Tag Archives: teva

Alder BioPharma Migraine Drug Scores In Trial; Stock Spikes

Small biotech Alder BioPharmaceuticals ( ALDR ) soared more than 50% to a two-month high in early trading Monday after its migraine drug candidate succeeded in a mid-stage trial, positioning it to compete with some giant rivals. Alder said that a single intravenous infusion of its monoclonal antibody, ALD403, had significantly reduced migraine days over a 12-week period compared to a placebo. Depending on the dose, between 44% and 57% of patients experienced a 50% reduction in migraine days, while 27% to 33% experienced a 75% reduction. “Evaluation of ALD403 continues to exhibit a potential best-in-class profile, which includes immediate, significant and durable migraine prevention with infrequent quarterly dosing,” Alder CEO Randall Schatzman said in a statement. “With our commitment to the accelerated development of ALD403 reinforced by today’s positive results, we look forward to advancing our development plan, and assuming FDA approval, independently marketing ALD403 in the U.S. to meet the critical medical needs of the 13 million patients nationwide who are candidates for migraine prevention therapy.” Alder’s decision to market its drug without a big-pharma partner, unusual for a small biotech, could pit it against some very big competitors developing similar drugs. ALD403 is an anti-calcitonin gene-related peptide (CGRP) antibody, similar to migraine candidates being developed by Amgen ( AMGN ), Teva Pharmaceutical Industries ( TEVA ) and Eli Lilly ( LLY ). Alder’s drug is distinguished by its infrequent dosing: Amgen and Teva’s drugs are injected once a month, while Lilly’s is biweekly. It would also be competing against Allergan ‘s ( AGN ) Botox, which is also quarterly but involves 31 separate shots. Credit Suisse analyst Vamil Divan wrote that ALD403’s results seem roughly equivalent to Teva’s in terms of effectiveness, but he did note that there was no significant improvement over the placebo in the number of patients who experienced a 100% reduction in migraine days. Between 4% and 8% of patients on the drug achieved this, which was rather lower than the 16% who had been headache-free in a previous trial. Alder stock, like so many other biotech stocks, had lost more than half its value since touching its all-time peak of 54.90 in July. But in early trading on the stock market today , shares were was up some 52% near 26. Image provided by Shutterstock .

5 Big-Name Medical Stocks Show Notable Chart Action

Loading the player… There’s a lot of news breaking in the medical sector today. Let’s take a look at five medical-related stocks with notable charts: Valeant Pharmaceuticals ( VRX ), Eli Lilly ( LLY ), Teva Pharmaceuticals ( TEVA ), Inogen ( INGN ) and Ligand Pharmaceuticals ( LGND ). Valeant Plunges On Results Valeant reported preliminary fourth-quarter earnings that missed expectations and slashed its guidance. The specialty drugmaker warned that it could potentially default if it doesn’t file its annual report by an April deadline. Valeant’s financials are under an ongoing review after a scandal broke out last fall. Shares plunged more than 50% in giant volume, hitting their lowest level in four years. The stock is now trading at 86% below its all-time high reached last August. Late-Stage Trial Change Hits Lilly Eli Lilly crumbled as much as 6% after announcing it’s changing the goal of the phase-three clinical trial for its Alzheimer’s treatment, signaling that the drug can only treat cognitive capabilities and not functional capabilities as well. The decline came in big turnover, and sent shares to a one-year low in intraday trade. Lilly is now 23% below its high reached in September. Teva’s Acquisition Delayed Teva Pharma’s $40.5 billion acquisition of Allergan’s generics unit has been delayed until June as it works to get regulators’ approval. Shares dropped more than 5% in intraday trade. Volume was heavy. Shares are now trading 14% below a consolidation buy point and 21% below their July high. Inogen Beats Views Inogen reported better-than-expected quarterly results on Tuesday. The company makes oxygen tanks for chronic respiratory conditions. The gap-up put shares above their 200-day line in intraday trade, but the stock was struggling to hold above that level as it pared some of its gains. Inogen was able to retake the 50-day line in Monday’s session. It’s now about 27% below its September peak. IBD 50’s Ligand Basing Meanwhile, IBD 50 stock Ligand Pharma is working on a double-bottom base with a potential buy point at 106.08. Shares are currently trading about 7% below the pivot.

Valeant Sinks, Confirms SEC Investigation And Withdraws Guidance

Embattled specialty drug maker Valeant Pharmaceuticals ( VRX ) on Monday confirmed investigations by the SEC and others, and late Sunday withdrew its financial guidance and said it would reschedule its Q4 earnings release, as CEO J. Michael Pearson returns after a long illness. Valeant stock plunged 18% Monday to 65.80 and hit a three-year low of 63.75. Valeant had planned to report its quarterly results Monday morning, though they would have been unaudited due to an ongoing review of the company’s finances following a scandal last fall that called into question Valeant’s accounting and its relationship with now-closed specialty pharmacy Philidor. In response to media inquiries, a Valeant spokeswoman confirmed that the company has several ongoing investigations, including investigations by the U.S. Attorney’s Offices for Massachusetts and the Southern District of New York, the SEC and Congress.  The company confirmed it received a subpoena from the SEC in Q4 2015 and said that, in the normal course, it would have included this disclosure in its 2015 10-K. The U.S. Justice Department also is investigating, as was known, something Valeant inherited with its $11 billion acquisition of Salix Pharmaceuticals last year. Last Monday, the committee reviewing those issues announced an interim finding that $58 million in Philidor-related revenue should not have been booked in 2014, leading to a 10-cent reduction in EPS for that year. However, since some of that revenue was supposed to be booked later, it would add 9 cents to 2015 EPS. Valeant CEO Fought Pneumonia Pearson came down with severe pneumonia at Christmastime and had to be hospitalized for so long that Valeant appointed former CFO Howard Schiller to take over his job temporarily. Pearson had also been chairman, but when he returned to work Monday the company said it would separate the two roles and appointed five-year board member Robert Ingram as chairman. Valeant affirmed its 2016 guidance in mid-January, calling for a 21% increase in sales and a 31% hike in EPS. The fact that it’s now withdrawing that guidance is a worrisome sign, say analysts. “While we had expected updated guidance, we struggle to fully understand the rationale for removing guidance altogether,” wrote Nomura analyst Shibani Malhotra in a research note. But Malhotra says Pearson’s return is a positive sign. “We believe investors still view much of Valeant’s strategy and success as driven by Pearson, and we expect that the ability to retain him as a leader will allow the company to maintain one of its more significant competitive advantages,” she wrote. “Perhaps more importantly, we believe the fact that Pearson is returning as CEO bolsters the credibility of the company and the board of directors, given that the board publicly supported Pearson and his leadership throughout the recent public scrutiny.” RBC Capital Markets analyst Douglas Miehm agreed, noting that Pearson said he would try to build stronger relationships with payers and government regulators and would improve Valeant’s accounting and transparency. “Having said this, we see the overall approach to rescheduling Q4 and withdrawing guidance after reiterating it in January as likely to carry more weight until Mr. Pearson has been able to reach out to the Street and provide some clarity,” Miehm wrote in his research note. Valeant also revealed that Actavis, the generic drug maker in the process of being acquired by Teva Pharmaceutical Industries ( TEVA ), had filed for FDA approval of a generic version of Xifaxan 550mg, a gastrointestinal drug that was the main selling point of Valeant’s Salix acquisition. “We note that Valeant currently has 22 patents covering Xifaxan 550, which are scheduled to expire between August 2019 and October 2029,” Miehm wrote. “We continue to believe a generic is unlikely for at least seven years.”