Here's a roundup of top developments in the biotech space over the last 24 hours:
Stocks In Focus
Humanigen Announces Agreement With French CDMO For Fill And Finish Services For Lenzilumab
Humanigen, Inc. (NASDAQ:HGEN) and Cenexi, a French CDMO, announced a collaboration aimed at making Cenexi a preferred supplier of lenzilumab in France and the European Union. The initial step of the collaboration includes the execution of a Master Supply Agreement providing for Cenexi to provide aseptic fill and finish services for lenzilumab for the next five years.
Humanigen shares were up 1.99% to $2.05 in premarket trading.
IGM Announces Advancement Of COVID-19 Antibody Treatment Into Phase 1 Study
IGM Biosciences, Inc. (NASDAQ:IGMS) announced it has advanced its IGM-6268, an anti-SARS-CoV-2 IgM monoclonal antibody for the treatment and prevention of COVID-19, into the clinics.
The first two dose cohorts of healthy volunteers from the Phase 1 study have been successfully cleared in the U.S. Data from the study is expected in the first half of 2022.
Related Link: The Week Ahead In Biotech (Feb. 6-12): Pfizer, AstraZeneca Earnings, Conference Presentations, IPOs And More
Bristol-Myers Squibb Announces $5B Accelerated Share Buyback Deal
Bristol-Myers Squibb Company (NYSE:BMY) said it has entered into an accelerated share repurchase transactions under agreements with investment banks, including Morgan Stanley, Barclays, Citibank, and JPMorgan Chase Bank, to repurchase in aggregate $5 billion of its common stock.
The stock was up 0.53% at $66.24 in premarket trading.
Click here to access Benzinga's FDA calendar.
Mersana Gains On Insider Buying, Fund Stake Disclosure
Mersana Therapeutics, Inc. (NASDAQ:MRSN) disclosed in a filing with the SEC that Bain Capital Life Sciences Fund II owns 3,294,423 shares or a 4.4% stake in the company. In a separate filing, the company said Andrew Hack, a director of the board, purchased 1.136 million shares in the company.
The stock was adding 5.08% to $4.55 in premarket trading.
Earnings
Deciphera Pharmaceuticals, Inc.'s (NASDAQ:DCPH) fourth-quarter revenues climbed from $19.49 million in 2020 to $24.2 million in 2021. The 2021 fourth-quarter revenues included $23.7 million in Qinlock net product revenue. The net loss per share widened from $1.10 to $1.51, while analysts had modeled a loss of $1.38 per share.
The stock was slipping 1.96% to $8 in premarket trading.
QIAGEN N.V. (NYSE:QGEN) said its fourth-quarter net sales rose 2% year-over-year to $582 million and adjusted earnings per share rose 9% to 74 cents. Sales were driven by high demand for COVID-19 test products and confirmed good trends in the non-COVID portfolio, the company said.
For 2022, the company expects net sales of at least $2.07 billion and adjusted EPS of at least $2.05. Analysts, on average, estimate $1.79 billion in net sales and $1.75 per share in EPS.
The stock was climbing 3.82% at $51.10 in premarket trading.
Offerings
Zosano Pharma Corporation (NASDAQ:ZSAN) said it is commencing an underwritten public offering of units consisting of shares of common stock and warrants to purchase common stock. All of the units in the offering are to be sold by Zosano.
The stock was plunging 51.65% to 22.85 cents in premarket trading.
On The Radar
Clinical Readouts/Presentations
WORLDSymposium Presentations
REGENXBIO Inc. (NASDAQ:RGNX): interim results from the Phase 1/2 clinical trials of RGX-121 for the treatment of mucopolysaccharidosis type II, also known as Hunter Syndrome, and RGX-111 for the treatment of mucopolysaccharidosis type I, also known as Hurler Syndrome.
AVROBIO, Inc. (NASDAQ:AVRO): updated clinical data from the collaborator-sponsored Phase 1/2 clinical trial of AVR-RD-04 in cystinosis.
4D Molecular Therapeutics, Inc. (NASDAQ:FDMT): updated interim clinical data from the on-going 4D-310 Phase 1/2 trial in patients with Fabry disease.
Sio Gene Therapies Inc. (NASDAQ:SIOX): update on the Phase 1/2 trial of AXO-AAV-GM1, its AAV 9-based gene therapy for the treatment of Type I, i.e. early infantile onset, and Type II, i.e. late infantile and juvenile onset GM1 gangliosidosis.
Earnings
Veru, Inc. (NASDAQ:VERU) (before the market open)
Teva Pharmaceutical Industries Limited (NYSE:TEVA) (before the market open)
Anavex Life Sciences Corp. (NASDAQ:AVXL) (before the market open)
PolyPid Ltd. (NASDAQ:PYPD) (before the market open)
Seagen Inc. (NASDAQ:SGEN) (after the market close)
Viking Therapeutics, Inc. (NASDAQ:VKTX) (after the market close)
Related Link: Attention Biotech Investors: Mark Your Calendar For These Key February PDUFA Dates
