PITTSBURGH, Pa. and TORONTO, Oct. 08, 2025 (GLOBE NEWSWIRE) -- Sharp Therapeutics Corp. ("Sharp" or the "Company") (TSX-V: SHRX) (OTCQB: SHRXF), a biotechnology company developing small-molecule therapeutics for genetic diseases, today announced that it will present preclinical data from its lead Phase 1 ready ‘901 program being developed to treat Gaucher disease and Glucocerebrosidase (GBA) Parkinson's disease at the World Orphan Drug Congress 2025. The meeting will take place from October 27 to 29, 2025, ...

Group 1 - The biotechnology company has launched a new direct-to-patient program called AmgenNow, which initially focuses on its drug Repatha [1]

SciSparc Ltd. (NASDAQ:SPRC) said Monday it has entered a framework agreement with AutoMax Motors Ltd. to mutually terminate their planned merger, officially ending a deal that would have expanded the company into Israel’s automotive market. The Tel Aviv-based drug developer stated that the October 6, 2025, agreement outlines repayment terms for prior loans extended to AutoMax and supersedes the earlier merger pact. Both companies agreed to end all merger-related obligations and settle financial commitments ...

Core Viewpoint - MoonLake Immunotherapeutics is under investigation for potential violations of federal securities laws following disappointing results from its Phase 3 VELA trials for sonelokimab, leading to a significant drop in stock price [1][3]. Company Overview - MoonLake Immunotherapeutics is a clinical stage biotechnology company focused on therapies for inflammatory skin and joint diseases [2]. Trial Results - On September 29, 2025, MoonLake reported week 16 results from the VELA Phase 3 trials, which were disappointing and raised concerns about the drug's regulatory approval and commercial viability [3]. - The stock price plummeted by $55.75 per share, nearly 90%, from $61.99 on September 28, 2025, to $6.24 on September 29, 2025, following the announcement of the trial results [3]. Legal Implications - Investors in MoonLake are encouraged to seek legal options due to the potential violations of securities laws related to the trial results [1][4]. Law Firm Background - Bleichmar Fonti & Auld LLP is a leading international law firm specializing in securities class actions and shareholder litigation, with a strong track record of recovering significant amounts for clients [6].

Core Insights - MediWound has received marketing authorization for NexoBrid from Australia's Therapeutic Goods Administration (TGA), allowing its use for both adults and children with deep partial- and full-thickness thermal burns [1][2] - NexoBrid is now authorized in 45 countries, establishing it as a new standard of care in burn management, with a commercial launch expected in Australia in Q4 2025 [2][3] - The company is expanding its manufacturing capabilities, which are on track for completion by the end of 2025, to meet global demand for NexoBrid [2][3] Product Overview - NexoBrid is a topically administered biological orphan drug designed for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns, preserving viable tissue while removing non-viable tissue [4] - The product is already approved in over 40 countries, including the United States, European Union, and Japan [4][5] Company Background - MediWound Ltd. is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair, with NexoBrid being its FDA-approved product [5] - The company is also advancing EscharEx, a late-stage investigational therapy for chronic wound debridement, which has shown clinical advantages over leading products in the market [5] Market Expansion - The TGA approval of NexoBrid is seen as a significant step in improving access to innovative burn care solutions in Australia and opens opportunities for expansion into the broader Asia-Pacific region [3] - Balance Medical, MediWound's exclusive partner in Australia, is expected to initiate the commercial launch of NexoBrid in the fourth quarter of 2025 [2][3]

Core Insights - Elicio Therapeutics announced promising immunogenicity data from its Phase 2 AMPLIFY-7P trial, showing that approximately 99% of evaluable patients generated strong mKRAS-specific T cell responses with an average increase of 145.3 times over baseline [1][4][6] Group 1: Trial Results - In the ongoing Phase 2 AMPLIFY-7P trial, 89 out of 90 evaluable patients exhibited robust mKRAS-specific T cell responses [1][4] - The average fold change in T cell response was 145.3x, with a median fold change of 44.3x and a range from 2.13x to 1310x [3][4] - The T cell response rate was 99% in the Phase 2 trial compared to 100% in the Phase 1 trial, which included only MRD+ patients [3][4] Group 2: Clinical Correlation - T cell immune responses in the ELI-002 trials were significantly correlated with clinical activity in minimal residual disease positive (MRD+) patients [2][5] - The Phase 1 ELI-002 2P trial indicated that an mKRAS-specific T cell response of approximately 9x over baseline correlated with delayed relapse or death in MRD+ patients [5] Group 3: Future Prospects - The final disease-free survival analysis for the AMPLIFY-7P trial is anticipated in the fourth quarter of 2025, which could support the expansion of ELI-002 to a broader patient population [2][6] - Elicio's AMP technology aims to enhance the education and activation of cancer-specific T cells, potentially leading to durable cancer immunosurveillance [12][10] Group 4: Product Overview - ELI-002 is a novel investigational Amphiphile cancer vaccine targeting KRAS mutations, which are prevalent in many cancers [8][12] - The ELI-002 7P formulation is designed to provide immune response coverage against seven common KRAS mutations, increasing the potential patient population [9][12]

