The Daily Biotech Pulse: Roxadustat Delay For FibroGen, AstraZeneca, Decision Day For KemPharm, NanoViricides Jumps On COVID-19 Drug Data

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

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs March 1)

• Acceleron Pharma Inc. XLRN
• Aerie Pharmaceuticals, Inc. AERI
• Aslan Pharmaceuticals Ltd ASLN (announced positive results for atopic dermatitis study)
• AtriCure, Inc. ATRC
• Bioanalytical Systems, Inc. BASI
• Cullinan Oncology, Inc. CGEM
• Dicerna Pharmaceuticals Inc DRNA
• Gemini Therapeutics, Inc. GMTX
• Glaukos Corp GKOS
• I-Mab IMAB
• Inspire Medical Systems Inc INSP
• Krystal Biotech, Inc. KRYS (reacted to fourth-quarter results)
• Landos Biopharma, Inc. LABP
• Morphic Holding, Inc. MORF (announced positive early stage data for irritable bowel syndrome drug)
• Organogenesis Holdings Inc ORGO
• Pandion Therapeutics Inc PAND
• PLx Pharma Inc. PLXP (announced label expansions for lead products Vazalore 325 mg and Vazalore 81 mg)
• Processa Pharmaceuticals, Inc. PCSA
• Terns Pharmaceuticals, Inc. TERN
• Theratechnologies Inc. THTX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 1)

• Athenex Inc ATNX (announced FDA rejection for its application for oral paclitaxel combo for breast cancer)
• Intercept Pharmaceuticals Inc ICPT
• Karyopharm Therapeutics Inc KPTI
• Lucira Health Inc LHDX
• Nabriva Therapeutics PLC – ADR NBRV

Stocks In Focus

Merck Withdraws Keytruda For Metastatic Small-Cell Lung Cancer In US

Merck & Co., Inc. MRK said it is voluntarily withdrawing the U.S. indication for Keytruda for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The withdrawal of this indication was done in consultation with the FDA, it added.

Merck is working to complete this process over the coming weeks. This decision does not affect other indications for the company's anti-PD-1 therapy, it said.

Merck received accelerated approval for Keytruda for small-cell lung cancer in 2019. However, the confirmatory trial, dubbed KEYNOTE-604, did not reach statistical significance for one of the two primary endpoints of overall survival.

The stock edged down 0.11% to $72.30 in after-hours trading.

FibroGen-AstraZeneca's Roxadustat Review Delayed As FDA Schedules Adcom Meeting

FibroGen Inc FGEN and AstraZeneca plc AZN announced FDA's Cardiovascular and Renal Drugs Advisory Committee will hold an advisory committee meeting to review the new drug application for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.

"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 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. 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. 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. 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.

The stock was down 4.53% premarket at $229.40.

Inovio Pharmaceuticals Inc 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 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 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. 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 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. 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 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 AQST for an oral film dosage of KP415.

Clinical Readouts

At the ESMO Targeted Anticancer Therapies Virtual Conference 2021, Spectrum Pharmaceuticals, Inc. 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 ATRS (before the market open)
• Eagle Pharmaceuticals Inc EGR (before the market open)
• GlycoMimetics Inc GLYC (before the market open)
• Seres Therapeutics Inc MCRB (before the market open)
• TherapeuticsMD Inc TXMD (before the market open)
• Rigel Pharmaceuticals, Inc. RIGL (after the close)
• Neuronetics Inc 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