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.
V小姐
3 days ago
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
V小姐
3 days ago
MPF Portfolio: April Update and Strategy
Global equities faced selling pressure in April amid US-China trade tensions sparked by President Donald Trump’s tariff policies. My Manulife MPF portfolio declined by 0.72%, reaching HK$860,350, slightly underperforming the MPFR All Fund Performance Index, which fell 0.61%. However, the portfolio h
Anthony Tran
1 week ago
Biotech Stock Updates
We focus to look at key drivers of biotech stocks' price movement on 14 May 2025. Incannex Healthcare (NASDAQ: IXHL) shares closed up 866% at US$0.82 following the completion of patient dosing in the Phase 2 portion of its Phase 2/3 RePOSA study evaluating IHL-42X for obstructive sleep apnea (OSA). Bluebird Bio (NASDAQ: BLUE), Carlyle, and SK Capital amended their acquisition agreement. Bluebird stockholders can now choose between US$3.00 per share plus a US$6.84 CVR upon achieving a sales milestone, or US$5.00 p Aytu BioPharma (NASDAQ: AYTU) reported quarterly earnings of US$0.21 per share, exceeding analyst estimates losses of US$0.17 by 223.5% and marking a 140.4% improvement from last year’s US$0.52 loss. Quarterly sales re Septerna (NASDAQ: SEPN) and Novo Nordisk (NASDAQ: NVO) have entered an exclusive global collaboration to discover, develop, and commercialize oral small-molecule medicines for obesity, type 2 diabetes, and other cardio Plus Therapeutics (NASDAQ: PSTV) is expected to report increased earnings on higher revenue for the quarter ending March 2025. Consensus estimates project a US$0.17 per share loss and US$1.85m in revenue. Surpassing th Quoin Pharmaceuticals (NASDAQ: QNRX) observed clear skin improvement in a pediatric peeling skin syndrome study after 12 weeks. Key endpoints showed significant improvement, and the treatment QRX003 was well-tolerated. Allurion Technologies (NASDAQ: ALUR) shares closed up 26% at US$3 following obesity data. Studies highlighted weight loss and muscle gain with their balloon and AI-powered care, both with and without GLP-1s. Combining
V小姐
1 week ago
Global Biotech Weekly
This week, we will focus on key Phase 3 catalysts left for the quarter anticipated in the immediate term over the next two months. Reviva Pharmaceuticals (NASDAQ: RVPH) is a clinical-stage biopharmaceutical company with a market cap under US$100m. The company is focused on developing therapies targe Brilaroxazine is being developed for schizophrenia, with results from the Phase 3 RECOVER trial showing broad-spectrum efficacy and a favorable long-term safety profile. NovoCure (NASDAQ: NVCR) is a commercial-stage oncology company with a market cap in the mid-single-digit billions, known for its Tumor Treating Fields (TTFields) platfor NovoCure’s Phase 3 PANOVA-3 trial evaluated TTFields combined with nab-paclitaxel and gemcitabine for locally advanced pancreatic cancer. Final results released in Decem Gossamer Bio (NASDAQ: GOSS) is a clinical-stage biopharmaceutical company focused on developing therapies for pulmonary diseases. The company has a small market cap unde Seralutinib is currently being evaluated in the Phase 3 PROSERA trial for PAH, following positive results from the Phase 2 TORREY study, which met its primary endpoint. InflaRx N.V. (NASDAQ: IFRX) is a clinical-stage biotech developing anti-inflammatory therapeutics, with a focus on complement factor C5a inhibition. The company has a sm Vilobelimab is in a pivotal Phase 3 trial for pyoderma gangraenosum (PG), a rare neutrophilic dermatosis. The ongoing study follows a promising Phase 2a dose-finding tri
V小姐
1 week ago
德牛中場
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年5月16日德牛中場 近云錢離美股四散他方，尤到歐洲。的確，環顧一眾股市，似僅德指DAX破頂。 廿七年七個月前後的DAX拼圖所見，目前德股儼如1997年尾時處大牛市中段，整固過後尚有三季升浪至明年初，屆時再整固後再展尾浪明秋完成牛市。真這樂觀？ 德股能否倍翻未知，也許升幅未必跟足，但基本因素卻不難解釋。不知不覺間，德國實質GDP已連續七季按年收縮。衰退通常甚少一口氣逾兩年，故時間上似近尾。何況今趟衰退確不像樣──自2023年秋衰起至今，DAX不斷破頂，確實衰得有趣。 衰退市尚如此，不衰自然不得了。一旦俄烏休戰，而中美仍戰令歐洲漁人得利，可見睇好德股的故仔其實早已擺在枱面，只欠一個藉口讓大行帶頭大規模將之炒起。 圖料本月底再輕輕稍插一腳後旋即開始爆上。 羅耕 [email protected]
Gang Law
1 week ago
Is Berkshire Hathaway a Buy Now?
