APTO On The Move, PLX To Effect Reverse Split, SCYX Plunges

pharma 061417 10dec19

Today's Daily Dose brings you news about Aurinia Pharma's secondary offering; Aptose Biosciences' early clinical data of CG-806 and APTO-253; the proposed reverse stock split of Protalix BioTherapeutics and Gilead's path forward for KTE-X19 in the treatment for relapsed or refractory mantle cell lymphoma.

Read on...

Aurinia Pharmaceuticals Inc. (AUPH) (AUP.TO) has offered to sell 11.12 million shares of its common stock to the public at a price of US$15.00 per share. The gross proceeds to the Company from this offering are expected to be approximately US$166.7 million.

The offering is expected to close on or about December 12, 2019.

The underwriters have a 30-day option period to purchase 1.67 million additional shares.

Last week, the Company reported positive efficacy and safety results from its pivotal phase III trial of voclosporin, in combination with mycophenolate and low-dose corticosteroids in the treatment of lupus nephritis, dubbed AURORA. The news sent the stock as much as 108% to $17.48 that day.

AUPH closed Monday's trading at $15.78, up 2.20%.

Aptose Biosciences Inc. (APTO), on Saturday, presented first clinical data from CG-806 in patients with chronic lymphocytic leukemia, highlighting the consistency between the drug's robust preclinical profile and the early clinical observations on safety, tolerability, pharmacokinetics, and activity.

CG-806, an oral, first-in-class mutation-agnostic FLT3/BTK kinase inhibitor, is in a phase I trial in patients with B cell malignancies, including CLL and non-Hodgkin lymphomas, who have failed or are intolerant to standard therapies.

Another drug candidate in the pipeline is APTO-253, which is under a phase 1b clinical trial for the treatment of patients with relapsed or refractory AML or high-risk myelodysplastic syndrome (MDS).

Aptose has completed dosing of the first three cohorts of the Phase 1b trial with APTO-253 in patients with AML and MDS.

APTO closed Monday's trading at $3.54, up 38.28%.

Kite, a Gilead Company (GILD), plans to submit a Biologics License Application for KTE-X19 to the FDA by the end of this year and a Marketing Authorization Application to the European Medicines Agency in the first quarter of 2020.

KTE-X19 is an investigational CD19 chimeric antigen receptor (CAR) T cell therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. This product candidate is designated a Breakthrough Therapy by the FDA and Priority Medicines (PRIME) by the EMA for relapsed or refractory mantle cell lymphoma.

GILD closed Monday's trading at $66.93, down 0.22%.

Hoth Therapeutics Inc. (HOTH) is planning to initiate a preclinical gene therapy study for the treatment of asthma and allergic inflammation in collaboration beginning on January 1, 2020.

The study, which will be conducted in collaboration with North Carolina State University, is designed to determine the best approach for targeting allergic inflammation in the airways with Splice-switching oligonucleotides (SSOs) and establish proof of principle by providing preclinical mouse data to inform consequent toxicology, ADME (absorption, distribution, metabolism and excretion), and Pharmacokinetics (PK) study or how an organism affects the drug.

HOTH closed Monday's trading at $4.52, up 2.73%.

Protalix BioTherapeutics Inc.'s (PLX) is slated to effect a reverse stock split at a ratio of 1-for-10 at midnight, December 19, 2019, and the following day, the Company's common stock will trade on the NYSE American on a post-split basis.

The reverse split will reduce the total number of authorized shares of the common stock from 350 million shares to 120 million shares.

Protalix and its development and commercialization partner, Chiesi Farmaceutici S.p.A., are planning to submit the Biologics License Application, seeking accelerated approval, for Pegunigalsidase alfa (PRX-102) for the treatment of Fabry disease, by April of 2020.

PLX closed Monday's trading at $0.31, up 2.42%.

Relmada Therapeutics Inc. (RLMD) has closed its previously announced underwritten public offering of 3.83 million shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase up to 500,000 additional shares of common stock, at a public offering price of $30.00 per share.

The gross proceeds from the offering were approximately $115.0 million.

On October 15, 2019, the Company reported promising results from its phase II clinical study evaluating two doses of REL-1017, 25 mg once a day and 50 mg once a day, as an adjunctive treatment in patients with treatment-resistant depression. The news sent the stock soaring 134% to $26 that day.

The Company's stock underwent a 1-for-4 reverse stock split on September 30, 2019, and the shares were uplisted to the Nasdaq Capital Market on October 10, 2019.

RLMD closed Monday's trading at $41.77, up 4.40%.

Shares of SCYNEXIS Inc. (SCYX) plunged 23% in after-hours on Monday, following the commencement of an underwritten public offering of shares of its common stock and warrants.

In addition, the sole underwriter of the offering H.C. Wainwright & Co. is expected to be granted a 30-day option to purchase up to an additional 15% of the shares of common stock and warrants being offered on the same terms and conditions.

SCYX closed Monday's trading at $0.95, down 0.18%. In after-hours, the stock fell another 23.29% to $0.73.

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