The Daily Biotech Pulse: Fulgent Nabs CDC Contract, Enzo Rallies, Solid Biosciences Releases Gene Therapy Data, Moderna Begins Pediatric Vaccine Study

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 15)

• Aclaris Therapeutics, Inc. ACRS
• Aerie Pharmaceuticals, Inc. AERI
• Amneal Pharmaceuticals, Inc. AMRX
• AngioDynamics, Inc. ANGO
• Axonics Modulation Technologies, Inc. AXNX
• BioCryst Pharmaceuticals, Inc. BCRX
• Champions Oncology, Inc. CSBR
• Elanco Animal Health Incorporated ELAN
• Gemini Therapeutics, Inc. GMTX
• GenMark Diagnostics, Inc. GNMK - announced a deal to be bought by Roche Holding AG RHHBY for $1.8 billion
• Harvard Bioscience, Inc. HBIO
• IDEAYA Biosciences, Inc. IDYA
• Omnicell, Inc. OMCL
• Oncternal Therapeutics, Inc. ONCT
• Organogenesis Holdings Inc. ORGO
• Prometheus Biosciences, Inc. RXDX (went public Friday)
• Renalytix AI plc RNLX
• Rubius Therapeutics, Inc. RUBY (announced positive initial Phase 1/2 data for investigational drug in advanced solid tumors)
• Silverback Therapeutics, Inc. SBTX (announced appointment of biopharma industry veteran Maria Koehler to its board)
• Sol-Gel Technologies Ltd. SLGL
• Sotera Health Company SHC
• Vincerx Pharma, Inc. VINC

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 15)

• Galecto, Inc. GLTO (an independent Data Safety Monitoring Board recommended discontinuation of certain arms of a Phase 2b trial of GB0139 for the treatment of idiopathic pulmonary fibrosis)

Stocks In Focus

Fulgent Genetics Awarded CDC Contract For Genomic Sequencing Of COVID-19 Samples

Fulgent Genetics, Inc. FLGT said the U.S. Centers for Disease Control and Prevention has awarded it a contract to provide genomic sequencing of samples of SARS-CoV-2 on an ongoing basis, leveraging its next-gen sequencing capabilities.

Under the agreement, Fulgent Genetics will sequence the genomes of random samples that have tested positive for SARS-CoV-2, the virus that causes COVID-19.

Fulgent will leverage its NGS platform and provide sequencing data to the CDC as part of the agency's initiative to conduct a large-scale genomic survey of the virus using random samples from across the U.S.

Ultimately, the CDC believes this large-scale genomic survey of the virus can provide important baseline information for national and state-level virus surveillance, Fulgent said.

The stock was up 6.67% premarket at $111.22. 

Solid Biosciences Issues Update On Phase 1/2 Gene Therapy Study In Duchenne Muscular Dystrophy

Solid Biosciences Inc. SLDB announced interim functional and biomarker data, and patient reported outcome measures from six patients treated with its lead gene therapy candidate SGT-001 in a Phase 1/2 Duchenne muscular dystrophy study. The six patients showed no drug-related safety findings 17-37 months after dosing.

The seventh patient, who was the first to be dosed in the trial under a previously reported clinical protocol amendment and using SGT-001 manufactured using the company's second-generation process, was also safely dosed, with transient and manageable adverse events.

The study was placed on clinical hold in November 2019, with the hold lifted in October 2020.

"The totality of data collected, and the re-initiation of dosing, support the continued enrollment of patients into the IGNITE DMD study," the company said.

In after-hours trading, the stock was down 0.79% to $28.89. 

Anchiano Gets Shareholder Nod For Merger With Chemomab

Anchiano Therapeutics Ltd. ANCN said its shareholders voted to approve a merger with Chemomab and the issuance of Anchiano shares in connection with the pending merger. Shareholders also approved a reverse split of Anchiano's common shares.

The stock soared 27.96% premarket to $5.72. 

Enzo Announces CEO Departure, Evaluation of Strategic Alternatives

Enzo Biochem, Inc. ENZ announced that its founder and CEO Elazar Rabbani has decision to step down and transition to a scientific role once a replacement is hired.

The company also said it has appointed former Laboratory Corporation of America Holdings LH CEO Gary Hugg as strategic consultant to board.

Enzo said it has retained Cain Brothers to assist with strategic initiatives to identify, evaluate and execute strategic and commercial opportunities.

Additionally, the company announced second-quarter results, showing a 62% year-over-year increase in revenue to $31.5 million and a profit of 5 cents per share as opposed to the loss of 16 cents per share it reported a year ago.

The stock was 28.72% higher premarket at $3.81.

Moderna Begins Testing COVID-19 Vaccine In Pediatric Population

Moderna Inc. MRNA said the first participants have been dosed in the Phase 2/3 KidCOVE study of mRNA-1273, its vaccine candidate against COVID-19, in children ages 6 months to less than 12 years. The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases.

