Biotech News & Trading Forum: Community User: Weedmaster

PDUFA- Termine in Q1 2020-01-17 AIMT AR101  PDUFA date late-January 2020. Advisory Committee meeting September 13, 2019 voted in favor of supporting approval. 2020-01-24 MRK DIFICID (fidaxomicin) PDUFA date January 24, 2020 2020-01-23 EPZM Tazemetostat PDUFA date priority review January 23, 2020. FDA Advisory Committee meeting December 18, 2019 voted voted 11 - 0 in favor. 2020-01-14 NKTR NKTR-181 Original PDUFA date August 29, 2019 not met due to the postponement of advisory committee (Adcom) meeting. New date for Adcom is January 14, 2020. 2020-01-16 DRRX POSIMIR CRL Feb 12 2014. Advisory Committee meeting scheduled for January 16, 2020. PDUFA date TBA. 2020-01-15 IPCIF Aximris XR (Oxycodone Hydrochloride extended release) CRL issued September 25, 2017. NDA resubmitted. Advisory Committee Meeting scheduled for January 15, 2020. No PDUFA date set. 2020-02-16 AGRX Twirla CRLs issued 2013 and 2017. New PDUFA extended by three months to February 16, 2020. Advisory Committee Meeting October 30, 2019 voted 14 to 1 in favor. 2020-02-18 MRK Keytruda PDUFA date February 18, 2020. 2020-02-21 ESPR Bempedoic acid PDUFA date February 21, 2020. 2020-02-26 ESPR Bempedoic Acid/ Ezetimibe PDUFA date February 26, 2020. 2020-02-14 XXII VLN cigarettes FDA Tobacco Products Scientific Advisory Committee (TPSAC) to meet February 14, 2020, regarding MRTP application. Readers on the FDA Calendar, please IGNORE the "NDA filing" stage. This is used as a placeholder as no MRTP stage is available in the system. 2020-03-17 ETON EM-105 PDUFA date March 17, 2020. 2020-03-25 BMY Ozanimod - RADIANCE PDUFA date March 25, 2020. 2020-03-26 HRTX HTX-011 PDUFA date March 26, 2020. 2020-03-26 IGXT RIZAPORT (RHB-103) PDUFA date March 26, 2020. 2020-03-28 RMTI IV Triferic PDUFA date March 28, 2020. 2020-03-08 HZNP Teprotumumab PDUFA date under priority review March 8, 2020. Advisory Committee meeting December 13, 2019 voted 12-0 in support of approval. 2020-03-10 BMY Opdivo and Yervoy PDUFA date under priority review March 10, 2020. 2020-03-25 ZGNX FINTEPLA (ZX008) Refusal to file Letter (RTF) issued April 8, 2019. NDA resubmitted with new PDUFA date under priority review March 25, 2020 2020-03-26 ICPT Ocaliva (Obeticholic acid (OCA)) - REGENERATE Advisory Committee meeting April 22, 2020. PDUFA date originally set for March 26, 2020 to be extended. Date TBC. 2020-03-29 AZN Imfinzi + tremelimumab (CASPIAN) PDUFA date under priority review announced November 29, 2019. No PDUFA date announced. Estimate March 29, 2019.

