The Daily Biotech Pulse: Merck's Breakthrough Therapy Designation, Sonoma Surges On Sanitizer News, Sanofi-Glaxo And More

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs July 28)

• Axonics Modulation Technologies Inc AXNX
• Capricor Therapeutics Inc CAPR
• Fulgent Genetics Inc FLGT
• ITAMAR MED LTD/S ADR ITMR
• Medpace Holdings Inc MEDP (saw an extension of its earnings-induced momentum)
• NeoGenomics, Inc. NEO(reacted to its second-quarter results)
• OncoSec Medical Inc ONCS
• Penumbra Inc PEN
• Qiagen NV QGEN
• TFF Pharmaceuticals Inc TFFP
• Trevena Inc TRVN
• X T L Biopharmaceuticals Ltd XTLB
• Zoetis Inc ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 28)

• Nkarta Inc NKTX
• Nurix Therapeutics Inc NRIX(IPOed Friday)
• Verrica Pharmaceuticals Inc VRCA
• Sonnet BioTherapeutics Holdings, Inc. SONN

Stocks In Focus

Alector Slips After Presenting Dementia Drug Trial Results

Alector Inc ALEC announced at the virtual 2020 Alzheimer's Association International Conference, or AAIC, preliminary results from a Phase 1b and open-label Phase 2 studies of AL001 for the treatment of people with frontotemporal dementia with a progranulin gene mutation, or FTD-GRN, with the Phase 1 study showing AL001 was generally safe and well-tolerated.

The company also said the Phase 2 study showed that treatment with AL001 resulted in sustained restoration of plasma progranulin levels in all FTD-GRN participants back to normal range and the majority of symptomatic FTD-GRN participants showed a decrease in plasma neurofilament light chain levels from baseline.

The stock fell 10.97% to $19 in after-hours trading.

Sonoma's Sanitizer Meets Standards For Use In Aircraft

Sonoma Pharmaceuticals Inc SNOA and its distribution partner MicroSafe Group Dubai announced that Microsafe Disinfectant & Sanitizer manufactured by Sonoma successfully passed both the Boeing Co BA Specification Standard BSS7434 and the British Aerospace Airbus SE EADSY specification AIMS09-00-002.

The passing of these tests validate the compatibility and safety of the product on the interior and exterior parts and materials of Boeing and Airbus commercial transport aircraft, Sonoma said.

Sonoma shares jumped 70.28% to $11 in after-hours trading.

Sanofi-Glaxo Agrees to Supply U.K. 60M Doses of Coronavirus Vaccine

Sanofi SA SNY and GlaxoSmithKline plc GSK said they have reached an agreement, subject to final contract, with the U.K. government for the supply of up to 60 million doses of a COVID-19 vaccine.

The companies expect a Phase 1/2 study to start in September, followed by a Phase 3 study by the end of 2020. The companies are also in talk with the European Commission, France and Italy and also other governments to ensure global access to the vaccine.

Separately, Sanofi reported a 4.9% drop in first-half sales but business EPS grew 9.2%. The company raised its full-year EPS growth forecast.

Merck's Oncology Drug Gets Breakthrough Designation

Merck & Co., Inc. MRK said the FDA has granted Breakthrough Therapy designation to the hypoxia-inducible factor-2 alpha inhibitor MK-6482, a novel investigational candidate in its oncology pipeline, for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma. The FDA also granted orphan drug designation to MK-6482 for VHL disease.

Roche's COVID-19 Treatment Candidate Flunks a Late-stage Study

Roche Holdings AG's RHHBY Genetech unit said a Phase III COVACTA study of Actemra did not meet its primary endpoint of improved clinical status in hospitalized adult patients with severe COVID-19 associated pneumonia. Key secondary endpoints, which included the difference in patient mortality at week four, were not met, the company said.

Pacira Reaches $3.5M Settlement Agreements With Respect to Its Non-opioid Pain Drug

Pacira Biosciences Inc PCRX announced settlement agreements that resolve all outstanding investigations and claims by the U.S. Department of Justice, the U.S. Department of Health and Human Services, various States Attorneys' General, and a private plaintiff. The company, however, said, it expressly denies all allegations and contentions and has admitted no wrongdoing in connection with the settlement agreements.

The five-year investigation related to the sale and marketing of Exparel, Pacira's long-acting non-opioid local analgesic for postsurgical pain management. Under the various settlement agreements, Pacira will pay about $3.5 million.

Earnings

Masimo Corporation MASI reported second-quarter revenues rose 31% to $301 million and non-GAAP net income climbed from 76 cents to 85 cents, while analysts estimated EPS of 81 cents. The company did not give guidance, citing COVID-19 uncertainties.

The stock moved down 3.12% to $228 in after-hours trading.

AtriCure Inc.'s ATRC second-quarter revenues fell 30.7% to $40.8 million, and net loss per share widened from 11 cents to 20 cents. Analysts estimated a loss of 57 cents per share.

In after-hours trading, the stock was down 3.09% to $43.29.

Amgen, Inc. AMGN second-quarter revenues rose 6% to $6.2 billion and non-GAAP EPS increased 7% to $4.25, ahead of the $3.82 consensus estimate. The company maintained its full-year revenue guidance and upwardly revised its non-GAAP EPS guidance.

The stock moved down 1.48% to $251.50 in after-hours trading.

Offerings

Arcturus Therapeutics Holdings Inc ARCT priced its underwritten public offering of 3.264 million shares of its common stock at $53 per share, for raising gross proceeds of about $173 million. The company said it intends to use the net proceeds of the offering to develop, test and manufacture the Company's LUNAR-COV19 vaccine candidate, among other things.

The stock slid 5.40% to $52.60 in after-hours trading.

Sunesis Pharmaceuticals, Inc. SNSS said it intends to offer shares of its common stock in an underwritten public offering. The net proceeds would be used to fund ongoing development of PDK1 inhibitor SNS-510 and general corporate purposes, it added.

In after-hours trading, the stock was down 11.57% to 35 cents.

ESSA Pharma Inc EPIX said it has priced an underwritten public offering of 7.1 million shares at $6 per share, for generating net proceeds of $39 million. The net proceeds would be used for pre-clinical and clinical activities, chemistry, manufacturing and controls, R&D, as well as working capital and general corporate purposes, the company added.

On The Radar

Clinical Readouts

AC Immune SA ACIU is due to present at the AAIC key data on its alpha-synuclein-positron emission tomography tracer program along with a second oral presentation of the Phase 1b trial of the anti-Abeta vaccine ACI-24 in Down syndrome.

Earnings

Boston Scientific Corporation BSX (before the market open)
Alkermes Plc ALKS (before the market open)
United Therapeutics Corporation UTHR (before the market open)
Hologic, Inc. HOLX (after the close)
Alimera Sciences Inc ALIM (after the close)
Merit Medical Systems, Inc. MMSI (after the close)
Taro Pharmaceutical Industries Ltd. TARO (after the close)
Viking Therapeutics Inc VKTX (after the close)