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

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