The Daily Biotech Pulse: Equillium Issues Positive Regulatory Update, Biogen In-Licenses Multiple Sclerosis Drug, Aridis Releases COVID-19 Antibody Cocktail Data

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 July 12)

• AbbVie Inc. ABBV
• Alexion Pharmaceuticals, Inc. ALXN
• Alnylam Pharmaceuticals, Inc. ALNY
• AngioDynamics, Inc. ANGO
• AtriCure, Inc. ATRC
• Bio-Techne Corporation TECH
• BioLife Solutions, Inc. BLFS
• Celldex Therapeutics, Inc. CLDX
• Elevation Oncology, Inc. ELEV
• Globus Medical, Inc. GMED
• Myriad Genetics, Inc. MYGN
• Protagonist Therapeutics, Inc. PTGX
• Recursion Pharmaceuticals, Inc. RXRX
• Sierra Oncology, Inc. SRRA
• West Pharmaceutical Services, Inc. WST
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 12)

• Aerovate Therapeutics, Inc. AVTE (IPOed June 30)
• Aptose Biosciences Inc. APTO
• Aziyo Biologics, Inc. AZYO
• Celyad Oncology SA CYAD
• Cogent Biosciences, Inc. COGT
• iRhythm Technologies, Inc. IRTC
• Kala Pharmaceuticals, Inc. KALA
• Kiromic BioPharma, Inc. KRBP
• Molecular Templates, Inc. MTEM
• NexImmune, Inc. NEXI
• Nymox Pharmaceutical Corporation NYMX
• Sigilon Therapeutics, Inc. SGTX
• Terns Pharmaceuticals, Inc. TERN
• TransCode Therapeutics, Inc. RNAZ (IPOed Friday)
• UroGen Pharma Ltd. URGN

Stocks In Focus

Equillium Announces End-Of-Phase 2 Meeting With FDA For Graft-Versus-Host Disease Treatment; Pivotal Late-Stage Study To Start In Q4

Equillium, Inc. EQ announced the completion of an end-of-Phase 1 meeting with the Food and Drug Administration for itolizumab in first-line treatment of patients with acute graft-versus-host disease. The meeting confirmed a path to advance itolizumab into a single Phase 3 pivotal study to support the biologics license application for the indication. The company said it plans to initiate the Phase 3 study in the fourth quarter.

The stock was up 3.19% at $5.82 in premarket trading.

Biogen In-Licenses Multiple Sclerosis Drug From Hong Kong's InnoCare 

Biogen, Inc. BIIB and Hong Kong-based InnoCare Pharma Limited announced a license and collaboration agreement for orelabrutinib for the potential treatment of multiple sclerosis.

Orelabrutinib has high selectivity and the ability to cross the blood-brain barrier, and is being studied in a multi-country, placebo-controlled Phase 2 trial in relapsing-remitting multiple sclerosis.

Under the agreement, Biogen will have exclusive rights to orelabrutinib in multiple sclerosis worldwide and certain autoimmune diseases outside of China, while InnoCare will retain exclusive worldwide rights to orelabrutinib in oncology and certain autoimmune diseases in China.

InnoCare will receive a $125-million upfront payment and is eligible to receive up to $812.5 million in potential milestone payments. It is also eligible to receive tiered royalties in the low to high teens on potential future net sales of any product resulting from the collaboration.

Biogen shares were edging up 0.28% to $350 in premarket trading.

Aslan Secures $45M In Debt Financing From K2 HealthVentures

ASLAN Pharmaceuticals ASLN said it has closed a secured loan facility provided by K2 HealthVentures. Under the terms of the facility, K2HV will provide ASLAN up to $45 million of secured debt financing. The facility consists of a $20-million initial term loan funded at closing, with the remaining $25 million subject to certain terms and conditions.

The company intends to use the proceeds of the loan facility to advance the clinical development of ASLAN003 for the potential treatment of autoimmune gastrointestinal and skin diseases, as well as for general corporate purposes. ASLAN expects to initiate a Phase 2 clinical trial for ASLAN003 in inflammatory bowel disease in early 2022.

