b'On October 5, 2018, Bank of America reported thatis valoctocogene roxaparvovec, an investigational physician demand for GOCOVRI had dropped due toadenoassociated virus gene therapy, which is in hurdles required for patients to adopt GOCOVRI suchPhase 3 clinical development for treatment of severe as prior authorization and step therapy requirements.hemophilia A. Initial Phase 1/2 study results for That day, Adamass stock price fell 8%. On Novembervaloctocogene roxaparvovec showed promise that 1, 2018, Adamas announced that it was reducing thethe therapy could be the first approved by FDA for number of physicians it was targeting for GOCOVRI byhemophilia A. However, in 2018, the company disclosed half, and disclosed that prescription growth had tapereddisappointing additional results from the Phase 1/2 trial. to a projected 2% in 2019, but nonetheless projectedThen, on May 28, 2019, BioMarin announced interim that GOCOVRI would penetrate 25% to 30% of theresults from its Phase 3 trial via a press release, which market. Adamass stock price fell by almost 30% on thisindicated that the therapy had a diminishing treatment news. During its Q4 2018 earnings call in March 2019,effecti.e., it was unclear based on the Phase 3 trial Adamas backed off its growth estimates for GOCOVRI,whether valoctocogene roxaparvovecs effectiveness warned that there would be a continued slow-downwould last as long as indicated in the initial Phase 1/2 in prescriptions, and declined to make any additionalstudy. This in turn cast doubt on whether the therapy predictions concerning market share. Following thecould be effective as a single treatment, or would call, Adamass stock price fell over 30%. In May 2019,instead require multiple treatments over a patients Adamas shifted its focus for GOCOVRI to the treatmentlife. After this announcement, BioMarins stock price of walking impairment due to multiple sclerosisfell by 5%. In July 2019, BioMarin announced that it (MSWI), and suggested that there was a strongwas planning to submit marketing applications to FDA opportunity for the drug in this patient population.based on its Phase 1/2 data and Phase 3 interim results. However, on August 8, 2019, Adamas announcedThereafter, in December 2019, BioMarin announced that operational issues with GOCOVRIs fulfillmentits submission of a BLA to FDA for valoctocogene processes had weakened demand for GOCOVRI,roxaparvovec. In February 2020, BioMarin announced leading to patient drop-offs. Adamas also noted thatthat FDA accepted priority review of its BLA, and made GOCOVRI was experiencing poor adoption as a resultstatements in its Form 10-K regarding the anticipated of its high cost and patients lack of awareness to theirtimeline of FDAs review. BioMarin also announced disease state. Thereafter, on September 30, 2019, oneupdated Phase 1/2 study results and Phase 3 study analyst published a report that a survey of doctorsresults in its Form 10-K, which purportedly supported found that physicians were were uncomfortablemarket viability of valoctocogene roxaparvovec and a with GOCOVRIs safety profile and would continuelikelihood of FDAs acceptance of the BLA. On May 31, to prescribe a different drug for patients with MSWI.and June 17, 2020, BioMarin announced further updates Adamass stock price fell over 40%.to its Phase 1/2 study results, which again purportedly On December 10, 2019, investors filed a putative classsuggested a likelihood of FDAs acceptance of the BLA. action complaint against Adamas and its officers,However, on August 19, 2020, BioMarin announced alleging violations of Sections 10(b) and 20(a) andreceipt of a CRL from FDA, which requested two Rule 10b-5 of the 1934 Act based on allegedly falseyears of data from the Phase 3 study to sufficiently and misleading statements concerning GOCOVRIsdemonstrate substantial evidence of a durable effect. insurance coverage and commercialization potential.The CRL stated that differences between the Phase 1/2 On June 14, 2020, defendants moved to dismisstrial and the Phase 3 trial limited [FDAs] ability to rely the amended complaint. Briefing on that motionon the Phase 1/2 study to support durability of effect, was complete as of September 2020. The motionand recommended that [BioMarin] complete the Phase remains pending.3 Study and submit two-year follow-up safety and efficacy data on all study participants. On this news, Tsantes v. BioMarin Pharmaceutical Inc.,BioMarins stock price fell more than 35%. et al., Case No. 3:20-cv-6719 (WHO)On September 25, 2020, a Biomarin investor filed a (N.D. Cal.)putative class action complaint, asserting claims under Sections 10(b) and 20(a) and Rule 10b-5 of the 1934 Prospects of FDA Approval and ReceiptAct against BioMarin and certain of its officers. The of CRL complaint alleges that defendants made materially false and misleading statements regarding and/or BioMarin Pharmaceutical, Inc. (BioMarin) is a bio- failed to disclose that: (1) the differences between technology company based in San Rafael, California,the Phase 1/2 and Phase 3 study of valoctocogene that develops and commercializes therapies to treatroxaparvovec limited the reliability of the Phase 1/2 serious and life-threatening rare diseases and medicalstudy to support durability of effect, and (2) as a result, conditions. Among BioMarins product candidatesit was foreseeable that FDA would not approve the BLA 56'