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The Daily Biotech Pulse: Novartis Scraps Deal To Sell Sandoz Assets, Nevro Pre-Announces Q1 Shortfall, Affimed Granted Orphan Drug Designation

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The Daily Biotech Pulse: Novartis Scraps Deal To Sell Sandoz Assets, Nevro Pre-Announces Q1 Shortfall, Affimed Granted Orphan Drug Designation

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

On a day when the three major averages shed over 4% in reaction to bleak forecasts concerning the COVID-19 pandemic's impact, none of the Nasdaq- or NYSE-listed biotech stocks hit 52-week highs or lows.

Stocks In Focus

InVitae Withdraws FY20 Guidance Due To Pandemic, Plans Offering 

InVitae Corp (NYSE: NVTA), a medical genetics company, pre-announced first-quarter results and said it expects revenue of more than $63 million, up 55% year-over-year, billable tests of 147,000, up 65%, and non-GAAP cash burn of less than $100 million. Analysts expect revenue of $60.3 million.

Citing the unknown duration and extent of COVID-19's impact on its business and the health care system in general, the company said it is withdrawing its guidance for 2020.

Separately, the company announced an underwritten public offering of 17.78 million shares priced at $9 per share. All the shares are being sold by the company. The company expects the offering to close April 6 and to raise gross proceeds of about $16 million.

The stock was down 11.96% at $10.31 in Thursday's premarket session. 

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Novartis Terminates Agreement To Sell Sandoz US Assets To Aurobindo

Novartis AG (NYSE: NVS) said it has mutually agreed with Aurobindo Pharma to terminate a previously announced deal to sell the Sandoz U.S. generic oral solids and dermatology businesses to Aurobindo. The decision follows a lack of FTC approval for the transaction within anticipated timelines.

Novartis shares were adding 1.57% to $82.20 in premarket trading Thursday.

Nevro Forecasts Q1 Revenue Shortfall, Withdraws 2020 Guidance

Nevro Corp (NYSE: NVRO) announced preliminary unaudited worldwide revenue for the first quarter of $86.4 million to $86.9 million, up from $82.1 million a year ago. This compares to the $94.96-million consensus estimate. The company attributed the potential shortfall to a rapid deceleration in March due to COVID-19 shelter-in-place policies and restrictions on elective surgical procedures.

The company also withdrew its 2020 guidance issued in late February due to the rapidly evolving environment and continued uncertainties related to COVID-19.

Separately, the company announced a public offering of 1.625 million shares of common stock and $165 million in aggregate principal amount of convertible senior notes due 2025.

The stock fell 3.86% to $86 in after-hours trading.

OpGen Closes On Curetis Purchase 

OpGen Inc (NASDAQ: OPGN) announced the consummation of its proposed acquisition of Dutch molecular diagnostics company Curetis N.V. OpGen shares paid as consideration for the sale will be distributed to Curetis, which will be dissolved and delisted from the Euronext exchange.

OpGen shares were trading 5.44% higher at $2.52 in Thursday's premarket session. 

See also: The Week Ahead In Biotech: Clinical Readouts, COVID-19 News Flow In Focus Amid Continuing Uncertainty

Eiger's HDV Study To Be Delayed, Company To Support Studies Of Peginterferon Lambda In COVID-19

Issuing an update on clinical development activity and business operations, Eiger Biopharmaceuticals Inc (NASDAQ: EIGR) said it has taken appropriate steps to ensure the safety of patients and integrity of the HDV Phase 3 D-LIVR trial. The trial is evaluating lonafarnib and ritonavir with or without PEGylated interferon-alfa-2a in patients with chronic hepatitis D virus infection.

It now expects the COVID-19 pandemic to lead to the shifting of the completion of enrollment in the study to 2021.

The company also said it has begun supporting multiple investigator-sponsored studies of peginterferon lambda in COVID-19.

"These studies will assess a 180 mcg, once-weekly, subcutaneous dose of Lambda, and will enroll at academic centers across the U.S., as well as international sites," the company said.

The shares advanced 6.27% to $6.27 in after-hours trading.

Affimed's Lead Drug Gets Orphan Drug Designation In T-Cell Lymphoma

Affimed NV (NASDAQ: AFMD) said the FDA has granted orphan drug designation to AFM13, its lead CD30- and CD16A-binding innate cell engager, for the treatment of patients with T-cell lymphoma.

Affimed shares were up 6.92% to $1.70 in the premarket session. 

BioCryst Names Anthony Doyle As CFO

BioCryst Pharmaceuticals, Inc. (NASDAQ: BCRX) announced the appointment of Anthony Doyle as CFO. Doyle previously served as a global contract research organization's CFO.

In premarket trading Thursday, BioCryst shares were adding 0.26% to $1.90.

Boston Scientific Lowers Q1 Revenue Guidance Due To COVID-19 Impact

Boston Scientific Corporation (NYSE: BSX) lowered its first-quarter revenue growth guidance to flat to slightly up from its previous estimate for 10-12% growth. The company attributed the predicament to a significant decline in procedural volumes in March due to COVID-19 impact.

Humanigen's Lenzilumab Gets FDA Nod For Compassionate Use In COVID-19 Patients

Humanigen Inc (OTC: HGEN) said the FDA approved the administration of its lenzilumab for COVID-19 patients under individual patient emergency IND applications to patients under its compassionate use program.

The company said it is advancing plans to conduct a multi-center, Phase 3 study of lenzilumab for the prevention of acute respiratory distress syndrome, ARDS and/or death in hospitalized patients with pneumonia associated with coronavirus 2 infection.

Applied Therapeutics Opens IND With FDA For AT-001 To Treat COVID-19-Related Lung Inflammation, Cardiomyopathy

Applied Therapeutics Inc (NASDAQ: APLT) said it has opened an INDA with the FDA for AT-001 to treat acute lung inflammation and cardiomyopathy in critical COVID-19 patients. The company noted that multiple AT-001 investigator-initiated trials are now underway to address these two issues.

Vir, Alnylam Expand Existing Collaboration To Include Additional Targets In COVID-19 Treatment

Vir Biotechnology Inc (NASDAQ: VIR) and Alnylam Pharmaceuticals, Inc. (NASDAQ: ALNY) announced an expansion of their existing collaboration for RNAi therapeutics for infectious diseases. The expansion includes up to three additional targets focused on host factors for SARS-CoV-2, including ACE2 and TMPRSS2, both of which are considered critical for viral entry.

Vir shares were gaining 2.45% to $30.50 in premarket trading Thursday.

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

 

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