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The Daily Biotech Pulse: Reata, Kadmon Clinical Readouts, Apyx Medical's Earnings Beat

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The Daily Biotech Pulse: Reata, Kadmon Clinical Readouts, Apyx Medical's Earnings Beat

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

Scaling The Peaks

(Biotech stocks hitting 52-week highs on Nov. 11)

  • ACADIA Pharmaceuticals Inc (NASDAQ: ACAD)
  • Agenus Inc (NASDAQ: AGEN) (struck a pact with Urogen Pharma Ltd (NASDAQ: URGN) to license its AGEN1884 to the former for developing it as a combo therapay along with Urogen's UGN-201 for high-grade non-muscle invasive bladder cancer)
  • Allergan plc (NYSE: AGN)
  • Arrowhead Pharmaceuticals Inc (NASDAQ: ARWR)
  • Cabaletta Bio Inc (NASDAQ: CABA)
  • Centogene N.V./EQ (NASDAQ: CNTG)(IPOed Nov. 7)
  • Deciphera Pharmaceuticals Inc (NASDAQ: DCPH)
  • DexCom, Inc. (NASDAQ: DXCM)
  • INNATE PHARMA S/S ADR (NASDAQ: IPHA)
  • Insulet Corporation (NASDAQ: PODD)
  • Karyopharm Therapeutics Inc (NASDAQ: KPTI)
  • Kodiak Sciences Inc (NASDAQ: KOD)
  • Neurocrine Biosciences, Inc. (NASDAQ: NBIX)
  • XOMA Corp (NASDAQ: XOMA)
  • Zai Lab Ltd (NASDAQ: ZLAB)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Nov. 11)

  • AcelRx Pharmaceuticals Inc (NASDAQ: ACRX)(Credit Suisse downgraded shares to Neutral)
  • Achieve Life Sciences Inc (NASDAQ: ACHV)
  • Adaptimmune Therapeutics PLC – ADR (NASDAQ: ADAP)
  • Applied DNA Sciences Inc (NASDAQ: APDN)
  • ASLAN PHARMACEU/ADR (NASDAQ: ASLN) ( reported a negative clinical readout)
  • Assertio Therapeutics Inc (NASDAQ: ASRT)
  • Auris Medical Holding Ltd (NASDAQ: EARS)
  • Biocept Inc (NASDAQ: BIOC)
  • BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX)
  • bluebird bio Inc (NASDAQ: BLUE)
  • Brickell Biotech Inc (NASDAQ: BBI)
  • China SXT Pharmaceuticals Inc (NASDAQ: SXTC)
  • Homology Medicines Inc (NASDAQ: FIXX)
  • Lipocine Inc (NASDAQ: LPCN) (FDA rejected its Tlando for third time)
  • Nemaura Medical Inc (NASDAQ: NMRD)(reported third-quarter results)
  • Neuronetics Inc (NASDAQ: STIM)
  • Obalon Therapeutics Inc (NASDAQ: OBLN)
  • Ocugen Inc (NASDAQ: OCGN)
  • Onconova Therapeutics Inc (NASDAQ: ONTX)
  • Oyster Point Pharma Inc (NASDAQ: OYST) (IPOed on Oct. 31)
  • PDS Biotechnology Corp (NASDAQ: PDSB)
  • Savara Inc (NASDAQ: SVRA)
  • Seelos Therapeutics Inc (NASDAQ: SEEL)
  • Sellas Life Sciences Group Inc (NASDAQ: SLS)
  • Sensus Healthcare Inc (NASDAQ: SRTS)
  • Syros Pharmaceuticals Inc (NASDAQ: SYRS)
  • TELA Bio Inc (NASDAQ: TELA)(IPOed on Nov. 7)
  • Therapix Biosciences Ltd – ADR (NASDAQ: TRPX)
  • Tonix Pharmaceuticals Holding Corp (NASDAQ: TNXP)
  • Unum Therapeutics Inc (NASDAQ: UMRX)
  • Vir Biotechnology Inc (NASDAQ: VIR)
  • X T L Biopharmaceuticals Ltd (NASDAQ: XTLB)

Stocks In Focus

Reata Aces Late-Stage Study Of Kidney Disease Drug

Reata Pharmaceuticals Inc (NASDAQ: RETA) said the Phase 3 portion of the CARDINAL study that evaluated its bardoxolone methyl in patients with chronic kidney disease caused by Alport syndrome met its primary and key secondary endpoints.

After 48 weeks of treatment, patients treated with bardoxolone had a statistically improvement compared to placebo in mean estimated glomerular filtration rate. Even after a four-week withdrawal period following 48 weeks of treatment, the treatment arm showed a statistically significant improvement.

Based on the positive results and subject to discussions with regulatory authorities, the company said it plans regulatory filings for marketing approval in the U.S. and internationally.

The stock slipped 7.80% to $197 in after-hours trading.

See also: Biotech Stock On The Radar: Alkermes At A Crossroads

Kadmon's Graft-Versus-Host Disease Drug Meets Primary Endpoint In Pivoral Study

Kadmon Holdings Inc (NYSE: KDMN) announced positive top-line results from the planned interim analysis of ROCKstar study that evaluated its KD025 in patients with chronic graft-versus-host disease, who have received at least two prior lines of systemic therapy. The company said the trial met the primary endpoint of overall response rate of 64% with KD025, 200mg twice daily.

"We look forward to sharing these results with the FDA at a pre-NDA meeting, where we will also discuss the timing for a regulatory filing for KD025 in cGVHD, which we expect to occur in 2020, subject to FDA input," the company said.

The stock rallied 21.07% to $3.62 in after-hours trading.

