Core Insights - Amplia Therapeutics Limited is making significant progress in the clinical development of its FAK inhibitor, narmafotinib, particularly for metastatic pancreatic cancer, with promising results from ongoing trials [2][3][17] Clinical Trial Updates - The ACCENT trial, which combines narmafotinib with gemcitabine and Abraxane®, has reported an overall response rate of 35%, significantly higher than the 23% response rate for chemotherapy alone [3][17] - The mean duration on trial for patients was 219 days, with some patients remaining on the study for over 12 months, indicating the drug's potential to halt cancer progression [4] - The AMPLICITY trial has commenced, investigating narmafotinib in combination with FOLFIRINOX chemotherapy, with patient recruitment ongoing in Melbourne and Sydney [6][7] Regulatory and Commercial Developments - Positive feedback from the US FDA has been received regarding the dose optimization strategy for narmafotinib, which supports its planned Phase 2b/3 trial [8] - A key patent for narmafotinib has been granted, extending protection until at least 2040 in the US and other jurisdictions [9] - Amplia has successfully uplisted to the US-based OTCQB Venture Market, enhancing its visibility and investor reach [10] Preclinical Studies - The second phase of a research collaboration with Next & Bio has been initiated, focusing on evaluating narmafotinib against patient-derived pancreatic cancer cells with specific genetic mutations [11] Financial Update - Amplia reported a cash position of $31.5 million at the end of December 2025, with net operating cash inflows of $2.4 million during the quarter [13] - The company received $3.8 million from government grants and tax incentives, while outflows included $0.9 million for staff and administration costs, and $0.9 million for research and development [14]

SOUTH SAN FRANCISCO, Calif., Jan. 30, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology,” Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend patients’ lives, today announced the pricing of an underwritten offering of common stock and pre-funded warrants. ALX Oncology is selling 76,979,112 shares of common stock and, in lieu of common stock to certain investors, pre-funded warrants to purchase 18,574,120 shares of ...

Core Insights - ALX Oncology announced new data from a Phase 1b/2 clinical trial evaluating the CD47-inhibitor evorpacept in combination with Jazz Pharmaceuticals' ZIIHERA® for metastatic breast cancer, reinforcing CD47 as a predictive biomarker for treatment response [1][2] Group 1: Clinical Trial Findings - The Phase 1b/2 trial demonstrated promising anti-tumor activity and a manageable safety profile in heavily pretreated HER2-positive breast cancer patients, with a median of six prior therapies [2] - The combination treatment achieved a confirmed objective response rate (cORR) of 56% (5 out of 9 patients) and a median progression-free survival (mPFS) of 7.4 months [2] - Additional exploratory analysis indicated that responses were largely restricted to patients with higher CD47 expression, supporting findings from the ASPEN-06 trial [3] Group 2: Future Directions - The company plans to adopt a biomarker-driven approach for patient selection in future trials involving evorpacept and HER2-targeted agents [2] - Full biomarker analysis from the Phase 1b/2 trial has been submitted for presentation at an upcoming scientific congress [4] Group 3: Company Overview - ALX Oncology is a clinical-stage biotechnology company focused on developing novel therapies for cancer treatment, with evorpacept as a lead candidate [5] - The company is also advancing a second pipeline candidate, ALX2004, which is currently in a Phase 1 trial for EGFR-expressing solid tumors [5]

- Exploratory analysis from Phase 1b/2 breast cancer trial reinforces CD47 as a predictive biomarker for response, as previously observed in the ASPEN-06 trial in HER2-positive gastric cancer – - Full data set submitted for presentation at an upcoming scientific conference - SOUTH SAN FRANCISCO, Calif., Jan. 30, 2026 (GLOBE NEWSWIRE) -- ALX Oncology Holdings Inc. (“ALX Oncology,” Nasdaq: ALXO), a clinical-stage biotechnology company advancing a pipeline of novel therapies designed to treat cancer and extend ...

