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36 minutes ago

United Therapeutics secures FDA clearance for SUMMIT trial

Full story: https://grafa.com/en/news/united-states/united-therapeutics-fda-clearance-summit-treprostinil-trial United Therapeutics received authorization to proceed with its Phase 2 SUMMIT trial of treprostinil SMI for pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). The 16-week study will evaluate safety and tolerability in approximately 40 patients, with secondary endpoints measuring exercise capacity and the heart-related biomarker NT-proBNP. United Therapeutics anticipates beginning a Phase 3 registration study in 2028, provided the Phase 2 results are successful. United Therapeutics (NASDAQ:UTHR) received FDA clearance to proceed with a Phase 2 trial of treprostinil SMI for pulmonary hypertension associated with COPD. The 16-week, double-blind S
United Therapeutics secures FDA clearance for SUMMIT trial
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42 minutes ago

Cullinan reports 30.2% brain metastasis response with zipalertinib

Full story: https://grafa.com/en/news/united-states/cullinan-zipalertinib-rezilient2-brain-metastases-response-2026 Cullinan Therapeutics and Taiho Oncology reported a 30.2% intracranial objective response rate among 43 evaluable patients in Cohort C of the Phase 2 REZILIENT2 trial. Zipalertinib achieved a 72.1% intracranial disease control rate and a median intracranial duration of response of 9.7 months in patients with EGFR-mutated lung cancer and active brain metastases. The companies plan to present the findings at the ESMO Congress 2026 in Madrid, October 23–27, while continuing zipalertinib's clinical and regulatory development. Cullinan Therapeutics (NASDAQ:CGEM) and Taiho Oncology reported a 30.2% intracranial response rate for zipalertinib in 43 evaluable lung cancer patients wit
Cullinan reports 30.2% brain metastasis response with zipalertinib
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42 minutes ago

Summit Therapeutics opens Phase 2 kidney cancer trial

Full story: https://grafa.com/en/news/united-states/summit-therapeutics-ivonescimab-phase-2-kidney-cancer-trial Summit Therapeutics announced the initiation of its Phase 2 SMT112-216 study of ivonescimab in previously untreated advanced clear cell renal cell carcinoma (ccRCC). The randomized study plans to enroll approximately 100 patients across the United States and China, evaluating ivonescimab alone and in combination with other cancer therapies. Summit and partner Akeso are expanding ivonescimab research beyond lung cancer, including kidney cancer treatment combinations and other solid tumors. Summit Therapeutics (NASDAQ:SMMT) announced the opening of a Phase 2 kidney cancer trial evaluating ivonescimab-based treatments in approximately 100 patients across two countries. The study wil
Summit Therapeutics opens Phase 2 kidney cancer trial
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52 minutes ago

Veradermics reports Phase 3 hair growth results

Full story: https://grafa.com/en/news/united-states/veradermics-vdphl01-phase-3-hair-growth-study-304 Veradermics reported that its investigational hair loss treatment, VDPHL01, met all primary and secondary endpoints in the Phase 3 Study 304 trial involving 536 men. Average hair counts increased by 28.6 hairs/cm² with once-daily treatment and 36.4 hairs/cm² with twice-daily treatment, compared with 6.6 hairs/cm² for placebo. The company said positive results from Studies 302 and 304 support its pursuit of FDA approval for VDPHL01, although the treatment remains investigational. Veradermics (NYSE:MANE) reported positive Phase 3 results for VDPHL01, with both dosing regimens significantly increasing hair counts versus placebo after six months. Average increases reached 28.6 hairs/cm² with o
Veradermics reports Phase 3 hair growth results
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54 minutes ago

Cosmos Health forecasts $15 million U.S. sales

Full story: https://grafa.com/en/news/united-states/cosmos-health-q4-2026-us-revenue-15-million-forecast Cosmos Health expects approximately $15 million in U.S. direct-to-consumer revenue for Q4 2026, supported by expanded marketing activity and subscription sales. The company forecasts approximately $10.5 million in gross profit, equivalent to a 70% gross margin, for its U.S. online business. Active U.S. subscriptions reportedly reached 8,940 on October 19, up 42% from October 14, with management targeting more than 40,000 by year-end. Cosmos Health (NASDAQ:COSM) forecasts approximately $15 million in fourth-quarter 2026 U.S. direct-to-consumer revenue, with projected gross profit of $10.5 million. The forecast represents a 70% gross margin for its U.S. online business, compared with roug
Cosmos Health forecasts $15 million U.S. sales
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11:58

