Diskusjon Triggere Porteføljer Aksjonærlister

Nordic Nanovector - Fundamentale forhold 2019 (NANO)

Nordic Nanovector ASA - Resolution not to proceed with a repair offering

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Tror dette var smart av Nano, da kan vi få ro rundt dette.
Siste emisjon så fulgte de jo opp med rep emi selv om kursen da også lå under emi kursen på 45, og husker jeg rett så tok det noen uker (?) før det var unnagjort, noe som lå som en klam hånd på kursen og trykket den ned.
Onwards, forward and upwards Nano! :+1:

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Nydelig !

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Hva kan grunnen være for at Nordic Nanovector ikke føler de trenger disse ekstra pengene? :wink:

Edit: Brain fart…

Lar denne stå som et bevis på at selv de beste kan ta feil.

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Hvor mye ekstra penger tror du kommer inn på dette? Hvor mange kjøper aksjer til 22kr i en emi når man kan kjøpe de for 20kr på børs? Kostnadene vil fort være høyere enn inntektene.

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Nordic Nanovector ASA: Mandatory notification of trade - primary insider

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Flott Tone !

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Tone hadde ikke kjøpt en flis av NANO hvis hun tvilte på fremtiden. Ferdig snakka. Bull.

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Fint med kjøp av Kvåle, men 100 000,- Litt puslete med tanke på 10x 20x … i fremtiden

Hun har 186k fra før

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100.000kr er relativt saftig spør du meg. Hvert fall basert på aksjer hun har fra før, samt opsjoner og psu.

Hadde hun het Tone Gates - skulle jeg klaget på beløpet hun handlet for selv​:+1::grin:

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Ja det måtte jo komme noen å kommentere at Tone BARE kjøper 5000 aksjer…

NANO aksjonærer er ikke som andre aksjonærer. “everything you say (and do) can and will be used against you…”

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Det er helt topp!

Jeg undrer meg nok heller over strategien ved å ikke kjøre Bravo sitt kjøp som en individuell melding istedenfor å gjemme den i emisjonsmeldingen.

Litt mer sus over en egen mld:

«Adm dir kjøper 50k aksjer i Nano til aksjekurs 22kr»

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Har tenkt på det samme selv. Burde jo egentlig alltid være egen børsmelding på slike transaksjoner?

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IR som er ansvarlig her :wink:

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I know. I told her :joy:

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Blir spennende å se hva slags data de presenterer her. Samme pop som NANO kjører i sin PARADIGME studie. De hadde som mål å få en ORR på mellom 40% og 50%, noe som jeg forventer at NANO sin betalutin også burde klare veldig greit. Så hva sier det om NANO sine sjangser for godkjennelse? Tror de er ganske jeg bra jeg :slight_smile:

Hele pressemeldigen

NEW YORK, Oct. 28, 2019 (GLOBE NEWSWIRE) – TG Therapeutics, Inc. (NASDAQ: TGTX), a biopharmaceutical company developing medicines for patients with B-cell mediated diseases, today announced that the follicular lymphoma (FL) cohort of the UNITY-NHL Phase 2b pivotal trial evaluating single agent umbralisib, the Company’s novel, once daily, PI3K delta inhibitor, met the primary endpoint of overall response rate (ORR) as determined by Independent Review Committee (IRC) for all treated patients (n=118) who have received at least two prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent. The results met the Company’s prespecified ORR target of 40-50%. Importantly, umbralisib monotherapy appeared to be well tolerated with a safety profile consistent with previous reports.

The Company plans to present the data at a future medical conference as well as discuss the data with the U.S. Food and Drug Administration (FDA).

Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, “We are extremely pleased to announce that the UNITY-NHL follicular lymphoma cohort evaluating umbralisib monotherapy met the primary endpoint of ORR. There are no fully approved drugs for patients with follicular lymphoma that have progressed following two or more prior lines of therapy and we are excited by the potential to offer a novel treatment for this underserved population. We look forward to sharing these results with the FDA and discussing submission opportunities for accelerated approval of umbralisib in follicular lymphoma." Mr. Weiss continued, “These are very exciting times for TG and with two additional major events targeted to occur over the next several months, including commencing our first NDA filing for umbralisib in patients with relapsed/refractory marginal zone lymphoma and results from our UNITY-CLL Phase 3 trial, we expect that excitement to continue. Taken together, we see 2020 shaping up as a pivotal year where we transition from a development-stage company into a fully-integrated development and commercial organization.”

