The Daily Biotech Pulse: Inovio's MERS Vaccine Data, Fast Track Designation For Erytech, FDA Approves Higher Dose Of Merck's Keytruda

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech stocks that hit 52-week highs April 28.)

• AstraZeneca plc AZN
• Arcturus Therapeutics Ltd ARCT
• Bio-Rad Laboratories, Inc. Class A Common Stock BIO
• Black Diamond Therapeutics Inc BDTX
• Erytech Pharma SA ERYP
• GenMark Diagnostics, Inc GNMK
• Halozyme Therapeutics, Inc. HALO
• I-Mab ADR IMAB
• Imara Inc IMRA
• Kiniksa Pharmaceuticals Ltd KNSA (reacted to first-quarter results)
• Novo Nordisk A/S NVO
• OraSure Technologies, Inc. OSUR
• Quest Diagnostics Inc DGX (announced direct-to-consumer COVID-19 antibody test)
• REDHILL BIOPHAR/S ADR RDHL (announced addition of its Talicia, meant to treat H. pylori infection, to Prime Therapeutics NetResults A-Series National Formulary)
• Syndax Pharmaceuticals Inc SNDX (presented positive preclinical and initial clinical data for SNDX-5613 in treating genetically defined acute leukemias)
• West Pharmaceutical Services Inc. WST
• Zentalis Pharmaceuticals Inc ZNTL
• Zynex Inc. ZYXI

None of the Nasdaq- or NYSE-listed biotech/medical device/diagnostics company hit 52-week lows Tuesday.

Stocks In Focus

Erytech's Lead Drug Granted Fast Track Designation In Second-Line Pancreatic Cancer

Erytech Pharma said the FDA has granted Fast Track designation for its lead product candidate eryaspace in treating second-line pancreatic cancer. The candidate is being evaluated in a late-stage study for the indication in 11 countries in Europe and the U.S.

Separately, the company provided an update on the pivotal Phase 3 trial of eryaspace in combination with chemotherapy as a second-line therapy for advanced metastatic pancreatic cancer. The company said the third independent safety review has again confirmed the favorable safety profile and that the trial has surpassed 75% of the planned target enrollment.

Due to the COVID-19 pandemic, the company said it now sees a limited delay of three to four months in completion of patient enrollment. The company said it now expects an interim superiority analysis around the end of the year and final results in the second half of 2021.

The stock was trading 44.15% higher at $11.95 in Wednesday's premarket session. 

Inovio Announces Positive Interim Data From Midstage Trial Of MERS Coronavirus Vaccine

Inovio Pharmaceuticals Inc INO and GeneOne Life Science announced positive interim data from a Phase 1/2a trial of its DNA vaccine INO-4700 for MERS coronavirus. Through week 16, the vaccine recipients showed strong antibody and T cell immune responses after two or three doses with 0.6 mg of INO-4700, the company said.

It added that the vaccination was also well-tolerated, with no vaccine-associated severe adverse events.

"As we have designed our COVID-19 vaccine INO-4800 using the same strategy as INO-4700, including the selection of full length Spike protein as the target and the use of intradermal CELLECTRA device, we are hopeful that the ongoing Phase 1 clinical trial with INO-4800 would generate similar clinical immune responses and safety data as we have just reported for INO-4700," CEO Dr. Joseph Kim said in a statement. 

Inovio shares were up 5.09% at $14.45 in Wednesday's premarket session.

See also: The Week Ahead In Biotech (April 26-May 2): Cancer Conference, Earnings News Flow In The Spotlight

Novartis' Cosentyx Approved In Europe For Spondyloarthritis

Novartis AG NVS said the European Commission has approved Cosentyx for the treatment of adult patients with active non-radiographic axial spondyloarthritis.

In premarket trading Wednesday, the stock was down 1.16% at $87.02.

