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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

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8 months ago

Global Healthcare Weekly

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

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8 months ago

Global Healthcare Weekly

Global Biotech Weekly

This week, we will focus on the critical near-term catalysts anticipated in the immediate term over the next two months. Nektar Therapeutics (NASDAQ: NKTR) is a biotechnology company with a market cap of about US$196m and a cash balance of approximately US$179m. The company has a history of developi NKTR runs two separate Phase 2b trials with rezpegaldesleukin (LY3471851), an IL-2 pathway agonist. One trial (REZOLVE-AA) targets severe to very severe alopecia areata (AA), with Lyra Therapeutics (NASDAQ: LYRA) is developing therapies for chronic rhinosinusitis (CRS), a highly prevalent inflammatory disease. The company has a market cap of around US$26m a The Phase 3 ENLIGHTEN II trial is evaluating LYR-210 in surgically naïve patients with CRS. This study resumed enrollment on 25 April 2023, and is expected to complete enrollment Theriva Biologics (NYSE: TOVX) is a micro-cap clinical-stage company focused on oncolytic virus therapies, with a market cap of approximately US$5.6m. The company has limited cash The VIRAGE trial is a Phase 2b/3 clinical study of VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), a cancer with extremely poor prognosis. The drug hol

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3 months ago

Global Biotech Weekly

Global Biotech Weekly

This week we focus on the catalysts due for Phase 1 and 2 trials. At this stage in development, these trials aim to test the safety, side effects, and best dose of a new treatment. Data from these trials can also review initial efficacy data that will then be used to compare with the drug’s efficacy

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2 months ago

Global Biotech Weekly

Global Biotech Weekly

This week, we are revisiting the small to mid-cap PDUFA left for the quarter. At this stage in development, these trials aim to test the safety, side effects, and best dose of a new treatment. UroGen Pharma (NASDAQ: URGN) has a market cap of US$181m and a float of approximately 43.76m shares. The co A regulatory decision is expected on 13 June 2025, for UGN-102 (VesiGel), a mitomycin-based intravesical th Nuvation Bio (NYSE: NUVB) is a clinical-stage oncology company with a market cap of approximately US$784m a A PDUFA date of 23 June 2025, has been set for Taletrectinib, a selective ROS1/NTRK inhibitor under priorit Unicycive Therapeutics (NASDAQ: UNCY) is a micro-cap company with a valuation near US$65m. It has limited r The FDA has assigned a PDUFA date of 28 June 2025, for Oxylanthanum Carbonate (OLC), a novel lanthanum-base

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2 months ago

Global Biotech Weekly

Biotech Stock Updates

We focus to look at key drivers of biotech stocks' price movement on 23 May 2025. Gyre Therapeutics (NASDAQ: GYRE) priced its public offering of 2.22m shares at US$9.00 each, expecting approximately US$20m in gross proceeds. Underwriters have a 30-day option to buy another 333k shares. Shares closed IMUNON (NASDAQ: IMNN) shares closed up 179% at US$1.16 after it reported that its Phase 2 OVATION 2 study showed significant survival improvements for advanced ovarian cancer patients treated with IMNN-001 plus standar Merus N.V. (NASDAQ: MRUS) reported interim phase 2 data for petosemtamab plus pembrolizumab in head and neck cancer showed a 63% response rate, 79% 12-month OS, and 9-month median PFS in 43 patients, leading Needham to Prothena Corporation (NASDAQ: PRTA) announced the Phase 3 AFFIRM-AL clinical trial evaluating birtamimab in patients with AL amyloidosis did not meet its primary endpoint (HR=0.915, p-value=0.7680). Based on these resu Immix Biopharma (NASDAQ: IMMX) shares closed down 17% at US$1.99 following NXC-201 data which demonstrated a 71% complete response rate (5/7 patients) in relapsed/refractory AL Amyloidosis in the NEXICART-2 trial and w BriaCell Therapeutics (NASDAQ: BCTX) reported at ASCO 2025 that patients receiving its selected Phase 3 Bria-IMT formulation showed significantly improved PFS (3.6 vs. 2.6 months) and OS (13.4 vs. 6.9 months) compared Biodexa Pharmaceuticals (NASDAQ: BDRX) will hold a 11 June 2025 meeting to propose a share capital reorganization and seek approval to issue new shares for acquisitions and financings, with the latest analyst rating ma

