The Good, Bad, and Ugly for Biogen Stock


2019-11-02 02:16:10 InvestorPlace


Investing in pharmaceutical companies is never easy. But with Biogen , that sentiment is multiplied a hundred fold. A nasty part of this business is that everything rides on key, flagship drugs. With science being the ultimate skeptic, passing clinical muster is an absolute. And Biogen stock demonstrated how critical this concept is within this year. Source: Shutterstock At the start of 2019, BIIB stock got off to a quick lead. Although shares have been frustratingly choppy over the trailing five years, Biogen did have one ace up its sleeve: aducanumab. A groundbreaking drug designed to slow cognitive decline in some Alzheimer’s disease patients, Biogen began conducting clinical trails a few years back. However, in March of this year, the pharmaceutical halted two late-stage trails for aducanumab. Unfortunately for both Biogen engineers and hopeful patients, an independent audit revealed that the drug was likely ineffective. Upon the news, Biogen stock collapsed more than 29%. InvestorPlace - Stock Market News, Stock Advice & Trading Tips And between that point and Oct. 21, BIIB stock really didn’t move much. Everything hinged on aducanumab, which represented – excuse the expression – a pharmaceutical cash cow. However, that same failed drug was responsible for a massive upswing in Biogen stock a day later on Oct. 22. Essentially, the Food and Drug Administration gave the green light for the underlying company to reapply for aducanumab’s approval. Going on the media circuit, Biogen CEO Michel Vounatsos expressed confidence that this time, aducanumab will receive FDA approval. But how likely is such an event, and how should investors approach BIIB stock? We’ll take a look at the good, the bad, and the ugly. According to Vounatsos, the key reason why aducanumab failed was due to a small sample size. Additionally, the first round of clinical trials did not feature dosage diversity. Basically, Biogen did not give patients a strong enough dosage. However, a new analysis on a much larger data set with the higher dosages revealed a stronger mitigation of Alzheimer’s disease symptoms. This encouraged Biogen to discuss the fresh findings with the FDA, leading to the green light to reapply. Of course, this does not guarantee that aducanumab will ultimately receive FDA approval. There’s a big difference between applying for an Ivy League school and getting into one. And while Vounatsos has emphasized his confidence, I would expect that from any CEO. Still, it gives aducanumab a chance. For now, that’s all investors need, having pushed BIIB stock roughly to where it was a year ago. But there’s also a human component to aducanumab. The Alzheimer’s Association estimates that 5.8 million Americans suffer from the disease. Further, it’s the sixth leading cause of death in the U.S. If aducanumab works as advertised this time around, it would represent a medical breakthrough. Plus, with so many people suffering from Alzheimer’s, Biogen stock will be worth its weight in gold. Although the enthusiasm is palpable for Biogen stock, investors should take a breather before acting on it. As with any equity, you don’t want to jump in after a big move without some serious thought. While the reasons forwarded for why the first trial of aducanumab failed makes sense, it doesn’t necessarily mean that this latest analysis implies a tangible success for the drug. And investors, medical researchers and patients have reasons to be skeptical. Indeed, I would guess that any intellectually honest medical doctor would advise his or her patient to keep grounded. First, no one outside of Biogen has seen the details of this larger data set analysis. Thus, without peer review, it’s hard to generate much excitement. As Dr. Michael Weiner, Alzheimer’s researcher at the University of California, San Francisco, told the New York Times, aducanumab could spark “the dawn of a new era.” However, Weiner noted that this is not a cure, but rather, “It is a slowing of decline. The practical impact on patients remains to be seen.” Not only that, research for Alzheimer’s and other dementia-related diseases is littered with failure. Roche (OTCMKTS:RHHBY), Eli Lilly (NYSE:LLY), AstraZeneca (NYSE:AZN), Pfizer (NYSE:PFE) and Merck (NYSE:MRK) have all abandoned this market. You can look at it two ways for BIIB stock: it’s a massive opportunity if the company wins, but that probability is very, very low. Thus, comes the million-dollar question: how should investors approach Biogen stock? Here’s the ugly truth: I have no idea. And I suspect that most analysts feel the same. Without the peer-reviewed analysis of Biogen’s new study, investors are operating in the dark. Therefore, if I had to make a guess, I would rely on what we do know. And that is Alzheimer’s treatments have a bad track record. Even Biogen’s initial clinical trial failed when held to an independent audit. Therefore, BIIB has the credibility hurdle. Given that we won’t know the details for some time, gambling on Biogen stock right now seems risky. As of this writing, Josh Enomoto did not hold a position in any of the aforementioned securities.
