The Daily Biotech Pulse: Merck's Disappointing Q2, Atreca Falls On Data, FDA Nod For Viatris, Nuvalent, Icosavax IPOs - iShares Biotechnology ETF (NASDAQ:IBB)

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 28)

AbbVie Inc. ABBV
Alkermes plc ALKS (reacted to second-quarter results)
Arvinas, Inc. ARVN
Bio-Rad Laboratories, Inc. BIO
BioNTech SE BNTX (reacted to COVID-19 vaccine sales revealed by Pfizer, Inc. in its quarterly results)
Cassava Sciences, Inc. SAVA (saw an acceleration in momentum set in motion by Alzheimer's data release)
Edwards Lifesciences Corporation EW
Globus Medical, Inc. GMED
Horizon Therapeutics Public Limited Company HZNP
Ironwood Pharmaceuticals, Inc. IRWD
Merit Medical Systems, Inc. MMSI
Repligen Corporation RGEN (reacted to second-quarter results)
ResMed Inc. RMD
West Pharmaceutical Services, Inc. WST
Translate Bio, Inc. TBIO

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 28)

89bio, Inc. ETNB
Acumen Pharmaceuticals, Inc. ABOS
Adicet Bio, Inc. ACET
Aerovate Therapeutics, Inc. AVTE
Biodesix, Inc. BDSX
Candel Therapeutics, Inc. Common Stock CADL (IPOed Tuesday)
Eledon Pharmaceuticals, Inc. ELDN
Ensysce Biosciences, Inc. ENSC
ERYTECH Pharma S.A. ERYP
Heron Therapeutics, Inc. HRTX
Ikena Oncology, Inc. IKNA
InflaRx N.V. IFRX
Lumos Pharma, Inc. LUMO
Lyell Immunopharma, Inc. LYEL
Metacrine, Inc. MTCR
Mirum Pharmaceuticals, Inc. MIRM
MorphoSys AG MOR
Nautilus Biotechnology, Inc. NAUT
NexImmune, Inc. NEXI
Otonomy, Inc. OTIC
Oyster Point Pharma, Inc. OYST
Scopus BioPharma Inc. SCPS (IPOed July 15)
Sera Prognostics, Inc. SERA (IPOed July 22)
Sophia Genetics SA SOPH (IPOed Friday)
Universe Pharmaceuticals INC UPC
Yumanity Therapeutics, Inc. YMTX
ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

FDA Approves Fusion Pharma's Clinical Study of Investigational Radiopharmaceutical

Fusion Pharmaceuticals Inc. FUSN said the Food and Drug Administration has cleared its investigational new drug applications FPI-1966 and imaging agent FPI-1967. FPI-1966 is a targeted alpha therapy designed to use vofatamab, a human monoclonal antibody, to target and deliver actinium-225 to tumor sites expressing fibroblast growth factor 3, a protein that is overexpressed in multiple tumor types, particularly head and neck and bladder cancers.

Fusion said it plans to initiate a Phase 1, non-randomized, open-label clinical trial in patients with solid tumors expressing FGFR3 intended to investigate safety, tolerability and pharmacokinetics and to establish the recommended Phase 2 dose.

The stock was up 12.55% at $9.24 in premarket trading.

Satsuma Commences Phase 3 Study Of Migraine Treatment Candidate STS101

Satsuma Pharmaceuticals, Inc. STSA announced randomization of the first subject in its SUMMIT Phase 3 efficacy trial of STS101 for the acute treatment of migraine.

"We believe SUMMIT will provide the basis for STS101, with subsequent FDA approval, to become the first and only DHE product to have established efficacy on the current standard and FDA-accepted endpoints for acute treatment of migraine in a randomized, placebo-controlled trial," said John Kollin, CEO of Satsuma.

The stock was gaining 6.54% to $5.70 in premarket trading.

