最新ニュース MannKind (NASDAQ:MNKD) 株価情報

MannKind

MannKind Corp is a biopharmaceutical company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. Its approved product, Afrezza (insulin human) Inhalation Powder, is an ultra-rapid-acting inhaled insulin used to improve glycemic control in adults with diabetes. The product consists of a dry powder formulation of human insulin delivered from a small portable inhaler.

MannKind Corp

The most oversold stocks in the health care sector presents an opportunity to buy into undervalued companies.
The RSI is a momentum indicator, which compares a stock&#8217;s strength on days when prices go up to its strength on days when prices go down. When compared to a stock&#8217;s price action, it can give traders a better sense of how a stock may perform in the short term. An asset is typically considered oversold when the<a href="https://www.benzinga.com/topic/rsi"> RSI is below 30</a>, according to <a href="https://pro.benzinga.com/">Benzinga Pro</a>.
Here's the latest list of major oversold players in this sector, having an RSI near or below 30.
<h3 class="wp-block-heading">MannKind Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>)</h3>
<ul class="wp-block-list">
<li>MannKind will highlight data from recent pediatric and adult studies of inhaled insulin at American Diabetes Association&#8217;s 85th Scientific Sessions. The company's stock fell around 19% over the past month and has a <a href="https://www.benzinga.com/quote/MNKD">52-week low of $3.89</a>.</li>
<li>RSI Value: 29.1</li>
<li>MNKD Price Action: Shares of MannKind fell 10.3% to close at $3.92 on Tuesday.</li>
<li>Edge Stock Ratings: 16.33 Momentum score with Value at 24.26. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/quote/mnkd"><img loading="lazy" decoding="async" width="432" height="162" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065518/image-154.png" alt="" class="wp-image-945947" style="width:317px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065518/image-154.png 432w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065518/image-154-300x113.png 300w" sizes="(max-width: 432px) 100vw, 432px" /></a></figure>
<h3 class="wp-block-heading">SS Innovations International Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SSII#NASDAQ">SSII</a>)&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</h3>
<ul class="wp-block-list">
<li>On May 14, SS Innovations posted a first-quarter loss of 3 cents per share on sales of $5.10 million. Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, said, &#8220;In the first quarter of 2025, we achieved record quarterly revenue of $5.1 million, up 40.8% from $3.6 million in the first quarter of 2024, driven by higher unit sales of our innovative, cutting-edge SSi Mantra 3 surgical robotic system to leading healthcare facilities in India and abroad." The company's stock fell around 59% over the past month and <a href="https://www.benzinga.com/quote/SSII">has a 52-week low</a> of $4.10.</li>
<li>RSI Value: 22.5</li>
<li>SSII Price Action: Shares of SS Innovations International fell 8.3% to close at $4.20 on Tuesday.</li>
<li>Benzinga Pro&#8217;s charting tool helped identify the trend in <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0611">SSII stock</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0611"><img loading="lazy" decoding="async" width="917" height="843" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065629/image-155.png" alt="" class="wp-image-945948" style="width:575px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065629/image-155.png 917w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065629/image-155-300x276.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065629/image-155-768x706.png 768w" sizes="(max-width: 917px) 100vw, 917px" /></a></figure>
<h3 class="wp-block-heading">INVO Fertility Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IVF#NASDAQ">IVF</a>)</h3>
<ul class="wp-block-list">
<li>On May 20, INVO Fertility posted a first-quarter loss of $12.53 per share, versus a year-ago loss of $7.55 per share. &#8220;After announcing the divestiture of a majority stake in NAYA TX, we&#8217;ve sharpened our focus on our core mission as a fertility company, poised to seize opportunities in a dynamic market bolstered by supportive policy shifts of the current administration supporting developments that underscore the importance of fertility care,&#8221; commented Steve Shum, CEO of INVO Fertility. &#8220;This strategic move aligns with the ongoing decline in U.S. fertility rates and growing demand for accessible fertility solutions, reinforcing our commitment to broadening care for patients in need.&#8221; The company's stock fell around 33% over the past month and has a 52-week <a href="https://www.benzinga.com/quote/IVF">low of $1.37</a></li>
<li>RSI Value: 26</li>
<li>IVF Ltd Price Action: Shares of INVO Fertility fell 6% to close at $1.42 on Tuesday.</li>
<li>Benzinga Pro&#8217;s signals feature notified of a potential breakout in <a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0611">IVF shares</a>. </li>
</ul>
<figure class="wp-block-image size-full is-resized"><a href="https://www.benzinga.com/pro/register?utm_adType=bzprocontent&amp;utm_campaign=14daytrial&amp;utm_ad=0611"><img loading="lazy" decoding="async" width="900" height="845" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065728/image-156.png" alt="" class="wp-image-945951" style="width:501px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065728/image-156.png 900w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065728/image-156-300x282.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/11065728/image-156-768x721.png 768w" sizes="(max-width: 900px) 100vw, 900px" /></a></figure>
Learn more about BZ Edge Rankings—click to see scores for other stocks in the sector and s<a href="https://www.benzinga.com/premium/ideas/benzinga-edge-2#:~:text=Turn%20Market%20Chaos,when%20markets%20rebound">ee how they compare.</a>
Read This Next: 
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/trading-ideas/short-ideas/25/06/45858699/top-2-tech-and-telecom-stocks-you-may-want-to-dump-in-q2">Top 2 Tech And Telecom Stocks You May Want To Dump In Q2</a> </li>
</ul>
Photo via Shutterstock

