The Daily Biotech Pulse: Moderna To Supply Variant-Specific Vaccine To Israel, Roche's Diagnostics Business Comes to Rescue

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 20)

• Alexion Pharmaceuticals, Inc. ALXN
• AtriCure, Inc. ATRC
• BioNTech SE BNTX
• China Biologic Products Holdings, Inc. CBPO (announced completion of going private transaction)
• Dicerna Pharmaceuticals, Inc. DRNA
• Integra LifeSciences Holdings Corporation IART
• MacroGenics, Inc. MGNX
• Medtronic plc MDT
• United Therapeutics Corporation UTHR
• West Pharmaceutical Services, Inc. WST
• Zimmer Biomet Holdings, Inc. ZBH (reacted to FDA 510(k) clearance of the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 20)

• 4D Molecular Therapeutics, Inc. FDMT
• ADC Therapeutics SA ADCT
• ADMA Biologics, Inc. ADMA
• Agile Therapeutics, Inc. (AGRX)
• Akoya Biosciences, Inc. AKYA (IPOed Friday)
• Allena Pharmaceuticals, Inc. ALNA
• Angion Biomedica Corp. ANGN
• Applied Genetic Technologies Corporation AGTC
• Assembly Biosciences, Inc. ASMB
• Aurinia Pharmaceuticals Inc. AUPH
• Axsome Therapeutics, Inc. AXSM
• Bellerophon Therapeutics, Inc. BLPH
• Biomea Fusion, Inc. BMEA (IPOed Friday)
• Biomerica, Inc. BMRA
• Brainstorm Cell Therapeutics Inc. BCLI
• BriaCell Therapeutics Corp. BCTX
• Calithera Biosciences, Inc. CALA
• Celyad Oncology SA CYAD
• Checkmate Pharmaceuticals, Inc. CMPI
• ChemoCentryx, Inc. CCXI
• Concert Pharmaceuticals, Inc. CNCE
• ContraFect Corporation CFRX
• Design Therapeutics, Inc. DSGN (Sell-side began initiating coverage following IPO quiet period expiry)
• Emergent BioSolutions Inc. EBS
• Enveric Biosciences, Inc. ENVB
• Evofem Biosciences, Inc. EVFM
• Finch Therapeutics Group, Inc. FNCH
• Foghorn Therapeutics Inc. FHTX
• Galera Therapeutics, Inc. GRTX
• Gracell Biotechnologies Inc. GRCL
• Fusion Pharmaceuticals Inc. FUSN
• Homology Medicines, Inc. FIXX
• Idera Pharmaceuticals, Inc. IDRA
• Inhibikase Therapeutics, Inc. IKT
• InMed Pharmaceuticals Inc. INM
• Karyopharm Therapeutics Inc. KPTI
• Kronos Bio, Inc. KRON
• Lixte Biotechnology Holdings, Inc. LIXT
• Lucira Health, Inc. LHDX
• MediciNova, Inc. MNOV
• Metacrine, Inc. MTCR
• Millendo Therapeutics, Inc. MLND
• NeuBase Therapeutics, Inc. NBSE
• NuCana plc NCNA
• OraSure Technologies, Inc. OSUR
• Pharvaris B.V. PHVS
• Pulmatrix, Inc. PULM)
• Sigilon Therapeutics, Inc SGTX
• Soleno Therapeutics, Inc. SLNO
• Stealth BioTherapeutics Corp MITO
• Universe Pharmaceuticals INC UPC
• Vaxcyte Inc PCVX
• VectivBio Holding AG VECT
• Viveve Medical, Inc. VIVE
• Vyne Therapeutics Inc VYNE
• Zymeworks Inc. ZYME

Stocks In Focus

Lilly Announces Presentation of Positive Phase 1/2 Study of Selpercatinib In RET fusion-positive Solid Tumors

Eli Lilly and Company LLY announced that it presented at the 2021 American Association for Cancer Research Annual Meeting data from the Phase 1/2 trial showing treatment with selpercatinib demonstrated encouraging antitumor activity and safety across RET fusion-positive advanced solid tumors beyond lung and thyroid cancers, including multiple treatment-refractory gastrointestinal malignancies.

