The Daily Biotech Pulse: Sanofi Bets Big On mRNA Tech, Decision Day For MediWound, DiaMedica Issues Kidney Disease Data Readout

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 June 28)

• Alexion Pharmaceuticals, Inc. ALXN
• Anavex Life Sciences Corp. AVXL (announced positive Phase 2 data for Parkinson's disease dementia treatment)
• AtriCure, Inc. ATRC
• Avid Bioservices, Inc. CDMO (moved ahead of its earnings report)
• Axonics, Inc. AXNX
• Catalyst Pharmaceuticals, Inc. CPRX (announced out-licensing of Firdapse for rare autoimmune neuromuscular disorder)
• Celldex Therapeutics, Inc. CLDX
• Graphite Bio, Inc. GRPH (IPOed Friday)
• Globus Medical, Inc. GMED
• Harvard Bioscience, Inc. HBIO
• Horizon Therapeutics Public Limited Company HZNP
• Intellia Therapeutics, Inc. NTLA (reacted to positive Phase 1 data for gene editing therapy in treating transthyretin amyloidosis)
• Intuitive Surgical, Inc. ISRG
• MediWound Ltd. MDWD (moved ahead of a PDUFA event)
• Molecular Partners AG MOLN
• Protagonist Therapeutics, Inc. PTGX
• Verve Therapeutics, Inc. VERV
• West Pharmaceutical Services, Inc. WST
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 28)

• Achilles Therapeutics plc ACHL
• Elevation Oncology, Inc. ELEV (IPOed Friday)
• Exelixis, Inc. EXEL (reacted to negative Phase 3 readout for Cabometyx combo therapy in previously untreated liver cancer patients)
• Gemini Therapeutics, Inc. GMTX
• Global Blood Therapeutics, Inc. GBT
• IMV Inc. IMV
• Mersana Therapeutics, Inc. MRSN
• Monte Rosa Therapeutics, Inc. GLUE (IPOed Thursday)
• ORIC Pharmaceuticals, Inc. ORIC
• Tempest Therapeutics, Inc. TPST (announced the completion of its reverse merger with Millendo Therapeutics)
• Terns Pharmaceuticals, Inc. TERN

Stocks In Focus

DiaMedica Reports Positive Phase 2 Data For DM199 In Chronic Kidney Disease Patients

DiaMedica Therapeutics Inc. DMAC announced positive interim results from its Phase 2 REDUX trial of DM199 in chronic kidney disease. DM199, the company noted, is demonstrating clinically meaningful improvements in kidney function in Cohorts 1 and 2, as measured by a simultaneously stabilizing estimated glomerular filtration rate and decreasing urine albumin-to-creatinine ratio.

In participants who were hypertensive, DM199 also reduced blood pressure by clinically significant levels.

The stock was seen adding 8.65% to $7.79 in premarket trading.

Sensei Reprioritizes Pipeline Program, Cash Runway To Extend To H1'24

Sensei Biotherapeutics, Inc. SNSE said it is reprioritizing its pipeline programs to focus on its product candidates, including its multi-antigenic next generation ImmunoPhage candidate, now referred to as SNS-401-NG, and its monoclonal antibody SNS-VISTA candidate.

With this reallocation of resources, Sensei said it expects its cash and cash equivalents will be sufficient to fund its operations into the first half of 2024.

The stock was down 8.13% at $9.95 in premarket trading.

Addex Commences Phase 2b/3 Study In Dyskinesia Associated With Parkinson's Disease

Addex Therapeutics Ltd ADXN announced screening of patients has started for its pivotal Phase 2b/3 study with dipraglurant for dyskinesia associated with Parkinson's disease. Dyskinesia is believed to be caused by increased glutamatergic neurotransmission. Dipraglurant selectively targets the metabotropic glutamate receptor subtype 5 to downregulate this neurotransmission through allosteric modulation.

Gilead Sciences Completes Regulatory Filing For Drug To Treat Multidrug-Resistant HIV-1 Patients

Gilead Sciences, Inc. GILD said it has completed submission of a new drug application to the FDA seeking approval of lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced people with multidrug-resistant HIV-1 infection.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established.

In premarket trading, Gilead shares were edging up 0.15% to $67.80.