Berkshire Hathaway (BRK.B), the financial conglomerate powered by its insurance business and a diversified portfolio of value stocks, grabbed headlines after major news. On 3 May 2025, legendary Chairman and CEO Warren Buffett stepped down at 94, sparking a sharp share price drop. Berkshire’s stock
Anthony Tran
2 weeks ago
Global Biotech Weekly
As the American Society of Clinical Oncology Conference (ASCO25) approaches, we’re spotlighting key data and late-breaking presentations to watch. With abstracts scheduled for release on 23 May and the conference taking place on 30 May 2025, this preview offers investors ample time to conduct furthe
V小姐
3 weeks ago
古金‧今幣
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年5月9日古金‧今幣 幣圈、fintech界勢必看好比特幣。幣市總值無疑曾自十年八載前的幾十億（bn）美元幾何級數式躍升至疫後的幾十萬億（tn）元；但須承認，過去四年仍徘徊於2兆。 這種現象跟金市的「黃金十年」一樣。自1970年代初廢金本位後，金飆過十年，但此後十年黃金變爛銅。其實，十年足夠讓資產泡沫化和新興的市場成熟化，如2000年代的油價和1920年代的美股。歷史經驗所見，這種十年狂飆過後，往往有廿年唞。 這種十年狂升廿年停之象，未見過一整個市場發展階段的幣圈教徒是難理解的。從當年金價和今日比特幣價發展所見（此圖不宜短線測價），前景似是橫行多於單邊。 羅耕 [email protected]
Gang Law
2 weeks ago
波波啓示
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年5月2日波波啓示 說美股難玩嗎？年初見頂後3月始急挫，劇本並不新鮮，試過多次。說易玩嗎？如斯大幅上落震走不少人。美股的波幅未必拼到好圖，但波幅的波幅則見十年循環。 如圖所料，VVIX確如十年前般短暫見頂，但踩上一格後不似會回，新常態從昔日90以下變為之上。怎理解波幅的波幅高了？波幅即VIX是一個月內標指有多大上落，而波幅的波幅高了即是VIX的波幅高了，意指標指時而窄幅、時而大上落，故難測。 以前VVIX能稍領先VIX，皆因跌市較有秩序，VIX升得漸進。但當指數暴挫、VIX動輒突飆時，其波幅即VVIX也呈相若模式，故亦突飆，使兩者時差接近消失。 這可能跟愈來愈多AI自動操盤有關。同類AI以類近數據訓練，結果行為相似，令市直上直落。反而人肉操盤各有睇法，不至於此。 羅耕 [email protected]
Gang Law
3 weeks ago
Biotech Stock Updates
We focus to look at recent key drivers of biotech stocks' price movement. Relmada Therapeutics (NASDAQ: RLMD) reported Phase 2 results for NDV-01 in non-muscle invasive bladder cancer, with a 90% overall response rate, 89% high-grade recurrence-free survival in papillary disease, and 100% complete r Silo Pharma (NASDAQ: SILO) filed a U.S. patent application for SPC-14, an intranasal Alzheimer’s treatment licensed from Columbia University, covering its novel dual targeting of NMDAR and 5-HT4 receptors to address cognitive Senti Biosciences (NASDAQ: SNTI) reported Phase 1 data for SENTI-202 in relapsed/refractory hematologic malignancies, with a 71% overall response rate across evaluable patients, including complete remissions and MRD negativity UroGen Pharma (NASDAQ: URGN) presented new patient-reported outcomes at AUA2025 showing that UGN-102 maintained bladder function, symptom burden, and quality of life in low-grade intermediate-risk NMIBC patients, reinforcing i Portage Biotech (NASDAQ: PRTG) reported preclinical data showing PORT-7, a selective A2B receptor inhibitor, outperformed anti-PD1 therapy in a mesothelioma model, with combination treatment further enhancing efficacy and prom CG Oncology (NASDAQ: CGON) presented Phase 3 BOND-003 Cohort C data at AUA2025 showing cretostimogene grenadenorepvec achieved a 75.5% complete response rate in high-risk BCG-unresponsive NMIBC, with durable responses lasting ADMA Biologics (NASDAQ: ADMA) announced FDA approval of its yield enhancement process, which increases production yields by approximately 20% from the same starting plasma volume, improving manufacturing efficiency. Tharimmune (NASDAQ: THAR) announced FDA feedback indicating no additional clinical trials are needed before submitting a 505(b)(2) NDA for TH104, a buccal film formulation of nalmefene designed for rapid absorption and potenti