Atreca Shares Slump On Cancer Drug Data

Atreca, Inc. BCEL announced initial data from the dose escalation portion of its ongoing Phase 1b trial evaluating ATRC-101 in select solid tumor types, showing the investigational asset was well-tolerated. Preliminary biomarker data supported the proposed mechanism of action found in preclinical studies.

"We anticipate reporting additional data from monotherapy dose expansion cohorts in the Phase 1b trial and from combination cohorts evaluating ATRC-101 with pembrolizumab in 2022, and initiating additional combination cohorts evaluating ATRC-101 with chemotherapy later this year," the company said.

The stock was shedding 19.61% to $6.60 in premarket trading.

Roche's Regulatory Application For Faricimab In Retinal Disorders Accepted For Priority Review In US

Roche Holding AG RHHBY said the FDA has accepted for priority review its biologics license application for faricimab for the treatment of neovascular or wet age-related macular degeneration and diabetic macular edema. The FDA has also accepted the company's submission for diabetic retinopathy.

Separately, Roche said the New England Journal of Medicine has published positive data from FIREFISH Part 2, a pivotal global study evaluating the efficacy and safety of Evrysdi in babies aged one to seven months old with symptomatic Type 1 spinal muscular atrophy.

Regeneron-Sanofi's Dupixent Aces Pivotal Late-Stage Skin Inflammatory Disease Study

Regeneron Pharmaceuticals, Inc. REGN and Sanofi SNY said a pivotal Phase 3 trial evaluating Dupixent in patients with moderate-to-severe chronic spontaneous urticaria, an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at 24 weeks.

Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-naïve patients, compared to those treated with antihistamines alone (placebo) in Study A of the LIBERTY CUPID clinical program., the companies said.

4D Pharma Secures $30M In Debt Financing

4D pharma plc LBPS announced the closing of a senior secured credit facility for up to $30 million with Oxford Finance, a specialty finance firm that provides senior debt to life sciences and health care services companies.

In premarket trading, the stock was up 4.1% at $9.84.

Marker Therapeutics' New Texas Manufacturing Facility Becomes Fully Functional

Marker Therapeutics, Inc. MRKR announced that its new cGMP manufacturing facility in Houston, Texas, located near the George Bush Intercontinental Airport, is fully operational.

The facility will manufacture Marker's MultiTAA-specific T cell products for the Phase 2 acute myeloid leukemia trial as well as future hematological and solid tumor trials, in addition to producing the potential commercial supply of any approved products.

In premarket trading, the stock was adding 5.02% to $2.30.

Viatris Gets FDA Approval For First Interchangeable Diabetes Biosimilar

The FDA approved Viatris Inc.'s VTRS Semglee, the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults and pediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.

It is both biosimilar to, and interchangeable with its reference product Lantus, a long-acting insulin analog, marketed by Sanofi.

Viatris is codeveloping Semglee with India's Biocon.

Viatris was up 4.92% at $14.93 in premarket trading.

Heron Announces Positive Data For Non-Opioid Pain Medication In Hernia Repair Surgery

Heron announced the results from the HOPE Hernia-1 study of Zynrelef in hernia repair surgery have been published online by Pain and Therapy.

In this study, Zynrelef, used with scheduled over-the-counter oral analgesics and a personalized opioid prescription algorithm in a real-world environment, enabled more than 90% of patients to be discharged without an opioid prescription, with no callbacks for pain management and 95% of patients to recover opioid-free.

Rhythm Pharma Announces Clinical Collaboration For Studying Ultra-Rare Genetic Disease

Rhythm Pharmaceuticals, Inc. RYTM announced a collaborative research agreement with the Clinical Registry Investigating Bardet-Biedl Syndrome.

Under the collaboration, health outcomes researchers will review data collected through registry questionnaires to quantify and describe unmet medical needs of adults and children with BBS and the impact severe obesity and hyperphagia has on them.

BBS is an ultra-rare genetic disease that affects multiple organ systems.