Long Ideas

News

Pre-Market Outlook

Markets

Trading Ideas

MNKD

SSII

Top 3 Health Care Stocks That May Rocket Higher This Quarter

Biotech

Events

General

MannKind to Highlight Data from Recent Pediatric and Adult Studies of Inhaled Insulin At American Diabetes Association's 85th Scientific Sessions

MannKind (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) reported quarterly earnings of $0.07 per share which beat the analyst consensus estimate of $0.04 by 75 percent. This is a 16.67 percent increase over earnings of $0.06 per share from the same period last year. The company reported quarterly sales of $78.35 million which beat the analyst consensus estimate of $76.13 million by 2.92 percent. This is a 18.25 percent increase over sales of $66.26 million the same period last year.

Earnings

Earnings Beats

MannKind Q1 Adj. EPS $0.07 Beats $0.04 Estimate, Sales $78.35M Beat $76.13M Estimate

AAOI

ABCL

ABEV

ACIC

ACIW

ACMR

ACTG

AFRM

AKAM

AKBA

ALGM

ALIT

ALRM

ALXO

Amplify YieldShares Oil Hedged MLP Income ETF

AMLX

AMPX

AMTX

APPN

APYX

AQMS

ARGX

ARHS

ARKO

ARLO

ASPN

ASTH

Adtalem Global Education Inc. Common Stock

ATGE

ATHM

ATUS

AUTL

AVAH

AVPT

AXGN

BAER

BBDC

BIGC

BILL

BIRD

BlackSky Technology Inc. Class A Common Stock

BKSY

BLFS

BLND

CARG

CARS

CBLL

CBUS

CCEC

CCOI

CCRD

CDTX

CION

CLAR

CLFD

CLNE

CLSK

CMPS

CMRE

CODX

COIN

COLD

COLL

COMP

CRNX

CRON

CROX

CRVS

CTEV

CTKB

CTLP

CVRX

DAVE

DCGO

DCTH

DIOD

DKNG

Earnings Scheduled For May 8, 2025

MannKind (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) is preparing to release its quarterly earnings on Thursday, 2025-05-08. Here's a brief overview of what investors should keep in mind before the announcement.
Analysts expect MannKind to report an earnings per share (EPS) of $0.06.
Investors in MannKind are eagerly awaiting the company's announcement, hoping for news of surpassing estimates and positive guidance for the next quarter.
It's worth noting for new investors that stock prices can be heavily influenced by future projections rather than just past performance.
<h3>Historical Earnings Performance</h3>
In the previous earnings release, the company beat EPS by $0.05, leading to a 4.39% drop in the share price the following trading session.
Here's a look at MannKind's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q4 2024</th>
<th>Q3 2024</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>0.03</td>
<td>0.03</td>
<td>0.01</td>
<td>0.03</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>0.08</td>
<td>0.06</td>
<td>0.05</td>
<td>0.05</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-4.0%</td>
<td>-1.0%</td>
<td>4.0%</td>
<td>-2.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2025/1746651700_0.png" alt="eps graph" />
<h3>Tracking MannKind's Stock Performance</h3>
Shares of MannKind were trading at $4.78 as of May 06. Over the last 52-week period, shares are up 12.53%. Given that these returns are generally positive, long-term shareholders are likely bullish going into this earnings release. 
<a href="https://www.benzinga.com/quote/MNKD/earnings">To track all earnings releases for MannKind visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

MannKind's Earnings Outlook

