BGNE Soars, DRNA Hits New High On Roche Deal, FDA Heeds REPH's Request

pharma 032017 01nov19

Today's Daily Dose brings you news about the reverse split of Applied DNA; the global strategic oncology collaboration between BeiGene and Amgen; better-than-expected earnings reported by Bio-Rad; upcoming catalysts of bluebird bio; licensing agreement between Dicerna Pharma and Roche; and an update on Recro Pharma's intravenous (IV) Meloxicam.

Read on…

Applied DNA Sciences Inc. (APDN) will implement a 1-for-40 reverse split of its outstanding common stock effective at 12:01 AM Eastern Time on November 1, 2019.

The reverse stock split is intended to increase the per-share trading price of Applied DNA's common stock to satisfy the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market.

The Company has been given time till December 31, 2019, to regain compliance with all applicable criteria for continued listing.

APDN closed Thursday's trading at $0.17, down 11.54%.

BeiGene Ltd. (BGNE) has entered into a global strategic oncology collaboration with Amgen (AMGN) for the commercialization of Amgen's XGEVA, KYPROLIS, and BLINCYTO in China.

XGEVA was approved in China in 2019 for patients with giant cell tumor of the bone and is in development for the prevention of skeletal-related events in cancer patients with bone metastases. KYPROLIS is in late-stage development in China for patients with multiple myeloma, and BLINCYTO is in late-stage development in China as a treatment for adult patients with relapsed or refractory acute lymphoblastic leukemia.

The two companies will jointly develop 20 Amgen oncology pipeline assets, with BeiGene responsible for the development and commercialization in China. As part of the collaboration, Amgen will purchase a 20.5% stake in BeiGene for roughly $2.7 billion in cash at $174.85 per American Depositary Share (ADS).

The transactions have been approved by the boards of directors of both companies and are expected to close in the first quarter of 2020.

Amgen will receive one seat on BeiGene's Board of Directors.

BGNE closed Thursday's trading at $138.34, down 0.52%. In after-hours, the stock was up 25% to $172.99.

Bio-Rad Laboratories Inc. (BIO) has reported better-than-expected earnings and a 2.8 percent sales growth for the third quarter ended September 30, 2019.

The Company develops and markets a range of products for the life science research and clinical diagnostic markets.

On a non-GAAP basis, the net income for the third quarter of 2019, jumped to $48.6 million or $1.61 per share from $27.6 million or $0.91 per share in the year-ago quarter. Analysts were expecting earnings of only $1.40 per share.

Third-quarter 2019 net sales were $560.6 million, an increase of 2.8 percent compared to $545.1 million reported for the third quarter of 2018.

For the full year 2019, the company is projecting revenue growth outlook of 4.0 to 4.5 percent while analysts are foreseeing a growth of 2.30 percent.

BIO closed Thursday's trading at $331.62, down 3.74%.

bluebird bio Inc. (BLUE) has a couple of catalysts coming its way this year-end.

The Company plans to initiate a rolling Biologics Licensing Application submission to the U.S. FDA for ZYNTEGLO in patients with transfusion-dependent ß-thalassemia (TDT) and non-ß0/ß0 genotypes by the end of 2019.

Enrollment of patients in the phase III HGB-210 study of LentiGlobin in patients with sickle cell disease is expected to commence by the end of this year.

Clinical update from the registration-enabling study of Ide-cel in patients with multiple myeloma, dubbed KarMMa, is expected to be provided by the end of this year.

BLUE closed Thursday's trading at $81.00, down 2.63%.

Clinigence Holdings Inc has become a publicly-traded company via a reverse merger with public company iGambit Inc. (IGMB.OB).

The combined company will be called Clinigence Holdings Inc. and will trade on the OTC Markets under the symbol CLNH.

Clinigence is a pioneer in clinical quality reporting and population health analytics, and iGambit wholly owns HealthDatix, a healthcare technology company with a platform for optimizing annual wellness visits/health risk assessments and chronic care management as well as the BioDatix wearable device for remote patient monitoring.

Dicerna Pharmaceuticals Inc. (DRNA) has inked a research collaboration and licensing agreement with Roche to develop novel therapies for the treatment of chronic hepatitis B virus infection using Dicerna's proprietary GalXC RNAi platform technology.

Under the terms of the agreement, Roche will gain worldwide license to Dicerna's novel RNAi therapy DCR-HBVS, for the treatment of chronic hepatitis B virus infection, which is in Phase 1 clinical development.

Dicerna stands to receive $200 million upfront plus up to $1.47 billion in potential milestone payments related to DCR-HBVS.

The collaboration also includes the discovery and development of therapies targeting multiple additional human and viral genes associated with HBV infection using the technology platforms of both companies.

DRNA closed Thursday's trading at $6.49, up 4.76%. The stock touched a new 52-week high of $18.39 in intraday trading.

Recro Pharma Inc.'s (REPH) appeal of the Complete Response Letter relating to the New Drug Application seeking approval for intravenous (IV) Meloxicam has been granted by the FDA.

Intravenous Meloxicam, proposed for the management of moderate to severe pain, was issued a Complete Response Letter in March 2019, with the FDA citing regulatory concerns about the role of IV Meloxicam as a monotherapy in acute pain, as well as how it would meet patient and prescriber needs in that setting.

Now that the appeal has been granted, the Company is in the process of preparing a comprehensive response to the FDA that includes proposed labeling and to provide the relevant evidence from the filed NDA to ensure safe and effective use of IV Meloxicam by prescribers.

REPH closed Thursday's trading at $15.77, up 14.19%.

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