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

The FDA went overdrive in the month of June, deciding on several regulatory applications before the July 4 holiday. There were favorable outcomes as well as disappointments.

Acer Therapeutics Inc ACER went about a freefall, shedding about 79% in a single session after the FDA issued a complete response letter to the NDA for its rare genetic disorder drug.

Merck & Co., Inc. MRK's Keytruda snagged two approvals in the month – for head and neck cancer as well as lung cancer.

As the first half of the year winds down, new molecular entity approvals thus far totaled 12 compared to 20 approvals in the same time last year.

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 dates to watch in July.

Karyopharm Awaits Positive Verdict After Initial Hiccups

• Company: Karyopharm Therapeutics Inc KPTI
• Type of Application: NDA
• Candidate: Selinexor in combination with dexamethasone
• Indication: Multiple myeloma
• Date: July 6

Selinexor, an oral selective inhibitor of nuclear export compound, is being evaluated in combination with dexamethasone for treating patients with relapsed refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody.

FDA's Oncologic Drug Advisory Committee, which met in late February, voted 8-5 recommending the FDA wait for results from a Phase 3 study dubbed BOSTON before making a final decision regarding approval. In mid-March, the company announced the FDA extended the review period by three months to July 6.

Merck Seeks Approval For Antibiotic Combo Treatment

• Company: Merck
• Type of Application: NDA
• Candidate: Combination of relebactam with imipenem/cilastatin
• Indication: Complicated urinary tract infection and complicated intra-abdominal infections
• Date: July 16

Merck communicated FDA acceptance of the application Feb. 5. The application is supported by the results of the pivotal Phase 3 RESTORE-IMI 1 trial.

Celgene Knocks The FDA Altar For Expanded Indication Of Psoriasis Drug

• Company: Celgene Corporation CELG
• Type of Application: sNDA
• Candidate: Otezla
• Indication: Behҫet's disease
• Date: July 21

Otezla has been already been approved for psoriatic arthritis and plaque psoriasis. Incidentally, Bristol-Myers Squibb Co BMY, which has agreed to acquire Celgene, decided to divest Otezla in a bid to appease regulators.

Bechet's disease is a rare disorder that causes blood vessel inflammation throughout the body, manifesting as mouth sores, eye inflammation, skin rashes and lesions.

Biohaven's Neurological Disorder

• Company: Biohaven Pharmaceutical Holding Co Ltd BHVN
• Type of Application: 510(b)(2)NDA
• Candidate: BHV-0223
• Indication: Amyotrophic lateral sclerosis
• Date: July (date not specified)

Adcom Calendar

FDA's Psychopharmacologic Drugs Advisory Committee will discuss Intra-Cellular Therapies Inc ITCI's NDA for lumateperone tosylate capsules for oral administration in treating schizophrenia.

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