Achieve Says Enrollment Target Achieved In Late-Stage Study Of Cytisinicline For Smoking Cessation

Achieve Life Sciences, Inc. ACHV announced that the Phase 3 ORCA-2 trial of cytisinicline has reached its enrollment target of 750 adult smokers. The ORCA-2 trial sites are no longer enrolling new subjects, however those currently in screening will be allowed to participate provided they meet entry criteria, the company added.

The stock was moving up 0.96% at $9.44 in premarket trading.

Arbutus Announces Clinical Collaboration To Study Triple Combo Therapy For Hepatitis B Virus Infection

Arbutus Biopharma Corporation ABUS and Antios Therapeutics announced that the companies have entered into a clinical collaboration agreement to evaluate a triple combination of Arbutus' proprietary GalNAc delivered RNAi therapeutic, AB-729, Antios' proprietary active site polymerase inhibitor nucleotide, ATI-2173 and Viread for the treatment of subjects with chronic hepatitis B virus infection.

Related Link: The Week Ahead In Biotech: Mediwound, Provention FDA Decisions, IPOs, Pending Clinical Readouts In Focus

Sanofi To Set Up mRNA Vaccine Center With Annual Spend of $476M

Sanofi SNY said it will invest approximately 400 million euros ($476 million) annually in a first-of-its kind vaccines mRNA Center of Excellence. The center, according to the company, will work to accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees integrating end-to-end mRNA vaccine capabilities.
The Center of Excellence will enable acceleration of the vaccines mRNA portfolio developed through the Translate Bio, Inc. TBIO collaboration established in 2018 and expanded in 2020, it added.

Sanofi shares were shedding 0.51% to $52.95 in after-hours trading.

Cerevel Reports Positive Early Stage Data For Schizophrenia Drug

Cerevel Therapeutics Holdings, Inc. CERE announced positive results from its Phase 1b clinical trial of CVL-231 in adult patients with schizophrenia. CVL-231 was generally well-tolerated, and discontinuation rates were similar between CVL-231 and placebo in the six weeks of dosing, at 22% each.

Both the 30 mg once-daily and the 20 mg twice-daily doses demonstrated clinically meaningful antipsychotic activity with an overall well-tolerated profile compared with placebo.

The stock was gaining 4.22% to $13.10 in premarket trading.

Setback For Catalyst As Health Canada Reissues Notice of Compliance To Rival Drug To Firdapse

Catalyst Pharmaceuticals said it is disappointed with Health Canada's decision to re-issue a notice of compliance for Jacobus Pharma's Ruzurgi, allowing the product to be marketed in Canada for the treatment of Lambert-Eaton myasthenic syndrome.

Health Canada's original NOC for Ruzurgi for marketing in Canada was quashed in a recent decision of the Federal Court of Canada, which sent the matter back to Health Canada to re-determine its decision to grant marketing authority to Ruzurgi despite Firdapse's data protection rights under Canadian law. Firdapse is Catalyst's drug approved for treating LEMS in adults.

Offerings

Zentalis Pharmaceuticals, Inc. ZNTL priced its underwritten public offering of 3.1 million shares of its common stock at $48.50 per share for total gross proceeds of approximately $150.4 million. All of the common stock is being offered by Zentalis.

The stock was losing 1.92% to $48.06 in after-hours trading.

Aligos Therapeutics, Inc. ALGS said it has commenced an underwritten public offering of 4 million shares of common stock. All of the shares of common stock are being offered by Aligos.

In premarket trading, the stock was falling 7.37% to $22.

Intellia, which rallied Monday on data, said it has commenced an underwritten public offering of $400 million in shares of its common stock. All of the shares in the proposed offering are to be sold by Intellia.

The stock was rising 1.18% to $135 in premarket trading.

On The Radar

PDUFA Dates

The Food and Drug Administration is scheduled to rule on MediWound Ltd.'s MDWD biologic license application for NexoBrid for eschar removal in adults with deep partial-thickness and/or full-thickness thermal burns. MediWound, an Israeli biopharma, has granted the North American license to NexoBrid to Vericel Corporation VCEL under a May 2019 agreement. The PDUFA goal date is set for Tuesday, June 29.

Earnings

Avid Bioservices, Inc. CDMO (Tuesday, after the close)
Valeo Pharma Inc. VPHIF (Tuesday, after the close)

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