The Daily Biotech Pulse: FDA Nod For Merck-Eisai, Seres' Ulcerative Colitis Drug Flunks Midstage Study, Pfizer To Invest In Arvinas, Absci IPO

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 21)

• Biohaven Pharmaceutical Holding Company Ltd. BHVN
• Bio-Techne Corporation TECH
• BioNTech SE BNTX
• Cassava Sciences, Inc. SAVA
• Cortexyme, Inc. CRTX (announced new preclinical data for its lead drug candidate atuzaginstat in periodontal disease)
• Intuitive Surgical, Inc. ISRG (reacted to better-than-expected second-quarter results)
• Forward Pharma A/S FWP
• Legend Biotech Corporation LEGN
• NeuroMetrix, Inc. NURO
• Protagonist Therapeutics, Inc. PTGX

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 21)

• Aerovate Therapeutics, Inc. AVTE
• Cyteir Therapeutics, Inc. CYT
• Elevation Oncology, Inc. ELEV
• Ensysce Biosciences, Inc. ENSC
• ERYTECH Pharma S.A. ERYP
• HCW Biologics Inc. HCWB (IPOed Tuesday)
• Lumos Pharma, Inc. LUMO (signaled a delay in clinical trials of its treatment for pediatric growth deficiency)
• Medicenna Therapeutics Corp. MDNA
• Nautilus Biotechnology, Inc. NAUT
• OptiNose, Inc. OPTN
• POINT Biopharma Global Inc. PNT
• Regencell Bioscience Holdings Limited RGC (IPOed Friday)
• VectivBio Holding AG VECT
• Yumanity Therapeutics, Inc. YMTX

Stocks In Focus

Erytech Plans Regulatory Submission For Eryaspase In Blood Cancer Following Positive Pre-BLA Meeting

Erytech said it intends to move forward toward the submission of a biologic license application to the U.S. Food and Drug Administration for eryaspase in hypersensitive acute lymphoblastic leukemia patients following feedback from the agency in a pre-BLA meeting.

The purpose for the meeting was to discuss clinical, non-clinical and quality content and expectations for potential BLA submission. Based on the discussion and the totality of the available information to the company to date, Erytech said it believes its regulatory package can potentially support an approval of eryaspase in hypersensitive ALL patients. Pending successful completion of remaining steps, the company anticipates submitting a BLA in the fourth quarter of 2021.

The stock was up 4.36% at $4.55 in premarket trading.

Roche's Diagnostics Business Props Up First-Half Results

Roche reported group sales of 31 billion Swiss francs ($33.76 billion) in the first half, up 8% in constant currency. The company's net income based on IFRS standard rose 2% and core earnings climbed 6%. Diagnostics division sales climbed 51%, while revenues from the Pharmaceutical division slipped 8%. The company confirmed its 2021 outlook that calls for 8% sales growth in constant currency and core EPS of 10.56 Swiss francs, up from 10.44 Swiss francs a year earlier.

NRx Announces New Formulation, Manufacturing Scale-Up For COVID-19 Treatment

NRx Pharmaceuticals, Inc. NRXP said it has validated the first commercial formulation of Zyesami for intravenous use, allowing for high volume manufacturing, with an anticipated one year or greater stability under appropriate storage conditions.

Simultaneously, NRx has achieved a 30-to-50-fold increase in its manufactured lot size of aviptadil, with a concurrent 90% reduction in the cost of its peptide supply. These two developments position NRx to potentially deliver millions of doses of Zyesami as potential regulatory approvals are obtained in various regions worldwide.

The stock was up 29.57% at $13.10 in premarket trading.

Seres Midstage Ulcerative Colitis Study Fails To Meet Primary Endpoint

Seres Therapeutics, Inc. MCRB announced topline results from the Phase 2b ECO-RESET study evaluating SER-287 in patients with mild-to-moderate ulcerative colitis, showing the study did not meet its primary endpoint of improving clinical remission rates compared to placebo.

Both dosing regimens of SER-287 were generally well tolerated. Given the lack of a clinical efficacy signal identified in ECO-RESET, the company said it has decided to close the open label and maintenance portions of the study.

"As with SER-109, we will again follow the science and the data, conduct a rigorous scientific analysis, and determine the optimal path forward for our UC franchise," said Eric Shaff, CEO at Seres.

"We are well resourced and continue to prepare for SER-109 commercialization, in collaboration with Nestlé Health Science, and we are excited about advancing the development of our SER-301 and SER-155 investigational candidates as well as our earlier stage pipeline."

The stock was slumping 44.26% to $11.61 in premarket trading.

Related Link: The Week Ahead In Biotech: Earnings Kickstart With J&J And Biogen, Albireo Awaits FDA Decisions, More IPOs

Merck, Eisai Get FDA Approval For Keytruda-Lenvima Combo In Advanced Endometrial Cancer With Certain Mutations

Merck & Co, Inc. MRK and Eisai Inc. ESALY said the FDA has approved the combination of the former's Keytruda, plus the latter's Lenvima for the treatment of patients with advanced endometrial carcinoma that is not 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.

In premarket trading, Merck shares were up 0.37% at $76.67.

Pfizer, Arvinas To Collaborate On Breast Cancer Study

Pfizer Inc. PFE Arvinas, Inc. ARVN announced a global collaboration to develop and commercialize ARV-471, which is in a Phase 2 dose expansion clinical trial for the treatment of patients with estrogen receptor-positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.

Under the terms of the agreement, Pfizer will pay Arvinas $650 million upfront. Separately, Pfizer will make a $350-million equity investment in Arvinas. The companies will equally share worldwide development costs, commercialization expenses and profits.

In premarket trading, Pfizer shares were up 0.15% at $41.08 and Arvinas was rallying 6.06% to $82.25.

Offerings

TRACON Pharmaceuticals, Inc. TCON said it has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 3.927 million shares of common stock at a price of $3.82 per share.

In premarket trading, the stock was down 22.92% to $3.80.

On The Radar

Earnings

• Abbott Laboratories ABT (before the market open)
• Biogen Inc. BIIB (before the market open)
• Quest Diagnostics Incorporated DGX (before the market open)
• NeuroMetrix, Inc. NURO (before the market open)
• Plus Therapeutics, Inc. PSTV (after the close)

IPOs

Vancouver, Wisconsin-based Absci Corp priced its initial public offering of 12.5 million shares at $16, the midpoint of the estimated price range of $15-$17. The company's AI-powered Integrated Drug Creation Platform enables the creation of novel biologics by unifying biologic drug discovery and cell line development into one simultaneous process. The stock will begin trading on the Nasdaq under the ticker symbol ABSI.

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