The Daily Biotech Pulse: Novavax Vaccine Deals, Trevena Awaits FDA Decision, 2 IPOs

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 6)

• ADiTx Therapeutics Inc ADTX (announced introduction of AditxtScore for COVID-19 to be used in detecting antibodies against SARS-CoV-2 antigens)
• Axonics Modulation Technologies Inc AXNX
• Biocept Inc BIOC (announced an agreement with Aegea for a highly sensitive PCR-based assay designed by the latter for detecting the COVID-19 virus)
• DarioHealth Corp DRIO
• Denali Therapeutics Inc DNLI( announced selection of candidate to enter Phase 3 study in Parkinson's disease)
• Editas Medicine Inc EDIT(moved on M&A speculation)
• Emergent Biosolutions Inc EBS
• Halozyme Therapeutics, Inc. HALO
• Harvard Bioscience, Inc. HBIO
• ITAMAR MED LTD/S ADR ITMR
• Meridian Bioscience, Inc. VIVO
• Natera Inc NTRA
• PDL BioPharma Inc PDLI
• Sangamo Therapeutics Inc SGMO (reacted to its second-quarter results)
• Shockwave Medical Inc SWAV
• SurModics, Inc. SRDX(reacted to its second-quarter results)
• Twist Bioscience Corp TWST
• Unity Biotechnology Inc UBX
• Zoetis Inc ZTS (reacted to its second-quarter results)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 6)

• Nkarta Inc NKTX
• Orchard Therapeutics PLC – ADR ORTX(announced its second-quarter results)

Stocks In Focus

Zosano Clinches Distribution Deal For Investigational Migraine Patch

Zosano Pharma Corp ZSAN said it has partnered with Eversana commercialize and distribute Qtrypta in the U.S. Qtrypta is Zosano's transdermal microneedle product candidate for the acute treatment of migraine. In March, the FDA accepted a NDA for Qtrypta and granted a PDUFA goal date of October 20. If approved, Qtrypta would be the first and only microneedle patch indicated for the acute treatment of migraine, Zosano said.

The stock jumped 31.62% to $1.79 in after-hours trading.

FDA Approves ViiV's Two-Drug Combo Treatment

ViiV Healthcare, majority owned by GlaxoSmithKline plc GSK and Pfizer Inc. PFE, said the FDA approved Dovato - dolutegravir/lamivudine - as a complete regimen for the treatment of HIV-1 infection to replace the current antiretroviral regimen in adults who are virologically suppressed on a stable ARV regimen with no history of treatment failure and no known resistance to the individual components of Dovato.

Novavax Strikes Coronavirus Vaccine Agreements With Takeda, India's Serum Institute

Novavax, Inc. NVAX and Takeda Pharmaceutical Co Ltd TAK announced a partnership for the development of the former's COVID 19 vaccine candidate - NVX CoV2373 - in Japan.

Takeda is to receive funding from the Government of Japan's Ministry of Health, Labour and Welfare to support the technology transfer, establishment of infrastructure and scale-up of manufacturing. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year.

Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine.

Separately, Novavax announced a license agreement with Serum Institute of India Private Limited for the development and commercialization of NVX CoV237 in low- and middle-income countries and India. The companies hope to make available a minimum of 1 billion doses of NVX-CoV2373 for India and low- and middle-income countries.

Novavax shares were adding 2.21% to $171.20, while Takeda was gaining 1.81% to $18.52.

Co-Diagnostics' COVID-19 Tests Authorized In Australia

Co-Diagnostics Inc CODX said the Logix Smart COVID-19 for use in detecting SARS-CoV-2, the virus that causes COVID-19, has been authorized for use in Australian.

The stock was gaining 3.25% to $27 in premarket trading.

Roche's Tencentriq-chemo Combo Flunks Breast Cancer Study

Roche Holdings AG Basel ADR Common Stock RHHBY said the Phase 3 IMpassion131 study, evaluating Tecentriq in combination with paclitaxel, in comparison to placebo plus paclitaxel, did not meet statistical significance on its primary endpoint of progression-free survival for first-line treatment of people with metastatic triple-negative breast cancer, in the PD-L1-positive population.

CytoDyn To Request Pre-submission Meetings for Approval of Leronlimab For AIDS and COVID-19 In U.K.