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>B of A Securities analyst Joshua Dennerlein initiated coverage on MSCI Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MSCI#NYSE">MSCI</a>) with a Neutral rating and announced a price target of $585. MSCI shares closed at $549.33 on Wednesday. <a href="https://www.benzinga.com/quote/MSCI/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Mizuho initiated coverage on MannKind Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) with an Outperform rating and announced a price target of $12. MannKind shares closed at $4.69 on Wednesday. <a href="https://www.benzinga.com/quote/MNKD/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Jefferies analyst Kelly Shi initiated coverage on Verastem, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VSTM#NASDAQ">VSTM</a>) with a Buy rating and announced a price target of $15. Verastem shares closed at $5.28 on Wednesday. <a href="https://www.benzinga.com/quote/VSTM/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>JP Morgan analyst Tami Zakaria initiated coverage on Westinghouse Air Brake Technologies Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WAB#NYSE">WAB</a>) with a Neutral rating and announces Price Target of $175. Westinghouse Air Brake shares closed at $175.82 on Wednesday. <a href="https://www.benzinga.com/quote/WAB/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Stifel analyst Annabel Samimy initiated coverage on Ligand Pharmaceuticals Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGND#NASDAQ">LGND</a>) with a Buy rating and announced a price target of $143. Ligand Pharmaceuticals shares closed at $103.85 on Wednesday.  <a href="https://www.benzinga.com/quote/LGND/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying LGND stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="642" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/04/10085936/image-67-1024x642.png" alt="" class="wp-image-865923" style="width:490px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/04/10085936/image-67-1024x642.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/04/10085936/image-67-300x188.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/04/10085936/image-67-768x482.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/04/10085936/image-67.png 1087w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
Read This Next: 
<ul>
<li><a href="https://www.benzinga.com/25/04/44710375/top-2-materials-stocks-that-may-fall-off-a-cliff-this-quarter">Top 2 Materials Stocks That May Fall Off A Cliff This Quarter</a></li>
</ul>
Photo via Shutterstock

Initiation

Analyst Ratings

LGND

MSCI

VSTM

This Ligand Pharmaceuticals Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Thursday

Mizuho initiates coverage on MannKind (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) with a Outperform rating and announces Price Target of $12.

Price Target

Mizuho Initiates Coverage On MannKind with Outperform Rating, Announces Price Target of $12

MannKind Corporation (NASDAQ:<a href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>), a company focused on the development and commercialization of inhaled therapeutic products and delivery devices for patients with endocrine and orphan lung diseases, will showcase data from recent studies of inhaled insulin across five presentations at the 18th International Conference on Advanced Technologies and Treatments for Diabetes to be held March 19-22 in Amsterdam.

MannKind to Present New Inhaled Insulin Data at Global Diabetes Conference in Amsterdam

ACAD

ADTN

ALEC

AMBA

AMBC

AMSF

ARDT

ARIS

ASTE

ATEC

AVDX

AVNS

BATRA

BATRK

BBSI

BLMN

BXSL

BYND

CAPL

CDNA

CERT

CLDT

CLPT

COCO

COMM

CORT

Core Scientific, Inc. - Class A Common Stock

CORZ

CPRX

CRGY

CSAN

CTRI

DHIL

DMRC

DOLE

DORM

EBAY

ECPG

EHTH

ENIC

ENOV

ERII

ESCA

ESTA

EVTC

FTAI

FWRD

GERN

GOGL

GSX Techedu Inc. American Depositary Shares

GOTU

GRBK

HCAT

HNST

IBTA

IMCR

Earnings Scheduled For February 26, 2025

WIIM

MannKind shares are trading higher after Wells Fargo initiated coverage on the stock with an Overweight rating and announced a price target of $9.

