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Over 10 years of professional equity research experience in a major international investment bank.
Global Healthcare Weekly
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, The FDA has set a PDUFA priority review date for January 15, 2025. Tabelecleucel has breakthrough therapy designation (BTD) for this rare indication, and approval could solidify Atara’s pre Axsome Therapeutics Inc. (NASDAQ: AXSM) is a late-stage biopharmaceutical company with a market cap of $3.88 billion, developing treatments for central nervous system disorders. The firm ha A key upcoming catalyst is the PDUFA decision for AXS-07, a combination of meloxicam and rizatriptan for the treatment of migraines, expected on January 31, 2025. AXS-07 has shown potential SpringWorks Therapeutics Inc. (NASDAQ: SWTX) with a market cap of about $1.93 billion, is focused on targeted oncology therapies. Its pipeline includes investigational treatments for rare d Mirdametinib is being developed for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas, a rare genetic disorder. The FDA has granted priority review with a PDUFA d Mesoblast Limited (NASDAQ: MESO) is a regenerative medicine company focused on developing cellular therapies. With a market cap of approximately $1.05 billion, the firm is working to commer A key upcoming catalyst is the PDUFA date for RYONCIL, scheduled for January 7, 2025. The FDA accepted the resubmission of the BLA on July 23, 2024. This product, if approved, could address
V小姐
9 months ago
Global Healthcare Weekly
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 cortiso
V小姐
8 months ago
Global Healthcare Weekly
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
8 months ago
Global Healthcare Weekly
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 A 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 patient 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 comp A 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 liv Immuron Limited (NASDAQ: IMRN) is a biopharmaceutical company focused on developing and commercializing polyclonal antibodies to address unmet medical needs, with research and development activi A 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 p
V小姐
8 months ago
Global Biotech Weekly
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 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 fibro Mineralys 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 Lorundrostat 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 t PolyPid 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 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 p Lyra 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 repo
V小姐
3 months ago
Biotech Stock Updates
We focus to look at key drivers of biotech stocks' price movement on 4 April 2025.Renovaro Biosciences (NASDAQ:RENB) announced that Predictive Oncology (NASDAQ: POAI) terminated their merger agreement, which Renovaro claims is a breach of binding agreements. Renovaro is demanding compliance with the deal, including an exclusive license agreement, and may pursue legal action if unNeuroOne Medical (NASDAQ: NMTC) announced the pricing of an US$8 million underwritten registered public offering of 16m shares of its common stock for US$0.50 per share. Shares closed down 45% at US$0.48.Sarepta Therapeutics (NASDAQ: SRPT) reported that an independent data monitoring committee reviewed safety data for ELEVIDYS after EU regulators flagged liver failure concerns. The committee upheld a favorable benefit-risk profile, allowing paused trials to continue. Sarepta and Roche will submit fiSangamo Therapeutics (NASDAQ: SGMO) licensed its STAC-BBB AAV capsid to Eli Lilly for CNS disease treatments, securing an US$18 million upfront fee and potential milestone payments up to US$1.4 billion, plus tiered royalties on future sales. Shares closed up 6% at US$0.66.Dynavax Technologies (NASDAQ: DVAX) filed preliminary proxy materials ahead of its 2025 annual meeting, highlighting ongoing strategy execution and nominating four independent directors (Brent MacGregor, Scott Myers, Lauren Silvernail, and Elaine Sun) for reelection. Shares closed down 2% at US$12.6Arvinas (NASDAQ: ARVN) reported first-in-human Phase 1 data for ARV-102, showing it was well tolerated and achieved robust, dose-dependent LRRK2 degradation in CSF and blood, supporting continued development in Parkinson’s and related neurodegenerative diseases. Shares closed down 5% at US$6.56.OS Therapies (NASDAQ: OSTX) received a Buy rating and a US$19.00 price target from Lake Street. Shares closed down 9% at US$1.4.
