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Visit One News Page for Italy news from around the world, aggregated from leading sources including newswires, newspapers and broadcast media. Search millions of archived news headlines. This feed provides the Italy news headlines.

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    PARIS, Oct. 22, 2018 (GLOBE NEWSWIRE) -- *BIOPHYTIS (Euronext Growth Paris: ALBPS), a biotechnology company specializing in the development of drug candidates to fight age-related degenerative diseases, **announces the publication of its interim financial report and communicates the perspective on its activity until year-end.**Stanislas Veillet, CEO of BIOPHYTIS*, stated: “In the first half of 2018, key steps in the clinical programs of our drug candidate Sarconeos were completed, with the opening of the first clinical centers of the phase 2b study SARA-INT in Sarcopenia, and the Orphan Drug Designation for Duchenne Muscular Dystrophy. The Company, which had €14 million of cash on June 30^th and has signed a €10 million loan with Kreos Capital in September, has the adequate financial resources to conduct SARA-INT and obtain the regulatory approvals for the MYODA clinical program in DMD.”

    The financial report can be downloaded at : http://www.biophytis.com/en/action/document/

    *Key highlights of 2018’s first semester*

    In the first semester 2018, BIOPHYTIS pursued the SARA clinical program for the drug candidate Sarconeos in sarcopenia. All 11 clinical centers of the SARA-OBS clinical study (a study of observation and pre-recruitment without administration) have been opened: 3 in the United States, 1 in Belgium, 3 in France, 4 in Italy. As of  June 30^th, 162 patients were enrolled in the study. At the same time, BIOPHYTIS continued the regulatory work to obtain the authorizations and the opening of clinical centers for the phase 2b of SARA-INT study, which allowed the opening of the first clinical center in Belgium in May.

    Also, the Company launched preparatory work for the MYODA program in Duchenne Muscular Dystrophy, which resulted in the receiving of Orphan Drug status for Sarconeos with the Food and Drug Agency (FDA) and European Medicines Agency (EMA).

    Finally, the research efforts have been maintained. The Company filed a new patent, the 7^th to date, concerning the research platform for MAS receptor activator for muscle and metabolism pathologies. Four scientific works were presented at the 8^th International Conference on Frailty & Sarcopenia Research in Miami. Finally, one poster was presented at the annual congress of the Association for Research in Vision and Ophthalmology (ARVO) in Honolulu, Hawaii, in May. The presented results demonstrate the strong potential of Macuneos in the treatment of Age-Related Macular Degeneration (AMD). 

    *Interim financial results 2018*

    In € thousands *H1 2018* *H1 2017*
    Net Research and Development Costs (4,136 ) (2,912 )
    General and administrative expenses (1,542 ) (1,247 )
    *Operating income* *(5,678* *)* *(4,159* *)*
    Financial income (12 ) (855 )
    *Net Income* *(5,690* *)* *(5,014* *)*

    The operating income at end of June 2018 was (5,678) k€ versus (4,159) k€ at end of June 2017. This change is mainly due to :

    · An increase of 653 k€ in third-party research and development expenses versus the same period in 2017, mainly due to the combination of conducting the last part of the SARA-OBS study and the launch of the SARA-INT study simultaneously ;
    · Increase in personnel expenses of 928 k€ versus the same period in 2017, mainly due to the increase of overall staff ;

    The financial result of (12) k€ at end of June 2018 versus (855) k€ at end of June 2017 significantly improved, as in 2017 the company was bearing the financial charges of convertible bonds, which was no longer the case in 2018.

             
    in € thousands *H1 2018*   *2017*
    Non-current financial assets (liquidity contract) 119   190
    Cash and cash equivalents 14,121   19,857
    Short-Term deposits 10,000   10,001
    Bank accounts 4,121   9,856
    *Available Cash* *14,240*   *20,047*

    At end of June 2018, the company held two short-term deposit accounts of respectively 7,000 k€ and 3,000k€.

    *Post-closing events*

    On September 10^th, the Company entered into a venture loan agreement with Kreos Capital V (UK) LTD (« KREOS ») by signing a Bonds Issue Agreement for up to 10 M€, with issuance of 442 477 warrants attached to the Tranche A (BSA2018-KREOS), and a pledge on part of the Company’s goodwill in favor of KREOS.