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2 months ago

Biotech Stock Updates

Biotech Stock Updates

We focus to look at key drivers of biotech stocks' price movement on 21 May 2025. UroGen Pharma (NASDAQ: URGN) announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 4–5 against the benefit-risk profile of its investigational therapy UGN-102 (mitomycin) for intravesical solution fo CEL-SCI Corporation (NYSE: CVM) announced that it intends to offer to sell shares of its common stock and/or pre-funded warrants in an underwritten public offering. Shares traded down 13% at US$3.95 during after hours Petros Pharmaceuticals (NASDAQ: PTPI) partnered with Innolitics to upgrade its SaaS platform by integrating AI, cybersecurity, and cloud-based capabilities. Innolitics, known for its work with Fortune 100 companies and Biodesix (NASDAQ: BDSX) shares traded higher after Jack Schulher bought 723,239 and 4,000,000 shares of the company at US$0.341 and US$0.2675, respectively, since last Friday. Shares closed up 46% at US$0.4. Jaguar Health (NASDAQ: JAGX) will raise capital via a direct offering of 246,306 shares at US$6.09/share, and a concurrent private placement of warrants for 492,612 shares at US$5.84/share. Shares closed down 27% at US NeurAxis (NYSE: NRXS) announced a US$5.0M direct offering, selling 1,538,461 common shares at US$3.25/share, priced at market under NYSE American rules. Shares closed down 20% at US$3.2. Quipt Home Medical (NASDAQ: QIPT) received an unsolicited, non-binding proposal from Forager Capital Management to acquire 100% of its common shares at US$3.10 per share. Shares closed down 9% at US$1.95.

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2 months ago

Biotech Stock Updates

Biotech Stock Updates

We focus to look at key drivers of biotech stocks' price movement on 29 May 2025. Alzamend Neuro (NASDAQ: ALZN) reported that the initial subject in the Phase II “Lithium-in-Brain” trial has received its dosage of AL001 for comparison against lithium carbonate. The study’s primary findings are antic Revelation Biosciences (NASDAQ: REVB) priced a US$4m public offering of 3.64m shares (or equivalents) and warrants for up to 14.56m shares at US$1.10 per share and warrant. Warrants are exercisable at US$1.10 upon stoc IMUNON (NASDAQ: IMNN) completed a US$3.25m private placement by selling 7,222,223 common shares and short-term warrants for an additional 14,444,446 shares at US$0.45 per share. The warrants could generate up to US$6.5 Applied DNA Sciences (NASDAQ: APDN) will implement a 1‑for‑15 reverse stock split effective 2 June 2025. Shares closed down 37% at US$0.33. Intensity Therapeutics (NASDAQ: INTS) will showcase a Trials‑in‑Progress poster on its Phase 3 INVINCIBLE‑3 study of intratumoral INT230‑6 in metastatic soft‑tissue sarcoma at ASCO 2025. Shares closed up 34% at US$0.39 ORIC Pharmaceuticals (NASDAQ: ORIC) reported Phase 1b data for ORIC-944 in mCRPC, with 59% PSA50 and 24% PSA90 confirmed response rates. They also secured approximately US$125m via a private placement at US$6.50 per sh Immunic (NASDAQ: IMUX) announced the pricing of a public offering including pre-funded warrants exercisable immediately, Series A warrants exercisable until 31 December 2025, and Series B warrants exercisable starting Intellia Therapeutics (NASDAQ: NTLA) shares are currently down during premarket hours after reporting a Grade 4 liver enzyme elevation in a patient in the late-stage MAGNITUDE trial for its Regeneron (NASDAQ: REGN)-par

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1 month ago

Biotech Stock Updates

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