Supernus Makes Regulatory Submission For ADHD Drug

Supernus Pharmaceuticals Inc (NASDAQ: SUPN) announced the filing of an NDA to the FDA for SPN-812, its investigational drug for attention deficit hyperactivity disorder.

The filing, according to the company, is supported by four Phase 3 trials that studied the pediatric patient population of ages 6-17 years, two Phase 2 trials, several Phase 1 trials, long-term label extension study, preclinical testing an drug manufacturing data.

Earnings

Apyx Medical Corp (NASDAQ: APYX) reported third-quarter revenue from continuing operations of $7.6 million, up 106% year-over-year. The company reversed to a loss of 13 cents per share from earnings of $1.98 per share. Analysts expected a loss of 18 cents per share.

The company raised its full-year guidance.

The stock rallied 13.30% to $8.18 in after-hours trading.

ICU Medical, Incorporated's (NASDAQ: ICUI) third-quarter revenues fell from $327.2 million in 2018 to $307.5 million in 2019. The company's adjusted earnings per share fell from $1.88 to $1.65. Analysts expected earnings of $1.62 per share for the quarter.

The stock advanced 11.24% to $187 in after-hours trading.

On The Radar

Clinical Readouts

American Association for the Study of Liver Diseases Liver Meeting Presentations

Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) – Phase 2 data for pegylated interferon lambda + ritonavir-boosted lonafamib for hepatitis delta virus

DURECT Corporation (NASDAQ: DRRX) – Phase 2a data for DUR-928 in alcoholic hepatitis

American College of Rheumatology/ARP 2019 Annual Meeting Presentations

Kezar Life Sciences Inc (NASDAQ: KZR) – Updated Phase 1b data for KZR-616 in lupus

Unity Biotechnology Inc (NASDAQ: UBX) – Phase 1b data for UBX0101 in osteoarthritis

AstraZeneca plc (NYSE: AZN) – Detailed Phase 3 data for aniforlumab in lupus

Earnings

Akebia Therapeutics Inc (NASDAQ: AKBA) (before the market open)
Avadel Pharmaceuticals PLC (NASDAQ: AVDL) (before the market open)
Sesen Bio Inc (NASDAQ: SESN) (before the market open)
Kodiak Sciences Inc (NASDAQ: KOD) (after the market close)
SAGE Therapeutics Inc (NASDAQ: SAGE) (before the market open)
Ocular Therapeutix Inc (NASDAQ: OCUL) (before the market open)
Reata Pharmaceuticals Inc (NASDAQ: RETA) (before the market open)
InspireMD Inc (NYSE: NSPR) (before the market open)
Diplomat Pharmacy Inc (NYSE: DPLO) (before the market open)
Editas Medicine Inc (NASDAQ: EDIT) (before the market open)
Eagle Pharmaceuticals Inc (NASDAQ: EGRX) (before the market open)
Helius Medical Technologies Inc (NASDAQ: HSDT) (before the market open)
Urogen Pharma Ltd (NASDAQ: URGN) (before the market open)
IVERIC bio Inc (NASDAQ: ISEE) (before the market open)
T2 Biosystems Inc (NASDAQ: TTOO) (before the market open)
Adamis Pharmaceuticals Corp (NASDAQ: ADMP) (after the market close)
Tetraphase Pharmaceuticals Inc (NASDAQ: TTPH) (after the market close)
Paratek Pharmaceuticals Inc (NASDAQ: PRTK) (after the market close)
Aptinyx Inc (NASDAQ: APTX) (after the market close)
Adaptive Biotechnologies Corp (NASDAQ: ADPT) (after the market close)
BioLife Solutions Inc (NASDAQ: BLFS) (after the market close)
BioDelivery Sciences International, Inc. (NASDAQ: BDSI) (after the market close)
Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX) (after the market close)
Catalyst Pharmaceuticals Inc (NASDAQ: CPRX) (after the market close)
Calithera Biosciences Inc (NASDAQ: CALA) (after the market close)
Sunesis Pharmaceuticals, Inc. (NASDAQ: SNSS) (after the market close)
OptiNose Inc (NASDAQ: OPTN) (after the market close)
Organogenesis Holdings Inc (NASDAQ: ORGO) (after the market close)
Opiant Pharmaceuticals Inc (NASDAQ: OPNT) (after the market close)
Transenterix Inc (NYSE: TRXC) (after the market close)
Tocagen Inc (NASDAQ: TOCA) (after the market close)
Cesca Therapeutics Inc (NASDAQ: THMO) (after the market close)
Kindred Biosciences Inc (NASDAQ: KIN) (after the market close)
Gossamer Bio In c (NASDAQ: GOSS) (after the market close)
Nabriva Therapeutics PLC – ADR (NASDAQ: NBRV) (after the market close)
Vermillion, Inc. (NASDAQ: VRML) (after the market close)
Halozyme Therapeutics, Inc. (NASDAQ: HALO) (after the market close)
Hookipa Pharma Inc (NASDAQ: HOOK) (after the market close)
Synlogic Inc (NASDAQ: SYBX) (after the market close)
Inovio Pharmaceuticals Inc (NASDAQ: INO) (after the market close)
Zosano Pharma Corp (NASDAQ: ZSAN) (after the market close)
Lineage Cell Therapeutics Inc (NYSE: LCTX) (after the market close)
Omeros Corporation (NASDAQ: OMER) (after the market close)
Precision BioSciences (Inc NASDAQ: DTIL) (after the market close)
Applied Genetic Technologies Corp (NASDAQ: AGTC) (after the market close)

Posted-In: Biotech Earnings News FDA Top Stories Pre-Market Outlook Trading Ideas Best of Benzinga

 

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