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li>Wells Fargo analyst Tiago Fauth initiated coverage on MannKind Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) with an Overweight rating and announced a price target of $9. MannKind shares closed at $6.30 on Thursday. See how other analysts view this stock.</li>
<li>Citigroup analyst Peter Christiansen initiated coverage on S&amp;P Global Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPGI#NYSE">SPGI</a>) with a Buy rating and announced a price target of $600. S&amp;P Global shares closed at $486.56 on Thursday. <a href="https://www.benzinga.com/quote/SPGI/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>JP Morgan analyst Alexander Hess initiated coverage on Fair Isaac Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FICO#NYSE">FICO</a>) with a Neutral rating and announced a price target of $2150. Fair Isaac shares closed at $2,044.89 on Thursday. <a href="https://www.benzinga.com/quote/FICO/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>HC Wainwright &amp; Co. analyst Andrew Fein initiated coverage on Avidity Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RNA#NASDAQ">RNA</a>) with a Buy rating and announced a price target of $72. Avidity Biosciences shares closed at $31.05 on Thursday. See how other analysts view this stock.</li>
<li>Chardan Capital analyst Rudy Li initiated coverage on Prothena Corporation plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRTA#NASDAQ">PRTA</a>) with a Buy rating and announced a price target of $40. Prothena shares closed at $16.01 on Thursday. <a href="https://www.benzinga.com/quote/PRTA/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying SPGI stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="589" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/20095106/image-183-1024x589.png" alt="" class="wp-image-701945" style="width:585px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/20095106/image-183-1024x589.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/20095106/image-183-300x172.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/20095106/image-183-768x441.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/20095106/image-183.png 1117w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
Read This Next: 
<ul>
<li><a href="https://www.benzinga.com/trading-ideas/long-ideas/24/12/42616196/jim-cramer-likes-walmart-recommends-buying-this-very-very-good-financial-stock">Jim Cramer Likes Walmart, Recommends Buying This &#8216;Very, Very Good&#8217; Financial Stock</a></li>
</ul>

FICO

PRTA

SPGI

This S&P Global Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Friday

Wells Fargo analyst Tiago Fauth initiates coverage on MannKind (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) with a Overweight rating and announces Price Target of $9.

Wells Fargo Initiates Coverage On MannKind with Overweight Rating, Announces Price Target of $9

RBC Capital analyst Gregory Renza upgrades MannKind (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) from Sector Perform to Outperform and raises the price target from $7 to $10.

