The Daily Biotech Pulse: Bausch Calls Truce With Icahn, Pfizer's Brain Inflammation Vaccine Gets Priority Review, BriaCell IPO

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 Feb. 23)

• AxoGen, Inc AXGN (reacted to its fourth-quarter results)
• Gemini Therapeutics Inc GMTX
• Orthofix Medical Inc OFIX
• Solid Biosciences Inc SLDB
• Vascular Biogenics Ltd VBLT

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Feb. 23)

• AbCellera Biologics Inc ABCL
• Acutus Medical Inc AFIB
• Bioventus BVS
• bluebird bio Inc BLUE
• Evaxion Biotech A/S – ADR EVAX
• Imara Inc IMRA
• Kinnate Biopharma Inc KNTE
• Neurobo Pharmaceuticals Inc NRBO
• Pharming Group PHAR
• Sana Biotechnology Inc SANA
• Sarepta Therapeutics Inc SRPT
• Talis Biomedical Corp TLIS
• Vallon Pharmaceuticals Inc VLON
• Virpax Pharmaceuticals Inc VRPX
• Voyager Therapeutics Inc VYGR

Stocks In Focus

Bausch Health Agrees to Induct Icahn Group Nominees to its Board

Bausch Health Companies Inc BHC said it will expand its board to add two designees from Carl Icahn and affiliated entities. The company has agreed to induct Icahn Group nominees Brett Icahn and Steven Miller into its board as new independent directors, effective in mid-March 2021, with each to serve a term expiring at the company's 2021 Annual Meeting.

The company has also agreed to include them on its slate of nominees for election at its 2021 Annual Meeting, which will be held on April 27. In return the Icahn Group, which beneficially owns approximately 7.83%, has agreed to vote all of its shares in favor of each of the nominees on the Board's slate.

Separately, the company reported above-consensus revenues for the fourth quarter and adjusted EBITDA of $911 million. The company issued in-line guidance for fiscal year 2021.

The shares were up 2.85% to $32.47 in premarket trading Wednesday.

Pfizer's Regulatory Application For Tick-borne Encephalitis Vaccine Accepted For Priority Review

Pfizer Inc. PFE said the FDA has accepted for priority review the company's biologics license application for TicoVac, its tick-borne encephalitis vaccine for active immunization to prevent TBE in individuals 1 year of age and older. If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children who are visiting or living in TBE endemic areas.

The anticipated PDUFA action date is August 2021.

Kura Gets Breakthrough Designation For Tipifarnib In Head & Neck Squamous Cell Carcinoma

Kura Oncology Inc KURA said its investigational drug, tipifarnib, has been granted breakthrough therapy designation by the FDA for the treatment of patients with recurrent or metastatic HRAS-mutant head and neck squamous cell carcinoma, with variant allele frequency of 20% or more, after disease progression on platinum-based chemotherapy.

Takeda Commences Phase 1/2 Study of Novavax' Coronavirus Vaccine Candidate In Japan

Takeda Pharmaceutical Co Ltd TAK said it has commenced the Phase 1/2 immunogenicity and safety study of Novavax, Inc.'s NVAX COVID-19 vaccine candidate in Japan. It also said it has completed enrollment in the Phase 1/2 immunogenicity and safety study of Moderna Inc's MRNA OVID-19 vaccine candidate in Japan.

The company expects results from the study of Moderna's vaccine study in the first half of 2021 and results from the Novavax' vaccine study in the second half of 2021. Once available, the study results will be submitted to the Japan Pharmaceuticals and Medical Devices Agency as part of the NDA filing process. Pending regulatory approval, Takeda said it intends to start distributing Moderna's vaccine in the first half of 2021 and aims to start distributing Novavax's vaccine in late 2021.

OncoCyte Gets Approval For Transfer of Share Listing to Nasdaq

OncoCyte Corp OCX said its shares has been approved for listing on the Nasdaq Global Market. The shares will continue to trade under its current symbol, OCX, with trading on Nasdaq expected to commence at the open of market on March 8. Oncocyte's shares will continue to trade on the NYSE American Exchange until the close of trading on Friday, March 5, 2021.