Related Link: The Week Ahead In Biotech: Adcom Test Awaits FibroGen, Data Readouts, IPOs In The Mix

J&J's COVID-19 Factsheet Updated To Include Risk Of Rare Autoimmune Disorder 

The FDA modified the fact sheet for Johnson & Johnson's JNJ one-shot coronavirus vaccine to include a warning about Guillain-Barré Syndrome during the 42 days following vaccination. Guillain-Barré Syndrome is a rare disorder in which your body's immune system attacks your nerves.

In mid-April, the FDA recommended a pause in the use of the vaccine, citing stray incidences of severe blood clots, and subsequently issued clearance.

The stock was retreating 1.17% to $167.50 in premarket trading.

PLx Pharma's Liquid Aspirin Capsules To Be Sold In Walmart Stores

PLx Pharma Inc. PLXP announced three stock-keeping units of Vazalore, the first and only FDA-approved liquid-filled aspirin capsules, will be available in over 4,500 Walmart Inc. WMT stores across the U.S. in mid-August.

The stock was jumping 23.25% to $15.32.

Aridis Says Coronavirus Antibody Cocktail Effective Against Delta Variant

Aridis Pharmaceuticals, Inc. ARDS announced its COVID-19 mAb cocktail AR-712 binds and neutralizes the Delta variant virus SARS-CoV-2 at a highly effective level. Binding analyses project that AR-712 will be effective against all variants on the U.S. Centers for Disease Control's "variants of interest" and "variants of concern" lists, it added.

AR-712 is being developed as a self-administered, at-home inhaled treatment for COVID-19 patients who are not yet hospitalized. The company said it remains on track to finalize the Phase 1/2/3 design for this program and initiate the clinical study in 2H 2021.

The stock was down 3.48% to $6.94 in premarket trading.

Cyclacel Commences Phase 1/2 Study Of Fadraciclib In Advanced Solid Tumors

Cyclacel Pharmaceuticals, Inc. CYCC announced dosing of the first patient in its multi-cohort Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors.

Ionis Pharma Exercises Option To License Bicycle Therapeutics' Targeted Drug Delivery Tech

Bicycle Therapeutics, Inc. BCYC announced that Ionis Pharmaceuticals, Inc. IONS has exercised its option and entered into an exclusive worldwide license and collaboration agreement for tissue-targeted delivery of oligonucleotide therapeutics using Bicycles with high affinity to the transferrin receptor.

Ionis had an option for an exclusive license under the terms of a December 2020 evaluation and option agreement. The agreement granted Ionis the right to evaluate tissue-targeting TfR1-binding Bicycles as vehicles to deliver oligonucleotide therapeutics to specific organ systems and an option to obtain an exclusive license at the end of the evaluation period.

Bicycle received a total of $45 million upfront, which included a license fee, an option fee and an $11-million equity investment. Bicycle is also eligible to receive development, regulatory and commercial milestone payments and royalties for each program developed under the collaboration.

Bicycle shares were up 1.87% at $32.17 in premarket trading.

Offerings

Acutus Medical, Inc. AFIB said it has commenced an underwritten public offering of 5.5 million shares of its common stock. All of the shares of common stock are being offered by Acutus.

The stock was slipping 8.5% to $14.10 in premarket trading.

Celldex Therapeutics, Inc. CLDX announced that it is proposing to offer and sell, subject to market conditions, $175 million in shares of its common stock in an underwritten public offering. All of the shares of common stock are being offered by the company.

In premarket trading, the stock was gaining 4.01% to $42.30.

IVERIC bio, Inc. ISEE said it is commencing an underwritten public offering of shares of its common stock.

The stock was moving down 2.33% to $8.80 in premarket trading.

On The Radar

Earnings

AngioDynamics, Inc. ANGO (before the market open)

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