Upgrades

RBC Capital Upgrades MannKind to Outperform, Raises Price Target to $10

MannKind Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) are trading lower Monday. The company released its six-month results from its Phase 3 INHALE-1 pediatric diabetes trial. Here&#8217;s what <a href="https://www.benzinga.com/quote/MNKD/news">you need to know</a>.
What To Know: The trial investigated the use of Afrezza (insulin human) Inhalation Powder in children and adolescents aged 4 to 17 years. Its primary endpoint was a non-inferior change in HbA1c levels after 26 weeks of treatment. 
The results showed that, while Afrezza met the non-inferiority criteria based on a modified intent-to-treat (mITT) analysis, a full intent-to-treat (ITT) analysis did not meet the predetermined non-inferiority margin, largely due to the variability introduced by one non-compliant patient. Despite this, the mITT analysis supported Afrezza&#8217;s non-inferiority to multiple daily injections (MDI) of rapid-acting insulin.
The study also showed no significant differences in lung function between the Afrezza and MDI groups, with both treatment groups maintaining stable FEV1 levels over the 26-week period. No major safety concerns, including hypoglycemia, were noted between the two treatment regimens.
Despite the encouraging efficacy and safety outcomes, the stock&#8217;s decline reflects investor cautiousness, as the company now plans to meet with the U.S. Food and Drug Administration (FDA) in the first half of 2025 regarding a supplemental new drug application (sNDA) for Afrezza's use in pediatric populations. This meeting is crucial for the potential next steps in expanding the treatment&#8217;s approval, which may contribute to further volatility in the stock price depending on the regulatory response.
MNKD Price Action: MannKind shares were down 4.28% at $6.27 at the time of writing, according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro.</a>
<figure class="wp-block-image size-large is-resized"><a href="https://bzresearch.myclickfunnels.com/benzinga-pro-content-webinar-registration/?utm_source=BZprocontent121624&amp;t=be2bearmibe3na1"><img loading="lazy" decoding="async" width="1024" height="545" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/16154357/MNKD-1024x545.png" alt="" class="wp-image-694664" style="width:453px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/16154357/MNKD-1024x545.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/16154357/MNKD-300x160.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/16154357/MNKD-768x408.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/12/16154357/MNKD.png 1256w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
Read Next:
<ul>
<li><a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/12/42516826/nvidia-and-5-other-stocks-are-analysts-top-semiconductor-picks-for-2025-sees-2-ai-trends">Nvidia And 5 Other Stocks Are Analyst&#8217;s Top Semiconductor Picks For 2025, Sees 2 AI Trends</a></li>
</ul>
Image Via Shutterstock.

Movers

MannKind Shares Are falling Today: What's Going On?

Health Care

MannKind Announced Six-month Results From Its Phase 3 Inhale-1 Study Of Afrezza (Insulin Human) Inhalation Powder In Children And Adolescents (Aged 4-17 Years). MannKind Expects To Submit A Request For Supplemental New Drug Application Meeting With FDA In 1H 2025

The CDSCO decision follows existing approvals in the United States and Brazil.

MannKind, Cipla Report CDSCO In India Has Approved Afrezza (Insulin Human) Inhalation Powder In Adults

MannKind (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>) reported quarterly earnings of $0.06 per share which beat the analyst consensus estimate of $0.03 by 100 percent. This is a 200 percent increase over earnings of $0.02 per share from the same period last year. The company reported quarterly sales of $70.079 million which missed the analyst consensus estimate of $74.500 million by 5.93 percent. This is a 36.73 percent increase over sales of $51.253 million the same period last year.

Earnings Misses

MannKind Q3 2024 Adj. EPS $0.06 Beats $0.03 Estimate, Sales $70.079M Miss $74.500M Estimate

MannKind Corporation (NASDAQ:<a href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>), a company focused on the development and commercialization of innovative inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced the successful completion of its first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis (IPF).
"These compelling results support advancing the development of nintedanib DPI for patients living with IPF, a chronic and progressive fibrotic lung disease with limited treatment options," said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation. "We look forward to discussing the Phase 1 trial results and our proposed late-stage development program at an end of phase 1 meeting with the FDA, planned for the first half of 2025."
The key highlights of the study included:
<ul>
<li>Nintedanib DPI was shown to be safe and well tolerated in healthy volunteers with the tested doses and study duration</li>
<li>Participants did not experience typical adverse events seen with oral nintedanib; specifically, no GI or neurologic adverse events (AEs) were reported</li>
<li>Two types of AEs noted - cough and drop in FEV-1
<ul>
<li>These AEs were mild, transient, and fully recovered</li>
<li>These AEs were not dose-dependent and there was no pattern of recurrence or worsening with repeated dosing</li>
<li>No bronchospasm, wheezing, other symptoms, or change in vital signs were reported</li>
</ul>
</li>
<li>No serious adverse events or study drug discontinuation &nbsp;</li>
</ul>
The completed Phase 1 was a single-site, randomized, placebo-controlled, single- (n=24) and multiple-ascending dose (n=16) study in healthy adult (older than 40 years old) participants. The primary objective of the study was to evaluate the safety and tolerability of nintedanib DPI. The secondary study objective was to evaluate the pharmacokinetics (PK) of MNKD-201.

