The Daily Biotech Pulse: AstraZeneca, Biogen Face Clinical Trial Disappointments, Novavax Studies Coronavirus-Flu Combo Vaccine, Decision Day For Takeda

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 June 14)

Alkermes plc ALKS
Apellis Pharmaceuticals, Inc. APLS
Bio-Techne Corporation TECH
Centessa Pharmaceuticals Limited CNTA
Dicerna Pharmaceuticals, Inc. DRNA
Dr. Reddy's Laboratories Limited (NYSE: RDY
Edwards Lifesciences Corporation EW
Enochian Biosciences, Inc. ENOB (announced FDA acceptance of pre-IND application for investigational HIV therapy)
GT Biopharma, Inc. GTBP
Jazz Pharmaceuticals plc JAZZ
LeMaitre Vascular, Inc. LMAT
Maravai LifeSciences Holdings, Inc. MRVI
NovoCure Limited NVCR
Ortho Clinical Diagnostics Holdings plc OCDX
PPD, Inc. PPD
Protagonist Therapeutics, Inc. PTGX
Psychemedics Corporation PMD
RAPT Therapeutics, Inc. RAPT (moved in reaction to positive early stage results for atopic dermatitis candidate)
ResMed Inc. RMD - rose after Koninklijke Philips N.V. PHG recalled rival sleep device
Sesen Bio, Inc. SESN
ShockWave Medical, Inc. SWAV
Verastem, Inc. VSTM
Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 14)

Achilles Therapeutics plc ACHL
Avenue Therapeutics, Inc. ATXI (received a complete response letter to new drug application for non-opioid pain drug)
Bolt Biotherapeutics, Inc. BOLT
Ikena Oncology, Inc. IKNA
Janux Therapeutics, Inc. JANX (went public Friday)
Nautilus Biotechnology, Inc. NAUT (listed on Thursday through a SPAC deal)
Vertex Pharmaceuticals Incorporated VRTX

Stocks In Focus

Fusion Pharma Announces Positive Phase 1 Data For FPI-1434 In Multiple Tumor Types

Fusion Pharmaceuticals Inc. FSUN announced the presentation of preliminary Phase 1 data from the single-dose portion of the study at the Society of Nuclear Medicine and Molecular Imaging Virtual Annual Meeting, demonstrating that treatment with its actinium-based targeted alpha therapy FPI-1434 was well-tolerated, and imaging shows uptake of the drug across multiple tumor types.

"Importantly, these data supported our ability to initiate the multi-dosing portion of the study, in which we would expect to begin reaching total cumulative levels of radiation necessary to demonstrate anti-tumor activity," said CEO John Valliant.

In after-hours trading, the stock gained 10.54% to $9.02.

AstraZeneca's Antibody Cocktail Fails To Prevent Symptomatic COVID-19 In People Recently Exposed To Virus

AstraZeneca PLC AZN said the STORM CHASER trial assessing the safety and efficacy of iAZD7442, a long-acting antibody combination, for the prevention of symptomatic COVID-19 in participants recently exposed to the SARS-CoV-2 virus did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo.

In the overall trial population, AZD7442 reduced the risk of developing symptomatic COVID-19 by 33% compared to placebo, which was not statistically significant.

The company said it now awaits results from PROVENT, its pre-exposure prevention trial and TACKLE, its treatment trial in preventing more severe disease, to understand the potential role of AZD7442 in protecting against COVID-19.

Separately, the company said new data from Public Health England demonstrated two doses of its COVID-19 vaccine are 92% effective against hospitalization due to the Delta variant, aka the Indian variant, and showed no deaths among those vaccinated. The vaccine also showed a high level of effectiveness against the Alpha variant, aka the Kent variant, with an 86% reduction of hospitalizations and no deaths reported.

Novavax Announces Positive Results For Co-Administered COVID-19, Flu Vaccines

Novavax, Inc. NVAX announced data from the first co-administration study of a SARS-CoV-2 vaccine candidate — NVX-CoV2373 — and an approved influenza vaccine, or a cell-based, quadrivalent seasonal influenza vaccine, with the findings suggesting simultaneous vaccination may be a viable immunization strategy.

In addition, the protection afforded by the candidate vaccine was consistent with the main study at 87.5% and 89.8%, respectively.

"As the first clinical study to evaluate safety, immunogenicity, and efficacy of a COVID-19 vaccine when co-administered with a seasonal influenza vaccine, these results demonstrate the promising opportunity for concomitant vaccination, which may improve the uptake of both vaccines," said Gregory Glenn, CEO of Novavax.

