The Daily Biotech Pulse: Bausch Health Issues Positive Pre-Announcement, Acorda Streamlines Operations

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 Jan. 12)

• AbbVie Inc ABBV
• AcelRx Pharmaceuticals Inc ACRX
• Aldeyra Therapeutics Inc ALDX
• Alkermes Plc ALKS
• AtriCure Inc. ATRC
• Bioanalytical Systems, Inc. BASI
• BIOLASE Inc BIOL (announced an agreement to expand laser adoption and hands-on training programs in targeted geographies)
• CareDx Inc CDNA
• Celsius Holdings, Inc. CELH
• DermTech Inc DMTK
• Dyne Therapeutics Inc DYN
• Edap Tms SA EDAP
• Evelo Biosciences Inc EVLO
• EXACT Sciences Corporation EXAS
• Eyenovia Inc EYEN
• Genetron Holdings Ltd – ADR GTH
• Guardant Health Inc GH (reacted to presentation at the JPMorgan Healthcare Conference)
• Intra-Cellular Therapies Inc ITCI
• Kaleido Biosciences Inc KLDO
• Laboratory Corp. of America Holdings LH
• Merus NV MRUS (announced presentation of Phase 1 data for MCLA-158 in metastatic colorectal cancer)
• OncoSec Medical Inc ONCS
• Pacira Biosciences Inc PCRX
• PRA Health Sciences Inc PRAH
• Provention Bio Inc PRVB
• SAGE Therapeutics Inc SAGE
• Supernus Pharmaceuticals Inc SUPN
• Syneos Health Inc SYNH
• Travere Therapeutics Inc TVTX
• Vericel Corp VCEL
• X T L Biopharmaceuticals Ltd XTLB
• Zai Lab Ltd – ADR ZLAB

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Jan. 12)

• Fusion Pharmaceuticals Inc FUSN
• Lexaria Bioscience Corp. (LXRP) (the company's shares uplisted to Nasdaq and it also announced a $9.6 million public offering)
• Viveve Medical Inc VIVE

Stocks In Focus

Acorda to Sell Parkinson's Disease Drug Manufacturing Facility, Reduce 16% of Workforce

Acorda Therapeutics Inc ACOR announced a definitive agreement to sell its Inbrija manufacturing operations in Chelsea, Massachusetts to Catalent Inc CTLT for $80 million in cash.

In connection with the sale, Acorda and Catalent have entered into a long-term global supply agreement under which Catalent will manufacture and package Inbrija for Acorda. As part of the deal, Catalent will absorb all Acorda employees who work at the Chelsea facility, and certain Acorda employees at the company's Waltham, Massachusetts facility.

Acorda also announced a corporate restructuring to reduce costs and focus its resources on Imbrija. In addition to the associates who will transition to Catalent, Acorda is reducing its combined Ardsley, Waltham and field headcount by approximately 16% through a reduction in force.

Acorda also said it entered into an at-the-market offering agreement with H.C. Wainwright & Co., for offering common stock having an aggregate value of up to $15.25 million.

Acorda shares jumped 59.91% to $6.78 in premarket trading Wednesday.

Morphosys, Incyte Announce Canadian Regulatory Submission For Blood Cancer Combo Treatment

Morphosys Ag MOR and Incyte Corporation INCY said Health Canada has accepted the new drug submission for tafasitamab, an anti-CD19 antibody, in combination with Bristol-Myers Squibb Co's BMY Revlimid for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

Incyte has exclusive commercialization rights for tafasitamab outside of the U.S. and, if approved, Incyte will hold the marketing authorization for tafasitamab in Canada.

Travere Gets Orphan Drug Designation For Sparsentan In Rare Kidney Disorder

Travere announced that the FDA has granted orphan drug designation to sparsentan for the treatment of IgA nephropathy, a rare kidney disorder that causes end-stage kidney disease. Sparsentan is an investigational product candidate currently being evaluated for the treatment of IgAN, as well as focal segmental glomerulosclerosis in pivotal Phase 3 clinical trials that are expected to report topline data from interim proteinuria assessments in 2021.

DermTech's Non-invasive Melanoma Genomic Test Recommended by National Comprehensive Cancer Network

DermTech said non-invasive genomic patch testing for melanoma, like DermTech's pigmented lesion assay, has received a recommendation from the National Comprehensive Cancer Network. The recommendation indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Clinical Practice Guidelines in Oncology for cutaneous melanoma recognize the use of noninvasive genomic patch testing to help guide biopsy decisions for cutaneous melanoma.

The stock gained 12.46% to $41.61 in after-hours trading.

Amgen In-licenses Autoimmune Disorder Programs For Over $240M

Amgen, Inc. AMGN executed a license and collaboration agreement with EVOQ Therapeutics for the discovery and development of novel drugs for autoimmune disorders. Under the terms of the agreement, Amgen and EVOQ will collaborate on preclinical development and Amgen will be responsible for clinical development and commercialization.

In exchange for exclusive rights to selected autoimmune programs, Amgen will make upfront and milestone payments potentially totaling more than $240 million, as well as pay royalties on sales of resulting therapies.

Mersana Shares Gain On Insider Buying

Mersana Therapeutics Inc MRSN shares gained after a filing with the SEC revealed that Andrew Hack, a member of the board, bought 250,000 shares in the company.

The stock added 7.34% to $19.45 in after-hours trading.

Preannouncements

Ahead of the presentation at the JPMorgan Health Conference Bausch Health Companies Inc BHC said it expects fourth-quarter revenues to be greater than $2.20 billion. For the full year of 2020, the company expects to report revenues above the high-end of its revenue guidance range of $7.8 billion–$8 billion.

Analysts, on average, estimate expect revenues of $2.12 billion for the fourth quarter and $7.94 billion for the full year.

The company also guided to strong adjusted EBITDA.

In after-hours trading, the stock rose 5.67% to $24.80.

Neuronetics Inc STIM preannounced fourth-quarter revenues of $15 million to $15.5 million, ahead of the guidance of $13 million and $13.5 million. For the full year, revenues are estimated between $48.7 million and $49.2 million. The consensus estimates call for revenues of $13.24 for the fourth quarter and $46.93 for the full year.

The stock rallied 14.82% to $13.40 in after-hours trading.

Clearpoint Neuro Inc CLPT preannounced above-consensus revenues for the fourth quarter and full year.

The stock was up 3.43% to $15.99 in after-hours trading.

Offerings

Provention Bio Inc PRVB said it has commenced an underwritten public offering of 6 million shares of its common stock. All of the shares to be sold in the offering are to be sold by the company.

The stock fell 10.03% to $17.50 in after-hours trading.

Affimed NV AFMD announced the commencement of an underwritten public offering of its common shares. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering, the company added.

In the after-hours session, the stock slipped 7.85% to $6.10.