The Daily Biotech Pulse: Pfizer, Amgen Shares Slip On Earnings, Editas Terminates Chief Medical Officer, Biogen Licenses Preclinical Rheumatoid Arthritis Biosimilar

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

Stocks In Focus

Axsome To Pay $312,500 To Settle Patent Infringement Litigation With Baudax

Axsome Therapeutics, Inc. AXSM disclosed in a filing that it reached a settlement with Baudax Bio, Inc. BXRX with regard to a lawsuit alleging that Axsome's AXS-07 infringed a couple of patents owned by Baudax. Under the settlement agreement, Baudax is to voluntarily dismiss the lawsuit and Axsome will make a one-time payment of $312,500 to Baudax. Axsome has not incurred any obligation to pay any royalty or other contingent consideration nor has it agreed to any other restriction on its manufacture or distribution of AXS-07.

Axsome shares were down 3.01% to $29.60 in premarket trading.

Editas Announces Termination Of Chief Medical Office With Immediate Effect

Editas Medicine, Inc. EDIT said in a filing with the SEC that Lisa Michaels' employment with Editas as its chief medical officer was terminated, effective immediately. In connection with the termination, Michaels will receive compensation in accordance with the company's amended and restated severance benefits plan.

In premarket trading, the stock was slipping 13.66% to $16.88.

Centogene's CFO René Just To Depart

Centogene N.V. CNTG announced plans for the transition of chief financial officer René Just and the appointment of Miguel Coego Rios as executive vice president of finance & legal and interim CFO.

Just's resignation will be effective March 31, 2022, after the expected filing date of company's annual report on Form 20-F. Coego Rios will join the company on Feb. 8, and work closely through the transition with Just. The company said it has initiated a search for a permanent CFO. 

Alkermes Announces Positive Late-Stage Study Of Schizophrenia Treatment

Alkermes plc ALKS announced positive topline results from ENLIGHTEN-Early, a Phase 3b study that evaluated the effect of Lybalvi compared to olanzapine on body weight in young adult patients with schizophrenia, schizophreniform disorder or bipolar I disorder who were early in their illness.

The study met its pre-specified primary endpoint, as patients treated with Lybalvi experienced statistically significantly less weight gain than patients treated with olanzapine at Week 12.

Lybalvi is approved for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes as monotherapy or an adjunct to lithium or valproate.

The stock was up 2.97% at $24.25 in premarket trading.

Related Link: The Week Ahead In Biotech (Feb. 6-12): Pfizer, AstraZeneca Earnings, Conference Presentations, IPOs And More

Sangamo Announces Positive Updated Preliminary Data For Fabry Disease Gene Therapy Candidate

Sangamo Therapeutics, Inc. SGMO announced updated preliminary results from the Phase 1/2 STAAR clinical study evaluating isaralgagene civaparvovec, or ST-920, a wholly owned gene therapy product candidate for the treatment of Fabry disease.

The latest data show that, as of the Nov. 9, 2021 cutoff date, the investigational treatment continued to be well tolerated and that the four longest treated patients continued to exhibit elevated alpha-galactosidase A activity.

The company is due to present the data at the 18th Annual WORLDSymposium on Tuesday.

Biogen Announces In-Licensing Of Biosimilar Of Rheumatoid Arthritis Drug

Biogen, Inc. BIIB and Xbrane Biopharma announced a commercialization and license agreement to develop and commercialize Xcimzane, a preclinical monoclonal antibody that is a proposed biosimilar, referencing UCB's Cimzia.

Under the agreement, Biogen will gain exclusive regulatory, manufacturing and commercial rights to Xcimzane and will be the marketing authorization holder.

Under the terms of the agreement, Biogen will make an upfront payment of $8 million to Xbrane. Should certain development and commercial milestones be achieved, Xbrane will be eligible to receive up to $80 million in potential milestone payments. Xbrane is also eligible to receive tiered royalties.

Biogen shares were up 0.71% at $222.87 in premarket trading.

Click here to access Benzinga's FDA Calendar.

Vir Appoints Biogen Veteran Johanna Friedl-Naderer As Global Chief Business Officer

Vir Biotechnology, Inc. VIR announced the appointment of Johanna Friedl-Naderer as executive vice president and chief business officer, global, effective March 2, 2022. Prior to joining Vir, Friedl-Naderer was president of Europe, Canada and partner markets for Biogen.

Earnings

Amgen, Inc. AMGN announced a 3% year-over-year increase in fourth-quarter sales to $6.8 billion and its non-GAAP EPS climbed 6% to $4.36. Analysts, on average, estimated earnings of $4.12 per share on revenues of $6.88 billion.

The stock was slipping 1.08% to $221.11 in premarket trading.

Pfizer Inc.'sPFE fourth-quarter revenues jumped 106% to $23.8 billion and adjusted EPS came in at $1.08. Excluding Comirnaty revenues and Paxlovid, revenues fell 2%, with the company attributing the softness to fewer selling days compared to a year ago.

The company guided 2022 revenues to $89 billion to $102 billion and adjusted EPS to $6.35-$6.55.

Pfizer shares were slipping 3.83% to $51.17 in premarket trading.

On The Radar

Earnings

Haemonetics Corporation HAE (before the market open)
Incyte Corporation INCY (before the market open)
Karyopharm Therapeutics Inc. KPTI (before the market open)
QIAGEN N.V. QGEN (after the market close)
Inspire Medical Systems, Inc. INSP (after the market close)
Deciphera Pharmaceuticals, Inc. DCPH (after the market close)

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

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