(RTTNews.com) - Based on after-hours trading activity, here's a list of pharma/biotech stocks you need to watch out for on Thursday.
1. A day after signing a deal with Sandoz AG, a division of Novartis, Canadian Cannabis Company Tilray Inc. (TLRY) has entered into a partnership with AB InBev, the world's leading brewer.
The partnership with AB InBev, which is limited to Canada, will focus on non-alcohol beverages containing tetrahydrocannabinol (THC) and cannabidiol (CBD), combining AB InBev's deep experience in beverages with Tilray's expertise in cannabis products.
The two companies intend to invest up to US$50 million each, for a total of up to US$100 million.
Tilray's collaboration agreement with Sandoz AG, signed on December 18, aims to increase availability of high quality medical cannabis products across the world.
TLRY closed Wednesday's trading at $71.00, down 7.19%. In after-hours, the stock was up 14.86% to $81.55.
2. Shares of Spectrum Pharmaceuticals Inc. (SPPI) plunged 34.39% in after-hours trading on Wednesday, following news that the FDA has refused to grant Breakthrough Therapy Designation to its drug candidate Poziotinib in previously treated metastatic non-small cell lung cancer with EGFR exon 20 mutations.
Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition, and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s). (Source: FDA).
The Company presented encouraging updated interim data from the MD Anderson phase II trial of Poziotinib in heavily pre-treated, non-small cell lung cancer (NSCLC) patients with exon 20 mutations in September. A phase II study evaluating Poziotinib in more than 300 NSCLC patients with EGFR or HER2 exon 20 insertion mutations, dubbed ZENITH20, in underway. The study consists of four cohorts, each of which is independently powered for a pre-specified statistical hypothesis.
Data required for the NDA filing for previously treated NSCLC patients with EGFR exon 20 insertion mutations is expected to come from an 87-patient cohort in the ZENITH20 study. The Company expects to complete enrollment in this cohort in the first quarter of 2019, and announce topline data in the second half of 2019.
SPPI closed Wednesday's trading at $10.44, down 1.51%. In after-hours, the stock was down another 34.39% to $6.85.
3. Shares of ADMA Biologics Inc. ( ADMA ) plunged over 45% in extended trading on Wednesday, after the FDA turned down its Prior Approval Supplement filing related to BIVIGAM.
BIVIGAM, an intravenous immune globulin indicated for the treatment of primary humoral immunodeficiency, received FDA approval on December 19, 2012, when it was under the aegis of Biotest Pharmaceuticals Corp. After selling the drug in the U.S. market for nearly 4 years, Biotest Pharma halted the production of BIVIGAM in December 2016.
ADMA Biologics obtained ownership and all rights, title and interest in BIVIGAM on June 6, 2017 as part of the Biotest Therapy Business Unit asset acquisition.
ADMA closed Wednesday's trading at $4.21, up 4.99%. In after-hours, the stock fell 45.61% to $2.29.
4. DBV Technologies S.A. (DBVT) took a hit in after-hours on Wednesday, following the withdrawal of its Biologics License Application for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years of age.
The decision to withdraw the application was based on feedback back from the FDA, which concluded that the current BLA, submitted on October 18, 2018, lacks sufficient detail regarding data on manufacturing procedures and quality controls. No concerns related to the safety or efficacy of Viaskin Peanut were raised by the regulatory agency, and the Company believes that the additional information needed to support this filing is available without further clinical studies.
Commenting on the latest developments, Daniel TassÃ©, CEO of DBV Technologies, said, "We remain confident in the clinical profile of Viaskin Peanut and its potential to offer treatment to peanut-allergic children. Our plan is to address these concerns as quickly as possible and to work closely with the FDA to provide an updated and complete file."
DBVT closed Wednesday's trading at $14.15, down 3.68%. In after-hours, the stock fell 48.76% to $7.25.
5. One man's loss is another one's gain. This was true in the case of Aimmune Therapeutics Inc. (AIMT) today, which is also developing a drug for patients with peanut allergy, just like DBV Technologies. While DBVT has disappointing news for investors, Aimmune has some encouraging news.
Aimmune has initiated an international, phase III clinical trial of AR101 in peanut-allergic children ages 1-3 years, dubbed POSEIDON. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.
The primary efficacy endpoint for POSEIDON is tolerating a 600-mg single dose of peanut protein (the equivalent of approximately two peanut kernels) with no more than mild symptoms in a progressive, exit, double-blind, placebo-controlled food challenge (DBPCFC) after approximately one year of treatment.
Aimmune reported positive results from a pivotal phase III efficacy trial of AR101 in patients with peanut allergy, dubbed PALISADE, in February of this year.
A phase II study of AR101 with adjunctive dupilumab in peanut-allergic patients, initiated in October, is underway.
The Company intends to submit regulatory filings for marketing approval of AR101 in the United States and Europe in 4-17-year-olds based on the positive data from the PALISADE clinical trial as well as data from additional ongoing and completed AR101 clinical trials.
AIMT closed Wednesday's trading at $21.71, down 1.18%. In after-hours, the stock rose 12.71% to $24.47.
6. G1 Therapeutics Inc. (GTHX) cratered over 26% in after-hours trading on Wednesday, despite its phase II trial of Trilaciclib in combination with Topotecan as a treatment for 2nd-/3rd-line small cell lung cancer achieving both primary endpoints of statistically significant reductions in the duration and occurrence of Grade 4 neutropenia.
The trial also demonstrated clinically meaningful reductions in rates of granulocyte-colony stimulating factor (G-CSF) usage and red blood cell (RBC) transfusion.
But what spooked investors were the lower objective response rate and clinical benefit rate in the Trilaciclib arm compared to placebo. The objective response rate was 13.3% in the Trilaciclib arm and 23.1% in placebo. Similarly, the clinical benefit rate was 61.5% for placebo, and 60% for Trilaciclib.
The median progression-free survival was 4.2 months for both placebo and Trilaciclib.
GTHX closed Wednesday's trading at $28.75, up 0.88%. In after-hours trading, the stock fell 26.09% to $21.25.
7. Shares of MannKind Corp. (MNKD) fell more than 18% in after-hours on Wednesday, following news of commencement of an underwritten public offering.
The Company has offered to sell 26.66 million shares of its common stock and warrants to purchase up to an aggregate of 26.66 million shares of its common stock. Each share of common stock is being sold together with a warrant to purchase one share of common stock for a combined purchase price of $1.50, for a gross deal size of $40.0 million.
The offering is expected to close on December 26, 2018, subject to customary closing conditions.
Leerink Partners is acting as sole book-running manager for the offering.
MNKD closed Wednesday's trading at $1.69, up 1.81%. In after-hours, the stock fell 18.34% to $1.38.
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