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. (NASDAQ:ALXN)
• AtriCure, Inc. (NASDAQ:ATRC)
• BioNTech SE (NASDAQ:BNTX)
• China Biologic Products Holdings, Inc. (NASDAQ:CBPO) (announced completion of going private transaction)
• Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA)
• Integra LifeSciences Holdings Corporation (NASDAQ:IART)
• MacroGenics, Inc. (NASDAQ:MGNX)
• Medtronic plc (NYSE:MDT)
• United Therapeutics Corporation (NASDAQ:UTHR)
• West Pharmaceutical Services, Inc. (NYSE:WST)
• Zimmer Biomet Holdings, Inc. (NYSE: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)

Stocks In Focus

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

Eli Lilly and Company (NYSE: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. (NASDAQ: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. (NASDAQ: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

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. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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. (NASDAQ: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.

Edwards Lifesciences Corporation (NYSE: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