    · The agreement allows for raising up to 10 M € by an issue of non-convertible Bonds for a total nominal amount of up to 10 M€ with a par value of 1€ per bond, divided into 4 tranches of 2,5 M € each. The issue dates are established as at the contract signature date : the first two tranches shall be issued by September 30^th 2018, the third and fourth tranches shall be issued in the 4^th quarter of 2018 and first quarter of 2019, with the possibility to postpone one of the issues to the second quarter of 2019. The nominal interest rate of each tranche is 10% per annum.  The tranches shall be repaid in accordance with a 36-months amortization schedule, following the nominal amount grace period, starting from April 2019. Tranches A and B were issued on 10th September.
    · Each warrant (BSA2018-KREOS) issued in favor of KREOS in the Tranche A scope gives the right to subscribe to one new share of the Company. The warrants are exercisable within a 7 year period starting from their emission date, at an exercise price of 2,67 €.
    · A pledge on part of the Company’s goodwill has been granted on September 10^th.

    *Perspective on the activity to come*

    The company will continue to advance its three clinical programs:

    *Development of Sarconeos in sarcopenia: Phase 2B clinical study, SARA-INT*
    The double-blind, placebo-controlled Phase 2b SARA-INT study will include approximately 334 patients. 7 centers are already open in the United States and in Belgium, and the company is awaiting authorizations from French and Italian regulatory agencies. More than 200 patients have already been recruited in the SARA-OBS study, which includes 11 clinical centers in Europe (Belgium, France and Italy) and in the United States. 60 have completed the observational study and are ready to enter the interventional study. The remaining patients will be recruited in 11 additional clinical centers. The company forecasts to complete recruitment in S1 2019.

    *Development of Sarconeos in Duchenne Muscular Dystrophy: MYODA clinical program*
    Sarconeos has already received orphan drug status granted by the FDA and the EMA (European Medicines Agency) in Duchenne Muscular Dystrophy. This status will allow BIOPHYTIS to benefit from numerous incentives for the development of its drug candidate, including a marketing exclusivity of 10 years in the European Community and 7 years in the USA. The company has requested scientific advice from the FDA and EMA regarding the clinical program, and expects to obtain regulatory approvals for the MYODA-PK study of safety and pharmacokinetics in patients in S1 2019.

    *Development of Macuneos in AMD: Phase 1/2a clinical study, MACA-PK*
    The company is currently conducting the industrial scale-up of the clinical lots of the Macuneos drug candidate. It intends to request scientific advice from the FDA and EMA in Q1 2019, and to obtain regulatory approvals for the MACA-PK study of safety and pharmacokinetics in healthy volunteers in S1 2019.

    *About BIOPHYTIS*
    BIOPHYTIS SA (www.biophytis.com), founded in 2006, develops drug candidates targeting diseases of aging. Using its technology and know-how, BIOPHYTIS has begun clinical development of innovative therapeutics to restore the muscular and visual functions in diseases with significant unmet medical needs. Specifically, the company is advancing two lead products into mid-stage clinical testing this year: Sarconeos (BIO101) to treat sarcopenic obesity and Macuneos (BIO201) to treat dry age-related macular degeneration (AMD).
    The business model of BIOPHYTIS is to ensure the conduct of the project until clinical activity in the patient is proven, then to license the technologies in order to continue the development in partnership with a pharmaceutical laboratory.
    Based on the Sorbonne Université campus, BIOPHYTIS collaborates with expert scientists from several Sorbonne Université institutes such as the Paris Seine Biology Institute, the Institute of Myology, and the Vision Institute.

    BIOPHYTIS is listed on the Euronext Growth market of Euronext Paris (ALBPS; ISIN: FR0012816825).

    For more information: http://www.biophytis.com

    Follow us on Twitter @biophytis

    BIOPHYTIS is eligible for the SMEs scheme

    *Disclaimer *
    This press release contains certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of risks and uncertainties which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors (“Facteurs de Risque”) section of the Listing Prospectus upon the admission of Company’s shares for trading on the regulated market Euronext Growth of Euronext Paris filed with the AMF, which is available on the AMF website (www.amf- france.org) or on BIOPHYTIS’ website (www.biophytis.com).

    This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall prevail.

    *BIOPHYTIS*
    *Stanislas VEILLET*
    CEO
    contact@biophytis.com
    Tel: +33 (0) 1 44 27 23 00 *Citigate Dewe Rogerson *
    *International media & Investors*
    *Laurence BAULT/Antoine DENRY*
    Laurence.bault@citigatedewerogerson.com
    antoine.denry@citigatedewerogerson.com
    Tel: +33 (0)1 53 32 84 78
    Mob: +33(0)6 64 12 53 61* * *LifeSci Advisors*
    *Chris MAGGOS*
    Managing Director, Europe
    chris@lifesciadvisors.com
    Tel: +41 79 367 6254 Reported by GlobeNewswire 4 hours ago.

