The Daily Biotech Pulse: Sanofi, Bristol-Myers Squibb Gain On Earnings, Valneva-Pfizer Tout Positive Lyme Disease Vaccine Data, UNITY Biotech Restructures

Here's a roundup of top developments in the biotech space over the last 24 hours.

Stocks In Focus

Valneva, Pfizer Announces Mid-Stage Results For Lyme Disease Vaccine Candidate

Valneva SE VALN and Pfizer, Inc. PFE announced further positive Phase 2 data for their Lyme disease vaccine candidate, VLA15. Based on these new results, Valneva and Pfizer plan to proceed with a three-dose primary series vaccination schedule in a planned Phase 3 clinical trial. The trial will evaluate VLA15 in adults and pediatric subjects 5 years of age and above and is expected to be initiated in 2022, subject to regulatory approval.

UNITY Biotech Announces Restructuring Including 50% Job Cuts and Halting Earlier-Stage Program

UNITY Biotechnology, Inc. UBX announced it has initiated a restructuring program to align its resources on later-stage programs in ophthalmology while further extending operating capital into the first quarter of 2023.

All the other programs will be paused. The company also said it will reduce its workforce, primarily in Discovery Research, by about 50%, reducing staff to 34 full-time employees by the middle of the year.

The stock was up 8.49% at $1.15 in premarket trading.

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Syndax Announces Promotion Of COO Michael Metzger To Role Of CEO

Syndax Pharmaceuticals, Inc. SNDX announced that Michael Metzger, President and Chief Operating Officer, will transition to the role of Chief Executive Officer, effective Thursday. Briggs Morrison, CEO, will transition to the role of President, Head of R&D.

Galapagos Says Biotech Investment Firm EcoR1 Holds 5.2% Stake In The Company

Galapagos NV GLPG noted that EcoR1 Capital held 3.4 million of the company's voting rights, consisting of 211,622 ordinary shares and 3.2 million ADRs. This represents 5.2% of Galapagos' outstanding shares.

The stock was rising 1.81% to $65.26 in premarket trading.

Insider Transactions

Shares of COVID-19 testing company OraSure Technologies, Inc. OSUR came under pressure after a series of filings with the SEC showed insider transactions.

The stock was shedding 6.22% to $8.44 in after-hours trading.

Akero Therapeutics, Inc.'sAKRO President and CEO Andrew Cheng sold 10,000 shares in the company that were acquired by exercising of options.

In premarket trading, the stock was dropping 5.12% to $16.50.

Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates


Sanofi SNY said its fourth-quarter sales rose 4.1% and business EPS increased 9.8% at constant exchange range. The results were ahead of the expectations of most analysts. The company said it still expects Phase 3 trials of its partnered COVID-19 vaccine to be completed in the first quarter.

Regeneron Pharmaceuticals, Inc.'s REGN fourth-quarter revenues jumped 104% to $4.95 billion and non-GAAP EPS came in at $23.72.The results were ahead of expectations.

Bristol-Myers Squibb Company BMY said its fourth-quarter revenues climbed 8% to $11.99 billion and non-GAAP EPS increased from $1.46 to $1.83. The revenues were shy of estimates, while the bottom-line exceeded expectations. The company expects 2022 non-GAAP EPS of $7.65-$7.95 and worldwide revenues of about $47 billion. Analysts, on average, estimate non-GAAP EPS of $7.86 on revenues of $47.12 billion. The company also reaffirmed its long-term targets.

Among the others that released earnings before the market are IRadimed Corporation IRMD, Meridian Bioscience, Inc. VIVO, Immunovant, Inc. IMVT andTwist Bioscience Corporation TWST.


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