Freelancer moves to operating profit as costs decline 11%

Full story: https://grafa.com/en/news/australia/freelancer-moves-to-operating-profit-as-costs-decline-11 Freelancer returned to an operating profit in the third quarter of 2026. Expenses decreased 11%, helping drive an operating profit of $0.1 million. Key drivers included record results from Loadshift and Escrow.com, offsetting revenue declines from a core Freelancer business still recovering from operational challenges. Freelancer (ASX:FLN) achieved an operating profit of $0.1 million for the third quarter of 2026, as a 11.0% cost reduction effort delivered savings. The result marks a significant improvement from the $0.3 million operating loss recorded in the first half of 2026. This improvement was primarily driven by lower operating expenses, which fell by $1.2 million to $8.9 million
Freelancer moves to operating profit as costs decline 11%
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11:56

Critical Resources secures exclusivity over third Suriname Gold Project

Full story: https://grafa.com/en/news/australia/critical-resources-secures-exclusivity-over-third-suriname-gold-project Critical Resources secured exclusivity to acquire a 90% interest in the Gadu Manda Gold Project in Suriname. The consideration structure includes US$200,000 in cash over two years alongside 2,500,000 company shares. The transaction expands the company's exclusivity footprint across Suriname to approximately 228km2. Critical Resources (ASX:CRR) has secured exclusivity to acquire a 90% interest in the Gadu Manda Gold Project covering approximately 29km2 in Suriname. The project adds to the company's existing Gonini and Greenstars projects secured under exclusivity in September. The consideration comprises US$200,000 in cash over two years, an initial US$10,000 exclusivity f
Critical Resources secures exclusivity over third Suriname Gold Project
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11:55

Sunshine Metals begins drilling at Sybil Gold Project

Full story: https://grafa.com/en/news/australia/sunshine-metals-begins-drilling-at-sybil-gold-project Sunshine Metals has started a 28-hole reverse circulation drilling programme at its Sybil Epithermal Gold Project. Shares in the exploration company traded unchanged at $0.024 following the update. The exploration aims to feed potential gold mineralisation to the company's nearby Mt Moss facility. Sunshine Metals (ASX:SHN) has commenced a 28-hole, 2,680m reverse circulation drilling programme at its 100%-owned Sybil Epithermal Gold Project in North Queensland. The programme represents the first drill testing at the Burdekin Veins and Cisco prospects while expanding work at Francis Creek. "Our recent drilling at Francis Creek has demonstrated the presence of high-grade gold mineralisation,
Sunshine Metals begins drilling at Sybil Gold Project
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11:53

ASIC scrutinises collapsed $7 billion Firmus float

Full story: https://grafa.com/en/news/australia/asic-scrutinises-collapsed-7-billion-firmus-float The ASIC announced it is making enquiries into the aborted $7 billion initial public offering by Firmus. The corporate watchdog confirmed that no formal investigation has been launched yet regarding whether prospective investors received misleading information. The enquiry follows concerns raised by parliamentarians regarding disclosure adequacy and the accuracy of representations made during the book building process. The Australian Securities and Investments Commission stated that it is making enquiries into the abandoned $7 billion initial public offering by Firmus, though a formal investigation has not yet commenced. The regulatory review follows a formal request by lawmakers who questione
ASIC scrutinises collapsed $7 billion Firmus float
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11:52

Metro Mining lowers 2026 shipment guidance to 6.5M tonnes

Full story: https://grafa.com/en/news/australia/metro-mining-lowers-2026-shipment-guidance-to-6-5m-tonnes Metro Mining updates 2026 bauxite shipment guidance to 6 to 6.5 million wet metric tonnes. The company adjusted its annual operational target following below-plan performance experienced in September. Management is implementing mitigation initiatives, including channel bed levelling and retention measures, to support production. Metro Mining (ASX:MMI) updated its 2026 bauxite shipment guidance to a range of 6.0 to 6.5 million wet metric tonnes following below-plan performance in September. The revised target contrasts with prior expectations and accounts for recent operational constraints alongside the progress of ongoing mitigation initiatives. The company stated that the adjustment r
Metro Mining lowers 2026 shipment guidance to 6.5M tonnes
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11:51