Core Insights - Actinogen Medical Limited is progressing with its pivotal phase 2/3 trial for Xanamem, targeting Alzheimer's disease, with interim analysis expected in January 2026 and final results anticipated in late 2026 [1][2] - The company has reached a significant agreement with the FDA regarding the pathway to marketing approval for Xanamem, which includes the design of an additional pivotal clinical trial and a limited number of ancillary studies [2][3] Group 1: Regulatory Developments - The FDA meeting confirmed the regulatory starting materials for drug substance synthesis and the design of one additional pivotal clinical trial [2][6] - Actinogen plans to submit a New Drug Application (NDA) in the US and to other global regulators, following the FDA's guidance [2][3] - A similar meeting with the European Medicines Agency is scheduled for 2026, indicating a global regulatory strategy [3] Group 2: Clinical Trial Details - The ongoing XanaMIA trial involves 220 participants with mild to moderate Alzheimer's disease and is currently enrolling in Australia and the US [7] - The pivotal trial will utilize a single 10 mg dose of Xanamem compared to a placebo, as agreed upon with the FDA [4][6] - The trial design includes a small number of ancillary clinical pharmacology trials and nonclinical studies to further characterize Xanamem [6] Group 3: Product Information - Xanamem (emestedastat) is a novel oral therapy designed to control cortisol levels in the brain, which is linked to Alzheimer's disease progression and depressive symptoms [8] - The drug has shown promising safety and efficacy in previous clinical trials, with over 400 participants treated [7][8] - Xanamem's mechanism of action involves inhibiting the cortisol synthesis enzyme 11β-HSD1, targeting areas of the brain where cortisol is known to be toxic [8]

Summary of Aligos Therapeutics Conference Call Company Overview - **Company**: Aligos Therapeutics - **Industry**: Biotechnology, focusing on liver and viral diseases - **Mission**: To improve patient outcomes by developing best-in-class therapies for chronic hepatitis B virus (HBV) infection and metabolic dysfunction-associated steatohepatitis (MASH) [1][34] Key Drug: ALG-000184 - **Type**: Capsid assembly modulator for HBV - **Discovery**: Originated from research by Professor Raymond Schinazi at Emory University, known for developing several antiviral drugs [3][4] - **Mechanism of Action**: - Binds to HBV core protein, preventing encapsulation of pregenomic RNA, thus blocking DNA production [4][16] - Evokes a secondary mechanism that reduces CCC DNA, a long-lived viral reservoir [6][17] - **Pharmacokinetics**: - Improved from 5% to 80% oral bioavailability [5] - Demonstrated significant reductions in HBV DNA and surface antigens in clinical studies [6][7] Clinical Data and Efficacy - **Phase 1B Study**: - 96-week data showed no emergence of drug resistance, allowing for potential monotherapy [10][11] - Achieved 100% of E antigen negative patients below 10 international units of HBV DNA at week 48, compared to historical data of around 20% for standard treatments [21][22] - **Endpoints**: - Primary endpoint for monotherapy is chronic suppression of HBV DNA [18][19] - Importance of achieving below 10 international units for better long-term outcomes, including reduced liver cancer progression [20][22] Future Development: B Supreme Study - **Design**: Ongoing phase 2 study comparing ALG-000184 with TDF in both E positive and E negative patients [24][25] - **Goals**: - Superiority in HBV DNA endpoints and antigen reductions [27][28] - Paired biopsies to quantify integration events and CCC DNA levels [28] Competitive Landscape - **Positioning**: ALG-000184 aims to become the standard of care for chronic HBV suppression and a backbone for functional cure regimens [30][31] - **Antisense Oligonucleotide Program**: Aligos is developing its own ASO program to complement ALG-000184, enhancing potential treatment options [31] Other Drug: ALG-055009 for MASH - **Mechanism**: Targets metabolic dysfunction in liver disease, showing significant fat reduction in phase 2A studies [36][37] - **Combination Potential**: Compatible with GLP-1 therapies, enhancing fat reduction and weight loss [38][39] Upcoming Milestones - **2025-2027 Timeline**: - Final data from the 96-week study of ALG-000184 to be presented at AASLD [41] - Interim readout from the B Supreme study in 2026 [41] - Partnership announcement for ALG-055009 expected early next year [42] Conclusion - Aligos Therapeutics is positioned to address significant unmet needs in the treatment of HBV and MASH, with promising clinical data and a robust pipeline aimed at improving patient outcomes in these areas [40][43]

