The Daily Biotech Pulse: ChemoCentryx Triples On Data Readout, Global Blood Given FDA Nod, Positive Safety Review For Genfit's NASH Drug - Genfit (NASDAQ:GNFT), iShares Biotechnology ETF (NASDAQ:IBB)

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs on Nov. 25.)

ACADIA Pharmaceuticals Inc. ACAD
Alnylam Pharmaceuticals, Inc. ALNY
Amgen, Inc. AMGN
Antares Pharma Inc ATRS
Arrowhead Pharmaceuticals Inc ARWR
Arvinas Inc ARVN (Guggenheim initiated coverage of stock with Buy rating and $50 price target)
Avadel Pharmaceuticals PLC AVDL (announced achievement of enrollment target in a Phase 3 trial of drug to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy)
Axsome Therapeutics Inc AXSM
Beigene Ltd BGNE
Bio-Rad Laboratories, Inc. Class A BIO
BIO-TECHNE Corp TECH
BioNTech SE – ADR BNTX
Collegium Pharmaceutical Inc COLL
Cue Biopharma Inc CUE
DexCom, Inc. DXCM
Dicerna Pharmaceuticals Inc DRNA
Epizyme Inc EPZM
ESSA Pharma Inc EPIX
Flexion Therapeutics Inc FLXN
GENMAB A/S/S ADR GMAB
Globus Medical Inc GMED
Halozyme Therapeutics, Inc. HALO
Horizon Therapeutics PLC HZNP
Incyte Corporation INCY
Kamada Ltd. KMDA
Karyopharm Therapeutics Inc KPTI
Krystal Biotech Inc KRYS
The Medicines Company MDCO (announced a deal to be bought by Novartis AG NVS
Molecular Templates Inc MTEM
Neoleukin Therapeutics Inc NLTX
Neurocrine Biosciences, Inc. NBIX
Nevro Corp NVRO
Qiagen NV QGEN
Seattle Genetics, Inc. SGEN (announced Health Canada approval for its sNDA for Adcetris along with chemotherapy for previously untreated lymphoma patients)
Verrica Pharmaceuticals Inc VRCA
Vertex Pharmaceuticals Incorporated VRTX

Down In The Dumps

(Biotech stocks that hit 52-week lows Nov. 25.)

Aethlon Medical, Inc. AEMD
BAUDAX BIO INC/SH BXRX
CymaBay Therapeutics Inc CBAY (announced halting of clinical programs evaluating its lead liver drug seladelpar)
Evelo Biosciences Inc EVLO
Genprex Inc GNPX
Interpace Biosciences Inc IDXG
Invivo Therapeutics Holdings Corp NVIV
La Jolla Pharmaceutical Company LJPC (announced plans to reassess continued development of its lead candidate and the departure of its CEO)
Merrimack Pharmaceuticals Inc MACK
Midatech Pharma PLC-ADR MTP
Neon Therapeutics Inc NTGN
Ocugen Inc OCGN
Onconova Therapeutics Inc ONTX
Sonoma Pharmaceuticals Inc SNOA
Theratechnologies Inc THTX
Vir Biotechnology Inc VIR
Viveve Medical Inc VIVE

Stocks In Focus

ChemoCentryx Reports Positive Results For Drug To Treat Small Blood Vessel Damage In Kidney

ChemoCentryx Inc CCXI and licensing partner Vifor Fresenius Medical Care Renal Pharma announced positive top-line data from the pivotal Phase 3 study of avacopan for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis, or ANCA vasculitis.

The global study that evaluated 331 patients met the primary endpoints of remission at 26 weeks and sustained remission at 52 weeks, as measured by the Birmingham Vasculitis Activity Score, or BVAS. For both primary endpoints, avacopan was found at least statistically non-inferior to the currently used glucocorticoid-containing standard-of-care.

ChemoCentryx stock was skyrocketing 337.1% higher to $35.23 in Tuesday's premarket session.

Ardelyx, Kyowa Kirin Enter R&D Pact; Japanese Company To Invest $20M In US Counterpart

Ardelyx Inc ARDX announced an expansion of its partnership with Japan's Kyowa Kirin to include two new agreements.

The companies have agreed to advance two of Ardelyx's research programs to design compounds for two undisclosed targets, for which the Japanese company will pay $10 million to support research. After the end of the research period, Kyowa Kirin has the option to license any candidates nominated for further development. In return, Ardelyx is eligible to receive $10.5 million in upfront payments and up to $500 million in development and sales milestones.

The agreement also provides for Kyowa Kirin making a $20-million equity investment in Ardelyx at $6.96 per share for 2.87 million shares.

Ardelyx shares were rising 5.8% to $6.75 in Tuesday's premarket session.

Genfit's NASH Trial Cleared For Continuation Without Modification

GENFIT S A/ADR GNFT said the Data Safety Monitoring Board issued a positive recommendation for continuation without modification of its RESOLVE-IT Phase 3 study evaluating elafibranor in non-alcoholic steatohepatitis, or NASH. The company said it expects to release top-line results from the study in the first quarter of 2020.

FDA OKs Global Blood's Sickle Cell Disease Drug

Global Blood Therapeutics Inc GBT announced accelerated FDA approval for Oxbryta tablets for the treatment of sickle cell disease in adults and children 12 years and older.

This oral once-a-daily therapy acts by directly inhibiting sickle hemoglobin polymerization, the root cause of SCD.

The stock was trading 11.76% higher to $67 in Tuesday's premarket session.

Acadia Reports Mixed Result For Schizophrenia Drug

Acadia said its ADVANCE study that evaluated pimavanserin as an adjunctive therapy in patients with predominantly negative symptoms of schizophrenia met the primary endpoint but did not differentiate itself from placebo on the key secondary endpoint.

The primary endpoint was change from baseline to week 26 on the Negative Symptom Assessment-16 total score, while the secondary endpoint was the Personal and Social Performance scale.

The company plans to initiate a second pivotal study with the highest dose — 34mg — in the first half of 2020.

The stock was down 0.54% at $47.50 in Tuesday's premarket session.

Motif Bio To Delist From Nasdaq

MOTIF BIO PLC/S ADR MTFB said it has notified the Nasdaq of its intention to delist its ADSs and listed warrants from the Nasdaq Capital Markets. The company also plans to file with the SEC regarding the delisting. The shares and the warrants are likely to cease trading on the Nasdaq on or about Dec. 16, the company said.

The decision comes in the wake of the higher costs associated with being listed on the Nasdaq and the uncertainties regarding regaining of compliance with the exchange's continued listing standards.

Astellas Prostate Cancer Drug Approved in China

ASTELLAS PHARMA/ADR ALPMY said the China National Medical Products Administration approved an NDA for Xtandi for the treatment of adult men with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.

Xtandi is developed by Astellas and Pfizer Inc. PFE.

Kindred's Drug to Treat Equine Fever Approved

Kindred Biosciences Inc KIN said the FDA has approved its Zimera for the control of pyrexia, or fever in horses.

The stock gained 8.59% to $8.22 in after-hours trading.

Offerings

X4 Pharmaceuticals Inc XFOR said it has commenced an underwritten public offering of its shares and Class B warrants to purchase its common stock. All the securities earmarked for the offering will be offered by the company.

The stock slipped 9.43% to $12 in after-hours trading.

Sonoma said it is launching a "best efforts" public offering of its shares. The company said it intends to use the net proceeds for general corporate purposes, marketing, product development and working capital.

The stock slipped 1.21% to $4.07 in after-hours trading.

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