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 July 20)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 20)

Stocks In Focus

Lumos Announces Potential Delay In Pediatric Growth Hormone Deficiency Studies

Giving a clinical trial update, Lumos Pharma, Inc. (NASDAQ:LUMO) said the OraGrowtH212 trial that will evaluate LUM-201 in pediatric growth hormone deficiency patients was initiated in June and is currently enrolling patients. This open-label trial will be extended from six months to twelve months to capture additional PK/PD and height velocity data.

The company also issued new guidance concerning the Phase 2 OraGrowtH210 trial of LUM-201 in PGHD. The pace of site initiation and enrollment of the trial has been slower than anticipated primarily due to COVID-19 restrictions. Given slower enrollment, the 6-month primary outcome data for OraGrowtH210 are now anticipated in the second half of 2023.

The stock was down 9.71% at $8.46 in after-hours trading.

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

Chembio Announces $28.3M Worth Orders For COVID-19 Antigen Test From Brazilian Government

Chembio said it received a $28.3 million purchase order from Bio-Manguinhos for the purchase of its DPP SARS-CoV-2 antigen tests for delivery during 2021 to support the urgent needs of Brazil's Ministry of Health in addressing the COVID-19 pandemic.

Chembio's delivery of the full number of tests covered by the purchase order may be affected by limitations of Chembio's supply chain, staffing, and liquidity, and other matters outside Chembio's control.

In premarket trading, the stock was jumping 103.88% to $4.20.

Roche's Venclexta Gets Breakthrough Designation For Blood Cancer

Roche Holding AG (OTC:RHHBY) announced its Venclexta, in combination with azacytidine, has been granted breakthrough therapy designation by the FDA for the treatment of adult patients with previously untreated intermediate, high- and very high-risk myelodysplastic syndromes.

Earnings

Johnson & Johnson's (NYSE:JNJ) second-quarter sales climbed 27.1% year-over-year to $23.312 billion and adjusted earnings per share climbed from $1.67 to $2.48.

Including COVID-19 sales, the company expects 2021 operational sales of $92.5 billion to $93.3 billion and adjusted EPS of $9.60-$9.70. This represented an upward revision from the estimates issued in April.

The stock was seen up 1.03% at $170.19 in premarket trading.

The stock was up 0.85% at $91.01 in premarket trading.

Intuitive Surgical, Inc. (NYSE:ISRG) said second-quarter revenues jumped 72% year-over-year to $1.46 billion and non-GAAP net income climbed from $1.11 to $3.92. The results exceeded expectations.

The stock was adding 2.82% to $982 in premarket trading.

Offerings

Acutus Medical, Inc. (NASDAQ:AFIB) priced its underwritten public offering of 5.5 million shares of its common stock at $14 per share. All of the shares of common stock are being offered by Acutus. The gross proceeds from the offering are expected to be $77 million.
The stock was adding 4.17% to $14 in premarket trading.

Natera, Inc. (NASDAQ:NTRA) announced the launch of a proposed follow-on public offering of $350 million of shares of its common stock.