This week, we highlight key Phase 3 catalysts of biotech companies expected over the next six months.Gyre Therapeutics Inc. (NASDAQ: GYRE) has a market cap of US$846M, with cash reserves of approximately US$75.3 million. The company has yet to generate product revenue and reported a modest net loss. Its lead asset, hydronidone (F351), has received Breakthrough Therapy Designation in China.Hydronidone is in a fully enrolled Phase 3 trial (NCT05115942) for chronic hepatitis B-associated liver fibrosis in China. This antifibrotic agent targets TGF-β signaling, a central pathway in fibrogenesis. Topline results are expected in Q2 2025, following last-patient dosing on 22 October 2024. AnMineralys Therapeutics Inc. (NASDAQ: MLYS) is a mid-cap biotech with a market cap of US$719M and roughly US$294 million in cash. The company’s lead candidate is lorundrostat, a selective aldosterone synthase inhibitor. Mineralys reported positive Phase 3 results and has significant institutional intLorundrostat is being evaluated in uncontrolled and resistant hypertension in the Launch-HTN Phase 3 trial. Topline data showed statistically significant reductions in systolic blood pressure with the 50 mg dose. The primary endpoint was met, and the full data readout is anticipated in 1H 2025. ThisPolyPid Ltd. (NASDAQ: PYPD) has a market cap of US$27.8M and is focused on developing localized drug-delivery systems to prevent surgical site infections. The company operates with limited cash and no product revenue to date.D-PLEX100 is being studied in the SHIELD II Phase 3 trial to prevent abdominal surgical site infections. The trial completed enrollment as of March 2025, with topline data expected in Q2 2025. The product uses a novel polymer-lipid matrix for local antibiotic release. It has been positioned as a potLyra Therapeutics Inc. (NASDAQ: LYRA) is a micro-cap biotech (US$9.3M market cap) developing therapies for chronic rhinosinusitis. The company operates with significant cash constraints and has reported substantial net losses. LYR-210 is an investigational implant delivering mometasone furoate direc
V小姐
54 minutes ago
In our global healthcare weekly, we focus on key stock catalysts for biotech companies before April 2025.NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) is a late-stage clinical biopharmaceutical company focused on developing oral, non-statin medications aimed at reducing the risk of cardiovascular disease (CVD) in patients with elevated low-density lipoprotein cholesterol (LDL-C). With a market capitaA critical upcoming catalyst for NewAmsterdam is the topline data from its pivotal Phase 3 TANDEM trial, evaluating the fixed-dose combination (FDC) of obicetrapib and ezetimibe in adult patients with heterozygous familial hypercholesterolemia (HeFH), atherosclerotic cardiovascular disease (ASCVD), Gyre Therapeutics Inc. (NASDAQ: GYRE) is a biopharmaceutical company focused on research and clinical development of protease therapeutics to address unmet medical needs in disorders of the complement and coagulation systems. With a market capitalization of US$1.3 billion and an estimated cash reserA pivotal catalyst for Gyre Therapeutics is the topline data readout anticipated in early 2025 from its Phase 3 clinical trial evaluating hydronidone for chronic hepatitis B (CHB)-associated liver fibrosis in China. This trial has fully enrolled 248 patients, with the last patient completing the 52-Immuron Limited (NASDAQ: IMRN) is a biopharmaceutical company focused on developing and commercializing polyclonal antibodies to address unmet medical needs, with research and development activities spanning Australia, Israel, and the United States. Immuron has a market capitalization of US$11.1 milA key upcoming catalyst for Immuron is the topline data readout expected in April 2025 for its Phase 2 clinical study of Travelan. The study, which aims to evaluate the efficacy of Travelan in preventing gastrointestinal infections, has reached 85% of its recruitment target of 866 participants. Thes
V小姐
5 months ago
《紅藥丸雜誌》專欄〈財經DNA〉2025年3月28日東升西降? 敝欄由報紙搬到這裏,且看可撐幾耐。近月講東升西降,謂美股升夠輪到亞洲。 無反對的,美股貴到離譜自要調整,而中港這邊殘得過分可彈。然而西升十年,東降也已十年,背後不無基本因素:近有東邊樓跌去槓桿有排衰,遠的有大國囂張,西方去之。這十年間大國經濟增長直線向下,AI抄得幾勁也難阻世界工廠生意流失。 行之有效的A股拼圖預料確在趨升,但拉勻年均數個巴仙,扣通脹後原地踏步。盛轉衰初,股市多會轉移陣地,由美轉歐,由歐轉亞。但隨着敗象漸出,轉無可轉,終歸也是避險收場。圖料今年後期A股似要跟外圍轉弱(框),儘管跌幅相對有限。 全球持續狂印銀紙,各地股市水漲船高,持續橫行的股市已是大輸家。什麼東升西降,還好意思大聲疾呼。 羅耕 [email protected]
Gang Law
1 week ago
