$3.040
-0.143 (-4.70%)Al cierre
Noticias de MNKD
Eventos de MNKD
Liquidia Updates on Litigation with United Therapeutics
Liquidia (LQDA) issued an update regarding the litigation filed by United Therapeutics (UTHR) in the U.S. District Court for the District of Delaware under the Hatch-Waxman Act concerning U.S. Patent No. 11,826,327 and the company's lead product, Yutrepia inhalation powder. The company stated: "Today, the Court ruled that claims 1 and 14 of the '327 patent, which generally cover the treatment of pulmonary hypertension with interstitial lung disease patients with inhaled treprostinil, including dry powder formulations of inhaled treprostinil, are valid and infringed by Liquidia. The remaining claims of the '327 patent that were asserted against Liquidia were found to be invalid. The parties have been directed to submit to the Court a form of judgment, which will specify the parties' proposed remedies for infringing such claims, within one week." Roger Jeffs, Chief Executive Officer of Liquidia, said: "We respectfully disagree with the Court's decision regarding claims 1 and 14 and are fully prepared to pursue all available appellate options. As previously communicated to the Court, we intend to submit a supplement to Yutrepia's New Drug Application to the FDA to remove PH-ILD from the label. Our commitment to patients remains unwavering." The company added: "Given the number of variables, including potential appeals and further proceedings, it is not possible at this time to reasonably estimate the range of potential outcomes or financial exposure. While the exact remedy to be awarded by the District Court remains uncertain, potential remedies could range from the removal of the indication to treat pulmonary hypertension associated with interstitial lung disease from Yutrepia's label to a broader restriction on product availability. In post-trial briefs, UTHR has asked the Court for injunctive relief that would restrict Yutrepia's availability on the market."
Liquidia's Yutrepia Faces Patent Infringement Ruling
Liquidia's (LQDA) Yutrepia faces a Delaware court finding of infringement of United Therapeutics' (UTHR) '327 patent, pressuring Liquidia shares but providing a positive read-through for MannKind's (MNKD) Tyvaso DPI royalties and United Therapeutics-linked services, Truist tells investors in a research note. The firm, which has a Buy rating and $6 price target on MannKind shares, continues to view MannKind as a back-half-weighted diversification story with 2027 tailwind potential,
MannKind and Rose Pharma Enter Worldwide Licensing Agreement for ROSE-010
MannKind and Rose Pharma announced that they have entered into a worldwide licensing and collaboration agreement to develop ROSE-010 Technosphere for weight management. ROSE-010 is an investigational, rapid-acting glucagon-like peptide-1, or GLP-1, receptor agonist that will be formulated using MannKind's proprietary Technosphere dry-powder inhalation technology. The companies intend to evaluate whether a rapid-acting, short-duration inhaled GLP-1 may offer a flexible approach to weight management. Under the agreement, Rose Pharma received an exclusive, worldwide license to use MannKind's Technosphere technology to develop and commercialize ROSE-010 Technosphere. MannKind will support formulation development and advancement of the program through pharmaceutical development services to completion of Phase 1b in weight management. As part of the transaction, MannKind will receive an equity interest in Rose Pharma and the right to receive royalties on potential future net sales of ROSE-010 Technosphere. The agreement also provides MannKind with representation on Rose Pharma's board of directors to support continued strategic alignment as the program advances. Rose Pharma will retain responsibility for the program's clinical development, regulatory strategy and commercialization. Specific financial terms of the agreement were not disclosed.
MannKind Announces Positive Results from INFLO-1 Study
MannKind announced positive topline results from INFLO-1, its Phase 1b randomized, double-blind, placebo-controlled study evaluating nintedanib dry powder inhalation in patients with idiopathic pulmonary fibrosis. The study met its primary objective, demonstrating that nintedanib DPI was generally safe and well tolerated in patients with IPF. The Phase 1b study enrolled 27 patients across 10 U.S. sites and evaluated two multiple-ascending dose regimens of nintedanib DPI administered over seven days. Key findings from the study included: No serious adverse events; No drug-related gastrointestinal side effects (i.e., diarrhea, nausea, vomiting); No bronchospasm events; No treatment discontinuations or dose reductions; No differences in spirometry parameters between nintedanib DPI and placebo (empty cartridges); Most patients experienced no cough; reported cough events were predominantly mild, transient and resolved. Additional data will be presented at a future conference.
MannKind Completes $50M Private Placement Financing
MannKind announced that it has entered into a securities purchase agreement in connection with a private placement to certain institutional investors. The gross proceeds from the private placement financing are expected to be approximately $50M. The closing of the financing is expected to occur on or about July 24, subject to the satisfaction of customary closing conditions.The private placement was led by Frazier Life Sciences, a longstanding biotech investment firm. Pursuant to the terms of the securities purchase agreement, MannKind is selling an aggregate of 10,440,838 shares of its common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase up to an aggregate of 2,412,632 shares of its common stock, at a purchase price of $3.89 per share and $3.88 per pre-funded warrant. The pre-funded warrants will have an exercise price of $0.01 per share and will be exercisable at any time after original issuance, subject to certain beneficial ownership limitations, and will not expire until exercised in full.
Esta página es solo para investigación y no constituye asesoramiento de inversión. Los modelos pueden equivocarse. El rendimiento pasado no garantiza resultados futuros.