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No 'social value' scores in CalMac ferries award

No 'social value' scores in CalMac ferries award

Yahoo07-04-2025

The contract award for seven new CalMac ferries won last month by a Polish firm was unable to score bids for "social value" without risk of legal challenge, according to Scotland's ferries procurement agency.
The nationalised Ferguson shipyard was among the shortlisted bidders - but lost out to Gdansk-based Remontowa which was able to undercut it on price.
The announcement prompted some politicians to ask whether "social value" had been considered as part of the evaluation.
Ferries body CMAL said assessments were required to be fair to overseas bidders, and there was no legal obligation in Scotland to include social value in the scoring.
However, it said some "community benefits" were secured during contract negotiations which will see 21 apprentices participate in sea trials in Scotland.
Ferguson shipyard misses out on new CalMac ferry order
Future of Ferguson shipyard 'uncertain' - watchdog
BBC Scotland News understands Ferguson Marine fared well in the technical assessment of its bid but lost out on price, which made up 35% of the scoring.
Remontowa offered to build the ferries for just over £21m each.
Port Glasgow-based Ferguson's had vowed to bid "aggressively" for the small vessels contract which was a key part of its five-year business strategy.
The electric ships are similar to ones it has built successfully in the past, and it hoped a pipeline of repeatable work would improve productivity, allowing it to move on from difficulties faced with two much larger gas-powered CalMac ferries.
While the yard has no confirmed orders beyond the second ship, MV Glen Rosa, it is pursuing private sector business and subcontracting work from BAE Systems.
Three years ago, a refreshed National Shipbuilding Strategy said it would seek to maximise opportunities for UK suppliers with a 10% social value component in government contracts.
The UK government's Procurement Act (2023) also introduced a requirement to "maximise public benefit" when awarding contracts.
But Scottish government-owned CMAL said it was not covered by the act, and it was not permitted to discriminate against overseas bidders.
A spokesperson said: "While Scottish public authorities can include social value considerations in procurements, they are not permitted to set requirements which would unlawfully discriminate against foreign shipyards and must at all times treat all bidders equally."
Critics of current public procurement rules claim they are too narrowly focused on headline project costs, and ignore the wider economic and social benefits.
Industry body Maritime UK has called for measures such as minimum levels of UK-based content in contracts, which is increasingly a feature of wind energy licences.
A 10% social value element - scoring bids on things like employment, training or environmental benefits - is required where appropriate for high value public contracts in other parts of the UK but is not mandatory in Scotland.
But any social value scoring has to be used in a non-discriminatory way, so a tender involving overseas bidders must also give them a fair chance of picking up points.
Procurement law expert Duncan Osler from legal firm Morton Fraser MacRoberts, says that despite Brexit, international trade agreements designed to create a level playing field still govern public procurement.
He said: "Simply to target a procurement so a local contractor can effectively have an advantage and win even if they are more expensive or lower quality would open the authority to a risk of legal challenge."
In other words, social value scoring could have a small impact in that it dilutes the influence of cost in the procurement exercise, but the overall effect is likely to be marginal.
The contract for the seven small CalMac ferries is the biggest multi-vessel deal in Remontowa's 79-year history.
The shipyard has previously built three CalMac ships between 2005 and 2011 - MV Bute, MV Argyle and MV Finlaggan.
In 2015 it was runner-up to Ferguson's when the Port Glasgow firm was awarded the contract for the two dual-fuel ferries MV Glen Sannox and MV Glen Rosa.
A BBC documentary later presented evidence that the contract for the complex ships may have been "rigged" in favour of Ferguson's, although a KC-led investigation commissioned by CMAL found no evidence of "criminal" corruption.
While the evaluation of the bids of the small vessels contract did not include any social value element, CMAL said it did subsequently agree some community benefits with Remontowa.
For each of the ferries, three apprentices will be involved in sea trials once they arrive in Scotland, beginning in 2027.
Remontowa will also contribute several thousand pounds to a community fund run by CMAL which has, in the past, helped pay for IT equipment in Scotland.
The value of the contract to the Polish firm is £147.5m, but a further £12.5m is being spent transporting the finished vessels, CMAL's costs overseeing the build and a 3% budget contingency.
Why was Glen Sannox so hard to build?
Were Scotland's new gas-powered ferries a bad choice?

