ to treat pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The review is expected to conclude by October 2021, with no identified review issues so far. Tyvaso DPI is a next-generation dry powder formulation, promising improved administration methods compared to traditional nebulization. The NDA includes data from the BREEZE study, which demonstrated the safety and tolerability of Tyvaso DPI.
MannKind Corporation (Nasdaq: MNKD) has partnered with Thirona Bio, Inc. for the development of FBM5712, a small molecule inhibitor targeting TGF-β for pulmonary fibrosis treatment. MannKind will conduct formulation and preclinical studies on this compound, which has potential applications for various fibrotic diseases. As part of the agreement, MannKind purchased a convertible note to support Thirona's financing. This collaboration aligns with MannKind's goal of launching new products annually from 2025 to 2030, amplifying its pipeline in pulmonary and dermatological conditions.
MannKind Corporation (Nasdaq: MNKD) announced that CEO Michael Castagna will present at the Lytham Partners Summer 2021 Investor Conference on June 14, 2021, at 11:45 AM (ET). Attendees can access the webcast link on the Company's website, where a replay will be available for 14 days post-presentation. MannKind specializes in developing inhaled therapeutic products, including its FDA-approved product, Afrezza®, an inhaled ultra-rapid-acting mealtime insulin, available in the U.S. and Brazil.
MannKind Corporation (Nasdaq: MNKD) announced a poster presentation at the ATTD 2021 conference showcasing a post hoc analysis from the STAT study. This analysis revealed that Afrezza (Technosphere Insulin) significantly reduced nocturnal hypoglycemia in adults with type 1 diabetes, showing a 62% reduction in Level 1 and a 78% reduction in Level 2 hypoglycemia compared to insulin aspart. The study included 60 patients over four weeks and highlighted Afrezza's ultra-rapid action as a potential benefit. Larger studies are needed to validate these results.
MannKind Corporation (Nasdaq: MNKD) partners with IndyCar driver Conor Daly, who is living with Type 1 diabetes (T1D), to engage local youth in a karting event. Scheduled for May 25, 2021, in Indianapolis, Daly will share his diabetes journey and offer karting tips. As the only professional U.S. racer with T1D, Daly aims to inspire others by proving that diabetes does not limit potential. The event will include a go-kart race to identify the fastest racers among the youth participants.
MannKind Corporation (Nasdaq: MNKD) announced a partnership with NTT INDYCAR SERIES driver Conor Daly, who is living with Type 1 diabetes, as part of its 2021 season sponsorship. Daly will debut the No. 20 MannKind Chevrolet at the GMR Grand Prix on May 15 at Indianapolis Motor Speedway. The car features a distinctive 'Tired of Pricks?' tagline, promoting innovative diabetes management. MannKind aims to raise awareness of diabetes, emphasizing that living with the condition shouldn't hinder pursuing dreams. This partnership underscores MannKind's commitment to finding new health management options.
MannKind Corporation (NASDAQ:MNKD) reported a 7% revenue increase to $17.4 million for Q1 2021, driven by Afrezza’s net revenue of $8.1 million and collaboration services revenue of $9.3 million. The company raised $230 million through senior convertible notes, significantly enhancing its financial position, with cash and equivalents at $278.3 million. While gross profit remained steady at $3.8 million, R&D and SG&A expenses rose by 39% and 21%, respectively. The net loss increased to $12.9 million, or $0.05 per share, partly due to higher interest expenses.