V小姐
3 months ago
Global Biotech Weekly
This week, we will focus on the critical near-term catalysts anticipated in summer 2025, particularly emphasizing those expected to materialize in the immediate term.InflaRx N.V. (NASDAQ:IFRX) is a Germany-based biopharmaceutical company focused on developing monoclonal antibodies that target activation products of the complement system, aiming to treat life-threatening inflammatory diseases. Its lead asset, IFX-1, is an intravenously administered anti-C5a monocThe ongoing Phase 2a basket trial of INF904, which began dosing in December 2024, is evaluating safety, pharmacokinetics, and potential signs of clinical benefit in 75 patients - 45 with chronic spontaneous urticaria (CSU) and 30 with HS. This open-label, multi-center trial consists of a 28-day treaLisata Therapeutics (NASDAQ:LSTA) is a clinical-stage pharmaceutical company focused on developing innovative therapies for advanced solid tumors and other serious diseases. The company’s lead program, certepetide (LSTA1), is being investigated in the Phase 2a BOLSTER trial for the treatment of intrThe BOLSTER trial is a double-blind, placebo-controlled, randomized Phase 2a study being conducted at multiple centers in the U.S. It includes two cohorts: patients with previously untreated CCA and those who have progressed following first-line therapy. Following accelerated enrollment, the first-lNuvalent (NASDAQ:NUVL) is a clinical-stage biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on developing small molecule kinase inhibitors for patients with genetically defined cancers. Founded in 2019, the company has built a pipeline targeting key oncogenic drivers, incThe ARROS-1 study is a pivotal, registrational-intent, dose escalation and expansion trial assessing the safety, tolerability, and efficacy of zidesamtinib. The trial includes both TKI-naïve and TKI-pretreated patients across five expansion cohorts, with Phase 1 focused on determining the recommende
V小姐
3 months ago
Global Biotech Weekly
This week, we highlight key PDUFA and regulatory catalysts for the next 6 months.Verastem (NASDAQ: VSTM) is a late-stage oncology company with a market cap of approximately US$227m and a float of 30.33m shares. As of year-end 2024, it reported US$88.8m in cash and investments, with a pro forma balance of US$151.3m following debt refinancing and equity issuance. Despite a signifiThe company’s lead program the combination of avutometinib (RAF/MEK clamp) and defactinib (FAK inhibitor) targets KRAS mutant recurrent low-grade serous ovarian cancer (LGSOC). The New Drug Application (NDA) for this combo therapy was accepted by the FDA under the accelerated approval pathway and grAbeona Therapeutics (NASDAQ: ABEO) is a clinical-stage biotech company with a market cap of approximately US$214m and a float of 32.13m shares. As of 31 December 2024, the company reported US$98.1m in cash, short-term investments, and restricted cash, an increase from US$52.6m a year earlier. This pAbeona’s lead program, pz-cel (prademagene zamikeracel), is an autologous, COL7A1 gene-corrected epidermal sheet therapy in development for recessive dystrophic epidermolysis bullosa (RDEB), a devastating genetic skin disorder. The BLA is under FDA priority review, with a PDUFA date of 29 April 2025Outlook Therapeutics (NASDAQ: OTLK) is a development-stage biopharmaceutical company with a market cap of approximately US$41m and a float of 22.54m shares. The company is pre-revenue, reporting an annual net loss of nearly US$74m, and holds about US$6.6m in cash, suggesting a need for additional caONS-5010 / LYTENAVA is currently under review by the U.S. FDA, with a Class 2 resubmission of its BLA accepted on 28 February 2025, and a new PDUFA date set for 27 August 2025. The resubmission follows a CRL issued in August 2023 and includes updated CMC data and full results from the pivotal NORSE
V小姐
3 months ago
Biotech Stock Updates
We focus to look at key drivers of biotech stocks' price movement on 11 April 2025.Future Pak has made two cash-and-CVR offers to buy all Theratechnologies (NASDAQ: THTX) shares, most recently proposing US$3.51 to US$4.50 per share. The deal values Theratechnologies at up to US$255m. Future Pak says the bid is fully financed and could be wrapped up in 4-6 weeks, but so far has recPalatin Technologies (NYSE American: PTN) received notice that NYSE will commence delisting proceedings after the company failed to regain compliance with stockholders’ equity requirements by the 10 April 2025 deadline. Shares closed down 60% at US$0.17.Recursion Pharmaceuticals (NASDAQ: RXRX) shares rose due to the FDA’s move to reduce animal testing, which could accelerate the adoption of AI drug discovery platforms. Shares closed up 28% at US$5.76.Scilex (NASDAQ: SCLX) announced that it will effect a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-35, to be effective as of 12:01 a.m. Eastern Time on 15 April 2025. Additionally, D. Boral Capital downgraded Scilex from Buy to Hold. Shares closed down 22% at US$Oncolytics Biotech (NASDAQ: ONCY) signed a US$20m share purchase agreement with Alumni Capital to support clinical development. Shares closed up 26% at US$0.62.Conduit Pharmaceuticals (NASDAQ: CDT) announced two new patents for tapinarof, including a dual active cocrystal that combines the drug with a complementary drug substance to address key patient needs in inflammatory skin conditions. Shares closed down 15% at US$0.91.Argenx SE (NASDAQ: ARGX) shares closed up 6% at US$580.94 following FDA approval of the VYVGART Hytrulo prefilled syringe for self-injection in treating generalized myasthenia gravis and chronic inflammatory demyelinating polyneuropathy.Shuttle Pharmaceuticals (NASDAQ: SHPH) filed a provisional patent application with the USPTO for PSMA-targeted PARP inhibitor conjugates, advancing its precision cancer therapy platform. Shares closed down 12% at US$0.37.Scotiabank maintained a Buy rating on Zai Lab (NASDAQ: ZLAB) and set a price target of US$55.00. Shares closed up 21% at US$29.54.Venus Concept (NASDAQ: VERO) agreed to sell 386,700 shares at US$4.06 each in a registered direct offering led by H.C. Wainwright, expected to raise approximately US$1.5m for general corporate purposes. Shares closed up 6% at US$4.31.
V小姐
3 months ago
Biotech Stock Updates
We focus to look at key drivers of biotech stocks' price movement on 23 April 2025.Ensysce Biosciences (NASDAQ: ENSC) received a USPTO Notice of Allowance for a patent covering composition and method claims for PF9001, a methadone prodrug using its TAAP and MPAR technologies to improve safety in opioid use disorder treatment. Shares closed up 96% at US$3.67.
V小姐
3 months ago
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