"While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible," said Enrique Conterno, CEO of FibroGen.

The PDUFA date, originally scheduled for March 20, will now likely be delayed.

Separately, FibroGen reported a sharp increase in fourth-quarter revenues to $65 million in 2020 from $8 million in 2019, with $29.2 million of it coming from Roxadustat sales in China. The company reported a wider-than-expected net loss for the fourth quarter.

FibroGen shares were down 24.6% at $38.10 premarket Tuesday.

Argenx's Regulatory Application For Efgartigimod In Neuromuscular Disease Accepted For Review

Argenx SE (NASDAQ: ARGX) announced that FDA has accepted for review the biologics license application for intravenous efgartigimod, the company's investigational FcRn antagonist and lead product candidate, for the treatment of generalized myasthenia gravis. The FDA has set a standard 10-month review process with a PDUFA target action date of Dec. 17, 2021.

Related Link: The Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings

NanoViricides' Coronavirus Drug Candidates Found Effective In Preclinical Lab Studies

NanoViricides, Inc. (NASDAQ: NNVC) reported on the strong pan-coronavirus effectiveness of its two COVID-19 clinical drug candidates for which the company is preparing a pre-IND application.

NV-CoV-2 is the company's broad-spectrum, anti-coronavirus clinical lead drug candidate for the treatment of COVID-19 patients based on its nanoviricides platform.

In addition, the company is also developing NV-CoV-2-R, a drug treatment that combines both NV-CoV-2 and remdesivir in a single drug that encapsulates and protects remdesivir inside NV-CoV-2.

Both NV-CoV-2 and NV-CoV-2-R are expected to work against most, if not all, coronaviruses and their variants, the company said.

The stock was jumping 108.06% to $8.78 in premarket trading Tuesday.

Cerecor Reports Positive Midstage Results For CERC-002 In COVID-19

Cerecor Inc. (NASDAQ: CERC) announced final efficacy data including 60-day mortality from its recently completed U.S.-based, Phase 2 trial of the human anti-LIGHT monoclonal antibody CERC-002, showing the investigational asset achieved the primary endpoint of achieving statistical significance in reducing respiratory failure and mortality at day 28 in patients hospitalized with COVID-19-associated pneumonia and mild to moderate acute respiratory distress syndrome.

The company noted that efficacy was highest in patients over the age of 60, the population most vulnerable to severe complications and death with COVID-19 infection.

Cerecor said it has applied for FDA breakthrough therapy and fast track designations, and plans to meet with FDA to discuss a potential path to emergency use authorization.

The stock was up 12.87% to $4.21 in premarket trading Tuesday.

Earnings

Novavax, Inc. (NASDAQ: NVAX) reported fourth-quarter revenues of $279.7 million in 2020 compared with $8.8 million in 2019, with much of the increase due to revenue for services performed under the CEPI agreement and participation on OWS. The net loss per share widened from $1.13 to $2.70. The results trailed expectations.

In an interview with CNBC, Novavax CEO Stanley Erck said he expects FDA to authorize the company's coronavirus vaccine candidate as early as May if it decides to base its decision on the results of the U.K. late-stage study.

If the FDA opts to wait for results from the ongoing trial in the U.S., the decision could be pushed back by one or two months.

View more earnings on IBB

The stock was down 4.53% premarket at $229.40.

Inovio Pharmaceuticals Inc (NASDAQ: INO) reported better-than-expected fourth-quarter results. The company also said enrollment in the 400-member strong Phase 2 segment of a Phase 2/3 study is complete.

The company indicated that it is evaluating pan-COVID-19 vaccine candidates that could be tailored to known and potentially unknown SARS-CoV-2 variants.

Separately, the company reported mixed results for a pivotal REVEAL 1 Phase 3 study of VGX-3100 in treating high-grade precancerous cervical dysplasia caused by HPV-16 and/or HV-18.

The stock moved down 5.09% to $11.01 in after-hours trading.

Regenxbio Inc's (NASDAQ: RGNX) fourth-quarter revenues climbed from $11.8 million in 2019 to $21.4 million in 2020. The loss per share widened from 72 cents to $1.24, while analysts expected a loss of 43 cents per share.

In after-hours trading, the stock slipped 7.06% to $39.51.

Xenon Pharmaceuticals Inc (NASDAQ: XENE) reported a 371% year-over-year increase in full-year revenues and a narrower loss per share.

The stock rallied 6.03% to $19 in after-hours trading.

Offerings

RedHill Biopharma Ltd. (NASDAQ: RDHL) announced that it has entered into an underwriting agreement with H.C. Wainwright & Co., under which the underwriter has agreed to purchase on a firm commitment basis 1.25 million ADSs at a price to the public of $8 per ADS. The closing of the offering is expected to occur on or about March 4, subject to satisfaction of customary closing conditions.

The stock fell 11.16% to $8.20 in after-hours trading.

Morphic announced a proposed underwritten public offering in which it intends to offer and sell $200 million of shares of its common stock. All of the shares of common stock are being offered by Morphic.

The stock pulled back 5.83% to $79.89 in after-hours trading.

Haemonetics Corporation (NASDAQ: HAE) announced its intention to offer, subject to market and other conditions, a $425 million aggregate principal amount of convertible senior notes due 2026 in a private offering to qualified institutional buyers.

In after-hours trading, the stock retreated 4.05% to $124.16.

Aslan announced that it has commenced an underwritten public offering of $60 million of its ADSs, representing ordinary shares. All ADSs to be sold in the offering will be offered by Aslan.

The stock moved down 3.05% to $5.09 in after-hours trading.

Karuna Therapeutics, Inc. (NASDAQ: KRTX) priced its underwritten public offering of 2.083 million shares of its common stock at a price of $120 per share, for raising gross proceeds of about $250 million. The offering is expected to close on or about March 4, subject to customary closing conditions. All the shares in the proposed offering are to be sold by Karuna.

On The Radar PDUFA Dates

The Food and Drug Administration is scheduled to issue its verdict on KemPharm Inc's (NASDAQ: KMPH) NDA for KP415, its product candidate for the treatment of attention deficit hyperactivity disorder. It contains serdexmethylphenidate, KemPharm's prodrug of d-methylphenidate.

KemPharm is collaborating with Aquestive Therapeutics Inc (NASDAQ: AQST) for an oral film dosage of KP415.

Clinical Readouts

At the ESMO Targeted Anticancer Therapies Virtual Conference 2021, Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) will present safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer. The presentation is scheduled at 11:25 am.

Earnings

• Antares Pharma Inc (NASDAQ: ATRS) (before the market open)

• Eagle Pharmaceuticals Inc (NASDAQ: EGR) (before the market open)

• GlycoMimetics Inc (NASDAQ: GLYC) (before the market open)

• Seres Therapeutics Inc (NASDAQ: MCRB) (before the market open)

• TherapeuticsMD Inc (NASDAQ: TXMD) (before the market open)

• Rigel Pharmaceuticals, Inc. (NASDAQ: RIGL) (after the close)

• Neuronetics Inc (NASDAQ: STIM) (after the close)

IPO Filings

Achilles Therapeutics plc, a clinical-stage biopharmaceutical company developing precision T cell therapies to treat solid tumors, announced it has filed a registration statement on Form F-1 with the SEC, relating to a proposed initial public offering in the U.S., its ADSs, each representing one ordinary share of the company. All ADSs to be sold in the proposed IPO will be offered by Achilles. The number of ADSs to be sold and the pricing terms for the proposed IPO have not yet been determined.

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

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