BOSTON, Mass. (
) -- I've updated the calendar (
) of expected U.S.
Food and Drug Administration
These can be make-or-break events for drug and biotech companies, so naturally, FDA decisions often move stocks significantly.
The following calendar covers most of the expected drug approval decisions by the FDA through the end of the year. To be included in this FDA calendar, a drug must already be submitted and under review by the agency.
I put the calendar together using company reports and the
service from Sagient Research -- a handy, subscription-based tool for keeping track of biotech and drug catalysts.
Let's start with updates on upcoming FDA approval decisions:
Drug/indication: Ampligen for chronic fatigue syndrome
FDA decision date: May 25
Hemispherx announced May 26 that the FDA requested a "brief delay" of one to two weeks to take action on the Ampligen application. But on a July 22 conference call, the company said it may get a response from the FDA in the fall.
Drug/indication: Qutenza for neuropathic pain
FDA decision date: Aug. 16
Qutenza is a skin patch that delivers a form of capsaicin through the skin to alleviate nerve pain. The patch/drug recently received approval in Europe.
Drug/indication: pixantrone for non-Hodgkin's lymphoma
FDA acceptance date: Aug. 24
Tentative FDA approval decision date: Dec. 24
The FDA will inform Cell Therapeutics on Aug. 24 whether it has accepted pixantrone for review under a priority, six-month review clock. If pixantrone is granted priority review, the FDA approval decision date would be Dec. 24.
Drug/indication: Nebido for testosterone replacement
FDA decision date: Sept. 2
Nebido is a long-acting injectable testosterone that Endo picked up when it acquired
Drug/indication: Zevalin for non-Hodgkin's lymphoma
FDA decision date: Sept. 7
Spectrum has a new FDA approval decision date following a July 5 request from the agency for additional clinical data. Spectrum submitted that data on July 9. Spectrum is seeking an expansion to the label for Zevalin to include consolidation therapy for patients with NHL. Zevalin is an effective drug that has been a commercial disappointment, so the company hopes the expanded FDA label will boost sales.
Drug/indication: Xiaflex for Dupuytren's contracture
FDA decision date: Aug. 28
FDA advisory panel date: Sept. 16
Xiaflex is designed to dissolve collagen deposits that form cords around joints in the hands and cause the fingers to contract and become inflexible. Notice that the advisory panel's review of Xiaflex is scheduled for after the FDA approval decision date, which likely means a delay.
Drug/indication: Telavancin for bacterial infections
FDA decision date: Sept. 16
The FDA review of telavancin for complicated skin and skin structure infections was delayed by the agency's request for additional information. Theravance is also seeking approval of telavancin for hospital-acquired pneumonia, with a second FDA approval decision date of Nov. 26.
Drug/indication: Zenpep for pancreatic insufficiency
FDA decision date: Sept. 24
Zenpep is a pancreatic enzyme replacement product for patients with pancreatic insufficiencies, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases.
Drug/indication: Pralatrexate for peripheral T-cell lymphoma
FDA decision date: Sept. 24
Allos expects the FDA to convene an advisory panel meeting to review pralatrexate, although a meeting has not been formally announced. The scheduling of the advisory meeting may delay the FDA's approval decision.
Drug/indication: Denosumab for osteoporosis
FDA advisory panel date: Aug. 13
FDA decision date: Oct. 19
Denosumab is the most important drug in the company's late-stage pipeline. Approval for osteoporosis, and later for certain cancer indications, could re-invigorate earnings growth after a couple of flat years. Denosumab's safety profile will be the focus of the Aug. 13 advisory panel meeting.
Drug/indication: Fampridine for multiple sclerosis
FDA decision date: Oct. 22
Fampridine improves nerve function and is being developed to improve the walking abilities of patients with multiple sclerosis.
Drug/indication: Acapodene for prostate cancer
FDA decision date: Oct. 30
Acapodene is designed to reduce bone fractures in prostate cancer patients being treated with androgen deprivation therapy.
Drug/indication: Intermezzo for insomnia
FDA decision date: Oct. 30
Intermezzo is a dissolvable, low-dose form of the sleep aid Ambien which will be marketed for people who awake in the middle of the night but can't fall back to sleep.
Drug/indication: Acetevance for acute pain/fever
FDA decision date: Nov. 13
Acetevance is an injectable form of the painkiller acetaminophen for use in hospitals.
Drug/indication: Silenor for insomnia
FDA decision date: Dec. 4
The FDA refused to approve Silenor last February, requesting additional clinical information from Somaxon. The company resubmitted Silenor in June.
Drug/indication: Onrigin for acute myelogenous leukemia
FDA decision date: Dec. 12
If approved, Onrigin would be used to induce remission in elderly AML patients.
Now, an updates of recently announced FDA approval decisions:
Drug/indication: Krystexxa for gout
FDA decision date: Aug. 1
The FDA declined to approve Krystexxa, citing concerns about the way the drug is manufactured. The FDA rejection came despite a recommendation for approval from an advisory panel in June. Savient plans to respond to the FDA's concerns in early 2010.
Drug/indication: Onsolis for breakthrough cancer pain
FDA decision date: June 15
The FDA approved Onsolis on July 16.
Drug/Indication: Feraheme for anemia due to chronic kidney disease
FDA decision date: June 26
The FDA approved Feraheme on June 30.
Drug/indication: DDS-04A for depression
FDA decision date: July 18
The FDA declined to approve DDS-04A on July 20, citing problems found during an inspection of the drug's manufacturing plant. Labopharm is working to address and correct the manufacturing issues and will submit a response to the FDA.
Drug/indication: Tyvaso for pulmonary arterial hypertension
FDA decision date: July 30
The FDA approved Tyvaso on July 30.
Advanced Life Sciences
Drug/indication: Restanza for community-acquired pneumonia
FDA decision date: July 31
The FDA rejected Restanza on July 31. The company said it will need to conduct a new clinical trial in order to get the drug approved.
-- Reported by Adam Feuerstein in Boston
Adam Feuerstein writes regularly for TheStreet.com. In keeping with TSC's editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet.com. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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