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 (NYSE: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 (NASDAQ: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 (NASDAQ: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.
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Novavax Starts Dosing In COVID-19 Booster Trial In Participants Aged 12 - 17 Years
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
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
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
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
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.
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