The Daily Biotech Pulse: Moderna Secures $483M In BARDA Funding, Gilead Remdesivir Data, Veracyte's Positive Pre-Announcement

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 16.)

• Abbott Laboratories ABT (reacted to first-quarter results and an announcement concerning development of a third rapid COVID-19 screening test)
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• Chembio Diagnostics Inc CEMI
• DexCom, Inc. DXCM
• Dr.Reddy's Laboratories Ltd RDY
• Eli Lilly And Co LLY
• Immunovant Inc IMVT
• Masimo Corporation MASI
• Moderna Inc MRNA
• Novavax, Inc. NVAX (its Australian developmental partner said COVID-19 vaccine human testing will begin in the coming weeks)
• OraSure Technologies, Inc. OSUR
• Pulmatrix Inc PULM (granted Sensory Cloud license to its PUR 003 and PUR 006)
• Regeneron Pharmaceuticals Inc REGN (announced FDA acceptance of BLA for REGN-EB3, a triple antibody cocktail treatment for Ebola virus infection, with Priority Review designation)
• Seattle Genetics, Inc. SGEN
• Thermogenesis Holdings Inc THMO (announced FDA concurrence that its COVID-19 antibody blood test has been properly validated and can now be distributed)

Down In The Dumps

(Biotech stocks that hit 52-week lows April 16)

• AxoGen, Inc Common Stock AXGN
• Celcuity Inc CELC

Stocks In Focus

Moderna Obtains $483M In BARDA Funding For COVID-19 Vaccine Research

Moderna said the Biomedical Advanced Research and Development Authority, or BARDA, has committed up to $483 million in funding to accelerate the development of its mRNA vaccine against the novel coronavirus — SARS-CoV-19. The agreement provides for BARDA releasing funds to get the candidate to the point of FDA licensing. 

Moderna also provided the likely timeline for the initiation of Phase 2 and 3 studies, with the midstage study to start in the second quarter and the late-stage study in fall 2020.

The stock rallied 18.62% to $48.16 in Friday's premarket session. 

Gilead's Remdesivir Reportedly Found Effective In Phase 3 US Trials

Gilead Sciences, Inc. GILD's remdesivir, which is being evaluated in clinical trials as a treatment option for SARS-CoV-2, was found to be effective, resulting in rapid recoveries in fever and respiratory symptoms, STAT reported, citing results from two Phase 3 clinical trials run by the University of Chicago Medicine.

The institution's infectious disease specialist Kathleen Mullane, who is overseeing the studies in which 125 people were enrolled, reportedly said in a video discussion with her colleagues that most of the patients have already been discharged, with only two deaths occurring, STAT said.

The stock was jumping 11.98% to $85.71 in premarket trading. 

Roche To Launch New Serology Test For SARS-CoV-2 Antibodies In May

Roche Holdings AG Basel ADR Common Stock RHHBY announced the development and upcoming launch of its Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people who have been exposed to the virus.

"Antibody testing is central to help identify people who have been infected by the virus, especially those who may have been infected but did not display symptoms," the company said in the release.

The company said it aims to have the antibody test available by early May in countries accepting the CE mark and is actively working with the FDA for an emergency use authorization. 

Benzinga is covering every angle of how the coronavirus affects the financial world. For daily updates, sign up for our coronavirus newsletter.

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

Veracyte Expects Q1 Revenue Above Consensus

Veracyte Inc VCYT preannounced first-quarter results and said it expects revenue of $30.5 million to $31.5 million, up from $29.5 million in the year-ago quarter. Analysts estimate revenue of $30.35 million.

The company also announced several measures to reduce costs amid the COVID-19 pandemic and withdrew its 2020 guidance.

Chi-Med Neuroendocrine Tumor Drug Gets Fast Track Designations For 2 Indications

HUTCHISON CHINA/S ADR HCM said the FDA granted two Fast Track Designations for the development of surufatinib in the treatment of both advanced and progressive pancreatic neuroendocrine tumors and extra-pancreatic NETs in patients who are not candidates for surgery.

Biofrontera Expects 5% Drop in Q1 Revenue Due to COVID-19 Impact

Biofrontera AG BFRA said its first-quarter revenue is likely to come in at 6.4 million euros to 6.6 million euros ($6.9 to $7.1 million), down about 5% from the year-ago period, as sales declines in U.S. more than offset growth in Europe.

Offerings

Pulmatrix said it has entered into definitive agreements with several institutional and accredited investors for the purchase and sale of 4.79 million shares of its common stock at $1.671 per share in a registered direct offering priced at-the-market. The company also said it has agreed to issue to the investors unregistered warrants to purchase up to an aggregate of 4.79 million shares. Gross proceeds from the offering are expected to be about $8 million.

The stock was down 25.99% to $1.31 in the premarket session. 

Cutera, Inc. CUTR said it has pricing an underwritten public offering of 2.385 million shares of its common stock at $10.50 per share to raise gross proceeds of $25 million. The offering is expected to close on or about April 21.

The stock dipped was down 13.25% at $11.65 in the premarket session.

Related Link:

Gilead Analysts Break Down Remdesivir Data Readout From Compassionate Use