The Daily Biotech Pulse: FDA Nod For Pfizer, Vanda Forges Partnership For COVID-19 Drug Research, Neuronetics Pre-Announces Revenue Shortfall

Here's 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 8)

• Keros Therapeutics Inc KROS (went public Wednesday and traded 25.5% higher to $20.08, up from the IPO price of $16)

None of the NYSE- or Nasdaq-listed stocks hit 52-week lows Wednesday.

Stocks In Focus

Mesoblast To Evaluate Investigational Stem Cell Therapy For COVID-19 Respiratory Distress

Australian biopharma Mesoblast limited MESO said it will evaluate its allogenic mesenchymal stem cell product candidate remestemcel-L in a randomized, placebo-controlled Phase 2/3 trial in 240 patients with acute respiratory distress syndrome caused by coronavirus infection.

The trial will be conducted as a public-private partnership in collaboration with the Cardiothoracic Trials Network established by the U.S. NIH's National Heart, Lung and Blood Institute.

The company has an IND application for the therapy from the FDA for use in the treatment of patients with COVID-19 ARDS.

The stock was trading 32.34% higher at $7.57 in Thursday's premarket session. 

Pfizer's Combo Therapy For Colorectal Cancer Gets FDA Nod

Pfizer Inc. PFE announced FDA approval for Braftovi in combination with cetuximab for the treatment of adults with metastatic colorectal cancer with BRAFV600E mutation. The company noted that the approval was given based on results from the BEACON CRC trial.

Pfizer shares were up 0.43% at $34.75 in the premarket session. 

Tiziana Develops Delivery Technology For Drug to Treat COVID-19

TIZIANA LF SCIE/S ADR TLSA said it has developed an investigational new technology to treat COVID-19 infections that consists of direct delivery of anti-IL-6 receptor monoclonal antibodies into the lungs using a handheld inhaler or nebulizer.

The development of the technology is a step toward expediting development of TZLS-501, a fully human anti-interleukin-6 receptor monoclonal antibody for treatment of patients infected with the coronavirus, according to Tiziana. The company said it has submitted a provisional patent application for the delivery technology. 

The stock was rallying by 79.72% to $3.90 in Thursday's premarket session. 

Vanda Ties Up With the University of Illinois For COVID-19 Drug

Vanda Pharmaceuticals Inc. VNDA announced a research partnership with the University of Illinois at Chicago for the investigation of small molecules for treating COVID-19.

The company said the collaboration will also cover the use of high-throughput screening assay to identify small molecules that may prevent cathepsin-L cleavage of SARS-CoV-2 glycoproteins that are required for viral processing in the host cell.

Vanda shares were up 2.75% at $11.20 at the time of publication.

Milestone Scientific Plans Common Stock, Warrant Offering

Milestone Scientific Inc. MLSS said it intends to sell shares of its common stock and warrants to purchase shares in an underwritten public offering. The company said it plans to use the net proceeds for the manufacturing, marketing and distribution of its CompluFl Epidural System and development of new products and new product uses, working capital and general corporate purposes.

The stock was slipping by 8.6% to 85 cents in the premarket session. 

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Announcements On COVID-Related Impacts

Neuronetics Inc STIM announced preliminary first-quarter revenue of $11.8 million to $12 million, below the $13.77-million consensus estimate. The company also announced withdrawal of its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.

The company also announced restructuring actions, including a reduction in discretionary expenses and head count. Consequently, the company lowered its operating expenses guidance for 2020.

The stock lost 1.69% to $1.74 in after-hours trading.

Anika Therapeutics Inc ANIK announced initiatives to strengthen its liquidity in light of the COVID-19 pandemic. As part of the initiatives, the company said it is drawing down $50 million from its existing credit facility. Following the drawdown, the company said it will have total liquidity of about $140 million.

The company said it is also exploring other sources of funding aimed at further supporting its liquidity profile, as well as maintaining business and organizational continuity.

The stock fell 2.52% to $30.13 in after-hours trading.

Organogenesis Holdings Inc ORGO announced preliminary first-quarter results, expecting net revenue of $61 million to $61.6 million, ahead of the $60.62-million consensus estimate. The company also withdrew its 2020 guidance.

The stock rose 0.93% to $3.25 in after-hours trading.

CareDx Inc CDNA announced preliminary first-quarter revenue of $38.3 million, up 47% year-over-year and ahead of the $37.76-million consensus estimate. The company also withdrew its guidance for 2020.

On The Radar

Earnings

• PAVmed Inc PAVM (after the close)
• Related Link: Co-Diagnostics COVID-19 Test Gets FDA Emergency Use Authorization