The Daily Biotech Pulse: ScPharma's Positive Data, Lilly Goes Shopping, LeMaitre Pre-Announces Q2 Revenues

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 13)

• Biohaven Pharmaceutical Holding Company Ltd. . BHVN
• AngioDynamics, Inc. ANGO (reacted to its fiscal-year 2021 fourth-quarter results)
• Bicycle Therapeutics plc BCYC (announced Ionis Pharmaceuticals, Inc. IONS exercised option to use its tissue-targeted delivery of oligonucleotide therapeutics tech)
• Celldex Therapeutics, Inc. CLDX
• Forward Pharma A/S FWP
• Intuitive Surgical, Inc. ISRG
• PLx Pharma Inc. PLXP (announced availability of FDA-approved liquid-filled aspirin capsules in Walmart Inc. WMT stores)
• Recursion Pharmaceuticals, Inc. RXRX
• Unicycive Therapeutics, Inc. UNCY (IPOed Tuesday)
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 13)

• AbCellera Biologics Inc. ABCL
• Achilles Therapeutics plc ACHL
• Adicet Bio, Inc. ACET
• Allogene Therapeutics, Inc. ALLO
• Aptose Biosciences Inc. APTO
• Avenue Therapeutics, Inc. ATXI
• Aziyo Biologics, Inc. AZYO
• BioXcel Therapeutics, Inc. BTAI
• Black Diamond Therapeutics, Inc. BDTX
• Codex DNA, Inc. DNAY
• Concert Pharmaceuticals, Inc. CNCE
• Cogent Biosciences, Inc. COGT
• Cue Biopharma, Inc. CUE
• CytomX Therapeutics, Inc. CTMX
• DURECT Corporation DRRX
• Foghorn Therapeutics Inc. FHTX
• HOOKIPA Pharma Inc. HOOK
• Ikena Oncology, Inc. IKNA
• iRhythm Technologies, Inc. IRTC
• Kala Pharmaceuticals, Inc. KALA
• Kiromic BioPharma, Inc. KRBP
• Leap Therapeutics, Inc. LPTX
• Medicenna Therapeutics Corp. MDNA
• Mersana Therapeutics, Inc. MRSN
• Minerva Neurosciences, Inc. NERV
• Miromatrix Medical Inc. MIRO
• Molecular Templates, Inc. MTEM
• Neoleukin Therapeutics, Inc. NLTX
• NextCure, Inc. NXTC
• NuCana plc NCNA
• Nymox Pharmaceutical Corporation NYMX
• Orchard Therapeutics plc ORTX
• PolyPid Ltd. PYPD
• Sensei Biotherapeutics, Inc. SNSE
• Sigilon Therapeutics, Inc. SGTX
• Singular Genomics Systems, Inc. OMIC
• Terns Pharmaceuticals, Inc. TERN
• TransCode Therapeutics, Inc. RNAZ (IPOed Friday)
• uniQure N.V. QURE
• Universe Pharmaceuticals INC UPC
• Vor Biopharma Inc. VOR

Stocks In Focus

ScPharma Reports Positive Results For Chronic Heart Failure Treatment

scPharmaceuticals Inc. SCPH announced positive topline results from its FREEDOM-HF study that is evaluating overall and heart failure-related costs of treating congestion in patients with chronic heart failure. Patients were treated with Furoscix, the company's investigational product, post-discharge from the emergency department compared to a historical comparator group that was treated with intravenous furosemide in the inpatient hospital setting.

The mean difference in heart failure-related costs between the two groups was $17,753 per study subject, favoring the Furoscix group.
Additional analyses, including 30-day overall healthcare cost, quality of life as well as patient and caregiver satisfaction, are ongoing and complete data will be submitted for publication or presentation at an upcoming scientific meeting, the company said.

The stock was up 4.41% at $6.87 in premarket trading.

Madrigal Commences Phase 3 Open-label Extension Study of Resmetirom In NAFLD Patients

Madrigal Pharmaceuticals, Inc. MDGL announced the first patient was dosed in a planned 52-week open label active treatment extension study of MAESTRO-NAFLD-1, a 52-week Phase 3 study of resmetirom in patients with non-alcoholic fatty liver disease, presumed non-alcoholic steatohepatitis.

The study is due to complete later this year with measures of safety and efficacy including reduction in imaging and biomarker measures of NASH, as well as the lowering of LDL-cholesterol and other atherogenic lipids.

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

SI-BONE's SI Joint Fusion Now Covered By Centene

SI-BONE, Inc., SIBN announced that Centene Corporation CNC has established a positive coverage policy for minimally invasive SI joint fusion.

The new Centene policy considers minimally invasive sacroiliac joint fusion medically necessary for the treatment of low back and buttock pain when certain criteria are met. This decision was based upon the extensive amount of published clinical evidence and reviews demonstrating the safety and effectiveness of the iFuse Implant System.

Lilly to Buy The Remainder of The Stake It Already Does Not Own In Promoter Technologies

Eli Lilly and Company LLY announced the acquisition of Protomer Technologies, a private biotech company. Protomer's proprietary peptide- and protein-engineering platform is used to identify and synthesize molecules that can sense glucose or other endogenous modulators of protein activity.

The transaction is valued at over $1 billion, contingent on achievement of future development and commercial milestones. Lilly previously led an equity investment in Protomer alongside the JDRF T1D Fund, providing it with 14 percent ownership of the company. Lilly is acquiring the remainder of the stock of Protomer beyond its initial investment.

Hologic Gets CE Mark Approval For Use of Saliva Samples With COVID-19 Molecular Diagnostic Test

Hologic, Inc. HOLX said it has obtained a CE Mark for the use of saliva samples with the Aptima SARS-CoV-2 assay in Europe. The Aptima SARS-CoV-2 test is a molecular diagnostic assay that detects the genetic material of the pathogen causing COVID-19. The test runs on the fully automated Panther system.

The stock was up 1.97% at $70 in premarket trading.

LeMaitre Preannounced Q2 Outperformance, to Offer 1M In Stock

LeMaitre Vascular, Inc. LMAT priced an underwritten public offering of 1 million shares of its common stock at $54.50 per share. Gross proceeds to LeMaitre from the offering are expected to be approximately $54.5 million. The offering is expected to close on or about July 16, subject to customary closing conditions.

The company announced preliminary second-quarter results, expecting net sales of $40.7 million, up 64% year-over-year, and gross margin of 65.5%-66.1%. The company expects operating income of $10.9 million to $11.3 million, with the midpoint of the guidance range representing a 128% increase.

Analysts, on average, estimate revenues of $37.97 million for the quarter.

The stock was retreating 7.96% to $55.25 in premarket trading.

Offerings

IMARA Inc. IMRA priced its previously announced underwritten public offering of shares of its common stock at $6 per share, for gross proceeds of $50 million. The offering is expected to close on July 16, subject to customary closing conditions. All shares are being offered by the company.

In premarket trading, the stock was slumping 15.37% to $6.

Allena Pharmaceuticals, Inc. ALNA announced it has entered into definitive agreements with several healthcare-focused institutional and accredited investors for the purchase and sale of 21.36 million shares of its common stock and warrants to purchase up to an aggregate of 10.68 million shares at a purchase price of $1.311 per share and associated warrant, in a registered direct offering priced at-the-market.

The warrants have an exercise price of $1.25 per share, are exercisable immediately and have a term of five years.

The gross proceeds from the offering are expected to be approximately $28 million.

The stock was dropping 18.71% at $1.13 in premarket trading.