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Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

Attention Biotech Investors: Mark Your Calendar For These June PDUFA Dates

The month of May saw several drugs passing the FDA muster, with new molecular entity approvals alone totaling five. NMEs are those innovative new products containing active moieties that haven't been approved by the agency previously, either as a single ingredient drug, or as part of a combination products.

Thus far this year, NME approvals have totaled 15 compared to 21 in the same period last year.

Biotech stocks had a fairly decent run thus far in May, with the iShares NASDAQ Biotechnology Index (ETF) (NASDAQ: IBB) up about 3.2 percent.

Here are some key PDUFA action dates to watch in June.

1. Valeant Psoriasis Treatment Awaits FDA Nod

  • Company: Valeant Pharmaceuticals Intl Inc (NYSE: VRX)
  • Type of Application: NDA
  • Candidate: IDP-118
  • Indication: Plaque psoriasis in adult patients
  • Date: June 18

IDP-118 is a halobetasol propionate and tazarotene topical lotion developed by Valeant unit Ortho Dermatologics, which allows a potentially expanded duration of use. Following its first-quarter results, the company raised its revenue and EBITDA guidance for 2018.

Valeant also has two other PDUFA action dates this year, one for its NDA for altreno, an acne treatment in lotion form, scheduled for Aug. 27, and another for bryhali, a topical treatment for plaque psoriasis, scheduled for Oct. 5.

2. Will Scpharma's Edema Treatment Pass The FDA Muster?

  • Company: Scpharmaceuticals Inc (NASDAQ: SCPH)
  • Type of Application: NDA
  • Candidate: Furoscix
  • Indication: Edema in patients with heart failure
  • Date: June 23

Furoscix, if approved, will be the first formulation of furosemide, subcutaneously administered, for treating edema in patients with heart failure. The company indicated in its first-quarter earnings release that it has continued pre-launch preparations for furoscix.

3. Achaogen On Tenterhook After Mixed FDA Panel Vote On Plazomicin

  • Company: Achaogen Inc (NASDAQ: AKAO)
  • Type of Application: NDA
  • Candidate: Plazomicin
  • Indication: Complicated urinary tract infections (cUTI) and bloodstream infections (BSI)
  • Date: June 25

The FDA had accepted the NDA on Jan. 2, 2018 for two indications:

  • cUTI, including pyelonephritis
  • bloodstream infections (BSI) due to certain Enterobacteriaceae in patients who have limited or no alternative treatment options

Achaogen suffered a setback on May 3, with shares losing one-quarter of their value, when a FDA panel issued a mixed ruling, favoring it for cUTI but nor for BSI. Since then, shares have languished around the level to which they pulled back following the Adcom meeting.

4. Will Epidiolex Give GW Pharma New Highs?

Company: GW Pharmaceuticals (NASDAQ: GWPH)

  • Type of Application: NDA
  • Candidate: Epidiolex
  • Indication: Adjunctive treatment of seizures, with Lennox-Gastaut syndrome (LGS) and Dravet
  • Date: June 27

FDA's Peripheral and Central Nervous System Drugs Advisory Committee, which met in April, unanimously recommended supporting the approval of epidiolex, which is purified plant-based cannabidiol oral solution (CBD) lacking the high associated with marijuana.

5. Merck's Wonder Cancer Drug Up Before FDA For Another Indication

  • Company: Merck & Co., Inc. (NYSE: MRK)
  • Type of Application: sBLA
  • Candidate: Keytruda
  • Indication: Advanced cervical cancer
  • Date: June 28

Merck is seeking FDA nod for its sBLA for its Keytruda- chemically pembrolizumab – for treating cervical cancer. Incidentally, this is the 14th regulatory submission for the anti PD-1 therapy.

6. Array Seeks Approval For Skin Cancer Treatment

  • Company: Array Biopharma Inc (NASDAQ: ARRY)
  • Type of Application: NDA
  • Candidate: Binimetinib and Encorafenib
  • Indication: BRAF-mutant, advanced, unresectable or metstatic melanoma
  • Date: June 30

The company indicated no Adcom meeting has been scheduled.

Adcom Meeting Schedule

FDA's Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee are set to give their decision on the NDA for remoxy, oxycodone extended-release capsules, to manage pain, severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

The NDA was submitted by DURECT Corporation (NASDAQ: DRRX) and Pain Therapeutics, Inc. (NASDAQ: PTIE)

"The committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse," the FDA said. Following the issue of a complete response letter on Sep. 26, 2016, the FDA accepted the refiling on March 1, 2018. The PDUFA date is set for Aug. 7.


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