The Daily Biotech Pulse: Xeris Gets OK For Initiating Hyperthyroidism Study, Merck-Eisai Snag FDA Approval For Drug Combo, Decision Day For Jazz Pharma

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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 Aug. 11)

  • Adagio Therapeutics, Inc. ADGI (IPOed Friday)
  • Alnylam Pharmaceuticals, Inc. ALNY
  • Cytek Biosciences, Inc. CTKB
  • Dynavax Technologies Corporation DVAX
  • Eliem Therapeutics, Inc. ELYM (IPOed Monday)
  • Erasca, Inc. ERAS (IPOed July 16)
  • Fulcrum Therapeutics, Inc. FULC (reacted to positive analyst actions following a positive clinical readout)
  • IN8bio, Inc. INAB
  • Ironwood Pharmaceuticals, Inc. IRWD
  • Maravai LifeSciences Holdings, Inc. MRVI (announced second-quarter results)
  • Monte Rosa Therapeutics, Inc. GLUE
  • Rani Therapeutics Holdings, Inc. RANI (IPOed July 30)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 11)

  • Adicet Bio, Inc. ACET
  • Akero Therapeutics, Inc. AKRO
  • Allogene Therapeutics, Inc. ALLO
  • Aptose Biosciences Inc. APTO
  • Ardelyx, Inc. ARDX
  • Arena Pharmaceuticals, Inc. ARNA
  • AVROBIO, Inc. AVRO
  • Baudax Bio, Inc. BXRX
  • Biodesix, Inc. BDSX (reacted to second-quarter results)
  • Cellectar Biosciences, Inc. CLRB
  • Celularity Inc. CELU
  • Codex DNA, Inc. DNAY (announced second-quarter results)
  • CytomX Therapeutics, Inc. CTMX
  • Edgewise Therapeutics, Inc. EWTX
  • Ensysce Biosciences, Inc. ENSC
  • Epizyme, Inc. EPZM
  • Eton Pharmaceuticals, Inc. ETON
  • Exicure, Inc. XCUR
  • EyeGate Pharmaceuticals, Inc. EYEG
  • FibroGen, Inc. FGEN (received a complete response letter for its anemia drug regulatory application)
  • Freeline Therapeutics Holdings plc FRLN
  • Grifols, S.A. GRFS
  • Harpoon Therapeutics, Inc. HARP
  • Ikena Oncology, Inc. IKNA
  • IMARA Inc. IMRA
  • Incyte Corporation INCY
  • Inventiva S.A. IVA
  • iRhythm Technologies, Inc. IRTC
  • Kamada Ltd. KMDA (announced second-quarter results)
  • Karyopharm Therapeutics Inc. KPTI
  • Kiniksa Pharmaceuticals, Ltd. KNSA
  • Kronos Bio, Inc. KRON
  • Kura Oncology, Inc. KURA
  • Lumos Pharma, Inc. LUMO
  • Madrigal Pharmaceuticals, Inc. MDGL
  • MediciNova, Inc. MNOV
  • Nautilus Biotechnology, Inc. NAUT
  • Nektar Therapeutics NKTR
  • Neurocrine Biosciences, Inc. NBIX
  • Nevro Corp. NVRO
  • Nuvation Bio Inc. NUVB
  • OptiNose, Inc. OPTN
  • Otonomy, Inc. OTIC
  • Outset Medical, Inc. OM
  • PharmaCyte Biotech, Inc. Common Stock PMCB
  • Relmada Therapeutics, Inc. RLMD (announced second-quarter results)
  • Rockwell Medical, Inc. RMTI
  • Seres Therapeutics, Inc. MCRB
  • Singular Genomics Systems, Inc. OMIC
  • Spruce Biosciences, Inc. SPRB
  • Talis Biomedical Corporation TLIS
  • TFF Pharmaceuticals, Inc. TFFP
  • TherapeuticsMD, Inc. TXMD
  • Trillium Therapeutics Inc. TRIL
  • Zogenix, Inc. ZGNX
  • ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

Xeris Allows Xeris To Proceed With Phase 1 Study of Hyperthyroidism Treatment

Xeris Pharmaceuticals, Inc. XERS said the Food and Drug Administration has allowed the investigational new drug application for its XeriSol levothyroxine for hypothyroidism to proceed.

