The Daily Biotech Pulse: Erytech Jumps On Fast Track Designation, GlaxoSmithKline FDA Nod, Alnylam's Clinical Collaboration, 4 IPOs

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 29)

• AbbVie Inc. ABBV
• Absci, CORP ABSI (IPOed July 22)
• Alkermes plc ALKS
• Arvinas, Inc. ARVN
• Axonics, Inc. AXNX
• Bio-Rad Laboratories, Inc. BIO
• Biohaven Pharmaceutical Holding Company Ltd. BHVN
• Bristol-Myers Squibb Company BMY
• Bio-Techne Corporation TECH
• BioNTech SE BNTX
• Cassava Sciences, Inc. SAVA (retreated after hitting a high early in the session)
• DexCom, Inc. DXCM
• Edwards Lifesciences Corporation EW
• Erasca, Inc. ERAS (IPOed July 16)
• Globus Medical, Inc. GMED
• Horizon Therapeutics Public Limited Company HZNP
• Innoviva, Inc. INVA (reacted to its second-quarter results)
• Ironwood Pharmaceuticals, Inc. IRWD
• Merit Medical Systems, Inc. MMSI
• Protagonist Therapeutics, Inc. PTGX (announced an amended R&D collaboration agreement with Johnson & Johnson's JNJ Janssen unit)
• ResMed Inc. RMD
• West Pharmaceutical Services, Inc. WST
• Translate Bio, Inc. TBIO (announced its second-quarter results)
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 28)

• 23andMe Holding Co. ME (reacted to its second-quarter results)
• 89bio, Inc. ETNB
• Adicet Bio, Inc. ACET
• Atreca, Inc. BCEL ( announced initial Phase 1b data from the study evaluating ATRC-101 in select solid tumor types)
• Candel Therapeutics, Inc. Common Stock CADL (IPOed Tuesday)
• Ensysce Biosciences, Inc. ENSC
• ERYTECH Pharma S.A. ERYP
• EyeGate Pharmaceuticals, Inc. EYEG
• Lumos Pharma, Inc. LUMO
• Mersana Therapeutics, Inc. MRSN
• Orchard Therapeutics plc ORTX
• Oyster Point Pharma, Inc. OYST
• Palisade Bio, Inc. PALI (announced topline Phase 2 clinical trial data for LB1148 in accelerating the return of bowel function in patients undergoing elective bowel resection surgery)
• Sophia Genetics SA SOPH (IPOed Friday)
• Taysha Gene Therapies, Inc. TSHA

Stocks In Focus

Erytech Eryapase Gets Fast Track Designation For Blood Cancer Treatment

Erytech said the FDA has granted its eryaspase fast track designation for the treatment of acute lymphocytic leukemia patients who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.

The stock was up 57.66% at $6.48 in premarket trading.

Bioventus to Buy Misonix In a Cash and Stock Deal Valued at $518M

Bioventus Inc. BVS announced an agreement to buy Misonix, Inc. MSON in a cash-and-stock deal. Under the terms of the agreement, Misonix stockholders will receive aggregate consideration that values Misonix at approximately $518 million on a fully diluted basis.

In premarket trading, Misonix was gaining 9.06% to $26, while Bioventus was losing 1.45% to $17.

Biogen, Eisai Announces Design of Phase 4 Study of Aduhelm In Alzheimer's Disease

Biogen, Inc. BIIB presented at the Alzheimer's Association International Conference the proposed design of the first real-world observational Phase 4 study, dubbed ICARE AD-US, of Aduhelm in Alzheimer's disease.

Aduhelm is co-developed by Biogen and Eisai Co., Ltd. ESALY

Biogen said the ICARE AD-US is one of the three programs to generate post-approval data on Aduhelm, including the re-dosing Phase 3b EMBARK study and the planned confirmatory Phase 4 post-marketing requirement study.

Separately, Biogen and Eisai announced at the conference results of a longitudinal preliminary assessment of the clinical effects of lecanemab, or BAN2401, following 18 months of treatment in the open-label extension of the Phase 2b proof-of-concept study in subjects with early Alzheimer's disease.

GlaxoSmithKline's Nucala Approved In U.S. For Treating Rhinosinusitis With Nasal Polyps

GlaxoSmithKline plc BMY said the FDA has approved Nucala, a monoclonal antibody that targets interleukin-5, as a treatment for patients with chronic rhinosinusitis with nasal polyps. This new indication for mepolizumab is for the add-on maintenance treatment of CRSwNP in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

Bristol-Myers Squibb's Opdivo Gets European Nod For Stomach Cancer

Bristol-Myers Squibb announced that the European Commission has approved Opdivo for the adjuvant treatment of adult patients with esophageal or gastroesophageal junction cancer who have residual pathologic disease following prior neoadjuvant chemoradiotherapy.

