The Daily Biotech Pulse: Valneva Gains On COVID Shot Regulatory Update, Lucira Health And Clearside Jump On Earnings, BeiGene Drug Snags Approval In China

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

Stocks In Focus

Valneva Says Confident Of Conditional Approval For COVID Vaccine Candidate In Europe

Valneva SE VALN received a small set of additional questions from the European Medicines Agency's Committee for Medicinal Products for Human Use regarding the regulatory review of its inactivated, COVID-19 vaccine candidate, VLA2001. Earlier in late February, the company received the first set of questions from the CHMP, to which it responded within two working days.

The company said it has received a tentative timetable from the EMA.

Valneva also anticipates receiving a positive CHMP recommendation for conditional approval of VLA2001 in April and subsequently it expects to start delivering planned doses of VLA2001 to European countries in the second quarter of 2022.

The stock was up 4.61% to $34.02 in premarket trading.

Click here to access Benzinga's FDA Calendar

Emergent BioSolutions Begins Phase 1 Study Of Cyanide Poisoning Treatment

Emergent BioSolutions Inc. EBS dosed the first participant in its Phase 1 study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of stabilized isoamyl nitrite, a treatment being developed for known or suspected acute cyanide poisoning.

Under an existing multi-year contract with the BARDA and in collaboration with the Southwest Research Institute, Emergent is developing the single-use intranasal spray intended for administration by first responders and medical personnel following a cyanide incident.

BeiGene's Cancer Antibody Therapy Gets Conditional Approval For Treating Certain Types Of Solid Tumors In China

BeiGene Limited BGNE said the China National Medical Products Administration has granted conditional approval to its anti-PD-1 antibody, tislelizumab, for the treatment of adult patients with advanced unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumors.

Counting both full and conditional approvals, tislelizumab has now been approved for seven indications in China.

Earnings

Lucira Health, Inc. LHDX reported fourth-quarter net revenue of $61.1 million, up 300% from the previous quarter and the net loss per share narrowed from $6.70 to 20 cents.

The company guided to first-quarter revenue of $80 million to $85 million, and full-year revenue in excess of $450 million, both of which are notably above estimates.

The stock was jumping 18.34% to $4 in premarket trading.

Clearside Biomedical, Inc. CLSD reported fourth-quarter license and other revenue of $25.7 million in 2021, up from $11,000 in the year-ago quarter. The strong increase was attributed primarily to milestone payments received from Xipere licensing partners. The company reversed to a profit of 31 cents per share from a loss of 14 cents per share.

Clearside received approval for Xipere for the treatment of macular edema associated with Uveitis in late October 2021.

The stock was surging up 23.70% to $1.67 in premarket trading.

Related Link: Attention Biotech Investors: Mark Your Calendar For March PDUFA Dates

On The Radar

Earnings

PLx Pharma Inc. PLXP (before the market open)
Bio-Path Holdings, Inc. BPTH (before the market open)
Leap Therapeutics, Inc. LPTX (before the market open)