Biotech Stocks Facing FDA Decision In April

(RTTNews) - The journey of new drugs from lab to market is a long one. Some drugs pass the FDA muster easily while some face a host of hurdles before getting the official stamp of approval.

Awaiting word from the FDA this month are the following companies:

Gilead Sciences Inc. (GILD)

A New Drug Application filed by Gilead for two fixed-dose combinations of Emtricitabine and Tenofovir alafenamide (200/10 mg and 200/25 mg) (F/TAF) last April is under review by the FDA - with a decision expected to be announced on April 7, 2016.

The company is seeking approval of F/TAF for the treatment of HIV-1 infection in adults and pediatric patients age 12 years and older, in combination with other HIV antiretroviral agents.

Known by the name Descovy, F/TAF received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) on February 26, 2016. The CHMP's recommendation will now be reviewed by the European Commission, and a final decision related to marketing of F/TAF in Europe will be made within two to three months.

GILD closed Friday's trading at $94.12, up 2.46%.

Will F/TAF receive final nod from the FDA?

Intercept Pharmaceuticals Inc. (ICPT)

On April 7, 2016, an FDA advisory panel of outside experts will review Intercept's New Drug Application for Obeticholic acid for the treatment of primary biliary cirrhosis and make its recommendations.

Primary biliary cirrhosis, or PBC, is a rare liver disease that primarily results from autoimmune destruction of the bile ducts that transport bile acids out of the liver, resulting in cholestasis. It is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40.

PBC is a leading cause of liver transplant among women in the United States. In Europe, the disease accounts for approximately half of liver transplants due to cholestatic diseases and 6% of all liver transplants.

Obeticholic acid is under priority review by the FDA and the regulatory agency was expected to announce its decision on February 29, 2016. However, with an FDA panel called to review Obeticholic acid, the final decision date got extended to May 29, 2016.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so.

ICPT closed Friday's trading 1.78% higher at $130.76.

Will Obeticholic acid get the backing of FDA panel?

Clovis Oncology Inc. (CLVS)

On April 12, 2016, an FDA panel is scheduled to vote on the New Drug Application for Clovis' cancer drug candidate Rociletinib.

The company is seeking approval of Rociletinib for the treatment of advanced EGFR-mutant non-small cell lung cancer.

The FDA granted Breakthrough Therapy designation for Rociletinib as treatment for mutant NSCLC in patients with the T790M mutation after progression on EGFR-directed therapy in May 2014.

The regulatory agency's final decision on Rociletinib is expected on June 28, 2016.

CLVS closed Friday's trading at $19.37, up 0.89%.

Will it be a smooth sailing for Rociletinib?

Chiasma Inc. (CHMA)

Mycapssa, an investigational new oral drug of Chiasma, proposed for the maintenance therapy of adult patients with acromegaly, is under FDA review, with a decision expected to be announced on April 15, 2016.

Acromegaly typically develops when a benign tumor of the pituitary gland produces too much growth hormone (GH). Facial changes, intense headaches, joint pain, impaired vision and enlargement of the hands, feet, tongue and internal organs are some of the features of acromegaly.

Dopamine agonists, GH antagonists, and injectable somatostatin analogs are the current standard of care for acromegaly.

Mycapssa exhibits the effects of somatostatin, a naturally occurring hormone that reduces the production of GH by binding to receptors on specialized cells in the pituitary gland.

If approved, Mycapssa will be the first oral somatostatin analog available to acromegaly patients.

CHMA closed Friday's trading at $9.79, up 6.88%.

Will Mycapssa make it to the finish line?

Heron Therapeutics Inc. (HRTX)

After being twice rejected by the FDA, Heron's investigational drug SUSTOL will learn its fate by early April 2016.

The company is seeking approval of SUSTOL prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) associated with moderately emetogenic chemotherapy (MEC) or highly emetogenic chemotherapy (HEC) regimens. SUSTOL was issued a complete response letter twice, in 2013 and 2010, requesting additional data.

Addressing the concerns raised by the FDA in the complete response letter of 2013, Heron resubmitted the New Drug Application for SUSTOL last July. The FDA was expected to announce its decision whether or not to approve SUSTOL on January 17, 2016. However, as the FDA couldn't conclude the review, the decision on SUSTOL got delayed and is now expected early this month.

SUSTOL is a long-acting formulation of 5-HT3 antagonist, Granisetron.

The global market for CINV drugs is expected to grow from $1.28 billion in 2014 to $1.88 billion in 2020, at a CAGR of 5.7%, according to Transparency Market Research, a market intelligence company.

