The Daily Biotech Pulse: Voyager, AbbVie End Collaboration, Thumbs Down For DBV's Peanut Allergy Patch, Tiziana Expedites COVID-19 Trial Plans

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 3)

• ABIOMED, Inc. ABMD
• ALX Oncology Holdings Inc ALXO
• Annexon Inc ANNX
• Atossa Therapeutics Inc ATOS
• Axonics Modulation Technologies Inc AXNX
• Catalent Inc CTLT
• Co-Diagnostics Inc CODX (announced FDA emergency use authorization for a third-party self-administered test that uses the company's technology)
• DexCom, Inc. DXCM
• Emergent Biosolutions Inc EBS
• Fulgent Genetics Inc FLGT
• Hologic, Inc. HOLX
• Immunic Inc IMUX (reported positive midstage results for its multiple sclerosis drug)
• Immunomedics, Inc. IMMU
• Inozyme Pharma Inc INZY
• ITAMAR MED LTD/S ADR ITMR
• NeoGenomics, Inc. NEO
• Novavax, Inc. NVAX
• OraSure Technologies, Inc. OSUR
• Penumbra Inc PEN
• Quidel Corporation QDEL
• Repligen Corporation RGEN
• Trevena Inc TRVN
• Varian Medical Systems, Inc. VAR (announced a deal to be bought by Siemens Healthineers for $16.4 billion)
• West Pharmaceutical Services Inc. WST
• Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 30)

• Legend Biotech Corp LEGN (announced resignation of its CEO)
• Natus Medical Inc NTUS (reacted to its second-quarter results)
• Pandion Therapeutics Holdco LLC PAND
• Verrica Pharmaceuticals Inc VRCA

Stocks In Focus

Voyager, AbbVie Terminate Vectorized Antibody Collaborations

Voyager Therapeutics Inc VYGR announced the termination of its tau and alpha-synuclein vectorized antibody collaborations with AbbVie Inc ABBV. Voyager said it now retains full rights to the vectorization technology and certain novel vectorized antibodies developed as part of the collaborations.

The research collaborations — announced in 2018 and 2019, respectively — called for Voyager to receive upfront payments for conducting research and preclinical studies.

Voyager said it does not expect its cash runway guidance to be impacted due to the termination.

Voyager shares were down 10.41% at $10.15 in Tuesday's premarket session.

Tiziana Expedites Clinical Trial Plans For COVID-19 Treatment

TIZIANA LF SCIE/S ADR TLSA said it has signed agreements with four CROs to expedite clinical development of TZLS-501, a novel fully human anti-interleukin-6 receptor monoclonal antibody for the treatment of COVID-19 patients. Tiziana expects to commence the clinical study in the first quarter of 2021.

In premarket trading Tuesday, Tiziana shares were rallying 9.49% to $6.

DBV's Peanut Allergy Patch Slapped With Complete Response Letter

DBV TECHNOLOGIE/S ADR DBVT said the FDA has issued a Complete Response Letter regarding its BLA for investigational Viaskin Peanut, a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4-11.

In the letter, the FDA identified concerns regarding the impact of patch-site adhesion on efficacy and indicated the need for patch modifications and subsequently a new human factor study, the company said.

Supplementary clinical data will need to be generated to support the modified patch, according to DBV, citing the FDA. In addition, the FDA requested additional Chemistry, Manufacturing and Controls data.

The stock was slumping 34.39% to $2.69 in premarket trading Tuesday.

See also: The Week Ahead In Biotech: Novavax Coronavirus Vaccine Readout, FDA Decisions And More Earnings

Novartis Reports Positive Midstage Results For CAR-T Cell Therapy

Novartis AG NVS announced positive results from the Phase 2 ELARA trial of Kymriah in patients with relapsed or refractory follicular lymphoma.

At the interim analysis, the global study met its primary endpoint of complete response rate, as assessed by independent review committee, Novartis said. No new Kymriah safety signals were observed, according to Novartis.

Alterity Reports Positive Preclinical Results For Neurological Disorder Drug

Alterity Therapeutics Ltd ATHE said new data from an experiment testing its lead candidate ATH434 in an animal model of Multiple System Atrophy independently confirmed and extended previous findings demonstrating that ATH434 reduces α-synuclein pathology, preserves neurons and improves motor performance.

The stock was skyrocketing 211.11% to $4.20 in premarket trading Tuesday.