Inovio, Qiagen Expands Collaboration to Develop Liquid Biopsy-based Companion Diagnostic Product

Inovio Pharmaceuticals Inc INO and Qiagen NV QGEN announced an extension in partnership with a new master collaboration agreement to develop liquid biopsy-based companion diagnostic products based on next-generation sequencing technology to complement Inovio's therapies.

The initial project in this expanded collaboration focuses on the co-development of a diagnostic test that identifies women who are most likely to benefit from clinical use of VGX-3100, INOVIO's immunotherapy to treat advanced cervical dysplasia associated with the human papillomavirus, the companies said.

Inovio shares were up 2.31% to $11.95 in premarket trading Wednesday, while Qiagen was down 1.91% at $52.42.

Earnings

AtriCure Inc. ATRC said its fourth-quarter revenues fell 5.9% year-over-year to $57.7 million and the adjusted loss per share narrowed from 37 cents to 18 cents. The company expects 2021 revenues of about $250 million and an adjusted loss of $1.15 per share. For the first quarter, the company expects revenues of $55 million to $57 million and an adjusted loss of 36-39 cents. The revenue guidance was below consensus estimates.

The stock was down 5.03% to $59.11 in after-hours trading.

Halozyme Therapeutics, Inc.'s HALO fourth-quarter revenues increased from $53.7 million in 2019 to $121.7 million in 2020. The company reversed to a profit of 50 cents from a loss of 24 cents.

The company's 2021 guidance was below consensus estimate.

Separately, the company announced its intention to offer, subject to market conditions and other factors, $500 million aggregate principal amount of convertible senior notes due 2027, to qualified institutional buyers.

The stock fell 5.74% to $44.50 in after-hours trading.

Inspire Medical Systems Inc INSP said its fourth-quarter revenues jumped 71% to $46 million and its net loss was 28 cents per share, narrower than the consensus loss estimate of 48 cents per share. The company also issued above-consensus revenue guidance for fiscal year 2021.

The stock was down 6.35% to $234.50 in after-hours trading.

Offerings

Biofrontera AG BFRA priced its U.S. underwritten public offering of 1.334 million ADSs, at an offering price of $6.68 per ADS. Each ADS represents two of Biofrontera's ordinary shares. The company said it expects to receive aggregate gross proceeds of approximately $8.9 million from this offering. The offering is expected to close on or about Feb. 26.

On The Radar

Earnings

SAGE Therapeutics Inc SAGE (before the market open)
Merit Medical Systems, Inc. MMSI (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Xtant Medical Holdings Inc XTNT (before the market open)
Horizon Therapeutics PLC HZNP (before the market open)
Repligen Corporation RGEN (before the market open)
Kura Oncology Inc KURA (before the market open)w
NeoGenomics, Inc. NEO (before the market open)
Ionis Pharmaceuticals Inc IONS (before the market open)
PPD Inc PPD (before the market open)
Vericel Corp VCEL (before the market open)
Harvard Bioscience, Inc. HBIO (before the market open)
Adaptive Biotechnologies Corp ADPT (after the close)
ACADIA Pharmaceuticals Inc. ACAD (after the close)
Alimera Sciences Inc ALIM (after the close)
Global Blood Therapeutics Inc GBT (after the close)
Coherus Biosciences Inc CHRS (after the close)
Nevro Corp NVRO (after the close)
CareDx Inc CDNA (after the close)
CytomX Therapeutics Inc CTMX (after the close)
Sangamo Therapeutics, Inc. SGMO (after the close)
Paratek Pharmaceuticals Inc PRTK (after the close)
Tandem Diabetes Care Inc TNDM (after the close)
Guardant Health Inc GH (after the close)
G1 Therapeutics Inc GTHX (after the close)

IPO

BriaCell Therapeutics Corp., a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, priced an underwritten public offering of 5.882 million units, each unit consisting of one share of common stock and one warrant to purchase one share of common stock and one warrant to purchase one share of common stock, in lieu thereof.

Each unit is being sold to the public at a price of US$4.25. The gross proceeds to the company from the offering are expected to be approximately $25 million.

The common shares and warrants have been approved to list on the Nasdaq under the symbols BCTX and BCTXW respectively, and will begin trading Wednesday.

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