Northern Minerals secures ASIC extension to March 2027

Full story: https://grafa.com/en/news/australia/northern-minerals-secures-asic-extension-to-march-2027 Northern Minerals received fresh regulatory relief from ASIC, pushing back its deadlines to hold both its 2025 and 2026 annual general meetings. Following the corporate update and extension news, company shares experienced an upward movement of 4.1% to reach 25 cents. The company stated that the extended timeline helps ensure compliance with federal foreign interest divestment orders prior to holding meetings. Northern Minerals (ASX:NTU) secured an extension from the Australian Securities and Investments Commission to hold its delayed 2025 and 2026 annual general meetings by March 2027. The new regulatory relief replaces a previous plan that required the mining company to host both shareh
Northern Minerals secures ASIC extension to March 2027
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11:50

Ingenia Communities extends talks with Warburg on $5.25 bid

Full story: https://grafa.com/en/news/australia/ingenia-communities-extends-talks-with-warburg-on-5-25-bid Ingenia Communities and Warburg Pincus have extended their negotiation deadline to Oct. 23 to finalise a process deed. Following the update, Ingenia Communities shares rose significantly on the market. Warburg Pincus maintains its conditional cash offer of $5.25 per security while conducting due diligence. Ingenia Communities (ASX:INA) and private equity firm Warburg Pincus have extended their negotiation deadline to Oct. 23, to finalise a process deed regarding a potential $5.25 per security cash acquisition proposal. The housing provider stated that it has granted Warburg Pincus comprehensive access to corporate books to conduct due diligence during this interim period. The company
Ingenia Communities extends talks with Warburg on $5.25 bid
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11:48

Percheron Therapeutics, Invion explore novel cancer combination

Full story: https://grafa.com/en/news/australia/percheron-therapeutics-invion-explore-novel-cancer-combination Percheron Therapeutics and Invion have agreed to evaluate a combination of their cancer therapies in preclinical studies. Following the announcement, the Percheron Therapeutics share price was unchanged at $0.003. Percheron stated that the study costs are expected to be modest and will not impact its cash runway. Percheron Therapeutics (ASX:PER) has entered into a preclinical research collaboration with Invion (ASX:IVX) to evaluate its clinical-stage antibody HMBD-002 alongside Invion's photodynamic therapy Photosoft. The agreement aims to build on a 2024 study at the Peter MacCallum Cancer Centre, which demonstrated superior tumour control when combining Invion's candidate with a
Percheron Therapeutics, Invion explore novel cancer combination
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11:47

HUB24 reports platform net inflows of $4B

Full story: https://grafa.com/en/news/australia/hub24-reports-platform-net-inflows-of-4b HUB24 reached total funds under administration of $168.8 billion as of Sept. 30, supported by platform net inflows of $4 billion. Platform net inflows fell 23% compared to the prior corresponding period, while platform funds under administration grew 18% year-on-year to $143.7 billion. The company stated that ongoing advice on industry transformation and shifting demographics continues to create structural growth opportunities across its platform services. HUB24 (ASX:HUB) reported total funds under administration of $168.6 billion for the first quarter of FY27, driven by quarterly platform  net inflows of $4 billion. The quarterly net inflows reflected a 23% decline compared to the prior correspon
HUB24 reports platform net inflows of $4B
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11:46

Corporate Travel Management releases $65M guarantee

Full story: https://grafa.com/en/news/australia/corporate-travel-management-releases-65m-guarantee The International Air Transport Association released a $65 million security guarantee back to Corporate Travel Management. The announcement improved investor sentiment, supporting stability in the travel provider's valuation. The decision follows the completion of the company's financial assessment and will boost working capital. Corporate Travel Management (ASX:CTD) announced that the International Air Transport Association released a $65 million security guarantee following the completion of its financial assessment. The temporary guarantee and adjusted settlement cycles were originally introduced in December 2025 while the company finalised its FY25 financial statements. "IATA’s decision i
Corporate Travel Management releases $65M guarantee
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11:40

