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China's First Domestic IL-23p19 Monoclonal Antibody: Innovent's PECONDLE® (Picankibart Injection) Received NMPA Approval
Prnewswire· 2025-11-28 09:06
Accessibility StatementSkip Navigation SAN FRANCISCO and SUZHOU, China, Nov. 25, 2025 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved PECONDLE (picankibart injection), a recombinant ...
Results of the Votes of the Combined Shareholders’ General Meeting of November 27, 2025
Globenewswire· 2025-11-28 07:30
Daix (France), New York City (New York, United States), November 28, 2025 – Inventiva (Euronext Paris and Nasdaq: IVA) (the “Company”), a clinical-stage biopharmaceutical company focused on the development of oral therapies for the treatment of metabolic dysfunction-associated steatohepatitis (“MASH”), today announced the results of the votes of its Combined Shareholders’ Meeting. The Combined Shareholders' Meeting was held on Thursday November 27, 2025, at 9 a.m. at Hôtel Villa M, 24-30 Bd Pasteur, 75015 ...
InnoCare Announces First Patient Dosed in the Global Phase II Clinical Trial of TYK2 Inhibitor Soficitinib for Treatment of Prurigo Nodularis
Globenewswire· 2025-11-28 01:55
Core Viewpoint - InnoCare Pharma has initiated a global Phase II clinical trial for its TYK2 inhibitor, Soficitinib, targeting prurigo nodularis in China, marking a significant step in its development pipeline for autoimmune diseases [1][5]. Company Overview - InnoCare Pharma is a biopharmaceutical company focused on developing treatments for cancer and autoimmune diseases, with a commitment to addressing unmet medical needs both in China and globally [6]. Product Development - Soficitinib is a selective TYK2 inhibitor aimed at treating various T-cell related autoimmune disorders, including prurigo nodularis, atopic dermatitis, and vitiligo, among others [2][5]. - The drug works by blocking cytokine signaling pathways associated with itching and inflammation, thereby alleviating symptoms of prurigo nodularis [3]. Market Potential - There are approximately 10 million patients suffering from prurigo nodularis globally, with the market for this condition valued at US$2 billion in 2024 and projected to grow to US$3 billion by 2034 [4].
Eisai Submits New Drug Application for Subcutaneous Formulation of “LEQEMBI®” for the Treatment of Early Alzheimer’s Disease in Japan
Globenewswire· 2025-11-28 00:30
Core Viewpoint - The announcement highlights Eisai and Biogen's application for lecanemab's subcutaneous formulation in Japan, which, if approved, would be the first at-home injection treatment for Alzheimer's disease in the country [1][2]. Group 1: Product Development and Approval - Eisai has filed a new drug application for lecanemab seeking approval for a subcutaneous autoinjector (SC-AI) in Japan [1]. - The application is based on Phase 3 Clarity AD open-label extension data, confirming that the once-weekly SC-AI 500mg administration is equivalent to the intravenous (IV) administration every two weeks [2]. - If approved, the SC-AI would allow patients to receive treatment at home, reducing the need for hospital visits for IV administration [3]. Group 2: Clinical Efficacy and Safety - Lecanemab targets both protofibrils and amyloid plaques, addressing the underlying neurotoxic processes in Alzheimer's disease [4]. - The safety profile of subcutaneous administration is similar to IV administration, with less than 2% incidence of systemic injection-related reactions [2]. Group 3: Market Presence and Regulatory Status - Lecanemab is currently approved in 51 countries and regions and is under regulatory review in 9 countries [4][9]. - The drug received manufacturing and marketing approval in Japan in September 2023 for treating mild cognitive impairment and mild dementia due to Alzheimer's disease [9]. Group 4: Collaboration and Strategic Alliances - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing and co-promoting the product [5][11]. - The collaboration between Eisai and BioArctic for the development of lecanemab has been ongoing since 2005, with Eisai obtaining global rights for its commercialization [12].
