Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

WHO Backs Pfizer's Oral COVID Antiviral Therapy For High-Risk Patients

The World Health Organization (WHO) endorsed Pfizer Inc's PFE oral COVID-19 antiviral treatment in high-risk patients after the analysis of trial data by the U.N. agency showed that the therapy dramatically cut the risk of hospitalization.

A WHO analysis of two Paxlovid clinical trials involving nearly 3,100 patients suggested it reduced the risk of hospitalization by 85%.

The WHO also updated its recommendation on Gilead Science Inc's GILD remdesivir, saying it should be used in mild or moderate COVID-19 patients at high risk of hospitalization.

Revance's Alternative To Botox Goes Under FDA Review For Frown Lines

The FDA has accepted for review Revance Therapeutics Inc's RVNC resubmission for DaxibotulinumtoxinA for Injection for moderate to severe glabellar lines.

The FDA designated the BLA as a Class 2 resubmission, which has a six-month review period and includes a required reinspection of the Company's manufacturing facility. 

Revance was provided a Prescription Drug User Fee Act (PDUFA) goal date of September 8, 2022.

Shares closed 6.33% higher at $17.96 during after-hours trading on Thursday.

Click here to access Benzinga's FDA Calendar

Novavax Starts Dosing In COVID-19 Booster Trial In Participants Aged 12 - 17 Years

Novavax Inc NVAX has initiated the administration of the first booster doses of NVX-CoV2373 in the pediatric expansion of the PREVENT-19 pivotal Phase 3 trial. 

The booster dose is identical to the active vaccine previously administered to the participants in a two-dose regimen (5 micrograms of recombinant spike protein plus 50 micrograms of Matrix-M adjuvant).

It can be administered at least five months after receiving the active vaccine. 

Vallon Pharma Explores Strategic Alternatives

Vallon Pharmaceuticals Inc VLON has engaged Ladenburg Thalmann & Co Inc to evaluate strategic alternatives.

The Company continues to assess the best path forward for ADAIR, its novel abuse-deterrent formulation of amphetamine for attention deficit hyperactivity disorder and narcolepsy, and ADMIR, its novel abuse-deterrent formulation of methylphenidate (Ritalin). 

The Company is also streamlining its operations to preserve its capital and cash resources.

Shares are surging 41.5% at $1.60 during the premarket session.

Scynexis's Oral Ibrexafungerp Shows Potency Against Severe Fungal Infections

SCYNEXIS Inc SCYX has announced interim data from its ongoing Phase 3 FURI and CARES studies of ibrexafungerp in severe fungal infections.

Of the 131 study cases analyzed, 61.1% achieved a complete or partial response or clinical improvement.

22.1% achieved stable disease, a favorable outcome in patients with severe progressive fungal infections.

Savara Announces Debt Refinancing of $26.5M

Savara Inc SVRA has entered into a term loan agreement of $26.5 million with Silicon Valley Bank to replace its existing credit facility with the bank.

The new facility represents a lower interest rate than the current loan rate and an initial 48-month interest-only period.

Shares are up 7.20% at $1.34 during the premarket session.

Offerings

SCYNEXIS Inc SCYX has priced its underwritten public offering of common stock, pre-funded warrants, and warrants for gross proceeds of $45 million.

The shares and warrants have an offer price of $3.00, and the pre-funded warrants are being sold at $2.999. 

Shares are down 17.5% at $2.59 during the premarket session.