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Belite Bio Inc. (NASDAQ: BLTE) Stock Upgrade and Phase 3 DRAGON Trial Success
Financial Modeling Prep· 2025-12-01 23:03
Core Viewpoint - Belite Bio Inc. has received a stock upgrade to "Buy" with a price target increase, driven by positive trial results for its drug Tinlarebant targeting a rare eye disease [1][5]. Group 1: Stock Performance - H.C. Wainwright upgraded Belite Bio's stock from a price target of $98 to $185, reflecting strong market sentiment [1][5]. - Following the successful trial results, the stock price rose to approximately $153.59, marking an increase of about 11.75% or $16.15 [4]. - The stock has fluctuated between $130.06 and $154.99, with the latter being its highest price in the past year [4]. - Belite Bio's market capitalization is approximately $5.36 billion, with a trading volume of 596,581 shares, indicating strong investor interest [4]. Group 2: Clinical Trial Results - The Phase 3 DRAGON trial for Tinlarebant demonstrated a 36% reduction in lesion growth compared to placebo, marking a significant milestone for treating Stargardt disease type 1 (STGD1) [2][5]. - The trial enrolled 104 patients and is noted as the first successful pivotal trial for STGD1, a rare eye disease causing progressive vision loss [2]. Group 3: Future Plans - Belite Bio plans to file a New Drug Application (NDA) with the FDA in the first half of 2026, which is a crucial step towards commercialization [3][5]. - Tinlarebant works by lowering serum retinol binding protein 4 (RBP4) levels, thereby reducing harmful bisretinoids in the eye, offering hope for over 50,000 STGD1 patients in the U.S. [3].
MLTX SHAREHOLDERS: MoonLake Immunotherapeutics Investors with Losses may have been Misled by the Company and are Urged to Contact BFA Law by December 15
Newsfile· 2025-12-01 20:18
MLTX SHAREHOLDERS: MoonLake Immunotherapeutics Investors with Losses may have been Misled by the Company and are Urged to Contact BFA Law by December 15December 01, 2025 3:18 PM EST | Source: Bleichmar Fonti & AuldNew York, New York--(Newsfile Corp. - December 1, 2025) - Leading securities law firm Bleichmar Fonti & Auld LLP announces that a lawsuit has been filed against MoonLake Immunotherapeutics (NASDAQ: MLTX) and certain of the Company's senior executives for potential violations of the f ...
Telix Pharmaceuticals (TLX) Faces Securities Class Action After Alleged Misstatements on Prostate Cancer Drug Progress and Supply Chain Reliability-- Hagens Berman
Prnewswire· 2025-12-01 19:15
Hagens Berman is actively investigating the allegations and urges Telix investors who suffered substantial losses to submit your losses now. Accessibility StatementSkip Navigation SAN FRANCISCO, Dec. 1, 2025 /PRNewswire/ -- Telix Pharmaceuticals Ltd. (NASDAQ: TLX), a commercial-stage biopharmaceutical company specializing in diagnostic and therapeutic radiopharmaceuticals, is now the target of a securities class action lawsuit following a series of regulatory setbacks and steep stock declines over the summe ...
What Makes Halozyme Therapeutics (HALO) a New Buy Stock
ZACKS· 2025-12-01 18:01
Halozyme Therapeutics (HALO) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by th ...
ARCT Stock Plunges 59% in Three Months: Here's What You Need to Know
ZACKS· 2025-12-01 17:52
Key Takeaways ARCT shares fell after interim phase II data for ARCT-032 showed no meaningful day 1-28 FEV1 improvement.Exploratory analysis found modest day 42 FEV1 gains and showed mucus-reduction trends in most patients.ARCT is advancing dose escalation and plans a 12-week study of ARCT-032 in up to 20 CF patients in 2026.Shares of Arcturus Therapeutics (ARCT) have plunged 59.4% in the past three months. The massive stock price drop was primarily due to the mixed nature of the interim results reported by ...
What Is Happening With BMY Stock?
Forbes· 2025-12-01 14:50
CHINA - 2025/10/12: In this photo illustration, the Bristol Myers Squibb logo is seen displayed on the screen of a tablet. (Photo Illustration by Sheldon Cooper/SOPA Images/LightRocket via Getty Images)SOPA Images/LightRocket via Getty ImagesBristol Myers Squibb (BMY) is finally showing signs of life. The stock has climbed 7.3% over the last five days, adding roughly $7 billion in market value — pushing its market cap back toward $100 billion. Yet despite this solid run, BMY still trades 13% below where it ...
MAIA Biotechnology Announces Open Market Purchases by CEO and Directors
Globenewswire· 2025-12-01 14:17
CHICAGO, Dec. 01, 2025 (GLOBE NEWSWIRE) -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the CEO and certain members of the Company’s Board of Directors purchased approximately 182,445 shares of MAIA common stock at market price between November 21 and 28, 2025. The average common stock price was $1.06. Vlad Vitoc, M.D., Chairman and CEO of MAIA, purchased 94,3 ...
X4 Pharmaceuticals: Betting On Mavorixafor For Chronic Neutropenia (NASDAQ:XFOR)
Seeking Alpha· 2025-12-01 14:09
X4 Pharmaceuticals, Inc. ( XFOR ) is a biopharmaceutical firm built around its main asset, called Mavorixafor. The treatment is commercially branded as Xolremdi, and it's approved in the US for WHIM syndrome. It's also in the process of expanding toMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Busine ...
X4 Pharmaceuticals: Betting On Mavorixafor For Chronic Neutropenia
Seeking Alpha· 2025-12-01 14:09
X4 Pharmaceuticals, Inc. ( XFOR ) is a biopharmaceutical firm built around its main asset, called Mavorixafor. The treatment is commercially branded as Xolremdi, and it's approved in the US for WHIM syndrome. It's also in the process of expanding toMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degree in computer science from Ohio University, Athens, OH, USA, a graduate degree in Busine ...
NeOnc Technologies (Nasdaq: NTHI) Announces AI-Driven Findings Showing Ultrasound Enhances the Potency of an Already Effective NEO100 in Treating Primary and Metastatic Brain Tumors
Globenewswire· 2025-12-01 14:00
CALABASAS, Calif., Dec. 01, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI), a clinical-stage biopharmaceutical company developing brain-penetrant therapeutics for central nervous system (CNS) cancers, today announced newly published preclinical findings from a research collaboration at the University of Southern California (USC). The study, now available on bioRxiv (https://www.biorxiv.org/content/10.1101/2025.11.25.690556v1), demonstrates that ultrasound further enhances and ampl ...