Bronte Capital, an investment management company, released its “Amalthea Fund” third-quarter 2023 investor letter. A copy of the same can be downloaded here. The fund gained 9.96% last quarter (-0.44% in September) compared to 0.02% (-3.70% in September) for the MSCI ACWI (in $A). In addition, you can check the top 5 holdings of the fund to know its best picks in 2023.
Bronte Capital Amalthea Fund highlighted stocks like Sarepta Therapeutics, Inc. (NASDAQ:SRPT) in the third quarter 2023 investor letter. Headquartered in Cambridge, Massachusetts, Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is a commercial-stage biopharmaceutical company. On November 7, 2023, Sarepta Therapeutics, Inc. (NASDAQ:SRPT) stock closed at $82.93 per share. One-month return of Sarepta Therapeutics, Inc. (NASDAQ:SRPT) was -32.50%, and its shares lost 21.14% of their value over the last 52 weeks. Sarepta Therapeutics, Inc. (NASDAQ:SRPT) has a market capitalization of $7.758 billion.
Bronte Capital Amalthea Fund made the following comment about Sarepta Therapeutics, Inc. (NASDAQ:SRPT) in its Q3 2023 investor letter:
“The FDA is widely considered to be the world’s foremost regulator of drug products, with a stringent and rigorous process for evaluating new marketing applications. Disagreements between the FDA and regulators in other developed markets (such as the European Medicines Agency or the Australian Therapeutic Goods Administration (TGA)) are rare, and when they do occur, it is usually because the FDA has taken a more critical view of the applicant’s evidence.
For a drug to be approved in the US, it must meet the statutory requirement of “substantial evidence of effectiveness” under the Federal Food, Drug, and Cosmetic Act. There are essentially three ways to meet this requirement. Normally, the FDA expects the sponsor to succeed in two “adequate and well-controlled studies”. Alternatively, the sponsor can rely on success from a single study if the results from that study are “very persuasive”, or if they are combined with some sort of independent confirmatory evidence. For the most part lobbying from the cohort of patients, the “patient voice”, has played a relatively minor role in the FDA’s decision-making process and the agency has been prepared to make tough but rational decisions when the “substantial evidence” standard is clearly not met.
However, this was not the case in 2016 when the FDA famously overruled its own review team and external advisory committee to approve Sarepta Therapeutics, Inc.’s (NASDAQ:SRPT) controversial drug for Duchenne muscular dystrophy (Exondys 51). At the time, Sarepta had completed a single phase 2 trial in just 12 patients which, per the FDA Commissioner (Robert Califf) himself, had “major flaws” in both its design and conduct. Ellis Unger, director of the Office of Drug Evaluation at the FDA, declared that the drug was a “scientifically elegant placebo”, and that patients and their families were taking on unknown risks for likely non-existent benefits…” (Click here to read the full text)
A biopharmaceutical scientist in a lab coat, working with test tubes in a lab environment.
Sarepta Therapeutics, Inc. (NASDAQ:SRPT) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 53 hedge fund portfolios held Sarepta Therapeutics, Inc. (NASDAQ:SRPT) at the end of second quarter which was 57 in the previous quarter.
We discussed Sarepta Therapeutics, Inc. (NASDAQ:SRPT) in another article and shared the list of stocks receiving downgrades from analysts. In addition, please check out our hedge fund investor letters Q3 2023 page for more investor letters from hedge funds and other leading investors.
Suggested Articles:
- 20 Most Valuable Financial Companies in the World
- 15 Biggest Renewable Energy Companies in Europe
- 15 Biggest Tea Producing Countries In The World
Disclosure: None. This article is originally published at Insider Monkey.
