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SHEEPWOLF'S $1,000,000.00 JOUR..
(Total Views: 295)
Posted On: 09/27/2017 12:50:33 PM
Post# of 106590
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Posted By: OldSaltDawg
Here is a listing of BioPharm stock catalysts. It's a good listing to show what is coming up on the radar:


​Axovant AXON tumbles on Phase 3 trial failure; PTCT - FDA Panel briefing documents released for upcoming Adcom
Axovant Sciences (NASDAQ: AXON) shares tumbled following the announcement that its Phase 3 MINDSET clinical trial of intepirdine in patients with mild to moderate Alzheimer's disease (AD) did not meet its co-primary efficacy endpoints. Shares closed down 74% to $6.33.

Genocea Biosciences, Inc. (NASDAQ:GNCA) shares plunged to close down 77% to $1.25 following its announcement Monday after-hours that it will cease development for GEN-003 for the treatment of genital herpes. The company had previously announced that a Phase 3 trial was due to commence in 4Q 2017.

PTC Therapeutics, Inc. (NASDAQTCT) shares slid following the release of briefing documents for its meeting with an FDA Panel this Thursday which will discuss its NDA of Ataluren for the treatment of Duchenne muscular dystrophy (DMD). The documents were hardly glowing as noted by the following comment:

The application contains a large number of exploratory analyses that lack interpretability and are often entirely based on unblinded data. The presentation of the data in the application is often unclear as to which analyses were used by the applicant. Ultimately, no positive results from any prospectively planned analyses that are persuasive have been provided with this application. In the one instance where an exploratory analysis (the unblinded post hoc analysis of Study 007) was prospectively tested (in Study 020), the results were clearly negative.

The company previously received a Received a Refusal to File letter for their NDA Filing in February, 2016, followed by and appeal in October, 2016 which was rejected. A decision was made by the company to resubmit its NDA under protest and the application was issued a new PDUFA date of October 24, 2017. Given the background information, the negative comments made in the briefing documents should not have surprised investors, yet shares still closed down 14% to $16.81.

Intra-Cellular Therapies, Inc. (Nasdaq:ITCI) announced that it has commenced an underwritten public offering of $150m of shares of its common stock.

Ascendis Pharma A/S (Nasdaq:ASND) also announced that it has commenced an underwritten public offering of $125mof American Depositary Shares.



Major price movers (stocks priced > $1.00, volume > 50k):

Refer to the BioPharmCatalyst Biotech Stocks page for Top 10 Gainers/Losers/Unusual Volume INCLUDING sub-$1 stocks.

ADVANCERS:

Bioblast Pharma Ltd (NASDAQ:ORPN): $2.22; +25%.

Myovant Sciences Ltd (NYSE:MYOV): $14.88; +20%.

Versartis Inc (NASDAQ:VSAR): $2.80; +14%.

Galectin Therapeutics Inc (NASDAQ:GALT): $2.30; +13%.

Moleculin Biotech Inc (NASDAQ:MBRX): $2.66; +10%.

DECLINERS:

ProQR Therapeutics NV (NASDAQRQR): $5.20 -19%,

Kadmon Holdings Inc (NYSE:KDMN): $3.24; -15%.

Repligen Corporation (NASDAQ:RGEN): $36.98; -14%.

TherapeuticsMD Inc (NYSEMKT:TXMD): $5.29; -13%.

Evoke Pharma Inc (NASDAQ:EVOK): $3.20; -11%.



Pipeline updates below:

DRUG STAGE CATALYST
TICKER: ADRO

ADU-S100

Solid tumors or lymphomas

PHASE 1B Phase 1b initiation of dosing announced September 26, 2017.
TICKER: ALNY

ALN-CC5 (cemdisiran)

Atypical hemolytic-uremic syndrome (aHUS)

PHASE 1/2 Phase 2 trial initiation announced September 26, 2017 with initial data due 2018.
TICKER: ARGS

ARGX-113

Pemphigus vulgaris (PV)

PHASE 2 Phase 2 initiation announced September 26, 2017 with interim data due 2H 2018.
TICKER: AXON

Intepirdine - MINDSET

Alzheimer's disease

PHASE 3 Phase 3 data released September 26, 2017 - primary endpoints not met.
TICKER: BLRX

BL-8040 in combination with atezolizumab - BATTLE

Acute myeloid leukemia (AML)

PHASE 1/2 Phase 1/2 initiation announced September 26, 2017.
TICKER: FCSC

FCX-007

Recessive dystrophic epidermolysis bullosa

PHASE 1/2 Phase 1/2 initial data from three patients released September 26, 2017.
TICKER: SVRA

AeroVanc - AVAIL

MRSA in cystic fibrosis

PHASE 3 Phase 3 initiation announced September 26, 2017.
TICKER: VTGN

AV-101

Adjunctive Treatment Major Depressive Disorder

PHASE 2 Phase 2 trial to commence January 2018 with completion due 2H 2018.
TICKER: VTGN

AV-101

Monotherapy Treatment Major Depressive Disorder

PHASE 2 Phase 2 top-line data due 1H 2018.

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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'


https://twitter.com/twitter/statuses/957208055766241280



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