Another drug approval for Exelixis. Why Alnylam’s stock is under pressure today

More good news came  from Exelixis (EXEL). It was expected by many but not by those who ignore the good news in favor of any negative news or lack of news. The announced news is that the FDA approved Exelixis’ Cabometyx® (cabozantinib) for hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.

More good news is Exelixis’ announcement that the firm is prepared to fully support the new indication immediately.

Michael M. Morrissey, Ph.D., President and Chief Executive Officer of Exelixis said that the approval is important for the firm as it continues to explore how Cabometyx may benefit people with difficult-to-treat-cancers beyond renal cell carcinoma.  

The Cabometyx approval was based on results from the CELESTIAL phase 3 pivotal trial of the targeted drug for advanced HCC patients who received prior sorafenib. In this trial Cabometyx demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) versus placebo.

We remind that in November 2018 Exelixis’ partner, Ipsen, received approval for Cabometyx tablets from the European Commission as a monotherapy for HCC in adult  patients who have been previously treated with sorafenib.

Ghassan K. Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center New York, and lead investigator on CELESTIAL, informed that when HCC progresses, following treatment with sorafenib, a few options remain. Physicians are eager for new options for these patients, and the results of the CELESTIAL trial demonstrate that Cabometyx has the efficacy and safety profile to become an important new therapy to slow disease progression and improve treatment outcomes.

For the details of the efficacy trial results please go to the firm’s press release.

For important safety information please click on the following link, https://cabometyx/downloads/CABOMETICSUSP.pdf/

Prohost Comments

The time has come for the non-believers to believe in Exelixis, as the best is yet to come for this firm.  Exelixis’ future is brighter than many investors actually still believe.  We will give you our reasoning in an upcoming article that we will post about this firm. 


Why Alnylam’s stock was facing a kind of a selloff in today’s premarket

Alnylam Pharmaceuticals’ stock was taking a dive in today’s early morning. The reason for the selling is Alnylam’s announcement of underwritten public offering of 5,000,000 shares of its common stock at a public offering price of $77.50 per share. The gross proceeds to Alnylam from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $387,500,000.

Alnylam intends to use the net proceeds from this offering for the ongoing commercialization of Onpattro® (patisiran), in the United States and Europe. Assuming favorable regulatory reviews and the potential expansion into additional countries, development efforts directed towards the potential expansion of the Onpattro label in the United States continuing to advance its late stage clinical pipeline and preparing for the potential global launch of several additional products. In addition to continuing investment in its early stage pipeline, including its CNS and ocular programs, clinical trial costs and other research and development expenses, continued growth of its manufacturing, quality, commercial and medical affairs capabilities to support its commercialization efforts, potential acquisitions, investments or licenses in businesses, products or technologies that are complementary to Alnylam’s business, working capital, capital expenditures and general and administrative expenses.

The offering will be made only by means of a prospectus supplement and related prospectus. Copies of the preliminary prospectus supplement and, when available, the final prospectus supplement and the accompanying base prospectus relating to the offering may be obtained by contacting Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or [email protected] (phone 888-603-5847).

This article shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state.

Prohost Comments

After losing over $6 in premarket, the stock is trading at now at $82.28, DOWN $1.74. We take advantage to remind that on August 10, 2018 Alnylam announced that the U.S. FDA  approved its product Onpattro™ (patisiran) lipid complex injection for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.

Onpattro is a first-of-its-kind RNA interference (RNAi) therapeutic and only FDA-approved treatment for this indication.

hATTR amyloidosis is a rare, inherited, rapidly progressive life-threatening disease. In addition to polyneuropathy, hATTR amyloidosis can lead to other significant disabilities including decreased ambulation with the loss of the ability to walk unaided, a reduced quality of life and a decline in cardiac functioning. In the largest controlled study of hATTR amyloidosis, Onpattro was shown to improve polyneuropathy – with reversal of neuropathy impairment in a majority of patients, reduce autonomic symptoms and improve activities of daily living.

Being the first and only FDA approved RNA interference (RNAi) product makes Onpattro remembered as a historical achievement.

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