Pharmaceuticals
Search documents
U.S. Food and Drug Administration (FDA) Accepts Teva's New Drug Application (NDA) for Olanzapine Extended-Release Injectable Suspension (TEV-'749) for the Once-Monthly Treatment of Schizophrenia in Adults
Globenewswire· 2026-02-20 19:43
Olanzapine long-acting injectable (LAI) suspension (TEV-'749) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation1If approved, TEV-'749 could help address a significant unmet need in available schizophrenia treatment options by addressing the lack of viable long-acting olanzapine formulations1Teva is committed to advancing this innovative treatment option and further building on its differentiated LAI franchise and scientific leadership in complex neurological c ...
Deadline Alert: Inovio Pharmaceuticals, Inc. (INO) Shareholders Who Lost Money Urged To Contact Glancy Prongay Wolke & Rotter LLP About Securities Fraud Lawsuit
Businesswire· 2026-02-20 18:41
Core Viewpoint - Inovio Pharmaceuticals, Inc. is facing a class action lawsuit due to alleged securities fraud, with a deadline for shareholders to file a lead plaintiff motion by April 7, 2026. The lawsuit claims that the company made misleading statements regarding its product development and regulatory prospects, leading to significant stock price declines [1]. Summary by Relevant Sections Company Performance - Inovio's stock price fell by $0.27 (3.1%) to close at $8.44 per share on August 9, 2024, following the announcement of a delay in submitting the Biologics License Application (BLA) for INO-3107 due to manufacturing issues [1]. - On December 29, 2025, the stock price dropped by $0.56 (24.45%) to close at $1.73 per share after the FDA accepted the INO-3107 BLA on a standard review timeline instead of the anticipated accelerated review [1]. Legal Proceedings - The class action lawsuit alleges that Inovio's management made materially false and misleading statements and failed to disclose adverse facts about the company's operations and prospects during the class period from October 10, 2023, to December 26, 2025 [1]. - Specific allegations include deficiencies in the manufacturing of Inovio's CELLECTRA device, the unlikelihood of timely BLA submission, and overstated regulatory and commercial prospects for INO-3107 [1]. Investor Actions - Shareholders who suffered losses during the class period are encouraged to contact Glancy Prongay Wolke & Rotter LLP to potentially pursue claims under federal securities laws [1].
Forget Ozempic: This High‑Flying Device Maker Can Thrive No Matter Which Weight Loss Drug Wins
Yahoo Finance· 2026-02-20 18:35
Drugmakers Novo Nordisk and Eli Lilly are battling it out in the GLP-1 weight loss market. The pill version of Novo Nordisk's Ozempic has reignited competition between theses two fierce rivals. Meanwhile, another major presence in the medical world -- device maker Intuitive Surgical (NASDAQ: ISRG) -- continues to chug along. And it looks set to do so regardless of which drug company wins the GLP-1 race. Where to invest $1,000 right now? Our analyst team just revealed what they believe are the 10 best sto ...
RARE Investor Alert: Kessler Topaz Meltzer & Check, LLP Encourages RARE Investors with Losses to Contact the Firm
Globenewswire· 2026-02-20 18:21
Did you buy RARE common stock between August 3, 2023, and December 26, 2025? Affected Ultragenyx Pharmaceutical Inc. Investor Summary Who: Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)What: Securities fraud class action lawsuit filedClass Period: August 3, 2023, through December 26, 2025Deadline to seek lead plaintiff status: April 6, 2026Key Lawsuit Allegations: Material misstatements and/or omissions concerning the company’s drug, setrusumabInvestor action: Contact Kessler Topaz Meltzer & Check, LLP (www. ...
ROSEN, A HIGHLY RECOGNIZED LAW FIRM, Encourages Inovio Pharmaceuticals Inc. Investors to Secure Counsel Before Important Deadline in Securities Class Action - INO
TMX Newsfile· 2026-02-20 18:12
Core Viewpoint - Rosen Law Firm is reminding investors who purchased Inovio Pharmaceuticals, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline for a class action lawsuit [1]. Group 1: Class Action Details - Investors who bought Inovio securities between October 10, 2023, and December 26, 2025, may be eligible for compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by April 7, 2026 [3]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. Group 2: Law Firm Credentials - Rosen Law Firm specializes in securities class actions and has a strong track record, including the largest securities class action settlement against a Chinese company [4]. - The firm has been ranked highly for its number of securities class action settlements, recovering hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4]. Group 3: Case Allegations - The lawsuit alleges that Inovio made false and misleading statements regarding the manufacturing of its CELLECTRA device and the likelihood of submitting the INO-3107 Biologics License Application to the FDA by the second half of 2024 [5]. - It is claimed that Inovio lacked sufficient information to justify the INO-3107 BLA's eligibility for FDA accelerated approval, leading to overstated regulatory and commercial prospects [5]. - The lawsuit asserts that these misrepresentations caused investors to suffer damages when the true information became public [5].
Merck vs. Bristol Myers: Which Pharma Stock Is a Better Pick in 2026?