V小姐
4 weeks ago
Biotech Stock Pre-Market Updates
What are the key pre-market updates for biotech stocks? Galmed Pharmaceuticals (NASDAQ: GLMD) announced it has signed a binding term sheet with Entomus s.r.o. for a license agreement to develop and commercialize a proprietary Self-Emulsifying Drug Delivery System (SEDDS) that enables sublingual abso Portage Biotech (NASDAQ: PRTG) reported confirmatory preclinical data showing that PORT-7 (TT-4), a selective adenosine A2B receptor inhibitor, outperformed anti-PD1 antibody treatment in a murine mesothelioma model. The combination of PORT-7 a CG Oncology (NASDAQ: CGON) announced that Phase 3 BOND-003 Cohort C data for cretostimogene grenadenorepvec monotherapy was presented at the 2025 AUA Annual Meeting. In high-risk NMIBC patients unresponsive to BCG, the study showed a 75.5% comp Merck KGaA (NYSE: MRK) and SpringWorks Therapeutics (NASDAQ: SWTX) announced a definitive agreement for Merck KGaA to acquire SpringWorks for US$47 per share in cash, valuing the company at approximately US$3.9bn in equity and US$3.4bn in enter Biohaven (NYSE: BHVN) announced an agreement with Oberland Capital Management LLC for an investment of up to US$600m, with an initial US$250m tranche set to be funded by 30 April 2025. ADMA Biologics (NASDAQ: ADMA) announced FDA approval of its innovative yield enhancement production process. This innovative process has demonstrated an ability to increase production yields by approximately 20% from the same starting plasma vo
V小姐
4 weeks ago
Biotech Stock Updates
We focus to look at key drivers of biotech stocks' price movement on 25 April 2025. Summit Therapeutics (NASDAQ: SMMT) shares closed down 36% at US$23.47 despite China approving Akeso’s ivonescimab (AK112) as a first-line lung cancer monotherapy after a Phase 3 trial showed superior progression-free Molecular Partners (NASDAQ: MOLN) shares traded up 22% at US$5.12 after MP0712, a ²¹²Pb-labeled Radio-DARPin targeting DLL3 for small-cell lung cancer, demonstrated strong preclinical efficacy and safety, with first- VYNE Therapeutics (NASDAQ: VYNE) reported that the FDA verbally informed VYNE Therapeutics that it had placed a clinical hold on the company’s Phase 1b study evaluating VYN202 for treating moderate-to-severe plaque p Acrivon Therapeutics (NASDAQ: ACRV) will present preclinical data at AACR 2025 showing how ACR-2316 a clinical-stage, AP3-enabled WEE1/PKMYT1 inhibitor drives potent single-agent tumor cell death by inducing mitotic BriaCell Therapeutics (NASDAQ: BCTX) priced a US$13.8m public offering of 3.1m units at US$4.50 each, with each unit consisting of one common