The Daily Biotech Pulse: Fate Therapeutics Inks Cell Therapy Deal With J&J, Zentalis 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 April 2)

BELLUS Health Inc BLU

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 2)

• BIOLASE Inc BIOL
• BioNano Genomics Inc BNGO (priced $18 million common stock and warrant offering)
• Celcuity Inc CELC
• China SXT Pharmaceuticals Inc SXTC
• Eloxx Pharmaceuticals Inc ELOX
• ENDRA Life Sciences Inc NDRA
• Eyepoint Pharmaceuticals Inc EYPT
• Madrigal Pharmaceuticals Inc MDGL
• Mediwound Ltd MDWD
• Merus NV MRUS
• Myokardia Inc MYOK
• Neovasc Inc NVCN
• Opko Health Inc. OPK
• PDS Biotechnology Corp PDSB
• Phio Pharmaceuticals Corp PHIO
• Precipio Inc PRPO
• Seelos Therapeutics Inc SEEL
• Sellas Life Sciences Group Inc SLS
• Chanticleer Holdings Common Stock SONN
• Vaccinex Inc VCNX

Stocks In Focus

Fate Announces CAR T-cell Therapy Licensing Deal With J&J's Janssen Unit

Fate Therapeutics Inc FATE said it has entered into a global collaboration and option agreement with Johnson & Johnson JNJ's Janssen unit, under which it will apply its iPSC product platform to research and preclinically develop new iPSC-derived chimeric antigen receptor, or CAR, NK and CAR T-cell product candidates.

Janssen will contribute proprietary antigen-binding domains for up to four tumor-associated antigen targets, and pay Fate $50 million in cash and also subscribe to $50 million in the latter's common shares at $31 per share.

Fate will be responsible for developing candidate until IND filing after which Janssen has the right to exercise options to license these.

Fate is eligible to receive payments of up to $1.8 billion upon the achievement of development and regulatory milestones and up to $1.2 billion upon the achievement of commercial milestones, plus double-digit royalties on worldwide commercial sales of products targeting the antigens.

Fate shares jumped 23.40% to $26 in after-hours trading.

Sanofi, Regeneron Announces Positive Latestage Data For Dupixent-SoC Combo In Eczema In Kids

Sanofi SA SNY and Regeneron Pharmaceuticals Inc REGN announced data from pivotal Phase 3 study of Dupixent combined with standard-of-care topical corticosteroidsin children aged 6-11 years with uncontrolled severe atopic dermatitis, which showed significantly improved disease signs, symptoms and health-related quality of life.

The company said detailed results will be presented during a session at the 2020 Revolutionizing Atopic Dermatitis Virtual Conference on Sunday.

See Also: Attention Biotech Investors: Mark Your Calendar For These April PDUFA Dates

Novartis, Incyte to Study Ruxolitinib For COVID-19 Related Cytokine Storm

Novartis AG NVS said it a plans to initiate a Phase 3 clinical trial in collaboration with Incyte Corporation INCY to evaluate the use of ruxolitinib for the treatment of a type of severe immune overreaction called cytokine storm that can lead to life-threatening respiratory complications in patients with COVID-19.

Novartis said it is taking steps to manage the anticipated increase in COVID-19 related requests for Jakavi – trade name of ruxolitinib in territories outside of the U.S. - without interrupting access for patients taking the drug for its licensed indications.

Novartis has licensed Jakavi from Incyte to commercialize in regions outside of the U.S., while Incyte markets it in the U.S. under the name Jakafi.

Novartis shares gained 1.18% to $84.59 in after-hours trading, while Incyte stock rose 1% to 1.86% to $78.50 in after-hours trading.

Immucell Pre-announces Q1 Net Product Sales Growth of 11.3%

ImmuCell Corporation ICCC announced preliminary first-quarter results, expecting product sales of $4.9 million, up 11.3% year-over-year.

Savara Licenses Latestage Inhaled Antibiotic Asset From Grifols

Savara Inc SVRA said it has entered into an exclusive license and collaboration agreement with Grifols SA - ADR ADR Class B GRFS for Apulmiq - inhaled liposomal ciprofloxacin. Apulmiq is a late-stage investigational inhaled antibiotic in Phase 3 development for the treatment of non-cystic fibrosis bronchiectasis.

The agreement provides for Savara obtaining worldwide rights to develop and commercialize Apulmiq for an upfront payment. if regulatory approval is obtained, Grifols will be eligible for regulatory milestone payments as well as royalties and potential tiered sales milestones upon commercialization.

Savara said it expects to work with regulatory agencies to plan a confirmatory Phase 3 study.

The stock rallied 11.83% to $2.08 in after-hours trading.

Emergent Biosolutions Gets $14.5M Grant For COVID-19 Therapy Development

Emergent Biosolutions Inc EBS said it has entered into a formal partnership with the U.S. government to expedite development of plasma-derived therapy for patients with COVID-19. The company said it has received $14.5 million from the BARDA for its COVID-HIG program – one of the hyperimmune development programs announced by the company in March.

Announcements On COVID-related Impacts

Updating on COVID-19 impact, Denali Therapeutics Inc DNLI, a neurodegenerative diseases-focused biopharma, said it does not expect delays to its clinical trials due to manufacturing or supply-chain issues. The company, however, said it has paused enrollment of new patients into some of its trials.

The company also said it has sufficient cash to fund business operations through 2022.

The stock slipped 2.41% to $17.02 in after-hours trading.

Dynavax Technologies Corporation DVAX announced withdrawal of its 2020 guidance, citing uncertainties about the duration and effect of the COVID-19 pandemic and the potential impact on hepatitis B vaccine - Heplisav-B - product sales.

The company also said it has already exceeded the Heplisav-B minimum product revenue covenant in its term loan agreement of $30 million for the annual measurement period ending June 30.

On The Radar

Clinical Readout

Prothena Corporation PLC PRTA said its development partner Roche Holdings AG Basel ADR RHHBY will present baseline data from the Phase 2 PASADENA study of prasinezumab in patients with early Parkinson's disease in an oral presentation at the Advances in Alzheimer's and Parkinson's Therapies AAT-AD/PD Focus Meeting being held virtually.

IPO

Zentalis Pharma, a biopharma focused on developing small molecule therapeutics targeting fundamental pathways of cancer, said it has priced its initial public offering of 9.18 million shares at $18 per share for raising gross proceeds of $165.2 million.
The company expects the offering to close April 7. The shares are to be listed on the Nasdaq under the ticker symbol ZNTL.