The Daily Biotech Pulse: Fulgent's Big Quarter, Gilead Awaits FDA Decision, Apellis Winds Up COVID-19 Study

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows March 4)

• AbCellera Biologics Inc. ABCL
• Acutus Medical, Inc. AFIB
• ADC Therapeutics SA ADCT
• Aptose Biosciences Inc. APTO
• Assembly Biosciences, Inc. ASMB
• Athenex, Inc. ATNX
• Biophytis SA BPTS
• Bioventus Inc. BVS
• Brainstorm Cell Therapeutics Inc. BCLI
• BriaCell Therapeutics Corp. BCTX
• Decibel Therapeutics, Inc. DBTX
• Dyne Therapeutics, Inc. DYN (reacted to fourth-quarter results)
• Epizyme, Inc. EPZM
• Freeline Therapeutics Holdings plc FRLN
• Galecto, Inc. GLTO
• Inhibikase Therapeutics, Inc. IKT
• Intercept Pharmaceuticals, Inc. ICPT
• Karyopharm Therapeutics Inc KPTI
• Legend Biotech Corporation LEGN
• Liquidia Corporation LQDA
• Lucira Health Inc LHDX
• Nabriva Therapeutics plc NBRV
• Nanobiotix S.A. NBTX
• NeuroBo Pharmaceuticals, Inc. NRBO
• NexImmune, Inc. NEXI
• NLS Pharmaceutics AG NLSP
• Olema Pharmaceuticals, Inc. OLMA
• Oncorus, Inc. ONCR
• Protara Therapeutics, Inc. TARA
• Qualigen Therapeutics, Inc. QLGN
• Repro Med Systems, Inc. KRMD
• Sana Biotechnology, Inc. SANA
• Sensei Biotherapeutics, Inc. SNSE
• Sigilon Therapeutics, Inc. SGTX
• Sonnet BioTherapeutics Holdings, Inc. SONN
• Talis Biomedical Corporation TLIS
• uniQure N.V. QURE
• Vallon Pharmaceuticals, Inc. VLON
• Virios Therapeutics, LLC VIRI
• Virpax Pharmaceuticals, Inc. VRPX
• Viveve Medical, Inc. VIVE
• Voyager Therapeutics, Inc. VYGR
• Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Moderna's Japanese Partner Takeda Submits New Drug Application For Coronavirus Vaccine In Japan

Moderna, Inc. MRNA said its Japanese partner Takeda Pharmaceutical Company Limited TAK submitted a new drug application to Japan's Ministry of Health, Labour and Welfare to import and distribute Moderna's vaccine candidate against COVID-19 in Japan.

Takeda is conducting a placebo-controlled Phase 1/2 study designed to evaluate the safety and immunogenicity of two vaccinations of mRNA-1273 at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan.

In October, the two companies entered into a pact under which Moderna will supply 50 million doses of its vaccine to Takeda for distribution in Japan.

Moderna shares were down 1.81% to $130.49 in premarket trading Friday.

Roche's Biologics Products Gets FDA Nod For Lung Disease

Roche Holding AG RHHBY said the FDA approved Actemra/RoActemra subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease, a debilitating condition with limited treatment options. Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease.

Sigilon's SIG-007 Gets Orphan Drug Designation For Fabry Disease

Sigilon said the FDA has granted orphan drug designation to SIG-007 for the treatment of Fabry disease, a progressive, life-threatening lysosomal disease.

Related Link: The Week Ahead In Biotech (Feb. 28-March 6): KemPharm, Gilead FDA Decisions and More Earnings

ALX Oncology to Collaborate With Tallac For Developing Cancer Immunotherapies

ALX Oncology Holdings Inc. ALXO announced a collaboration with privately held Tallac Therapeutics to jointly develop, manufacture, and commercialize a novel class of cancer immunotherapeutics. Under the terms of the agreement, ALX Oncology and Tallac will share equally in the cost of R&D and any profits or losses incurred.

The companies said they will leverage their respective scientific and technical expertise to advance an anti-SIRPα antibody conjugated to a Toll-like receptor 9 agonist for targeted activation of both the innate and adaptive immune systems.

Apellis Shelves Study Of APL-9 In Severe COVID-19 Patients

Apellis Pharmaceuticals, Inc. APLS said it will not pursue additional development of APL-9, an investigational targeted C3 therapy designed for acute interventions, for the treatment of severe COVID-19. The decision followed an interim review of mortality data from the Phase 1/2 study by an independent data monitoring committee, which found no meaningful reduction in the overall mortality rate in patients treated with APL-9 in combination with standard of care therapy compared to standard of care alone. No safety signals were observed by the DMC.

The stock fell 1.42% to $45 in after-hours trading.

Ocular Therapeutix Application For Dextenza Label Expansion Accepted For Review

Ocular Therapeutix, Inc. OCUL announced the supplemental new drug application for Dextenza 0.4 mg for intracanalicular use, has been accepted for review by the FDA. The FDA has set an action date under the Prescription Drug User Fee Act of no later than Oct. 18. If approved, this sNDA would include the treatment of ocular itching associated with allergic conjunctivitis as an additional approved indication of Dextenza.

The stock rose 2.42% to $17.75 in after-hours trading.

Earnings

Fulgent Genetics, Inc. FLGT reported fourth-quarter revenues of $295 million, up over 3,400% year-over-year. The non-GAAP net income came in at $6.20 per share, ahead of the $4.02 per share estimated by analysts.

The stock jumped 34.46% to $115 in after-hours trading.

Acorda Therapeutics Inc ACOR reported fiscal-year 2020 fourth-quarter revenues of $38.16 million, down from $50.50 million a year-ago. The company reversed to a loss per share of $9.82 from a profit of $8.26 per share.
The stock slipped 11.5% to $6 in after-hours trading.

Opiant Pharmaceuticals Inc's OPNT fourth-quarter revenues climbed from $7.67 million in 2019 to $9.924 million in 2020. The company reversed to a loss of 16 cents per share from a profit of 20 cents per share. The consensus estimates had called for a profit of 7 cents per share on revenues of $9.92 million.

In after-hours trading, the stock rose 5.34% to $14.

DermTech Inc DMTK said its fourth-quarter revenues increased 33% year-over-year to $2.1 million. The net loss per share widened from 48 cents to 43 cents.

The company said it estimates that first-quarter assay revenue will be between $1.6 and $1.9 million.

The stock moved down 7.95% to $48.77 in after-hours trading.

On The Radar

PDUFA Dates

The FDA will decide on the approvability of Gilead Sciences, Inc.'s GILD Yescarta, or axicabtagene ciloleucel, which is being evaluated for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma after two or more prior lines of systemic therapy. Yescarta is a CAR T-cell therapy that came into Gilead's stable through its Kite purchase. 

Earnings

• IMARA Inc. IMRA (before the market open)
• Oncolytics Biotech Inc. ONCY (before the market open)

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