Biotech Fund Reveals $15 Million MoonLake Exit After Stock's 90% Crash
The Motley Fool· 2025-11-27 21:54
Core Insights - MPM BioImpact fully divested its position in MoonLake Immunotherapeutics, selling 313,571 shares and reducing exposure by approximately $14.8 million, which previously constituted 2.6% of its assets under management [2][7] - MoonLake's stock experienced a dramatic decline of nearly 90% in a single day due to mixed Phase 3 trial results for its investigational therapy, sonelokimab, leading to a class-action lawsuit and significant market value loss [6][9] - As of the latest market close, MoonLake's shares were priced at $13.80, reflecting a 74% decrease from the previous year, while the S&P 500 index increased by 13% during the same period [3][4] Company Overview - MoonLake Immunotherapeutics is a Switzerland-based clinical-stage biotechnology company focused on developing sonelokimab, a Nanobody therapy aimed at treating inflammatory diseases such as hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis [5] - The company operates a clinical-stage biopharmaceutical model, investing in research and development to advance its pipeline through clinical trials, with future revenue dependent on successful product commercialization and regulatory approval [5] Financial Metrics - As of the latest report, MoonLake's market capitalization stands at $977.7 million, with a net income of -$210.5 million over the trailing twelve months [4] - The company reported $380.5 million in cash, projecting a financial runway into the second half of 2027, and is preparing for a crucial FDA meeting on December 15 to evaluate its evidence package for sonelokimab [8]
This Biotech Fund Just Dumped $14.8 Million in MBX Biosciences — Right Before Key 2026 Milestones
The Motley Fool· 2025-11-27 20:38
Core Insights - MPM BioImpact has divested its entire stake in MBX Biosciences, selling 1,294,416 shares and reducing its exposure by approximately $14.8 million [2][7] - Despite the divestment by MPM, MBX Biosciences has shown strong performance, with its stock price increasing by 71% over the past year, significantly outperforming the S&P 500 [3][4] Company Overview - MBX Biosciences focuses on developing precision peptide therapies for endocrine and metabolic disorders, with key candidates including MBX 2109, MBX 1416, and MBX 4291 [5] - The company operates as a clinical-stage biopharmaceutical entity, aiming to generate value through research, development, and potential commercialization of its drug candidates [5] - As of the latest market close, MBX's stock price is $33.82, with a market capitalization of $1.5 billion and a net income of -$80.5 million over the trailing twelve months [4] Recent Developments - MBX reported positive topline Phase 2 results for canvuparatide in hypoparathyroidism and completed a $200 million upsized offering, ending the quarter with $391.7 million in cash, sufficient to fund operations into 2029 [9] - The CEO emphasized the potential of canvuparatide in a multibillion-dollar market and highlighted upcoming Phase 3 trials and key milestones expected in 2026 [9] - The stock has rebounded sharply after a significant decline post-IPO, reflecting a changed risk profile due to strengthening clinical data and renewed investor interest [6]
Here is Why Growth Investors Should Buy Neurocrine (NBIX) Now
ZACKS· 2025-11-27 18:46
Core Insights - Growth investors are attracted to stocks with above-average financial growth, but identifying such stocks can be challenging due to their inherent risks and volatility [1] Group 1: Company Overview - Neurocrine Biosciences (NBIX) is highlighted as a recommended growth stock based on the Zacks Growth Style Score, which evaluates a company's growth potential beyond traditional metrics [2] - The company currently holds a favorable Growth Score and a top Zacks Rank, indicating strong investment potential [2] Group 2: Earnings Growth - Neurocrine's historical EPS growth rate stands at 16.2%, but the projected EPS growth for this year is significantly higher at 99.6%, surpassing the industry average of 26% [5] - This exceptional earnings growth is a key factor that attracts investor interest and suggests strong future stock price gains [4] Group 3: Cash Flow Growth - The year-over-year cash flow growth for Neurocrine is reported at 35.4%, which is substantially higher than the industry average of 3.2% [6] - Over the past 3-5 years, the company's annualized cash flow growth rate has been 39.5%, compared to the industry average of 6.9%, indicating robust financial health [7] Group 4: Earnings Estimate Revisions - The current-year earnings estimates for Neurocrine have been revised upward, with the Zacks Consensus Estimate increasing by 15.4% over the past month [9] - Positive trends in earnings estimate revisions are correlated with near-term stock price movements, further validating the stock's potential [8] Group 5: Investment Positioning - Neurocrine has achieved a Zacks Rank 1 (Strong Buy) due to favorable earnings estimate revisions and a Growth Score of B, positioning it well for outperformance in the market [11]
GENFIT Announces Appointment of new Chief Medical Officer