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    The S&P 500 and Dow Jones Industrial Average dropped in volatile trading on Monday as a boost from news in China and Italy faded and losses in energy and financial stocks weighed, but gains in technology stocks helped limit losses and lifted the Nasdaq. Reported by Reuters 4 hours ago.

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    · *US dollar still remains strong on risk aversion and Fed policy expectations. *
    · *Euro pressured by Italy’s budget drama and Brexit.* 

    The EUR/USD pair bottomed during the US session at 1.1454. It rebounded from the lows to 1.1475. As of writing was trading at 1.1470, 45 pips below last week close. The euro erased Friday’s gains and continues under pressure. 

    Price is back near the low bottom of a consolidation range with technical indicators favoring the downside. But in order to trigger more losses, a consolidation significantly below 1.1460 appears to be needed it. 

    From a fundamental perspective, Brexit negotiations affected risk appetite. The rating agency Moody’s offered some support to the euro by keeping the outlook ‘stable’ despite revising lower its credit rating. Still the euro looks vulnerable. Beyond Italy and Brexit, the next key events will be on Thursday: the European Central Bank meeting. No change in rates is expected but the statement and Draghi’s tone could influence the euro. 

    *EUR/USD Levels to watch *

    To the downside, the immediate support is the 1.1460 area. Below, the 1.1430 zone (last week lows) would be exposed and a break lower could trigger more losses to the 1.1400 area.  On the flip side, resistance could be located at 1.1495 (20-hour moving average), 1.1525 (Oct 18 high) and 1.1550 (Oct 22 high). 
      Reported by FXstreet.com 3 hours ago.

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    Barry Jenkins keeps it cool and casual while walking the red carpet at the photo call and press conference for his latest film If Beale Street Could Talk held during the 2018 Rome Film Fest at Auditorium Parco Della Musica on Sunday (October 21) in Rome, Italy. The 38-year-old Oscar-winning writer-director then switched into a [...] Reported by Just Jared 3 hours ago.

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    Paolo Pizzoli, Senior Economist at ING, points out that developments signal little willingness to substantially amend the budget draft regarding Italy’s saga.  He sees a risk of a continuation of a challenging attitude by the government.

    *Key Quotes: *

    “Late on Friday, Moody’s announced that it had downgraded Italy to Baa3 (from Baa2), switching to a neutral outlook.”

    “Next Friday, S&P will release its update to the Italian sovereign rating, currently at BBB with a neutral outlook. Moody’s decision to some extent has stolen the thunder from S&P, which is at least expected to change its outlook to negative.”

    “The content of Tria’s reply letter does not legitimize the strong optimism on the government's willingness to revise the budget draft.”

    “On the back of the budget draft and of the letter which re-affirmed its validity, the EU Commission will have to formally reply by the end of the month. We expect the Commission to ask the Italian government to submit a revised draft. Barring a substantial acceleration of market pressure on Italian bonds, we would expect the Government to be willing to concede only limited amendments to the current text, possibly in the direction of a commitment to resume the structural adjustment already in 2020 and not in 2022. This would probably be not enough to stop the Commission from re-opening an excessive deficit procedure against Italy, more likely in 2019.”

    “With the 2019 European elections looming, the risk is that the Italian government will maintain a challenging attitude towards Europe over the next few months, without pushing the relationship to the extreme. This is an environment that will tend to keep volatility in the Italian government bond market elevated.”
      Reported by FXstreet.com 3 hours ago.

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    The right-wing League has won control of the northern Italian province of Trento, ousting the center-left coalitions that have ruled for decades, in the latest breakthrough by the anti-immigrant party. Reported by Reuters 1 hour ago.

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    The Mexican filmmaker, 54, is going to helm a “stop motion musical” version of the story set in 1930s Italy, the streaming service announced Monday. Reported by FOXNews.com 2 hours ago.