ZACKS· 2026-02-20 18:06
Core Insights - Merck & Co. (MRK) and Bristol Myers Squibb (BMY) are significant players in the pharmaceutical industry with diverse product portfolios [1][2] - Merck is recognized for its leadership in oncology, while Bristol Myers focuses on breakthrough therapies across multiple therapeutic areas [1][2] Merck (MRK) Overview - Merck has over six blockbuster drugs, with Keytruda accounting for 54% of total sales in 2025, driving revenue growth [3][4] - Keytruda's sales increased by approximately 7% in 2025, benefiting from its approval for various oncology indications [4] - The FDA approved Keytruda Qlex for subcutaneous administration in September 2025, with peak sales targeted at $35 billion by 2028 [5] - Other oncology drugs like Welireg, Lynparza, and Lenvima are contributing to growth, alongside a strong launch of Winrevair in pulmonary arterial hypertension [6] - Merck is enhancing its vaccine portfolio, particularly with the new 21-valent pneumococcal conjugate vaccine, Capvaxive [7] - The company has around 80 ongoing late-stage studies, expecting over $70 billion in potential commercial opportunities by the mid-2030s [8] Bristol Myers Squibb (BMY) Overview - BMY's growth portfolio includes key brands such as Opdivo, Yervoy, and Reblozyl, with a strong oncology focus [12] - Opdivo's consistent label expansion has maintained its momentum, and the approval of Opdivo Qvantig has strengthened its franchise [13] - BMY's Reblozyl sales exceed $2 billion annually, and strong performance in cardiovascular drug Camzyos has boosted revenues [14] - However, legacy drugs face significant generic competition, with expected sales declines of 12-16% in 2026 [15] - BMY is pursuing strategic acquisitions and collaborations, including a recent agreement with BioNTech to co-develop a bispecific antibody [16][17] - The company aims for $2 billion in annualized cost savings by the end of 2027, having achieved approximately $1 billion in savings in 2025 [18] Financial Performance and Valuation - MRK's 2026 sales are estimated to increase by 2.59%, but EPS is expected to decline by 38.75% [20] - BMY's 2026 sales are projected to decrease by 2.32%, while EPS is expected to increase by 0.33% [20] - MRK shares trade at 21X forward earnings, while BMY trades at 9.74X, with the industry average at 18.74X [24] - BMY offers a higher dividend yield of 4.22% compared to MRK's 2.79% [25] Investment Outlook - BMY is currently viewed as a stronger near-term investment option compared to MRK, which faces multiple headwinds [9][30] - BMY's strategic initiatives and new drug approvals position it favorably against MRK's challenges, including declining sales of Gardasil and competitive pressures on Keytruda [27][30]
Teva Pharmaceutical Industries (TEVA) Upgraded to Buy: Here's What You Should Know
ZACKS· 2026-02-20 18:01
Core Viewpoint - Teva Pharmaceutical Industries Ltd. has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [4]. Company Performance and Outlook - The upgrade for Teva implies an improvement in the company's underlying business, suggesting that investors may respond positively by driving the stock price higher [5]. - Teva is expected to earn $2.72 per share for the fiscal year ending December 2026, with a 1.3% increase in the Zacks Consensus Estimate over the past three months [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have averaged a +25% annual return since 1988 [7]. - Teva's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].
Why Is Johnson & Johnson (JNJ) Up 13% Since Last Earnings Report?
ZACKS· 2026-02-20 17:30
A month has gone by since the last earnings report for Johnson & Johnson (JNJ) . Shares have added about 13% in that time frame, outperforming the S&P 500.But investors have to be wondering, will the recent positive trend continue leading up to its next earnings release, or is Johnson & Johnson due for a pullback? Well, first let's take a quick look at the most recent earnings report in order to get a better handle on the recent catalysts for Johnson & Johnson before we dive into how investors and analysts ...
Ironwood vs. Bausch Health: Which GI Drug Stock is a Better Pick Now?
