b'made in November  2018 about OS data. Specifically,the bodys nerves and organs. There are two separate plaintiffs alleged that in press releases and public filingsmanifestations of hATTR: polyneuropathy, which mani-throughout mid-2017 through mid-2018, AVEO misstat- fests in nerve damage, and cardiomyopathy, which re-ed when topline results were expected, first claimingsults in damage to the heart. Alnylam initiated a Phase they were expected in the first quarter of 2018, then3 clinical trial for its patisiran drug candidate, designed incrementally pushing back the expected timeline untilprimarily to evaluate the investigational drugs efficacy eventually disclosing in May 2018 that results wereand safety for polyneuropathy, but which secondarily expected in the fourth quarter of 2018. Plaintiffs assert- sought to measure the efficacy of patisiran on various ed that these statements were materially misleadingother metrics, including cardiac health. In September because AVEO was aware that PFS events were not oc- 2017, Alnylam disclosed topline data for the Phase 3 curring fast enough for the company to meet its timelinetrial, and suggested that the data showed a favorable estimates. Plaintiffs also alleged that defendants maderesponse to polyneuropathy and on certain cardiac materially misleading statements in the November 2018measures. Alnylams stock price increased by 51% after press release and investor call concerning the studysthis announcement. In December 2017, the company preliminary OS results, which plaintiffs claimed mislead- submitted an NDA for patisiran, seeking approval for ingly omitted that the OS results (1) were incompletethe treatment of both polyneuropathy and cardiomyop-and thus insufficient to obtain FDA approval, (2) didathy. FDA approved patisiran in August 2018, but only not include data on all OS events from the study, and (3)for the treatment of polyneuropathy. Alnylams stock could delay tivozanibs FDA approval.price fell by 6% after disclosure of this development. In The district court granted defendants motion to dis- September 2018, a report by a division of FDA con-miss. As to defendants statements regarding the timingcerning its review of patisiran was released. The report of the studys topline results, the court held that eachsuggested that Alnylam had not submitted sufficient statement was protected by the PSLRAs safe harborcardiac efficacy data in support of the NDA and that provision. In particular, all of the statements were clear- FDA was troubled by cardiac-related deaths in patients ly forward-looking, and were accompanied by cau- treated with patisiran. Alnylams stock price thereafter tionary language, including AVEOs explicit represen- fell by another 5%.tation that the timeline was uncertain. As to AVEOsOn September 26, 2018, investors filed a putative statements regarding the OS results, the court heldclass action complaint alleging securities fraud in that plaintiff failed to adequately plead the materialitythe Southern District of New York, which was subse-of any alleged misstatement or omission. In particular,quently transferred to the District of Massachusetts the company expressly disclosed that the OS resultsin November of 2018. Plaintiffs then filed an amend-were incomplete when it reported them in November ofed complaint, alleging that between February and 2018, and also indicated that it was working to gatherSeptember of 2018, defendants made materially additional OS data on as many . patients as possi- misleading statements about the efficacy and safety of ble. This, according to the court, adequately apprisedpatisiran for treating cardiomyopathy and the results investors that the OS data were not final. The court alsoof its Phase 3 clinical trial, in violation of Section 10(b) noted that AVEO emphasized that any additional OSand Rule 10b-5 of the 1934 Act, as well as Section 20(a) data collected could impact the outlook of tivozanib forof the Act. Plaintiffs identified 38 allegedly false and better or worse, such that the further details plaintiffsmisleading statements generally falling into two cate-alleged were omitted would not have significantlygories: (i) statements concerning the prospects of FDA altered the total mix of information available to share- approval [of patisiran] for all manifestations of hATTR holders. The court therefore dismissed the complaintand whether the drugs label would encompass treat-with prejudice. No appeal was filed. ment of cardiomyopathy, and (ii) statements concerning the results and data from the Phase 3 clinical trial.Leavitt v. Alnylam Pharmaceuticals, Inc.,Defendants moved to dismiss, and on March 23, 2020, et al., Case No. 18-cv-12433 (NMG),the court granted the motion. First, the court rejected plaintiffs claim that, because the Phase 3 clinical trial 451 F. Supp. 3d 176 (D. Mass. 2020) was not intended to evaluate efficacy for cardiomy-Statements Concerning Clinical Trialsopathy, any statement by Alnylam concerning the use of patisiran to treat cardiomyopathy was necessarily Alnylam Pharmaceuticals, Inc. (Alnylam) is bio-misleading.pharmaceutical company based in Cambridge,Second, the court held that statements interpreting Massachusetts, that develops and commercializesthe results of the Phase 3 trial and cardiac data were treatments for a gene mutation called hereditary trans- non-actionable opinions, which, although ultimately thyretin-mediated amyloidosis (hATTR). hATTR causesincorrect, were not fraudulent or misleading. Third, the potentially harmful build-up of certain proteins in 18'