The Daily Biotech Pulse: ESMO Conference Gets Underway, J&J's Darzalex Snags Another Approval, Kaleido Biosciences CFO To Leave - Johnson & Johnson (NYSE:JNJ), iShares Biotechnology ETF (NASDAQ:IBB), Novartis (NYSE:NVS), GSK (NYSE:GSK)

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. 26.)

AstraZeneca plc AZN
GlaxoSmithKline plc GSK
Sanofi SA SNY
ZEALAND PHARMA/S ADR ZEAL

Down In The Dumps

(Biotech stocks that hit 52-week lows Sept. 26.)

ABIOMED, Inc. ABMD
Adaptive Biotechnologies Corp ADPT
Aduro BioTech Inc ADRO
AEterna Zentaris Inc. AEZS
Akcea Therapeutics Inc AKCA
Amicus Therapeutics, Inc. FOLD
AnaptysBio Inc ANAB
Aridis Pharmaceuticals Inc ARDS
AzurRx BioPharma Inc AZRX
Bellerophon Therapeutics Inc BLPH
BioMarin Pharmaceutical Inc. BMRN (announced submission of clinical trial application to U.K. regulators for its investigational therapy for phenylketonuria)
BioNano Genomics Inc BNGO
BridgeBio Pharma Inc BBIO
Calithera Biosciences Inc CALA
Catalyst Biosciences Inc CBIO
Cellectis SA CLLS
China SXT Pharmaceuticals Inc SXTC
Corvus Pharmaceuticals Inc CRVS
CytomX Therapeutics Inc CTMX
strong>DiaMedica Therapeutics Inc DMAC
Eloxx Pharmaceuticals Inc ELOX
Enanta Pharmaceuticals Inc ENTA (announced mid-stage results of NASH treatment candidate)
Enochian Biosciences Inc ENOB
Erytech Pharma SA ERYP
Five Prime Therapeutics Inc FPRX
Gemphire Therapeutics Inc GEMP
Gritstone Oncology Inc GRTS
HTG Molecular Diagnostics Inc HTGM
IGM Biosciences Inc IGMS (initial public offering on Sept. 18)
Innoviva Inc INVA
Kalvista Pharmaceuticals Inc KALV
KemPharm Inc KMPH
Mersana Therapeutics Inc MRSN
Miragen Therapeutics Inc MGEN
Myovant Sciences Ltd MYOV
Neuronetics Inc STIM
Neon Therapeutics Inc NTGN
Novelion Therapeutics Inc NVLN
Nuvectra Corp NVTR
PDS Biotechnology Corp PDSB
Plus Therapeutics Inc PSTV
Rubius Therapeutics Inc RUBY
Sarepta Therapeutics Inc SRPT
Sophiris Bio Inc SPHS
Spring Bank Pharmaceuticals Inc SBPH
SpringWorks Therapeutics Inc SWTX
Stealth BioTherapeutics Corp MITO
Surface Oncology Inc SURF
Synlogic Inc SYBX
Tocagen Inc TOCA
Taro Pharmaceutical Industries Ltd. TARO
Urogen Pharma Ltd URGN
Viveve Medical Inc VIVE
Xenetic Biosciences Inc XBIO
X T L Biopharmaceuticals Ltd XTLB

Stocks In Focus

Applied Genetic Q4 Loss Widens, Cash Sufficient Until 2021

Applied Genetic Technologies Corp AGTC's fourth-quarter revenue declined from $5.4 million in 2018 to $400,000 in 2019. The net loss widened from 36 cents to 58 cents.

The company said its current cash, cash equivalents and investments of around $82 million will suffice to allow generation of data from its ongoing clinical programs; to move the pre-clinical optogenetic program in collaboration with Bionic Sight into the clinic; and fund the currently planned research and discovery programs into the first half of 2021.

The stock added 2.5% to $4.10 in after-hours trading.

Pfizer Aces Late-Stage Study Of Skin Disease Drug

Pfizer Inc. PFE announced positive topline results from a pivotal second Phase 3 study evaluating the efficacy and safety of its investigational oral Janus Kinase 1 inhibitor, abrocitinib, in patients ages 12 and older with moderate to severe atopic dermatitis.

Safety results showed that both doses of abrocitinib were well-tolerated and were broadly consistent with a previous monotherapy program, the company said.

J&J's Darzalex Approved For NewlyDiagnosed, Stem Cell Transplant Eligible Multiple Myeloma Patients

Johnson & Johnson JNJ's Janssen unit said the FDA approved Darzalex in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed multiple myeloma patients who are candidates for autologous stem cell transplant.

Anavex Presents Positive Midstage Results For Rett Syndrome Drug

Anavex Life Sciences Corp AVXL presented detailed preliminary efficacy data from the pharmacokinetic cohort — Part A — of the Phase 2 study for AVANEX 2-73 in Rett syndrome at the 6th European Rett Syndrome Conference. The company said the results are encouraging.

The data showed encouraging safety and efficacy signals on both caregiver and clinical-based measures of severity. Avanex said correlations with a key biomarker are related to disease pathogenesis.

The company sees the results as highly significant due to the magnitude of change, short duration of treatment, older age of participants and clinical significance.

XOMA Acquires Royalty Interest In 6 Clinical-stage Assets For $10M

XOMA Corp XOMA said it has acquired a royalty interest in six clinical-stage assets that target the adenosine pathway for $10 million from Palobiofarma S.L.

One of the assets for which Xoma acquired royalty interest is being developed by Novartis AG NVS as a checkpoint inhibitor for the treatment of solid tumors, while the remaining six assets are being developed by Palobiofarma.

Under the agreement, the company said it will receive low single-digit royalties on future sales of the six assets.

Kaleido Biosciences CFO To Depart

Kaleido Biosciences Inc KLDO announced the departure Joshua Brumm as its COO and CFO effective Oct. 11. He is leaving to serve as CEO of a biotech company.

The company said it will initiate a search for a CFO. In the interim, Richard Scalzo, corporate controller, will serve as principal accounting officer and assume some of Brumm's responsibilities.

Aytu Revenue Doubles, Loss Narrows

Aytu Bioscience Inc AYTU said its revenue for the fiscal year ended June 30 climbed 100% to $7.3 million.

The results do not include the September agreement to acquire Innovus Pharmaceuticals Inc INNV.

The loss narrowed from $15.31 to $3.48 per share.

With the Innovus acquisition, Aytu said it will form an integrated specialty pharma company with combined trailing 12-month revenue of $31 million.

The stock fell 5.07% to $1.31 in after-hours trading.

On The Radar

PDUFA Dates

The FDA is scheduled to give its verdict on Johnson & Johnson's Invokana for treating chronic kidney disease in Type 2 diabetes patients.

Clinical Trial Readouts

European Society for Medical Oncology 2019 Conference Presentations

Aravive Inc ARAV – Phase 1b data for AVB-S6-500 in ovarian cancer

TrovaGene Inc TROV – Phase 1/2 data for onvansertib in acute myeloid leukemia Incyte Corporation INCY – Phase 2 data for pemigatinib in cholangiocarcinoma.

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