BPC December 16 update

EVOK shares rally on pre-NDA​ feedback from the FDA. Comical error on CNBC causes wild swings for CYTX

Price and Volume Movers

Cytori Therapeutics Inc (NASDAQ:CYTX) shares spiked in late trading following a comical error on CNBC when a commentator on the business news television channel confused the ticker CYTK and mistakenly mentioned CYTX. Shares of the company, which were up only 8% prior to the error, rallied for 45 minutes post the error to an intra-day high up 22% before selling off during the final hour to close the session up 10% on 29x volume.

Shares of Evoke Pharma Inc (NASDAQ:EVOK) surged to close up 44% on 95x average volume. The company announced after-hours on Thursday guidance from its pre-NDA (New Drug Application) meeting with the FDA regarding its pipeline candidate Gimoti indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis in adult women. The FDA noted that;

“demonstration of equivalent exposure to the listed drug (Reglan 10 mg Tablets) in a healthy volunteer pharmacokinetic (PK) trial could serve as a portion of an NDA for Gimoti.  Upon demonstration of appropriate exposure in a PK trial, Evoke will submit the PK data and prior clinical studies to the Agency for review in the Gimoti NDA.  The FDA agreed that no new efficacy or safety study would be required, if bioequivalence criteria were met.”

XBiotech Inc (NASDAQ:XBIT) shares tumbled to close down 22% on 11x average volume following its announcement  of concerns noted in the Day 180 List of Outstanding Issues received from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding its Marketing Authorization Application (MAA) for Xilonix for the treatment of advanced colorectal cancer. The company stated that;

"Major objections remain relating to clinical and quality matters. Clinical objections pertain primarily to benefit risk justification of the therapy and pharmacokinetics. Quality objections relate to qualification of the cell line used to produce the antibody and scaled down systems used to demonstrate robustness of the purification process as well as clarification of critical process controls."

RXi Pharmaceuticals Corporation (NASDAQ: RXII) announced the pricing of a public offering at a price of $0.90 per unit, with each unit consisting of one share and warrants to purchase one share, for proceeds of $10m. Shares plummeted to close down 38% on 7x average volume.

Vericel Corp (NASDAQ:VCEL) shares also dropped following the pricing of its public offering. The company, which earlier in the week announced the FDA approval of MACI, priced its offering of 6.2m shares at $2.75 per share for proceeds of $17m. Shares closed down 13% on 3x average volume.

Agios Pharmaceuticals, Inc. (Nasdaq:AGIO), which announced after hours on Thursday that the FDA has placed a clinical hold on AG-519, saw its shares close down 19% on 6x average volume.


Other major price movers (10%+):

ADVANCERS:

Egalet Corp (NASDAQ:EGLT): +13%; 4x average volume.

Flex Pharma Inc (NASDAQ:FLKS): +12%.

Infinity Pharmaceuticals Inc. (NASDAQ:INFI): +10%.

Horizon Pharma PLC (NASDAQ:HZNP): +10%; 3x average volume.

DECLINERS:

Catalyst Biosciences Inc (NASDAQ:CBIO): -19%; 2x average volume.

Northwest Biotherapeutics, Inc (NASDAQ:NWBO): -19%; 3x average volume.


Full pipeline updates below

Pipeline Database Updates

Drug Stage Catalyst

ADMP
Epinephrine Pre-filled Syringe (PFS)
Emergency treatment of anaphylaxis.

PDUFA CRL issued March 27 2015. CRL issued again June 6, 2016. NDA resubmission announced December 16, 2016. NDA acceptance announced January 19, 2017. No PDUFA date announced. PDUFA date estimate June 15, 2017 using 6-month time frame from resubmission.

AVDL
Micropump Sodium Oxybate
Excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy

Phase 3 Phase 3 SPA agreed on - October 2016. Initiation of dosing announced December 16, 2016.

EVOK
Gimoti - EVK-001
Female diabetic gastroparesis

Phase 3 Phase 3 data released July 2016. Primary endpoint not met. However, the company noted December 15, 2016 that following discussions with FDA regarding possible NDA submission, no new efficacy or safety study would be required, if bioequivalence criteria were met in a pharmacokinetic (PK) trial. NDA filing to be submitted by late 2017 or early 2018.

ALNY
Givosiran
Acute hepatic porphyrias

Phase 1 Phase 1 additional data due June 2017 with a Phase 3 trial to be initiated in late 2017.

ALNY
ALN-TTRsc02
ATTR amyloidosis

Phase 1 Development plan to be confirmed following APOLLO data release in mid 2017.

ALNY
Fitusiran (ATLAS)
Hemophilia

Phase 3 Phase 3 program to be initiated 2Q 2017, with initial data due mid-late 2017

ALNY
Patisiran APOLLO
Familial Amyloidotic Polyneuropathy (FAP) in Patients with ATTR

Phase 3 Phase 3 data due mid 2017.

MDCO
Inclisiran
Hypercholesterolemia

Phase 3 Phase 3 trial to be initiated mid-2017.