The stock rose 0.52% to $208.80 in after-hours trading.

Biogen's Gene Therapy Flunks Late-Stage Study In Inherited Progressive Retinal Degeneration Disease

Biogen Inc. BIIB announced negative topline results from the Phase 3 STAR study of timrepigene emparvovec, an investigational gene therapy for the potential treatment of choroideremia.

The STAR study, the company said, did not meet its primary endpoint of proportion of participants with a 15-letter or more improvement from baseline in best corrected visual acuity at month 12, in the interventional group in comparison to the non-interventional control group, as measured by the Early Treatment of Diabetic Retinopathy Study chart.

In addition, the study did not demonstrate efficacy on key secondary endpoints. Safety results from the Phase 3 STAR study were consistent with previous studies.

The stock was down 1.26% at $401.01 in premarket trading.

Sage-Biogen Report Positive Late-Stage Results For Major Depressive Disorder Study

Sage Therapeutics, Inc. SAGE and Biogen announced that the WATERFALL Phase 3 study in patients with major depressive disorder met its primary endpoint with zuranolone (SAGE-217/BIIB125) 50 mg showing statistically significant improvement in depressive symptoms compared with placebo at day 15 as assessed by the 17-item Hamilton Rating Scale for Depression total score.

Sage shares were down 2.51% at $71.03 in premarket trading Tuesday.

Biodesix Commercially Launches Antigen Test To Detect Coronavirus

Biodesix, Inc. BDSX announced the broad commercial launch of a SARS CoV-2 neutralization antibody test named cPass.

The test uses ELISA technology to detect circulating neutralizing antibodies against the receptor binding domain of the SARS-CoV-2 virus and is the first and only surrogate neutralizing antibody test with FDA emergency use authorization.

The stock was adding 5.92% to $17 in premarket trading Tuesday.

Ampio Gets FDA Nod For Conducting COVID-19 Drug Study In India

Ampio Pharmaceuticals, Inc. AMPE announced it has received FDA approval to expand enrollment of its AP-019 Phase 2 study to India. The study will utilize inhaled Ampion to treat those suffering from respiratory distress due to COVID-19.

In premarket trading Tuesday, the stock was jumping 30.56% to $2.35.

Eloxx Shares Rally On Roche Stake

Eloxx Pharmaceuticals, Inc. ELOX shares rallied after a SEC filing revealed that Roche Holding AG's RHHBY finance unit has a 5.3% stake in the rare disease gene therapy company.

Eloxx shares spiked 15.58% to $2.30 in after-hours trading.

Avrobio Gains On Insider Buying

AVROBIO, Inc. AVRO revealed in a series of filings with the SEC, several of its executives acquired options to buy stocks in the company.

The stock rose 4.71% to $10.01 in after-hours trading.

Offerings

RAPT Therapeutics, Inc. RAPT announced that it has commenced an underwritten public offering of $125 million of its common stock. All of the shares of common stock are being offered by RAPT.

The stock rallied 13.77% to $45.52 in after-hours trading following a more than 100% gain in the regular session.

Protagonist Therapeutics, Inc. PTGX announced that it has commenced an underwritten public offering of $100 million of shares of its common stock. All of the shares of common stock are being offered by Protagonist.

The stock fell 4.52% to $39.25 in after-hours trading,

C4 Therapeutics, Inc. CCCC announced that it has launched a proposed public offering of 4.25 million shares of its common stock. All of the shares of common stock in the offering will be offered by the company.

The company said it intends to use the net proceeds of the offering to fund R&D activities.

In after-hours trading, the stock moved down 3.47% to $40.65.

PDS Biotechnology Corporation PDSB said it has commenced an underwritten public offering of shares of its common stock. All of the shares of common stock to be sold in the offering will be offered by the company.

PDS Biotech intends to use a portion of the net proceeds from this offering for the development of its clinical pipeline and for general corporate purposes including working capital.

The stock slumped 19.05% to $10.41 in after-hours trading.

On The Radar

PDUFA Date

The FDA is likely to announce by Tuesday, June 15 its decision on Takeda Pharmaceutical Company Limited's TAK new drug application for TAK-721 as a treatment option for eosinophilic esophagitis.

IPO

Alzamend Neuro, Inc., a preclinical stage biopharma focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, priced its initial public offering of 2.5 million shares of its common stock at a price to the public of $5 per share.

The gross proceeds from the offering to Alzamend are expected to be $12.5 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol "ALZN."

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