NuVasive's Pulse Platform Gets FDA Clearance

NuVasive, Inc. NUVA said it received FDA 510(k) clearance for its Pulse platform. In addition, the company announced the commercial launch of Pulse which is now available for sale in targeted global regions.

Alnylam Announces Collaboration to Develop Peptide-siRNA Conjugates For Delivering RNAi Therapeutics Outside Liver

Alnylam Pharmaceuticals, Inc. ALNY and Japan's PeptiDream announced a license and collaboration agreement to discover and develop peptide-siRNA conjugates to create multiple opportunities to deliver RNAi therapeutics to tissues outside the liver.

Under the terms of the alliance, Alnylam will select a set of receptors and PeptiDream will select, optimize, and synthesize peptides for each receptor. Alnylam will then generate peptide-siRNA conjugates and perform in vitro and in vivo studies to support final peptide selection.

The agreement provides for PeptiDream receiving an upfront payment as well as R&D funding over the term of the research collaboration. PeptiDream may also receive payments based on the achievement of specified development, regulatory, and commercial milestones potentially totaling up to $2.2 billion. In addition, PeptiDream is eligible to receive low-to-mid single digit royalties on sales on any such　Alnylam products.

aTyr Announces Award of Patent Covering Use of Lead Drug For Reducing Inflammatory Response In Lungs

aTyr Pharma, Inc. LIFE announced that the U.S. Patent and Trademark Office has granted a patent covering methods for the use of histidyl-tRNA synthetase Fc fusion proteins for reducing inflammatory response in the lung. The patent covers the use of the company's lead therapeutic candidate, ATYR1923, for reducing inflammatory response in the lung.

The stock was adding 1.31% to $4.64 in premarket trading.

BeiGene Announces Positive Phase 3 Data For Brukinsa In Blood Cancer Patients

BeiGene, Ltd. BGNE announced positive topline results from an interim analysis of the Phase 3 SEQUOIA trial comparing Brukinsa to bendamustine and rituximab in patients with treatment-naïve chronic lymphocytic leukemia or small lymphocytic lymphoma, whose tumor did not exhibit the deletion of chromosome 17p13.1.

Earnings

Medtech company Zynex, Inc. ZYXI reported 61% year-over-year revenue growth to $31 million in the second quarter, just shy of the consensus estimate of $31.31 million. The EPS, however, fell from 9 cents to 8 cents.

In premarket trading, the stock was receding 8.72% to $15.28.

Gilead Sciences, Inc. GILD reported second-quarter revenues of $6.2 billion for the second quarter, up 21% year-over-year. The company's non-GAAP EPS jumped 68% to $1.87. It guided 2021 product sales to $24.4 billion to $25 billion and non-GAAP EPS to $6.90-$7.25.

The results were ahead of expectations and the guidance was in line.

The shares were down 1.48% at $68.80.

Offerings

RedHill Biopharma Ltd. RDHL said in a filing it may offer to the public from time to time in one or more series or issuances, ADSs, ordinary shares, warrants, subscription rights and/or units consisting of two or more of these classes or series of securities, worth up to $200 million in total. Each ADS represents 10 of ordinary Shares.

In premarket trading, the stock was slipping 7.12% to $6.13.

On The Radar

Earnings

AbbVie Inc. ABBV (before the market open)
ImmunoGen, Inc. IMGN (before the market open)
Lexicon Pharmaceuticals, Inc. LXRX (before the market open)

IPOs

Immuneering Corporation IMRX, a biopharma advancing a robust pipeline of oncology and neuroscience product candidates designed to uniquely disrupt cellular signaling dynamics, priced its upsized initial public offering of 7.5 million shares of Class A common stock at $15 per share, for total gross proceeds of $112.5 million.

The Class A common stock is expected to begin trading on the Nasdaq under the ticker symbol "IMRX."

MaxCyte, Inc., MXCN, a provider of cell-engineering platform technologies, priced its upsized IPO of 13.5 million shares of common stock at $13.00 per share. The company expects gross proceeds of $175.5 million from the offering. The shares will begin trading on the Nasdaq under the ticker symbol "MXCN."

RxSight, Inc., RXST an ophthalmic medical device company, priced its IPO of 7.35 million shares of common stock at $16 per share. The gross proceeds to RxSight from the offering are expected to be $117.6 million. RxSight's common stock is expected to begin trading on the Nasdaq under the ticker symbol "RXST."

IN8bio, Inc. INAB, a clinical-stage biopharma focused on the development of gamma-delta T cell therapies utilizing its DeltEx platform priced its IPO of 4 million shares at $10 per share. IN8bio's common stock is expected to begin trading on The Nasdaq Global Market on July 30, 2021, under the symbol "INAB."