The Daily Biotech Pulse: J&J, Novartis Report Solid Results, Chembio Soars On COVID Test Order, Lumos Signals Clinical Trial Delay

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)

• Alnylam Pharmaceuticals, Inc. ALNY
• Biohaven Pharmaceutical Holding Company Ltd. BHVN
• Bio-Techne Corporation TECH
• Dicerna Pharmaceuticals, Inc. DRNA
• Erasca, Inc. ERAS (IPOed Friday)
• Forward Pharma A/S FWP
• Legend Biotech Corporation LEGN
• Moderna, Inc. MRNA (announced deal to supply additional vaccine doses to Japan)
• NeuroMetrix, Inc. NURO (received FDA breakthrough therapy designation for its neurostimulation device in the treatment of fibromyalgia)
• PLx Pharma Inc. PLXP (announced availability of its liquid-filled aspirin capsules in Walgreens stores in August)
• Protagonist Therapeutics, Inc. PTGX
• ResMed Inc. NRMD

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 20)

• 4D pharma plc LBPS
• AbCellera Biologics Inc. ABCL
• Adaptimmune Therapeutics plc ADAP
• Aerovate Therapeutics, Inc. AVTE (IPOed June 30)
• Ardelyx, Inc. ARDX ( flagged a potential regulatory delay for the approval of tenapanor)
• Assertio Holdings, Inc. ASRT
• Biodesix, Inc. BDSX
• BiondVax Pharmaceuticals Ltd. BVXV
• Chembio Diagnostics, Inc. CEMI
• CytomX Therapeutics, Inc. CTMX
• Ensysce Biosciences, Inc. ENSC
• ERYTECH Pharma S.A. ERYP
• Freeline Therapeutics Holdings plc FRLN
• Global Blood Therapeutics, Inc. GBT
• Liminal BioSciences Inc. LMNL
• Lumos Pharma, Inc. LUMO
• Madrigal Pharmaceuticals, Inc. MDGL
• Medicenna Therapeutics Corp. MDNA
• Mersana Therapeutics, Inc. MRSN
• MorphoSys AG MOR
• Orchard Therapeutics plc ORTX
• Otonomy, Inc. OTIC
• Outset Medical, Inc. OM
• Pharming Group N.V. PHAR
• POINT Biopharma Global Inc. PNT
• Regencell Bioscience Holdings Limited RGC (IPOed Friday)
• Sera Prognostics, Inc. SERA (IPOed Thursday)
• Singular Genomics Systems, Inc. OMIC
• Sonoma Pharmaceuticals, Inc. SNOA
• Tiziana Life Sciences PLC TLSA
• TScan Therapeutics, Inc. TCRX (IPOed Friday)
• Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Lumos Announces Potential Delay In Pediatric Growth Hormone Deficiency Studies

Giving a clinical trial update, Lumos Pharma, Inc. 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 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 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.

Novartis AG NVS reported that its second-quarter sales rose 14% to $12.96 billion and its core operating income climbed 18% to $4.35 billion. The core EPS climbed from $1.36 to $1.66, ahead of the $1.52 per share consensus estimate. The company guided to second-quarter net sales growth in mid-single digit range in 2021, while core operating income is expected to grow mid-single digit in constant currency.

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

Intuitive Surgical, Inc. 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. 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. NTRA announced the launch of a proposed follow-on public offering of $350 million of shares of its common stock.