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The Daily Biotech Pulse: Puma Leaps, Aerie Borrows, Hepion Back In Nasdaq's Good Books

Shanthi Rexaline

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 Sept. 3)

  • Ardelyx Inc (NASDAQ: ARDX) (reported positive results from a late-stage of its lead compound tenapanor in combination with phosphate binders to treat hyperphosphatemia in patients with chronic kidney disease on dialysis)
  • China Biologic Products Holdings Inc (NASDAQ: CBPO)
  • DURECT Corporation (NASDAQ: DRRX)
  • Insulet Corporation (NASDAQ: PODD) (announced private offering of convertible senior notes)
  • Lipocine Inc (NASDAQ: LPCN)
  • NextCure Inc (NASDAQ: NXTC)
  • The Medicines Company (NASDAQ: MDCO) (announced positive Phase 3 results for inclisiran)

Down In The Dumps

(Biotech stocks hitting 52-week lows on Sept. 3)

  • Adamis Pharmaceuticals Corp (NASDAQ: ADMP)
  • Aduro BioTech Inc (NASDAQ: ADRO)
  • Aerie Pharmaceuticals Inc (NASDAQ: AERI)
  • Agios Pharmaceuticals Inc (NASDAQ: AGIO)
  • Alimera Sciences Inc (NASDAQ: ALIM)
  • Assembly Biosciences Inc (NASDAQ: ASMB)
  • BIOLINERX LTD/S ADR (NASDAQ: BLRX) (announced completion of dose-escalation part of the Phase 1/2a study of AGI-134)
  • Cumberland Pharmaceuticals, Inc. (NASDAQ: CPIX)
  • DelMar Pharmaceuticals Inc (NASDAQ: DMPI)
  • Esperion Therapeutics Inc (NASDAQ: ESPR)
  • Gemphire Therapeutics Inc (NASDAQ: GEMP)
  • HTG Molecular Diagnostics Inc (NASDAQ: HTGM)
  • ICU Medical, Incorporated (NASDAQ: ICUI)
  • Kezar Life Sciences Inc (NASDAQ: KZR)
  • Kiniksa Pharmaceuticals Ltd (NASDAQ: KNSA)
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND)
  • Mirum Pharmaceuticals Inc (NASDAQ: MIRM)
  • Nephros, Inc. (NASDAQ: NEPH)
  • ProQR Therapeutics NV (NASDAQ: PRQR)
  • Protalix Biotherapeutics Inc (NYSE: PLX)
  • Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL)
  • Rubius Therapeutics Inc (NASDAQ: RUBY)
  • Sarepta Therapeutics Inc (NASDAQ: SRPT)
  • Synlogic Inc (NASDAQ: SYBX)
  • Wright Medical Group NV (NASDAQ: WMG)

See Also: The Week Ahead In Biotech: Cardiology, Analyst Conferences In The Spotlight

Stocks In Focus Puma's Breast Cancer Drug Gets Orphan Drug Designation For Expanded Indication

Puma Biotechnology Inc (NASDAQ: PBYI) announced the FDA granted Orphan Drug Designation to its Nerlynx for the treatment of breast cancer patients with brain metastases.

Nerlynx is indicated as an adjuvant therapy for adult patients with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab-based therapy.

The stock rose 8.82% to $11.35 in after-hours trading,

Aerie To Offer $250M Worth Of Debt

Aeries, an ophthalmic pharma company, said it plans to offer $250 million aggregate principal amount of its convertible notes due 2024, subject to market conditions and other factors. The notes are to be offered in a private offering to qualified institutional buyers, and will be senior, unsecured obligations of the company bearing interest semi-annually in arrears.

The stock fell 3.68% to $19.65 in after-hours trading.

Hepion Regains Compliance With Nasdaq Listing Standards

Hepion Pharmaceuticals Inc (NASDAQ: HEPA), formerly Contravir Pharma, said it has received a notification from the Nasdaq that it has regained compliance with the exchange's minimum shareholders' equity rule and is in compliance with other applicable requirements.

The stock rose 4.74% to $2.65 in after-hours trading.

Melinta Names Insider As Interim CEO

Melinta Therapeutics Inc (NASDAQ: MLNT) said it has appointed Jennifer Sanfilippo as its interim CEO and director, Sanfilippo was earlier serving as SVP and general counsel.

Mallinckrodt Finalizes Questcor Settlement Agreement With DoJ

Mallinckrodt PLC (NYSE: MNK) finalized a previously disclosed $15.4 million settlement agreement with the DoJ to resolve a Civil False Claims Act investigation of Questcor's legacy sales and marketing activities first filed in 2012. Questcor was acquired by Mallinckrodt in August 2014.

The company noted that the settlement agreement contains no admission of wrong doing.

The stock gained 0.78% to $2.57 in after-hours trading.

On The Radar Clinical Trial Readouts Society For The Study Of Inborn Errors Of Metabolism Annual Symposium 2019 Presentations

Orchard Therapeutics PLC – ADR (NASDAQ: ORTX) – Phase 2 data for OTL-200 in metachromatic leukodystrophy

Synlogic Inc (NASDAQ: SYBX) – Full Phase 2 data for SYNB1619 in phenylketonuria

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