Plenty of biotech companies will be releasing their third-quarter financial reports next week. Let’s take a quick look at some of these companies and their top stories they reported through 3Q2018.
Monday, October 29
BrainStorm Cell Therapeutics – Brainstorm, located in New York City and Petach Tikvah, Israel, focuses on developing adult stem cell therapies derived from autologous bone marrow cells to treat neurodegenerative diseases. In the third quarter, the company completed a pre-specified interim analysis of safety outcomes for the first 31 participants in the Phase III trial for NurOwn in amyotrophic lateral sclerosis (ALS). No safety concerns were identified. In September, Arturo O. Araya came on board as chief commercial officer. Araya was formerly Global Head of Commercial of Novartis’ Cell and Gene Therapies Unit.
Tuesday, October 30
Allergan – In August, Allergan exercised its option to develop and commercialize Cambridge, Mass.-based Editas Medicine’s EDIT-101 for the treatment of LCA10. Allergan paid Editas $15 million in conjunction with the exercise, and Editas is eligible for another $25 million once EDIT-101 is accepted by the Food and Drug Administration (FDA) for an investigational new drug (IND) application. Later in the month, the FDA rejected Allergan’s new drug application (NDA) for ulipristal acetate (UPA) for the treatment of abnormal uterine bleeding in women with uterine fibroids. In early September, Allergan launched the new SkinMedica LUMIVIVE System. And later in September, the company announced plans to build the first Medical Aesthetics Innovation Center in Chengdu, China.
Pfizer – In late August, Pfizer released positive primary results from its Phase III trial of Tafamidis in Transthyretin Cardiomyopathy (ATTR-ACT), but only days later terminated two ongoing clinical trials of domagrozumab for Duchenne muscular dystrophy (DMD), both Phase II trials. In late September, the FDA granted Pfizer’s 20-Valent Pneumococcal Conjugate Vaccine (20vPnC) Breakthrough Therapy designation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes. And on September 27, the FDA approved the company’s Vizimpro (dacomitinib) for the treatment of non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved assay.
Clovis Oncology – In early August, Clovis announced the randomization of the first patient in its Phase III ATHENA trial to evaluate the combination of Rubraca (rucaparib) and Bristol-Myers Squibb’s Opdivo (nivolumab) for advanced ovarian cancer. In October the FDA granted Breakthrough Therapy designation for Rubraca as a monotherapy for adults with BRCA1/2-mutated mCRPC who have had at least one previous androgen receptor-directed therapy and taxane-based chemotherapy. And on October 19, the company presented initial results from its ongoing TRITON program for Rubraca in metastatic castration-resistant prostate cancer.
Wednesday, October 31
Acorda Therapeutics – At the beginning of this quarter, Acorda announced that Rick Batycky, its chief technology officer, was leaving the company as of August 20. David Lawrence, the company’s chief of business operations, was taking over the company’s Chelsea, Mass. manufacturing plant, which produces Inbrija (levodopa inhalation powder) and Ampyra (dalfampridine). Burkhard Blank, the company’s chief medical officer, was taking over the company’s Pharmaceutical Development and Technical Operations teams. And on September 10, the United States Court of Appeals for the Federal Circuit, upheld the U.S. District Court for the District of Delaware’s decision to invalidate four Ampyra patents.
Takeda Pharmaceutical – This will be the second-quarter report on Takeda’s fiscal year, having reported Q1 results on July 31. Since then, the company has announced a broad range of partnerships and deals, including opening a production site for Ninlaro (ixazomib) in Yaroslavl, Russia; creating a joint investment fund with Japan-based Alternative Asset Management Firm, Whiz Partners with a goal of promoting a drug discovery ecosystem in Japan; and signing a liver disease partnership with Ambys Medicines, in Redwood City, Calif. The next quarterly report will undoubtedly include some update on the company’s acquisition of Shire. On September 14, the deal was approved by the State Administration for Market Regulation in China. It received approval in the U.S. in mid-July, and in late August in Brazil.
Thursday, November 1
Agios Pharmaceuticals – It’s been a relatively quiet quarter for Agios, although a busy year. Updates for the quarter will likely include progress on Tibsovo (ivosidenib), which was approved by the FDA for adults with relapsed or refractory acute myeloid leukemia with a susceptible isocitrate dehydrogenase-1 mutation in late July. The company’s first drug, Idhifa (enasidenib), with Celgene, was approved in August 2017, so this quarter will mark a full year of sales. Also, in September, the company announced that David Schenkein, the company’s executive chairman of the board and chief executive officer, will step down and be replaced by Jacqualyn Fouse as CEO.
Shire – Although the pending acquisition by Takeda is likely to be high on the list of topics covered, Shire has had quite a bit of activity in the quarter. On August 23, the FDA approved Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years of age and older. On September 12, the European Commission (EC) granted Marketing Authorization for Veyvondi for bleeding events and treatment and prevention of surgical bleeding in adults with von Willebrand disease (VWD) when desmopressin treatment is ineffective.
Teva Pharmaceuticals – The Israeli company announced that the FDA approved Ajovy (fremanezumab-vfrm) for migraine on September 14. Later in the month the company filed for a generic version of Cialis (tadalafil) in the U.S. And on October 21, the company, with State of New Jersey Governor Phil Murphy, formalized the company’s consolidation of its North America Commercial business areas into New Jersey. They will be in Parsippany-Troy Hills.
Friday, November 2
AbbVie – On August 22, AbbVie released data from its Phase III ELARIS UF-EXTEND trial that showed its low-dose hormone therapy, Elagolix, reduced heavy menstrual bleeding in women with uterine fibroids. Five days later, the FDA approved Imbruvica plus Rituxan (rituximab) for patients with Waldenstrom’s macroglobulinemia (WM). And in mid-September, the company released new patient-reported outcomes data from three Phase III trials evaluating risankizumab in adults with moderate to severe plaque psoriasis.