The Daily Biotech Pulse: Illumina Lights Up, Cara Soars On Index Inclusion, Novavax Starts Crossover Vaccine Study, Turning Point Data Readout

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 April 5)

• Aclaris Therapeutics, Inc. ACRS
• Cara Therapeutics, Inc. CARA
• Gain Therapeutics, Inc. GANX
• IDEAYA Biosciences, Inc. IDYA
• Magenta Therapeutics, Inc. MGTA
• MiMedx Group, Inc. MDXG
• PPD, Inc. PPD
• Surmodics, Inc. SRDX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows April 5)

• ACADIA Pharmaceuticals Inc. ACAD (received a complete response letter for dementia drug)
• Achilles Therapeutics plc ACHL (went public Wednesday)
• Coherus BioSciences, Inc. CHRS
• Gracell Biotechnologies Inc. GRCL
• Landos Biopharma, Inc. LABP
• Lucira Health, Inc. LHDX
• Metacrine, Inc. MTCR

Stocks In Focus

Illumina Issues Positive Preannouncement For Q1, Lifts FY21 Guidance

Illumina, Inc. ILMN announced preliminary first-quarter revenue and upwardly revised its revenue guidance for fiscal year 2021.

The company expects revenue of $1.085 billion for the first quarter, representing 26% year-over-year growth. Analysts, on average, estimate revenue of $945.23 million for the quarter.

The company attributed the strength to record orders of $1.4 billion, sequencing consumables growth of about 25% and sequencing instrument growth of 120%.

Illumina raised its 2021 revenue growth guidance from 17%-20% to 25%-28%, ahead of the consensus forecast of 21.6% growth.

The stock was up 9.22% premarket at $420. 

Cara To Join S&P SmallCap 600 Index

Standard & Poor's announced that Cara Therapeutics, Inc. CARA will replace MTS Systems Corp. MTSC in the S&P SmallCap 600 effective prior to the opening of trading on Thursday.

This follows MTS Systems being acquired by Amphenol Corp. APH

The stock was up 12.05% premarket at $26.69. 

Turning Point's Drug Shows Promise In Treating RET-Altered Cancers In Phase 1/2 Study

Turning Point Therapeutics, Inc. TPTX announced initial data from the Phase 1/2 dose-finding study of TPX-0046, which showed clinical activity, including objective responses and a generally well-tolerated safety profile. TPX-0046 is being evaluated for RET-altered non-small cell lung cancer or medullary thyroid cancer.

Tumor regression was seen in four of the five patients who were not previously treated with a targeted theory known as tyrosine kinase inhibitors, while in TKI-pretreated patients, tumor regression was seen in three of the nine participants.

The company said it continues to evaluate doses and schedules to determine a recommended Phase 2 dose. It also plans to revise the study protocol to include Phase 1 expansion cohorts at the recommended Phase 2 dose.

The stock shed 6.17% to $84.40 in after-hours trading.

Novavax Commences Crossover Study In Ongoing COVID-19 Trials In UK, South Africa

Novavax, Inc. NVAX announced the initiation of crossover arms in two clinical trials of NVX-CoV2373, its COVID-19 vaccine candidate.

For those participating in the ongoing trials who elect to receive an additional round of injections, an additional two-dose regimen of either vaccine for those who were put on placebo or placebo for those who were given the vaccine will be administered. This will ensure all trial participants receive active vaccine.

While the crossover study has begun for the South African and U.K. trial, the company is planning a crossover in the ongoing PREVENT-19 Phase 3 study in the U.S. and Mexico. The company expects an initial readout from the PREVENT-19 trial in the second quarter.

The company is also planning to expand the PREVENT-19 trial to include pediatric and adolescent arms, which are also expected to begin in the second quarter.

The stock was up 0.71% premarket at $178.54. 

