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 6)
- Ambrx Biopharma Inc. AMAM
- Alkermes plc ALKS
- Clearside Biomedical, Inc. CLSD
- Connect Biopharma Holdings Limited CNTB
- Dicerna Pharmaceuticals, Inc. DRNA
- Elevation Oncology, Inc. ELEV (IPOed June 25)
- Intuitive Surgical, Inc. ISRG
- IVERIC bio, Inc. ISEE (announced receipt of written FDA agreement regarding design of a pivotal study of Zimura in geographic atrophy)
- Recursion Pharmaceuticals, Inc. RXRX
- Syneos Health, Inc. SYNH
- West Pharmaceutical Services, Inc. WST
- Zoetis Inc. ZTS
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows July 6)
- 89bio, Inc. ETNB
- AbCellera Biologics Inc. ABCL
- Achilles Therapeutics plc ACHL
- Acurx Pharmaceuticals, Inc. ACXP (IPOed June 25)
- Agile Therapeutics, Inc. AGRX
- Angion Biomedica Corp. ANGN
- Assembly Biosciences, Inc. ASMB
- Aziyo Biologics, Inc. AZYO
- Baudax Bio, Inc. BXRX
- Biophytis SA BPTS
- BioXcel Therapeutics, Inc. BTAI
- Black Diamond Therapeutics, Inc. BDTX
- Bolt Biotherapeutics, Inc. BOLT
- Celyad Oncology SA CYAD
- Checkmate Pharmaceuticals, Inc. CMPI
- Chembio Diagnostics, Inc. CEMI
- CytomX Therapeutics, Inc. CTMX
- CVRx, Inc. CVRX (IPOed June 30)
- DURECT Corporation DRRX
- Galapagos NV GLPG
- Gemini Therapeutics, Inc. GMTX
- Ikena Oncology, Inc. IKNA
- IMV Inc. IMV
- Kala Pharmaceuticals, Inc. KALA
- Mersana Therapeutics, Inc. MRSN
- Nabriva Therapeutics plc NBRV
- NeuBase Therapeutics, Inc. NBSE
- NexImmune, Inc. NEXI
- NuCana plc NCNA
- Pharvaris N.V. PHVS
- POINT Biopharma Global Inc. PNT (debuted Thursday following a SPAC deal)
- Provention Bio, Inc. PRVB (received a complete response letter for its diabetes treatment)
- Sensei Biotherapeutics, Inc. SNSE
- Terns Pharmaceuticals, Inc. TERN
- Theravance Biopharma, Inc. TBPH
- VectivBio Holding AG VECT
- Vivos Therapeutics, Inc. VVOS
- Voyager Therapeutics, Inc. VYGR
- Yumanity Therapeutics, Inc. YMTX
Stocks In Focus
Opiant Announces Positive Pharmacokinetic Data For Nasal Spray of Opioid Overdose Drug
Opiant Pharmaceuticals, Inc. OPNT announced positive topline results from its confirmatory pharmacokinetic study for OPNT003, nasal nalmefene, for opioid overdose.
The study was conducted in 68 healthy subjects and compared OPNT003, nalmefene hydrochloride nasal spray, 3 mg, with an intramuscular nalmefene hydrochloride injection, 1 mg, which was the comparator previously agreed upon with FDA.
According to initial analysis, the topline data demonstrated that nasal nalmefene achieved significantly higher plasma concentrations compared to an intramuscular injection. The time for nasal nalmefene to achieve maximum plasma concentrations was consistent with data from the previously completed pilot study.
"We are very pleased with the results of this confirmatory PK study. Importantly, the data are consistent with the findings of our initial pilot study," said Roger Crystal, CEO and President, of Opiant.
The stock was up 38.44% at $18.35 in premarket trading.
OncoSec Strikes Clinical Trial Collaboration with Merck For Study of Combo Therapy In Advanced Skin Cancer Patients
OncoSec Medical Incorporated ONCS announced it has entered into a clinical trial collaboration and supply agreement with Merck & Co., Inc. MRK to evaluate the combination of OncoSec's DNA-plasmid interleukin-12 Tavo with Merck's anti-PD-1 therapy, Keytruda in a global Phase 3 study dubbed, KEYNOTE-C87.