Sparc Technologies secures $1.3M for hydrogen development

Full story: https://grafa.com/en/news/australia/sparc-technologies-secures-1-3m-for-hydrogen-development Sparc Technologies, Fortescue, and Adelaide University committed $1.3 million in pro-rata equity funding to advance Sparc Hydrogen. The funding supports technology scale-up, expanded material sourcing, and collaborative testing following successful initial pilot facility operations. The joint venture aims to develop low-cost green hydrogen technology alongside Sparc Technologies' ongoing commercial graphene operations. Sparc Technologies (ASX:SPN) locked in $1.3 million in joint pro-rata funding alongside Fortescue and Adelaide University to advance Sparc Hydrogen into its next development stage. The new capital follow-up comes after initial operations at the first-of-its-kind SHARP pil
Sparc Technologies secures $1.3M for hydrogen development
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11:39

Gentrack secures Momentum Energy contract for g2 platform

Full story: https://grafa.com/en/news/australia/gentrack-secures-momentum-energy-contract-for-g2-platform Gentrack Group has secured a new contract with Momentum Energy to power over 200,000 residential and business metre points across Australia. Financial terms of the agreement were not disclosed, but the deal expands Gentrack's footprint across Australian energy retailers. Momentum Energy selected the platform to simplify its technology structure, lower operational costs, and build a foundation for future digital and AI solutions. Gentrack (ASX:GTK) has signed an agreement with Momentum Energy to support more than 200,000 Australian residential and business metre points using its g2 billing solution. The contract follows a competitive evaluation process where Momentum Energy selected Gen
Gentrack secures Momentum Energy contract for g2 platform
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11:38

Starpharma secures majority stake in Petalion Therapeutics

Full story: https://grafa.com/en/news/australia/starpharma-secures-majority-stake-in-petalion-therapeutics Starpharma expanded its ownership in Petalion Therapeutics from 22.5% to 66%. The transaction includes up to $5 million to fund Petalion’s oncology programme through its next development phase. Starpharma gains governance control and operational leadership over a fibroblast activation protein drug candidate. Starpharma (ASX:SPL) increased its equity interest in Petalion Therapeutics to 66%. The transaction raises Starpharma’s stake from 22.5% to secure majority governance control and operational leadership. “Petalion is strongly aligned with our strategy to build a focused portfolio of differentiated targeted-oncology therapies,” said Starpharma CEO Cheryl Maley. Starpharma agreed to
Starpharma secures majority stake in Petalion Therapeutics
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11:34

Beacon Minerals generates $49.8M gold revenue

Full story: https://grafa.com/en/news/australia/beacon-minerals-generates-49-8m-gold-revenue Beacon Minerals produced 6,250 ounces of gold and achieved total gold sales of 8,300 ounces during the September 2026 quarter. The company recorded total gold sales receipts of $49.8 million at an average realised sale price of $5,998 per ounce. Processing operations resumed on key ore sources alongside early commissioning of the processing plant upgrade ahead of schedule. Beacon Minerals (ASX:BCN) produced 6,250 ounces of gold at its Jaurdi Gold Project and generated $49.8 million in total gold sales receipts during the September 2026 quarter. The quarterly operational results reflected total gold sales of 8,300 ounces at an average sale price of $5,998 per ounce. Beacon Minerals Executive Chairma
Beacon Minerals generates $49.8M gold revenue
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11:33

Blackpearl Group narrows loss to $3M

Full story: https://grafa.com/en/news/australia/blackpearl-group-narrows-loss-to-3m Blackpearl Group narrowed its Q2 FY27 EBITDAF loss to $2.97 million and delivered NZ$7.3 million in H1 FY27 revenue. Operational changes reduced the company's quarterly cost base by approximately 27% on a run-rate basis. The group established its first US distribution partnership and pushed back its EBITDAF profitability target to Q1 FY28. Blackpearl Group (ASX:BPG) narrowed its quarterly EBITDAF loss to NZ$3 million while growing first-half revenue by 42% year-on-year to NZ$7.3 million. The reduced operating loss represents a 34% performance improvement over the first quarter, backed by consolidated sales, marketing, and development functions across its ventures. The company stated that the operating model
Blackpearl Group narrows loss to $3M

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