The Daily Biotech Pulse: NRx's Zyesami Face Regulatory Rejection, Puma Slumps On Q3 Miss, Pfizer Has Good Tidings On Oral Antiviral COVID-19 Pill

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

Stocks In Focus

NRx's COVID-19 Drug Fails to Get Authorization From FDA Due To Insufficient Data

NRx Pharmaceuticals NRXP announced that the U.S. Food and Drug Administration has declined to issue an emergency use authorization for Zyesami. The FDA stated it was unable to issue the EUA at this time due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of it in patients suffering from critical COVID-19 with respiratory failure.

The stock was slumping 25.90% to $6.61 in premarket trading.

Novavax Files With The WHO For Authorization Of COVID Vaccine Candidate

Novavax, Inc. NVAX announced the completion of its rolling submission to the World Health Organization for emergency use listing of NVX-CoV2373, its COVID-19 vaccine candidate. Separately, the company reported third-quarter results that trailed expectations.

The stock was adding 5.35% to $189 in after-hours trading.

Click here to access Benzinga's FDA Calendar

Opiant's Opioid Overdose Drug Gets FDA's Fast Track Designation

Opiant Pharmaceuticals, Inc. OPNT said the FDA has granted fast track designation for OPNT003, nasal nalmefene, its investigational treatment for opioid overdose.

The stock was moving up 2.18% to $23 in premarket trading.

Calithera Pulls The Plug On Mid-Stage Lung Cancer Study Due to Lack of Clinical Benefit

CALA announced the decision to terminate its phase 2 KEAPSAKE clinical trial based on a lack of clinical benefit observed in patients treated with telaglenastat in an interim analysis. The investigational asset is being evaluated with chemotherapy in first-line KEAP1/NRF2-mutated, non-squamous non-small cell lung cancer.

The stock was down 29.47% to $1.34 in premarket trading.

Pfizer Reports Positive Phase 2/3 Data For Oral Antiviral COVID Pill

Pfizer, Inc. PFE anounced its investigational novel COVID-19 oral antiviral candidate, Paxlovid significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness. The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset.

At the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, Pfizer said it will cease further enrollment into the study due to the overwhelming efficacy demonstrated in these results and plans to submit the data as part of its ongoing rolling submission for authorization as soon as possible.

Pfizer's shares were up 10.33% at $48.38 in premarket trading.

Ocugen Files For Authorization For Partnered Vaccine Candidate For Pediatric Use

Ocugen, Inc. OCGN said it has submitted a request to the FDA for emergency use authorization of its COVID-19 vaccine candidate BBV152, known as Covaxin outside of the U.S., for pediatric use.

The stock was gaining 8.25% to $10.89 in premarket trading.

Genmab Raises 2021 Revenue Guidance On Stronger-than-Expected Darzalex Sales

Genmab A/S GMAB raised its guidance for 2021 revenue, primarily consisting of Darzalex royalties. Such royalties are based on Genmab's revised estimate of Darzalex net sales of $5.9–$6.2 billion compared to the previous estimate of $5.6-5.9 billion.

Earnings

Puma Biotechnology, Inc. PBYI reported third-quarter results that came in below estimates, primarily due to weaker Nerlynx sales.

The stock was seen slipping 23.94% to $4.86 in premarket trading.

Axonics, Inc. AXNX said its net revenue was $46.9 million in the third quarter of 2021, an increase of 33% compared to $35.2 million in the prior year period. The net loss per share widened from 24 cents to 38 cents. The revenue trailed expectations, while the bottom-line results were below expectations.

The company expects 2021 revenues of $177 million, up about 55%, and fourth-quarter revenues of $49.8 million, with both coming in below the consensus estimates.

In premarket trading, the stock was moving down 12.27% to $60.50.

Emergent BioSolutions Inc. EBS reported third-quarter revenues of $329 million, down from $385.2 million a year ago. The company reversed from a loss of 73 cents per share to a profit of 61 cents per share. The results were below expectations.

The stock was plunging 13.95% to $45.27 in after-hours trading.

Assertio Holdings, Inc.'s ASRT third-quarter revenues fell from $34.57 million in 2020 to $25.47 million in 2021. The company reversed from a loss of 35 cents to a profit of 8 cents per share. The results exceeded estimates.

The stock was jumping 25.23% to $1.39 in premarket trading.

Chembio Diagnostics, Inc. CEMI reported third-quarter revenues of $12.1 million, up 17% year-over-year, and the net loss per share narrowed from 28 cents to 24 cents, trailing the 22-cent per share consensus estimate. The company also sounded out substantial doubt about its ability to continue as a going concern for the twelve-month period following the Issuance Date.

In premarket trading, the stock was slipping 10.61% to $2.19.

Offerings

Merus N.V. MRUS priced an underwritten public offering of 3.860 million common shares at $28.50 per share. The gross proceeds from the offering are expected to be about $110 million. All of the shares in the offering are to be sold by Merus.

The stock was losing 5.86% to $29.55 in premarket trading.

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

On The Radar

Clinical Readouts/Presentations

The American Society of Nephrology Kidney Week 2021 Presentations

GlaxoSmithKline plc GSK: late-breaking Phase 3 data will for daprodustat as a potential treatment for patients with anaemia due to chronic kidney disease in both dialysis and non-dialysis populations

International C. diff Conference & Health Expo Presentations

Acurx Pharmaceuticals, Inc. ACXP: new microbiome data from the Phase 2a clinical trial for C. difficile Infection

Earnings

Elanco Animal Health Incorporated ELAN (before the market open)
Oncolytics Biotech Inc. ONCY (before the market open)
Syros Pharmaceuticals, Inc. SYRS (before the market open)
Orthofix Medical Inc. OFIX (before the market open)

IPOs

Mainz Biomed B.V. MYNZ priced its initial public offering of 2 million ordinary shares at $5, the middle of the estimated price range of $4-$6, for raising gross proceeds of $10 million. The shares of the molecular genetics cancer diagnostic company will begin trading on the Nasdaq under the ticker symbol "MYNZ."

IO Biotech, Inc. IOBT,a clinical-stage biopharmaceutical company developing immune-modulating cancer therapies based on its T-win technology platform, priced its IPO of 7.15 million shares at $14 per share, potentially raising $100.1 million from the offering. The shares will begin trading on the Nasdaq under the ticker symbol "IOBT."