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 ACAD
• Agenus Inc AGEN (struck a pact with Urogen Pharma Ltd 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 AGN
• Arrowhead Pharmaceuticals Inc ARWR
• Cabaletta Bio Inc CABA
• Centogene N.V./EQ CNTG(IPOed Nov. 7)
• Deciphera Pharmaceuticals Inc DCPH
• DexCom, Inc. DXCM
• INNATE PHARMA S/S ADR IPHA
• Insulet Corporation PODD
• Karyopharm Therapeutics Inc KPTI
• Kodiak Sciences Inc KOD
• Neurocrine Biosciences, Inc. NBIX
• XOMA Corp XOMA
• Zai Lab Ltd ZLAB

Down In The Dumps

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

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

Stocks In Focus

Reata Aces Late-Stage Study Of Kidney Disease Drug

Reata Pharmaceuticals Inc 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 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 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 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 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 EIGR – Phase 2 data for pegylated interferon lambda + ritonavir-boosted lonafamib for hepatitis delta virus

DURECT Corporation DRRX – Phase 2a data for DUR-928 in alcoholic hepatitis

American College of Rheumatology/ARP 2019 Annual Meeting Presentations

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

Unity Biotechnology Inc UBX – Phase 1b data for UBX0101 in osteoarthritis

AstraZeneca plc AZN – Detailed Phase 3 data for aniforlumab in lupus

Earnings

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