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7 stories mentioning MNKDUpdated 38d ago

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MannKind's Diversified Portfolio Seen Leading to Higher Revenue in H2, Wedbush Says

MannKind's (MNKD) increasingly diversified portfolio is seen bringing in higher revenue in H2, with 2026 being a "year of execution" on the commercial and clinical fronts, Wedbush said in a Thursday note.The company plans to prioritize its Furoscix therapy, with its ReadyFlow autoinjector delivery system priced at around the same level as the on-body infusor but with a 70% higher gross margin, the firm said. MannKind stated that 2026 total net revenue could be nearer to the lower end of guidance of $110 million, but the inventory buying pattern may impact H2 revenue significantly, according to the note.MannKind's partner United Therapeutics (UTHR) expects future demand for ralinepag DPI and Tyvaso DPI to require all of its manufacturing capacity, pointing to strong revenue potential, Wedbush said.Further, MannKind plans to focus on the pediatric market in the near term for Afrezza after the drug's approval from the US Food and Drug Administration in May, the firm said.Wedbush's rating on the company's stock is outperform with a price target of $8.Price: $3.81, Change: $-0.29, Percent Change: -7.07%

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Wire

MannKind Top-Line Data From Phase 1b INFLO-1 Study 'Positive,' Wedbush Says

MannKind's (MNKD) top-line data from the phase 1b INFLO-1 study evaluating nintedanib dry powder inhalation in patients with idiopathic pulmonary fibrosis is "positive," Wedbush said in a Thursday note.The firm said nintedanib data indicated a comparable cough rate and a significantly higher plasma Cmax, and therefore, more efficient delivery to the deep lung, compared to a nebulized formulation.Guidance on the timing for data readout from the second phase of the trial is expected in H2 once there is clarity on the pace of patient enrollment, Wedbush said.The firm said that "positive" INFLO-1 data marks an important forward step for MannKind as it builds a diversified product portfolio with proven technology to target a multi-billion-dollar market opportunity.Wedbush has an outperform rating and an $8 price target on the stock.Shares of the company were up 4% in Thursday trading.Price: $4.01, Change: $+0.16, Percent Change: +4.03%

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Wire

MannKind Says Phase 1b Study Shows Idiopathic Pulmonary Fibrosis Treatment Generally Safe, Well-Tolerated

MannKind's (MNKD) phase 1b study evaluating nintedanib dry powder inhalation in patients with idiopathic pulmonary fibrosis showed that the drug was generally safe and well-tolerated, meeting its primary endpoint, the company said Wednesday.The study, which enrolled 27 patients across 10 US sites and assessed two multiple-ascending dose regimens, showed that 60% reported no cough and 30% reported mild cough, according to a statement.There were no serious adverse events, no drug-related gastrointestinal side effects, and no treatment discontinuations or dose reductions, MannKind said.The company said it is enrolling patients for the phase 2 trial, which is expected to have around 210 participants across 85 sites worldwide and is designed to further evaluate the safety, tolerability, and efficacy of the drug.Price: $3.90, Change: $-0.01, Percent Change: -0.28%

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Wire

MannKind's Furoscix Auto-Injector Approval, Launch Could Provide Strong Upside to 2026 Revenue Expectation, Wedbush Says

MannKind (MNKD) is expected to get FDA approval for the Furoscix ReadyFlow auto injector by July 26 and launch it in August, providing significant upside to its full-year 2026 revenue expectation, Wedbush Securities said in a research note Friday.Management reiterated its 2026 ReadyFlow net revenue guidance of $110 million to $120 million, assuming about 14% of annual dispenses are generated in Q1 and without any significant contribution from ReadyFlow, the firm noted. Given that assumption, the auto-injector approval could provide strong revenue upside and diversify commercial portfolio, the note added.Wedbush expects Furoscix revenue growth to resume in Q2, projecting revenue of $22.5 million versus consensus of $24.7 million. With ReadyFlow's contribution, the brokerage expects revenue growth to further accelerate in the second half.The company's research suggests approximately 65% of healthcare providers expect to increase the use of Furoscix upon ReadyFlow's approval, the brokerage noted.Wedbush kept an outperform rating on MannKind with a price target of $8 per share.Price: $4.05, Change: $+0.16, Percent Change: +4.11%

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Sectors

Sector Update: Healthcare Stocks Flat to Higher Premarket Friday

Healthcare stocks were flat to higher premarket Friday, with the iShares Biotechnology ETF (IBB) inactive and the State Street Health Care Select Sector SPDR ETF (XLV) advancing by 0.3%.Tenet Healthcare (THC) shares were up more than 17% after the company posted higher Q2 adjusted earnings and revenue, and raised its 2026 guidance.MannKind's (MNKD) Furoscix ReadyFlow injection has been approved by the US Food and Drug Administration for the treatment of edema, or fluid overload, in adults with heart failure or chronic kidney disease, the company said. MannKind shares were up more than 2% pre-bell.Sanofi (SNY) stock was down more than 1% after the company said it stopped clinical testing and global regulatory applications for its amlitelimab medication for moderate-to-severe atopic dermatitis.

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Wire

MannKind Agrees to $50 Million Private Stock Sale

MannKind (MNKD) said Friday it agreed to a $50 million private placement with institutional investors led by Frazier Life Sciences.The firm is selling about 10.4 million common shares for $3.89 each and pre-funded warrants to buy up to roughly 2.4 million shares at $3.88 per warrant, the company said.The transaction is expected to close on or about Friday, and the business plans to use the net proceeds for general corporate purposes, including a $45 million contingent value rights payment related to the recent US Food and Drug Administration approval of Furoscix ReadyFlow, MannKind said.Shares of the company were up 6.4% in Friday premarket trading.

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Wire

MannKind Says FDA Approves Afrezza for Children, Adolescents With Diabetes

MannKind (MNKD) said Friday the US Food and Drug Administration approved Afrezza, its inhaled mealtime insulin, for use in children and adolescents aged six and older with type 1 or type 2 diabetes.The approval expands Afrezza's label beyond adults and was supported by results from the phase 3 INHALE-1 study and additional long-term safety and efficacy data, the company said.MannKind said eligible patients can access Afrezza for $35 or less per month through its patient support program.Price: $3.80, Change: $+0.16, Percent Change: +4.40%

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