The active IND enables Xeris to initiate a Phase 1 clinical study for XP-8121 using its novel formulation of levothyroxine in a subcutaneous injection for the treatment of hypothyroidism. The Phase 1 study will characterize Pharmacokinetics and evaluate the safety and tolerability of XP-8121 in healthy participants, the company said.

The stock was up 14.04% at $2.68 in premarket trading.

Merck-Eisai's Drug Combo Gets FDA Approval as First-line Treatment For Kidney Cancer

Merck & Co, Inc. MRK and Eisai Co., Ltd. ESALY said the FDA approved the combination of Keytruda plus Lenvima for the first-line treatment of adult patients with advanced renal cell carcinoma.

The approval is based on results from the pivotal Phase 3 KEYNOTE-581 trial, in which the combo treatment demonstrated statistically significant improvements versus sunitinib in the efficacy outcome measures of progression-free survival, overall survival and confirmed objective response rate.

Merck shares were up 0.36% at $75.48 in premarket trading.

Related Link: The Week Ahead In Biotech (Aug. 8-14): Jazz Pharma FDA Decision, Earnings Deluge and IPOs In The Spotlight

C4 Therapeutics' Multiple Myeloma Drug Gets Orphan Drug Designation

C4 Therapeutics, Inc. CCCC said the FDA granted orphan drug designation to CFT7455 for the treatment of multiple myeloma. The designation provides certain benefits, including financial incentives, to support clinical development and the potential for up to seven years of market exclusivity in the U.S. upon regulatory approval.

In premarket trading, the stock was up 1.64% at $36.50.

Earnings

Revolution Medicines, Inc. RVMD reported a decline in its second-quarter revenue from $10 million in 2020 to $8.7 million in 2021. The loss per share widened from 46 cents to 60 cents. The company guided to full-year GAAP loss of $170 million to $190 million.

The stock was slipping 2.53% to $26.22 in premarket trading.

TELA Bio, Inc. TELA reported second-quarter revenue of $7.6 million, up 116% year-over-year. The revenue exceeded the consensus estimate. The loss per share widened from 53 cents to 57 cents.

The stock was jumping 18.77% to $15.44 in premarket trading.

TRACON Pharmaceuticals, Inc. TCON's second-quarter net loss narrowed from 70 cents per share to 58 cents per share, while analysts expected a narrower loss of 31 cents per share.

In premarket trading, the stock was down 8.47% to $3.35.

On The Radar

PDUFA Dates

The FDA is scheduled to rule on Jazz Pharmaceuticals plc JAZZ's supplemental new drug application for Xywav (JZP-258) as a treatment option for idiopathic hypersomnia in adults. The PDUFA goal by date is Thursday, Aug. 12.

Click here to access Benzinga's FDA Calendar.

Earnings

  • F-star Therapeutics, Inc. FSTX (before the market open)
  • Entasis Therapeutics Holdings Inc. ETTX (before the market open)
  • Virios Therapeutics, Inc. VIRI (before the market open)
  • Synlogic, Inc. SYBX (before the market open)
  • Ikena Oncology, Inc. IKNA (before the market open)
  • VYNE Therapeutics Inc. VYNE (before the market open)
  • Veru Inc. VERU (before the market open)
  • Celsion Corporation CLSN (before the market open)
  • Organon & Co. OGN (before the market open)
  • PDS Biotechnology Corporation PDSB (before the market open)
  • Selecta Biosciences, Inc. SELB (before the market open)
  • Precision BioSciences, Inc. DTIL (before the market open)
  • Apyx Medical Corporation APYX (before the market open)
  • Evaxion Biotech A/S EVAX (before the market open)
  • HOOKIPA Pharma Inc. HOOK (before the market open)
  • CymaBay Therapeutics, Inc. CBAY (after the close)
  • Trevi Therapeutics, Inc. TRVI (after the close)
  • TFF Pharmaceuticals, Inc. TFFP (after the close)
  • Onconova Therapeutics, Inc. ONTX (after the close)
  • Achieve Life Sciences, Inc. ACHV (after the close)
  • AbCellera Biologics Inc. ABCL (after the close)
  • Acutus Medical, Inc. AFIB (after the close)
  • Applied DNA Sciences, Inc. APDN (after the close)
  • Atea Pharmaceuticals, Inc. AVIR (after the close)
  • Brickell Biotech, Inc. BBI (after the close)
  • Daré Bioscience, Inc. DARE (after the close)
  • BIOLASE, Inc. BIOL (after the close)
  • Co-Diagnostics, Inc. CODX (after the close)
  • ImmuCell Corporation ICCC (after the close)
  • CorMedix Inc. CRMD (after the close)
  • Capricor Therapeutics, Inc. CAPR (after the close)
  • Lineage Cell Therapeutics, Inc. LCTX (after the close)
  • OpGen, Inc. OPGN (after the close)
  • PAVmed Inc. PAVM (after the close)
  • NeuroPace, Inc. NPCE (after the close)
  • Spectrum Pharmaceuticals, Inc. SPPI (after the close)
  • Relay Therapeutics, Inc. RLAY (after the close)
  • Progenity, Inc. PROG
  • Viveve Medical, Inc. VIVE (after the close)
  • PolarityTE, Inc. PTE (after the close)
  • Dyadic International, Inc. DYAI (after the close)
  • Eledon Pharmaceuticals, Inc. ELDN (after the close)
  • Helius Medical Technologies, Inc. HSDT (after the close)
  • Lucira Health, Inc. LHDX (after the close)
  • ThermoGenesis Holdings, Inc. THMO (after the close)

Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates

Overview
ABCL Logo
ABCLAbCellera Biologics Inc
$2.85-%
ACET Logo
ACETAdicet Bio Inc
$1.056.34%
ACHV Logo
ACHVAchieve Life Sciences Inc
$4.49-%
AFIB Logo
AFIBAcutus Medical Inc
$0.0710-21.1%
AKRO Logo
AKROAkero Therapeutics Inc
$30.914.07%
ALLO Logo
ALLOAllogene Therapeutics Inc
$2.171.64%
ALNY Logo
ALNYAlnylam Pharmaceuticals Inc
$253.690.74%
APDN Logo
APDNApplied DNA Sciences Inc
$0.17197.00%
APTO Logo
APTOAptose Biosciences Inc
$0.19671.44%
APYX Logo
APYXApyx Medical Corp
$1.50-1.32%
ARDX Logo
ARDXArdelyx Inc
$5.744.27%
AVIR Logo
AVIRAtea Pharmaceuticals Inc
$2.90-1.02%
BDSX Logo
BDSXBiodesix Inc
$1.353.44%
BIOL Logo
BIOLBiolase Inc COM PAR $.001 NEW
$0.0174-%
BXRX Logo
BXRXBaudax Bio Inc Ordinary Shares
$0.0218-%
CAPR Logo
CAPRCapricor Therapeutics Inc
$15.103.92%
CCCC Logo
CCCCC4 Therapeutics Inc
$4.3210.6%
CELU Logo
CELUCelularity Inc
$2.351.08%
CLRB Logo
CLRBCellectar Biosciences Inc
$1.381.10%
CODX Logo
CODXCo-Diagnostics Inc
$0.89008.54%
CRMD Logo
CRMDCormedix Inc
$9.58-1.24%
CTKB Logo
CTKBCytek Biosciences Inc
$6.46-1.22%
CTMX Logo
CTMXCytomX Therapeutics Inc
$1.181.29%
DARE Logo
DAREDare Bioscience Inc
$3.220.63%
DTIL Logo
DTILPrecision BioSciences Inc
$5.93-2.47%
DVAX Logo
DVAXDynavax Technologies Corp
$12.880.39%
DYAI Logo
DYAIDyadic International Inc
$1.564.70%
ELDN Logo
ELDNEledon Pharmaceuticals Inc
$4.646.42%
ENSC Logo
ENSCEnsysce Biosciences Inc
$8.201597.9%
ERAS Logo
ERASErasca Inc
$2.993.10%
ETON Logo
ETONEton Pharmaceuticals Inc
$12.702.58%
EVAX Logo
EVAXEvaxion Biotech AS
$1.411.81%
EWTX Logo
EWTXEdgewise Therapeutics Inc
$33.004.53%
EYEG Logo
EYEGAB Corporate Bond ETF
$36.350.19%
FGEN Logo
FGENFibroGen Inc
$0.3802-6.19%
FULC Logo
FULCFulcrum Therapeutics Inc
$3.963.52%
GLUE Logo
GLUEMonte Rosa Therapeutics Inc
$9.598.55%
GRFS Logo
GRFSGrifols SA
$7.242.26%
HOOK Logo
HOOKHOOKIPA Pharma Inc
$2.512.45%
HSDT Logo
HSDTHelius Medical Technologies Inc
$0.5899-4.85%
ICCC Logo
ICCCImmuCell Corp
$4.500.67%
IKNA Logo
IKNAIkena Oncology Inc
$1.711.49%
INAB Logo
INABIN8bio Inc
$0.2995-0.17%
INCY Logo
INCYIncyte Corp
$75.751.10%
IRTC Logo
IRTCiRhythm Technologies Inc
$83.612.70%
IRWD Logo
IRWDIronwood Pharmaceuticals Inc
$3.31-0.75%
IVA Logo
IVAInventiva SA
