The Daily Biotech Pulse: Dicerna Slips On Data, Novavax Tightlipped On US Vaccine Approval, Adagio IPO

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 Aug. 5)

• Alkermes plc ALKS
• Alnylam Pharmaceuticals, Inc. ALNY
• AtriCure, Inc. ATRC (reacted to its second-quarter results)
• Bio-Rad Laboratories, Inc. BIO
• Bio-Techne Corporation TECH (announced its fourth-quarter results)
• BioCryst Pharmaceuticals, Inc. BCRX (reacted to its second-quarter results)
• Caribou Biosciences, Inc. CRBU (IPOed July 23)
• Celldex Therapeutics, Inc. CLDX
• Cortexyme, Inc. CRTX
• Erasca, Inc. ERAS (IPOed July 16)
• Edwards Lifesciences Corporation EW
• Genmab A/S GMAB
• Immuneering Corporation IMRX (IPOed July 30)
• Innoviva, Inc. INVA
• Impel NeuroPharma, Inc. IMPL
• Intuitive Surgical, Inc. ISRG (announced a 3-for-1 stock split)
• Maravai LifeSciences Holdings, Inc. MRVI
• Moderna, Inc. MRNA
• Monte Rosa Therapeutics, Inc. GLUE
• Novo Nordisk A/S NVO (reacted to half-yearly results)
• Oramed Pharmaceuticals Inc. ORMP
• OrthoPediatrics Corp. KIDS (reacted to its second-quarter results)
• PAVmed Inc. PAVM
• Repligen Corporation RGEN
• West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 5)

• ACADIA Pharmaceuticals Inc. ACAD (reacted to its second-quarter results)
• Acurx Pharmaceuticals, Inc. ACXP
• Akero Therapeutics, Inc. AKRO
• Alzamend Neuro, Inc. ALZN
• Amryt Pharma plc AMYT (announced completion of Chiasma acquisition)
• Aridis Pharmaceuticals, Inc. ARDS
• Atai Life Sciences N.V. ATAI
• Athenex, Inc. ATNX (announced second-quarter results)
• AVROBIO, Inc. AVRO (reacted to second-quarter results)
• Aytu Biopharma, Inc. AYTU
• Avenue Therapeutics, Inc. ATXI
• Baxter International Inc. BAX
• Baudax Bio, Inc. BXRX (announced its second-quarter results)
• Catalyst Biosciences, Inc. CBIO (announced to second-quarter results)
• Cytosorbents Corporation CTSO
• Esperion Therapeutics, Inc. ESPR
• Exicure, Inc. XCUR
• EyeGate Pharmaceuticals, Inc. EYEG
• GlycoMimetics, Inc. GLYC (announced second-quarter results and the appointment of a new CEO)
• Immunic, Inc. IMUX
• Indaptus Therapeutics, Inc. Common Stock INDP (IPOed Wednesday)
• iRhythm Technologies, Inc. IRTC
• Kala Pharmaceuticals, Inc. KALA (announced its second-quarter results)
• Karyopharm Therapeutics Inc. KPTI
• Kinnate Biopharma Inc. KNTE
• Magenta Therapeutics, Inc. MGTA (announced second-quarter results)
• MaxCyte, Inc. MXCT
• Nevro Corp. NVRO ( reacted to quarterly results)
• Orphazyme A/S ORPH
• Otonomy, Inc. OTIC (reacted to its second-quarter results)
• Outset Medical, Inc. OM
• Pharming Group N.V. PHAR
• Pluristem Therapeutics Inc. PSTI
• Progenity, Inc. PROG
• Puma Biotechnology, Inc. PBYI
• Rhythm Pharmaceuticals, Inc. RYTM
• Rockwell Medical, Inc. RMTI
• RxSight, Inc. RXST (IPOed July 30)
• Spruce Biosciences, Inc. SPRB
• Stoke Therapeutics, Inc. STOK
• Talis Biomedical Corporation TLIS
• Unicycive Therapeutics, Inc. UNCY (IPOed July 13)
• VectivBio Holding AG VECT
• Vivos Therapeutics, Inc. VVOS
• Xeris Pharmaceuticals, Inc. XERS (announced second-quarter results)

Stocks In Focus

Dicerna Reports Positive Results from Pivotal Study of Nedosiran In Primary Hyperoxaluria

Dicerna Pharmaceuticals, Inc. DRNA announced positive top-line results from the PHYOX2 pivotal clinical trial of nedosiran, which is in development as a once-monthly treatment for primary hyperoxaluria. Nedosiran is Dicerna's lead GalXC RNAi therapeutic candidate.The PHYOX2 clinical trial included participants with PH subtypes 1 and 2.

Nedosiran achieved the primary endpoint in the PHYOX2 trial, demonstrating a statistically significant reduction from baseline in urinary oxalate excretion compared to placebo. The study also achieved the key secondary endpoint, with a significantly higher proportion of patients given nedosiran achieving and sustaining normal or near-normal Uox at two or more consecutive visits after Day 90 compared to placebo.

Uox reductions were significant in participants with PH1, while participants with PH2 showed inconsistent results in this trial, the company said.

Nedosiran was generally well tolerated in the study with an overall adverse event profile consistent with previously reported data from PHYOX trials.

The stock was plunging 26.87% to $27.73 in after-hours trading.

Click here to access Benzinga's FDA Calendar

Aprea's Myeloid Malignancy Program Placed On Partial Clinical Hold

Aprea Therapeutics, Inc. APRE said the Food and Drug Administration has placed a partial clinical hold on its clinical trials of eprenetapopt in combination with Bristol-Myers Squibb Company BMY's Vidaza in its myeloid malignancy programs.

