After tracking the opinion of the Endpoints 100 — biotech execs, mostly CEOs, who give us semi-annual feedback on key issues and trends — for the past four years, one thing stands out: Opinions tend to run along lines of consensus; by and large they track as a pack.
So when right at 60% of the 81 execs participating in the H2 survey turn thumbs down on whether the FDA should have OK’d Aduhelm — that ultra controversial and very expensive Alzheimer’s drug waved through at the agency despite the clear lack of positive efficacy data — it’s not hard to conclude that a clear majority aren’t having it. With another 22% undecided still, you have some lingering doubts that need to be resolved. But only 18% are in the solid ‘yes’ camp — leaving Biogen with little in the way of professional industry support in its lonely corner.
The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.
RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.
Once riding high with its non-opioid drug for knee pain, Flexion was at the center of the M&A rumor mill for a 10-figure buyout. Years later, that shine has worn off — and now Flexion will hand over the keys in a significantly smaller acquisition.
Pacira BioSciences will acquire Flexion for $8.50 per share in a deal valued at $450 million, a steep discount for a biotech that once commanded attention from the likes of drug giant Sanofi, the companies said Monday.
The FDA has slapped a clinical hold on Allogene’s clinical trials after a patient in one of their early-stage studies for the off-the-shelf cell therapy ALLO-501A developed a “chromosomal abnormality” in their CAR-T cells.
The biotech $ALLO reported after the market close on Thursday that executives plan to follow up in the coming weeks with regulators as the FDA considers the biotech’s plan to take this drug into a pivotal trial.
Supernus is marking its expansion into the Parkinson’s disease arena, striking a deal to buy out Adamas Pharmaceuticals in a deal worth more than $400 million.
A year after swooping in on its first Parkinson’s acquisition, the two companies announced that they had reached an agreement for Supernus to pay up to $9.10 per share in cash as part of the acquisition — close to $450 million.
Two longtime trustees of Dana-Farber Cancer Institute have resigned in the wake of an investigation by the Boston Globe’s Spotlight team into its somewhat unorthodox practice of allowing trustees to invest in its biotech spinouts and even — at one time — negotiate on behalf of those startups.
Marc Cohen, a serial biotech entrepreneur and investor who co-founded the protein degradation pioneer C4 Therapeutics with Jay Bradner, and retired Harvard Business School professor Malcolm Salter said they will now focus on advising the institute’s venture philanthropy program, launched last year. They joined the board in 2004 and 1998, respectively, before resigning last week.
Sumitovant Biopharma’s subsidiary Enzyvant late Friday won approval for its first treatment, which is also the first promising treatment for babies without a thymus, an organ that plays a crucial role in helping to fight infections.
The treatment, known as Rethymic (allogeneic processed thymus tissue-agdc), is a one-time regenerative therapy for what’s formally known as congenital athymia. Enzyvant, which licensed the drug from Duke University in 2017, said that usually about 20 babies per year in the US are born with the condition, and many often die from infections or autoimmune manifestations by age two or three.
Two years after Bayer swallowed the remaining shares of his regenerative cell therapy company, Emile Nuwaysir has found himself a new “big hairy goal”: in vivo cell therapy.
Ensoma Therapeutics, an ambitious and well-backed startup out of Fred Hutch and the University of Washington, has tapped Nuwaysir as the new CEO. It’ll be the serial executive’s second stint as a CEO after BlueRock, where he shepherded a first-of-its-kind cell therapy for Parkinson’s disease into clinical trials.
Biotech deal cash continued to gush through Q3, but a careful look at the details in aggregate suggests that the rosy tint to the biotech boom has started to lose some of its color.
Once again, deal master Chris Dokomajilar at DealForma has crunched the numbers on all the gauges we use to assess the performance of the biotech sector. And there’s been a distinct cooling of overall activity, particularly around IPOs and venture cash infusions.
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R&D strategies are central to any biopharma company — and especially the larger ones. John Carroll has invited a stellar slate of guests to talk about exactly that at the European Biopharma Summit coming up next week. You can view the line up and reserve a spot here.
加拿大皇家银行资本市场（RBC Capital Markets）最近对投资者进行了调查，以了解市场的温度，这是专家/通才和只做多/多空投资策略的混合。进入下半年，投资者大多认为该行业被低估(49%)，与上半年只有20%的人认为该行业被低估相比有了很大变化。大约41%的投资者现在认为，生物技术将在2021年下半年表现低于标准普尔500。尽管有这种观点，54%的人计划维持市场头寸，41%的人仍计划增持。
达纳-法伯癌症研究所（Dana-Farber Cancer Institute）的两名长期受托人辞职，此前《波士顿环球报》(Boston Globe）的聚光灯团队（Spotlight）调查了该研究所（Boston Globe）允许受托人投资其生物技术分拆公司，甚至一度代表这些初创公司谈判的有点非正统的做法。
马克·科恩（Marc Cohen）是一名连续的生物技术企业家和投资者，他与杰伊·布拉德纳（Jay Bradner）共同创建了蛋白质降解先驱C4治疗学（C4 Therapeutics)，退休的哈佛商学院教授马尔科姆·索尔特（Malcolm Salter）表示，他们现在将专注于为该研究所去年启动的风险慈善项目提供建议。他们分别于2004年和1998年加入董事会，上周辞职。
Fred Hutch和华盛顿大学的雄心勃勃、资金雄厚的初创公司Ensoma Therapeutics已经任命Nuwaysir为新首席执行官。这将是这位连续高管继BlueRock之后的第二次首席执行官任期，在BlueRock中，他带领一种首次用于帕金森病的细胞疗法进入临床试验。