ACST – Acasti Pharma Inc. CaPre (TRILOGY 1 and 2) Hypertriglyceridemia Phase 3 top-*** data due in January 2020 from both trials. MK: $191.7 million  AXSM – Axsome Therapeutics Inc. AXS-05 STRIDE-1 Treatment resistant depression Phase 3 data due 1Q 2020. MK: $3.3 billion BHVN – Biohaven Pharmaceutical Holding Company Ltd. Rimegepant Migraine - preventative Phase 3 top-*** data due early-1Q 2020. MK: $3 billion EXEL – Exelixis Inc., BMY – Bristol-Myers Squibb Company CABOMETYX (cabozantinib) with Opdivo and Yervoy - CheckMate 9ER First-*** renal cell carcinoma Phase 3 data due early 2020. MK: $5.6 billion GNFT – GENFIT S.A. Elafibranor - RESOLVE-IT Non-alcoholic steatohepatitis (NASH) Phase 3 interim data due 1Q 2020. MK: $805.4 million ITRM – Iterum Therapeutics plc Sulopenem Complicated urinary tract infections (cUTI) Phase 3 data due 1Q 2020. MK: $59.8 million KALA – Kala Pharmaceuticals Inc. KPI‑121 0.25% STRIDE 3 Dry eye disease Phase 3 data due 1Q 2020. MK: $183.9 million KPTI – Karyopharm Therapeutics Inc Selinexor - BOSTON Multiple myeloma Phase 3 data due early 2020. MK: $1.2 billion MIST – Milestone Pharmaceuticals Inc. Etripamil - NODE-301 Paroxysmal supraventricular tachycardia (PSVT) Phase 3 top-*** data due around end of 1Q 2020. MK: $404.1 million MNLO – Menlo Therapeutics Inc. Serlopitant Pruritus associated with prurigo nodularis Phase 3 data due March/April 2020. MK: $136.9 million SNGX – Soligenix Inc. SGX301 (synthetic hypericin) Cutaneous T-Cell Lymphoma (CTCL) cancer Phase 3 completion of enrolment announced December 3, 2019 with top-*** data 1Q 2020. MK: $34.7 million TGTX – TG Therapeutics Inc. TG-1101 and TGR-1202 - UNITY-CLL study Chronic Lymphocytic Leukemia (CLL) and non-Hodgkin's Lymphoma (NHL) Phase 3 PFS data due early 2020. MK: $1.3 billion

22nd Century Group - XXII VLN cigarettes MRTP application FDA Tobacco Products Scientific Advisory Committee (TPSAC) to meet February 14, 2020, regarding MRTP application. https://ir.xxiicentury.com/news-media/press-releases/detail/380/22nd-century-group-to-present-its-modified-risk-tobacco Cash: 43.7mio$ burn: 1mio$/month reicht noch 40 Monate. (30.09.2019) MARKET CAP 135,763,794 SHARES 134,419,598 AV. DAILY VOLUME 2,292,814 http://stocktwits.com/cameron4333/message/189954043 http://stocktwits.com/fnu2/message/189914573 https://ir.xxiicentury.com/news-media/press-releases/detail/375/22nd-century-group-files-2019-third-quarter-report https://ir.xxiicentury.com/news-media/press-releases/detail/376/22nd-century-group-comments-on-delay-of-reduced-nicotine

Grossartiges Forum hier. Danke an @lle für sämtliche Infos, Tipps und den Umgang miteinander.

Danke Gottsbrain für den Hinweis. Dachte wäre etwas Neues. 😅

Für was dann die benachrichtigung? Kann doch jeder errechnen was die 500k anteile nun wert sind 🙄

January 10, 2020 - Fny Investment Advisers, Llc has filed a 13F-HR form disclosing ownership of 500,000 shares of InflaRx N.V. (NASDAQ:IFRX) with total holdings valued at $1,980,000 USD as of December 31, 2019. Fny Investment Advisers, Llc had filed a previous 13F-HR on October 25, 2019 disclosing 500,000 shares of InflaRx N.V. at a value of $1,235,000 USD. This represents a change in shares of 0.00 percent and a change in value of 60.32 percent during the quarter. Die Anteile sind die selben wie im Oktober nur der Wert hat sich geändert weil der Kurs gestiegen ist. Keine geänderten Anteile.

Will ich euch nicht vorenthalten. Gestern Inflarx 13er Insiderkauf. https://fintel.io/so/us/ifrx/fny-investment-advisers

Argh, ich bin statt in Titan in Ritter rein und hab den ersten Schwung nicht genutzt. Mal sehen was da noch geht...Rock on

Lipocine krabbelt auch langsam wieder Gen Norden.

Kempharm 🚀

Hier geht es also ans Eingemachte

Tolle *** :)

Inflarx 🚀

Akari 👍

Die sind mindestens 20$ Wert 😁