The company clarified that the partial clinical hold does not apply to its ongoing clinical trials in lymphoid malignancies and solid tumors, or the APR-548 clinical trial.

The stock was slipping 9.77% to $3.88 in premarket trading.

Sierra Oncology In-licenses Myelofibrosis Drug From AstraZeneca

Sierra Oncology, Inc. SRRA said it has acquired an exclusive global license from AstraZeneca plc. AZN for AZD5153, a potent and selective BRD4 BET inhibitor with a novel bivalent binding mode.

Sierra plans to initiate a Phase 2 study examining momelotinib in combination with AZD5153 in myelofibrosis patients in the first-half of 2022.

Under the terms of the agreement, Sierra will pay AstraZeneca an upfront payment, as well as certain pre-determined development, regulatory and commercial milestones. In addition, Sierra will provide tiered royalty payments based on future commercial success.

Novavax Announces Positive Data For Booster Dose of COVID Vaccine; Q2 Results Trail Expectations

Novavax, Inc. NVAX announced preliminary data demonstrating that a single booster dose of its recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant, NVX-CoV2373, given six months after an initial two-dose regimen, elicited a 4.6-fold increase in functional antibody titers.

Additionally, functional ACE-2 binding inhibition antibodies cross-reactive with the Delta variant were more than 6-fold higher than the primary vaccination series.

Separately, the company announced along with its partner Serum Institute of India Pvt. Ltd, it has filed regulatory submissions for emergency use authorization of its vaccine in India, Indonesia and the Philippines.

The company announced second-quarter results that trailed expectations.

The stock was down 9.44% at $213.91 in premarket trading.

Athersys Announces Japanese Partner Reports Positive COVID-19 Study Data

Athersys, Inc. ATHX announced that its partner in Japan, HEALIOS has released positive topline data from its ONE-BRIDGE clinical trial evaluating the safety and efficacy of multiStem cell therapy invimestrocel in patients with acute respiratory distress syndrome.

In premarket trading, the stock was climbing 14.94% at $1.77.

Guardant Health Announces New Leadership Structure to Fuel Growth

Guardant Health, Inc. GH announced a new leadership structure to support the its strategic objectives for future growth. Under this structure, Helmy Eltoukhy, CEO, and AmirAli Talasaz, President, will serve as co-CEOs of Guardant Health.

Both Eltoukhy and Talasaz will continue to serve on the board and Eltoukhy will assume the role of chairman. In addition, Meghan Joyce, chief operating officer and EVP of Platform at Oscar Health, Inc. OSCR , will join the its board as an independent director.

Guardant Health shares were up 3.45% at $119.37 in premarket trading.

Ocular Says Regeneron Terminates a Licensing Agreement For Its Sustained-use Hydrogel Tech

Ocular Therapeutix, Inc. OCUL said Regeneron Pharmaceuticals, Inc. (REGN) has terminated an option and license agreement with the company. The agreement announced in 2016 envisaged development and commercialization of products containing Ocular's sustained-release hydrogel technology in combination with Regeneron's large molecule vascular endothelial growth factor-targeting compounds to address conditions of the eye.

Earnings

Aurinia Pharmaceuticals Inc. AUPH reported second-quarter revenues of $6.6 million, well ahead of the $40,000 consensus. The loss per share of 37 cents was wider than the consensus estimate.

The stock was soaring 15.29% to $13.50 in premarket trading.

Collegium Pharmaceutical, Inc. COLL said its second-quarter revenues increased from $78.06 million in 2020 to $82.94 million in 2021, missing the consensus estimate. The earnings per share climbed from 23 cents to $1.79. The company lowered its revenue guidance for 2021.

The stock was losing 10.63% to $22.20 in premarket trading.

Chembio Diagnostics, Inc. CEMI reported second-quarter revenues of $6.46 million, below the consensus estimate of $8.53 million. The loss per share widened from 45 cents to 42 cents.

The stock was slipping 13.35% to $3.05 in premarket trading.

Nabriva Therapeutics plc NBRV reported second-quarter results that exceeded expectations.

The stock was gaining 10.34 to $1.28 in premarket trading.

On The Radar

PDUFA Dates

The Food and Drug Administration is scheduled to announce its verdict on Eton Pharmaceuticals, Inc.'s ETON new drug application for topiramate oral solution.

The drug candidate is being evaluated as a treatment option for three indications – as a monotherapy for partial-onset or primary general tonic-clonic seizures in patients two years age and older, an adjunctive treatment of partial-onset seizures, including seizures associated with Lennox-Gastaut syndrome in patients two years of age and older, and as preventative treatment of migraine in patients 12 years of age and older.

Earnings

PLx Pharma Inc. PLXP (before the market open)
ANI Pharmaceuticals, Inc. ANIP (before the market open)
Twist Bioscience Corporation TWST (before the market open)
Oncolytics Biotech Inc. ONCY (before the market open)
Orthofix Medical Inc. OFIX (before the market open)
Meridian Bioscience, Inc. VIVO (before the market open)
Mersana Therapeutics, Inc. MRSN (before the market open)

IPOs

Adagio Therapeutics, Inc., ADGI, a clinical-stage biopharma focused on the development and commercialization of antibody-based solutions for infectious diseases with pandemic potential, priced its initial public offering of 18.2 million shares of common stock at a price to the public of $17 per share. The gross proceeds to Adagio from the offering are expected to be $309.4 million.
All of the shares are being offered by Adagio. The shares will begin trading on the Nasdaq under the symbol "ADGI."

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