The Daily Biotech Pulse: Dynavax-Clover Start Phase 2/3 Vaccine Study. BrainStorm Reports Positive MS Readout, NeoGenomics Goes Shopping

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 23)

• BioLife Solutions, Inc. BLFS (announced a M&A transaction and quarterly results)
• Gain Therapeutics, Inc. GANX (IPOed Thursday)
• Oramed Pharmaceuticals Inc. ORMP
• Organogenesis Holdings Inc. ORGO
• Soliton, Inc. SOLY
• Radius Health, Inc. RDUS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 23)

• Adagene Inc. ADAG
• Bellerophon Therapeutics, Inc. BLPH
• Concert Pharmaceuticals, Inc. CNCE
• Connect Biopharma Holdings Limited CNTB (IPOed Friday)
• Epizyme, Inc. (EPZM)
• Finch Therapeutics Group, Inc. FNCH (IPOed Friday)
• Frequency Therapeutics, Inc. FREQ
• Galapagos NV GLPG
• Galecto, Inc. GLTO
• Harmony Biosciences Holdings, Inc. HRMY
• Ibere Pharmaceuticals IBER
• Instil Bio, Inc. TIL (IPOed Friday)
• Odonate Therapeutics, Inc. ODT
• Reviva Pharmaceuticals Holdings, Inc. RVPH
• Soleno Therapeutics, Inc. SLNO
• Voyager Therapeutics, Inc. VYGR

Stocks In Focus

LabCorp to Review Structure And Capital Allocation Strategy

Laboratory Corporation of America Holdings LH said its board is undertaking a review of its structure and capital allocation strategy to ensure the company is best positioned to unlock shareholder value while it continues to support patients and customers around the world.

In after-hours trading, the stock added 2.60% to $245.

Clover, Dynavax Commence Phase 2/3 Study of COVID-19 Vaccine Candidate

Clover and Dynavax Technologies Corporation DVAX, which are partnering on a COVID-19 vaccine program, said the first participants have been dosed in the Phase 2/3 clinical trial evaluating the efficacy, safety and immunogenicity of Clover's protein-based S-Trimer COVID-19 vaccine candidate adjuvanted with Dynavax's CpG 1018 plus alum.

Solid Biosciences, Clearside Move On Insider Transactions, Fund Buying

Solid Biosciences Inc. SLDB revealed in a series of filings with the SEC that RA Capital Management and Perceptive Advisors bought shares in the company.

The stock was up 8.89% to $6 in after-hours trading.
Clearside Biomedical, Inc. CLSD said in a filing that its CEO George Lasezkay bought 3,370 shares in the company for $2.82 per share.

The stock rose 5.72% to $2.39 in after-hours trading.

Related Link: FDA Decisions For Pfizer, Eli Lilly And Bluebird Bio, Bristol-Meyers Squibb, Plus New Data And Earnings

BrainStorm's Autologous Stem Cell Therapy Aces Mid-stage Multiple Sclerosis Study

BrainStorm Cell Therapeutics Inc. BCLI announced positive topline data from its Phase 2 trial evaluating three repeated administrations of NurOwn cells, each given two months apart, as a treatment for progressive multiple sclerosis.

The study achieved the primary endpoint of safety, and improvements were observed in secondary endpoints spanning neurologic function, cognition, and biomarkers, the company said.

The stock jumped 40.31% to $5.50 in premarket trading Wednesday.

Kaleido Announced Positive Results For Study of KB109 in COVID-19 Patients

Kaleido Biosciences, Inc. KLDO announced positive results from a non-IND study of KB109 in patients with mild-to-moderate COVID-19. An analysis from the full dataset demonstrated a reduction in overall COVID-19 related healthcare utilization—comprised of hospitalizations, emergency room visits, and urgent care visits.

The study also demonstrated a significant reduction in recovery time for patients age 45 and older or with one or more comorbidity who received KB109 plus self-supportive care as compared to patients receiving self-supportive care alone.

Neogenomics to Buy Precision Oncology-focused IT Company Trapelo Health For $65M

NeoGenomics, Inc. NEO, said it has agreed to acquire Intervention Insights, Inc. d/b/a Trapelo Health, an IT company focused on precision oncology, of $65 million. The consideration will be paid $35 million in cash on hand and $30 million in stock. The company expects the deal to close in April 2021.

Myovant, Pfizer Report Positive Late-stage Study of Relugolix Combo In Uterine Fibroids

Myovant Sciences MYOV and Pfizer Inc. PFE announced positive data from the Phase 3 LIBERTY randomized withdrawal study of relugolix combination therapy in women with uterine fibroids, showing 78.4% of women on the combo therapy remained responders through Week 76 compared with 15.1% of women with discontinued treatment.

About 69.8% of women who continued the combo therapy remained responders through Week 104, while 88.3% of women who discontinued, relapsed with heavy menstrual bleeding on average 5.9 weeks after discontinuation.

The combo therapy has a scheduled PDUFA date of June 1 with the FDA.

This study was designed to assess the safety and efficacy of continued treatment with relugolix combination therapy for up to two years.

Earnings

Unity Biotechnology, Inc. UBX reported a narrower than expected loss for its fourth quarter.
The stock gained 8.73% to $6.85 in after-hours trading.

SELLAS Life Sciences Group, Inc. SLS reported licensing revenues of $1.9 million and a narrower net loss for the fiscal year 2021.

The stock retreated 10.01% to $8.90 in after-hours trading.

aTyr Pharma, Inc.'s LIFE fourth-quarter revenues increased from $0.4 million in 2019 to $10.5 million in 2020. The loss per share narrowed from $1.54 to 47 cents.

In after-hours trading, the stock was up 5.69% to $5.20.

Bionano Genomics, Inc.'s BNGO fourth-quarter revenues for fiscal year 2020 increased by $1.2 million to $4 million. The loss per share, however, widened from $7.9 million to $11.7 million.

The stock rose 6.93% to $8.95 in after-hours trading.

Offerings

CASI Pharmaceuticals, Inc. CASI said it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the offering/All of the shares of common stock in the offering will be sold by CASI.

The stock pulled back 11.94% to $2.01 in after-hours trading.

Prothena Corporation plc PRTA said it has commenced an underwritten public offering of its ordinary shares. All of the ordinary shares in the offering will be sold by Prothena.

The stock lost 1.79% to $21.35 in after-hours trading.

On The Radar

Adcom Meeting

FDA's Arthritis Advisory Committee, along with the Drug Safety and Risk Management Advisory Committee, is scheduled to meet March 24-25 to discuss Pfizer Inc.'s PFE biologic license application for tanezumab subcutaneous injection for the proposed indication of relief of signs and symptoms of moderate to severe osteoarthritis in adult patients for whom use of other analgesics is ineffective or not appropriate. Tanezumab is being jointly developed by Pfizer and Eli Lilly and Company LLY.

Clinical Readouts

ProQR Therapeutics N.V. PRQR is due to present Wednesday results from its Phase 1/2 Stellar trial of QR-421a in adults with Usher syndrome and non-syndromic retinitis pigmentosa. Usher syndrome is a rare genetic disorder that affects both hearing and vision.

Earnings

Forte Biosciences, Inc. FBRX (before the market open)
Aptinyx Inc. APTX (after the close)
TELA Bio, Inc. TELA (after the close)
Navidea Biopharmaceuticals, Inc. NAVB (after the close)
STRATA Skin Sciences, Inc. SSKN (after the close)