PARAMUS, NJ, Jan. 30, 2026 (GLOBE NEWSWIRE) -- Polaryx Therapeutics (“Polaryx” or the “Company”) a clinical-stage biotechnology company dedicated to the discovery, development, and commercialization of novel, disease-modifying therapies for rare, pediatric lysosomal storage disorders (“LSDs”), today announced that shares of the Company’s common stock have been approved for listing on the Nasdaq Capital Market (“Nasdaq”) under the ticker symbol “PLYX”. Shares of Polaryx common stock are expected to commence ...

Extends cash runway into 2028 Proceeds expected to enable completion of ProMIS’ landmark  Phase 1b AD study and support execution of key clinical milestones Blinded 6-month top-line data expected mid-2026; 12-month top-line data expected toward end of 2026 CAMBRIDGE, Massachusetts , Jan. 30, 2026 (GLOBE NEWSWIRE) -- ProMIS Neurosciences Inc. (Nasdaq: PMN) (“ProMIS” or the “Company”), a clinical-stage biotechnology company focused on the generation and development of antibody therapeutics and vaccines targe ...

I have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space.Analyst’s Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wr ...

− Phase 2 Data Strengthened, Strong Cash Position, and Phase 3 Planning Well Advanced − Highlights Phase 2 data for ATH434 in Multiple System Atrophy (MSA) strengthened by additional analyses and multiple international scientific presentations during the quarter.Regulatory planning activities advancing toward a pivotal Phase 3 program, including preparation for FDA End-Of-Phase-2 meeting in mid-2026.Ongoing partnering and strategic discussions with pharmaceutical companies and corporate advisers to explore ...

Immunocore announces R&D leadership evolution Dr. David Berman will depart the Company Dr. Mohammed Dar, Chief Medical Officer, and Mark Moyer, Head of Regulatory Sciences, promoted to Executive Vice President roles (OXFORDSHIRE, England & RADNOR, Penn. & GAITHERSBURG, Md., US, 30 January 2026) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for p ...

Core Insights - Regeneron Pharmaceuticals reported strong financial performance in 2025, driven by four blockbuster medicines and a promising late-stage clinical portfolio [2][3] - The company achieved significant label expansions and new approvals for its key products, including EYLEA HD and Dupixent, enhancing their commercial potential [2][4] Financial Highlights - Total revenues for Q4 2025 were $3,884 million, a 3% increase from Q4 2024, while full year revenues reached $14,343 million, up 1% from 2024 [3][14] - GAAP net income for Q4 2025 was $845 million, down 8% from Q4 2024, with a full year GAAP net income of $4,505 million, an increase of 2% [3][14] - Non-GAAP net income for Q4 2025 was $1,249 million, a decrease of 10% from Q4 2024, while full year non-GAAP net income was $4,888 million, down 8% [3][14] Business Highlights - Dupixent global net sales increased by 34% in Q4 2025 to $4.9 billion, with full year sales rising 26% to $17.8 billion [4][14] - EYLEA HD U.S. net sales surged 66% in Q4 2025 to $506 million, with full year sales increasing 36% to $1.6 billion [4][14] - Libtayo received additional approvals and is now the leading immunotherapy for non-melanoma skin cancers [2][4] Pipeline Progress - Regeneron has approximately 45 product candidates in clinical development, with several key updates expected in 2026 [4][10] - Upcoming milestones include FDA decisions for EYLEA HD pre-filled syringe and Dupixent's regulatory submissions for new indications [13][28] Capital Allocation - The company repurchased $671 million of its common stock in Q4 2025 and $3.5 billion for the full year, with $1.5 billion remaining for future repurchases [26] - A cash dividend of $0.94 per share was declared, payable on March 5, 2026 [27] 2026 Financial Guidance - Regeneron projects GAAP R&D expenses between $6.450 billion and $6.680 billion for 2026, with non-GAAP R&D expenses expected to be between $5.900 billion and $6.100 billion [28][29] - The company anticipates a GAAP effective tax rate of 12% to 14% for 2026 [28]