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

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 28)

Stocks In Focus

FDA Approves Fusion Pharma's Clinical Study of Investigational Radiopharmaceutical

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. (NASDAQ: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. (NASDAQ: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 (OTC: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

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.

Related Link: The Week Ahead In Biotech: Big Pharma Earnings, Iterum FDA Decision, Alzheimer's Conference, IPOs and More

4D Pharma Secures $30M In Debt Financing

4D pharma plc (NASDAQ: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. (NASDAQ: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 (NASDAQ: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. (NASDAQ: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 (NASDAQ: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 (NASDAQ: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 (NASDAQ: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. (NASDAQ: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. (NASDAQ: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

IPOs

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."

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