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Upcoming Stock Splits This Week (June 16 to June 20)
Upcoming Stock Splits This Week (June 16 to June 20)

Business Insider

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Upcoming Stock Splits This Week (June 16 to June 20)

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Whether to attract investor attention or to meet listing standards, these maneuvers can offer important clues about a company's current priorities and future strategy. Let's take a look at the upcoming stock splits for the week. Jianzhi Education Technology Group (JZ) – Beijing‑based Jianzhi is a digital education provider offering online learning platforms and professional development content to higher education institutions and individuals across China. On June 12, the company announced an upcoming 1‑for‑10 reverse ADS split to boost its ADS trading price and maintain Nasdaq listing compliance. The split is scheduled to be effective at the start of trading on June 16. GlycoMimetics (GLYC) – U.S.-based GlycoMimetics is a clinical-stage biotech company developing treatments for sickle cell disease and cancer by targeting cell adhesion. On June 5, the company announced a 1-for-100 reverse stock split to support its planned merger with Crescent Biopharma. 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US Export-Import Bank considering $120M loan for Greenland rare earths project
US Export-Import Bank considering $120M loan for Greenland rare earths project

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US Export-Import Bank considering $120M loan for Greenland rare earths project

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Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress
Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress

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Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress

With up to three years of follow-up, a single dose of lonvo-z led to a 98% mean reduction in monthly HAE attack rate in all 10 patients All 10 patients were attack-free and treatment-free for a median of 23 months through the latest follow-up, demonstrating the potential of lonvo-z to become the first one-time therapy for most HAE patients Lonvo-z was well tolerated and continues to demonstrate a favorable safety profile The global Phase 3 HAELO trial of lonvo-z has concluded screening ahead of schedule with more than half screened from U.S. sites; Intellia to provide an update on enrollment in the future CAMBRIDGE, Mass., June 15, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom. 'Today's results underscore the promising potential of Intellia's approach to gene editing therapy – a one-time treatment that was well tolerated and offered a highly differentiated, durable effect for patients suffering from a serious disease,' said Intellia President and Chief Executive Officer John Leonard, M.D. 'Seeing all 10 patients in the Phase 1 portion of this study free from both HAE attacks and chronic therapy at nearly two years of median follow-up is incredibly encouraging. These data fuel our optimism for the outcomes of our ongoing Phase 3 HAELO study, which we expect to report in the first half of 2026, and highlight the strong value we believe it will offer patients, physicians and payers.' 'People living with HAE often report a reduced quality of life because they worry about the likelihood of their next attack, either because they still experience attacks or are reminded of it by their use of chronic therapy,' said Dr. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc. 'Based on the data, it is reasonable to expect lonvo-z could offer patients the potential to be free from both physical HAE attacks and the burden of managing chronic HAE treatment.' In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12 data cutoff, patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Safety Across all three dose levels, lonvo-z has been well tolerated and continues to demonstrate a favorable safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to 3 years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing. Clinical Development Plans Intellia's global Phase 3, randomized, double-blind, placebo-controlled HAELO trial is ongoing to assess the safety and efficacy of lonvo-z at the 50 mg dosage. The Company announced today the HAELO trial has successfully completed screening ahead of schedule, with over half of the patients being screened in the United States. The study is no longer recruiting and Intellia will provide an update on enrollment in the future. New and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study is planned to be presented in the second half of 2025. Intellia expects to submit a biologics license application (BLA) in 2026 to support the Company's plans for a U.S. launch in 2027. For more information on HAELO (NCT06634420), please visit About the Lonvoguran Ziclumeran (lonvo-z, also known as NTLA-2002) Clinical Program Intellia's ongoing Phase 1/2 study is evaluating the safety and efficacy of lonvo-z in adults with Type I or Type II hereditary angioedema (HAE). The Phase 1 portion of the study is an international, open-label study designed to identify the dose level of lonvo-z selected for further evaluation in the Phase 2 portion of the study. Enrollment in both portions of the Phase 1/2 study is complete. Intellia dosed the first patient in the global Phase 3, randomized, double-blind, placebo-controlled HAELO trial in January of 2025. Visit (NCT05120830) for more details. About Lonvo-z Based on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an investigational in vivo CRISPR-based gene editing therapy designed to prevent HAE attacks by inactivating the kallikrein B1 ( KLKB1 ) gene, which encodes for prekallikrein, the kallikrein precursor protein. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate, as well as consistent, deep and durable reductions in kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission. About Intellia Therapeutics Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia's deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at and follow us @intelliatx. Forward-Looking Statements This press release contains 'forward-looking statements' of Intellia Therapeutics, Inc. ('Intellia' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia's beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for lonvoguran ziclumeran or 'lonvo-z' (also known as NTLA-2002) for hereditary angioedema ('HAE'), including the ability to successfully complete its global Phase 3 HAELO study; its expectation to present additional data regarding lonvo-z, including reporting outcomes of the Phase 3 HAELO study in the first half of 2026 and presenting new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study of lonvo-z in the second half of 2025; and its expectation to be able to support a biologics license application for lonvo-z for the treatment of HAE by 2026 for a U.S. launch in 2027. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to Intellia's relationship with third parties, including its contract manufacturers, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies' evaluation of regulatory filings and other information related to our product candidates, including lonvo-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including our ability to complete the Phase 3 HAELO study for HAE; the risk that any one or more of Intellia's product candidates, including lonvo-z, will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia's other product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Intellia's most recent annual report of Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Intellia Contacts: Investors:Brittany ChavesSenior Manager, Investor Relations [email protected]

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