The Daily Biotech Pulse: Enanta Aces Midstage NASH Study, Takeda's Ulcerative Colitis Drug Found Superior To AbbVie's, Decision Day For J&J

The following is a roundup of top developments in the biotech space over the last 24 hours.

Scaling The Peaks

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

Coherus Biosciences Inc CHRS

The Medicines Company MDCO

Down In The Dumps

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

Adaptive Biotechnologies Corp ADPT

Advaxis, Inc. ADXS

AnaptysBio Inc ANAB

Aridis Pharmaceuticals Inc ARDS

AzurRx BioPharma Inc AZRX (announced lackadaisical efficacy data for pancreatic insufficiency drug)

BridgeBio Pharma Inc BBIO

Calithera Biosciences Inc CALA

China SXT Pharmaceuticals Inc SXTC

Catalyst Biosciences Inc CBIO

Cellectis SA CLLS

CytomX Therapeutics Inc CTMX

DelMar Pharmaceuticals Inc DMPI

Eloxx Pharmaceuticals Inc ELOX

Exagen Inc XGN (IPOed on Sep. 16)

Five Prime Therapeutics Inc FPRX

Fulcrum Therapeutics Inc FULC

Gemphire Therapeutics Inc GEMP

Kalvista Pharmaceuticals Inc KALV

Kiniksa Pharmaceuticals Ltd KNSA

Myovant Sciences Ltd MYOV

Neon Therapeutics Inc NTGN

Novelion Therapeutics Inc NVLN

Nuvectra Corp NVTR

Onconova Therapeutics Inc ONTX

PDS Biotechnology Corp PDSB

Plus Therapeutics Inc PSTV

Sarepta Therapeutics Inc SRPT

Seelos Therapeutics Inc SEEL

Sophiris Bio Inc SPHS

Spring Bank Pharmaceuticals Inc SBPH

Stealth BioTherapeutics Corp MITO

Surface Oncology Inc SURF

Tocagen Inc TOCA

Titan Pharmaceuticals, Inc. TTNP

Urogen Pharma Ltd URGN

Vaxart Inc VXRT (announced positive topline results for an early-stage study of its oral tableted bivalent norovirus vaccine in healthy adults)

Xenetic Biosciences Inc XBIO

Zosano Pharma Corp ZSAN

Stocks In Focus

Enanta Pharma NASH Drug Aces Midstage Study

Enanta Pharmaceuticals Inc ENTA announced topline results from the Phase 2a ARGON-1 study that evaluated its EDP-305 for the treatment of non-alcoholic steatohepatitis, or NASH, which showed that the study met the primary endpoint, with a statistically significant ALT reduction of 28 U/L in the EDP-305, 2.5mg arm compared to 15 U/L in the placebo arm at week 12.

The company also noted that there was a statistically significant reduction in liver fat content with EDP-3-5 at the 2.5mg dose, as measured by MRI-PDFF.

The majority of treatment-emergent adverse events were mild to moderate, Enanta said. Yet pruritus, a treatment-emergent adverse event, was observed in 51% of the subjects in the 2.5mg arm and discontinuation due to pruritus was 20.8% for the 2.5mg arm compared to 1.8% for the 1mg arm.

The stock was down 21.65% at $55.85 in Thursday's premarket session. 

See also: The Week Ahead In Biotech: Spotlight On ESMO Conference

Jazz Presents Positive Data For Excessive Daytime Sleepiness Drug

Jazz Pharmaceuticals PLC JAZZ made oral and poster presentations of Phase 3 data onJZP-258 for the treatment of cataplexy and excessive daytime sleepiness in adults with narcolepsy at the World Sleep 2019 conference in Vancouver, Canada.

"These data support the efficacy and overall safety profile of a lower-sodium oxybate formulation for people living with narcolepsy, a chronic condition that may require lifelong therapy," said Jed Black, SVP of sleep and neuroscience at Jazz.

Takeda's Ulcerative Colitis Drug Found Superior to AbbVie's

TAKEDA PHARMACE/S ADR TAK announced the publication in the New England Journal of Medicine of additional data from the VARSITY study.

The study showed the superiority of the gut-selective biologic vedolizumab over AbbVie Inc ABBV's anti-tumor necrosis factor-alpha biologic adalimumab, in achieving the primary endpoint of clinical remission at week 52 in patients with moderately to severely active ulcerative colitis, Takeda said. 

Nektar's Drug Shows Promise In Breast Cancer

Updated Phase 1/2 data for NKTR-214 presented by Nektar Therapeutics NKTR at the 5th CRI-CMT-EATI-AACR International Cancer Immunotherapy Conference in Paris, France showed that NKTR-214 in combination with Bristol-Myers Squibb Co BMY's Opdivo showed promising clinical activity in patients with PD-L1 negative baseline tumors.

"Responses were prolonged and occurred in patients with multiple negative predictive factors for clinical benefit with a checkpoint inhibitor, including prior treatment with taxane therapy and multiple sites of metastases," Nektar said.

These data support potential future development of this doublet in combination with chemotherapy in the population of TNBC patients with the highest unmet medical need, the company said. 

Zoegnix Refiles NDA For Seizure Drug

Zogenix, Inc. ZGNX said it has resubmitted the NDA for Fintepla for the treatment of seizures associated with Dravet syndrome

The NDA is based on data from two pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study that included 232 patients treated for up to 24 months.

In April, the company received a refuse to file letter from the FDA, citing non-submission of certain non-clinical studies as well as incorrect version of a clinical dataset contained in the application.

On The Radar

PDUFA Dates

The FDA is set to rule on Johnson & Johnson JNJ's sBLA for daratumumab in combination with bortezomib, thalidomide and dexamethasone in newly-diagnosed multiple myeloma patients who are candidates for autologous stem cell transplant.

GENMAB A/S/S ADR GMAB has licensed daratumumab to J&J's Janssen unit under a 2012 agreement.

Earnings

Aytu Bioscience Inc AYTU (after the market close)

Applied Genetic Technologies Corp AGTC (after the market close)

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