The planned clinical trial, the company said, will evaluate the overall survival of patients treated with the Tavo in combination with Keytruda versus standard of care in late-stage patients with metastatic melanoma who are refractory to immune checkpoint therapy.
Under the terms of the Agreement, Merck will provide Keytruda while OncoSec will provide the investigational drug, Tavo Each party will be responsible for its own internal costs, with OncoSec covering third party costs.
OncoSec shares were jumping 32.97% to $3.71 in premarket trading.
Seelos Announces Positive Pre-clinical Data For Parkinson's Disease Treatment
Seelos Therapeutics, Inc. SEEL announced positive in vivo data demonstrating down-regulation of SNCA mRNA and protein-expression from a study of SLS-004 in an in-vivo rodent model utilizing CRISPR-dCas9 gene therapy technology.
A single dose of SLS-004 produced a therapeutically desirable 27% reduction on SNCA mRNA and a 40% reduction in SNCA protein expression.
The SNCA gene has been implicated as a highly significant genetic risk factor for Parkinson's disease.
Biohaven Reports Strong Migraine Drug Sales For Q2
Biohaven Pharmaceutical Holding Company Ltd. BHVN announced preliminary net product revenue of $93 million from sales of Nurtec ODT in the second quarter. Analysts, on average, estimate total revenues of $54.72 million for the quarter.
The stock was rallying 6.22% to $105 in premarket trading.
ImmuCell Pre-announces Product Sales Growth of 53% For Q2
ImmuCell Corporation ICCC announced preliminary, unaudited sales results for the second quarter, expecting total product sales of $4.5 million, up 53% year-over-year.
"This level of quarterly sales is a near record for us, second only to the $4.9 million we recorded during the seasonally-high first quarter of 2020. We expect to report a 10%, or $773,000, increase in total product sales to approximately $8.6 million during the six-month period ended June 30, 2021, versus the same period of the prior year," said Michael Brigham, President and CEO of ImmuCell.
Arbutus Gets FDA Nod to Proceed With Phase 2a Study of AB-729 For Patients With Chronic Hepatitis B Virus Infection
Arbutus Biopharma Corporation ABUS said it has received authorization from FDA to proceed with its investigational new drug application for AB-729 in a Phase 2a clinical trial. The Phase 2a proof-of-concept clinical trial will evaluate the safety and efficacy of AB-729 in combination with ongoing nucleos(t)ide analog therapy and short courses of Peg-IFNα-2a in subjects with chronic hepatitis B virus infection.
Eloxx to Present Data From Phase 2 Cystic Fibrosis Study In Q4
Eloxx Pharmaceuticals, Inc. ELOXX said it expects to present data from the first four treatment arms of the global Phase 2 clinical program for ELX-02 for the treatment of cystic fibrosis in patients with at least one G542X allele, in the fourth quarter.
The company said it will continue to enroll additional patients to support Phase 3 clinical trial planning. The Phase 2 trials are designed to evaluate the safety of ELX-02 and assess its biological activity.
In premarket trading, the stock was up 3.63% at $2.
NextCure Commences Phase 1/2 Study of NC762 In Solid Tumors
NextCure, Inc. NXTC announced the initiation of a Phase 1/2 clinical trial for NC762, a humanized B7-H4 monoclonal antibody, in solid tumors.
The company expects to report initial data from this trial in mid-2022.
XBiotech Announces $2.50/Share Special Dividend
XBiotech Inc. XBIT said its board has declared an extraordinary cash dividend of approximately $2.50 per share, or up to an aggregate of $75 million, to holders of its common stock. This one-time, special dividend will be payable on July 23 to stockholders of record at the close of business on July 16.
The stock was up 6.23% at $17.06 in premarket trading.
IDEAYA Biosciences, Inc. IDYA said it intends to offer and sell up to $80 million of shares of its common stock in an underwritten public offering.
The stock was slipping 8.49% at $20.79 in premarket trading.
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