The Daily Biotech Pulse: Amarin Reports Strong Q1 Vascepa Sales, BeiGene Aces Late-Stage Lung Cancer Study, Glaxo, Sanofi Strike COVID-19 Vaccine Partnership

The following is a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs April 13.)

• Chembio Diagnostics Inc CEMI
• Cytosorbents Corp CTSO (rallied on FDA emergency use authorization for its blood purification system for COVID-19 patients)
• Dr.Reddy's Laboratories Ltd RDY
• Kala Pharmaceuticals Inc KALA
• Keros Therapeutics Inc KROS (IPOed April 8)
• Neubase Therapeutics Inc NBSE
• Pluristem Therapeutics Inc. PSTI (announced treatment of first COVID-19 patient with Plx cells in the U.S.)
• Regeneron Pharmaceuticals Inc REGN
• SUMMIT THERAPEU/S ADR SMMT

Down In The Dumps

(Biotech stocks that hit 52-week lows on April 13.)

• Biofrontera AG BFRA

Stocks In Focus

Amarin Pre-Announces Q1 Revenue Beat

Amarin Corporation plc AMRN said in an 8-K filing that it expects net revenue for the March quarter to be about $150 million, reflecting Vascepa fish oil pill sales in the U.S. Analysts currently estimate revenues of $130.33 million. As of March 31, the company had cash and cash equivalents and short-term investments of more than $620 million.

The stock, which suffered a severe setback in late March in the wake of a negative court ruling, was trading more than 4% higher to $6.65 in Tuesday's premarket session.  

BeiGene Reports Positive Late-Stage Data For Anti-PD-1 Antibody In Lung Cancer

BeiGene Ltd BGNE announced positive results for the Phase 3 study that is evaluating its anti-PD-1 antibody tislelizumab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of patients with non-squamous non-small cell lung cancer.

The combo therapy showed a statistically significant improvement in progression-free survival compared to pemetrexed and platinum chemotherapy alone at the planned interim analysis, suggesting the study met the primary endpoint. The safety profile of the triple combination was consistent with the known risks of each study treatment, with no new safety signals identified.

BeiGene said it plans to submit a sNDA to the Chinese drug regulatory agency and present detailed data at upcoming medical conferences.

Sanofi, Glaxo Partner On COVID-19 Vaccine Development

Sanofi SA SNY and GlaxoSmithKline plc GSK said they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19 using innovative technology from both companies.

In premarket trading Tuesday, Sanofi shares were rising 3.06% to $45.74 and GlaxoSmithKline shares were gaining 2.34% to $39.85.

See also: The Week Ahead In Biotech: Urogen FDA Decision, Amarin, J&J Earnings And More COVID-19 Updates

Madrigal Says Late-Stage NASH, NAFLD Studies Progress Without Disruptions

Madrigal Pharmaceuticals Inc MDGL said both its Phase 3 MAESTRO-NASH and MAESTRO-NAFLD-1 studies are continuing without changes to protocol. The studies are well-established and are proceeding without modification, the company said.

At a recently conducted Data Monitoring Committee meeting, it was recommended the studies proceed without modification, according to Madrigal. 

Madrigal also said that new data showed liver fat reductions achieved by resmetirom predict NASH resolution and fibrosis reduction.

Genmab Reports Strong Sales Of Out-Licensed Drug

GENMAB A/S/S ADR GMAB said worldwide sales of Darzalex totaled $937 million in the first quarter, with the company due to receive royalties on worldwide net sales under a licensing agreement with Johnson & Johnson JNJ.

In premarket trading Tuesday, Genmanb shares were edging 1% higher to $22.22.

Announcements Related To COVID-19 Impact

Inspire Medical Systems Inc INSP said it has priced an underwritten public offering of 2 million shares at $58 per share. All the shares are being offered by the company. The offering is expected to close April 16.

Separately, the company announced preliminary first-quarter revenue of $21.3 million, below the $22.52-million consensus estimate. The company also withdrew its 2020 guidance.

The stock was sliding by 2.59% to $61.75 in Tuesday's premarket session. 

Intersect ENT Inc XENT announced preliminary first-quarter revenue of $19.5 million to $19.8 million, below the $25.69-million consensus estimate. Cash and marketable securities at the end of March 31, 2020 are likely to be at $87 million to $88 million.

The company also withdrew its 2020 guidance, citing COVID-19 impact.

The stock slipped 14.97% to $10 in after-hours trading.

LeMaitre Vascular Inc LMAT announced preliminary first-quarter results, expecting revenue of $30.4 million to $30.6 million and earnings per share of 15-16 cents. Analysts estimate EPS of 17 cents on revenue of $30.46 million.

Citing the pandemic that began to impact sales in the second half of March, the company withdrew its guidance.

ENDRA Life Sciences Inc NDRA said it is enacting a 33% cash salary reduction for its management team for the remainder of 2020. The company is paying restricted stock units to the extent the salaries are being cut. The company also said it would pay annual retainers for its non-employee directors for the remainder of the year in restricted stock units instead of cash.

The stock edged down 0.26% to 74 cents in after-hours trading.

On The Radar

Earnings

Johnson & Johnson posted first-quarter sales of $20.69 billion vs. the consensus estimate of $19.48 billion and non-GAAP EPS of $2.30 against a consensus estimate of $1.99. J&J lowered its full-year sales and adjusted EPS guidance and hiked its dividend by 6.3% to $1.01 per share. 

Related Link: Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use