UroGen Announces Licensing, Supply Deal For Jelmyto In Israel

UroGen Pharma Ltd URGN announced an exclusive license for Neopharm to market and sell Jelmyto for pyelocalyceal solution in Israel, subject to regulatory approval. Jelmyto is the first and only FDA approved medicine for adult patients with low-grade upper tract urothelial cancer.

Earnings

Exact Sciences Corporation EXAS reported second-quarter revenues of $434.8 million, up 62% year-over-year, while the net loss widened from 45 cents per share to $1.03 per share. Analysts, on average, estimated a loss of 76 cents per share. The company raised its full-year revenue guidance, although it revised its screening revenue guidance lower.

The stock was slipping 6.94% at $108 in premarket trading.

On The Radar

PDUFA Dates

The FDA is scheduled to announce its verdict on Ardelyx, Inc.'s ARDX NDA for tenapanor as a treatment option for hyperphosphatemia. The company announced in mid-July the FDA communicated that it has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time.

Clinical Readouts

Alzheimer's Association International Conference Presentations

Alector, Inc. ALEC: six- and 12-month data from the open-label Phase 2 INFRONT-2 study evaluating AL001 in individuals with frontotemporal dementia due to a progranulin gene mutation.

Cassava Sciences, Inc. SAVA: results of an interim analysis of safety and cognition data from the Phase 2b open-label extension study of simufilam in patients with Alzheimer's disease.

Earnings

Merck & Co., Inc. MRK (Q2 Revenues at $11.4 billion, up 22%, and non-GAAP EPS $1.31, both missing consensus, FY21 guidance below consensus)
AstraZeneca plc AZN (before the market open)
Intercept Pharmaceuticals, Inc. ICPT (before the market open)
NovoCure Limited NVCR (before the market open)
Morphosys (before the market open)
West Pharmaceutical (before the market open)
Laboratory Corporation of America Holdings LH (before the market open)
Agios Pharmaceuticals, Inc. AGIO (before the market open)
Blueprint Medicines Corporation BPMC (before the market open)
Evelo Biosciences, Inc. EVLO (before the market open)
Travere Therapeutics, Inc. TVTX (after the close)
Emergent BioSolutions Inc. EBS (after the close)
Bio-Rad Laboratories, Inc. BIO (after the close)
Seagen Inc. SGEN (after the close)
QIAGEN N.V. QGEN (after the close)
Gilead Sciences, Inc. GILD (after the close)
OPKO Health, Inc. OPK (after the close)
Veracyte, Inc. VCYT (after the close)
Ligand Pharmaceuticals Incorporated LGND (after the close)
PTC Therapeutics, Inc. PTCT (after the close)
Silk Road Medical, Inc SILK (after the close)
Vertex Pharmaceuticals Incorporated VRTX (after the close)
DexCom, Inc. DXCM (after the close)
CareDx, Inc CDNA (after the close)
Edwards Lifesciences Corporation EW (after the close)
Corcept Therapeutics Incorporated CORT (after the close)
Merit Medical Systems (after the close)

IPOs

Nuvalent, Inc., NUVL a biopharma focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, priced its initial public offering of 9.75 million shares of common stock, consisting of 9.15 million shares of Class A common stock and 600,000 shares of Class B common stock, each at a price to the public of $17 per share. All shares are being offered by Nuvalent.

The gross proceeds to Nuvalent from the offering are expected to be approximately $165.75 million. The Class A common stock is expected to begin trading on the Nasdaq under the ticker symbol "NUVL."

Icosavax, Inc. ICVX, a biopharma leveraging its innovative virus-like particle platform technology to develop vaccines against infectious diseases, priced its upsized IPO of 12.13 million shares at $15 per share. All of the shares are being offered by Icosavax. The gross proceeds from the offering are expected to be approximately $182 million. The shares are expected to begin trading on the Nasdaq under the ticker symbol "ICVX."

Market News and Data brought to you by Benzinga APIs