Evoke Pharma mit KZ 12 USD
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Evoke Pharma plan for accelerated review of NDA for lead product candidate Gimoti now more so; shares ahead 57%
Feb. 15, 2017 11:19 AM ET|About: Evoke Pharma, Inc. (EVOK)|By: Douglas W. House, SA News Editor
Nano cap Evoke Pharma (EVOK +56.7%) jumps on a healthy 14x surge in volume in response to its announcement that the FDA will not require it to conduct a human factors study to support an NDA filing for lead product candidate Gimoti, its nasal delivery formulation of metoclopramide for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women.
The company intends to submit its U.S. marketing application by year end under the accelerated 505(b)(2) pathway which allows the inclusion of data from studies performed by others.
Previously: Evoke Pharma mines data from failed late-stage study of Gimoti in diabetic gastroparesis; valid treatment effect in subset of patients; shares up 47% (Jan. 4)
Now read: Healthcare - Top 5 Gainers / Losers as of 11:00 am »
CRL für Gimoti (NDA)
https://seekingalpha.com/news/...moti-nda-shares-38-percent-premarket
in 2018
- keine Umsätze
- Verluste ~8 Mio. $
- Cash 5 Mio. $
- MK 16 Mio. $
https://evokepharmainc.gcs-web.com/news-releases/...ar-2018-financial
Evoke meldet Zahlen für Q1/19
- keine Umsätze
- Verlust 2 Mio. $
- Cash 4 Mio. $
- MK 12 Mio. $
- Projected cash runway extended to first quarter 2020
https://evokepharmainc.gcs-web.com/news-releases/...financial-results
Zahlen für Q1/20
- keine Umsätze
- Verlust 1,8 Mio. $
- Cash 4,1 Mio. $
- MK 58 Mio. $
"The Company expects that its current cash balance will be sufficient to support operations into the third quarter of 2020, excluding the Eversana line of credit of $5 million that will become available if FDA approves Gimoti."
https://evokepharmainc.gcs-web.com/news-releases/...ncial-results-and
Zulassung für GIMOTI
"The FDA approval of GIMOTI allows Evoke to access its existing $5 million line of credit from EVERSANA to support manufacturing and other aspects of GIMOTI’s commercialization. As of May 31, 2020, the Company’s cash and cash equivalents were approximately $4.7 million. Evoke believes, based on its current operating plan, that its cash and cash equivalents, together with the EVERSANA line of credit, will support the company’s operations into 2021, without consideration of potential GIMOTI revenue."
https://evokepharmainc.gcs-web.com/news-releases/...s-evokes-gimotitm
https://seekingalpha.com/news/...oke-pharmaplus-71-pm-on-fda-approval