In our global healthcare weekly, we focus on identifiying key stock catalysts for biotech companies in the fourth quarter this week.Corcept Therapeutics Incorporated (NASDAQ: CORT) is pharmaceutical company focusing on the discovery, development, and commercialization of drugs that modulate cortisol activity. With a market capitalization of US$5.1 billion and an estimated cash balance of US$523.5 million, Corcept is best known fRelacorilant has received orphan drug designations (ODD) from both the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Cushing’s syndrome, which provides regulatory incentives and extended market exclusivity if approved. The GRADIENT trial focuses on patMarinus Pharmaceuticals Inc. (NASDAQ: MRNS) is a biopharmaceutical company focused on developing and commercializing treatments for rare genetic epilepsies and seizure disorders. With a market capitalization of US$101.6 million, Marinus has a limited cash runway of 2.6 months. The firm’s approved prEnrollment for the TrustTSC trial was completed in May 2024 with 129 participants, and the final patient visit occurred in September. The trial is designed to assess seizure reduction, with the goal of demonstrating a 25% improvement in seizure frequency compared to placebo. A low discontinuation raOmega Therapeutics Inc. (NASDAQ: OMGA) is a biopharmaceutical company with a focus on using mRNA therapeutics as programmable epigenetic medicines through its OMEGA Epigenomic Programming platform. With a market capitalization of US$58.46 million and a cash reserve of $30.4 million, Omega is in the The MYCHELANGELO I trial is progressing with positive early data. In March 2024, Omega reported that OTX-2002 showed consistent dose-dependent pharmacokinetics, no dose-limiting toxicities, and effective downregulation of MYC expression in patients across the first three monotherapy dose levels. Not
V小姐
5 months ago
In our global healthcare weekly, our focus turns to finding key stock catalysts for biotech companies expected in November and December 2024.Autolus Therapeutics plc (NASDAQ: AUTL) a London-based biotech company with a US$1.19 billion market cap, focuses on developing engineered T-cell therapies for hematological cancers. Its lead product candidate, Obe-cel (AUTO1), is designed for B-cell Acute Lymphoblastic Leukemia (B-ALL). AUTO1 has rObe-cel is an autologous CAR T-cell therapy that targets CD19, aiming to deliver high specificity with reduced treatment-related toxicity. Data presented at EHA and additional data expected at ASCO in 2024 have shown promising response rates and durability in patients. This upcoming PDUFA decision iTrevi Therapeutics, Inc. (NASDAQ: TRVI) a company with a market cap of US$222 million, focuses on developing therapies for serious neurologically mediated conditions. Haduvio, its lead product, is being evaluated in a Phase 2b trial for treating chronic cough in idiopathic pulmonary fibrosis (IPF), The Phase 2b CORAL study evaluates Haduvio’s efficacy as a potential anti-tussive agent, specifically for chronic cough associated with IPF. Following promising Phase 2a findings, this larger study is expected to yield interim data in late 2024, with topline data projected during the first half 2025Puma Biotechnology, Inc. (NASDAQ: PBYI) with a market cap of approximately US$149 million, is advancing its portfolio in oncology, primarily focusing on small-cell lung cancer (SCLC). The firm’s lead drug candidate, Alisertib, is now in a Phase 2 trial targeting SCLC, where it has demonstrated diseThe ongoing Phase 2 ALISCA-Lung1 trial explores the efficacy of Alisertib at a 30mg dose for SCLC. Previously presented data at ASCO showed an overall response rate of 9.5% and a disease control rate of 81%. Additional interim data, expected in Q4 2024, will further clarify Alisertib’s potential impCardiff Oncology Inc. (NASDAQ: CRDF) valued at US$135.7 million, is advancing therapies for difficult-to-treat cancers. Its lead candidate, CRDF-004, targets metastatic colorectal cancer (mCRC) and is currently in a Phase 2 trial. Cardiff’s cash reserves of US$48.3 million supports continued trial pCRDF-004 combines Onvansertib with standard-of-care therapies to enhance therapeutic response in mCRC. Early data from Phase 1b showed favorable safety and efficacy, making this combination encouraging in a high-need area. Upcoming data in H2 2024 will be critical to validate its impact on mCRC, wheQuince Therapeutics, Inc. (NASDAQ: QNCX) is a small biotech company with a market cap of US$47.2 million, primarily developing EryDex for Ataxia-Telangiectasia (A-T), a rare neurodegenerative disease. The firm recently lifted an IND hold and initiated dosing for its Phase 3 NEAT trial in June 2024, EryDex is designed to modulate immune responses and reduce neuroinflammation, targeting the specific complications of A-T. The Phase 3 trial will assess the efficacy and safety of EryDex over an extended period, positioning it as a potential disease-modifying therapy. The Q4 2025 data readout would
V小姐
5 months ago
In our global healthcare weekly, we focus on identifiying key stock catalysts for biotech companies this week. Atara Biotherapeutics (NASDAQ: ATRA) with a market cap of around $41.8 million, focuses on developing T-cell immunotherapies for cancers and autoimmune diseases. The firm’s lead candidate,
V小姐
6 months ago
Contact Us:
Copyright ©2025 Fortress Hill Media limited. All rights reserved