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Attention Biotech Investors: Keep Your Date With July PDUFA Action-Days

Attention Biotech Investors: Keep Your Date With July PDUFA Action-Days

June was event-filled as far as the PDUFA calendar was concerned. The month ushered in good tidings for the biotech sector, as most applications for approval pending before the FDA were favorably viewed.

The iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) has been up 11.70 percent thus far this month compared to a 12.39-percent gain for the NYSE ARCA Biotech Index.

Benzinga took a look at what is in store for the sector in the upcoming month.

A June Recap

Recapping the approvals in June:

  • Alkermes Plc (NASDAQ: ALKS) announced FDA approval for its sNDA for two-month dosing interval of Aristada extended-release injectable suspension for the treatment of schizophrenia. The stock reaction to the approval was muted.
  • Coherus Biosciences Inc (NASDAQ: CHRS) was in for a disappointment after the FDA issued a complete response letter in response to its aBLA for Amgen, Inc.(NASDAQ: AMGN)'s Neulasta biosimilar candidate. The stock has lost roughly 30 percent since then.
  • Adamis Pharmaceuticals Corp (NASDAQ: ADMP) received FDA approval for its NDA for Epinephrine pre-filled syringe meant as an emergency treatment of anaphylaxis. The stock soared more than 53 percent on June 15, the decision day, with the approval coming about after three rejections.
  • Neos Therapeutics Inc (NASDAQ: NEOS) announced FDA approval for its Cotempla XR-ODT for treating attention deficit/hyperactivity disorder in patients aged between 6 and 17. The stock, however, trended downward after the approval, as a competing product from Shire PLC (ADR) (NASDAQ: SHPG) got the go-ahead around the same time.
  • Ligand Pharmaceuticals Inc. (NASDAQ: LGND) and its partner Melinta received FDA vetting for their oral as well as IV Baxdela, used to treat acute bacterial skin and skin structure infections.

    Brand Approval In June

    New Molecular Entities, or NME, approvals have increased to 22 thus far this year, with two molecules receiving approval in June:

    1. Portola Pharmaceuticals Inc (NASDAQ: PTLA)'s Bevyxxa was approved for treating venous thromoboembolism in adult patients hospitalized for an acute medical illness.

    2. Privately-held Melinta Therapeutics announced FDA approval for Baxdela for acute bacterial skin and structure infection.

    NEOS Chart

    Source: Y Charts

    A Peek Into July Decisions

    1. Ocular Looks To Bulls Eye After Failure.

      Company: Ocular Therapeutix Inc (NASDAQ: OCUL).
      Type of Application: NDA.
      Drug/Treatment Candidate: Dextenza (dexamethasone)
      Indication: Treating ocular pain occurring after ophthalmic surgery.
      Date: July 19.

    On July 25, 2016, the FDA issued a CRL for Dextenza, citing deficiencies in manufacturing process and controls identified during a pre-NDA approval inspection of the manufacturing facility. On Feb. 22, 2017, the FDA accepted the company's resubmission.


    Source: Ocular Therapeutics.

    2. Puma Biotechnology's Leap Of Faith In Breast Cancer Therapy.

      Company: Puma Biotechnology Inc (NASDAQ: PBYI).
      Type of Application: NDA.
      Treatment Candidate: PB272 (neratinib).
      Indication: Extended adjuvant treatment of breast cancer to be used alongside the current standard of care such as chemotherapy.
      Date: by July 21.

    The company announced FDA acceptance of its NDA filing on Sept. 20, 2016, with the PDUFA date estimated to be July 21, 2017. An FDA Advisory Committee meeting held on May 24, 2017, voted 12–4 in favor of recommending approval.

    3. GlaxoSmothKline's Lupus Drug Up For Approval.

      Company: GlaxoSmithKline plc (ADR) (NYSE: GSK).
      Type of Application: BLA.
      Treatment Candidate: Benlysta (belimumab).
      Indication: Subcutaneous formulation in patients with active, autoantibody-positive systemic lupus erythematosus, or SLE.
      Date: July 23.

    Benlysta is a human monoclonal antibody currently licensed for use intravenously as a one-hour infusion every four weeks. The BLA filing completed on Sept. 23, 2016, was based on results from the BLISS-SC Phase III pivotal study, which evaluated belimumab 200mg administered weekly via subcutaneous injection plus standard of care.


    Source: What-when-how

    4. Eagle Looks To Strike It Rich With Heat Stroke Drug.

      Company: Eagle Pharmaceuticals Inc (NASDAQ: EGRX).
      Type of Application: NDA.
      Treatment Candidate: Ryanodex (dantrolene sodium).
      Indication: Exertional heat stroke.
      Date: July 23.

    The FDA granted priority review status for the treatment candidate on March 27, 2017.

    "There is currently no approved pharmacological treatment for EHS. If Ryanodex is approved, Eagle will be the first to market with a potentially transformational therapy. EHS can strike anyone, but athletes, our military and outdoor workers are especially vulnerable. We look forward to working with the FDA throughout the review process and to their expedited decision in July 2017," said Scott Tarriff, CEO of Eagle, in the release announcing its priority review status.

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    Related Articles (ALKS + ADMP)

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