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) 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:
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 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 Source: Y Charts
A Peek Into July Decisions
1. Ocular Looks To Bulls Eye After Failure.
- Company: Ocular Therapeutix Inc 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.
2. Puma Biotechnology's Leap Of Faith In Breast Cancer Therapy.
- Company: Puma Biotechnology Inc 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) 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.
4. Eagle Looks To Strike It Rich With Heat Stroke Drug.
- Company: Eagle Pharmaceuticals Inc 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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