MannKind Completes Phase 1 Trial of Inhaled Therapy for Lung Disease, Results Show Nintedanib DPI Safe and Tolerable

MannKind Corporation (NASDAQ:<a href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>), a company focused on the development and commercialization of inhaled therapeutic products and devices for patients with endocrine and orphan lung diseases, today announced top-level 30-week results from its Phase 4 INHALE-3 study, in which additional patients living with type 1 diabetes achieved target A1c levels during the extension phase. The completer analysis which included all people on inhaled insulin, evaluated two separate groups – one that utilized Afrezza&#xAE; (plus basal insulin) over 30 weeks, and a second group of patients who switched to Afrezza at week 17 from usual care, defined as multiple daily injections (MDI), an automated insulin delivery system, (AID) or a pump without automation.
"The data from the extension phase of this study showed that more people living with T1D are able to reach target A1c levels when they remain on Afrezza (plus basal insulin) or switch to Afrezza from usual care – whether they are using multiple daily injections or pumps," said Michael Castagna, PharmD, Chief Executive Officer for MannKind Corporation. "We believe this data demonstrates to healthcare practitioners that Afrezza is an effective tool for their patients who want to improve their glycemic control."
Key Findings: There was continued improvement in the Afrezza (plus degludec)-treated group, with additional subjects achieving A1c &lt;7% at 30 weeks – a 100% increase from baseline:
&nbsp;<img src="https://ml.globenewswire.com/Resource/Download/31d76640-1047-4108-b133-36b48e91775d/image1.jpg" alt="Afrezza Group Change in HbA1c from Randomization to 30 Weeks" /> &nbsp;&nbsp;
<img src="https://ml.globenewswire.com/Resource/Download/650dc7f2-1e72-487b-9047-d0fdce0a795f/image2.jpg" alt="Afrezza Group Participants Meeting HbA1c Target" /> &nbsp;
Switching from usual care to Afrezza (plus degludec) at week-17 allowed more than double the subjects to achieve A1c &lt;7% at week-30, compared to the number at goal at week-17: &nbsp;
<img src="https://ml.globenewswire.com/Resource/Download/040e275d-bd09-4b8c-abff-4b7d76b32321/image3.jpg" alt="HbA1c Change from 17 Weeks to 30 Weeks in Usual Care-to-Afrezza Subjects" /> &nbsp;
"With the positive data received at both 17- and 30-weeks, we continue to affirm that Afrezza is an important option for adult patients managing their diabetes," said Dr. Kevin Kaiserman, Senior Vice President, Therapeutic Area Head, Endocrine Diseases for MannKind Corporation. "We look forward to discussing more details of the 30-week study results at ATTD next March and additional conferences in 2025."
About the INHALE-3 Study The INHALE-3 study is a 17-week, randomized controlled trial with a 13-week extension conducted across 19 U.S. sites. The study, which enrolled 141 patients (123 randomized), assigned participants over 18 years of age with T1D who are using MDI, an automated insulin delivery system, or a pump without automation to either continue their standard of care or initiate an insulin regimen of a daily basal injection plus Afrezza for boluses (mealtime and corrections). Subjects utilizing Afrezza (inhaled insulin) received a higher initial conversion dose than in the current U.S. product label. Both arms utilized continuous glucose monitoring to assess glucose control.
The randomized control trial (RCT) included an inhaled insulin group that began with 62 subjects at randomization and 57 at 17 weeks; the usual care group consisted of 61subjects at randomization and 58 at 17 weeks. The <a href="https://www.globenewswire.com/Tracker?data=TI60SziG0RhGZNEA5RI2SJ5ByKAZ7RbYuekeJ4VNFdyn2xJj7vBxn3F1-ieEQnO_haT6t32oFEy-0HuRk4_YqF1w6xZ4QG5Vq_qGtjFhAKH-ObJkQ_nROK_nTn749E48SDxVPIHJQZPkq3agscXzSjsIkJuglZTvKZa3fJITomoch34bhIuLQJbRMPJvbU6oq7Efby3cxy80hZr4zXFHiWXh-kDMlt4UXgABv72TMT0DNwhHeq6tMYBhdB2dWGWVGGclGx806ZRo4dt9YWUBB2AZ6kwvPEMjuxGT6xf37DT6upl-k8vHw1S3D5Xx8l6qM1eVl5_t9eDJkz41IDAiTjT7WxneHIUTh1yzQM0IGF6jYv9WW6wWDtHaEfOTPy0f">17-week results</a> previously shared that the study met its primary efficacy endpoint of a non-inferior change in HbA1c between baseline and week 17 compared to the usual care group. At 17 weeks, those who utilized Afrezza (plus basal insulin) continued with it through the extension phase, and those who were on usual care switched over to Afrezza to week 30. The extension phase started with 45 subjects from the inhaled insulin group and 43 completed the extension; the usual care-to-Afrezza group started with 49 in the extension, with 42 completing. There was no control group in the extension phase. A1c levels were obtained at baseline, 17 and 30-weeks.
<img src="https://ml.globenewswire.com/Resource/Download/72bbb5f4-f42f-4a1e-9121-3d4ff8c57790/image4.jpg" alt="Study Design INHALE-3" /> &nbsp;
More information on the INHALE-3 study is available at: <a href="https://www.globenewswire.com/Tracker?data=TRJc0HFwHf9_Kd31JrPug7XoLBMSmDbAWnUCKY-t9n7aMjvxsMn0IfLNAA99yQVgRXIIild8Mlane3Zvviwem0w91-MGoivCHDQTtc7EpuSQSWoanyhL7ZA3TB42YYCfgBJFxSIQB16YFBWsgki96R-DwMXgg29ToMS0uRhrLPd_gESnGiYIB0KOOSj8aGxdgXRWIml6z177svbbki5QOQ==">ClinicalTrials.gov(NCT05904743)</a>.