Some of the approved treatments for CINV include 5-HT3 inhibitors like Aloxi (palonosetron), Zofran (ondansetron) and Kytril (granisetron), Emend, an NK1 antagonist, which is always used in combination with a 5-HT3 antagonist, and Akynzeo (netupitant-palonosetron).

HRTX gained 10.06% on Friday to close the day's trading at $20.90.

Will SUSTOL finally join the list of approved CINV drugs?

Progenics Pharmaceuticals Inc. (PGNX)

Progenics awaits FDA word on the oral version of RELISTOR for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain on April 19, 2016.

The development and commercialization rights for RELISTOR have been licensed by Progenics to Salix Pharmaceuticals, Inc., a subsidiary of Valeant Pharmaceuticals International Inc. (VRX)

The subcutaneous injection formulation of RELISTOR has been approved by regulatory authorities in the U.S., countries in the E.U., Canada, Australia and elsewhere since 2008 for treatment of OIC in advanced-illness patients receiving palliative care when laxative therapy has not been sufficient and in the U.S. since 2014 for the treatment of OIC in patients with non-cancer pain.

Net sales of RELISTOR injection for full year 2015 totaled $43.8 million, up from $20.3 million in 2014.

PGNX closed Friday's trading at $4.41, up 1.15%.

Will oral RELISTOR be green lighted by the FDA?

Sarepta Therapeutics Inc. (SRPT)

An FDA panel is scheduled to vote on Eteplirsen, Sarepta's drug candidate for Duchenne Muscular Dystrophy amenable to exon 51 skipping, on April 25, 2016.

Duchenne Muscular Dystrophy, or DMD in short, is a rare genetic muscle-wasting disease caused by the absence of dystrophin, a protein necessary for muscle function. DMD usually affects boys, and its prevalence is roughly 1 in every 3,500 - 5,000 boys worldwide. Children affected by DMD lose their ability to walk and they will be confined to wheelchairs by late childhood.

Eteplirsen was originally slated to be reviewed by an FDA panel on January 22, 2016, and a final decision was to be announced on February 26, 2016. However, due to severe weather conditions then in the Washington D.C. area, the panel meeting to review Eteplirsen was postponed to April 25, 2016, and the FDA pushed back the decision date to May 26, 2016.

SRPT closed Friday's trading at $19.98, up 2.36%.

Will Eteplirsen clear the penultimate regulatory hurdle in the U.S.?

Collegium Pharmaceutical Inc. (COLL)

Xtampza ER, developed by Collegium, which was granted tentative approval by the FDA last November for the management of pain severe enough to require daily, around the clock, long term opioid treatment and for which alternative treatment options are inadequate, is all set to receive final regulatory approval on April 26, 2016.

The FDA granted tentative approval then because though Xtampza met the required quality, safety and efficacy standards for approval, it was subject, at that time, to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue in March 2015.

However, with the District Court of Massachusetts entering a judgment in Collegium's favor in February of this year, the automatic stay has expired and a final approval is awaited.

COLL closed Friday's trading at $19.17, up 5.62%.

Flamel Technologies (FLML) A New Drug Application for Éclat #3, an undisclosed compound, filed by Flamel is under review by the FDA - with a decision date set for April 30, 2016.

Flamel focuses not only on new drug development but also seeks approval of drugs that are currently marketed, as yet still "unapproved" products, but with well-established medical efficacy.

The company currently has FDA approvals for and markets two previously Unapproved Marketed Drugs (UMD) in the U.S. - Bloxiverz and Vazculep.

Bloxiverz is indicated for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Vazculep is indicated for the treatment of clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia.

The NDA for Éclat #3 represents Flamel's third filing to seek FDA approval of an Unapproved Marketed Drug. Based on IMS and other third-party data, the company estimates that current U.S. market sales of the unapproved versions of this drug are in the range of $70 million to $80 million per year.

FLML closed Friday's trading at $10.97, down 0.63%.

Will Flamel score a hat trick in its UMD strategy?

Supernus Pharmaceuticals Inc. (SUPN)

Trokendi XR, developed by Supernus, which is an FDA-approved antiepileptic drug, is under FDA review for label expansion to include treatment for adults for prophylaxis of migraine headache.

The supplemental new drug application for Trokendi XR, seeking approval for use in migraine was accepted for review by the FDA last October, and a decision is expected this quarter.

Trokendi XR, which was approved in August 2013 for the treatment of epilepsy, raked in sales of $110.3 million for full year 2015, an increase of 70% from 2014.

SUPN closed Friday's trading at $16.21, up 6.30%.

Will Trokendi XR nab approval for label expansion?