Related Link: The Week Ahead In Biotech: Regeneron, Supernus FDA Decisions, Cancer Conference Presentations In The Spotlight

Biodesix Announces 2 Patent Awards For Blood-Based Immunotherapy, Pipeline Testing

Biodesix, Inc. BDSX announced two patent awards by the U.S. Patent and Trademark Office that will enhance its ability to develop blood-based immunotherapy and pipeline testing strategies.

Dynavax Says COVID-19 Vaccine Using Its Adjuvant Aces Phase 1/2 Study

Dynavax Technologies Corporation DVAX said the French biopharma Valneva reported positive initial results for Part A of the Phase 1/2 clinical trial of Valneva's inactivated COVID-19 vaccine candidate VLA2001 using Dynavax's CpG 1018 adjuvant in 153 healthy adults ages 18-55. 

Valneva plans to commence a pivotal Phase 3 clinical trial by the end of April 2021, subject to regulatory approval.

The stock was up 2.74% to $10.11 in premarket trading Tuesday.

Opiant Commences Head-To-Head Comparison Study To Evaluate Opioid Overdose Drug

Opiant Pharmaceuticals, Inc. OPNT said the first subjects were dosed in a head-to-head clinical study comparing the effectiveness of its investigational opioid antagonist OPNT003, nasal nalmefene, with nasal naloxone.

The study in heathy volunteers will evaluate the effectiveness of 3mg nasal nalmefene in comparison to 4 mg nasal naloxone to reverse the respiratory depression produced by the synthetic opioid remifentanil. Top-line data from the trial is expected in the fourth quarter of 2021.

The stock was up 0.89% premarket at $11.30. 

Nkarta Rises On Fund Buying

Nkarta, Inc. NKTX gained ground after a filing revealed that RA Capital Management, which is a 10% stake owner in the biopharma, bought 568,033 shares in the company priced at $32.90 each. 

In after-hours trading, the stock added 4.42% to $35.

HTG Molecular Expects Q1 Revenue To Miss Consensus On COVID-19 Resurgence

HTG Molecular Diagnostics, Inc. HTGM said it expects its 2021 revenue to increase by 30%-40% year-over-year. The resurgence of COVID-19 has impacted first-quarter results, with the impact expected to continue at least through the first half of 2021, the company said. 

For the first quarter, the company expects revenue of about $1.4 million, below the $2.39-million consensus estimate. Cash, cash equivalents and short-tern marketable securities are expected at about $30.8 million as of March 31.

The stock fell 7.21% to $5.28 in after-hours trading.

Aptinyx Resumes Suspended Midstage Parkinson's Disease Study

Aptinyx Inc. APTX said patient screening has resumed in a Phase 2 study of NYX-458 in patients with mild cognitive impairment and mild dementia associated with Parkinson's disease and dementia with Lewy bodies. The study was temporarily suspended due to the escalation of the COVID-19 pandemic.

The company expects data readout from the study in the second half of 2022.

The stock was adding 6.52% to $3.43 in premarket trading Tuesday.

Landos Receives Approval To Commence Clinical Study Of Omilancor In Esophageal Inflammation

Landos said the FDA has cleared its investigational new drug application for omilancor in development for the treatment of eosinophilic esophagitis. The company expects to initiate patient dosing in the first half of 2022.

Offerings

Maravai LifeSciences Holdings, Inc. MRVI announced the commencement of a public offering of its Class A common stock by certain selling stockholders. The selling stockholders are offering 15 million shares of the company's Class A common stock. The company said it will not receive any proceeds from the offering.

The stock was down 1.62% premarket at $34.02. 

XOMA Corporation XOMA said it has commenced an underwritten registered public offering of depositary shares, each representing 1/1000th fractional interest in a share of its Series B cumulative perpetual preferred stock.

The company said it expects to use the net proceeds of this offering to fund the segregated dividend account and the remaining net proceeds for general corporate purposes, including funding future acquisitions of milestone and royalty rights associated with drug development programs with third-party funding.

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