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The Daily Biotech Pulse: ESMO Conference Gets Underway, J&J's Darzalex Snags Another Approval, Kaleido Biosciences CFO To Leave

Shanthi Rexaline

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 (NYSE: AZN)
  • GlaxoSmithKline plc (NYSE: GSK)
  • Sanofi SA (NASDAQ: SNY)
  • ZEALAND PHARMA/S ADR (NASDAQ: ZEAL)

Down In The Dumps

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

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

Stocks In Focus Applied Genetic Q4 Loss Widens, Cash Sufficient Until 2021

Applied Genetic Technologies Corp (NASDAQ: 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. (NYSE: 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.

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

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

Johnson & Johnson (NYSE: 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 (NASDAQ: 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 (NASDAQ: 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 (NYSE: NVS) as a checkpoint inhibitor for the treatment of solid tumors, while the remaining six assets are being developed by Palobiofarma.

View more earnings on IBB

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 (NASDAQ: 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 (NASDAQ: 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 (OTC: 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 (NASDAQ: ARAV) – Phase 1b data for AVB-S6-500 in ovarian cancer

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

Related Link: Axsome Shares Flirt With Record High: How Much Upside Is Left?

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