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 Post subject: Re: 沙里淘金
PostPosted: 1/5/18 22:01 
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Joined: 1/5/18 21:58
Posts: 10
现在有什么公司正在研发这两种?


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/6/18 01:12 
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Joined: 11/15/09 14:44
Posts: 1892
Merrill Lynch’s top #biotech picks for 2018:VRTX ESPR CELG IRWD


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/6/18 01:23 
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Posts: 1892
换名了
ITEK - it is now Rocket RCKT
PPHM will change to CDMO


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/6/18 01:35 
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Posts: 1892
PIPER Drug Discovery
2018 Top Picks: EXEL, XNCR, FATE;


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/7/18 11:46 
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Joined: 1/5/18 21:58
Posts: 10
谢谢哈!


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/7/18 18:23 
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WSJ Reports Celgene likely to acquire Impact Biomedicines for up to $7bn (1B upfront).So CELG taking 1BILLION dollar chance they can get this drug approved. If they do they pay 6 billion more later. Big market potential here (compete with INCY)


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/7/18 18:32 
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Jeff: $CELG May acquire NDA-ready drug for
myelofibrosis; $1B+ pot'l oppt'y looks
attractive

Initial look at the story around privately-held Impact Biomedicines suggests a
Phase III-completed JAK2 pill for MF which would compete against INCY's Jakafi
drug which has peak $2B pot'l. We think this looks like a good deal because it
provides synergistic new $1B+ revenue growth oppty for CELG and back-ended
payments which are smart.

The Wall Street Journal is reporting that CELG is close to acquiring San Diegobased
Impact Biomedicines for up to $7B - though that likely includes notable
back-ended milestone payments if successful - with a potential announcement as
early as Monday. The acquisition would comprise of a $1B upfront payment, followed by
two other stages that are contingent upon FDA approval and successful commercialization
- and which seems wise and logical that CELG only pay if the drug is able to get approved.
Bottom line - the drug is a pot'l competitor to INCY Jakafi in first line and
looks similar or better in efficacy but also works in Jakafi failures (2L). The
drug previously had been on clinical hold at Sanofi due to cases of rare Wernicke’s
Encephalopathy (WE) but Impact convinced the FDA the cases were not necessarily due to
the drug and it was released off clinical hold recently in August 2017 (data was presented
at ASH 2017). Hence it would appear CELG is likely to take over and get the NDA submitted
and prepare to launch the drug later in 2019-2020 if all goes well - providing some new
revenue growth beyond 2020-23+...
In October 2017, Impact Biomedicines secured a $22.5M Series A and $90M
debt financing to develop its oral JAK2 fedratinib for myelofibrosis (bone marrow
disorder) which is NDA-ready and polycythemia vera (blood cancer) which completed Phase
II studies. Impact plans to submit an NDA for myelofibrosis in 2018, and the company
believes fedratinib's use could also extend to AML and colorectal cancer.
Notably - the drug came from Sanofi which had previously completed a positive
Phase III placebo-controlled trial evaluating 288 first-line myelofibrosis patients taking
fedratinib doses of 400mg and 500mg daily. Fedratinib achieved a statistical significant
positive result in its (1) primary endpoint, showing a 47% response of a >35% reduction
in spleen size at week 24 and (2) secondary endpoint, which was a >50% reduction in
total symptom score at 24 weeks. **Contact us for posters and data** Separately,
fedratinib has been evaluated in a Phase II study (JAKARTA-2) in 97 patients who were
ruxolitinib resistant or intolerant. Results showed that 55% of the patients had a >35%
reduction in spleen size, and the most common adverse events were hematological (anemia,
thrombocytopenia) and gastrointestinal (nausea, diarrhea and vomiting).
In 2013, Sanofi (SAN FP, Hold) discontinued fedratinib's development after a
FDA clinical hold due to cases of Wernicke’s encephalopathy (neurological side
effects), though Impact later provided additional data to the FDA in a Type A meeting,
prompting the FDA to ultimately lift the hold and permit fedratinib's development. We
believe the lift helps validate Impact’s belief that the benefits of fedratinib outweigh the
risks. Specifically, data demonstrated patients treated with fedratinib in clinical trials did not
experience a decrease in thiamine levels, and the prevalence of Wernicke Encephalopathy
(WE) in the trials was less than originally perceived, and that after in-depth analysis of
the data, only 1 clear case of WE was concluded and that occurred in a significantly
malnourished and debilitated patient which could have been prevented and is treatable. The
diagnosed patient entered the trial with >10% weight loss and had preceding protracted
nausea and vomiting, suggesting this as a contributing factor to malnutrition and thiamine
deficiency. This patient was treated with IV thiamine and WE was considered resolved 2
months later.