The company noted a confirmed objective response rate of 47%, with responses observed in nine unique cancer types. Median duration of response was not reached at 13 months, with 11 of 15 responses ongoing, it added. The company also said safety was consistent with the known profile of selpercatinib.

Moderna Strikes Deal to Supply Israel Variant-specific COVID Vaccine In 2022

Moderna, Inc. MRNA announced a new supply agreement, with Israel, under which Israel also retains an option to purchase doses of one of Moderna's variant-specific vaccine candidates in 2022, subject to regulatory approval.

This follows two earlier agreements between Israel and Moderna to supply a total of 10 million doses of the COVID-19 Vaccine. The Israeli Ministry of Health authorized COVID-19 Vaccine Moderna for use on Jan. 4.

Lumos Announces Retirement of CFO, Names Insider to the Role

Lumos Pharma, Inc. LUMO said chief financial officer Carl Langren, who has been with the company for 40 years, has announced his plans to retire effective as of July 4. Langren has been serving in the current role since November 2019.

Lori Lawley, currently SVP, Finance and Corporate Controller, will succeed Langren as CFO. The company also announced the appointment of Eddie Varnado as VP, Finance and Corporate Controller.

Evelo Presents Positive Data for Phase 1b Study of Atopic Dermatitis Drug

Evelo Biosciences, Inc. EVLO presented full clinical data from the Phase 1b clinical trial cohort evaluating EDP1815 for the treatment of mild and moderate atopic dermatitis in a poster presentation at the International Society of Atopic Dermatitis. The full results reinforce the data released on January 20, demonstrating that treatment with EDP1815 resulted in clinically meaningful improvements in both patient- and physician-reported outcomes, the company said.

The stock was up 1.48% at $11 in after-hours trading.

Trevena Says Its Investigational Asset Included In Global Study For COVID-19 Treatment

Trevena, Inc. TRVNA said its TRV027 has been selected for inclusion in an international, multi-site, adaptive, Phase 2-Phase 3 trial in COVID-19 patients.

The stock was up 4.71% to $1.78 in premarket trading Wednesday.

Humanigen Announces Pharma Industry Veteran Adrian Kilcoyne as Chief Medical Officer

Humanigen, Inc. HGEN, which is evaluating its lead drug lenzilumab for cytokine storm associated with COVID-19, said it has appointed Adrian Kilcoyne to the newly-created role of chief medical officer, effective immediately, reporting to Cameron Durrant, CEO of Humanigen.

He recently served as VP of Oncology Global Medical Affairs, Head of Evidence Generation and External Alliances, at AstraZeneca plc. AZN.

In premarket trading Wednesday, Humanigen shares gained 1.18% to $13.70.

Applied DNA Pre-announces Above-consensus Q2 Revenues

Applied DNA Sciences, Inc. APDN announced preliminary estimated second-quarter revenues in the range of $2.5 million to $2.7 million, up from $1.6 million in the first quarter and $552,000 in the year-ago quarter. Analysts, on average, estimate, revenues of $2.41 million.

The company attributed the sequential growth, principally to demand for safeCircle, its pooled COVID-19 surveillance testing program, and from sales of its Linea COVID-19 Assay Kit.

The company also said it's currently debt free.

Earnings

Intuitive Surgical, Inc. ISRG said its first-quarter revenues climbed 18% year-over-year to $1.29 billion, and the non-GAAP net income per share climbed from $2.70 to $3.52, ahead of the $2.63 per share consensus.

The stock rose 3.81% to $842.02 in after-hours trading.

Roche Holding AG RHHBY reported group sales of 14.93 billion francs ($16.26 billion) for the first quarter, down 1% but up 3% on a constant exchange rate. Sales of its Pharmaceutical business declined in all geographies, and the weakness was offset by a 50% increase in sales of its diagnostics business. The company confirmed its outlook for 2021.

Edwards Lifesciences Corporation EW said its first-quarter sales climbed 8% to $1.2 billion and EPS came in at 54 cents, exceeding the 47-cent per-share consensus estimate. The company raised its adjusted EPS guidance for 2021.

The stock added 3.76% to $93 in after-hours trading.

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