投资制药公司从来不容易。但是有了百健(Biogen),这种情绪就增加了100倍。这项业务的一个令人讨厌的部分是,所有产品都依赖于关键的旗舰药物。随着科学成为终极怀疑者,通过临床试验是绝对的。百健(Biogen)公司的股票展示了这个概念在今年内的重要性。 资料来源: Shutterstock 2019年初, BIIB 股票迅速领先。尽管在过去的五年里,股价一直在令人沮丧地起伏不定,但百健(Biogen)确实有一个王牌:阿杜卡乌马。百健(Biogen)是一种突破性的药物,旨在减缓一些阿尔茨海默氏症患者的认知能力下降,几年前开始进行临床试验。 然而,在今年3月,制药公司停止了两个后期的阿杜卡马迹。不幸的是,对于百健(Biogen)的工程师和有希望的病人,一项独立的审计显示,该药物可能是无效的。消息传出后,百健(Biogen)股价暴跌逾29%. 投资场所-股票市场新闻、股票咨询和交易提示 从这一点到10月21日, BIIB 股票的走势确实不大。一切都取决于阿杜卡努马,它代表了——以这个表达为借口——制药摇钱树。 然而,10月22日晚些时候,同样失败的药物导致了生物股的大幅上涨。从本质上讲,美国食品药品监督管理局(Food and Drug Administration)( FoodandDrugAdministration )给了标的公司重新申请阿杜卡umab 批准的绿灯。 在媒体上,百健(Biogen)公司首席执行官 MichelVounsos 表示有信心这一次,阿杜卡马布将获得 FDA 的批准。但这类事件的可能性有多大,投资者应如何看待 BIIB 股票? 我们将看看好的,坏的,丑陋的。 根据 Vounsos 的说法,阿杜卡umab 失败的关键原因是因为样本很小。此外,第一轮临床试验并不具有剂量多样性。基本上,百健(Biogen)没有给病人足够的剂量. 然而,一项对大得多、剂量较高的数据集的新分析显示,对阿尔茨海默病的症状有更强的缓解作用。这鼓励百健(Biogen)与 FDA 讨论新发现,导致绿灯重新出现。 当然,这并不能保证阿杜卡umab 最终会获得 FDA 的批准。申请常春藤盟校和申请常春藤盟校有很大区别。尽管 Vounsos 强调了他的信心,但我希望任何一位首席执行官都能做到这一点。 不过,这给了阿杜卡乌布一个机会。就目前而言,这是所有投资者所需要的,他们把 IB 的股票推到了一年前的水平。 但是阿杜卡乌布也有人类成分。阿尔茨海默氏症协会估计有580万美国人患有这种疾病。此外,这是美国第六主要原因。如果阿杜卡马布能像这次宣传的那样工作,这将代表医学上的突破。 此外,由于有这么多人患有阿尔茨海默氏症,百健(Biogen)的股票将值得其黄金的重量。 尽管对百健(Biogen)股票的热情是显而易见的,但投资者在采取行动之前应该先呼吸一下。和任何股本一样,如果没有认真考虑,你不想在一次大动作之后跳进去。 虽然阿杜卡单抗第一次试验失败的原因是有道理的,但这并不一定意味着这一最新的分析表明该药取得了切实的成功。投资者、医学研究人员和患者有理由对此持怀疑态度。 事实上,我想,任何一位理智上诚实的医生都会建议他或她的病人停药。首先,除了百健(Biogen)之外,没有人看到过这个更大的数据集分析的细节。因此,没有同行评议,很难产生太多兴奋。 正如加州大学旧金山分校的阿尔茨海默症研究员迈克尔·韦纳博士对《纽约时报》所说,阿杜卡马布可以激发“一个新时代的曙光”。然而,韦纳指出,这不是一种治疗方法,而是“它是一种衰退的减缓。”对患者的实际影响仍有待观察。” 不仅如此,对阿尔茨海默氏症和其他与痴呆症有关的疾病的研究也充满了失败。罗氏(Roche)( OTCMKTS : RHHBY )、礼来(Eli Lilly)( NYSE : LLY )、阿斯利康(AstraZeneca)( NYSE : AZN )、辉瑞(Pfizer)( NYSE : PFE )和默克(Merck)( NYSE : MRK )都放弃了这个市场。 你可以从两个方面来看待 BIIB 股票:如果公司获胜,这是一个巨大的机会,但概率非常低。 因此,百万美元的问题来了:投资者应该如何对待百健(Biogen)股票? 这是丑陋的事实:我不知道。我想大多数分析师也是一样的。 如果没有对百健(Biogen)新研究的同行评议分析,投资者就在黑暗中运作。因此,如果我不得不猜测,我会依赖我们所知道的。这就是阿尔茨海默氏症的治疗有一个不好的记录。 即使是百健(Biogen)的首次临床试验也未能通过独立审计。因此,亚投行面临信誉障碍。考虑到我们不会知道细节一段时间,现在对百健(Biogen)股票的赌博似乎有风险。 截至本文撰写之日, Josh Enomoto 未持有上述任何证券的头寸。