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    The new institutional cryptocurrency trading platform Caspian has wrapped up its private and public token sale early after successfully raising $19.5 million. Caspian’s platform, which recently went live, provides institutional crypto investors with a sophisticated institutional cryptocurrency trading platform. Contributors to the token sale came from Canada, the UK, Hong Kong, Singapore, Italy, South Korea, Australia and Switzerland. “Selling out the crowdsale is a huge milestone in the growth of our company and our journey to build the first institutional grade full-stack crypto trading and risk management platform for professional traders and investors,” says Caspian’s chief operating officer and co-founder David Willis in a statement. “Caspian is a critical tool to assist the rapidly growing number of financial institutions seeking to trade cryptocurrencies,” Willis added. READ: CryptoCann™ Report: Port of Rotterdam to track shipments with blockchain; Oregon chef serves weed-fed pork Fifteen crypto institutions, including Techemy, Blockstars and Galaxy Digital, are already trading crypto on the platform while another 170 customers are waiting to be onboarded, according to Caspian. The company also boasts another 15 clients in the onboarding process including Lykke, ID Theory, Bletchley Park and ex-Point 72 manager Travis Kling’s Ikigai Asset Management. Robert Dykes CEO and Co-Founder of Caspian, says: “The tools institutions need to make serious investments in this space are gaining momentum. With Fidelity announcing the launch of a much needed custodial solution that allows investors to outsource the safekeeping of their assets to a trusted intermediary, coupled with the intuitive and user-friendly nature of a software platform like Caspian for the management of these assets, the floodgates have opened for institutional money to enter the market.” Caspian is a full-stack crypto asset management platform tying together the biggest crypto exchanges in a single interface. The platform also offers compliance, algorithms, portfolio management, risk and reporting. Contact Ellen Kelleher at ellen@proactiveinvestors.com Reported by Proactive Investors 1 hour ago.

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    The new institutional cryptocurrency trading platform Caspian has wrapped up its private and public token sale early after successfully raising $19.5 million. Caspian’s platform, which recently went live, provides institutional crypto investors with a sophisticated institutional cryptocurrency trading platform. Contributors to the token sale came from Canada, the UK, Hong Kong, Singapore, Italy, South Korea, Australia and Switzerland. “Selling out the crowdsale is a huge milestone in the growth of our company and our journey to build the first institutional grade full-stack crypto trading and risk management platform for professional traders and investors,” says Caspian’s chief operating officer and co-founder David Willis in a statement. “Caspian is a critical tool to assist the rapidly growing number of financial institutions seeking to trade cryptocurrencies,” Willis added. READ: CryptoCann™ Report: Port of Rotterdam to track shipments with blockchain; Oregon chef serves weed-fed pork Fifteen crypto institutions, including Techemy, Blockstars and Galaxy Digital, are already trading crypto on the platform while another 170 customers are waiting to be onboarded, according to Caspian. The company also boasts another 15 clients in the onboarding process including Lykke, ID Theory, Bletchley Park and ex-Point 72 manager Travis Kling’s Ikigai Asset Management. Robert Dykes CEO and Co-Founder of Caspian, says: “The tools institutions need to make serious investments in this space are gaining momentum. With Fidelity announcing the launch of a much needed custodial solution that allows investors to outsource the safekeeping of their assets to a trusted intermediary, coupled with the intuitive and user-friendly nature of a software platform like Caspian for the management of these assets, the floodgates have opened for institutional money to enter the market.” Caspian is a full-stack crypto asset management platform tying together the biggest crypto exchanges in a single interface. The platform also offers compliance, algorithms, portfolio management, risk and reporting. Contact Ellen Kelleher at ellen@proactiveinvestors.com Reported by Proactive Investors 2 hours ago.

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    In a market wrap, analysts at ANZ Bank New Zealand explained that the European equities finished the day lower, with the DAX down 0.3%, the CAC 40 off 0.6%, and the FTSE 100 down 0.1%.

    *Key Quotes:*

    "US markets opened lower as well, with the Dow Jones down 0.5% at the time of writing and the S&P 500 down 0.2%, but the Nasdaq up 0.4% boosted by the FANG heavy-hitters ahead of earnings results this week.

    Sovereign bonds generally rallied to start the week, with UK 10-year Gilt yields down 5bp, Spanish government bond yields down 3bp, but Italy’s BTP yields up 1bp. In the US, 10-year Treasury yields were flat.

    In currencies, the USD was the best performer, while the GBP underperformed. Oil prices were lower, with WTI spot off 0.25% at USD68.95/bbl. Gold was softer at USD1222, down 0.4%."

    *Data event pulse*

    *Italy's bonds steady:*

    "Italian government bonds rallied to open the session, following Moody’s announcement that it will maintain them at investment grade, increasing the likelihood that they will remain above junk status for the foreseeable future (S&P will reviews its rating of BTPs on Friday). However, the move was later retraced. A letter from Italian finance minister Tria to the EC was published, arguing the need for dialogue, while on a conciliatory note, PM Conte indicated that the 2.4% deficit target is the upper limit and his Government doesn’t intend to exceed it."