Globenewswire· 2025-11-27 17:00
Core Insights - GENFIT has appointed Dr. Pejvack Motlagh as the new Chief Medical Officer, who will oversee the company's clinical development strategy and execution [1][2][5] - Dr. Motlagh brings over 20 years of experience in the pharmaceutical and biotechnology sectors, with a strong background in drug development across various therapeutic areas [3][4] - The company focuses on addressing unmet medical needs in rare and life-threatening liver diseases, particularly Acute on-Chronic Liver Failure (ACLF) and related conditions [6][7] Company Overview - GENFIT is a biopharmaceutical company dedicated to improving the lives of patients with rare liver diseases, with a history of over two decades in liver disease research and development [6] - The company is headquartered in Lille, France, with additional offices in Paris, Zurich, and Cambridge, MA, and is listed on the Euronext regulated market [9] - GENFIT's R&D portfolio includes therapeutic assets targeting ACLF, acute decompensation, hepatic encephalopathy, cholangiocarcinoma, urea cycle disorders, and organic acidemias [7] Recent Developments - The appointment of Dr. Motlagh is seen as pivotal for advancing GENFIT's clinical programs, particularly in the context of increasing focus on ACLF within the liver disease community [5] - The company achieved accelerated approval for Iqirvo® (elafibranor) in 2024 for the treatment of Primary Biliary Cholangitis (PBC), which is now marketed in several countries [8] - GENFIT also has a diagnostic franchise, including NIS2+® for detecting Metabolic dysfunction-associated steatohepatitis (MASH) [8]
This Fund Leaned Into 2025's Big Biotech Rally with a $9.5 Million Bet on Mineralys
The Motley Fool· 2025-11-27 16:34
Core Insights - Findell Capital Management has initiated a new position in Mineralys Therapeutics, acquiring 250,000 shares valued at $9.5 million, representing 3.7% of its U.S. equity portfolio as of September 30 [2][6] - Mineralys Therapeutics has seen its share price increase by 246% over the past year, significantly outperforming the S&P 500's 13% gain during the same period [3] Company Overview - Mineralys Therapeutics is a clinical-stage biotechnology company focused on developing therapies for hypertension and cardiovascular diseases, specifically through its proprietary candidate, lorundrostat [5] - The company has a market capitalization of $3.4 billion and reported a net loss of $171.4 million over the trailing twelve months [4][5] - As of the latest market close, shares of Mineralys Therapeutics were priced at $43.36 [4] Financial Performance - Mineralys ended the third quarter with no product revenue and a net loss of $36.9 million, while continuing to advance its drug candidate lorundrostat [7] - The company raised $287.5 million through a recent offering, which has expanded its cash runway and indicated rising institutional support [6] Investment Context - The investment by Findell Capital reflects a high-risk, high-reward profile typical of pre-revenue biotech companies, with a focus on clinical progress and market momentum [6][8] - The company is still in the early stages of its lifecycle, primarily utilizing capital for research and development, manufacturing, and pre-commercial planning [7][8]
12 Hot Penny Stocks to Invest in Right Now
Insider Monkey· 2025-11-27 12:31
Core Insights - The article discusses the current investment landscape for penny stocks, emphasizing that their performance is influenced more by market psychology than macroeconomic conditions [1] - Small-cap stocks are gaining momentum, particularly after strong third-quarter earnings, making them more attractive compared to large-cap stocks [2] - Several catalysts are driving interest in small-cap stocks, including M&A activity, biotech developments, and opportunities in sectors linked to AI [3] Small-Cap Stock Performance - The Russell 2000 index has increased by 21.60% over the past six months, although it has experienced four consecutive weeks of decline recently [4] Methodology for Stock Selection - The list of 12 hot penny stocks was compiled based on stocks priced under $5, with over 50% returns in the last three months and an upside potential exceeding 20% as of November 24, 2025 [6] - Hedge fund sentiment was also considered, utilizing data from Insider Monkey's hedge fund database tracking 983 hedge funds as of Q2 2025 [7] Individual Stock Highlights - **Shattuck Labs, Inc. (NASDAQ:STTK)**: - 3-month performance of 102.21% with an average upside potential of 45.63% [9] - The company has a cash balance of $86.10 million and reported a net loss of $10.1 million for Q3 2025 [10][11] - **Erasca, Inc. (NASDAQ:ERAS)**: - 3-month performance of 93.08% with an average upside potential of 73.01% [13] - The company reported a net loss of $30.6 million for Q3 2025 but has a solid cash position of $362.4 million [15][17] - **CytomX Therapeutics, Inc. (NASDAQ:CTMX)**: - 3-month performance of 107.50% with an average upside potential of 78.09% [18] - The company reported a revenue decline to $6 million for Q3 2025 but maintains a cash balance of $143.6 million [20][21]