CytoDyn Inc CYDY said it will submit requests for pre-submission meetings in the U.K. for leronlimab as a HIV treatment in combination with HAART for highly treatment experienced HIV patients, as well as for emergency approval of leronlimab for COVID-19 patients with mild-to-moderate symptoms.

Earnings

PDL Biopharma said its second-quarter revenues fell from $7.5 million in 2019 to $5.2 million in 2020. The loss per share widened from 43 cents to 4 cents, while analysts estimated a profit of 10 cents per share.

The stock plunged 13.84% to $3.02 in after-hours trading.

Adamas Pharmaceuticals Inc's ADMS second-quarter revenues climbed from $12.69 million in 2019 to $18.79 million in 2020, with Gocovri contributing $18 million, up 41% year-over-year. The net loss per share narrowed from 90 cents to 37 cents. Analysts had estimated a wider loss of 61 cents per share.

The stock jumped 18.77% to $3.10 in after-hours trading.

Coherus Biosciences Inc CHRS reported an increase in its second-quarter revenues from $83.43 million to $135.67 million, and earnings per share improved from 32 cents to 70 cents, while analysts expected earnings of 33 cents per share.

In after-hours trading, the stock advanced 13.10% to $19.69.

Illumina, Inc.'s ILMN second-quarter revenues fell 25% year-over-year to $633 million, and non-GAAP earnings per share fell from $1.99 to 32 cents.

The stock slid 12.10% to $351 in after-hours trading.

GW Pharmaceuticals PLC- ADR GWPH reported a year-over-year increase in second-quarter revenues from $72 million in 2019 to $121.3 million in 2020, with Epidiolex revenues at $117.7 million. The company reversed from a profit of 21 cents per share to a loss of 2 cents per share.

The stock slipped 9.16% to $120 in after-hours trading.

Applied DNA Sciences Inc's APDN fiscal-year third-quarter revenues fell 79% year-over-year to $432,000, with the steep drop reflecting a decrease in licensing revenue in the cannabis industry as well as cannabis feasibility pilots. The loss per share narrowed from $1.55 to 72 cents, but was wider than the consensus loss estimate of 67 cents per share.

The stock was retreating 15.68% to $9.25 in premarket trading Friday.

Capricor Therapeutics Inc CAPR reported a loss of 23 cents per share for its second quarter compared to a loss of 59 cents in the year-ago period. Analysts, on average, estimated a loss of 37 cents per share for the quarter.

"We are now well underway in animal studies and have seen promising results showing the mRNA vaccine is capable of generating an antibody response to multiple antigens expressed by COVID-19," the company said.

The stock was declining 11.39% to $7 in premarket trading Friday.

Vaxart Inc VXRT reported second-quarter revenues of $532,000 in 2020 compared to $85,000 a year-ago. The loss per share narrowed from 39 cents to 12 cents, while analysts estimated a loss of 6 cents per share.

Updating on the its coronavirus vaccine program, the company said it is now laser focused on preparing to enter a Phase 1 clinical trial with its lead COVID-19 vaccine candidate, which is an oral tablet.

In premarket trading, the stock was adding 11.82% to $10.17.

On The Radar

PDUFA Dates

Trevena Inc TRVN has a tryst with the FDA, with respect to its NDA for its pain drug oleceridine, which was once rejected by the agency on the premise of inadequacy of clinical data.

Earnings

Arbutus Biopharma Corp ABUS (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)
Ocular Therapeutix Inc OCUL (before the market open)
Mersana Therapeutics Inc MRSN (before the market open)
Jounce Therapeutics Inc JNCE (before the market open)
Replimune Group Inc REPL (before the market open)

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

IPOs

Freeline Therapeutics Holdings plc, a clinical-stage AAV-based gene therapy company focusing on inherited systemic debilitating diseases, priced its initial public offering, or IPO, of 8.824 million ADSs, representing 8.824 million ordinary shares, at $18 per share compared to the estimated price range of $16-$18, for generating gross proceeds of about $158.8 million. The shares will be listed on the Nasdaq under the ticker symbol FRLN. The offering is expected to close on Aug. 11.

Checkmate Pharmaceuticals, Inc., a clinical stage oncology-focused biotech, said it priced its IPO of 5 million shares at $15, at the midpoint of the estimated price range of $14-$16. The company expects to raise gross proceeds of $75 million from the offering. The shares will be listed on the Nasdaq under the ticker symbol CMPI.