Karuna Not to Go Ahead With Evaluation of KarXT For Pain Following Failed Exploratory Study

Karuna Therapeutics Inc KRTX said topline results of an exploratory Phase 1b trial did not provide conclusive evidence of an analgesic benefit of KarXT on experimentally induced pain in healthy volunteers.

The company said it will not proceed with the evaluation of KarXT for the treatment of pain.

Earnings

DURECT Corporation's DRRX second-quarter revenues increased from $4 million to $14.3 million. The company reversed from a loss of 4 cents per share to a profit of 7 cents per share. Analysts, on average, estimated EPS of 1 cent.

In premarket trading, the stock jumped 7.46% to $2.52.

Pacific Biosciences of California Inc PACB said its second-quarter revenues declined from $24.6 million in 2019 to $17.1 million in 2020. The loss per share narrowed from 16 cents to 15 cents, while the consensus estimate had called for 18 cents per share.

The stock fell 5.37% to $3.70 in after-hours trading.

Neurocrine Biosciences, Inc. NBIX reported second-quarter revenues that increased from $183.5 million in 2019 to $302.4 million in 2020 on strong Ingrezza sales. Non-GAAP EPS increased from 71 cents to $1.42.

The stock was up 3.25% to $127.01 premarket. 

Offerings

Veracyte Inc VCYT said it has commenced an underwritten public offering of 6 million shares of its common stock. All of the shares are being offered by the company.

Veracyte intends to use the net proceeds from the offering for working capital and other general corporate purposes, and also for acquiring or investing in complementary businesses, technologies or other assets.

The stock was down 3.09% premarket at $34.21. 

Achieve Life Sciences, Inc. ACHV announced a proposed underwritten public offering in which it intends to offer shares of its common stock and, to certain investors, pre-funded warrants to purchase shares of common stock.

The stock was down 8.28% premarket at $10.75. 

On The Radar

Clinical Readouts

BioSig Technologies Inc BSGM CEO Kenneth Londoner will present at the Proactive Investors One2One Virtual Event with an update on a Phase 2 clinical study of merimepodib in combination with remdesivir in adult patients with advanced COVID-19.

Earnings

• Haemonetics Corporation HAE (before the market open)
• Incyte Corporation INCY (before the market open)
• Karyopharm Therapeutics Inc KPTI (before the market open)
• Intersect ENT Inc XENT (before the market open)
• Oxford Immunotec Global PLC OXFD (before the market open)
• Epizyme Inc EPZM (before the market open)
• Neuronetics Inc STIM (before the market open)
• Mallinckrodt PLC MNK (before the market open)
• Evofem Biosciences Inc EVFM (before the market open)
• Zimmer Biomet Holdings Inc ZBH (before the market open)
• Strongbridge Biopharma plc SBBP (before the market open)
• BIO-TECHNE Corp TECH (before the market open)
• Avanos Medical Inc AVNS (before the market open)
• Amarin Corporation plc AMRN (before the market open)
• Aquestive Therapeutics Inc AQST (after the close)
• Akcea Therapeutics Inc AKCA (after the close)
• Acorda Therapeutics Inc ACOR (after the close) (after the close)
• BioMarin Pharmaceutical Inc. BMRN (after the close)
• Corcept Therapeutics Incorporated CORT (after the close)
• Xencor Inc XNCR (after the close)
• Vapotherm Inc VAPO (after the close)
• Rigel Pharmaceuticals, Inc. RIGL (after the close)
• NuVasive, Inc. NUVA (after the close)
• Qiagen NV QGEN (after the close)
• Jazz Pharmaceuticals PLC JAZZ (after the close)
• Fulgent Genetics Inc FLGT (after the close)
• Enanta Pharmaceuticals Inc ENTA (after the close)
• Otonomy Inc OTIC (after the close)
• Inspire Medical Systems Inc INSP (after the close)
• Myokardia Inc MYOK (after the close)
• Curis, Inc. CRIS (after the close)
• CareDx Inc CDNA (after the close)
• Cardiovascular Systems Inc CSII (after the close)
• Cytosorbents Corp CTSO (after the close)
• GenMark Diagnostics, Inc GNMK (after the close)
• Deciphera Pharmaceuticals Inc DCPH (after the close)
• Cerus Corporation CERS (after the close)
• Inspire Medical Systems Inc INSP (after the close)

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