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

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

Biotech stocks bucked the broader market uptrend in April, thanks to the volatility associated with the sector. Some of the catalysts that drove stocks include clinical trial readouts, capital raising and regulatory decisions.

PDUFA dates are deadlines for the FDA to review new drugs. The FDA is normally given 10 months to review new drugs. If a drug is selected for priority review, the FDA is allotted six months to review the drug. These time frames begin on the date that an NDA is accepted by the FDA as complete.

Here are the key PDUFA catalysts for the upcoming month.

Can Sanofi's Controversial Dengue Vaccine Clear FDA Hurdle?

  • Company: Sanofi SA (NASDAQ: SNY)
  • Type of Application: BLA
  • Candidate: Dengvaxia dengue vaccine
  • Indication: Dengue
  • Date: May 1

The FDA accepted the BLA with priority review designation in October. Dengvaxia has already been approved in some countries, with the initial approval coming through in 2015. However, data released subsequently has shown the vaccine can cause serious infections if administered to people who haven't been infected previously.

An FDA panel in March voted 13-1 in favor of the efficacy of the vaccine in children and adolescents aged between 9 and 17. On safety, the panel voted 10-4 in favor of approval for this group.

However, for a broader age group, the vote was 6-7 against efficacy and 7-7 for safety.

Regeneron Eyeing Expanded Indication For Eylea

  • Company: Regeneron Pharmaceuticals Inc (NASDAQ: REGN)
  • Type of Application: sBLA
  • Candidate: Eylea
  • Indication: moderately severe to severe non-proliferative diabetic retinopathy without diabetic macular edema
  • Date: May 13

The application was accepted by the FDA on Sept. 13, 2018, with the filing supported by a Phase 3 study, dubbed PANORAMA. Eylea, administered as a 2mg intravitreal injection, has already been approved for wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in patients with diabetic macular edema.

The opportunity in the new indication could be as much as $700 million by 2023, Leerink analysts have said.

Incyte Awaits Positive Verdict On Jakafi sNDA

  • Company: Incyte Corporation (NASDAQ: INCY) & Novartis
  • Type of Application: sNDA
  • Candidate: Jakafi, or ruxolitinib
  • Indication: treating patients with acute graft-versus-host disease, or GVHD, who have had an inadequate response to corticosteroids
  • Date: May 24

The sNDA was submitted last August and the FDA had granted it priority review status as well as Breakthrough Therapy Designation. On Feb. 7, Incyte announced a three-month extension of the FDA review period, as the regulatory body required additional time to review the additional data submitted by the company.

See Also: 6 Gene Therapy M&A Targets On The Radar

Novartis' Novel Gene Therapy On The Cusp Of Approval

  • Company: Novartis AG (NYSE: NVS)
  • Type of Application: BLA
  • Candidate: Zolgensma
  • Indication: Spinal muscular atrophy, or SMA, Type 1
  • Date: May (date not confirmed)

Zolgensma is an investigational gene replacement therapy for SMA, which is caused due to a defective or missing SMN1 gene that would lead to a rapid loss of motor neurons responsible for muscle functions.

The therapy is to be delivered as a single one-time infusion and works by replacing the missing or defective SMN1 gene with a functional copy that makes SMN protein.

The recent death of an infant evaluated in a late-stage trial has stirred safety concerns, although the company maintained it is unrelated to the treatment.

Zolgensma, if approved, could be up against Biogen Inc (NASDAQ: BIIB)'s Spinraza, and could be priced at around $2 million, Fierce Pharma reported.

Will Allergan's Vraylar Win Label Expansion?

  • Company: Allergan plc (NYSE: AGN)
  • Type of Application: sNDA
  • Candidate: Vraylar, or Cariprazine
  • Indication: depressive episodes associated with bipolar disorder in adults
  • Date: May (date not confirmed)

Cariprazine was approved by the FDA in 2015 for the treatment of schizophrenia in adults and acute treatment of manic or mixed episodes associated with bipolar disorder in adults.

Adcom Meetings

FDA's Pulmonary-Allergy Drugs Advisory Committee is set to discuss privately-held Chiesi USA, Inc.'s NDA for mannitol inhalation powder for oral inhalation that is being evaluated for the management of cystic fibrosis to improve pulmonary function in patients 18 years of age and older, in conjunction with standard therapies.

The Oncologic Drugs Advisory Committee will discuss DAIICHI SANKYO/S ADR (OTC: DSNKY)'s NDA for pexidartinib capsule for treating adult patients with giant cell tumor of the tendon sheath. The committee will also vote on the Japanese company's NDA for quizartinib tablets being tested in adults with relapsed or refractory acute myeloid leukemia which is FLT3-ITD positive.


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