    *Sterling takes a pounding:*

    "The sterling fell to its lowest value in two weeks on Monday, following the weekend news that the Eurosceptic parts of the Conservative party are becoming increasingly frustrated with how PM May is handling the Brexit negotiations. Amid the speculation about a leadership challenge, PM May addressed Parliament about the conditions under which a negotiation extension would be needed. This failed to calm markets though, and the sterling is not far off session lows at time of writing." Reported by FXstreet.com 2 hours ago.

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    The Governing Council of the European Central Bank will meet on Thursday. According to the Research Department at BBVA, the central bank is expected to leave monetary policy unchanged and they consider that it will confirm its expectation of ending QE by December and maintaining interest rates at their current level through the summer of 2019. They warn about the risk of a reassessment in balance risks. 

    *Key Quotes: *

    “The habitually cautious tone can be reinforced on the back of growing risk due to lingering concerns about protectionism, recent stock market correction and renewed bond sell-off in Italy. In this regard, we do not expect the strategy on QE to be altered at all.”

    “On monetary policy, it should give some clues about how the reinvestment framework will be instrumented as the APP will end in December. While moving forward, the focus will turn to the pace at which interest rates will rise. So far, the ECB seems comfortable with market expectations.”

    “Incoming data so far are broadly in line with the ECB’s macro view in September, but *domestic uncertainty has intensified recently,* especially in Italy, with potential spillover to other peripherals, in addition to increasing protectionism and stress in emerging markets, which could lead the ECB to reassess the balance of risks to the downside and reinforce its cautious mode going forward.” Reported by FXstreet.com 2 hours ago.

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    United Colors of Benetton co-founded dies aged 77 The former head of family holding company Edizione which controls Italy's biggest infrastructure group Atlantia, died after a short illness, the family said on Monday. Reported by MailOnline 31 minutes ago.

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    MONZA, Italy (AP) — Silvio Berlusconi has been reunited with Cristian Brocchi after appointing the former AC Milan player and manager as coach of third-division Monza.Berlusconi's company took over Monza last month, less than 18... Reported by New Zealand Herald 19 minutes ago.

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    GENOA, Italy (AP) — Sampdoria was held to a 0-0 home draw by Sassuolo on Monday as it failed to make it three wins in a row.There were few clear-cut chances in a drab match but Sassuolo forward Domenico Berardi curled an effort... Reported by New Zealand Herald 19 minutes ago.

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    Reported by Telegraph.co.uk 2 hours ago.

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    Reported by MarketWatch 2 hours ago.

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    · *The index looks to pick up pace above the 96.00 mark.*
    · *US stock markets opened with sharp losses today.*
    · *Yields of the US 10-year note tumble below 3.12%.*

    The greenback, in terms of the *US Dollar Index* (*DXY*), has trimmed part of the earlier losses and is now looking to re-test the 96.00 area and above.

    *US Dollar upside still capped beyond 96.00*

    The index is struggling for direction on a volatile session, following an earlier test of highs near 96.20 and the subsequent drop to the 95.80 zone.

    The greenback remains under some pressure amidst declining yields of the key US 10-year note, which have retreated to fresh 3-week lows in the 3.12% area.

    Absent publications and events in the US calendar, investors are closely following the US stock markets, where the DowJones has started the session under heavy pressure, down almost 500 pts at the time of writing.

    On the broader picture, the buck is poised to remain underpinned by risk-off mood and rising jitters over Italy and Brexit.

    Later in the NA session, Atlanta Fed R.Bostic (voter, centrist) is due to speak.

    *US Dollar Index relevant levels*

    As of writing the index is losing 0.04% at 95.99 and a breakdown of 95.49 (10-day SMA) would open the door to 95.36 (21-day SMA) and finally 94.79 (low Oct.12). On the flip side, the next hurdle is located at 96.15 (high Oct.23) seconded by 96.16 (high Oct.9) and then 96.98 (2018 high Aug.13). Reported by FXstreet.com 2 hours ago.

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    Wall Street stocks tumbled more than 2 percent on Tuesday as disappointing forecasts from industrial bellwethers Caterpillar and 3M piled on to concerns over Saudi Arabia's diplomatic isolation, Italy's finances and trade-war fears. Reported by Reuters 2 hours ago.

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    Wall Street sank more than 1 percent on Tuesday as disappointing forecasts from industrial bellwethers Caterpillar and 3M piled on to concerns over Saudi Arabia's diplomatic isolation, Italy's finances and trade-war fears. Reported by Reuters 1 hour ago.

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    A wave of extreme weather has hit the country Reported by Independent 2 hours ago.

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