The Daily Biotech Pulse: Arcturus Soars On COVID-19 Vaccine Updates, Merck's Keytruda On Track For More Label Expansions, Eliem Debuts

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. 9)

• Adagio Therapeutics, Inc. ADGI (IPOed Friday)
• Alnylam Pharmaceuticals, Inc. ALNY
• Axonics, Inc. AXNX
• BioLife Solutions, Inc. BLFS (announced a deal to buy privately-held Sexton Biotech to expand cell and gene therapy tools portfolio)
• BioNTech SE BNTX (reacted to its quarterly results and raised vaccine sales forecast)
• Caribou Biosciences, Inc. CRBU (IPOed July 23)
• Cortexyme, Inc. CRTX (announced its second-quarter results)
• Cytokinetics, Incorporated CYTK
• Day One Biopharmaceuticals, Inc. DAWN
• Dynavax Technologies Corporation DVAX
• Edwards Lifesciences Corporation EW
• Eli Lilly and Company LLY
• Impel NeuroPharma, Inc. IMPL (announced publication of positive Phase 3 data for migraine treatment)
• Intersect ENT, Inc. XENT
• Intuitive Surgical, Inc. ISRG
• Maravai LifeSciences Holdings, Inc. MRVI
• Moderna, Inc. MRNA (reacted to continuing vaccine news flow)
• Monte Rosa Therapeutics, Inc. GLUE
• Oramed Pharmaceuticals Inc. ORMP
• OrthoPediatrics Corp. KIDS
• PAVmed Inc. PAVM
• Pfizer Inc. PFE
• Repligen Corporation RGEN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 9)

• Adicet Bio, Inc. ACET
• Akero Therapeutics, Inc. AKRO
• Arena Pharmaceuticals, Inc. ARNA
• Atai Life Sciences N.V. ATAI
• AVROBIO, Inc. AVRO
• Axsome Therapeutics, Inc. AXSM (communicated in its earnings release a potential delay in approval of its major depressive disorder treatment)
• Biophytis SA BPTS
• bluebird bio, Inc. BLUE (reacted to clinical hold imposed by the FDA on its gene therapy studies)
• CytomX Therapeutics, Inc. CTMX
• Epizyme, Inc. EPZM (announced its second-quarter results)
• Eton Pharmaceuticals, Inc. ETON (reacted to a 3-month delay in the review period for its antiepileptic topiramate oral solution)
• Exicure, Inc. XCUR
• EyeGate Pharmaceuticals, Inc. EYEG
• Flexion Therapeutics, Inc. FLXN
• Freeline Therapeutics Holdings plc FRLN
• Heron Therapeutics, Inc. HRTX
• Incyte Corporation INCY
• Inventiva S.A. IVA
• Itamar Medical Ltd. ITMR
• Kura Oncology, Inc. KURA
• Nektar Therapeutics NKTR
• Pharming Group N.V. PHAR
• Protara Therapeutics, Inc. TARA
• Pulmatrix, Inc. PULM
• Relmada Therapeutics, Inc. RLMD
• Spruce Biosciences, Inc. SPRB
• Teligent, Inc. TLGT
• TherapeuticsMD, Inc. TXMD
• VYNE Therapeutics Inc. VYNE
• ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

Arcturus' COVID-19 Vaccine Found Effective Against Variants In Animal Studies, to Commence Phase 3 Study

Arcturus Therapeutics Holdings Inc. ARCT announced updates on its COVID-19 vaccine program, including plans to begin Phase 3 study of its STARR mRNA vaccine candidate codenamed ARCT-154 in Vietnam. The company targets emergency use authorization filing in December,

ARCT-154 was found to produce robust neutralizing antibody titers against all variants, including the Delta variant, tested in primates, the company said. It also plans to begin a multinational Phase 3 efficacy study of its single-shot STARR RNA COVID-19 vaccine ARCT-021.

Arcturus also reported June quarter results, showing a decline in revenues from $2.3 million in 2020 to $2 million in 2021. The loss per share widened to 55 cents to $2.07.

The stock was climbing 37.83% to $66.49 in premarket trading.

Flexion Announces Publication of Positive Phase 2 Data For Zilretta In Osteoarthritis Shoulder Pain

Flexion announced publication in "Drugs in R&D" the results from the Phase 2 pharmacokinetic trial of Zilretta, showing Zilretta's release profile in the shoulder is consistent with what was observed in the knee, strengthening confidence in its to make a meaningful difference in the lives of people confronting OA shoulder pain.

The study compared the plasma PK profile of Zilretta to immediate-release triamcinolone acetonide in crystalline suspension and assessed the safety and general tolerability of it in osteoarthritis of the shoulder.

Organogenesis Gets Funding, Reports Q2 Beat

Organogenesis Holdings Inc. ORGO announced a new credit agreement with Silicon Valley Bank, the lead agent, and several other lenders, for a credit facility in the aggregate principal amount of $200 million, consisting of a $75 million term loan facility and a $125 million revolving credit facility.

Separately, the company reported second-quarter results, showing a 79% jump in revenues to $123.2 million and a net income of 15 cents per share, reversing from a year-ago loss of 5 cents per share. The results exceeded expectations.