ZACKS· 2026-02-20 17:01
Core Viewpoint - Ironwood Pharmaceuticals (IRWD) and Bausch Health (BHC) are both active in the branded gastrointestinal (GI) drug market, focusing on treatments for irritable bowel syndrome (IBS) and other therapeutic areas. Ironwood is a smaller, focused company centered around its key GI drug, while Bausch Health is a larger, diversified drugmaker with a broader product range [1][2]. Group 1: Ironwood Pharmaceuticals (IRWD) - Ironwood's primary product, Linzess (linaclotide), is approved for treating IBS with constipation (IBS-C) and functional constipation, marketed in collaboration with AbbVie (ABBV) [3][4]. - In the first nine months of 2025, Ironwood's share of net profit from Linzess sales in the U.S. was $244.1 million, with sales increasing due to strong demand [5]. - Ironwood anticipates total revenues of $450-$475 million in 2026, representing a 54% year-over-year increase at the midpoint [6]. - The company is developing apraglutide, a next-generation GLP-2 analog for short bowel syndrome with intestinal failure, with a confirmatory study expected to start in the first half of 2026 [7]. - Despite the positive outlook for Linzess and apraglutide, Ironwood's heavy reliance on a single product raises concerns [8]. Group 2: Bausch Health (BHC) - Bausch Health operates across multiple therapeutic areas, with its eye health business under Bausch + Lomb Corporation, and reported fourth-quarter 2025 results that missed earnings estimates but exceeded revenue expectations [9]. - The Salix business segment, which includes GI products, is a significant revenue contributor, with Xifaxan being the top revenue generator [11]. - Bausch Health expects 2026 revenues to be between $10.625 billion and $10.875 billion, with $5.375 billion to $5.475 billion coming from Bausch + Lomb [10][14]. - The company faced a setback with the failure of the RED-C clinical program, which did not meet its primary endpoint [15]. - Bausch Health's high levels of debt and generic competition in the market are ongoing concerns [16]. Group 3: Comparative Analysis - The Zacks Consensus Estimate for Ironwood's 2026 sales suggests a year-over-year increase of approximately 50.5%, while Bausch Health's estimate indicates a 4.2% increase [17][19]. - In the past six months, Ironwood's shares have surged by 291.5%, contrasting with a 21% decline in Bausch Health's shares [22]. - Ironwood's shares trade at a price-to-sales (P/S) ratio of 2.42, significantly higher than Bausch Health's 0.22, indicating a more expensive valuation for Ironwood [23]. - Ironwood is rated as a Zacks Rank 1 (Strong Buy), while Bausch Health holds a Zacks Rank 3 (Hold), suggesting a more favorable investment outlook for Ironwood [26]. - Despite Bausch Health's diversified operations, Ironwood's growth momentum and potential for long-term profitability position it as the better investment choice [28].
Elite Pharmaceuticals Stock Dips Post Q3 Earnings Despite Revenue Jump
ZACKS· 2026-02-20 17:01
Core Insights - Elite Pharmaceuticals, Inc. (ELTP) has experienced a significant decline in stock price, losing 10.7% since its earnings report for the quarter ended December 31, 2025, compared to a 0.2% gain in the S&P 500 Index during the same period [1] Financial Performance - For Q3 fiscal 2026, Elite Pharmaceuticals reported total revenues of $31.6 million, a 119.9% increase from $14.4 million in the same quarter last year [2] - Manufacturing fees rose by 128.4% to $31.4 million from $13.7 million, while licensing fees fell by 67.2% to $0.2 million from $0.6 million [2] - Gross profit increased by 111.7% year over year to $12.9 million from $6.1 million, with a gross margin of 41%, slightly down from 43% in the prior-year period [2] Operating Expenses and Income - Operating expenses decreased by 21.5% year over year to $3.9 million from $5 million, attributed to lower research and development and general administrative costs [3] - Income from operations surged to $9 million from $1.1 million in the prior-year quarter, while net income reached $18.6 million compared to a net loss of $10.9 million a year earlier [3] - On a per-share basis, ELTP earned $0.01 against a loss of $0.01 in the prior-year quarter [3] Business Segments - Elite Pharmaceuticals operates in a single reportable segment focused on ANDA (generic) products, generating operating income of $11.9 million in the quarter, up from $4.3 million a year earlier [4] Year-to-Date Performance - For the first nine months of fiscal 2026, revenue totaled $108.1 million, up from $52 million in the comparable period last year [5] - Gross profit for the nine-month period rose to $54.3 million from $22.8 million, and income from operations increased to $38.9 million from $8.4 million [5] - Operating cash flow improved significantly to $14.6 million for the nine months ended December 31, 2025, from $3.5 million in the prior-year period [5] Balance Sheet Strength - The balance sheet strengthened, with cash rising to $21.1 million as of December 31, 2025, from $11.3 million as of March 31, 2025 [6] - Working capital improved to $83.6 million as of December 31, 2025, from $45.9 million as of March 31, 2025 [6] Management Commentary - Management attributed revenue and profit growth to strong sales of recently launched Elite-label generics and broader product portfolio expansion [7] - The company has transitioned into a larger-scale generic supplier, with increased market penetration and customer reach as key drivers of improved financial performance [7] Margin Insights - Management noted that the gross margin dip compared to the year-ago quarter was due to a higher proportion of indirect sales through wholesalers, which typically carry lower margins [8] - Certain one-time costs related to new product introductions did not recur in the December period, impacting earlier quarters [8] Research and Development - Research and development expenses declined by 41.9% year over year to $1 million in the quarter from $1.8 million, reflecting a shift in resource allocation [9] - General and administrative expenses also decreased by 9.5% year over year to $2.5 million from $2.7 million [9] Strategic Priorities - While no formal quantitative guidance was provided, management expressed confidence in fiscal 2026 being the strongest year to date, with year-to-date revenue already exceeding prior full-year results [11] - The company highlighted continued investment in research and development, additional ANDA filings, and potential merger and acquisition opportunities as strategic priorities [11] - Management is also evaluating uplisting alternatives should suitable M&A opportunities not materialize [11] Recent Developments - During the quarter, Elite Pharmaceuticals expanded its generic portfolio, receiving FDA approval in November 2025 for a generic version of Ropinirole Extended-Release Tablets [12] - Earlier asset acquisitions included approved ANDAs for products such as Methadone Hydrochloride Tablets under an agreement with Nostrum Laboratories [12]