The Daily Biotech Pulse: FDA Approves Sanofi's Meningococcal Vaccine, Pluristem Secures $54M In Funding For COVID-19 Treatment, Oric Pharma Prices 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 April 23.)

• Arcturus Therapeutics Ltd ARCT
• Chembio Diagnostics Inc CEMI
• Cue Biopharma Inc CUE
• Eli Lilly And Co LLY (reported strong Q1 results)
• Exelixis, Inc. EXEL
• GenMark Diagnostics, Inc GNMK
• Halozyme Therapeutics, Inc. HALO
• Immunomedics, Inc. IMMU (announced FDA nod for its ADC to treat triple-negative breast cancer)
• Incyte Corporation INCY (announced publication of positive data for Jakafi in acute graft-versus-host disease)
• Iovance Biotherapeutics Inc IOVA
• Johnson & Johnson JNJ
• Novo Nordisk A/S NVO
• OraSure Technologies, Inc. OSUR
• Pluristem Therapeutics Inc. PSTI (announced advancement of its placental cells to modulate cytokine storm)
• Quidel Corporation QDEL (filed with the FDA EUA for its SARS-CoV-2 virus assay for direct sampling)
• Repligen Corporation RGEN
• Seattle Genetics, Inc. SGEN
• Verastem Inc VSTM
• Vermillion, Inc. VRML
• Vertex Pharmaceuticals Incorporated VRTX
• West Pharmaceutical Services Inc. WST (reacted to its first-quarter results)
• Zai Lab Ltd ZLAB
• Zentalis Pharmaceuticals Inc ZNTL

Down In The Dumps

(Biotech stocks hitting 52-week lows April 23.)

• NanoVibronix Inc NAOV

Stocks In Focus

GlaxoSmithKline Anti-PD-1 Monoclonal Antibody Shows Efficacy Against Endometrial Cancer In Early Stage Study

GlaxoSmithKline plc GSK released data from an updated analysis of the Phase 1 GARNET study that showed that dostarlimab, an investigational anti-PD-1monoclonal antibody, provided clinically meaningful results in women with recurrent or advanced mismatch repair-deficient endometrial cancer who progressed on or after a platinum-based regimen.

The patients were administered 500mg of dostarlimab once every three weeks for four doses, followed by 1,000 mg once every six weeks until disease progression.

Lilly, Innovent Announces Acceptance Of Regulatory Filing For Expanded Indication Of Cancer Drug In China

Eli Lilly And Co LLY and Innovent Biologics announced the National Medical Products Administration of China has accepted the sNDA for Tyvyt sintilimab injection in combination with Alimta and platinum as first-line therapy in non-squamous non-small cell lung cancer.

Tyvyt was officially approved by the NMPA in December 2018 for the treatment of relapsed or refractory classical Hodgkin's lymphoma after at least two lines of systemic chemotherapy.

FDA Approves Sanofi's Meningococcal Vaccine

Sanofi SA SNY announced FDA approval for MenQuadfi — Meningococcal Conjugate Vaccine — for the prevention of invasive meningococcal disease in persons 2 years and older.

The stock was trading 0.76% higher at $48.74 in Friday's premarket session. 

See also: Some Biogen Analysts Unimpressed By Explanation For Aducanumab Filing Delay

Pluristem Secures $53.92M To Advance Pipeline Asset For COVID-19 Treatment

Pluristem Therapeutics Inc. PSTI said the European Investment Bank has approved 50 million euros ($53.92 million) in non-dilutive financing for supporting its R&D in the EU to further advance its regenerative cell therapy platform, and to assist moving the products in its pipeline to market, with a special focus on clinical development of PLX cells as a treatment for complications associated with COVID-19.

The funds will be disbursed in three tranches, with the first tranche consisting of 20 million euros, according to the company. 

In premarket trading Friday, Pluristem shares were climbing 17.28% to $12.15.

Earnings

Edwards Lifesciences Corp's EW first-quarter sales rose 14% to $1.1 billion and adjusted EPS climbed 14% to $1.51, ahead of the $1.33-per-share consensus estimate.

Citing the impact from the COVID-19 pandemic, the company lowered its 2020 sales guidance from a range of $4.6 billion-$5 billion to $4 billion-$4.5 billion. The adjusted EPS guidance was lowered from $6.15-$6.40 to $4.75-$5.25.

The stock was up 6.99% at $236.50 in Friday's premarket session. 

Merit Medical Systems, Inc. MMSI reported first-quarter worldwide revenue of $243.5 million, up 2.2%, and non-GAAP EPS of 38 cents. Analysts estimated EPS of 26 cents. The company withdrew its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.

The stock rose 1.88% to $38.57 in after-hours trading.

Takeda Divests Non-Core OTC, Prescription Drugs In Europe For Up To $670M

Takeda Pharmaceutical Co Ltd TAK said it has entered into an agreement to divest a portfolio of select non-core OTC and prescription pharmaceutical products sold in Europe and two manufacturing sites located in Denmark and Poland to Danish pharma company Orifarm Group for up to $670 million.

Takeda said the portfolio to be divested fetched sales of $230 million in fiscal year 2018, driven by strong sales of cough/cold and vitamin OTC brands as well as prescription products Warfarin and Levaxin.

On The Radar

IPO

Oric pharma, a clinical-stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, priced its upsized IPO of 7.5 million shares at $16 per share, the upper end of the previously estimated price range of $14-$16.

The company's shares will be listed on the Nasdaq under the ticker symbol "ORIC."

Related Link: Moderna Gains More Than 40% This Week: What You Should Know