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

The busy calendar of June proved positive for drug approvals, with most scheduled events producing positive outcomes. New molecular entity, or NME, approval for the month totaled two, taking the total NME approvals for the year to 24.

Among the NME approvals was Viela Bio Inc's VIE lead drug Uplinza, which is indicated for neuromyelitis optica spectrum disorder. Although Upliinza will be pitched against Alexion Pharmaceuticals, Inc.'s ALXN Soliris, the absence of black box warning gives the former an edge, H.C. Wainwright analyst Raghuram Selvaraju said in a note.

There were disappointments too. Nabriva Therapeutics PLC's – ADR NBRV antibiotic Contepa, as expectedly, was handed down a second complete response letter, or CRL, and AbbVie Inc's ABBV eye disorder drug also faced rejection at the FDA altar.

Here are the key PDUFA dates scheduled for July.

Endo Awaits Nod For CCH In Cellulite

• Company: BioSpecifics Technologies Corp. BSTC and Endo International PLC ENDP
• Type of Application: BLA
• Candidate: collagenase clostridium histolyticum, or CCH
• Indication: for treating cellulite
• Date: July 6

CCH is developed by BioSpecifics and has already been approved for treating Dupuytren's contracture and Peyronie's disease in 2010 and 2013, respectively, and it is marketed in the U.S. by its partner Endo.

The original BLA for CCH in cellulitis, was accepted for review Nov. 19, 2019. Cellulite is a localized alteration in the contour of the skin that is reported in 85%-98% of post-pubertal females, caused by a thickening of the collagen septae that attach the skin to the underlying fascia layers with additional contributing protrusions of subcutaneous fat.

The septae tether the skin, causing surface dimpling, and cellulite is present mainly on the buttocks, thighs, lower abdomen and arms.

Endo said in its first-quarter earnings release in May that it is moving its anticipated product launch to the first quarter of 2021 due to medical aesthetics physician office closures and softer consumer spending in the wake of COVID-19.

Can Second Time Be Charm For Eagle Pharma?

• Company: Eagle Pharmaceuticals Inc EGRX
• Type of Application: NDA
• Candidate: Ryanodex
• Indication: exertional heat stroke, or EHS.
• Date: July 8

Ryanodex, or dantrolene sodium for injectable suspension, is indicated for the treatment of malignant hyperthermia in conjunction with appropriate supportive measure. The original NDA for treating EHS was handed down a CRL in July 2017. Eagle resubmitted the application in Jan. 2020.

EHS, a severe form of heat-related illness, is characterized by core body temperature of 104° F or greater, and significant neurological dysfunction, such as sudden changes in behavior, seizures or coma.

"We believe expectations for approval are low; thus, if EGRX is successful in gaining approval on or by the PDUFA date, we would expect this to be positively received given that it would provide upside not fully reflected in current estimates," Cantor Fitzgerald said in a recent note.

Verrica Seeks Approval For Topical Skin Infection Treatment

• Company: Verrica Pharmaceuticals Inc VRCA
• Type of Application: NDA
• Candidate: VP-102
• Indication: treatment of molluscum contagiosum
• Date: July 13

VP-102, or cantharidin 0.7% topical solution, is being evaluated as a potential treatment option for molluscum contagiosum and common warts. Molluscum, according to Verrica, is a highly contagious viral skin infection affecting approximately six million people, primarily children, in the U.S.

Verrica submitted the NDA Sept. 13, 2019, with the FDA accepting the application for review Nov. 26.

H.C. Wainwright analyst Oren Livnat estimates peak sales of about $400 million, assuming that it captures peak share just under 40% of total procedure volume.

Osmotica Seeks FDA Approval For ‘First-of-its-kind' Treatment Option For Droopy Eyelid

• Company: Osmotica Pharmaceuticals PLC OSMT
• Type of Application: NDA
• Candidate: RVL-1201
• Indication: acquired blepharoptosis (droopy eyelid or ptosis)
• Date: July 16

The FDA accepted the regulatory filing for RVL-1201 in November. RVL-1201 is a once-daily ophthalmic formulation of oxymetazoline, a direct-acting α-adrenergic receptor agonist, which when administered to the eye is believed to selectively target Müller's muscle and elevate the upper eyelid.

Acquired blepharoptosis, which can be congenital or acquired, is a unilateral or bilateral drooping of the upper eyelid that usually occurs from a partial or complete dysfunction of the muscles that elevate the upper eyelid. The current standard of care is surgery, which is often reserved only for severe cases and may carry an increased risk of adverse events such as infection, bleeding, and asymmetry.

If approved, RVL-1201 will be the first pharmacologic treatment option for the wide range of patients suffering from droopy eyelid, Osmotica said.

Following an investor call with the management, SunTrust Robinson Humphrey analyst Gregory Fraser noted the company is currently in labeling discussion with the FDA, and expects approval to come by the PDUFA date.

"The company will determine pricing for RVL-1201 closer to launch but is leaning towards the lower end of the $75-100/month range that it has previously discussed," the analyst said.

Jazz Burns Midnight Oil as Excessive Daytime Sleepiness Drug Nears Decision Day

• Company: Jazz Pharmaceuticals PLC JAZZ
• Type of Application: NDA
• Candidate: JZP-258
• Indication: treatment of cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy
• Date: July 21

JZP-258 is a novel oxybate product candidate with a unique composition of cations resulting in 92%, or approximately 1,000 to 1,500 milligrams, less sodium than Xyrem, the current standard of care. The NDA was accepted for review on March 25.

GW Pharma Seeks Label Expansion For Epidiolex

• Company: GW Pharmaceuticals PLC- ADR GWPH
• Type of Application: sNDA
• Candidate: Epidiolex
• Indication: seizures associated with tuberous sclerosis complex, or TSC
• Date: July 31

Adcom Meeting Schedule

FDA's Oncologic Drugs Advisory Committee is scheduled to discuss GlaxoSmithKline plc's GSK BLA for belantamab mafodotin as a potential treatment option for relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

The investigational asset is being co-developed with Seattle Genetics, Inc. SGEN, which has contributed its antibody-drug conjugate technology. The Adcom meeting is scheduled for Tuesday, July 14.