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Actionable news in ALNY: Alnylam Pharmaceuticals, Inc.,

TherapeuticsMD TXMD rallies on intention to refile Yuvvexy NDA

Price and Volume Movers

Collegium Pharmaceutical, Inc. (Nasdaq:COLL) announced that the FDA will not meet the set PDUFA date of November 4 for its Supplemental New Drug Application (sNDA) of a label expansion of Xtampza ER (oxycodone extended-release), an abuse-deterrent, extended-release opioid, for the management of pain.

“The FDA hasn’t requested any additional scientific information or data,” said Michael Heffernan, CEO of Collegium.

TherapeuticsMD Inc (NASDAQ:TXMD) shares closed up 32% to $5.74 following notification from the company that it intends to resubmit its NDA of Yuvvexy for the treatment of moderate to severe pain during intercourse within the coming weeks. The pending resubmission is in response to a Complete Response Letter (CRL) issued in May, 2017, where the FDA cited a lack of long-term endometrial safety data.

Other 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:

Genocea Biosciences Inc (NASDAQ:GNCA): $1.27; +21%.

Kala Pharmaceuticals Inc (NASDAQ:KALA): $18.70; +15%.

Ovid Therapeutics Inc (NASDAQ:OVID): $8.84; +14%.

Sorrento Therapeutics Inc (NASDAQ:SRNE): $2.90; +12%.

Marinus Pharmaceuticals Inc (NASDAQ:MRNS): $6.88; +11%.

DECLINERS:

Neos Therapeutics Inc (NASDAQ:NEOS): $10.83; -16%.

Vical Incorporated (NASDAQ:VICL): $1.81; -14%.

Achieve Life Sciences Inc (NASDAQ:ACHV): $1.40; -13%.

Novan Inc (NASDAQ:NOVN): $5.70; -10%.

Fibrocell Science Inc (NASDAQ:FCSC): $1.86; -9%.

Pipeline updates below (after-hours updates uploaded tonight):

Pipeline Database Updates

Drug Stage Catalyst

AIMT
AR101 PALISADE
Peanut Allergy

Phase 3 Phase 3 initiated January 2016. Enrollment completion announced November 28, 2016. Top-line data due 1Q 2018.

AKCA
AKCEA-APO(a)-LRx
Hyperlipoproteinemia(a) and established cardiovascular disease

Phase 2b Phase 2b initiation announced March 30, 2017. Data due 2018.

AKCA
AKCEA-ANGPTL3-LRx
Rare hyperlipidemias

Phase 2 Phase 2 trial to be initiated 2017.

AKCA
AKCEA-ANGPTL3-LRx
Non-alcoholic fatty liver disease (NAFLD)

Phase 2 Phase 2 trial to be initiated 2017.

AKCA
AKCEA-APOCIII-LRx
Hyperlipoproteinemia(a) and established cardiovascular disease

Phase 2b Phase 2b trial to be initiated 4Q 2017.

ANTH
Sollpura - RESULT
Exocrine pancreatic insufficiency

Phase 3 Phase 3 data due end 1Q 2018.

CHRS
CHS-1701
Pegfilgrastim biosimilar

CRL CRL announced June 12, 2017. BLA to be resubmitted mid-1Q 2018.

CNCE
CTP-543
Alopecia areata

Phase 2a Phase 2 clinical hold placed May 17, 2017 lifted July 10, 2017. Trial completion due 2H 2018.

COLL
Xtampza ER (oxycodone)
Severe pain

Approved Approval announced November 7, 2017.

DERM
Olumacostat glasaretil (DRM01)
Acne

Phase 3 Phase 3 completion of enrollment announced October 5, 2017. Data are due 1Q 2018.

IONS
Inotersen (IONIS-TTRRx)
NEURO-TTR - familial amyloid polyneuropathy (FAP).

NDA Filing Phase 3 data released May 15, 2017 - primary endpoint met but with safety concerns. Data presented November 2, 2017. NDA submission announced November 6, 2017.

ESPR
Bempedoic Acid/ Ezetimibe (1002FDC-053)
Hypercholesterolemia

Phase 3 Phase 3 initiation announced November 6, 2017. Data due 4Q 2018.

FLKS
FLX-787 - COMMEND US trial
Amyotrophic lateral sclerosis (ALS)

Phase 2 Phase 2 start noted August 1, 2017. Data due 3Q 2018.

FLKS
FLX-787 COMMIT
Charcot-Marie-Tooth (CMT)

Phase 2 Phase 2 trial initiation announced October 16, 2017 with data due 3Q 2018.

FPRX
FPA144 + chemo (FIGHT)
Gastric and gastro-esophageal junction cancer

Phase 1 Phase 1 portion of Phase 1/3 trial to be initiated by end of 2017.

IDRA
IMO-2125 + ipilimumab
Cancer - melanoma

Phase 2 Phase 1/2 data released September 10, 2017. 6/9 disease control with one CR. Phase 3 trial to be initiated 1Q 2018.

IDRA
IMO-8400
Dermatomyositis

Phase 2 Phase 2 initiated November 2015. Enrollment to be completed by the end of 2017 with data due 2Q 2018.

MDCO
Inclisiran
Hypercholesterolemia

Phase 3 Phase 3 trial commencement announced November 10, 2017. Data due by end of 2019.

NERV
MIN-117
Major Depressive Disorder

Phase 2a Phase 2a data released May 2016. Endpoints met. Phase 2b trial to be initiated early 2018.

SUPN
SPN-812
ADHD

Phase 2b Phase 2b trial met primary endpoint - October 11, 2016. Phase 3 commenced 2H 2017.

SUPN
SPN-810
Impulsive Aggression in ADHD

Phase 3 Phase 3 enrollment to continue through mid-2018. Noted September 18, 2017 that the lower of the two doses will be discontinued following interim analysis.

TXMD
TX-001HR
Moderate to severe vasomotor symptoms (VMS)

Phase 3 Phase 3 data released December 5, 2016. NDA filing due December 2017.

TXMD
Yuvvexy
Moderate-to-severe vaginal pain

CRL CRL announced May 8, 2017. Company noted that FDA cited a lack of long-term endometrial safety data. Noted November 6 that NDA filing will be resubmitted in the coming weeks.

URGN
RTGel in combination with BOTOX
Overactive Bladder (OAB)

Phase 2 Phase 2 trial initiation announced November 6, 2017.

XNCR
XmAb5871
IgG4-Related Disease (IgG4-RD)

Phase 2 Phase 2 final data presented November 4, 2017. Phase 3 trial to commence 2H 2018.

ZIOP
Ad-RTS-hIL-12 + veledimex
Glioblastoma multiforme (GBM)

Phase 2/3 Phase 3 pivotal trial to be initiated 2017.

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