MannKind's Afrezza Demonstrates A1c Control In Diabetes Patients During MannKind's Phase 4 Trial

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders often look for circumstances when the market estimation of an option diverges away from its normal worth. Abnormal amounts of trading activity could push option prices to hyperbolic or underperforming levels. 
Below are some instances of options activity happening in the Health Care sector: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>PFE</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/17/25</td>
<td>$32.50</td>
<td>$70.5K</td>
<td>38.1K</td>
<td>2.5K</td>
</tr>
<tr>
<td>BMY</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>10/04/24</td>
<td>$51.00</td>
<td>$32.5K</td>
<td>829</td>
<td>797</td>
</tr>
<tr>
<td>BNTX</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>10/18/24</td>
<td>$120.00</td>
<td>$34.5K</td>
<td>1.3K</td>
<td>625</td>
</tr>
<tr>
<td>CI</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>09/27/24</td>
<td>$355.00</td>
<td>$71.7K</td>
<td>16</td>
<td>505</td>
</tr>
<tr>
<td>TGTX</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>01/17/25</td>
<td>$40.00</td>
<td>$137.7K</td>
<td>2</td>
<td>383</td>
</tr>
<tr>
<td>JNJ</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>12/20/24</td>
<td>$175.00</td>
<td>$45.4K</td>
<td>513</td>
<td>382</td>
</tr>
<tr>
<td>BHVN</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>10/18/24</td>
<td>$45.00</td>
<td>$48.4K</td>
<td>74</td>
<td>365</td>
</tr>
<tr>
<td>VKTX</td>
<td>CALL</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>11/15/24</td>
<td>$60.00</td>
<td>$189.7K</td>
<td>4.5K</td>
<td>172</td>
</tr>
<tr>
<td>GMED</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BEARISH</td>
<td>12/20/24</td>
<td>$70.00</td>
<td>$31.6K</td>
<td>7</td>
<td>122</td>
</tr>
<tr>
<td>MNKD</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>11/15/24</td>
<td>$3.50</td>
<td>$30.0K</td>
<td>121</td>
<td>100</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These itemized elaborations have been created using the accompanying table. 
• For PFE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), we notice a call option sweep that happens to be bullish, expiring in 116 day(s) on January 17, 2025. This event was a transfer of 1500 contract(s) at a $32.50 strike. This particular call needed to be split into 47 different trades to become filled. The total cost received by the writing party (or parties) was $70.5K, with a price of $47.0 per contract. There were 38163 open contracts at this strike prior to today, and today 2583 contract(s) were bought and sold. 
• Regarding BMY (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>), we observe a call option sweep with bearish sentiment. It expires in 11 day(s) on October 4, 2024. Parties traded 500 contract(s) at a $51.00 strike. This particular call needed to be split into 24 different trades to become filled. The total cost received by the writing party (or parties) was $32.5K, with a price of $65.0 per contract. There were 829 open contracts at this strike prior to today, and today 797 contract(s) were bought and sold. 
• Regarding BNTX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), we observe a call option sweep with bullish sentiment. It expires in 25 day(s) on October 18, 2024. Parties traded 150 contract(s) at a $120.00 strike. This particular call needed to be split into 19 different trades to become filled. The total cost received by the writing party (or parties) was $34.5K, with a price of $230.0 per contract. There were 1345 open contracts at this strike prior to today, and today 625 contract(s) were bought and sold. 