Immunomedics Prices Common Stock Offering 

Immunomedics, Inc. IMMU said it has priced an underwritten public offering of 14.74 million shares of its common stock at $28.50 per share to generate gross proceeds of $420 million. The company expects the offering to close on or about May 1.

In premarket trading, Immunomedics shares were trading 5.3% higher at $30.60. 

Supernus to Buy WorldMed's CNS Portfolio For Up to $530M

Supernus Pharmaceuticals Inc SUPN announced a definitive agreement under which it will acquire the CNS portfolio of US WorldMeds, a privately held biopharmaceutical company, for an upfront payment of $300 million, plus cash milestone payments of up to $230 million.

The proposed purchase will help strengthen the neurology portfolio by adding three marketed CNS products and a late-stage pipeline, Supernus said.

In premarket trading Wednesday, the stock was gaining 2.67% to $20.01.

Merck Gets FDA Nod For Higher Dosage Option For Keytruda In All Adult Indications

Merck & Co., Inc. MRK said the FDA has approved an additional recommended dosage of 400mg every six weeks for its anti-PD-1 therapy Keytruda across all adult indications, including monotherapy and combination therapy.

This dosage is in addition to the current dose of 200mg every three weeks.

FDA Clears Chimerix For Rolling NDA Submission For Antiviral Drug To Treat Smallpox

Chimerix Inc CMRX said it has received clearance from the FDA for a rolling submission of its NDA for brincidofovir as a medical countermeasure for smallpox. The company said it intends to begin the rolling NDA submission in May 2020, with completion targeted for mid-2020.

Separately, the company also said it has initiated a Phase 2/3 study of dociparstat sodium in COVID-19 patients with acute lung injury.

The stock was advancing 32.45% to $2 in premarket trading Wednesday.

Pfizer, BioNTech Dose First Cohort of Participants In Phase 1/2 Coronavirus Vaccine Study

Pfizer Inc. PFE and BioNTech SE – ADR BNTX said the first cohort consisting of 12 participants in the latter's Phase 1/2 clinical trial in Germany has been dosed. The companies said they plan to initiate trials for BNT162 in the U.S. upon regulatory approval, which is expected shortly. 

In premarket trading, Pfizer was rising 1.61% to $38.52 and BioNTech shares were advancing 6.85% to $48.97.

reTORbio to Reverse Merge With Adicet

resTORbio, Inc. TORC announced a reverse merger with Adicet Bio, Inc., a privately held biopharma, with the focus on developing Adicet's off-the-shelf allogeneic gamma delta T cell therapies for oncology and other indications.

Earnings

AstraZeneca reported better-than-expected first-quarter results and maintained its full-year guidance.

Masimo Corporation's MASI first-quarter revenue climbed 16.4% to $269.6 million and non-GAAP net income came in at 97 cents per share, ahead of the 91-cent-per-share consensus estimate.

The stock was trading 2.56% higher at $218 in Wednesday's premarket session.

DexCom, Inc. DXCM reported first-quarter revenue of $405.1 million, up 44.1%, and its non-GAAP net income per share increased from 5 cents to 44 cents. Analysts had estimated EPS of 14 cents per share.

The company said it is suspending its 2020 guidance, citing the uncertainty associated with the COVID-19 pandemic.

In premarket trading, the stock gained 7.57% to $337.27.

On The Radar

Earnings

• Alkermes Plc ALKS (before the market open)
• Boston Scientific Corporation BSX (before the market open)
• United Therapeutics Corporation UTHR (before the market open)
• Laboratory Corp. of America Holdings LH (before the market open)
• Alimera Sciences Inc ALIM (after the close)
• AtriCure Inc. ATRC (after the close)
• BioMarin Pharmaceutical Inc. BMRN (after the close)
• Vertex Pharmaceuticals Incorporated VRTX (after the close)
• SurModics, Inc. SRDX (after the close)
• Hologic, Inc. HOLX (after the close)

Related Link: A Deep Dive On Coronavirus Vaccine Plays Moderna, Inovio