FDA Nod For JAZZ's Drug, BYSI's PROTECTIVE-2 Trial Meets Goals, EDSA To Begin COVID-19 Drug Trial

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Today's Daily Dose brings you news about Momenta Pharma's positive results from myasthenia gravis trial; BeyondSpring's phase III trial results of Plinabulin in chemotherapy-induced neutropenia; Edesa's progress in COVID-19 drug trial; FDA approval of Jazz Pharma's Zepzelca and Celldex Therapeutics' stock offering.

Read on…

1. BeyondSpring's PROTECTIVE-2 Trial Meets Goals

BeyondSpring's (BYSI) phase III trial evaluating drug candidate Plinabulin in combination with approved drug Neulasta against Neulasta alone in chemotherapy-induced neutropenia has met the primary endpoint.

Neulasta is a long-lasting G-CSF that is the current standard of care for treating chemotherapy-induced neutropenia (CIN).

In the trial, dubbed PROTECTIVE-2, the interim results have shown significant enhancement of the combination over Neulasta in the rate of Grade 4 neutropenia prevention, which is the primary endpoint for the study.

The interim results also met its key secondary endpoint, the duration of severe neutropenia (DSN) in Cycle 1, the Company added.

"This interim result shows Plinabulin-Neulasta combination's potential for the first superior therapy and significant enhancement to G-CSF in preventing neutropenia in the last 30 years," concluded Lan Huang, BeyondSpring's CEO and Co-Founder.

BYSI closed Monday's trading at $17.80, up 7.16%.

2. Celldex Prices Stock Offering

Celldex Therapeutics Inc. (CLDX) has offered to sell 13.38 million shares of its common stock, par value $0.001 per share, at a price to the public of $9.75 per share.

The underwriter has a 30-day option to purchase up to an additional 2 million shares of common stock.

Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

The gross proceeds from the offering, excluding the exercise of the underwriter's option, are expected to be about $130.4 million. Assuming the full exercise of the underwriter's option, gross proceeds would be approximately $150.0 million, the Company noted.

The Company's lead investigational asset is CDX-3379, which is under phase II study in combination with Erbitux in patients with HPV negative, Erbitux-resistant advanced head, and neck squamous cell cancer (HNSCC).

The other clinical programs are:

-- CDX-0159, a potential treatment for chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CINDU), both mast cell-related diseases. CDX-0159 is currently in a phase Ia study in healthy subjects. The compound is expected to advance into phase Ib study by year-end.

-- CDX-1140 in a phase I study in patients with recurrent, locally advanced, or metastatic cancers.

CLDX touched a new 52-week high of $11.11, before closing the day's trading at $10.71, up 37.31%.

3. Edesa Biotech To Begin COVID-19 Drug Trial

Shares of Edesa Biotech Inc. (EDSA) soared as much as 247 percent in intraday reading on Monday, following expedited approval from Health Canada to begin a phase II/III clinical study of its investigational drug, EB05, in moderate to severe COVID-19 patients.

The Company has the EB05 drug product and is seeking government grants to accelerate the initiation and rollout of the study, beginning at up to 30 sites.

Edesa Biotech licensed EB05 and EB06, two monoclonal antibodies having potential in a broad range of diseases, including infectious diseases, from Swiss pharmaceutical development company Light Chain Bioscience in April this year.

The planned phase II/III study will evaluate the efficacy and safety of EB05 in adult hospitalized patients with moderate to severe COVID-19. The company plans to enroll up to 355 patients in the phase II part of the study. Should the phase II part show promising results, the study will advance to the pivotal phase III part.

EDSA touched a high of $10 in intraday trading before closing the day at $5.80, up 101.39%.

4. Jazz Gets Early FDA Nod

Jazz Pharmaceuticals plc.'s (JAZZ) Zepzelca has received accelerated approval from the FDA for the treatment of adult patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy.

The approval comes two months ahead of the decision date of August 16, 2020, based on the overall response rate and duration of response demonstrated in an open-label, monotherapy clinical trial.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Zepzelca is expected to be commercially available in the U.S. in early July.

JAZZ closed Monday's trading at $110.50, up 5.56%.

5. Momenta Moves On Myasthenia Gravis Study Data

Shares of Momenta Pharmaceuticals Inc. (MNTA) jumped more than 14 percent on Monday, following positive topline data from an interim analysis of its phase II study of Nipocalimab in generalized myasthenia gravis.

The study, dubbed Vivacity-MG, met the primary endpoint with a strong relationship between Immunoglobulin G (IgG) reduction and MG-ADL (myasthenia gravis activities of daily living) clinical benefit.

Nipocalimab induced a rapid and durable response in the myasthenia gravis activities of daily living score at all doses.

The study is expected to be completed in the third quarter of 2020. The Company plans to present the 16-week data with analysis of secondary endpoints and importantly, duration of efficacy, in the fourth quarter of 2020.

Based on the promising data, the Company has begun preparations to conduct an end of phase II meetings with regulatory agencies before the end of 2020.

MNTA closed Monday's trading at $35.65, up 14.81%. In after-hours, the stock was up 1.26% at $36.10.

6. Stocks That Moved On No News

Nemaura Medical Inc. (NMRD) closed Monday's trading at $10.38, up 38.40%.

NeuBase Therapeutics Inc. (NBSE) closed Monday's trading at $10.32, up 22.27%.

NantKwest Inc. (NK) closed Monday's trading at $8.32, up 20.93%.

IMARA Inc. (IMRA) closed Monday's trading at $38.91, down 14.95%.

Phathom Pharmaceuticals Inc. (PHAT) closed Monday's trading at $43.14, down 12.74%.

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