$2.650.38%
JAZZ Logo
JAZZJazz Pharmaceuticals PLC
$122.11-0.84%
KMDA Logo
KMDAKamada Ltd
$5.99-0.17%
KNSA Logo
KNSAKiniksa Pharmaceuticals International PLC
$21.381.91%
KPTI Logo
KPTIKaryopharm Therapeutics Inc
$0.7910-0.68%
KRON Logo
KRONKronos Bio Inc
$1.020.49%
KURA Logo
KURAKura Oncology Inc
$10.790.75%
LCTX Logo
LCTXLineage Cell Therapeutics Inc
$0.58442.30%
LUMO Logo
LUMOLumos Pharma Inc
$4.33-%
MCRB Logo
MCRBSeres Therapeutics Inc
$0.82471.23%
MDGL Logo
MDGLMadrigal Pharmaceuticals Inc
$318.111.62%
MNOV Logo
MNOVMediciNova Inc
$2.353.98%
MRK Logo
MRKMerck & Co Inc
$103.34-0.20%
MRVI Logo
MRVIMaravai LifeSciences Holdings Inc
$5.090.10%
NAUT Logo
NAUTNautilus Biotechnology Inc
$2.1411.5%
NBIX Logo
NBIXNeurocrine Biosciences Inc
$128.411.57%
NKTR Logo
NKTRNektar Therapeutics
$1.02-%
NPCE Logo
NPCENeuroPace Inc
$11.340.56%
NUVB Logo
NUVBNuvation Bio Inc
$2.884.15%
NVRO Logo
NVRONevro Corp
$4.02-1.23%
OGN Logo
OGNOrganon & Co
$15.15-2.63%
OM Logo
OMOutset Medical Inc
$1.200.84%
OMIC Logo
OMICSingular Genomics Systems Inc
$20.405.15%
OPGN Logo
OPGNOpGen Inc
$1.40-1.41%
OPTN Logo
OPTNOptiNose Inc
$0.559011.8%
PAVM Logo
PAVMPAVmed Inc
$0.98001.28%
PDSB Logo
PDSBPDS Biotechnology Corp
$2.147.00%
PMCB Logo
PMCBPharmaCyte Biotech Inc
$1.56-4.88%
RANI Logo
RANIRani Therapeutics Holdings Inc
$1.85-%
RLAY Logo
RLAYRelay Therapeutics Inc
$4.587.13%
RLMD Logo
RLMDRelmada Therapeutics Inc
$0.45591.31%
RMTI Logo
RMTIRockwell Medical Inc
$2.15-1.38%
RVMD Logo
RVMDRevolution Medicines Inc
$47.961.40%
SPRB Logo
SPRBSpruce Biosciences Inc
$0.50491.99%
SYBX Logo
SYBXSynlogic Inc
$1.420.77%
TCON Logo
TCONTRACON Pharmaceuticals Inc
$0.0322-%
TELA Logo
TELATELA Bio Inc
$2.957.66%
TFFP Logo
TFFPTFF Pharmaceuticals Inc
$0.2879-6.53%
THMO Logo
THMOThermoGenesis Holdings Inc
$0.00050-%
TLIS Logo
TLISTalis Biomedical Corp
$1.83-58.2%
TRVI Logo
TRVITrevi Therapeutics Inc
$2.776.54%
TXMD Logo
TXMDTherapeuticsMD Inc
$1.23-2.38%
VERU Logo
VERUVeru Inc
$0.7017-2.54%
VIVE Logo
VIVEViveve Medical Inc
$0.000001-99.0%
VYNE Logo
VYNEVYNE Therapeutics Inc
$2.747.03%
XCUR Logo
XCURExicure Inc
$24.928.60%
XERS Logo
XERSXeris Biopharma Holdings Inc
$3.69-1.21%
ZIVO Logo
ZIVOZivo Bioscience Inc
$19.453.57%
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