This week's biotech landscape features key FDA approvals, clinical holds and go-aheads, trial discontinuations, and clinical trial data readouts across key therapeutic areas such as Endometrial cancer, Colorectal cancer, Weight Management, Acne, and Duchenne muscular dystrophy. Let us unpack the key developments and milestones in the biotech space this week.FDA Approvals & RejectionsIntellia Gets FDA Green Light to Resume MAGNITUDE-2 Phase 3 TrialIntellia Therapeutics, Inc. (NTLA) said the U.S. FDA has lif ...

Key Takeaways OM shares gain 14.3% after FDA 510(k) clearance for its next-generation Tablo hemodialysis system.OM's redesigned Tablo embeds cybersecurity across hardware, software and cloud.OM plans to ship the new Tablo in Q2 2026, with upgrade eligibility for existing customers.Outset Medical, Inc. (OM) recently announced that its next-generation Tablo hemodialysis system has received 510(k) clearance, marking a key regulatory milestone for the company. The clearance positions Tablo as the first dialysis ...

SAN JOSE, Calif., Jan. 27, 2026 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM), a medical technology company pioneering a first-of-its-kind technology to improve clinical outcomes in dialysis with less cost and complexity, today announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) of its next-generation Tablo platform, designed to deliver enterprise-level security, reliability and connectivity for hospitals, health systems and home providers of dialysis. With the clearance, Tablo ...

SAN JOSE, Calif., Jan. 26, 2026 (GLOBE NEWSWIRE) -- Outset Medical, Inc. (Nasdaq: OM) (“Outset”), a medical technology company pioneering a first-of-its-kind technology to reduce the cost and complexity of dialysis, today announced that it will release financial results for the fourth quarter and full-year 2025 after the close of trading on Wednesday, February 11, 2026. On the same day, at 1:30 p.m. Pacific time (4:30 p.m. Eastern time), Leslie Trigg, Chair and Chief Executive Officer, and Renee Gaeta, Chie ...

MONTRÉAL, Jan. 22, 2026 (GLOBE NEWSWIRE) -- Osisko Metals Incorporated (the "Company" or "Osisko Metals") (TSX: OM; OTCQX: OMZNF; FRANKFURT: 0B51) is pleased to announce new drill results from the Gaspé Copper Project, located in the Gaspé Peninsula of Eastern Québec. New analytical results are presented below (see Table 1), including 29 mineralized intercepts from ten new drill holes. Infill intercepts are located inside the 2024 MRE model (see November 14, 2024 news release), and are focused on upgrading ...

Core Insights - Osisko Metals has announced new drill results from the Gaspé Copper Project, highlighting significant mineralization and potential resource expansion [1][2]. Summary by Category Drill Results - The recent drilling program included 35 mineralized intercepts from ten new drill holes, focusing on upgrading inferred mineral resources to measured or indicated categories [2]. - Drill hole 30-1143 (Southern Extension) reported 163.5 metres averaging 0.47% Cu and 3.41 g/t Ag, confirming higher grades in this zone [16]. - Drill hole 30-1142 showed 585.0 metres averaging 0.24% Cu and 245.0 metres averaging 0.55% Cu, indicating significant mineralization depth [15]. - Drill hole 30-1144 reported 748.0 metres averaging 0.27% Cu, extending mineralization to a vertical depth of 895 metres [17]. Mineral Resource Expansion - The current drill program aims to convert the November 2024 Mineral Resource Estimate (MRE) to Measured and Indicated categories and test for deeper and lateral expansions [22]. - The Gaspé Copper Project hosts the largest undeveloped copper resource in eastern North America, with current Indicated Mineral Resources of 824 million tonnes averaging 0.34% CuEq [29]. Geological Context - Mineralization at Gaspé Copper is characterized as porphyry copper/skarn type, with significant occurrences of chalcopyrite, pyrite, and molybdenite [20]. - The drilling strategy involves targeting altered calcareous stratigraphy, intersecting skarn/marble horizons that host the bulk of the disseminated copper mineralization [23]. Future Outlook - The next scheduled MRE update is anticipated in Q1 2026, incorporating new mineralized intersections below the previously defined resource limits [22].

Company Overview - Outset Medical is a California-based med tech company focused on improving dialysis care, aiming to enhance patient outcomes while reducing costs and complexity [2] Market Presence - The company operates in the $2.5 billion acute and post-acute market, with over 1,000 hospitals using its product, Tablo, to deliver approximately 1 million treatments annually [2] - Tablo has been utilized for over 3.5 million treatments in the U.S. [2] - Outset Medical is also establishing a presence in the $8.9 billion home dialysis market, which has been underserved [3]

Outset Medical (NasdaqGS:OM) FY Conference January 14, 2026 07:30 PM ET Company ParticipantsLeslie Trigg - Chair and CEORenee Gaeta - CFODenise Liu - Healthcare Investment Banking AssociateConference Call ParticipantsNone - Analyst 3None - Analyst 1None - Analyst 2Denise LiuHi everyone, my name is Denise Liu. I am an Associate here in Healthcare Investment Banking at JPMorgan. We're excited to be continuing the annual healthcare conference today with Leslie Trigg, Chair and CEO of Outset Medical. We'll have ...

Core Viewpoint - Outset Medical, Inc. experienced a significant stock price increase of 22.2% to $5.57, driven by strong trading volume and positive investor sentiment following the announcement of its unaudited revenue for Q4 and fiscal year 2025 [1][2]. Group 1: Financial Performance - For the fourth quarter of fiscal year 2025, Outset Medical reported revenue of approximately $28.9 million, contributing to a total revenue of about $119.5 million for the year, reflecting a 5% year-over-year increase [2]. - The upcoming quarterly report is expected to show a loss of $0.45 per share, which represents a year-over-year change of +91.9%, with revenues anticipated to be $26.9 million, down 8.7% from the previous year [3]. Group 2: Market Sentiment and Stock Performance - The stock's price increase is attributed to investor optimism regarding the company's financial outlook and the recent appointment of Karen N. Prange to the board of directors [2]. - The consensus EPS estimate for Outset Medical has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4]. - Outset Medical holds a Zacks Rank of 2 (Buy), suggesting a favorable outlook compared to other stocks in the same industry, such as Clover Health Investments, which has a Zacks Rank of 3 (Hold) [4].

Revenue Projections - Outset Medical expects fourth quarter revenue for 2025 to be approximately $XX million, representing a year-over-year increase of XX%[5] - The company anticipates full year revenue for 2025 to be around $XX million, reflecting a growth of XX% compared to 2024[5] - Tablo console shipments are projected to increase significantly, contributing to the overall revenue growth[14] Cost Management and Optimization - The company is implementing cost reduction actions and initiatives to optimize its commercial organization, aiming to improve gross margins[14] - Outset Medical's cash position at year-end 2025 is expected to be sufficient to reach cash flow breakeven[14] Market Expansion and Product Development - The company is focusing on expanding its market presence and addressing total addressable market opportunities for Tablo[14] - The company is committed to enhancing its product offerings and exploring new technologies to drive future growth[14] Leadership Changes - Outset Medical has appointed Karen Prange to the Board of Directors, filling the vacancy left by Andrea Saia's resignation[8] Macroeconomic Outlook - Management is optimistic about the impact of macroeconomic factors on the company's operations and customer relationships[14] Reporting and Transparency - The company will provide further details in its upcoming Annual Report on Form 10-K[6]