NEW YORK, NY / ACCESSWIRE / September 18, 2018 / Wall Street was cheering for Teva on Monday after the Israeli pharmaceutical giant received FDA approval finally for its migraine drug Ajovy. Shares of TG Therapeutics were tumbling hard yesterday despite any news or catalyst.
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Teva Pharmaceutical Industries Limited
TG Therapeutics, Inc.
Teva Pharmaceutical Industries Limited shares were climbing higher yesterday, seeing a gain of 2.54% at the close. The Israeli pharmaceutical company announced that the FDA had approved fremanezumab (Ajovy), its long-awaited migraine drug. The approval had been expected back in June but the FDA had delayed it due to a warning letter sent to Teva’s manufacturing partner Celltrion. The FDA provided a PDUFA (Prescription Drug User Fee Act) date of September 16. "With the approval in hand, Teva now looks positioned to be the second CGRP on the market, behind Amgen's Aimovig and potentially a couple of weeks ahead of [Eli Lilly & Co.'s] galcanezumab, for which action from the FDA is expected by the end of the month," remarked Leerink Partners LLC analyst Ami Fadia. Teva said that Ajovy will be available in about two weeks. It is the first and only anti-CGRP treatment for migraine prevention with quarterly (675 mg) and monthly (225 mg) dosing options. "Although we only assume minimal financial contribution from Ajovy in 2018, we believe that Teva will need to execute well through the rest of the year in order to reach our [long-term] peak share of 20%," added Fadia.
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TG Therapeutics, Inc. shares were down 11.63% at the close on Monday on about 2.6 million shares traded. There was no news from the company to explain the drop. It was in late August that SunTrust Banks issued their Q3 2018 EPS estimates for shares of the company. The firm's analyst P. Lawson expects that the biopharmaceutical company will earn ($0.51) per share for the quarter. SunTrust Banks also issued estimates for TG Therapeutics Inc common stock’s Q4 2018 earnings at ($0.52) EPS, FY2018 earnings at ($2.20) EPS, FY2019 earnings at ($2.14) EPS, FY2020 earnings at ($1.73) EPS, FY2021 earnings at ($0.52) EPS and FY2022 earnings at $1.26 EPS. The company posted second quarter earnings results in early August, posting a loss of 59 cents for the quarter while analysts had expected a loss of 55 cents. CEO Michael S. Weiss stated during the earnings call, "I want you all to know we've been working extremely hard to build shareholder value and to advance our pipeline vigorously toward approval. Please be confident that we are working tirelessly to develop our drugs with the best interest of the patients in mind, and we are confident that, that will eventually translate into significant shareholder value. We hear every day about patients who are benefiting from our drugs."
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