The stock was rallying 4.72% to $15.52 in premarket trading.

Reata Reports Adverse Regulatory Development For Bardoxolone

Reata Pharmaceuticals, Inc. RETA said in a mid-cycle communication, the FDA identified four significant clinical and statistical review issues with respect to the new drug application the company filed for bardoxolone for the treatment of patients with chronic kidney disease caused by Alport syndrome. An Adcom meeting for reviewing the application is scheduled for Dec. 8, with the PDUFA goal date at Feb. 22, 2022.

On the registrational trial for bardoxolone in autosomal dominant polycystic kidney disease patients, the company said it had a Type B meeting with the FDA following which it said it plans to modify the protocol so that the primary endpoint will be the Year 2 off-treatment analysis.

Related Link: The Week Ahead In Biotech (Aug. 8-14): Jazz Pharma FDA Decision, Earnings Deluge and IPOs In The Spotlight

Merck's 2 Keytruda BLAs Accepted For Regulatory Reviews

Merck & Co, Inc. MRK said the FDA has accepted for review a new supplemental biologics license application, seeking approval for Keytruda as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.

The FDA has set a PDUFA date of March 28, 2022.

Separately, the company said the regulator has accepted and granted priority review for a new sBLA for Keytruda for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

The FDA has set a PDUFA goal date of Dec. 10.

The stock was edging up 0.37% to $75.60 in premarket trading.

Fulcrum Announces Positive Phase 1 Results For FTX-6058 as Potential Treatment Option For Hemoglobinopathies

Fulcrum Therapeutics, Inc. FULC announced positive interim results from the Phase 1 trial with FTX-6058 in healthy adult volunteers. FTX-6058 is an investigational asset with the potential to treat hemoglobinopathies, such as sickle cell disease and beta-thalassemia.

Results from the multiple ascending dose portion of the trial demonstrated proof of biology as evidenced by a dose proportional induction in HBG mRNA and accompanying increases in HbF-containing reticulocytes, the company said.

The stock was adding 6.84% to $8.90 in premarket trading.

Earnings

Halozyme Therapeutics, Inc. HALO reported second-quarter revenues of $136.5 million and non-GAAP EPS of 66 cents. The results exceeded estimates. The company raised its 2021 guidance.

In premarket trading, the stock was gaining 11.28% to $45.

Fulgent Genetics, Inc. FLGT said its second-quarter revenues jumped 790% year-over-year to $153.6 million, missing the $197.34 million consensus estimate. The company reported non-GAAP net income of $2.55 per share, below the $2.81 per share consensus estimate.

For the third quarter, the company expects revenues of $125 million to $150 million, with core revenues at about $32 million. The company guided to full-year revenues of $800 million, with core revenues at $110 million, and non-GAAP EPS of $12.50 per share. The guidance trailed expectations.

The stock was slipping 14.95% to $93.35 in after-hours trading.

On The Radar

Earnings

Harmony Biosciences Holdings, Inc. HRMY (before the market open)
TransDigm Group Incorporated TDG (before the market open)
Marinus Pharmaceuticals, Inc. MRNS (before the market open)
Fulcrum Therapeutics, Inc. FULC (before the market open)
BioXcel Therapeutics, Inc. BTAI (before the market open)
Matinas BioPharma Holdings, Inc. MTNB (before the market open)
Aptinyx Inc. APTX (before the market open)
aTyr Pharma, Inc. LIFE (after the close)
Akoya Biosciences, Inc. AKYA (after the close)
Talis Biomedical Corporation TLIS (after the close)
Clearside Biomedical, Inc. CLSD (after the close)
Bioventus Inc. BVS (after the close)
ClearPoint Neuro, Inc. CLPT (after the close)
Inari Medical, Inc. NARI (after the close)
Cumberland Pharmaceuticals Inc. CPIX (after the close)
OncoCyte Corporation OCX (after the close)
Maravai LifeSciences Holdings, Inc. MRVI (after the close)
KemPharm, Inc. KMPH (after the close)
Regulus Therapeutics Inc. RGLS (after the close)
Relmada Therapeutics, Inc. RLMD (after the close)
Neovasc Inc. NVCN (after the close)

Click here to access Benzinga's FDA Calendar

IPOs

Eliem Therapeutics, Inc. ELYM, which is developing therapies for neuronal excitability disorders, said it has priced its initial public offering of 6.4 million shares of common stock at 12.50 per share. All of the shares are being offered by Eliem. The gross proceeds of the offering are expected to be $80 million.

The shares will begin trading on the Nasdaq under the ticker symbol "ELYM."

PharmaCyte Biotech, Inc. PMCB, a biotech focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, announced uplisting of its shares to the Nasdaq under the ticker symbol PMCB.

The company also announced pricing of its previously announced offering, consisting of 3.53 million shares of its common stock (or pre-funded warrants to purchase common stock in lieu of common stock) and warrants to purchase up to an aggregate of 3.53 million shares of common stock.

PharmaCyte said it expects to receive gross proceeds from the underwritten public offering of approximately $15 million.