Biotech News & Trading Forum: Community User: Weedmaster
Kommentare 5.258
Mandrake.,
28.08.2020 21:30 Uhr
0
Marinus kommt mal auf die Watchlist. Danke Schorsch 👍.
Schorsch11,
28.08.2020 15:45 Uhr
0
https://finance.yahoo.com/news/billionaire-israel-englander-goes-big-193043507.html?theme=2&_v=1&color=1&hl=en&sp=1&guccounter=1
Schorsch11,
27.08.2020 13:40 Uhr
0
Bei Redhill könnte auch was gehen die nächsten Wochen
A pre-scheduled independent Safety Monitoring Committee (SMC) has recommended that the U.S. Phase 2 COVID-19 study with opaganib continue with no changes; the study is more than 50% enrolled and enrollment is planned to be completed in the coming weeks
--
The global Phase 2/3 COVID-19 study with opaganib, being conducted in parallel to the U.S. Phase 2 study, received approval in Italy; this study has also been approved in the UK, Russia and Mexico, and is under review in additional countries
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The first patients have been enrolled in the global Phase 2/3 study with opaganib, which is set to enroll up to 270 patients hospitalized with severe COVID-19 pneumonia across up to 40 clinical sites
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Potential submission of global emergency use applications as early as Q4/2020
https://www.benzinga.com/pressreleases/20/08/g17265222/redhill-biopharma-announces-positive-recommendation-from-independent-committee-to-continue-u-s-pha
Schorsch11,
27.08.2020 13:38 Uhr
0
CANF
Piclidenoson Phase III rheumatoid arthritis and psoriasis interim data expected Q4 2020
Achieved efficacy and safety endpoints in Phase II NASH trial
IND filed with FDA for Phase II study of Piclidenoson in treatment of COVID-19
https://www.benzinga.com/pressreleases/20/08/b17265212/can-fite-reports-second-quarter-2020-financial-results-provides-clinical-update
A
Alien91,
27.08.2020 12:15 Uhr
0
Auf ST spekulieren einige mit einem Aufkauf der CF Pipeline von 7-11 USD/Share, was natürlich der Wahnsinn wäre. Vor allem, weil man dann trotzdem noch Shares vom neuen Unternehmen hat. Also ich bleibe auf jeden Fall mal drinnen.
Sebastian_383,
26.08.2020 22:57 Uhr
0
Danke Ali3n für deine Einschätzung. Ich wollte demnächst wieder einsteigen und auf den gleichen Hype wie letztes Jahr spekulieren. Diese Veränderung ist aber leider nicht planbar... mal schauen
A
Alien91,
26.08.2020 14:40 Uhr
0
@Sebastian_383, ich weiß auch nicht wirklich was ich davon halten soll, allerdings denke ich, dass die die CF pipe dann hoffentlich zu den 100% verkaufen, denn das BoD hat ja auch massig Aktien von PTI.
Aber unterm Strich, werd ich mal halten, denn ein Mittel gegen Alzheimer wie auch eines gegen Parkinson, dauert zwar in der Entwicklung, aber bei jeder neuen Phase legt das Unternehmen bei positiven Ergebnissen (vorausgesetzt) ordentliche Sprünge nach oben hin.
Mal sehn was raus kommt.
A
Alien91,
26.08.2020 14:36 Uhr
0
https://www.vbivaccines.com/wire/preclinical-coronavirus-data-candidate-selection/
Sebastian_383,
26.08.2020 11:06 Uhr
0
Was haltet ihr aktuell von Proteostasis insbesondere zum geplanten Merger? Leider findet man wenig über Yumanity Therapeutics.
Weedmaster,
26.08.2020 9:47 Uhr
0
Kurz feucht gewischt. Soll ja biologisch bleiben. 😉
Schorsch11,
26.08.2020 8:51 Uhr
0
Miragen Therapeutics MGEN
Progress on next generation microRNA-29 mimic for use in pulmonary fibrosis (MRG-229) includes new preclinical data; additional NIH grant funding triggered
Exploratory preclinical safety and pharmacokinetic data for MRG-229 expected before year end
Plan to receive guidance from the FDA on proposed regulatory pathway for cobomarsen in ATLL before year end
A majority of patients in the Phase 2 SOLAR trial of cobomarsen in CTCL have continued to receive uninterrupted treatment and are being evaluated for clinical response
Reported $30.6 million in cash and cash equivalents as of June 30, 2020; anticipate cash runway into Q3 2021
Mandrake.,
25.08.2020 13:24 Uhr
0
Co-Diagnostics Reports Q2 Sales Increased By 1,503% To $24M Driven By Its COVID-19 Tests
Benzinga · 25.8.2020, 12:38:10
Schorsch11,
25.08.2020 12:52 Uhr
0
Will Lipocine Succeed With Its Fourth Try?
Company: Lipocine Inc (NASDAQ: LPCN)
Type of Application: NDA
Candidate: Tlando
Indication: Hypogonadism
Date: Aug. 28
Tlando, a novel oral prodrug of testosterone containing testosterone undecanoate, is designed to help restore normal testosterone levels in hypogonadal men.
The investigational asset stumbled at the FDA altar three times in the past. Following Lipocine's third resubmission, the FDA has established a PDUFA action date of Aug. 28
Roche Hopes To Be Better Late Than Never
Company: Roche
Type of Application: BLA
Candidate: Satralizumab
Indication: neuromyelitis optica spectrum disorder, or NMOSD
Date: Aug. 29
Satralizumab is an investigational humanized monoclonal antibody that targets the IL-6 receptor. The cytokine IL-6 is thought to be a key driver of NMOSD, triggering the inflammation cascade and leading to damage and disability.
Roche announced FDA acceptance of the BLA Oct. 30, and assuming a standard ten-month review period, the decision is expected Aug. 29.
Earlier this year, the Japanese drug regulatory agency approved satralizumab for treating NMOSD.
If the approval comes through, Roche may have to face competition from two drugs already in the market, namely Alexion Pharmaceuticals, Inc.'s (NASDAQ: ALXN) Soliris and Viela Bio Inc's (NASDAQ: VIE) Uplizna.
Morphosys-Incyte Await FDA Word On Lymphoma Drug
Company: Incyte Corporation(NASDAQ: INCY) and Morphosys Ag (NASDAQ: MOR)
Type of Application: BLA
Candidate: Tafasitamab
Indication: diffuse large B cell lymphoma, or DLBCL
Date: Aug. 30
Tafasitamab is an investigational humanized Fc-engineered monoclonal antibody directed against CD19. Morphosys had licensed the investigational asset from Xencor Inc (NASDAQ: XNCR) in 2010. In January, Morphosys and Incyte entered into a a collaboration and licensing agreement to commercialize tafasitamab globally.
The FDA accepted March 2, Morphosys' BLA, seeking approval for tafasitamab, in combination with Revlimid, as a treatment option for relapsed or refractory DLBCL. The agency set a PDUFA action date of Aug. 30.
Gottsbrain,
25.08.2020 10:07 Uhr
0
Glaub Weed muss mal durchwischen 🤦♂️
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