Core Insights - Septerna, Inc. is advancing its next-generation oral small molecule PTH1R agonist program for hypoparathyroidism, with plans to select a development candidate in Q3 2025 and initiate a Phase 1 clinical trial in H1 2026 [2][3] - The company is also initiating a Phase 1 clinical trial for SEP-631, an oral small molecule for mast cell diseases, in Q3 2025 [7] - Septerna's cash position is strong, with $379.2 million in cash and equivalents as of June 30, 2025, and an expected cash runway extending into 2029 following a $195 million upfront payment from Novo Nordisk [12][15] PTH1R Agonist Program - The PTH1R agonist program aims to provide full-day calcium control for patients with hypoparathyroidism, with a development candidate selection expected in Q3 2025 [3] - A Phase 1 clinical trial is planned to commence in the first half of 2026 after successful preclinical development [3] SEP-631 MRGPRX2 NAM Program - SEP-631 is a selective oral small molecule MRGPRX2 negative allosteric modulator for mast cell diseases, with a Phase 1 trial to assess safety and tolerability in healthy volunteers starting in Q3 2025 [7] Collaboration with Novo Nordisk - A global collaboration and license agreement with Novo Nordisk became effective on July 1, 2025, focusing on the discovery and development of oral small molecule therapies for obesity, type 2 diabetes, and other cardiometabolic diseases [7] - Septerna received a $195 million upfront payment as part of this collaboration [7] Business Highlights - The company continues to progress its TSHR NAM program, moving multiple lead compounds closer to development candidate selection for treating Graves' disease and thyroid eye disease [7] - Septerna's discovery-stage programs are advancing across various therapeutic areas utilizing its Native Complex Platform™ [7] Financial Results - For Q2 2025, Septerna reported R&D expenses of $22.2 million, up from $15.0 million in Q2 2024, and G&A expenses of $6.9 million, compared to $3.4 million in the same period [12] - The net loss for Q2 2025 was $24.8 million, compared to a net loss of $16.4 million in Q2 2024 [12][14]

Core Insights - Relay Therapeutics reported a strong second quarter for 2025, exceeding analyst expectations in both earnings and revenue, with GAAP earnings per share of $0.41 compared to an expected $(0.49) and GAAP revenue of $0.7 million versus an estimate of $0.07 million [1][2] Financial Performance - The company achieved a year-over-year reduction in R&D expenses by 30.6%, amounting to $63.9 million, and a decrease in G&A expenses by 32.3%, totaling $13.6 million [2][7] - Cash, cash equivalents, and investments stood at $656.8 million as of June 30, 2025, down from $710.4 million at the end of Q1 2025, but projected to fund operations into 2029 [2][8] Clinical Development - The lead drug candidate, RLY-2608, demonstrated positive results in clinical trials, with a median progression-free survival of 10.3 months and a 39% objective response rate in patients with specific breast cancer mutations [5][6] - The initiation of the Phase 3 ReDiscover-2 trial for RLY-2608 combined with fulvestrant marks a significant milestone, with additional studies exploring combination therapies for advanced breast cancer [6][9] Strategic Focus - The company is concentrating on advancing its clinical trials, managing costs effectively, and leveraging strategic collaborations to enhance drug development and commercialization [4][10] - Relay Therapeutics did not provide specific financial guidance for future quarters but emphasized the importance of enrolling patients for the pivotal Phase 3 trial of RLY-2608 [9][10]