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/7/18 20:01 
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Joined: 1/5/18 21:58
Posts: 10
celg 下周二的报告。


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/7/18 20:55 
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Joined: 11/15/09 14:44
Posts: 1892
VANCOUVER, British Columbia--(BUSINESS WIRE)--

Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, today provided key accomplishments from the past year and announced priorities for 2018.

“2017 was a great year for Zymeworks and we are poised to achieve a number of important corporate milestones in 2018,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “We anticipate notable progress across our business, including additional clinical results for ZW25, the establishment of new partnerships and presenting preclinical data showcasing the breadth of our technology and emerging therapeutic pipeline. In addition, we expect to hear about the further advancement of our partners’ bispecific therapeutics built using our Azymetric platform.”

ZW25 – Accelerating Clinical Development

Zymeworks’ lead clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody targeting two distinct domains of the HER2 receptor resulting in multiple differentiated mechanisms of action. In 2017, the company reported results from the dose escalation portion of its ongoing Phase 1 clinical trial, showing encouraging tolerability and anti-tumor activity in heavily pretreated patients with HER2-expressing cancers, including breast and gastric cancers.

“Over the last year we observed meaningful clinical responses in a number of late-stage breast and gastric cancer patients,” said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. “Based on this success, we are prioritizing strategies to accelerate development of ZW25 in 2018.”

Business Development – Progressing and Expanding Partnerships

In November 2017, Zymeworks provided a license to Janssen to develop multiple bispecific antibodies in a transaction worth up to US$1.45 billion including a US$50 million upfront payment as well as tiered royalties on product sales.

“Given Janssen’s biologics expertise and experience with other bispecific platforms, we believe this establishes Azymetric™ as an industry-leading solution for the development of bispecific antibody therapeutics,” said Dr. Tehrani of Zymeworks.

Janssen was the sixth global pharmaceutical partner to gain access to Zymeworks’ Azymetric™ platform in a notable group that also includes Merck, Lilly, Celgene, GSK and Daiichi Sankyo. All these partnerships are actively identifying drug candidates for clinical evaluation. Earlier in 2017, two partners (Lilly and Merck) announced that they had selected lead Azymetric™ bispecific candidates for advancement towards the clinic and Daiichi Sankyo’s program achieved a significant research milestone resulting in a milestone payment to Zymeworks.

2018 Milestones

Building on its 2017 accomplishments, over the next 12 months, Zymeworks expects to:

Complete enrollment and report additional data from its adaptive Phase 1 clinical study of ZW25;

Refine the regulatory strategy and accelerate the development of ZW25;

File an Investigational New Drug (IND) Application for one of its wholly-owned product candidates;

Present preclinical data showcasing its maturing candidate pipeline and evolving therapeutic platforms; and

Establish new strategic drug development partnerships.

Additionally, Zymeworks expects its partners’ Azymetric™ programs to begin entering the clinic in 2018.


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/8/18 09:54 
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Joined: 10/18/15 23:19
Posts: 76

koi wrote:
AXON Axovant Sciences announces negative results for Intepirdine in Phase 2b HEADWAY and pilot Phase 2 gaint and balance studies; Positive trends in efficacy seen in pilot Phase 2 Nelotanserin study (5.37 ) Investigational drug Intepirdine did not meet its primary efficacy endpoints in the Phase 2b HEADWAY and pilot Phase 2 Gait and Balance studies. Intepirdine program to be discontinued based on MINDSET, HEADWAY, and Gait and balance study results. Company to advance to larger confirmatory nelotanserin DLB study focused on motor function and psychosis. Conference Call Today at 8:00 a.m. EST


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/8/18 17:51 
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Joined: 11/15/09 14:44
Posts: 1892
Last,不好意思,axon赌错方向了。希望你没有太大损失。


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/8/18 18:17 
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Joined: 10/18/15 23:19
Posts: 76
不好意思啊,我不是赖皮啊,好像一年就看了,决定一跟就不幸了,咋办?


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/8/18 18:34 
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Joined: 11/15/09 14:44
Posts: 1892
现在这个位置,我就不割了,等他们再买新的molecule,下次hype的时候再出


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/8/18 18:42 
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Joined: 10/18/15 23:19
Posts: 76
你也没说,我开盘把锅碗瓢盆都加进去了,关盘前全歌了,把筷子抢回来了,这咋办?要不你定向增发十个pick ?


 
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 Post subject: Re: 沙里淘金
PostPosted: 1/8/18 18:46 
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Joined: 11/15/09 14:44
Posts: 1892
你这么说,我就放心了,呵呵,看来伤的不重


 
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