share and one warrant exercisable at US$5.25. The company intends to use t Lexaria Bioscience (NASDAQ: LEXX) announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale of 2.0m shares of common stock at a purchase price of US$1.00 Cyclacel Pharmaceuticals (NASDAQ: CYCC) issued a US$0.15 per share quarterly dividend payable on 1st May to shareholders recorded by 29th April, the ex-dividend date. Separately, Cyclacel Pharmaceuticals has been gra
V小姐
4 weeks ago
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
V小姐
4 weeks ago
金牛至今秋
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年4月25日金牛至今秋 金價升進3字頭後始趨波動，無他，說驚通脹但通脹跌，金升之初雖有基本面，但現漸脫離並已始泡沫化。泡沫本義是愈升愈急，最終偏離基本而爆，問題是幾時。 跟1980年代比較的拼圖更新過後，可見現將結束第二段升浪，時為一、兩週內；第一升浪為2011至15年熊市後的2016至20年。第三或最後升浪勢必急勁，多於一、兩季內完成。圖料尾浪將為時一季至8月底。那幅度呢？ 從來拼圖度時間準過度空間。今天通脹沒如1980年般失控，會否呈此尖頂成疑。然則目前調整確未必太深，料跌盡五、七百元。至於8月終極頂，目測較有把握為5,500元，再高則可遇不可求。這類終極高/低，通常見到開價亦做不到。 泡爆以後，跌回來亦以3,000元為底，故此前買者別恐；當然，無息收是另回事。 羅耕 [email protected]
Gang Law
4 weeks 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
1 month 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
1 month ago
兩操作位
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年4月18日兩操作位 七年前後，又是特朗普，又是關稅戰，美股又是1月見頂，又是次季挫。縮命？ 特朗普上屆時並無一埋位即開戰，而是拖至2018年才打，故時差七年而非八年。七年前後之別，在於當年之前並無孳息曲線倒掛，當年沒有衰退，失業率還在下跌。今舖截然不同，故當年無熊不等於今舖無，當年首個跌浪僅逾一成，今已超過兩成。 短線睇，也許4、5月間應完成首輪造腳，恰巧另些拼圖也有此預示。至於下半年V彈也在預計之中，但即使當年無熊調整也衰收尾呈M字回落，今舖看來只有更劣，起碼彈不易破頂，跌則更易穿底，儘管今年全年埋單計也許似大上落多於失重直落。 縱貿戰最終縮窄至僅中美兩國打，殺傷力亦不低。對食勢者而言，今年的操作位看來仍僅立夏、立冬各一。 羅耕 [email protected]
Gang Law
1 month ago
又大蕭條？
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年4月11日又大蕭條？ 美股日前在關稅背景下大冧，坊間都在跟大蕭條比，包括美股。 美股在1929股災前P/E達30倍許，而兩個月前見頂時僅25倍許，還未及當年。據NBER紀錄美國衰退始自1929年8月，股市9月見頂，而斯姆特霍利關稅法則遲至1930年6月中才生效。顯然，關稅導致股災、大蕭條之說，在時序上完全站不住腳。 追本溯源，若未曾長升泡沫過又哪來股災？比較兩段歷史，皆先有呆滯十幾年，再有咆哮的十年，分別在於2010年代有量寬水浸市，升得靚，而咆哮1920年代則無。1920年代後期，歷史尚短的美股經歷首度瘋癲，相對於九十二年後則市場成熟得多。 當年有連翻政策錯誤，今天則有科技突破利好，解釋了緣何今不是大蕭條跌市；而如圖所見，道指事實上亦沒重蹈當年的覆轍。宜慎妨妖言惑眾。 羅耕 [email protected]
Gang Law
1 month 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
1 month 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
1 month 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
2 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
7 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
2 months ago
債市測股
《紅藥丸雜誌》專欄羅耕〈財經DNA〉2025年4月4日債市測股 早輪還講金髮女郎，如今市跌如此，終於想起衰退，進而醒起孳息曲線倒掛。 倒掛測衰之所以教人氣憤，還因訊號太早兼不準時──領先四至六季且誤差大，但這卻是其正宗本質。等到衰退埋身，不少人早已忘記了這訊號，甚至已認定失準。 須知這倒掛不是普通一個經濟指標，而是集全球最有眼光最有錢的債市看法──最叻的炒手最大的盤，都在債而非股。債市睇到達四至六季，股市只睇到一、兩季。 長短息差測美股，要測按年變幅；附圖更新過後時差修正至兩年，短線有偏差，但大方向尚可。圖料今年美股要按年跌好幾成；以坊間兩成為熊界，這無疑是熊市。 較諸之前熊市，今次（藍線）所料的為時不短，且料跌幅不小。債佬一早睇到，只是股佬轉了熊市仍能保持樂觀。 羅耕 [email protected]
Gang Law
2 months ago
東升西降？
《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
2 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 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
7 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
7 months ago
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,
V小姐
7 months ago
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