The stock was up 2.51% to $147.27 in premarket trading Tuesday.

Related Link: The Week Ahead In Biotech (March 14-20): Update On Fibrogen-AstraZeneca's Anemia Drug, Earnings and Presentations

AC Immune To Advance Down Syndrome Vaccine Candidate To Phase 2 Study

AC Immune SA ACIU said it plans to advance its novel anti-amyloid-beta vaccine into midstage clinical testing to treat and prevent the progression of Down syndrome-related Alzheimer's disease. Topline results showed that ACI-24 demonstrated encouraging immunogenicity and safety in Phase 1b clinical testing in people with DS.

The stock was moving 7.55% higher at $8.69 in premarket trading Tuesday.

Can-Fite Signs Out-Licensing Deal With Ewopharma For Distribution Of Psoriasis, Liver Disease Drugs In Europe

Can-Fite BioPharma Ltd. CANF said it has signed an exclusive distribution agreement with Switzerland-based Ewopharma for piclidenoson in the treatment of psoriasis and namodenoson in the treatment of liver diseases.

Under the terms of the distribution agreement, Ewopharma will pay Can-Fite $2.25 million upfront with up to an additional $40.45 million payable upon the achievement of regulatory and sales milestones plus 17.5% royalties on net sales.

In exchange, Ewopharma will have the exclusive right to market and sell piclidenoson in central Eastern European countries and Namodenoson in CEE countries and Switzerland.

Can-Fite shares were jumping 74.02% to $3.55 in premarket trading Tuesday.

J&J Unit Announces Positive Long-Term Data For Psoriatic Arthritis Drug

Johnson & Johnson's JNJ Janssen unit announced positive long-term data from the Phase 3 study showing that the skin clearance, joint symptom relief and safety of Tremfya previously demonstrated through 24 weeks and one year in adults with active psoriatic arthritis continued through two years.

Roche Launches COVID-19 Test To Detect Coronavirus Variants

Roche announced the launch of the Cobas SARS-CoV-2 Variant Set 1 Test to detect and differentiate mutations found in variants that originated in the U.K., South Africa and Brazil.

This research use-only laboratory test can be used to help scientists track mutation prevalence and to assess any potential impact on diagnostics, vaccines and therapeutics, providing crucial insight for health care systems in making appropriate measures to combat COVID-19, the company said.

Savara Gains On Insider Buying

Savara Inc. SVRA shares moved higher after a trio of filings revealed that the company's CFO David Lowrance and directors David Ramsay and Joseph MacCracken purchased a cumulative 157,723 shares at a price of $1.45 per share.

The stock was up 21.53% premarket at $2.15.

Inspire Gets FDA Nod For Improved Surgical Procedure

Inspire Medical Systems, Inc. INSP announced the FDA approved an improved surgical implant procedure that eliminates one incision with a revised placement of the pressure-sensing lead. This newly approved procedure will reduce the average procedure time for Inspire therapy by approximately 20%, the company said.

The stock rose 3.02% to $224.75 in after-hours trading.

Earnings

AcelRx Pharmaceuticals, Inc. ACRX reported a loss of 10 cents per share for the fourth quarter of 2020, narrower than the year-ago loss of 18 cents per share and in line with the consensus estimate.

In after-hours trading, the stock lost 5.96% to $2.05.

Predictive Oncology POAI said its full-year 2020 revenue fell from $1.41 million in 2019 to $1.25 million in 2020. The loss per share narrowed from $6.86 to $2.21.

The stock was down 6.42% premarket at $2.04. 

Offerings

Rubius Therapeutics, Inc. RUBY announced it has commenced an underwritten public offering of $150 million in common stock. All the shares in the offering are to be sold by Rubius.

The stock was down 3.24% premarket at $29.31.

Biohaven Pharmaceutical Holding Company Ltd. BHVN said it has priced its underwritten public offering of 2.686 million shares of its common stock at $76 per share. The gross proceeds from the offering are expected to be approximately $200 million. The offering is expected to close on March 17, subject to satisfaction of customary closing conditions.

In premarket trading, the stock was down 6.45% to $76.25. 

Sotera Health announced the launch of a secondary offering of 25 million shares of its common stock. All the shares are being offered by selling stockholders, which include certain affiliates of Warburg Pincus and GTCR, as well as certain current and former members of management of the company. The company said it will not receive any of the proceeds from the offering.

On The Radar

Earnings

• Calithera Biosciences, Inc. CALA (after the close)
• Cue Biopharma, Inc. CUE (after the close)
• Curis, Inc. CRIS (after the close)
• Kindred Biosciences, Inc. KIN (after the close)
• Exagen Inc. XGN (after the close)
• OncoCyte Corporation OCX (after the close)
• Eton Pharmaceuticals, Inc. ETON (after the close)
• Organogenesis Holdings Inc. ORGO (after the close)
• Infinity Pharmaceuticals, Inc. INFI (after the close)
• Ra Medical Systems, Inc. RMED (after the close)

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