ABOUT THE UNITY-NHL PHASE 2b STUDY—FOLLICULAR LYMPHOMA COHORT

The multicenter, open-label, UNITY-NHL Phase 2b study – Follicular Lymphoma cohort was designed to evaluate the safety and efficacy of single agent umbralisib, the Company’s novel, once daily, PI3K delta inhibitor, in patients with FL who have received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. The primary endpoint is overall response rate (ORR) as determined by Independent Review Committee (IRC) assessment. Secondary endpoints include safety, duration of response, and progression-free survival (PFS).

The positive ORR outcome announced today was based on 118 FL patients that received at least one dose of umbralisib and who previously had received at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent.

CONFERENCE CALL INFORMATION

The Company will host a conference call today, Monday, October 28, 2019 at 8:30 AM ET to discuss the UNITY-NHL FL news. In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Update Call.

A live audio webcast of this call will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

ABOUT FOLLICULAR LYMPHOMA

Follicular lymphoma (FL) is typically a slow-growing or indolent form of non-Hodgkin lymphoma (NHL) that arises from B-lymphocytes, making it a B-cell lymphoma. Follicular lymphoma is usually not considered to be curable, and is a chronic disease. Patients can live for many years with this form of lymphoma. With an annual incidence in the United States of approximately 15,000 newly diagnosed patients1, FL is the most common indolent lymphoma accounting for approximately 20 percent of all NHL cases2.

ABOUT TG THERAPEUTICS, INC.

TG Therapeutics is a biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. Currently, the company is developing two therapies targeting hematological malignancies and autoimmune diseases. Ublituximab (TG-1101) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing umbralisib (TGR-1202), an oral, once-daily inhibitor of PI3K-delta. Umbralisib uniquely inhibits CK1-epsilon, which may allow it to overcome certain tolerability issues associated with first generation PI3K-delta inhibitors. Both ublituximab and umbralisib, or the combination of which is referred to as “U2”, are in Phase 3 clinical development for patients with hematologic malignancies, with ublituximab also in Phase 3 clinical development for Multiple Sclerosis. Additionally, the Company has recently brought its anti-PD-L1 monoclonal antibody, TG-1501, its covalently-bound Bruton’s Tyrosine Kinase (BTK) inhibitor, TG-1701, as well as its anti-CD47/CD19 bispecific antibody, TG-1801, into Phase 1 development. TG Therapeutics is headquartered in New York City.

Cautionary Statement

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. In addition to the risk factors identified from time to time in our reports filed with the Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: our ability to successfully and cost effectively complete preclinical and clinical trials; the risk that the clinical trial results from the UNITY-NHL FL cohort will not be sufficient to support a filing for approval; the risk that the positive data from the UNITY-NHL FL cohort will not be reproduced in future studies or in other cohorts of the UNITY-NHL study; the risk that umbralisib will not receive accelerated approval based on data from the UNITY-NHL FL cohort; the risk that duration of response or progression free survival data from the UNITY-NHL FL cohort when available will not be positive or supportive of approval; the risk that safety issues will arise when the safety data is cleaned and analyzed for the UNITY-NHL FL cohort; the risk that the differentiated tolerability profile for umbralisib previously observed in clinical trials will not be reproduced in the UNITY-NHL study, the UNITY-CLL study or any other on-going studies; the risk that patients with relapsed/refractory FL or MZL as studied in UNITY-NHL will not be considered an unmet medical need by regulatory authorities; the risk that the Company’s target ORR will not be considered sufficient to establish clinical efficacy in the opinion of any regulatory authority; the risk that the Company will not commence an NDA filing for umbralisib in patients with relapsed/refractory FL or marginal zone lymphoma in the planned timeframe or at all; the risk that data from the UNITY-CLL Phase 3 trial will not be available in the planned timeframe or not be sufficient to support a regulatory filing. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

CONTACT:

Jenna Bosco
Senior Vice President,
Corporate Communications
TG Therapeutics, Inc.
Telephone: 212.554.4351
Email: ir@tgtxinc.com

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Hvis alle bare kunne lese denne for å se hvor “lavt” hinderet for å få godkjenning er per nå hadde det vært fint. Interrimen til NANO er nok også satt opp slik at armene må passere 40-50% ORR for å få gå videre, kan jeg tenke meg.

Takk @larsmkn.

Håper vi på >60% ORR?

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Så det er med stor sannsynlighet over 40-50% ORR? Når skal det fremlegges? Konkurransen spisser seg til for NANO på bakgrunn av dette?

Vi håper på rundt 60% ORR med rundt 20% CR.
Tidligere data på disse pasientene fra NANO i tabell under. RTX-refractory:
image

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