• Regarding CI (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>), we observe a put option sweep with bullish sentiment. It expires in 4 day(s) on September 27, 2024. Parties traded 239 contract(s) at a $355.00 strike. This particular put needed to be split into 15 different trades to become filled. The total cost received by the writing party (or parties) was $71.7K, with a price of $300.0 per contract. There were 16 open contracts at this strike prior to today, and today 505 contract(s) were bought and sold. 
• For TGTX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TGTX#NASDAQ">TGTX</a>), we notice a put option sweep that happens to be bearish, expiring in 116 day(s) on January 17, 2025. This event was a transfer of 82 contract(s) at a $40.00 strike. This particular put needed to be split into 12 different trades to become filled. The total cost received by the writing party (or parties) was $137.7K, with a price of $1680.0 per contract. There were 2 open contracts at this strike prior to today, and today 383 contract(s) were bought and sold. 
• For JNJ (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), we notice a call option sweep that happens to be bearish, expiring in 88 day(s) on December 20, 2024. This event was a transfer of 329 contract(s) at a $175.00 strike. This particular call needed to be split into 11 different trades to become filled. The total cost received by the writing party (or parties) was $45.4K, with a price of $138.0 per contract. There were 513 open contracts at this strike prior to today, and today 382 contract(s) were bought and sold. 
• For BHVN (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BHVN#NYSE">BHVN</a>), we notice a put option trade that happens to be bearish, expiring in 25 day(s) on October 18, 2024. This event was a transfer of 149 contract(s) at a $45.00 strike. The total cost received by the writing party (or parties) was $48.4K, with a price of $325.0 per contract. There were 74 open contracts at this strike prior to today, and today 365 contract(s) were bought and sold. 
• Regarding VKTX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VKTX#NASDAQ">VKTX</a>), we observe a call option trade with neutral sentiment. It expires in 53 day(s) on November 15, 2024. Parties traded 150 contract(s) at a $60.00 strike. The total cost received by the writing party (or parties) was $189.7K, with a price of $1265.0 per contract. There were 4588 open contracts at this strike prior to today, and today 172 contract(s) were bought and sold. 
• For GMED (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GMED#NYSE">GMED</a>), we notice a put option sweep that happens to be bearish, expiring in 88 day(s) on December 20, 2024. This event was a transfer of 102 contract(s) at a $70.00 strike. This particular put needed to be split into 31 different trades to become filled. The total cost received by the writing party (or parties) was $31.6K, with a price of $310.0 per contract. There were 7 open contracts at this strike prior to today, and today 122 contract(s) were bought and sold. 
• For MNKD (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNKD#NASDAQ">MNKD</a>), we notice a call option sweep that happens to be bullish, expiring in 53 day(s) on November 15, 2024. This event was a transfer of 100 contract(s) at a $3.50 strike. This particular call needed to be split into 5 different trades to become filled. The total cost received by the writing party (or parties) was $30.0K, with a price of $300.0 per contract. There were 121 open contracts at this strike prior to today, and today 100 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more about unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Comments

MannKind

ニュース

最新ニュース MannKind (NASDAQ:MNKD) 株価情報

こんな人も見ています

ニュース

パートナーシップ

ベンジンガ・グローバル